Confo Therapeutics Announces Global Licensing Agreement With Lilly For Peripheral Pain Candidate, CFTX-1554
Confo Therapeutics Announces Global Licensing Agreement With Lilly For Peripheral Pain Candidate, CFTX-1554
- Confo to receive upfront and milestone payments totaling $630M
- Company is eligible for up to $590M in additional milestones if Lilly proceeds with a second product candidate
- Tiered royalties payable to Confo on net sales
- Confo to have a co-investment option
Ghent, Belgium – March 2, 2023 – Confo Therapeutics, a leader in the discovery of medicines targeting G-protein coupled receptors (GPCRs), today announced a worldwide licensing agreement with Eli Lilly and Company for Confo’s clinical stage CFTX-1554 and back-up compounds.
CFTX-1554, a novel inhibitor of the angiotensin II type 2 receptor (AT2R) currently in Phase 1 clinical development, represents a non-opioid approach to treating neuropathic pain, a devastating condition caused by damage to the nerves outside of the brain and spinal cord, and potentially additional peripheral pain indications. Current treatment methods are often insufficiently effective and can lead to serious side effects including addiction. Patients suffering from peripheral pain are therefore in urgent need of effective analgesics that are well-tolerated and do not impact quality of life.
Under the terms of the agreement, Lilly will continue the clinical development program beyond Phase 1. In addition, the agreement considers a program to further develop Confo’s existing therapeutic antibody candidates targeting the same receptor. Confo will receive a USD 40M upfront payment from Lilly as well as up to USD 590M in potential milestone payments per program and tiered royalties. Confo maintains a co-investment option to participate in the funding of future development programs after clinical proof-of-concept for additional royalties.
“We are pleased that Lilly, an expert in chronic pain with a wealth of experience in bringing novel therapies to patients, has recognized Confo’s ability to develop best-in-class GPCR drug candidates,” said Cedric Ververken, CEO of Confo Therapeutics. “CFTX-1554’s progression through the clinic will benefit from Lilly’s experience and global organization, while we will continue to develop and expand our growing, innovative pipeline of GPCR-targeted assets, both small molecules and biologics.”
About CFTX-1554
CFTX-1554 is Confo Therapeutics’ first product candidate in clinical development and is a non-opioid approach designed to address peripheral (neuropathic) pain while avoiding centrally mediated side effects, such as addiction and sedation. The compound is a novel inhibitor of angiotensin II type 2 receptor (AT2R), a clinically precedented target for the treatment of neuropathic pain. Whereas previous compounds targeting AT2R have failed to reach market approval, CFTX-1554 is distinct in that it interacts more efficiently with the AT2R binding site, resulting in improved drug-like properties. CFTX-1554 is currently being examined in a Phase 1 first-in-human clinical study (ClinicalTrials.gov Identifier: NCT05260658).
About Confo Therapeutics
Confo Therapeutics’ unparalleled technology stabilizes functional conformations of GPCRs (G protein-coupled receptors), thereby enabling the discovery of chemical or biological ligands that are conformationally selective. This platform combined with the pharmacologic and biologic insight it provides, allows Confo to build a multi-indication pipeline of drug candidates with the vision of transforming therapeutic outcomes for patients with severe illnesses lacking disease-modifying treatments. Confo Therapeutics was spun out of VIB-VUB (Vrije Universiteit Brussel) in 2015. Supported by international life-science focused investors and led by an experienced team of entrepreneurial professionals and scientists from successful biopharmaceutical companies, Confo Therapeutics benefits from the rich scientific and innovative ecosystem in Belgium.
For more information, visit www.confotherapeutics.com
For more information, please contact:
Confo Therapeutics
Dr. Cedric Ververken, CEO
+ 32 (0) 9 396 74 00
MinervaX appoints Lidia Oostvogels as Chief Medical Officer and provides clinical and regulatory update on its novel GBS vaccine
- Newly appointed CMO with more than 25 years’ experience in vaccine development
- Fast Track status granted by US Food and Drug Administration
- Completion of enrolment of its 2nd phase II clinical trial in pregnant women
Copenhagen, Denmark, 5 January 2023 – MinervaX ApS, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), today announces the appointment of Lidia Oostvogels as Chief Medical Officer and provides an update on its novel GBS vaccine.
Lidia Oostvogels brings a wealth of experience in vaccine development with more than 25 years’ experience in clinical development. Prior to joining MinervaX, she was Senior Vice President, Area Head, Infectious Diseases and Senior Vice President, Clinical Development, for Prophylactic Vaccines CureVac AG. Oostvogels worked for GSK plc for more than 12 years, where she was Director of Vaccine Discovery and Development, Clinical, focused on Influenza and Zoster. Prior to GSK, she spent nine years Boehringer Ingelheim in a clinical development role. She gained her medical doctor qualification from Ghent University in Belgium. Oostvogels’ experience will be instrumental as MinervaX progresses its GBS vaccine towards phase III clinical development.
MinervaX completed enrolment of its 2nd phase II clinical trial of its novel GBS vaccine in pregnant women across Denmark, the UK and South Africa. The randomized, multicenter trial will evaluate the safety, tolerability and immunogenicity of one and two doses of its GBS vaccine at different dosing regimens in healthy pregnant women. Details of MinervaX’s clinical trials can be found at clinicaltrials.gov under the identifiers NCT04596878, NCT05154578 and NCT05005247.
MinervaX’s GBS vaccine has been granted Fast Track regulatory status by the US Food and Drug Administration. The process is designed to facilitate the development of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and frequent communication with the FDA throughout the entire drug development and review process and marketing application.
This follows the European Medicines Agency’s decision to award Priority Medicine (PRIME) status to the vaccine in September, an initiative that optimizes development and evaluation of medicines targeting an unmet medical need.
Per Fischer, Chief Executive Officer of MinervaX, said: “I am delighted to welcome Lidia Oostvogels to the leadership team. Her extensive track record in vaccine development will be invaluable as we continue to make significant progress with our novel GBS vaccine. We are looking forward to an exciting and pivotal year of development milestones in 2023 as we continue to advance our vaccine for the prevention of the large unmet medical need, Group B Streptococcal infections.”
