Immatics Announces $35 Million Equity Investment from Bristol Myers Squibb

Immatics Announces $35 Million Equity Investment from Bristol Myers Squibb

TuebingenGermany and HoustonTX, July 24, 2023 – 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 that Bristol Myers Squibb (NYSE: BMY) has made a $35 million equity investment in Immatics. Bristol Myers Squibb purchased 2,419,818 ordinary shares in a private placement transaction at a subscription price per share of $14.461. Additionally, Bristol Myers Squibb has the right to appoint a member to the Immatics Scientific Advisory Board.

“This investment is further testimony to the strength of the relationship and of our differentiated platform technologies that are the foundation of our TCR-based cell therapies and bispecifics,” commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “We remain steadfast in our commitment to advancing innovative treatment options for patients in their fight against cancer, and look forward to providing further clinical results in the second half of the year.”

The securities referenced above have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

– END –

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.

Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on TwitterInstagram 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 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
Eva Mulder or Charlotte Spitz
Trophic Communications
Phone: +31 6 52 33 15 79

 

Immatics N.V.
Anja Heuer Jordan Silverstein
Senior Director, Corporate Communications Head of Strategy
Phone: +49 89 540415-606 Phone: +1 281 810 7545


Carisma Therapeutics Announces First Patient Dosed in Phase 1 Study of CT-0508 in Combination with KEYTRUDA® (pembrolizumab) in Patients with HER2 Overexpressing Solid Tumors

Carisma Therapeutics Announces First Patient Dosed in Phase 1 Study of CT-0508 in Combination with KEYTRUDA® (pembrolizumab) in Patients with HER2 Overexpressing Solid Tumors

Study is designed to evaluate the potential for a synergistic effect of CAR-M therapy in combination with KEYTRUDA®

PHILADELPHIA, June 28, 2023 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced that the first patient has been dosed in its Phase I clinical trial that will test the safety and tolerability of the Company’s lead product candidate, CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M) in combination with Merck’s anti-PD1 therapy KEYTRUDA® (pembrolizumab) for the treatment of HER2 overexpressing cancers.

Pre-clinical data presented at SITC in 2022 demonstrated that the mice that received both therapies had improved tumor control, overall survival, and tumor microenvironment (TME) activation as compared to either treatment alone, indicating synergy and the capacity for CAR-M to sensitize solid tumors to checkpoint blockade.

This first patient’s cells were manufactured at the Novartis Cell Therapy Site in Morris Plains, New Jersey, following the successful completion of the tech transfer of CT-0508 to Novartis earlier this year. This is Carisma’s first clinical product to be manufactured and administered from this collaboration.

“We are excited by the progress being made on our CT-0508 clinical program with the dosing of the first patient in the combination study with KEYTRUDA®,” said Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma Therapeutics. “The CT-0508 monotherapy trial has demonstrated early clinical validation of the CAR-M mechanism of action, and we are eager to explore this sub-study to assess the potential synergistic effect of CAR-M therapy in combination with KEYTRUDA®. The initiation of clinical manufacturing at Novartis’ GMP cell therapy site is also a meaningful step forward in progressing our overarching manufacturing strategy, and demonstrates our desire to work alongside best-in-class companies.”

In January 2023, Carisma appointed nationally regarded cancer immunologist and oncologist, Dr. Padmanee Sharma, MD, PhD, to the company’s Scientific Advisory Board. The Company expects that Dr. Sharma’s scientific knowledge in immunotherapy will provide valuable guidance in the studies of CT-0508 and KEYTRUDA®.

The clinical trial sub-study of CT-0508 in combination with KEYTRUDA® has been initiated at multiple site locations in the U.S. and will enroll patients with different types of recurrent or metastatic cancers with HER2 overexpressing solid tumors. To learn more about this, please visit ClinicalTrials.gov (NCT04660929) or Carisma’s clinical trial website.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CT-0508

CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers are not eligible for treatment with currently available HER2-targeted therapies or who do not respond to treatment. The trial is enrolling participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for our CAR-M. The Phase 1 clinical trial is first-of-its-kind, marking the first time that genetically engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) the University of Pennsylvania Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.

About Carisma Therapeutics

Carisma Therapeutics Inc. is a clinical stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, 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.

