Elthera and the Institute of Oncology Research in Bellinzona Receive Innosuisse Grant

On October 6, 2020 Elthera reported that it has been awarded a non-dilutive grant from the Swiss Innovation Agency (Innosuisse) with a total budget of more than CHF 1.0 M. In collaboration with the Institute of Oncology Research (IOR) in Bellinzona (Switzerland), Elthera will use the grant to validate the target L1CAM in rare types of cancer (Press release, Elthera, OCT 6, 2020, View Source;utm_medium=rss&utm_campaign=elthera-and-the-institute-of-oncology-research-in-bellinzona-receive-innosuisse-grant [SID1234568135]).

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Gunther Spohn, CSO of Elthera, commented: "We are excited to initiate this collaboration with IOR, one of the most renowned cancer research organizations in Switzerland. The Innosuisse funds will allow us to explore the therapeutic potential of our anti-L1CAM compounds in rare types of cancer, which are not adequately treated with current therapies. By combining Elthera’s knowledge in the development of therapeutic antibodies and IOR’s expertise in basic and translational research in rare cancer types we aim to develop new efficacious immunotherapies for diseases, which are often neglected by global drug development companies."

Prof. Francesco Bertoni, Deputy Director of IOR, commented: "The collaboration with Elthera will allow us to elucidate the role of L1CAM in the development and progression of rare malignancies, where a high medical need for better treatment exists. By elucidating L1CAM-dependent disease mechanisms and establishing the efficacy of Elthera’s anti-L1CAM compounds in preclinical disease models, we aim to lay the ground for new and better therapies for the affected patients."

Halozyme Announces Expansion Of Collaboration And License Agreement With argenx For ENHANZE® Technology

On October 6, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Halozyme and argenx are expanding their existing global collaboration and license agreement that was signed in February 2019 (Press release, Halozyme, OCT 6, 2020, View Source [SID1234568134]).

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Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme’s ENHANZE drug delivery technology for three additional targets upon nomination for a total of up to six targets under the existing and newly expanded collaboration. To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn and complement component C2.

"We are pleased to be expanding the scope of our collaboration with Halozyme and to continue our productive relationship. We recognize that patients have different preferences and we want to secure our ability to offer subcutaneous delivery of our current and future candidates to reach as many patients as possible. We already have exclusive access to ENHANZE for our FcRn antagonist efgartigimod, which is in late stage development for multiple severe autoimmune diseases, and additionally have nominated our complement inhibitor targeting C2," said Keith Woods, Chief Operating Officer of argenx.

"We are delighted that argenx has agreed to expand our global collaboration and license agreement to include up to six targets," said Dr. Helen Torley, president and chief executive officer. "argenx has made rapid progress in the clinic with efgartigimod utilizing ENHANZE since signing the original agreement, moving to a Phase 2 study initiation for an indication being developed only as SC, within just fourteen months. argenx is also working to bring SC efgartigimod to patients suffering from myasthenia gravis following the successful ADAPT trial results."

Chugai Enters into a License Agreement for Chugai’s Antibody Engineering Technologies with argenx

On October 6, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has entered into a license agreement with argenx that grants argenx worldwide non-exclusive rights for Chugai’s antibody engineering technologies (Press release, Chugai, OCT 6, 2020, View Source [SID1234568132]).

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Under the terms of the agreement, argenx will receive the rights to use two Chugai’s antibody engineering technologies (SMART-Ig and ACT-Ig) for their research activities, and option to develop and market therapeutic antibodies applying those technologies. In return for the license, Chugai will receive a fee for technology access. In case argenx creates a candidate antibody and exercises the option, Chugai will receive upfront payment, milestone payment according to the development status, and royalty payment if the compound is launched as an approved antibody drug.

Halozyme Announces Expansion Of Collaboration And License Agreement With argenx For ENHANZE® Technology

On October 6, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Halozyme and argenx are expanding their existing global collaboration and license agreement that was signed in February 2019 (Press release, Halozyme, OCT 6, 2020, View Source [SID1234568121]).

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Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme’s ENHANZE drug delivery technology for three additional targets upon nomination for a total of up to six targets under the existing and newly expanded collaboration. To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn and complement component C2.

"We are pleased to be expanding the scope of our collaboration with Halozyme and to continue our productive relationship. We recognize that patients have different preferences and we want to secure our ability to offer subcutaneous delivery of our current and future candidates to reach as many patients as possible. We already have exclusive access to ENHANZE for our FcRn antagonist efgartigimod, which is in late stage development for multiple severe autoimmune diseases, and additionally have nominated our complement inhibitor targeting C2," said Keith Woods, Chief Operating Officer of argenx.

