Moderna and Immatics Announce Strategic Multi-Platform Collaboration to Develop Innovative Oncology Therapeutics
Moderna and Immatics Announce Strategic Multi-Platform Collaboration to Develop Innovative Oncology Therapeutics
- Collaboration combines leading technologies to develop breakthrough, mRNA-enabled in vivo expressed TCER® molecules
- Companies to leverage Immatics’ XPRESIDENT® target discovery platform and Moderna’s mRNA technology for the development of novel cancer vaccines
- Collaboration to include evaluation of Immatics’ investigational IMA203 PRAME TCR-T in combination with Moderna’s investigational PRAME mRNA cancer vaccine
- Immatics to receive $120 million upfront cash payment plus research funding with the potential for additional milestone and royalty payments
Cambridge, Massachusetts and Tuebingen, Germany, September 11, 2023 – Moderna, Inc. (NASDAQ: MRNA, “Moderna”) and Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced a strategic research and development collaboration to pioneer novel and transformative therapies for cancer patients with high unmet medical need. This broad multi-platform collaboration will leverage the deep scientific expertise and core operational capabilities of both companies, combining Immatics’ TCR platform with Moderna’s cutting-edge mRNA technology, and span various therapeutic modalities including bispecifics, cell therapy and cancer vaccines.
The strategic R&D collaboration between Moderna and Immatics focuses on three pillars:
- Applying Moderna’s mRNA technology for in vivo expression of Immatics’ next-generation, half-life extended TCR bispecifics (TCER®) targeting cancer-specific HLA-presented peptides.
- Enabling the discovery and development of novel mRNA-based cancer vaccines by leveraging Moderna’s deep knowledge of mRNA science and customized information from Immatics’ wealth of tumor and normal tissue data included in the target discovery platform XPRESIDENT® and its bioinformatics and AI platform XCUBE™.
- Evaluating Immatics’ IMA203 TCR-T therapy targeting PRAME in combination with Moderna’s PRAME mRNA-based cancer vaccine. The collaboration contemplates conducting preclinical studies and a Phase 1 clinical trial evaluating the safety and efficacy of the combination with the objective of further enhancing IMA203 T cell responses.
“We are excited to embark on this strategic collaboration with Immatics, a pioneer in developing innovative cancer immunotherapies. This partnership presents a groundbreaking opportunity to leverage our mRNA technology alongside Immatics’ TCR platform, potentially diversifying and augmenting the way we approach cancer treatment. We believe this collaboration will accelerate the development of novel oncology therapies and bring us one step closer to providing significant benefits for patients with high unmet medical needs,” said Rose Loughlin, Ph.D., Moderna’s Senior Vice President for Research and Early Development.
“We are thrilled to join forces with Moderna in our quest to pioneer innovative and transformative therapies to combat cancer. We believe Immatics’ cancer target and TCR platforms, along with Moderna’s cutting-edge mRNA technology, represent a powerful combination that has the potential to deliver meaningful benefits to cancer patients,” said Toni Weinschenk, PhD, Chief Innovation Officer at Immatics. “The rapid advancement of our first 2 TCER® programs into the clinic, with additional TCER® compounds fueling our pre-clinical pipeline, underscores our commitment to develop innovative therapeutics. We are confident that we can explore the optimal delivery of TCER® molecules through this collaboration to maximize clinical benefit in a broad patient population,” added Carsten Reinhardt, MD, PhD, Chief Development Officer of Immatics.
About the Collaboration
Under the terms of the agreement, Immatics will receive an upfront payment of $120 million. Immatics will also receive research funding and is eligible to receive development, regulatory, and commercial milestone payments that could exceed $1.7 billion. Immatics is also eligible to receive tiered royalties on global net sales of TCER® products and certain vaccine products that are commercialized under the agreement. Under the agreement, Immatics has an option to enter into a global profit and loss share arrangement for the most advanced TCER®.
Moderna will lead the clinical development and commercialization of cancer vaccines and TCER® therapeutics resulting from the collaboration. Immatics will be responsible for conducting the preclinical studies and a potential Phase 1 clinical trial investigating IMA203 TCR-T in combination with the PRAME mRNA vaccine to further enhance IMA203 T cell responses. Each party will retain full ownership of its investigational PRAME compound, and the parties will fund the clinical study on a cost sharing basis.