Cautionary Note on Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma Therapeutics’ business, strategy, future operations, cash runway, the advancement of Carisma Therapeutics’ product candidates and product pipeline, and clinical development of Carisma Therapeutics’ product candidates, including expectations regarding timing of initiation and results of clinical trials, and participation by Carisma Therapeutics in future healthcare industry and investor conferences. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 11, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

Media Contact:
Julia Stern
(763) 350-5223

Investor Contact:


nyra health raises €4.5m Seed Round to advance its digital neuro-therapy

nyra health’s app-based neuro-therapy enables unprecedented treatment for speech and cognitive issues for individual patients in clinics and at home.

Vienna, Munich, Singapore, 22 June 2023 — nyra health, a digital therapy platform for neurological patients has successfully closed a €4.5m oversubscribed seed round, co-led by MassMutual Ventures (MMV) and Wellington Partners.

Previously known as myReha, this announcement coincides with the company’s rebrand to nyra health. nyra health’s flagship therapy app provides personalized therapy plans for each user, focusing on their individual needs in speech and cognition to maximise the potential of their rehabilitation process.

The CE-certified app contains over 35,000 interactive exercises to support patients after a neurological illness such as a stroke, dementia or long COVID-19.
The app combines industry leading machine learning models that analyse speech patterns and provide accurate, immediate feedback on pronunciation with adaptive cognitive games to create personal therapy training plans to improve an individual’s memory, speech and attention.

The technology constructs highly detailed speech profiles and automatically adapts each patient’s weekly plan based on individual performance and various speech biomarkers. These speech profiles also facilitate the mapping of long-term changes in dementia and other neurodegenerative diseases.

The funds will empower nyra health to scale its presence in the DACH region, enhance its AI technology, and establish a firm foundation for expanding into English-speaking markets.

“We are thrilled to have the backing of such a great team of investors who share our vision. Their commitment to our Seed Round is not just an investment in our company, but also a strong vote of confidence in our mission and potential. It’s fantastic to be able to scale our team and further enhance our AI-driven platform. By converging data from treatment and monitoring, we will be deeply integrated into the healthcare system and present throughout the whole patient journey for all neurological issues“, explained Moritz Schöllauf, Co-Founder and CEO of nyra health.

“We are witnessing a global increase in neurological disorders, ranging from stroke to dementia, largely driven by an aging population. In response to this escalating issue, nyra health has innovated a personalized therapy platform that not only addresses this pressing health concern but also offers significant scalability potential, enabling swift expansion into new markets,” stated Ryan Collins, Managing Partner at MassMutual Ventures.

Dr. Johannes Fischer, Principal at Wellington Partners commented: “We were deeply impressed by nyra health’s ability to support patients at every stage of their journey. With over 35 hospital customers in Germany and Austria, nyra health has started to demonstrate significant benefits for both patients and clinics. The company’s capability to deliver Ai-guided digital support for patients throughout their often year-long recovery journey presents a unique and persuasive proposition in the healthcare sector.”

The Family Office behind EVER Pharma is continuing its support in this Seed Round after investing already in the Pre-Seed Round in January 2021 and contributing its expertise for the company’s ongoing clinical trials. Philipp Schulte-Noelle, an experienced healthcare manager with deep knowledge of the sector is joining as a Business Angel.

About nyra health

nyra health specializes in AI-powered therapy solutions for neurological patients. Their first product, the myReha app, provides individual therapy plans for speech and cognitive impairments to maximize the potential of patients’ rehabilitation process. Combined with their second product, nyra.insights, nyra health offers an unprecedented view of the patient’s progress starting with the moment of diagnosis and accompanying them on every step of the patient journey. By integrating nyra health’s technology, clinics can substantially enhance the quality of patient care both in in-clinic use and as a tele-rehab solution.

nyra health was founded in 2020 by Philipp Schöllauf, a medical doctor specialised in neurology, Mario Zusag, a machine learning researcher previously working at Google AI and IBM Research and Moritz Schöllauf, a lawyer with background in regulatory affairs, nyra health is based in Vienna, Austria and has to date raised €7m in private and public funding.
For more information, visit www.nyra.health/

About MassMutual Ventures

MassMutual Ventures (MMV) is a multistage global venture capital firm investing in financial technology, enterprise SaaS, climate technology, healthtech, and cybersecurity. With teams based in Boston, Singapore, and London, MMV manages over $1 billion in investment capital across the globe. MMV helps accelerate the growth of companies by providing capital, connections and advice. With a deep expertise and extensive Fortune 500 network, MMV helps entrepreneurs build compelling and scalable companies of value.
For more information, visit www.massmutualventures.com.

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 totalling 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 58 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).


