UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence
UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence
STeP inclusion reflects the potential improvements in safety of its UroActive™ System
GRENOBLE, France and MINNEAPOLIS, April 20, 2023 /PRNewswire/ — UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive Smart Continence Therapy. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices.
“We are delighted to receive this designation and excited to advance the development of our UroActive system – the 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. “We thank the FDA for acknowledging the importance of safety above all for patients.”
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.
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.
“The STeP approval is proof that the FDA recognizes the potential for UroActive to improve upon safety for patients with severe SUI, while also designed for an improved surgical experience for the OR team, surgeons and most importantly, their patients,” 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 poorly treated 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.
About STeP
Launched in January of 2021, the FDA’s Safer Technologies Program is a voluntary program for certain medical devices and device-led combination products that have the potential to be safer than currently available treatments or medical diagnostics. The program is intended to help patients have more timely access to products by expediting their development, assessment, and review, while maintaining the FDA’s standards for safety and effectiveness, data requirements, and quality of review.1
STeP participation does not imply product authorization. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States.
About UroActive
UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, 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.
About UroMems
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.
1 https://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2023
Media Contact
Shelli Lissick
651-276-6922
SOURCE UroMems
MinervaX Commences First Phase 1 Clinical Study of Novel GBS Vaccine in Older Adults
MinervaX Commences First Phase 1 Clinical Study of Novel GBS Vaccine in Older Adults
• Expands development of novel GBS vaccine in older adult population
• Targeting significant and growing unmet medical need of GBS infection
Copenhagen, Denmark, 17 April 2023 – MinervaX ApS, a privately held Danish biotechnology company developing a novel vaccine against Group B Streptococcus (GBS), announces the first phase 1 clinical study in older adults of its novel GBS vaccine, at CEVAC (Centre for Vaccinology) in Ghent, Belgium.
GBS is a global unmet medical burden and can cause serious illness in people of all ages, worldwide. It is normally associated with infection in pregnant women and new-born babies; however, invasive GBS disease in adults has been increasing over the last 40 years. The older adult population (>65 years of age) and adults with underlying chronic health conditions (diabetes mellitus, cancer, immune suppression, obesity) are at particular risk of invasive GBS disease. There is currently no vaccine available.
The clinical study will investigate the safety and immunogenicity of two dose levels on the MinervaX novel GBS vaccine in an older adult population from 55 to 75 years of age, with and without underlying medical conditions. The trial will investigate the safety and immune response to the dose level currently under development for use in pregnant women (50 μg of each fusion protein) and a higher dose of 125 μg of each fusion protein. Since older adults, certainly those with comorbidities, often mount a less strong immune response than a younger population, up to three doses will be investigated in this trial [clinicaltrials.gov under the identifier NCT05782179].
MinervaX has completed enrolment and dosing of its 2nd phase II clinical trial of its novel GBS vaccine in pregnant women across Denmark, the UK and South Africa. Details of MinervaX’s ongoing clinical trials can be found at clinicaltrials.gov under the identifiers NCT04596878 and NCT05154578.
Lidia Oostvogels, Chief Medical Officer of MinervaX, said: “Expanding the development of our GBS vaccine for use in an older adult population, including people with increased risk for GBS due to underlying co-morbidities, is a very important step for MinervaX in the battle against this pathogen. This builds on our efforts and experience to develop a product to provide protection to the most vulnerable populations, i.e., neonates in our maternal immunization program, and now older adults including those with certain co-morbid conditions.”
Prof. Isabel Leroux-Roels, Principal Investigator at CEVAC, commented: “GBS is known to cause potentially life-threatening infections in Older Adults and currently there is no vaccine available to prevent this. All the team at CEVAC are very happy to contribute to the development of this vaccine for this high-risk population.”
Prof. Paul Heath, Director of the St George’s Vaccine Institute, London and Lead Investigator of MinervaX’s Phase IIb study across Denmark, the UK and South Africa, remarked: “Streptococcus agalactiae is a common commensal in humans and approximately 25% of all adults will be colonised with GBS in the gastrointestinal or genitourinary tracts at any given time. We are aware of the considerable global burden of this invasive GBS disease in babies and pregnant women and of the urgent need for a vaccine to prevent this. More recently, we have become aware of the burden of GBS in non-pregnant adults, particularly in older adults, and those with underlying health conditions such as diabetes mellitus. There is no current mechanism for preventing GBS disease in this growing population, and there is a well recognised morbidity and mortality. The need for a vaccine for this group of people is therefore urgent and the commencement of GBS vaccine trials in this population is therefore an important and welcome development.”