Within the collaboration, preclinical activities conducted by Immatics will be managed by the Immatics Discovery Unit, a recently created internal division at Immatics integrating its technology platforms into one interdisciplinary team focused on all early-stage preclinical pipeline and collaboration programs.
The collaboration is subject to customary antitrust clearance in the United States.
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About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immune-oncology, rare diseases, cardiovascular diseases, and autoimmune diseases. Moderna Genomics was created to leverage the recent advancement in both the RNA delivery platform and the genomic medicines to create the next generation of in vivo gene editing therapeutics. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.
Moderna Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the agreement between Moderna and Immatics to develop innovative oncology therapeutics; the opportunity presented by the collaboration to leverage Moderna’s mRNA technology alongside Immatics’ TCR platform to potentially diversify and augment the way we approach cancer treatment; the potential for the collaboration to accelerate the development of novel oncology therapies; and the antitrust clearance process in the United States. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this press release.
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 Twitter, Instagram and LinkedIn.
Immatics 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.
Moderna Contacts:
| Media Contact | |
| Chris Ridley | |
| Vice President, Communications | |
| Phone: +1 617-800-3651 | |
| Investor Relations Contact | |
| Lavina Talukdar | |
| Senior Vice President & Head of Investor Relation | |
| Phone: +1 617-209-5834 | |
Immatics Contacts:
| Media and Investor Relations Contact | |
| Eva Mulder or Charlotte Spitz | |
| Trophic Communications | |
| Phone: +31 6 52 33 15 79 | |
| Immatics N.V. | |
| Anja Heuer | Sabrina Schecher, Ph.D. |
| Senior Director, Corporate Communications | Senior Director, Investor Relations |
| Phone: +49 89 540415-606 | Phone: +49 89 262002433 |
Confo Therapeutics Appoints Dieter Weinand, Former CEO of Bayer Pharmaceuticals, as Independent Chairman
Confo Therapeutics Appoints Dieter Weinand, Former CEO of Bayer Pharmaceuticals, as Independent Chairman
Ghent, Belgium – August 29, 2023 – Confo Therapeutics, a leader in the discovery of medicines targeting G-protein coupled receptors (GPCRs), today announced the appointment of Dieter Weinand as Independent Chairman of its Board of Directors. Mr. Weinand brings with him a wealth of experience with more than 35 years in the pharmaceutical industry and over 25 years as the leader of geographic and strategic business units and drug commercialization efforts across global organizations, including several years as the President, CEO and Chairman of the Board of Bayer Pharmaceuticals AG. He joins Confo as the company advances its pipeline and continues to leverage its proprietary GPCR drug discovery engine. Mr. Weinand succeeds John Berriman, who is retiring from his current position as Chairman of Confo’s Board of Directors.
“Dieter is an exceptional leader in the pharmaceutical industry with a proven track record across the spectrum of research and development to commercialization, bringing impactful medications to patients. A chairman of his caliber will be invaluable as we continue progressing as an organization with a truly innovative GPCR-targeting technology and a growing pipeline of novel drug candidates,” said Cedric Ververken, CEO of Confo Therapeutics. “On behalf of the Confo team, I sincerely thank John Berriman for his guidance over the past seven years and his contributions to Confo’s growth into a clinical-stage drug development company.”
“Confo is moving on an exciting trajectory, harnessing the momentum of a pivotal agreement with Eli Lilly for its first clinical program, CFTX-1554, and building out a robust pipeline of large and small molecules based on its unique platform,” added Dieter Weinand, Independent Chairman. “I look forward to working together with the Confo team to advance the company through its next stages of growth and to achieve its future strategic business and pipeline objectives.”
