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.
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).