For further information please contact:
MinervaX
Per Fischer | Chief Executive Officer
Email:
Optimum Strategic Communications
Mary Clark / Jonathan Edwards/ 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, and now also for vaccination of older adults, 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)
Streptococcus agalactiae or Lancefield’s Group B Streptococcus (GBS) is a common commensal in humans, approximately 25% of all adults will be colonised with GBS at any given time. Invasive GBS disease is normally associated with infection in pregnant women and new-born babies; however, invasive GBS disease in adults has been increasing over the last 40 years. The older adult population (>65 years of age) and adults with underlying chronic health conditions (diabetes mellitus, cancer, immune suppression, obesity) are at particular risk of invasive GBS disease.
Group B Streptococcus disease in non-pregnant adults causes secondary and primary bacteraemia, septic arthritis, endocarditis, prosthetic joint infection, and necrotising myositis and fasciitis.
It is apparent that outside of pregnancy and the neonatal period, GBS infection results in high morbidity and mortality rates. There is no preventative treatment, cases are managed with antibiotics when an infection is diagnosed. There is a clear unmet medical need for a preventative vaccine that could provide protection to all adults but particularly to the older adult population or those at risk of infection due to underlying medical or demographic conditions. In addition, the incidence is increasing and will probably continue to increase with an increasing older adult population and an increase in the prevalence of obesity and type 2 diabetes around the world.
Sidekick Health chosen as partner for White House’s CancerX project to rapidly accelerate the pace of cancer innovation in the U.S.
Sidekick Health chosen as partner for White House’s CancerX project to rapidly accelerate the pace of cancer innovation in the U.S.
Recently announced by U.S. President Joe Biden and Dr. Jill Biden as part of the reignited national Cancer Moonshot initiative, Sidekick is one of 15 organizations chosen to help tackle the root causes of health inequity and accelerate digital innovation to solve some of the most pressing challenges facing patients with cancer.
Sidekick Health today announces that it will be a partner on the inaugural CancerX project, a public-private partnership that was recently launched by U.S. President Joe Biden and Dr. Jill Biden as part of the reignited national Cancer Moonshot initiative. The project, co-hosted by the Digital Medicine Society (DiMe) and Moffitt Cancer Center, aims to unite the diverse stakeholders and innovators necessary to design and create a future that is dedicated to improving cancer outcomes.
The Cancer Moonshot initiative has ambitious goals to cut the death rate from cancer by at least 50% over the next 25 years and to improve the experience of people and their families living with and surviving cancer. The inaugural project, “Advancing Digital Innovation to Improve Equity and Reduce Financial Toxicity in Cancer Care and Research,” is already formed and will start work in early April. It will focus on the root causes of financial toxicity (a term used to describe how out-of-pocket costs related to cancer care can result in financial problems for patients and their families) and health inequity to accelerate human-centered digital innovation to solve some of the most pressing challenges facing cancer patients, providers, and researchers.
In 2023, the American Cancer Society reported that there would be an estimated 1.9 million new cancer diagnoses, yet innovative digital approaches for delivery and precision oncology care remain limited. Existing approaches are also not yet applied at scale to minimize the burden of financial toxicity to patients with cancer and reduce the associated healthcare access, outcome, and economic disparities. The opportunity to improve cancer care and outcomes is clear and significant. For digital innovation to deliver on its potential to improve the lives of all people with cancer, prioritization of opportunities for the greatest impact is key. This includes improving access, equity, and inclusion when developing and deploying digital solutions for cancer care.
By identifying the biggest areas of potential impact, developing actionable tools, and providing incentive models, Sidekick, alongside other partner organizations, will share its wealth of expertise in digital therapeutics and help pave the way in fulfilling the promise of digital innovation across the full continuum of care.