Mr. Weinand has had a highly successful career across all areas of pharmaceutical development, commercialization, and international organizational leadership. Most recently, he was Head of Global Primary Care Business at Sanofi where he led the optimization of the company’s portfolios. Before this, he was President, CEO, and Chairman of the Board of Bayer Pharmaceuticals AG, where he was responsible for integrating the R&D, manufacturing, and all commercial and support functions of the healthcare business of the Bayer AG corporation. Mr. Weinand held various senior management positions across international corporations including at Bristol-Meyers Squibb and Pfizer. He has been instrumental in the launch and marketing of some of the industry’s pivotal products including Lipitor®, Neurontin®, Abilify® and Cipro®. Mr. Weinand holds a B.A. in Biology from Concordia College, New York, and an M.S. in Pharmacology and Toxicology from Long Island University, New York. Mr. Weinand is Chairman of the Board of Nasdaq-listed Replimune (REPL), FORE Biotherapeutics, and ZielBio, among others.
About Confo Therapeutics
Confo Therapeutics is the only GPCR company with a proprietary discovery engine that precisely targets desired GPCR conformations. This unique capability allows us to unlock a vast untapped potential for the discovery and development of breakthrough medicines. We are advancing a robust pipeline of large and small molecules focused on validated targets in endocrine and metabolic diseases, as well as addressing a broader array of critical unmet medical needs in collaboration with our partners. Our team of accomplished experts is dedicated to advancing our patent protected technology, expanding our capabilities, and building out our pipeline in order to achieve the best possible therapeutic outcomes for patients. For more information, visit www.confotherapeutics.com
For more information, please contact:
Confo Therapeutics
Dr. Cedric Ververken, CEO
+ 32 (0) 9 396 74 00
Email:
Trophic Communications
Valeria Fisher or Desmond James
+49 175 8041816 or +49 (0) 1516 7859086
Email:
Quanta™ Announces Enrollment Completion in Home Run Study
Quanta™ Announces Enrollment Completion in Home Run Study
Multi-center trial assesses efficacy and safety of the Quanta Dialysis System
BEVERLY, Massachusetts – August 17, 2023 – Quanta Dialysis Technologies® today announced that it has completed enrollment of its Home Run study for at-home hemodialysis. The Home Run study is a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for home hemodialysis. Results are expected to be announced in the second half of 2023.
“People with end-stage kidney disease on hemodialysis are currently limited as to options available. Although frequent home hemodialysis is proven to deliver superior outcomes, for many, in-center dialysis treatment three times a week is the only viable option,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, FASN. “We hope that FDA clearance of an additional home hemodialysis device will contribute to more patients having access to regular care in their home environment. Enrollment completion is the first step forward in a potential new alternative for people with this life-threatening disease.”
About the Home Run Study
The Home Run study is establishing non-inferiority in safety and efficacy when the Quanta Dialysis System is used in the self-care home environment with a care partner compared to a hemodialysis facility. Following enrollment, study participants begin hemodialysis treatments using the system on a prescription of four-hour treatments, three times per week for a minimum of four weeks. During this time, both patients and their caregivers will undergo extensive training and competency sign off on all aspects of safely administering hemodialysis treatment in the home. Upon completion of training and a one-week transition period, participants will perform home treatment four times per week for three-and-one-half hours per treatment for eight weeks.
About End-Stage Kidney Disease (ESKD)
End-stage kidney disease is the final stage of chronic kidney disease, where kidney function has declined enough to the point where the kidneys can longer function on their own. With fully functioning kidneys, waste and excess fluids from the blood are filtered and then excreted in urine. For those with ESKD, the kidneys lose their filtering abilities and dangerous levels of fluid, electrolytes and waste build up in the body. Approximately 800,000 people in the United States are living with ESKD, 71% of which rely on dialysis to manage the disease, while the remaining 29% have a functioning kidney transplant.
About the Quanta Dialysis System
The Quanta Dialysis System is a compact, easy-to-use hemodialysis device FDA-cleared for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. It is also CE-mark approved for use in center or at-home in the UK by adult patients with AV fistula or graft or central venous catheter, and who have an estimated dry weight of greater than 40kg.
About Quanta Dialysis Technologies
Quanta Dialysis Technologies is committed to making dialysis accessible to every patient in every setting with its Quanta Dialysis System. As a portable device with performance comparable to larger, traditional machines, the Quanta Dialysis System is a modular and powerful solution that provides the clinical versatility needed to deliver dialysis care across multiple settings. With a simple-to-use and intuitive user interface, it is designed to be operated by a broad range of users to bring dialysis directly to patients.