"We are delighted that argenx has agreed to expand our global collaboration and license agreement to include up to six targets," said Dr. Helen Torley, president and chief executive officer. "argenx has made rapid progress in the clinic with efgartigimod utilizing ENHANZE since signing the original agreement, moving to a Phase 2 study initiation for an indication being developed only as SC, within just fourteen months. argenx is also working to bring SC efgartigimod to patients suffering from myasthenia gravis following the successful ADAPT trial results."

Transgene, NEC and BostonGene Announce Strategic Collaboration for Two Ongoing Clinical Trials for Patients with Ovarian and Head & Neck Cancers

On October 6, 2020 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 and network technologies, and BostonGene Corporation (BostonGene), a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a strategic collaboration for two ongoing Phase 1 clinical trials of TG4050, an individualized therapeutic vaccine for ovarian and head & neck cancers based on Transgene’s proprietary myvac platform and NEC’s AI-driven Neoantigen Prediction System in Europe and the United States (Press release, NEC, OCT 6, 2020, View Source [SID1234568106]).

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Transgene’s myvac platform brings together a series of highly innovative technologies, such as viral genome engineering, to achieve high-speed modular manufacturing of bespoke immunotherapies.

TG4050 is an individualized cancer vaccine based on the myvac platform; it is based on an optimized viral platform for cancer vaccination and integrates NEC’s artificial intelligence capabilities. This therapeutic vaccine aims at stimulating the immune system of patients to induce a T-cell response against tumor-specific antigenic alterations, called neoantigens. These neoantigens are derived from genomic mutations and selected using NEC’s Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. TG4050 has been designed to target up to 30 patient-specific neoantigens. Transgene is sponsoring two Phase 1 trials that are expected to deliver a first proof of concept of this virus-based individualized approach.

As part of the collaboration, BostonGene will conduct genomic and transcriptomic analyses of primary patient tumors collected from patients enrolled in these two clinical trials to identify predictors of response to TG4050 and the cancer cell-intrinsic and -extrinsic factors that may mediate each patient’s response to the vaccine. BostonGene’s platform integrates the genomic and transcriptomic analyses to simultaneously assess the activity of the tumor and the microenvironment through the identification of significant somatic alterations, evaluation of gene expression, estimation of tumor heterogeneity and classification of the microenvironment.

BostonGene generates a Tumor Portrait Report, involving the data-driven, visually appealing and self-explanatory tumor schematics elegantly depicting tumor activity, tumor cellular composition, and functionality of the immune-microenvironment and other tumor-associated processes. The comprehensive report will provide insights into the individual oncogenic state and immunogenicity of the patient’s tumor.

"BostonGene’s unique solution and deep expertise in Next Generation Sequencing (NGS) analysis provide us with the detailed profiles of a tumor and its micro-environment. These Tumor Portrait Reports will help us look at our patient data in light of the current published evidence and could help us accelerate the development of TG4050," said Éric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene. "This novel way of analyzing patient data is part of an ambitious translational program that supports the development of our myvac platform. By integrating these types of approaches into our studies, we seek to build an integrated framework for the use of viral-based immunotherapeutics."

"NEC looks forward to strengthening its collaboration with BostonGene through these trials of TG4050. BostonGene’s advanced analysis of NGS among cancer patients provides excellent profiling that we believe will add important insight into the understanding of each patient’s tumor environment and how it reflects on the clinical outcomes of our treatment," said Osamu Fujikawa, Senior Vice President at NEC Corporation.

"BostonGene is proud to support Transgene and NEC during these critical Phase 1 clinical trials," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "This collaboration represents our ongoing commitment to improve immunotherapy options and transform personalization of treatment for cancer patients."

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) 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 for each patient and can be produced in a very short time frame.

This best-in-class candidate is being evaluated in two Phase 1 clinical trials for patients with ovarian cancers (new windowNCT03839524) and HPV-negative head and neck cancers (new windowNCT04183166).

About myvac
myvac is a viral vector (MVA) 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, recognize and destroy tumors using the patient’s 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 NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction utilizes its proprietary artificial intelligence (AI), such as graph-based relational learning, which is combined with other sources of data to discover candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a primary focus placed on its in-house major histocompatibility complex (MHC) binding affinity prediction trained on public and proprietary datasets. These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient.