On March 5, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies and BostonGene Corporation (BostonGene), a leading company in AI-based molecular and immune profiling, reported the expansion of their collaboration for the randomized Phase I/II trial of TG4050, an individualized therapeutic vaccine for patients with head and neck cancers (Press release, NEC, MAR 5, 2024, View Source [SID1234640734]).

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BostonGene is partnering with NEC and Transgene to continue performing tumor molecular profiling and microenvironment analysis and provide high-throughput sequencing services. The partnership with BostonGene will enable fast turnaround of next-generation sequencing (NGS) data, and sophisticated analytics will enable comprehensive profiling of patient immune contexture.

TG4050, a personalized immunotherapy designed to stimulate the immune system of patients to induce a neoantigen specific T-cell response that can recognize and destroy tumor cells, is based on Transgene’s myvac platform and powered by NEC’s AI-driven Neoantigen Prediction System.

"Our collaboration with BostonGene has provided in-depth information on patient phenotypes in the Phase I trial. It has allowed us to understand the baseline status of our patients and how the tumor micro-environment (TME) might evolve following treatment," said Dr. Alessandro Riva, Chairman and CEO of Transgene.

"The combined expertise of Transgene, NEC and BostonGene will continue to provide a streamlined pipeline for the timely delivery of patient-tailored vaccines as well as data to guide the future development of new personalized treatment options, elevating the standard of care for head and neck cancer patients," said Masamitsu Kitase, Corporate SVP and Head of the Healthcare and Life Sciences Division at NEC Corporation.

"We are committed to supporting Transgene and NEC as they advance these clinical trials," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our molecular and immune profiling techniques comprehensively analyze the tumor, microenvironment, and immune system to identify key predictors of response to TG4050, ultimately improving treatment outcomes."

About myvac
myvac is a viral vector (MVA – Modified Vaccinia Ankara) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient’s immune system to recognize and destroy tumors using their own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded "Investment for the Future" funding from Bpifrance for the development of its platform myvac. TG4050 is the first myvac-derived product being evaluated in clinical trials.

About TG4050
TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) and machine learning (ML) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.

TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient.

Initial immunological and clinical data from the ongoing Phase I trial in the adjuvant treatment of HPV-negative head and neck cancers were presented at several conferences in 2023 and are very encouraging.

On March 4, 2024 Proen Therapeutics, a company specializing in the development of new anticancer drugs, reported that it has completed a strategic investment from global beauty and bio-healthcare company Korea Kolmar Holdings (Press release, ProEn Therapeutics, MAR 4, 2024, View Source;bmode=view&idx=19525174&t=board [SID1234649258]). Both parties agreed not to disclose the investment amount.

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This investment was conducted in an open innovation program jointly hosted by Korea Kolmar Holdings and the Hongneung Gangseo Special Zone Business Group to support the discovery of promising companies and investment activation by evaluating their technological prowess, marketability, and potential for follow-up collaboration, and Proen Therapeutics was selected as a result.

Proen Therapeutics is a company that has competitiveness in the development of antibody functional parts among antibody-drug conjugate (ADC) new drug development companies that have recently been receiving increasing attention worldwide.

The company’s ‘ArtBodyTM’ technology, a platform technology that develops cancer antigen-specific binding proteins optimized for ADCs, is a technology that can significantly improve toxicity to normal cells and tissues, which is a limitation of existing antibody-based ADCs. It is Proen Therapeutics’ exclusive platform technology that maximizes the selective binding characteristics of cancer cells.

As part of its strategic investment and open innovation cooperation, Korea Kolmar Holdings will continue to pursue joint development projects between its affiliates HK inno.N and Proen Therapeutics. As a top priority, it signed a joint development contract for a CAR-T new drug for the treatment of solid cancer.

Proen Therapeutics CEO Lee Il-han said, "Through this strategic investment and joint research agreement, we expect to discover competitive candidate substances and accelerate R&D through the synergy effects of the technologies owned by both companies."

On March 4, 2024 DotBio reported its lead candidate, DB007, has begun animal efficacy studies (Press release, DotBio, MAR 4, 2024, View Source [SID1234646740]). DB007 is a tri-specific antibody designed to reinvigorate exhausted immune cells to fight cancer more effectively. This study was conducted in the Agency for Science, Technology and Research (A*STAR).

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On March 4, 2024 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to A2B530 for the treatment of germline heterozygous HLA-A*02(+) patients with colorectal cancer that expresses carcinoembryonic antigen (CEA) and has lost HLA-A*02 expression (Press release, A2 Biotherapeutics, MAR 4, 2024, View Source [SID1234640748]).