The Quanta Dialysis System is commercially available in the United Kingdom for home and
hospital use and in the United States, it is FDA-cleared (K222067) for use in chronic and acute care settings. It is not cleared for home or nocturnal use in the United States.
To learn more about Quanta and its products, visit quantadt.com.
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Media Contact:
Melinda Freson
Immatics Initiates Phase 1/2 Clinical Trial to Evaluate PRAME TCR Bispecific IMA402 in Patients with Advanced Solid Tumors
Immatics Initiates Phase 1/2 Clinical Trial to Evaluate PRAME TCR Bispecific IMA402 in Patients with Advanced Solid Tumors
TCER® IMA402 is the first next-generation, half-life extended TCR Bispecific targeting PRAME to enter the clinic Patient enrollment for IMA402 Phase 1/2 trial underway The trial will evaluate safety, tolerability, and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors First clinical data expected in 2024
Tuebingen, Germany and Houston, Texas, August 10, 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 the initiation of a Phase 1/2 clinical trial with its proprietary Bispecific T cell engaging receptor (TCER®) IMA402. IMA402 is the second product candidate in Immatics’ TCER® pipeline of next-generation, half-life extended bispecific molecules to enter clinical development. It targets an HLA-A*02:01-presented peptide derived from PRAME, a clinically established cancer target frequently expressed in a large variety of solid tumors.
The Phase 1/2 clinical trial (NCT05958121) investigates TCER® IMA402 in HLA-A*02:01-positive patients with PRAME-expressing recurrent and/or refractory solid tumors. The dose escalation part of the study is designed as a basket trial in focus indications to accelerate signal finding. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others.
“The addition of IMA402 to our clinical pipeline is a truly exciting step and aligns with our strategic goal to harness the full potential of PRAME, one of the most promising cancer targets in solid tumors. With our half-life extended format, we believe IMA402 has the potential to be an attractive treatment option by enhancing efficacy, minimizing toxicities, and providing favorable dosing regimen for cancer patients.,” said Cedrik Britten, Chief Medical Officer at Immatics. “We are working with urgency to bring IMA402 to a broad patient population as quickly as possible and look forward to sharing first clinical data in 2024.”
Primary objectives of the IMA402 Phase 1/2 trial are to determine the maximum tolerated dose (MTD) and/or the recommended doses for trial extensions, as well as to characterize safety and tolerability of IMA402. Secondary objectives are to evaluate anti-tumor activity and assess pharmacokinetics of IMA402. The Phase 1a dose escalation will be followed by a Phase 1b dose expansion, with the plan then to initiate a Phase 2 with indication-specific cohorts and/or combination therapies. Immatics has implemented an adaptive design for the dose escalation with the goal of accelerating the clinical development timeline of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an early opportunity for adjustment of the treatment interval based on the half-life extended TCER® format. The trial is initially planned to be conducted at approximately 15 sites in Europe, with extension into the US at dose expansion stage. The Phase 1a is designed to enroll approximately 45 patients.
The trial initiation is based on the comprehensive preclinical studies with IMA402 presented at the European Society for Medical Oncology (ESMO) Congress 2022.
TCER® IMA402 is the second Immatics clinical program targeting PRAME, with the first being ACTengine® IMA203, a TCR-T cell therapy which is currently being evaluated in a Phase 1b dose expansion. Both approaches, ACTengine® and TCER®, are distinct therapeutic modalities that Immatics believes to have the potential to provide innovative treatment options for a variety of cancer patient populations with different medical needs.
About IMA402
TCER® IMA402 is a drug candidate owned by Immatics. IMA402 is Immatics’ second TCER® molecule from the bispecifics pipeline and is 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®. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies.