Lidia Oostvogels, Chief Medical Officer of MinervaX, said: “I am hugely excited to join MinervaX and look forward to contributing to the further development of its GBS vaccine. There is a major need for more options to prevent this disease and I am delighted to be working with the experienced team at MinervaX to bring this important vaccine to populations at risk.”
For further information please contact:
MinervaX
Per Fischer | Chief Executive Officer
Email :
Optimum Strategic Communications
Mary Clark / Manel Mateus / Richard Staines/ Zoe Bolt
Email:
Tel: +44 (0) 203 882 9621
Notes to Editors:
About MinervaX
MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, likely to have superior characteristics compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s vaccine will confer protection against virtually 100% of all GBS isolates. www.minervax.com
About Group B Streptococcus (GBS)
GBS is responsible for nearly 50% of all life-threatening infections in newborns. At any given time, some 15-25% of women are spontaneously colonized with GBS, and they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS colonization may lead to late abortions, premature delivery, or stillbirth and, in the newborn child, may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long- term disability or death.
Currently, the only preventative strategy available involves the use of intravenously delivered prophylactic antibiotics which does not comprehensively prevent GBS infection in utero or protect against late-onset infection in newborns. Not only is this approach expensive and logistically challenging, it fails to cover all, including the most severe cases in the US and Europe, and is rarely available in resource- limited settings.
The development of a GBS vaccine is also endorsed by Group B Strep Support and Group B Strep International, and GBS has been prioritized by a number of public health organizations. Both increased uptake of immunization among pregnant women and greater awareness of the implications of GBS suggest that a safe and effective vaccine targeting GBS would be well suited to address this unmet need.
MinervaX announces 72M EUR financing to advance development of novel vaccine against Group B Streptococcus
- Financing from new investors Trill Impact Ventures and Pureos Bioventures as well as existing investors
- Backing from European Investment Bank
- Planning for Phase 3 clinical development of novel GBS vaccine
Copenhagen, Denmark, 15 December 2022 – MinervaX ApS, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), today announces the successful completion of a 72 million EUR financing round. The equity financing of 22 million EUR was co-led by new investors Trill Impact Ventures and Pureos Bioventures and includes existing investors REPAIR Impact Fund (Novo Holdings), Sunstone Life Science Ventures, LF Investment, Wellington Partners, Sanofi Ventures, Adjuvant Capital and Industrifonden. In addition to the equity financing, the European Investment Bank provided a 50 million EUR loan facility.
MinervaX has had an exciting year of clinical development for its novel GBS vaccine. The Company commenced enrolment of pregnant women in its Phase 2 clinical trial in Denmark, the UK, and South Africa and completed the dosing of healthy adult women, previously dosed with its GBS vaccine, in a Phase 1 booster clinical trial in the UK.
The financing will enable MinervaX to advance the late-stage development of its GBS vaccine candidate in preparation for a Phase 3 clinical trial. The vaccine candidate was recently awarded PRIME status by the European Medicines Agency (EMA) due to its potential to prevent life-threatening infections in newborn babies. MinervaX also aims to expand its clinical development team and evaluate the Phase 2 clinical data for efficacy and safety ahead of publication next year.
Per Fischer, Chief Executive Officer of MinervaX, said: “We are delighted to announce this financing, which gives us the firepower to accelerate the development of our novel GBS vaccine. GBS can be life-threatening for newborn babies and there is no approved, universally available vaccine to date. I would like to thank the investors and the MinervaX team who have worked very hard on our vaccine candidate in preparation for
the final stage of clinical development.”
In conjunction with the financing, Bita Sehat, Senior Director at Trill Impact Ventures, and Veronica Gambillara, Partner of Pureos Bioventures, will join the Board of Directors.
Veronica Gambillara, Partner at Pureos Bioventures, commented: “We are excited to join the MinervaX team and support the development of this vaccine which could protect against one of the leading causes of neonatal and infant sepsis. We are impressed with the clinical data previously generated and the dedication of the leadership team. This financing will expedite the development of a product that has the potential to drastically improve the options available to address GBS infections.”
Bita Sehat, Senior Investment Director at Trill Impact Ventures, added: “MinervaX’s GBS vaccine holds great promise to address a large unmet medical need globally by preventing serious infections in both newborns and pregnant women. Its successful development will not only save lives, it will also contribute to combatting antimicrobial resistance. We are happy to join forces with a strong shareholder base and an excellent management team to support turning this promise into reality. We view MinervaX as a great example of societal and commercial impact going hand in hand.”
EIB Vice president Christian Thomsen, responsible for Denmark, added: “We are delighted to be supporting MinervaX with its medical research into the unmet medical need. Being one of the biggest financiers of innovation in Europe, this fits our investment strategy; to support highly innovative biotech companies developing breakthrough Life Science products, which have the potential to transform and improve people’s lives.”
Details of MinervaX’s clinical trials can be found at clinicaltrials.gov under the identifiers NCT04596878, NCT05154578 and NCT05005247.
Forfurther information please contact:
MinervaX
Per Fischer | Chief Executive Officer
Email :
Optimum Strategic Communications
Mary Clark / Manel Mateus / Richard Staines/ Zoe Bolt
Email:
Tel: +44 (0) 203 882 9621
Notes to Editors:
About MinervaX
MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, likely to have superior characteristics compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s vaccine will confer protection against virtually 100% of all GBS isolates. www.minervax.com
About Group B Streptococcus (GBS)
GBS is responsible for nearly 50% of all life-threatening infections in newborns. At any given time, some 15-25% of women are spontaneously colonized with GBS, and they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS colonization may lead to late abortions, premature delivery, or stillbirth and, in the newborn child, may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long- term disability or death.
Currently, the only preventative strategy available involves the use of intravenously delivered prophylactic antibiotics which does not comprehensively prevent GBS infection in utero or protect against late-onset infection in newborns. Not only is this approach expensive and logistically challenging, it fails to cover all, including the most severe cases in the US and Europe, and is rarely available in resource- limited settings.
The development of a GBS vaccine is also endorsed by Group B Strep Support and Group B Strep International, and GBS has been prioritized by a number of public health organizations. Both increased uptake of immunization among pregnant women and greater awareness of the implications of GBS suggest that a safe and effective vaccine targeting GBS would be well suited to address this unmet need.