Resminostat: 4SC Filed Letter of Intent to the European Medicines Agency (EMA)

Resminostat: 4SC Filed Letter of Intent to the European Medicines Agency (EMA)

Planegg-Martinsried, Germany, 31 May 2023 – 4SC AG (4SC, FSE Prime Standard: VSC) has now filed with EMA its letter of intent to file for Marketing Authorization for resminostat in cutaneous T cell lymphoma (CTCL) and request the appointment of rapporteurs.  Given the clear benefit provided by resminostat with respect to the lengthening of progression free survival in CTCL patients 4SC is moving forward with its Marketing Authorisation Application (MAA) process for resminostat and to initiate pre-submission interactions with EMA.  4SC remains on track to submit the MAA in Q1, 2024.

RESMAIN is a pivotal study, conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluating resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy.

Jason Loveridge, CEO of 4SC commented: “Our assessment of the initial data from RESMAIN, and in particular the highly significant outcome for the primary endpoint, justifies us moving rapidly forward with the first steps towards the submission of our MAA for resminostat. We continue to actively analyse the data from RESMAIN and we expect a more detailed dataset will be published at a scientific meeting probably in Q3, 2023”.

Further information

About 4SC

4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that target key indications in cancer with high unmet medical needs. 4SC’s pipeline is protected by a comprehensive portfolio of patents and currently comprises one drug candidate in clinical development: resminostat.

4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 16 employees as of 31 March 2023 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A3E5C40).

About resminostat

Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that potentially offers an approach to treating different kinds of cancer. Resminostat demonstrated that it is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body’s immune response to cancer.  Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) as maintenance treatment by 4SC in Europe and by Yakult Honsha in Japan.

About cutaneous T-cell lymphoma (CTCL)

CTCL is a rare disease with approximately 5,000 patients being newly diagnosed in Europe each year. The disease arises from malignant transformation of T-cells, a specialized subgroup of immune cells, primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.

Currently, CTCL is not curable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available treatment options, the duration of response is often short-lived and declines as the severity of the disease increases. The key therapeutic challenge in advanced-stage CTCL is therefore to make remissions more durable by halting disease progression and improving patient’s quality of life.

About the RESMAIN study – resminostat for maintenance treatment of CTCL

The pivotal RESMAIN study is being conducted at more than 50 clinical centers in 11 European countries and Japan. It included 201 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) that have achieved disease control with systemic therapy. The patients were randomized 1:1 to receive either resminostat or placebo. Patients who experience disease progression – while being on placebo – will be offered resminostat in an open label treatment arm. The primary goal of the study is to determine whether maintenance treatment with resminostat prolongs progression-free survival. The key secondary objective is to prolong the time to symptom worsening (pruritus).

About the concept of maintenance therapy

The pivotal RESMAIN study is focused on patients with advanced-stage, incurable cutaneous T-cell lymphoma (CTCL). Such patients suffer from painful and itchy skin lesions resulting in disfigurement and a severely impaired quality of life. Furthermore, lymph nodes, blood or visceral organs can be involved. The current therapeutic options rarely provide long-lasting responses or stabilization of disease for meaningful periods, with most patients progressing within several months.

Resminostat is being evaluated as maintenance treatment – a unique innovative treatment approach in CTCL (Stadler et al., 2021) - intended to prolong the period patients are stable and not progressing. Furthermore, recent preclinical data suggests that resminostat has the potential to alleviate the itching in CTCL patients, thereby additionally improving their quality of life.

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.


Brain Computer Interface (BCI) Enables Thought-Controlled Walking after Spinal Cord Injury

Brain Computer Interface (BCI) Enables Thought-Controlled Walking after Spinal Cord Injury

Pioneering study in Nature demonstrates that adding a BCI to ONWARD® ARC Therapy™ can
enable thought-controlled standing, walking, and stair climbing

EINDHOVEN, the Netherlands — May 24, 2023 — ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces a publication in Nature showing that a wireless brain-computer interface (BCI) can use thought to modulate ARC Therapy. Researchers reported that when paired with ARC Therapy, an implanted BCI allowed an individual to gain augmented control over when and how he moved his paralyzed legs.

“This publication shows the remarkable potential of ARC Therapy to be enhanced with the introduction of a BCI, facilitating more natural movement based on the thoughts of a person living with paralysis,” said Dave Marver, CEO of ONWARD. “We have positioned ONWARD as a leader in the BCI field with our unique understanding of spinal cord stimulation for people with SCI.”