Through partnerships with health insurers and pharmaceutical companies, Sidekick’s unique platform already supports people living with cancer both in the US and Europe. For example, in a strategic collaboration with Eli Lilly, Sidekick provides patients living with breast cancer access to a tailored digital health plan, engaging in health-improving tasks which promote behavior modification and overcome barriers to change. It focuses on five main areas: stress management, physical activity, diet, sleep, and medication adherence, the latter representing a significant obstacle to recovery in patients undergoing cancer treatment. Patients are also given access to educational content that has been created in close collaboration with clinical experts, patients, and patient advocacy groups, helping to provide them with unique insights into living with cancer. Sidekick also delivers programs for other chronic conditions, such as obesity and cardiometabolic diseases, and promotes a personalized approach through adaptive care pathways. As part of the CancerX project, Sidekick will help champion the value of high-quality digital innovation in cancer, address methodological gaps where they exist, and define best practices for successful and equitable implementation.
Confo Therapeutics Enters into Collaboration Agreement with Daiichi Sankyo to Discover Novel Medicines for CNS Diseases
Confo Therapeutics Enters into Collaboration Agreement with Daiichi Sankyo to Discover Novel Medicines for CNS Diseases
- Collaboration to make use of Confo’s unique suite of ConfoBody®-enabled technologies for fragment- and structure-based drug design
- Confo to receive upfront and milestone payments totaling EUR 168M
- Tiered royalties payable to Confo on net sales from resulting products
Ghent, Belgium – March 30, 2023 – Confo Therapeutics, a leader in the discovery of medicines targeting G-protein coupled receptors (GPCRs), today announced that it has entered a collaboration agreement with Daiichi Sankyo (TSE: 4568) for the discovery and development of small molecule agonists against an undisclosed target associated with CNS diseases.
Under the terms of the agreement, Confo will lead the discovery process deploying its GPCR platform to generate lead series of small molecule compounds. Daiichi Sankyo has an exclusive option to acquire a worldwide exclusive license for the resulting compounds and advance them towards clinical development and commercialization. Confo has the potential to receive upfront payments, development and commercial milestones totaling EUR 168M and royalties.
“Daiichi Sankyo has historically been at the forefront of leveraging innovative technologies to develop novel medicines. We are excited by this collaboration in which we will be using Confo’s expertise and platform to pursue a previously undruggable GPCR target in an area of high unmet medical need,” said Cedric Ververken, CEO of Confo Therapeutics. “As we expand the scope of our internal drug discovery and development efforts, we look forward to continuing to enter partnerships with leading innovators to create new therapeutic options for patients.”
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
ImCheck Appoints Thomas Civik as Independent Chairman of the Board
ImCheck Appoints Thomas Civik as Independent Chairman of the Board
Marseille, France, March 23, 2023 – ImCheck Therapeutics announced today the appointment
of Thomas Civik as independent Chairman of its Board of Directors. With a distinguished career
of 30 years in the biopharmaceutical industry, Mr. Civik has extensive experience in bringing
oncology innovations to patients and from executive leadership roles, most recently as CEO of
Five Prime Therapeutics. He will join ImCheck’s Board as the company further develops its lead
program ICT01 and a range of antibody therapeutics targeting butyrophilins,
a novel superfamily of immunomodulators. Dr. Debasish Roychowdhury, Chairman since 2018, will step
down from the Board and remain an advisor to the company.
“Welcoming Tom to our Board represents an important milestone as we transition into a more mature
organization advancing a broad and promising pipeline of immunomodulatory antibodies. With our
lead program ICT01 moving toward later-stage clinical evaluation, Tom will make important strategic
contributions through his experience and insights in clinical and corporate development. He will also
provide an extensive network in the U.S. as we continue to expand our footprint there,” said Pierre
d’Epenoux, Chief Executive Officer of ImCheck Therapeutics. “I would like to thank Debasish for
his steadfast support and guidance over the past five years.”
Mr. Civik added: “ImCheck has established a leadership position in gamma delta T-cell activation in
immuno-oncology and has created substantial value through the potential of its unique approach. I
look forward to joining ImCheck’s Board and being a part of the next exciting phase of the company’s
evolution.”
Thomas Civik’s most recent corporate position was as CEO and President of Five Prime
Therapeutics, where he oversaw the clinical development of the company’s oncology pipeline
and the acquisition by Amgen in 2021. Prior to that, he was the Chief Commercial Officer at
Foundation Medicine and led the launch of the first-ever, FDA-approved pan-cancer
comprehensive genomic test. Mr. Civik spent the majority of his career at Genentech, where
for over 15 years, he held increasing levels of responsibility, lastly as Vice President and
Franchise Head, after starting in the pharmaceutical industry at Sanofi. He holds an MBA from
the Kellogg School of Management at Northwestern University and currently serves on the
Board of Directors at Repare Therapeutics and Pyxis Oncology.