About TCER®
Immatics’ next-generation half-life extended TCER® molecules are antibody-like “off-the-shelf” biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. The design of the TCER® molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. Immatics proprietary biologics are engineered with two binding regions: a TCR domain and a T cell recruiter domain. The TCER® format is designed to maximize efficacy while minimizing toxicities in patients. It contains a high-affinity TCR domain that is designed to bind specifically to the cancer target peptide on the cell surface presented by an HLA molecule. The antibody-derived, low-affinity T cell recruiter domain is directed against the TCR/CD3 complex and recruits a patient’s T cells to the tumor to attack the cancer cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule at the tumor site instead of the periphery, TCER® are engineered to reduce the occurrence of immune-related adverse events, such as cytokine release syndrome. In addition, the TCER® format consists of an Fc-part conferring half-life extension, stability, and manufacturability. TCER® are “off-the-shelf” biologics and thus immediately available for patient treatment. They can be distributed through standard pharmaceutical supply chains and provide the opportunity to reach a large patient population without the need for specialized medical centers.
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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
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 Twitter, Instagram 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 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 |
Quanta™ Receives FDA 510(k) Clearance for Expanded Indication of Continuous Renal Replacement Therapies
Quanta™ Receives FDA 510(k) Clearance for Expanded Indication of Continuous Renal Replacement Therapies
Quanta Dialysis System becomes first-in-class to perform three standard-of-care dialysis modalities in one device
BEVERLY, Mass., Aug. 3, 2023 /PRNewswire/ — Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device, for two modalities of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis (CVVHD) and slow continuous ultrafiltration (SCUF). Under the new 510(k), the Quanta Dialysis System is the only dialysis device FDA-cleared to provide intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED) or bagless CRRT which creates dialysate on demand – all in a single machine.
The Quanta Dialysis System was originally designed to serve the more than two million people with end-stage kidney disease (ESKD) worldwide who receive treatment with dialysis or a kidney transplant. The latest addition of its Trinal Kidney Therapy™ (TKT) software provides a treatment solution for critically ill patients diagnosed with acute kidney injury (AKI) who require dialysis. It features dialysate flow rates from 50 to 500 mL/min and treatment times up to 24 hours of continuous delivery.
“This clearance is a true game-changer for acute care settings,” said Quanta Chief Executive Officer, Alejandro Galindo. “Hospitals are often constrained with limited space and nursing staff. The Quanta Dialysis System with TKT software provides an all-in-one solution for hospitals with an intensive care unit (ICU) looking to reduce their device footprint, maximize their operational efficiencies, reduce burden on nurses and substantially lower consumables expenses.”
Mortality for ICU patients with severe AKI who need dialysis has been reported to exceed 50% in patients often requiring intravenous life support to maintain a minimum blood pressure. CRRT offers a slower and gentler alternative to conventional dialysis; continuous dialysis runs 24 hours a day as compared to traditional hemodialysis which occurs over a four-hour period enabling better real time management of volume and biochemistry for patients.
“Critically ill patients that are hemodynamically unstable, such as those with severe AKI, are more challenging to manage in the ICU balancing volume status, inotropic support and ventilation requirements. Because of its slower rate of fluid removal, CRRT may cause less stress for the patient and enable more real-time decision making for clinical teams on a minute-to-minute basis,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, FASN. “However, once the hemodynamic status of the patient has improved, a transition to IHD or SLED may be the best option. A device than can perform all three modalities in one is ideal.”
Quanta is ready to commercialize the Quanta Dialysis System with TKT software and expects to officially launch the product at the 2023 American Society of Nephrology Annual Meeting.
About Quanta Dialysis Technologies
Quanta Dialysis Technologies is committed to making dialysis accessible to every patient in every setting with its Quanta Dialysis System. As a portable device with performance comparable to larger, traditional machines, the Quanta Dialysis System is a modular and powerful solution that provides the clinical versatility needed to deliver dialysis care across multiple settings. With a simple-to-use and intuitive user interface, it is designed to be operated by a broad range of users to bring dialysis directly to patients.
The Quanta Dialysis System is commercially available in the United Kingdom for home and hospital use and in the United States, it is FDA-cleared (K222067) for use in chronic and acute care settings. It is not cleared for home or nocturnal use in the United States.
To learn more about Quanta and its products, visit quantadt.com.
Immatics Announces $35 Million Equity Investment from Bristol Myers Squibb
Immatics Announces $35 Million Equity Investment from Bristol Myers Squibb
Tuebingen, Germany and Houston, TX, 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.
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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
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 Twitter, Instagram 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.
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.