“The BCI establishes a continuous link between movement intentions and spinal cord stimulation, allowing for more natural restoration of mobility,” said neuroscientist Grégoire Courtine, professor at EPFL, and co-author of the Nature paper. “I look forward to working with the ONWARD team to advance this important new technology.”

The data published today are part of an ongoing clinical feasibility study investigating the safety and preliminary effectiveness of brain-controlled spinal cord stimulation after SCI. The study is being coordinated by .NeuroRestore co-Directors – Grégoire Courtine and Jocelyne Bloch, a neurosurgeon at Lausanne University Hospital (CHUV) – as well as Guillaume Charvet, Head of the Medical Device Development Lab at CEA-Leti / Clinatec.

All ONWARD devices and therapies, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, are investigational and not available for commercial use.

About ONWARD Medical
ONWARD is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of science and preclinical research conducted at leading neuroscience laboratories, the Company has received nine Breakthrough Device Designations from the U.S. Food and Drug Administration for its ARC Therapy™ platform.

ONWARD® ARC Therapy, which can be delivered by external ARC-EX™ or implantable ARCIM™ systems, is designed to deliver targeted, programmed spinal cord stimulation. Positive results were presented in 2023 from the Company’s pivotal study, called Up-LIFT, evaluating the ability for transcutaneous ARC Therapy to improve upper extremity strength and function. The Company is now preparing regulatory approval submissions for ARC-EX for the US and Europe. In parallel, the Company is conducting studies with its implantable ARC-IM platform, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI in 2022. These studies include combination use of ARC-IM with a brain-computer interface (BCI).

Headquartered in Eindhoven, the Netherlands, ONWARD has a Science and Engineering Center in Lausanne, Switzerland and a U.S. office in Boston, Massachusetts. The Company also has an academic partnership with .NeuroRestore, a collaboration between EPFL, the Swiss Federal Institute of Technology in Lausanne, and Lausanne University Hospital (CHUV).

For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.

For Media Enquiries:
Aditi Roy, VP Communications

For Investor Enquiries:
Lara Smith Weber, CFO

Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s 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. 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. All ONWARD devices and therapies referenced here, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, are investigational and not available for commercial use.


4SC AG – RESMAIN Trial Meets Primary Endpoint in Cutaneous T-Cell Lymphoma (CTCL)

4SC AG – RESMAIN Trial Meets Primary Endpoint in Cutaneous T-Cell Lymphoma (CTCL)

  • Resminostat met the primary endpoint in the RESMAIN study, demonstrating a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo
  • Resminostat is the first and only drug to show statistically proven PFS improvement in the maintenance setting in CTCL
  • Resminostat did not meet the key secondary endpoint – time to symptom (pruritus) worsening
  • 4SC intends to approach the European Medicines Agency in order to evaluate the preparation of its Marketing Authorization Application
  • 4SC also intends to file for Orphan Drug Designation for Resminostat in CTCL in both Europe and the United States

Planegg-Martinsried, Germany, 23 May 2023 – 4SC AG (4SC, FSE Prime Standard: VSC) announced today that resminostat has met the primary endpoint in the RESMAIN study and demonstrated a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo. The study confirmed the already well known safety profile of resminostat in CTCL.

RESMAIN is a pivotal study, conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluating resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at 50 clinical centers in 11 European countries and 5 centers in Japan.

Given that the RESMAIN study did not meet its key secondary objective, 4SC will now approach the European Medicines Agency in order to better understand the feasibility of submitting a Marketing Authorization Application.

In addition, 4SC also intends to file for Orphan Drug Designation for Resminostat in CTCL in both Europe and the United States.

The results of the RESMAIN study will be presented at an upcoming medical meeting.

_________________________________________________________________________

Information and Explanation of the Issuer to this News:

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

About resminostat

Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that potentially offers an approach to treating different kinds of cancer. Resminostat demonstrated that it is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body’s immune response to cancer.  Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) as maintenance treatment by 4SC in Europe and by Yakult Honsha in Japan.

About cutaneous T-cell lymphoma (CTCL)

CTCL is a rare disease with approximately 5,000 patients being newly diagnosed in Europe each year. The disease arises from malignant transformation of T-cells, a specialized subgroup of immune cells, primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.

Currently, CTCL is not curable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available treatment options, the duration of response is often short-lived and declines as the severity of the disease increases. The key therapeutic challenge in advanced-stage CTCL is therefore to make remissions more durable by halting disease progression and improving patient’s quality of life.