About IMCHECK THERAPEUTICS
ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic
antibodies targeting butyrophilins, a novel super-family of immunomodulators.
As demonstrated by lead clinical-stage program ICT01, which has a mechanism of action to
simultaneously modulate innate and adaptive immunity, ImCheck’s “first-in-class” activating
antibodies may be able to produce superior clinical results as compared to the first-generation
of immune checkpoint inhibitors and, when used in combination, to overcome resistance to this
group of agents. In addition, ImCheck’s antagonist antibodies are being evaluated as potential
treatments for a range of autoimmune and infectious diseases.
Co-founder of the Marseille Immunopole cluster, ImCheck benefits from support from Prof.
Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille Université), a worldwide
leader in γ9δ2 T cells and butyrophilins research; from the experience of an expert management
team; and from the commitment of leading US and European investors.
For further information: https://www.imchecktherapeutics.com/
Press contacts:
US and EU
Trophic Communications
Gretchen Schweitzer
+49 (0) 172 861 8540
France
ATCG PARTNERS
Céline Voisin
+33 (0)9 81 87 46 72 / +33 (0)6 62 12 53 39
Seamless Therapeutics Launches with $12.5M Seed Financing to Advance Transformative Gene Editing Platform Based on Programmable Precision Designer Recombinases
Seed round co-led by Wellington Partners and Forbion, with non-dilutive funding from BMBF GO-Bio enables maturation of platform and pipeline towards first clinical evaluation
Dresden, Germany, March 16, 2023 – Seamless Therapeutics today announced a $12.5 million (€11.8M) seed financing round which will accelerate further development of its designer recombinases, a novel gene editing platform to transform the treatment of severe diseases. The company’s pioneering recombinase platform is able to program a widely used and established molecular biology tool to unlock the full potential of gene editing enabling the targeting of any site within the genome. The seed round was co-led by Wellington Partners and Forbion and includes non-dilutive financing from BMBF GO-Bio, a prestigious German government initiative aimed at supporting the most innovative startups in the life sciences. Representatives from both Wellington and Forbion will join the company’s newly formed board of directors. The proceeds from the round will be used to further advance the company’s proprietary technology platform to build a pipeline of therapeutic candidates towards first-in-human readiness as well as to expand the company’s presence in the EU & US.
Seamless Therapeutics was founded based on ground-breaking discoveries from its scientific founders, Prof. Dr. Frank Buchholz, Dean of Research at the Faculty of Medicine and Head of Systems Biology at the University Cancer Center of the Technische Universität Dresden, and Felix Lansing, PhD, Co-Founder and Chief Scientific Officer of Seamless Therapeutics. Both are pioneers in reprogramming recombinases. Felix Lansing, PhD, will be responsible for the continued development of the company’s proprietary technology.
“Our goal is to apply our deep understanding of recombinases to leverage their inherent benefits to repair genetic alterations that cause disease. We believe our pioneering technology will allow us to shatter the boundaries that exist in gene editing methods today,” said Anne-K. Heninger, PhD, Co-Founder and Chief Executive Officer of Seamless Therapeutics. “Both Wellington and Forbion are visionaries and highly experienced biotech investors, and we look forward to working closely with them in our efforts to transform the gene editing landscape.”
“Our modular platform has succeeded in reprogramming site-specific recombinases to any given target sequence effectively breaking the existing hurdles of leveraging this potential best-in-class gene editing system to treat human disease,” commented Felix Lansing, Co-Founder and Chief Scientific Officer of Seamless Therapeutics. “I look forward to working with our founding investors and our highly skilled team to apply our deep knowledge of recombinases to develop a pipeline of novel treatments.”
“We have entered a new era in drug discovery based on the promise of how precision gene editing can change the way we treat disease in the future. Seamless Therapeutics has a first-mover position with its innovative platform capable of modifying the long held standard recombination technology into a universal gene editing tool with unprecedented specificity. We are excited to support Seamless Therapeutics in its pursuit of taking a leadership position in the rapidly evolving gene editing arena,” added Karl Nägler, PhD, Managing Partner at Wellington Partners.