About Trill Impact
Trill Impact is a pioneering Impact House with EUR 1,2 billion in assets under management across its investment strategies. With a team of more than 35 experienced professionals based in the Nordics and Germany, Trill Impact aims to become a force for positive change and realize its vision of delivering real returns and lasting impact for the benefit of investors, businesses and society at large. For further information, please visit www.trillimpact.com
About Pureos Bioventures
Pureos Bioventures is venture capital fund advised by Swiss-based Pureos Partners that invests exclusively in private innovative drug development companies, with a special emphasis on the next generation of biological drugs and drug formats. The fund’s portfolio companies are built on scientific excellence to develop therapies across a broad indication spectrum including oncology, immunology, ophthalmology, rare diseases, and neuroscience. Pureos has built a team with in-depth investment, operating and clinical expertise, that strives to impact patients’ lives by advancing innovative treatments for devastating diseases. For further information, please visit www.pureosbio.com
About the European Investment Bank
The European Investment Bank (EIB) is the bank of the European Union, owned by the EU27 Member States. It is active in some 160 countries and is the world’s largest multilateral lender for climate action projects. The bank is providing long term financing for economically sustainable investments to contribute to the European Union’s political objectives. The EIB Group has set “ensuring a just transition for all” as one of the four overarching objectives in its Climate Bank Roadmap 2025. The EIB’s ambition is to support €1 trillion of climate action and environmental sustainability investments in the decade to 2030 and align all its new operations with the goals and principles of the Paris Agreement.
About InnovFIN-IDFF
The InnovFin Infectious Diseases Finance Facility (IDFF) provides financial products ranging from standard debt to equity-type financing for amounts typically between €7.5 million and €75 million to innovative players active in developing or manufacturing innovative vaccines, medicines, medical and diagnostic devices or novel research to combat infectious diseases. Project costs may include laboratory-validated technologies, which require clinical testing for further development, in addition to complementary pre-clinical research. The product is available directly through the European Investment Bank and will continue to support innovative infectious diseases projects until the end of 2022. For further information, please visit www.eib.org
TRiCares Successfully Closes Series C Financing, Raising €51m to Fund Further Development and Clinical Trials of Minimally Invasive Treatment for Tricuspid Regurgitation
TRiCares Successfully Closes Series C Financing, Raising €51m to Fund Further Development and Clinical Trials of Minimally Invasive Treatment for Tricuspid Regurgitation
TRiCares Successfully Closes Series C Financing, Raising €51m to Fund Further Development and Clinical Trials of Minimally Invasive Treatment for Tricuspid Regurgitation
Paris, France and Munich, Germany, December 6, 2022 – TRiCares SAS (“TRiCares”) a privately held pioneer in the field of minimally invasive treatment of tricuspid regurgitation, is pleased to announce today the second closing and completion of its Series C financing round, successfully raising a total of €51m for the round.
The proceeds of this financing will primarily be used to continue the development of the company’s transfemoral tricuspid heart valve replacement system (“Topaz”) up through to the application for a pivotal investigational device exemption (“IDE”) trial in the United States. To this end, TRiCares plans to initiate an early feasibility study across five centers in the US and Canada in 2023.
The proceeds of this financing will also support the on-going TRICURE first-in-human clinical study in Belgium as well as potential additional clinical trial applications elsewhere in Europe, along with further compassionate use implantations as appropriate.
The Series C financing was led by 415 Capital and joined by Bayern Kapital, the venture/growth capital company of the State of Bavaria in Germany, with strong support from existing investors Andera Partners, BioMed Partners, Credit Mutuel Innovation, GOCapital, Karista and Wellington Partners. Total gross proceeds were €51m.
TRiCares is developing a transcatheter-based tricuspid valve replacement system aimed at addressing the need for a better treatment for this frequent and severe disease that avoids open heart surgery. Heart valve diseases are among the most serious cardiac conditions, affecting more than 12.7 million patients in Europe and many more worldwide. Owing to high mortality risk, access to open heart surgery is severely restricted and is not considered an option for more than 99% of patients with tricuspid regurgitation, leaving surgeons seeking minimally invasive, lower risk solutions to improve outcomes for patients with no other viable treatment options.
Topaz is an innovative device developed to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The Topaz device is implanted in a minimally invasive procedure through the patient’s femoral vein. It is designed specifically to fit the tricuspid valve anatomy and thus supports ease of positioning and functionality.
Helmut J. Straubinger, Chief Executive Officer of TRiCares, said: “Millions of patients with tricuspid regurgitation have no effective long-term treatment option, and their prognosis is very poor. The Topaz tricuspid valve replacement system is being developed with the aim of delivering a much-needed solution for these patients. With encouraging clinical signs, the strong support of world-class investors and our successful Series C financing, we look forward to the further development of the Topaz system with a focus on the necessary preparations for a pivotal IDE trial in the US along with the continued progress of our clinical activities in Europe.”
Dr. Georg Ried, Managing Director of Bayern Kapital, said: “Open heart tricuspid valve surgeries are among the riskiest curative procedures, with more than 99% of affected patients deemed unfit due to high mortality rates. With Topaz, TRiCares is developing an innovative product with excellent potential to fill this major gap in the treatment of valvular heart disease. We are very pleased to support TRiCares on its further course towards market approval.”
Frederik Groenewegen, General Partner at 415 Capital, commented: “We believe that the technology developed by TRiCares has the potential to establish itself as the gold standard in the treatment of patients with tricuspid regurgitation and to restore the quality of life of millions of patients in the long term. We are impressed with the initial clinical cases with the Topaz system and look forward to helping the team bring this novel therapy to patients in the U.S. and Europe.”
-ends-
About TRiCares
TRiCares is a young medical device startup company located in Paris and Munich having the vision to bring to the market a transfemoral tricuspid valve replacement system. This system aims at helping patients suffering from severe tricuspid regurgitation (TR) without the need for open heart surgery. The experienced team of TRiCares is supported by the leading European life science venture capital firms: Andera Partners, BioMed Partners, Credit Mutuel Innovation, GoCapital, Karista, Wellington Partners, 415 Capital and Bayern Kapital.