About the RESMAIN study – resminostat for maintenance treatment of CTCL

The pivotal RESMAIN study is being conducted at more than 50 clinical centers in 11 European countries and Japan. It includes more 201 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) that have achieved disease control with systemic therapy. The patients were randomized 1:1 to receive either resminostat or placebo. Patients who experience disease progression – while being on placebo – will be offered resminostat in an open label treatment arm. The primary goal of the study is to determine whether maintenance treatment with resminostat prolongs progression-free survival. The key secondary objective is to prolong the time to symptom worsening (pruritus).

About the concept of maintenance therapy

The pivotal RESMAIN study is focused on patients with advanced-stage, incurable cutaneous T-cell lymphoma (CTCL). Such patients suffer from painful and itchy skin lesions resulting in disfigurement and a severely impaired quality of life. Furthermore, lymph nodes, blood or visceral organs can be involved. The current therapeutic options rarely provide long-lasting responses or stabilization of disease for meaningful periods, with most patients progressing within several months.

Resminostat is being evaluated as maintenance treatment – a unique innovative treatment approach in CTCL (Stadler et al., 2021) - intended to prolong the period patients are stable and not progressing. Furthermore, recent preclinical data suggests that resminostat has the potential to alleviate the itching in CTCL patients, thereby additionally improving their quality of life.


Upon FDA approval, Advanced Medical Balloons launches innovative hygh-tec catheter system for ICU stool drainage in U.S. market

Upon FDA approval, Advanced Medical Balloons launches innovative hygh-tec catheter system for ICU stool drainage in U.S. market

• Creative Balloons operates under new name Advanced Medical Balloons (AMB)
• AMB’s microscopically thin polyurethane (PUR) balloon catheter systems address indications in intensive care
• 1st product from the ICU portfolio now launched in U.S.: hygh-tec® enables reliable and contamination-free stool drainage
• Strong performance in Germany, with strong market share growth

Waghaeusel (Germany), May 4, 2023 – Advanced Medical Balloons GmbH (formerly Creative Balloons GmbH), a specialist in medical technology from Waghaeusel near Heidelberg, today announced that the company is expanding its intensive care business to the United States. This is based on the approval which has recently been granted by the U.S. Food and Drug Administration (FDA) for their innovative catheter system hygh-tec®.1, 2 The novel fecal management system hygh-tec provides maximum seal and prevention of fecal leakage in patients receiving intensive care.

“We are delighted that the FDA cleared hygh-tec, which is a major milestone for AMB in accessing the U.S. market. Offering the first product from our unique portfolio in the U.S. for medical supply of ICU patients makes us very proud,” said Frank Gehres, CEO of Advanced Medical Balloons. “hygh-tec’s reliably high leak tightness means a significant reduction in workload and saving time for caregivers. The trans-anal sealing mechanism could also support early mobilization of cardiac patients or contribute to preventing infection in severely burnt patients. For physicians, this smart fecal management opens up novel therapeutic possibilities.”

Along with the start of U.S. sales, the company operates globally as Advanced Medical Balloons (AMB) since April 1, 2023. Advanced Medical Balloons Inc. is based in Atlanta, GA, and is currently establishing its own U.S. sales structure under the leadership of experienced General Manager Kent Johnson. “While building out our commercial team, we have initiated clinical use in ICU patients in the U.S. and are rolling out hygh-tec with intensive care clinicians throughout the country,” said Kent Johnson. “We have already seen very encouraging feedback from healthcare professionals confirming their need for a next-generation fecal management system, and I am extremely positive regarding our commercial success.”

Frank Gehres confirms: “While hygh-tec is already established in its lead market Germany, where we currently have almost a quarter of market share in ICUs and are continuously growing, the USA is the most important market for AMB, globally. With approximately 110,000 intensive care beds, we see a market potential in the mid three-digit million range. I am therefore very pleased that we have been able to win Dr. Ramona Koenig as Chief Operating Officer to support the roll-out of our products and the expansion of our business activities.” Ramona Koenig, a trained physicist with a PhD in physical chemistry, joined AMB on March 1, 2023, from Rottendorf Pharma.

The technical basis for hygh-tec is its innovative design of the elastic and deformable polyurethane catheter tube, which allows an unmatched trans-anal sealing performance. It clings to the rectal mucosa free from tension and spontaneously adapts to the sphincter dynamics and movements of the patient.