“At Forbion our philosophy is to seek out pioneering technologies early in their development and to enable founding teams to harness the true potential of their innovation. The team has developed a powerful new platform that has overcome key limitations of existing gene editing tools, such as CRISPR, prime & base editors,” said Dmitrij Hristodorov, PhD, Partner at Forbion.
Seamless Therapeutics’ platform has succeeded in reprogramming site specific recombinases to any given target sequence and make a range of specific changes including inversion, excision, exchange, and insertion from small to larger DNA fragments. Recombinases are a class of enzymes that have been widely used in scientific research for decades to precisely modify the genome of model organisms but until now could not be applied as a therapeutic due to their limited programmability to act on new target sites.
***
About Seamless Therapeutics
Seamless Therapeutics is changing the paradigm of gene editing through a pioneering approach to restore health in patients with severe conditions in a safe and precise manner. Our technology platform unlocks the reprogramming of recombinases, a highly versatile class of enzymes. We are applying our proprietary know-how to develop a pipeline of disease-modifying product candidates across a broad spectrum of indications to expand the therapeutic potential of gene editing.
About Wellington Partners
Wellington Partners is a leading European venture capital firm investing in the most promising early- and growth stage life science companies in the fields of biotechnology, therapeutics, medical technology, diagnostics and digital health. With funds totaling more than €1.2 billion, thereof €590 million committed to life sciences, Wellington Partners has been actively supporting world class private companies translating true innovation into successful businesses with exceptional growth. To date, Wellington Partners has invested in 56 innovative life science companies, including Actelion (acquired by J&J), Definiens (acquired by AZ), Immatics (Nasdaq: IMTX). invendo (acquired by Ambu), MTM Laboratories (acquired by Roche/Ventana), Oxford Immunotec (acquired by PerkinElmer), Rigontec (acquired by MSD), Symetis (acquired by Boston Scientific), and Themis (acquired by MSD).
About Forbion
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio) pharmaceutical space. Forbion manages well over EUR 2.3 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 95 companies. Besides financial objectives, Forbion selects investments that will positively affect the health and wellbeing of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BioGeneration Ventures (BGV), the manager of seed and early-stage funds, especially focused on Benelux and Germany.
About BMBF GO-Bio
The BMBF funding initiative GO-Bio supports life science researchers with innovative ideas who are looking to go into business. It provides excellent conditions from an early project stage on for a successful switch from the lab to the economy.
https://www.go-bio.de/gobio/de/go-bio/go-bio/go-bio_node.html
For more information, please contact:
Seamless Therapeutics
Dr. Anne-K. Heninger, CEO
Phone: +49 351 212 469 0
Email:
Seamless Therapeutics media inquiries
Trophic Communications
Desmond James / Stephanie May
Tel: +49 1516 7859086 or +49 171 1855682
Email:
Carisma Therapeutics Closes Merger with Sesen Bio
Carisma Therapeutics Closes Merger with Sesen Bio
Shares of Carisma to commence trading on Nasdaq under new ticker symbol “CARM” on March 8, 2023
Resulting cash position of approximately $140 million provides runway through 2024; expected to enable multiple clinical readouts across Carisma programs
PHILADELPHIA, March 7, 2023 /PRNewswire/ — Carisma Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, and Sesen Bio, Inc. (“Sesen Bio”), announced today the closing of their previously announced merger. The combined company will operate under the name Carisma Therapeutics Inc. and shares of its common stock will commence trading under the ticker symbol “CARM” on March 8, 2023 on the Nasdaq Global Market.
“This merger represents a very exciting opportunity for stockholders of each company, and we believe it gets us one step closer to our goal of revolutionizing the field of immunotherapy,” said Steven Kelly, President and Chief Executive Officer of Carisma. “It will provide us with the financial strength to not only continue to develop our lead candidate CT-0508 but also accelerate the growth of our platform and pipeline within and outside of oncology and continue to develop additional strong strategic partnerships.”
Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio, said, “I want to thank the entire Sesen Bio team for their steadfast commitment to our mission to save and improve lives. Patients, caregivers and investigators around the world have been important advocates of Sesen Bio and I want to thank them for their support. I am confident in the potential of Carisma’s promising technology and through the combined company, we can continue to advance our shared mission of saving and improving the lives of patients with cancer. I know the future of Carisma is bright and I am optimistic for their continued success.”