About Tricuspid Regurgitation (TR)
The tricuspid valve is the heart valve that regulates the blood flow between the right atrial and ventricular chamber. Tricuspid regurgitation occurs when the tricuspid valve fails to close properly, causing blood to flow backwards into the right atrium. Tricuspid regurgitation is a frequent problem and a severe disease that was neglected for many years, leading to a large number of untreated patients without an effective treatment option. Cardiac surgeons and interventional cardiologists have long waited for a transcatheter based solution. The progress in developing minimally invasive treatment options for heart valves as well as the experience gained in numerous research projects has strongly increased the awareness of the importance of this disease.
About the Medical Need
Heart valve diseases are among the most serious cardiac complications affecting at least 12.7 million patients in Europe and many more worldwide. In the last decade, innovative minimally invasive catheter-based solutions have been developed for the treatment of aortic and mitral heart valve disease, creating a fast-growing transcatheter heart valve replacement market. However, for patients with tricuspid heart valve disease (tricuspid regurgitation), no solution exists to replace the diseased heart valve due to anatomic, functional and technological challenges. Only repair options by so-called clipping devices have been developed. But this technique is not suitable for all patients and the treatment success is limited. Consequently, open-heart surgeries to repair the insufficient valve and medical treatments still represent the standard treatment options. Due to excessive risk of the procedures (10–35 % surgical mortality), more than 99 % of TR patients are considered ineligible for the curative surgeries and are only maintained on symptomatic pharmacologic treatment with poor prognosis (2.2 years median survival). Therefore, physicians are urgently seeking minimally invasive, low-risk solutions to improve clinical outcomes in TR patients.
For further information please contact:
TRiCares SAS
Helmut J. Straubinger,
President and Chief Executive Officer
Consilium Strategic Communications
Matthew Cole
T: +44 (0)20 3709 5700
ONWARD Reports Interim Clinical Outcomes for Implantable ARC Therapy Demonstrating Potential to Improve Blood Pressure Regulation after Spinal Cord Injury
ONWARD Reports Interim Clinical Outcomes for Implantable ARC Therapy Demonstrating Potential to Improve Blood Pressure Regulation after Spinal Cord Injury
Low blood pressure is a major issue for people with spinal cord injury that impacts
cardiovascular health and quality of life
ARC Therapy resulted in immediate improvement in blood pressure regulation in
all study participants
EINDHOVEN, the Netherlands, LAUSANNE, Switzerland, and BOSTON, MA USA—December
8, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating
innovative therapies to restore movement, independence, and health in people with spinal cord
injury (SCI), today reported interim clinical outcomes from the first ten1 people treated to regulate
blood pressure with implantable ARC Therapy, ONWARD’s targeted spinal cord stimulation
technique. ARC Therapy immediately improved blood pressure levels for all participants; this
benefit has been sustained for the duration of the current follow-up period. Participants have also
reported improved quality of life, increased energy and vitality, and reduced dizziness.
Aaron Phillips, PhD, Associate Professor, Physiology and Pharmacology, Biomedical
Engineering, Cardiac Sciences, Clinical Neurosciences, Cumming School of Medicine, University
of Calgary, and the Principal Investigator of the HEMO study, said: “Low blood pressure has long
been a hidden complication of spinal cord injury that often goes unrecognized and leaves people
feeling unwell. It also potentially predisposes them to cardiovascular disease. The results reported
today with ARC Therapy are compelling and may open a new avenue to help people with spinal
cord injury truly feel better, while also addressing heart health.”
The interim outcomes reported today are from ten people with spinal cord injury who were treated
at clinical centers in Canada and Switzerland. In addition to a sustained increase in blood pressure
levels, participants who were taking an anti-hypotension drug prior to entering the study were able
to significantly reduce or discontinue their medication. Participants also reported improved
general well-being: Participants reported a reduction in orthostatic hypotension, including reduced
dizziness and improved energy, and those prone to fainting or light-headedness prior to implant
indicated that such incidents declined dramatically following treatment with ARC Therapy.
Participants continue to be followed, in one case for as long as three years, and the therapy
remains beneficial in all cases.
Dave Marver, CEO of ONWARD, said: “We are excited by these highly promising outcomes,
which reinforce our plan to further develop and bring ARC-IM to the market for this important
indication. Today, there are limited and ineffective options for treating people with low blood
pressure after spinal cord injury, and our therapy has the potential to address an issue that
significantly impacts their quality of life.”
1 A total of 10 people have received ARC Therapy across three studies: STIMO-HEMO, HEMO, and HemON, as well
as a clinical proof-of-concept, published in Nature in January 2021
2
Over 40% of people with spinal cord injury, or approximately 262,000 people in the U.S. and
Europe2
, are estimated to experience hypotension, or low blood pressure. Hypotension may limit
active participation in physical rehabilitation programs and facilitate the deterioration effects of
immobilization and development of undesirable secondary medical complications.
Based on the promising interim outcomes from these feasibility studies, ONWARD is preparing
to initiate further clinical trials to include U.S. participants in 2023.
About Spinal Cord Injury
Spinal cord injury (SCI) represents a major unmet medical need for which there is no cure.
Approximately 7 million people globally have a spinal cord injury, with over 650,000 in the U.S.
and Europe alone. The quality of life of people with SCI can be poor, with paralysis and loss of
sensation, issues with blood pressure control and trunk stability, increased potential for infection,
incontinence, and loss of sexual function. Assistance is required for daily living activities. And SCI
is costly, with the average lifetime cost for paraplegia (paralysis of the legs) of $2.5 million and $5
million for tetraplegia (paralysis of all four limbs). Treatments are urgently needed to restore
movement and improve quality of life.
About ONWARD Medical
ONWARD is a medical technology company creating innovative therapies to restore movement,
independence, and health in people with spinal cord injuries. ONWARD’s work builds on more
than a decade of basic science and preclinical research conducted at the world’s leading
neuroscience laboratories. ONWARD’s ARC Therapy, which can be delivered by implantable
(ARC-IM) or external (ARC-EX) systems, is designed to deliver targeted, programmed spinal cord
stimulation to restore movement and other functions in people with spinal cord injury, ultimately
improving their quality of life.