By adapting to the current pressure, intelligent synchronization with the sphincter is possible. When the tone decreases and the sphincter muscle opens, the sheath can spontaneously straighten in the anal canal and allows unobstructed defecation.

About Advanced Medical Balloons
Advanced Medical Balloons (AMB) is a specialized medical technology company. The company develops and markets novel catheter technology based on microscopically thin, complex shaped balloon films made of polyurethane (PUR). AMB taps the properties of these extraordinary structures for problem-solving platform concepts in the Fecal, Urinary and Respiratory segments. The current focus is on systems for the containment of patient contamination. In this context, AMB is developing contamination-free drainage technology for fecal management in intensive care patients, which provides significant benefits in nursing, hygiene management and patient therapy. The first product utilizing this technology, hygh-tec®, is already used in German-speaking countries with great success and since 2023 also marketed in the USA. AMB was founded in 2009 by Dr. med. Fred Göbel and is based in Waghäusel, near Heidelberg, Germany, and in Atlanta, GA, USA. https://www.amb-medtec.com/en/

Contact:
Advanced Medical Balloons GmbH
Frank Gehres, CEO
Phone: +49-7254-4039710

Media relations:
MC Services AG
Eva Bauer
Phone: +49-89-210228-0

1 From the letter of authorization: “The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administration of medications. The device is not intended for use on pediatric patients.” U.S. Food and Drug Administration, 2023

2 hygh-tec® is a registered trademark of Advanced Medical Balloons GmbH.


Immatics Reports Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME

Immatics Reports Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME

Company to host conference call today, May 2, at 8:30 am EDT / 2:30 pm CEST

  • Update covers data from 11 heavily pre-treated, last-line patients in Phase 1b dose expansion Cohort A treated with IMA203 TCR-T monotherapy against PRAME
  • Objective response rate (ORR): 64% (7/11) initial ORR at week 6 and 67% (6/9) confirmed ORR at month 3
  • Median duration of response not reached at median follow-up time of 8.5 months at data cut-off
  • Objective responses independent of solid tumor type at low, medium and high PRAME expression levels in checkpoint-refractory cutaneous melanoma, platinum-resistant ovarian cancer, uveal melanoma, head and neck cancer and synovial sarcoma
  • Cohort A IMA203 monotherapy TCR-T treatment continues to show manageable tolerability with no high-grade CRS and no ICANS; no dose dependent increase of CRS observed
  • Proprietary rapid manufacturing process with 7 days of manufacturing time; manufacturing success rate of 94% to reach current recommended Phase 2 dose
  • Next data update and pathway towards registration-directed trials planned to be set out in 4Q 2023
  • Company well capitalized with cash position1 of $386m at YE 2022 and reach into 2025 to leverage multi-cancer PRAME opportunity

Houston, Texas and Tuebingen, Germany, May 2, 2023 – 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 an interim clinical data update for 11 patients with recurrent and/or refractory solid cancers treated with ACTengine® IMA203 TCR-T monotherapy in the ongoing Phase 1b dose expansion Cohort A. IMA203 TCR-T cells are directed against an HLA-A*02-presented peptide derived from PRAME, a broadly expressed solid cancer target with clinical proof-of-concept for IMA203 demonstrated by Immatics in 2022. Overall, IMA203 showed a high rate of deep and durable objective responses, with a confirmed objective response rate of 67% (6/9), across multiple tumor types, including two confirmed partial responses (cPR) ongoing at more than 9 months after treatment and three additional partial responses ongoing at data cut-off. IMA203 monotherapy continues to be well tolerated in heavily pre-treated patients at doses of up to approximately 9 billion CD8+ TCR-T cells. No high-grade cytokine release syndrome (CRS) and no immune effector cell associated neurotoxicity syndrome (ICANS) were observed in Cohort A at data cut-off.

The data will be presented by Martin Wermke, MD, Professor at the University Hospital Dresden and Coordinating Investigator of the ACTengine® IMA203 TCR-T trial during a conference call today, May 2, at 8:30 am EDT / 2:30 pm CEST.

“The treatment of solid cancer patients who have exhausted all available standard of care options remains a significant challenge. These patients typically show fast progressing disease with very poor prognosis,” said Martin Wermke, MD, Coordinating Investigator of the ACTengine® IMA203 TCR-T trial. “It is therefore very encouraging to see that IMA203 is able to provide durable, clinically relevant responses in a variety of solid cancer patients.”

“Today marks a significant step in our efforts towards bringing our ACTengine® IMA203 monotherapy to patients with solid tumors, as we present for the first time longer-term clinical data demonstrating deep and durable responses, some of them ongoing beyond 9 months after treatment,” commented Cedrik Britten, MD, Chief Medical Officer at Immatics. “Furthermore, we show that these responses are agnostic of tumor type and that ACTengine® IMA203 achieved objective responses at widely differing PRAME expression levels. These data further increase our confidence in the success and broad potential of targeting PRAME, and our product candidate IMA203. We continue executing and anticipate announcing a potential fast-to-market pathway for the first 1-2 indications by the end of the year.”

Safety data for IMA203 TCR-T monotherapy in Phase 1b Cohort A: Treatment with IMA203 monotherapy continues to show manageable tolerability at doses as high as ~9×109 TCR-T cells.

  • At data cut-off on April 4, 2023, 11 PRAME-positive patients were infused with IMA203 TCR-T cells at dose level (DL) 4 or DL5 with a mean total infused dose of 3.67×109 TCR-T cells (range 1.30-8.84×109 TCR-T cells).
  • Based on data review of 6 patients in the exploratory highest DL5, this DL was cleared by the DSMB (Data and Safety Monitoring Board) for safety, and the updated provisional recommended Phase 2 dose (RP2D) now includes DL4 and DL5. The final RP2D will be defined prior to starting Phase 2.
  • Most frequent treatment-emergent adverse events (TEAEs) were as expected for cell therapies.
  • All 11 patients experienced expected cytopenia (Grade 1-4) associated with lymphodepletion. 10 patients (91%) had a low to moderate (Grade 1-2) cytokine release syndrome (CRS), of which 5 patients (45%) had Grade 1, and 5 patients (45%) had Grade 2 CRS. No high-grade (Grade 3 or higher) CRS and no immune effector cell associated neurotoxicity syndrome (ICANS) were observed in any of these 11 patients. No dose-dependent increase of CRS was observed across Phase 1a and Phase 1b Cohort A (N=38 patients infused with IMA203 in total).
  • No additional dose limiting toxicities (DLT) were observed in Cohort A since the initial Phase 1a dose escalation.

Clinical activity for IMA203 TCR-T monotherapy in Phase 1b Cohort A: IMA203 monotherapy demonstrates a high rate of deep objective responses with ongoing durability of more than 9 months after treatment in some patients.

  • At data cut-off on April 4, 2023, 11 patients were infused with IMA203 TCR-T cells and evaluable for at least one tumor response assessment post treatment.
  • Objective responses were observed in last-line solid cancer patients including cutaneous melanoma, ovarian cancer, uveal melanoma, head and neck cancer, synovial sarcoma.
  • Patients were heavily pre-treated with a mean of ~4 lines of prior systemic treatments and had exhausted all available standard of care treatments.
  • All cutaneous melanoma patients were checkpoint inhibitor-refractory, all ovarian cancer patients were platinum-resistant.
  • Initial objective response rate (ORR) of 64% (7/11) was observed at ~week 6 (partial responses, PR, according to RECIST 1.1).
  • Confirmed ORR of 67% (6/9) was observed at ~month 3; initial responses at week 6 were confirmed for all 6 responders with available subsequent 3-month scan.
  • Median duration of response2 was not reached (min 1.3+ months, max 8.8+ months) at a median follow-up3 of 8.5 months.
  • At data cut-off, 5 of 7 responses remain ongoing:
    • 2 cPRs (cut. & uveal melanoma) ongoing at 9+ months
    • 1 cPR (cut. melanoma) ongoing at 6+ months
    • 1 cPR (ovarian cancer) ongoing at ~3 months
    • 1 PR (synovial sarcoma) ongoing at 6+ weeks
  • Objective responses were observed in patients independent of tumor type at all PRAME expression levels above Immatics’ mass spectrometry-guided RNA threshold including expression levels at or just above this threshold.
  • IMA203 T cells were found in all evaluable tumor tissues and the level of tumor infiltration was associated with objective responses.

Best Overall Response – Phase 1b Cohort A

 

1 Ovarian cancer patient A-DL5-04 erroneously received one dose of nivolumab and is part of intent-to-treat population (shown here) but not per-protocol population; NET: Neuroendocrine Tumor; PD: Progressive disease; SD: Stable disease; PR: Partial response; cPR: Confirmed partial response; BL: Baseline; BOR: Best Overall Response

Response over Time – Phase 1b Cohort A

 

Manufacturing of IMA203 TCR-T cells

  • Immatics’ proprietary manufacturing process has a manufacturing time of 7 days (+7-day expedited release testing), with a success rate of 94% in achieving the provisional RP2D.
  • Manufacturing improvements (including monocyte depletion) and higher applied cell doses implemented for the Phase 1b part of the trial led to significantly increased levels of IMA203 T cells in the blood of patients in Phase 1b Cohort A compared to patients in the Phase 1a dose escalation.
  • Immatics is currently building a state-of-the-art facility designed to manufacture ACTengine® IMA203 TCR-T products, as well as other cell therapy candidates, for registration-directed trials and initial commercial supply. Built with flexibility and cost-efficiency in mind, the facility is designed to be scalable via a modular design to accommodate manufacturing demands. The facility is expected to be operational in 2024.

Development strategy to realize the multi-cancer opportunity PRAME

Immatics believes, the results presented today further validate PRAME as one of the most promising solid tumor targets for TCR-based therapies. Immatics’ IMA203 development strategy is based on two pillars aimed initially at a (1) fast-to-market approach and, later at a (2) broad development.

The first objective is to deliver the PRAME-targeted TCR-T cell therapy in 1-2 last-line solid cancer types as fast as possible with a focus on indications with PRAME prevalence above 80% and where clinical proof-of-concept has been demonstrated, such as cutaneous melanoma (potentially bundled with uveal melanoma) and/or ovarian cancer. The buildout of the manufacturing facility will support Immatics’ efforts to maximize speed to market. Immatics plans to start a first Phase 2 trial in 1H 2024, which is intended to be designed as a registration-directed trial.

As a second step, Immatics plans to also expand development to other cancer types, such as uterine cancer, lung cancer, breast cancer, head and neck cancer and other tumor types having a broad patient reach.

An update on all three IMA203 Phase 1b Cohorts and clinical development path for PRAME TCR-T monotherapy towards registration-directed trials and potential commercialization is planned for 4Q 2023.

In addition to ACTengine® TCR-T, Immatics is addressing PRAME-positive cancers with a second therapeutic modality, TCR Bispecifics (TCER®), to leverage the full potential of the multi-cancer opportunity PRAME. Immatics’ TCER® IMA402 is a next-generation, half-life extended TCR Bispecific for which Immatics submitted a clinical trial application (CTA4) to the Paul-Ehrlich-Institute (PEI) on April 14, 2023, to initiate the Phase 1/2 trial. The trial is expected to commence in 2H 2023 with first clinical data planned in 2024.

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 will continue to evaluate which of these therapeutic modalities (ACTengine® vs. TCER® or both) is best suited for each cancer type.

Immatics conference call
Immatics will host a conference call today, May 2nd, 2023, at 8:30 am EDT / 2:30 pm CEST to discuss the clinical data. The webcast and presentation can be accessed directly through this link. Participants may also access the slides presented in 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 Immatics 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 program’s 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.

ACTengine® IMA203 TCR-T is currently being evaluated in three ongoing Phase 1b dose expansion cohorts in last-line patients: Cohort A IMA203 TCR-T monotherapy, Cohort B IMA203 in combination with an immune checkpoint inhibitor; Cohort B is focused on generating safety data for potential further investigation of a combination approach as a front-line therapy, and Cohort C IMA203CD8 TCR-T monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor. IMA203CD8 is currently being explored in DL4a (up to 0.8×109 TCR-T cells/m2 BSA).

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).

– END –

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.

Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on TwitterInstagram 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 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. 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
Eva Mulder or Charlotte Spitz
Trophic Communications
Phone: +31 65 2331 579
Immatics N.V.
Anja Heuer Jordan Silverstein
Senior Director, Corporate Communications Head of Strategy
Phone: +49 89 540415-606 Phone: +1 281 810 7545

1 Cash position includes cash and cash equivalents as well as other financial assets and was €362.2 million as of December 31, 2022 ($386.3 million using the exchange rate published by the European Central Bank in effect as of December 31, 2022 (1 EUR = 1,0666 USD).
2 Duration of response (DOR) in confirmed responders is defined as time from first documented response until disease progression/death. Patients with ongoing response will be censored at date of data cut-off. Median DOR is analyzed by using the Kaplan-Meier method.
3 Median follow-up is analyzed by using the reverse Kaplan-Meier method.
4 Clinical Trial Application (CTA) is the European equivalent of an Investigational New Drug (IND) application.


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 MINNEAPOLISApril 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 MozerHamid 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.