Concurrent with the closing of the merger, Carisma completed a $30 million financing from a syndicate of investors, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio. The projected cash and cash equivalents as of the close of the business combination are expected to be approximately $140 million, providing anticipated operating runway at least through the end of 2024.
In connection with the closing of the merger, a one-time special cash dividend of $75 million, or approximately $0.36 per share, will be paid no later than March 10, 2023 to Sesen Bio stockholders of record at the close of business on March 7, 2023. Under the terms of the merger, Sesen Bio stockholders also received one Contingent Value Right, which entitles the holder to receive a cash payment related to any potential proceeds from the sale of Sesen Bio’s legacy assets, including Vicineum, and the potential $30 million milestone payment under the Roche Asset Purchase Agreement.
The combined company will be headquartered in Philadelphia, Pennsylvania, and will be led by Steven Kelly, President and Chief Executive Officer of Carisma. The board of directors of the combined company will be composed of seven members, including Sanford Zweifach (Chair), Regina Hodits, Briggs Morrison, Björn Odlander, Chidozie Ugwumba, Steven Kelly (Carisma President & Chief Executive Officer) and Michael Torok.
“The successful completion of this merger marks an important milestone in Carisma’s journey and significantly strengthens its cash resources to advance the company’s differentiated pipeline and platform,” said Chairman of the Board Sanford Zweifach. “The dedication of the Carisma team, as well as the support and guidance of our advisors and stockholders, have been instrumental in bringing us to this moment. The Board and I look forward to the opportunities that lie ahead.”
SVB Securities acted as the exclusive financial advisor to Sesen Bio for the transaction, and Hogan Lovells US LLP served as Sesen Bio’s legal counsel. Evercore served as lead financial advisor to Carisma for the transaction, and BofA Securities, Inc. also served as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore served as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel.
About Carisma Therapeutics
Carisma Therapeutics Inc. is a biopharmaceutical company dedicated to developing a differentiated and proprietary cell therapy platform focused on engineered macrophages, cells that play a crucial role in both the innate and adaptive immune response. The first applications of the platform, developed in collaboration with the University of Pennsylvania*, are autologous chimeric antigen receptor (CAR)-macrophages for the treatment of solid tumors. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com
*Carisma has licensed certain Penn-owned intellectual property from the University of Pennsylvania, and Penn’s Perelman School of Medicine receives sponsored research and clinical trial funding from Carisma. Penn and certain of its faculty members are current equity holders in Carisma and have received and may be entitled to receive future financial consideration from Carisma from the development and commercialization of products based on licensed Penn intellectual property.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about Carisma’s future expectations, plans and prospects, strategy or future operations, and other statements containing the words “anticipate,” “believe,” “contemplate,” “expect,” “intend,” “may,” “plan,” “predict,” “target,” “potential,” “possible,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. For example, statements concerning Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of clinical trials are forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including without limitation: (i) risks associated with the possible failure to realize certain anticipated benefits of the merger, including with respect to future financial and operating results; (ii) the effect of the completion of the merger on Carisma’s business relationships, operating results and business generally; (iii) the outcome of any legal proceedings instituted against Sesen Bio, Carisma or any of their respective directors or officers related to the merger agreement or the transactions contemplated thereby; (iv) the ability of Carisma to protect its intellectual property rights; (v) competitive responses to the merger and changes in expected or existing competition; (vi) the success and timing of regulatory submissions and pre-clinical and clinical trials; (vii) regulatory requirements or developments; (viii) changes to clinical trial designs and regulatory pathways; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (xi) legislative, regulatory, political and economic developments; and (xii) other factors discussed in the Company’s reports filed with the Securities Exchange Commission. In addition, the forward-looking statements included in this press release represent Carisma’s views as of the date hereof. Carisma anticipates that subsequent events and developments will cause its views to change. However, while Carisma may elect to update these forward-looking statements at some point in the future, Carisma specifically disclaims any obligation to do so, except as required under applicable law. These forward-looking statements should not be relied upon as representing Carisma’s views as of any date subsequent to the date hereof.
Media Contact:
Julia Stern
(763) 350-5223
SOURCE Carisma Therapeutics Inc.
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