ONWARD has received five Breakthrough Device Designations from the U.S. FDA encompassing
both ARC-IMand ARC-EX. ARC-EX is an external, non-invasive platform consisting of a wearable
stimulator and wireless programmer. Positive top-line data were reported in September 2022 from
the company’s first pivotal study, called Up-LIFT, evaluating the ability of transcutaneous ARC
Therapy to improve upper extremity strength and function. The company is now preparing
marketing approval submissions for the U.S. and Europe. ARC-IM consists of an implantable
pulse generator and lead that is placed near the spinal cord. The company completed its first-inhuman use of the ARC-IM neurostimulator in May 2022.
ONWARD is headquartered in Eindhoven, the Netherlands. It maintains a Science and
Engineering Center in Lausanne, Switzerland, and has a growing U.S. presence in Boston,
Massachusetts. The company has an academic partnership with .NeuroRestore, a collaboration
between the Swiss Federal Institute of Technology (EPFL) and Lausanne University Hospital
(CHUV). For additional information about the company, please visit ONWD.com.
2 2020 NSCISC Annual Statistical Report Complete Public Version; company data
3
For Company Enquiries:
For Media Enquiries:
MC Services AG
US: Laurie Doyle, P: +1 339 832 0752
Europe: Dr. Johanna Kobler, Katja Arnold, Kaja Skorka P: +49 89 210 228 0
For Investor Enquiries:
Disclaimer
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the
Company or, as appropriate, the Company directors’ current expectations and projections about future
events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions
that could cause actual results or events to differ materially from those expressed or implied by the forwardlooking statements. These risks, uncertainties and assumptions could adversely affect the outcome and
financial effects of the plans and events described herein. A multitude of factors including, but not limited
to, changes in demand, competition, and technology, can cause actual events, performance, or results to
differ significantly from any anticipated development. The interim outcomes presented in this press release
need to be confirmed in a large-scale clinical study, the results of which could differ from the outcomes
described herein. Forward-looking statements contained in this press release regarding past trends or
activities should not be taken as a representation that such trends or activities will continue in the future.
As a result, the Company expressly disclaims any obligation or undertaking to release any update or
revisions to any forward-looking statements in this press release as a result of any change in expectations
or any change in events, conditions, assumptions, or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary
undertakings or any such person’s officers or employees guarantees that the assumptions underlying such
forward-looking statements are free from errors nor does either accept any responsibility for the future
accuracy of the forward-looking statements contained in this press release or the actual occurrence of the
forecasted developments. You should not place undue reliance on forward-looking statements,
which speak only as of the date of this press release
Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence
UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence
UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence
This initial clinical trial is a key milestone in the development of its UroActive™ System
GRENOBLE, France, Nov. 29, 2022 /PRNewswire/ — UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive.
“This is a historic milestone for UroMems, patients, physicians and the industry as this is a first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “This is the next important step in delivering our novel technology to a large, underserved patient population with unmet needs not addressed by current options on the market.”
The first male patient procedure was successfully completed at La Pitié-Salpêtrière University Hospital (AP-HP, Sorbonne University, Paris, France) by Professor Emmanuel Chartier-Kastler, principal investigator, with approval from the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration).
“We believe this groundbreaking therapy will change the way SUI is treated worldwide, establishing a new standard of care,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder.
UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated chronic conditions by the commitment to change the perception that these disorders are inevitable as one grows older and is simply something to endure with no real solution. UroMems is revolutionizing the treatment of SUI with smart active implants, using the latest technological advances in the field of embedded systems and micro-technologies for the development of its groundbreaking solutions.
UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethral duct and is automatically controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.
“We see a high rate of today’s AUS implants that are revised or removed after three years,” said Professor Daniel Elliott, urologist at Mayo Clinic in Rochester, Minn., and clinical advisor to UroMems. “The potential of being able to personalize the therapy to the patient automatically, post-implantation is very appealing.”
SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the muscle (the sphincter) around the urethra, caused by activities involving high intra-abdominal pressure, like coughing, laughing and exercising. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. While mild SUI is addressed by pelvic floor re-education and bulking agents, moderate and severe SUI historically have only had two options: mesh sling or artificial urinary sphincter.
UroActive is an active implantable electronic artificial urinary sphincter that has been developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bioelectronic platform using embedded smart, AI-based, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience.
Founded in 2011 by Professor Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated chronic conditions by the commitment to change the perception that these disorders are inevitable as one grows older and is simply something to endure with no real solution. The first challenge for the company will be applying embedded mechatronics methods and smart systems for treating urinary incontinence: designed by urologists and collaborating scientists and engineers, UroActive intends to provide a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.
Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes two financing rounds totaling 46 million euros, led by Wellington Partners, Bpifrance, Supernova Invest, b-to-v Partners AG, Cita Investissement, Hil-Invent, Financière Arbevel and the founders. The company has received several awards for innovation, including the Prix Galien Award Medstart’up and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com.
Media Contact
Shelli Lissick
651-276-6922
SOURCE UroMems
Boditech Med and SphingoTec close global licensing agreement for kidney function biomarker Proenkephalin A 119-159 (penKid)
- Worldwide licensing agreement signed to develop and offer penKid as test on Boditech’s fully automated immunoassay systems.
- The biomarker penKid adds diagnostic value and addresses current unmet needs in the management of patients suffering from acute kidney injury.
- PenKid’s availability on Boditech’s global network of analyzers will amplify the reach of penKid to the wider critical care community.
Gangwon-do, Republic of Korea and Hennigsdorf/Berlin, Germany, November 15, 2022 - Boditech Med Inc. (“Boditech”) and SphingoTec GmbH (“SphingoTec”) today announced they have entered into a nonexclusive royalty-bearing license agreement. Under the terms of this agreement, Boditech has obtained the rights to develop and commercialize clinical tests for the kidney function biomarker penKid on its renowned AFIAS and ichroma Point of Care platforms. Through this partnership, Boditech and SphingoTec will make the biomarker penKid available on Boditech’s worldwide installed base with the goal of improving the management of patients suffering from acute kidney injury (AKI).