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A2B530 is the first autologous logic-gated cell therapy developed from A2 Bio’s proprietary TmodTM platform. The Tmod platform utilizes a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. This novel design is aimed at tackling the fundamental challenge in solid tumor cancer medicines – the ability to selectively kill tumor cells and protect normal cells. A2B530 consists of an activator that targets CEA and a blocker that targets HLA-A*02.

Enrollment is ongoing in EVEREST-1 (NCT05736731), a seamless Phase 1/2 study to evaluate safety and efficacy of A2B530 in colorectal, pancreatic and non-small cell lung cancers.

"The FDA granting Orphan Drug Designation validates the tremendous unmet need for improved therapies for patients with colorectal cancer," said William Go, M.D., Ph.D, Chief Medical Officer of A2 Bio. "This designation supports our commitment to use our novel technology platform to develop new treatment options for patients with difficult-to-treat cancers."

FDA Orphan Drug Designation incentivizes the development of innovative drugs and biologics for the safe and effective treatment of rare diseases and conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies A2 Bio for certain development incentives related to the A2B530 clinical program, including tax credits for clinical trials, prescription drug user fee exemptions and potentially up to seven years of market exclusivity upon regulatory approval.

On March 4, 2024 Biomunex Pharmaceuticals, a French biopharmaceutical company specialized in the development of cutting-edge therapies through the discovery and development of bi- and multi-specific antibodies for the treatment of cancer, reported the signature of an exclusive license and exploitation agreement with Institut Curie (Press release, BIOMUNEX Pharmaceuticals, MAR 4, 2024, View Source [SID1234640747]). This agreement covers the development of a new class of antibodies, capable of specifically targeting and engaging MAIT cells to kill cancer cells. Biomunex, which was already co-inventor and a 50% co-owner of this unique innovative approach, now holds full worldwide rights.

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First identified and described in 1999 by Dr. Olivier Lantz, Director of the Clinical Immunology Laboratory at Institut Curie and scientific advisor to Biomunex, MAIT cells are a subpopulation of non-conventional T cells found throughout the body, particularly in mucosal and barrier tissues. MAIT cells are potent cytotoxic T cells capable of proliferating, migrating and infiltrating solid tumors.

Biomunex’s objective is to use these unique properties to develop MAIT engagers, a new class of antibodies capable of redirecting MAIT lymphocytes to eliminate cancer cells and induce the destruction of tumors, particularly solid tumors, while significantly reducing "dose-limiting" toxicity. This novel approach should also reduce the risk of cytokine release syndrome1, a serious adverse event often observed in immunotherapies based on T cell redirection targeting CD3, which are widely used today in cancer treatment.

In addition, MAIT cells present the MDR-12 protein on their surface, providing them with a natural resistance to some major chemotherapies. This property could enable the combination of MAIT engagers with chemotherapy, or their use directly before or after treatment: a key advantage compared with other T cell engagers.

This new approach has been developed through several collaborations with the Cancer Immunotherapy Center (Institut Curie, Inserm) headed by Dr. Sebastian Amigorena, Biomunex’s scientific advisor, and Dr. Olivier Lantz’s team at Institut Curie.

Building on its collaboration with Institut Curie, France’s first and leading cancer research center, and its advanced work on MAIT cells, Biomunex should soon initiate a Phase 1 clinical trial for the evaluation of its first MAIT engager in the treatment of solid tumors with a high unmet medical need, and in which MAIT cells are particularly present (e.g. colorectal, liver, gastric, lung, esophageal cancers, etc.). Biomunex currently develops two MAIT engager programs in preclinical stage with several others in discovery. Biomunex is currently expanding this approach in several directions (e.g. novel antibodies targeting MAIT cells, trispecific engagers, etc.).

"We are very pleased to announce the signing of this major agreement with Institut Curie, a leading institute in global oncology research and a major historical partner of Biomunex", said Dr. Pierre-Emmanuel Gerard, Founder and CEO of Biomunex. Dr. Simon Plyte, Chief Scientific Officer of Biomunex, added: "This agreement positions Biomunex as the world’s leading player in the disruptive field of MAIT engagers, based on the unique BiXAb best-in-class bi- and multi-specific antibody platform."

"The development of new immunotherapy approaches in oncology has become a key challenge if we are to provide an answer to the millions of cancer patients for whom standard treatments can no longer do anything," continued Dr. Sebastian Amigorena. "The research performed at Institut Curie has led to a major discovery which now opens up promising new therapeutic options. This agreement will enable Biomunex to initiate clinical development to harness the unique properties of MAIT cells and thus bring to life this breakthrough therapies for the benefit of patients", concluded Dr. Olivier Lantz.