AKI affects one in five hospitalized patients (1). The critical state is currently diagnosed by standard-ofcare biomarkers when 50% of the kidney function is already lost (1). PenKid addresses these pitfalls, offering an earlier and more precise determination of kidney function in acute and critical care settings (2).
Eui-Yul Choi, CEO, Boditech Med said “Expanding our critical care portfolio with innovation in the field of acute diseases can, in the future, support our customers applying medical advancements and improve patient outcomes. After successfully evaluating the feasibility of penKid on our diagnostic solutions, we are looking forward to working with SphingoTec for the development and commercialization of the new test.”
Jörg Menten, CEO, SphingoTec said “Boditech is a leader in point of care diagnostics with a strong global footprint. The agreement entered into with Boditech marks a significant milestone in SphingoTec’s mission to provide early detection of acute kidney injury to the international acute and critical care community. Our scientific research shows the future potential of penKid to monitor kidney function in further clinical settings such as renal replacement therapy (3) and pediatric AKI management (4,5). We are excited to work with our new partner to bring these advancements to critical care physicians around the globe very soon.”
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References:
1. Kellum, J.A. et al. Acute kidney injury. Nat Rev Dis Primers 7, 52 (2021). https://doi.org/10.1038/s41572-021-00284-z
2. Hollinger A, et al. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006.
3. von Groote et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). https://doi.org/10.1186/s13054-022-04217-4
4. Smeets NJL, Hartmann O, Schulte J, Schreuder MF, de Wildt SN. Proenkephalin A as a marker for glomerular filtration rate in critically ill children: validation against gold standard iohexol GFR measurements. Clin Chem Lab Med. 2022 Oct 27. doi: 10.1515/cclm-2022-0545.
5. Hartman et al (2020), Proenkephalin as a New Biomarker for Pediatric Acute Kidney Injury - Reference Values and Performance in Children Under One Year of Age, Clin Chem Lab Med, doi: 10.1515/cclm2020-0381
About Boditech
Boditech Med (based in Chuncheon, Gangwon-do, Republic of Korea) is a leading company in the field of point-of-care diagnostics, which has accumulated more than 20 years of business expertise in the field. The company has more than 85 types of in vitro diagnostic products that detect biomarkers related to infectious diseases, diabetes, cardiovascular diseases, cancer, and hormone-related diseases with its immunofluorescence lateral flow technology, quantitative immunofluorescence technology and spectrophotometric technology. And the list continues to grow with new high-valueadded products. With its instrument platform installed in more than 120 countries, the company also has a stable revenue model. The company is currently strengthening its value as a global company by expanding its manufacturing bases in the US, China, India, and Indonesia.
About SphingoTec
SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarker for the diagnosis, prediction and monitoring of acute medical conditions. Sphingotec’s innovative markers are made available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for assessment of endothelial function in conditions like sepsis, and Proenkephalin A 119-159 (penKid), a biomarker for assessment of kidney function in critical diseases.
About penKid
Proenkephalin A 119-159 (penKid) is a blood-based biomarker for assessing the kidney function in acute and critical conditions. The biomarker offers a blood-based alternative for the complex and time-consuming in vivo measurement of true glomerular filtration rate (GFR). PenKid is independent of common comorbidities (e.g. hypertension and diabetes) and the frequently occurring inflammation in critically ill patients. Rising penKid blood levels predict acute kidney injury earlier than today’s standard of care and decreasing penKid blood levels indicate the improvement of kidney function. Scientific evidence shows that penKid also reflects kidney function in children, representing a potential biomarker for pediatric AKI.
Press contact
Boditech Med Inc.
Duk Seung Na
Email:
Phone: +821028451778
www.boditech.co.kr
SphingoTec GmbH
Ruxandra Lenz
Email:
Phone: +49-3302-20565-0
www.sphingotec.com
NEUWAY Pharma and WACKER Launch Research Project to Develop RNA-Based Actives for the Treatment of Central Nervous System Diseases
Joint Press Release by WACKER and NEUWAY Pharma
Munich and Bonn, Oct 12, 2022- Bonn-based biotech company NEUWAY Pharma and Munich-based chemical company WACKER have launched a research project to identify and manufacture RNA-based actives for the treatment of diseases of the central nervous system (CNS). They will make use of NEUWAY’s protein-based drug delivery technology EnPC®. EnPC® allows for targeted drug delivery via the blood-brain barrier into the CNS.
Under the collaboration agreement, NEUWAY Pharma and WACKER intend to jointly research active substances based on ribonucleic acid (RNA) for the treatment of CNS-related diseases; the companies will also study related manufacturing processes. They will make use of NEUWAY Pharma’s protein-based drug delivery technology EnPC® (Engineered Protein Capsules), where active ingredient molecules are encapsulated by protein capsules and thereby transported across the blood-brain barrier – which is difficult to pass – into the CNS.
The blood-brain barrier serves as natural protection against harmful substances. Crossing it has so far posed a major challenge for the treatment of CNS diseases. EnPC® now makes effective transport of drugs into the CNS possible. This technology also offers a range of advantages for RNA-related therapies. Alongside lower costs in manufacturing, dosing of drugs based on EnPC® can be handled flexibly, for instance. Intravenous administration is furthermore possible, which eases the burden on clinicians, healthcare providers, payors and patients.
Within the research project, WACKER will take on the production and analysis of various mRNA grades, in particular mRNA – mRNA (messenger RNA) is a special type of RNA made from DNA. NEUWAY is responsible for manufacturing the EnPCs, the encapsulation and the design of selected RNA compounds, as well as associated (bio-)analysis and investigation of therapeutic relevance, both in vitro and in vivo.
“We see great opportunities in the joint research project with WACKER. WACKER’s expertise in the production of mRNA supports our strategy of advancing transformative neuropharmaceuticals for the treatment of diseases of the central nervous system,” says Oliver Ernst, CEO and managing director of NEUWAY Pharma. “We are pleased that, with our expertise, we can contribute to research into new treatment methods for diseases of the central nervous system. The combination of mRNA-based drugs with NEUWAY’s delivery system has great therapeutic potential,” says Hagen Richter, who is responsible for research in the area of nucleic acids at WACKER. The molecular biologist is in charge of the project on WACKER’s side.
About NEUWAY Pharma
NEUWAY Pharma is a German biotech company based in Bonn. It is developing an entirely novel class of biotherapeutics, based on its patent-protected Engineered Protein Capsules (EnPC®). These can cross the blood-brain barrier and deliver innovative neuropharmaceuticals for the treatment of diseases of the central nervous system (CNS). Find out more at www.neuway-pharma.com.
About WACKER
Wacker Chemie AG is a global company with state-of-the-art specialty chemical products found in countless everyday items, ranging from cosmetic powders to solar cells. WACKER’s portfolio comprises more than 3,200 products supplied in over 100 countries. WACKER has a global network of 27 production sites, 23 technical competence centers and 52 sales offices. In 2021, the Group’s 14,400 employees generated global sales of €6.21 billion. Wacker Chemie AG is listed on the Deutsche Boerse Prime Standard and on the MDAX (ISIN: DE000WCH8881). Find out more at www.wacker.com.
Contact
Wacker Chemie AG
Manuela Dollinger
Tel.: +49 89 6279-1629
NEUWAY Pharma
Christine Kuhn
Tel.: +49 228-522198-0
Immatics Reports Interim Clinical Data Update on ACTengine® IMA203 TCR-T Monotherapy Targeting PRAME
Immatics Reports Interim Clinical Data Update on ACTengine® IMA203 TCR-T Monotherapy Targeting PRAME
Immatics Reports Interim Clinical Data Update on ACTengine® IMA203 TCR-T Monotherapy Targeting PRAME
- Clinical validation of PRAME as multi-tumor target with large potential for TCR-based therapies: confirmed responses in different solid cancers, in patients with high and low PRAME expression
- Update covers data from 27 patients in completed Phase 1a dose escalation and first 5 patients in Phase 1b dose expansion (cohort A) treated with IMA203 monotherapy
- Confirmed objective response rate (cORR): 50% (6/12) at target dose or above with at least 1 billion infused TCR-T cells across Phase 1a and 1b; thereof 80% cORR (4/5) in Phase 1b patients alone with all responses ongoing at data cut-off
- Confirmed responses across different solid tumor types: cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma
- Treatment with IMA203 continues to show manageable tolerability; biological data including T cell engraftment, persistence and tumor infiltration consistent with clinical data
- IMA203 TCR-T is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME; next data read-outs on IMA203 monotherapy, IMA203 in combination with a checkpoint inhibitor and 2nd generation IMA203CD8 planned during 2023
Houston, Texas and Tuebingen, Germany, October 10, 2022 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced a clinical data update for the IMA203 monotherapy covering the completed Phase 1a dose escalation part of the trial and initial data from the first 5 patients in the ongoing Phase 1b dose expansion cohort A (monotherapy). In the Phase 1 trial with ACTengine® IMA203, Immatics is treating recurrent and/or refractory solid cancer patients utilizing TCR-T cells directed against an HLA-A*02-presented peptide derived from PRAME, which is frequently expressed across several solid cancer indications. Overall, IMA203 continues to be well tolerated and achieved confirmed objective responses across multiple solid cancers such as cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma. Encouraging early signs of improved durability were seen with a 50% (6/12) confirmed objective response rate, when patients were infused at the target dose or above with more than 1 billion TCR-T cells.
Key clinical findings from IMA203 TCR-T monotherapy
The data obtained during the Phase 1a and Phase 1b cohort A trial provide clinical validation of PRAME as a highly promising T cell target for solid cancers. Confirmed clinical responses were observed at high and low PRAME-expression levels above threshold, indicating IMA203’s potential to provide clinical benefit for all PRAME biomarker-positive cancer patients. The predicted high PRAME prevalence across key indications has so far been supported by prevalence rates obtained during the clinical screening of patients.
Moving from Phase 1a to Phase 1b, Immatics has continued to introduce planned improvements that may influence clinical outcomes including (1) applying higher cell doses (DL4 and exploratory DL5), (2) optimizing the cell product through manufacturing enhancements and (3) working with disease area experts to gradually reduce the fraction of very heavily pre-treated patients with extreme tumor burden who have exhausted standard of care and have undergone multiple clinical trials. In addition, the focus in Phase 1b is also shifting from initial objective response rate (ORR) determined at the ~6-week scan to confirmed ORR determined at the ~12-week scan.
Preliminary Objective Response Rates (ORR; RECIST 1.1) in Phase 1a and Phase 1b Cohort A
| Phase 1a | Phase 1a + Phase 1b | Phase 1b only | ||
| All pts (DL1-4) | DL4 pts only 1 | DL4/DL5 pts only1 | All pts (DL4/DL5)1 | |
| Patients Treated | 27 | 7 | 12 | 5 |
| ORR (~week 6) | 48% (13/27) | 57% (4/7) | 67% (8/12) | 80% (4/5) |
| cORR (~week 12)2 | 19% (5/27) | 29% (2/7) | 50% (6/12)* | 80% (4/5)* |
1 All patients received >1 billion total TCR-T cells; 2confirmed ORR (cORR), * 1 patient with SD at ~6-week scan with pending ~12-week scan considered as non-responder for cORR; DL – dose level
Positively evolving durability profile for IMA203 was observed at higher doses: 6 of 12 patients (50%) treated with more than 1 billion infused TCR-T cells (DL4 and DL5) in the Phase 1a and Phase 1b cohort A part of the trial experienced a confirmed objective response (partial response according to RECIST 1.1). In the Phase 1b part of the trial alone, 4 of 5 patients (80%) had a confirmed objective response which were all ongoing at the timepoint of data cut-off.
“The data presented today highlight the clinical potential of PRAME as one of the most promising multi-tumor targets to achieve meaningful benefits for a large cancer patient population,” commented Cedrik Britten, MD, Chief Medical Officer at Immatics. “In addition to this first data from IMA203 monotherapy today, we are awaiting data from two additional dose expansion cohorts: IMA203 together with an immune checkpoint inhibitor and our 2nd generation product candidate IMA203CD8. As we continue to shift our focus from Phase 1a to Phase 1b, we look forward to reporting meaningful data throughout 2023, including safety and response rates, as well as durability of response with a longer follow-up time. In addition, we are excited to start a first-in-human trial with our half-life extended Bispecific against PRAME, TCER® IMA402, also in 2023.”
Safety data for IMA203 monotherapy across Phase 1a and Phase 1b: Treatment with IMA203 continues to show manageable tolerability profile.
- At data cut-off on September 6, 2022, 32 patients were infused with IMA203 TCR-T cells.
- Most frequent treatment-emergent adverse events (TEAEs) were as expected for cell therapies.
- All patients experienced expected cytopenia (Grade 1-4) associated with lymphodepletion. 31 patients (97%) experienced cytokine release syndrome (CRS) of any grade: 29 patients had low to moderate (Grade 1-2), and 2 patients had Grade 3 CRS that occurred in Phase 1a; both recovered to Grade ≤2 after 3 and 4 days. 5 patients (16%) experienced a low to moderate (Grade 1-2) immune effector cell associated neurotoxicity syndrome (ICANS). No dose-dependent increase of CRS and ICANS was observed.
- No additional dose limiting toxicities (DLT) were observed since the initial data release in March 2021.
Phase 1a – Clinical activity: IMA203 demonstrated a high initial objective response rate in several solid tumor types.
- At data cut-off on September 6, 2022, a total of 27 patients received IMA203 monotherapy in the Phase 1a dose escalation trial:
- High initial objective response rate (ORR; partial responses according to RECIST 1.1) of 48% (13/27) was observed at the first CT scan post infusion at ~week 6, and a confirmed ORR of 19% (5/27) the second CT scan at ~week 12.
- 7 out of 27 patients received doses above 1 billion TCR-T cells (DL4); initial ORR was 57% (4/7) and confirmed ORR was 29% (2/7) in these patients.
- Patients were heavily pre-treated with a mean of 4.2 lines of prior systemic treatment and a particularly high baseline tumor burden.
- The provisional recommended Phase 2 dose (RP2D) for Phase 1b dose expansion was determined to be DL4.
Phase 1b Cohort A – Clinical activity: IMA203 monotherapy demonstrates high confirmed objective response rate of 80% with early signs of prolonged durability.
- At data cut-off on September 6, 2022, 5 patients received IMA203 monotherapy at DL4 and DL5 in the Phase 1b cohort A dose expansion trial:
- 4 out of 5 patients (80%) experienced an initial objective response at ~week 6 (PR according to RECIST 1.1).
- In all 4 patients, objective responses were confirmed at ~week 12 and were ongoing at data cut-off: confirmed ORR was 80% (4/5).
- All 4 responses were observed in different solid tumor types: cutaneous melanoma, ovarian cancer, uveal melanoma and head and neck cancer.
- Patients were heavily pre-treated with a mean of 4.0 lines of prior systemic treatment and high to moderate baseline tumor burden.
ACTengine® IMA203 is currently being evaluated in an ongoing Phase 1b study including three expansion cohorts: (A) IMA203 as a monotherapy, (B) IMA203 in combination with an immune checkpoint inhibitor and (C) IMA203CD8, a next-generation cell therapy where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor. Further data read-outs on the individual cohorts are planned throughout 2023. In addition to the ACTengine® programs, Immatics is addressing PRAME-positive cancers with a second therapeutic modality: TCR Bispecifics. The company’s TCER® IMA402 is a next-generation, half-life extended TCR Bispecific which will enter the clinic in 2023. Both approaches, ACTengine® and TCER®, are distinct therapeutic modalities that have the potential to provide innovative treatment options for a variety of cancer patient populations with different medical needs.
Immatics conference call
Immatics will host a conference call today, October 10, 2022, at 8:30 am EDT / 2:30 pm CEST to discuss these clinical data. The webcast and presentation can be accessed directly through this link. Participants may also access the slides and the webcast on the Immatics website in the Investors section under “Presentations” at www.investors.immatics.com/events-presentations. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Company’s website for at least 90 days.
About IMA203 and target PRAME
ACTengine® IMA203 T cells are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.
About ACTengine®
ACTengine® is a personalized cell therapy approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine® product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.
The ACTengine® T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth. The ACTengine® Programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).
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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
For regular updates about Immatics, visit www.immatics.com. You can also follow us on Twitter and LinkedIn.
Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.
For more information, please contact:
| Media and Investor Relations Contact | |
| Jacob Verghese or Eva Mulder | |
| Trophic Communications | |
| Phone: +49 89 2070 89831 or +31 65 2331 579 | |
| Immatics N.V. | |
| Anja Heuer | Jordan Silverstein |
| Director, Corporate Communications | Head of Strategy |
| Phone: +49 89 540415-606 | Phone: +1 281 810 7545 |
Immatics Announces $110 Million Underwritten Offering of Ordinary Shares
Immatics Announces $110 Million Underwritten Offering of Ordinary Shares
Immatics Announces $110 Million Underwritten Offering of Ordinary Shares
Houston, Texas and Tuebingen, Germany, October 10, 2022 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, announced today that it has agreed to sell, by way of an underwritten public offering, 10,905,000 of its ordinary shares at a price of $10.09 per share. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be approximately $110 million. The offering is expected to close on October 12, 2022, subject to customary closing conditions.
The offering included participation from investors including Armistice Capital Master Fund Ltd., Dellora Investments, EcoR1 Capital, Nantahala Capital, Perceptive Advisors, Rock Springs Capital, RTW Investments, LP, Samsara BioCapital, SilverArc Capital, Sofinnova Investments, Wellington Management, 683 Capital and other specialist biotech investors.
Jefferies and SVB Securities are acting as joint book-running managers for the offering.
A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (the “SEC”) and was declared effective on August 9, 2021. The offering is being made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained for free from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 821-7388, email: ; or SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: .
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.
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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the closing of the public offering and gross proceeds therefrom are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements.
For more information, please contact:
| Media and Investor Relations Contact | |
| Jacob Verghese or Eva Mulder | |
| Trophic Communications | |
| Phone: +49 89 2070 89831 or +31 65 2331 579 | |
| Immatics N.V. | |
| Anja Heuer | Jordan Silverstein |
| Director, Corporate Communications | Head of Strategy |
| Phone: +49 89 540415-606 | Phone: +1 281 810 7545 |