On March 13, 2019 Transgene (Euronext Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported that the NEOVIVA project was selected by the "Investments for the Future" (IFP) Programme (Programme d’Investissements d’Avenir) operated by Bpifrance for the development of an industrial sector focused on Transgene’s individualized immunotherapy platform myvac (Press release, Transgene, MAR 13, 2019, View Source [SID1234534268]). Under the agreement, the NEOVIVA project will receive €5.2 million over the five-year duration of the program from Bpifrance, of which Transgene will receive €2.6 million.

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Transgene holds the intellectual property of the myvac platform and is actively working to further develop this innovative technology in collaboration with its three French partners participating in the NEOVIVA project: HalioDx in Marseille, Traaser in Evry and the Curie Institute in Paris. The NEOVIVA project complements the already existing collaboration between Transgene and the Japanese company NEC focused on the clinical validation of an individualized immunotherapy based on artificial intelligence.

The goal of the NEOVIVA project is to develop and validate a manufacturing approach that would provide all solutions needed for the development of individualized immunotherapies. These are designed to stimulate the patient’s immune system to recognize and kill cancer cells by using their own genetic mutations. Two proof of concept clinical trials are being prepared in Europe and US for the treatment of HPV-negative head and neck cancers and ovarian cancer. These are expected to start in H2 2019.

"We would like to thank Bpifrance for its financial support which will accelerate the development of myvac. This funding is a further recognition of the myvac platform and reinforces our ambition to stand as a world leader in the development of individualized viral-vector (MVA) based immunotherapies. We believe the synergies among our partners and their respective teams are highly complementary and harness creativity which will lead to the success of our project. We are delighted to have access to our partners’ expertise through the NEOVIVA project," said Philippe Archinard, CEO and Chairman of Transgene.

Aïcha Douhou, Leader of the Health sector at the innovation department, Bpifrance commented: "We are delighted to support Transgene and its partners HalioDX, Traaser and the Curie Institute in their innovative approach for the design and development of individualized immunotherapy against solid tumors. We expect this project to further boost the development of Transgene bioproduction manufacturing unit for this individualized immunotherapy."

This consortium which combined bio-engineering, bioIT and a recognized know-how in viral vectorisation will be led by Transgene and each partner will contribute to the project as follows:

Transgene will be responsible for the project’s strategy and the clinical development plan. The product design for each patient will be generated in collaboration with NEC which will provide bioIT predictions needed to finalise the immunotherapy. Transgene will also manufacture the myvacTM clinical batches in its pilot manufacturing unit on the short timelines required for the treatment;
Traaser will be in charge of the interpretation of the genomic profiles determined by DNA sequencing. This will be used to facilitate, guide and secure the study of the individualized virotherapy artificial intelligence algorithms results;
HalioDx will study biomarkers to monitor and maximize the clinical efficacy of myvacTM with Immunogram, a high-tech clinical research platform that includes a suite of proprietary tests including Immunosign and the Immunoscore assay suite;
The Curie Institute (Immunotherapy Cancer Centre, led by Dr Amigorena) will contribute to the project in generating translational data and characterizing the therapy’s mechanism of action.

On March 13, 2019 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR, as of March 14, 2019), a clinical-stage biopharmaceutical company focused on the development of novel therapeutics for the treatment of rare diseases, reported the completion of its merger with Arsanis, Inc. (Nasdaq: ASNS, through March 13, 2019), effective as of March 13, 2019 (Press release, X4 Pharmaceuticals, MAR 13, 2019, View Source [SID1234534287]).

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"With the acquisition of synergistic R&D capabilities, X4 intends to establish a globally-recognized Center of Research Excellence to build upon our core science and technology, and to create long-term growth for a sustainable global rare disease business."

The holders of shares of X4 capital stock outstanding immediately prior to the merger received 0.5702 shares of Arsanis common stock in exchange for each share of X4 capital stock in the merger. On March 13, 2019, Arsanis is effecting a six-for-one reverse stock split. As a result of the reverse stock split, every six shares of Arsanis common stock outstanding following the merger, including the shares issued to the holders of shares of X4 capital stock in the merger, will be combined and reclassified into one share of Arsanis common stock. No fractional shares will be issued in connection with the reverse stock split. Instead, cash, based on the average closing price per share of Arsanis common stock on the Nasdaq Global Market on the 10 consecutive trading days prior to March 13, 2019, will be paid in lieu of fractions of shares.

Following the merger and the reverse stock split, the combined organization is expected to have approximately 6.7 million shares outstanding.

In connection with the merger, Arsanis will change its name to X4 Pharmaceuticals, Inc. The combined organization will commence trading on March 14, 2019 on the Nasdaq Capital Market under the symbol "XFOR".

The combined organization will operate under the leadership of X4’s management team prior to the merger, including Paula Ragan, Ph.D., President and Chief Executive Officer, and Adam S. Mostafa, Chief Financial Officer. The board of directors of the combined organization is comprised of six directors: four directors from the former X4 board, Michael S. Wyzga, Isaac Blech, Gary J. Bridger, Ph.D. and Dr. Ragan, and two directors from the former Arsanis board, David McGirr and René Russo, Pharm.D., BCPS. Mr. Wyzga is the new chairman of the board. The corporate headquarters of the combined organization is located in Cambridge, Massachusetts.

About WHIM Syndrome

WHIM syndrome is a primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene resulting in susceptibility to certain types of infections. WHIM is an abbreviation for the characteristic clinical symptoms of the syndrome: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis. There is no approved therapy for the treatment of WHIM syndrome.

On March 12, 2019 BioChain, a US-based company, reported that Epigenomics AG of Germany seriously violated the terms of an ongoing licensing contract by publicly announcing on March 6, 2019 the unilateral termination of BioChain’s licensing right of Septin9 marker in China (Press release, Biochain, MAR 13, 2019, View Source [SID1234534315]). The termination of the contract by Epigenomics is not legally effective.

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BioChain’s CEO, Grace Tian stated that according to the terms of the contract, disputes between the two parties require the parties to go through a mediation and arbitration process. BioChain filed a request with the contractually specified mediation and arbitration center on March 1, 2019 in accordance with the contract, before Epigenomics unilaterally terminated the contract.

BioChain and its affiliates, as the exclusive licensee of Septin9 marker in China, have diligently worked to expand its market position despite challenging market conditions, including the fact that one relevant patent of Epigenomics was invalidated in China and the news was publicly published in May 2018.

Tian said, "Epigenomics’ termination of the Septin9 contract has incurred damages to BioChain’s reputation and investment and BioChain will take further legal actions to protect its interests".

On March 13, 2019 Bellicum Pharmaceuticals presented an Investor Presentations (Press release, Bellicum Pharmaceuticals, MAR 13, 2019, View Source [SID1234534271]).

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On March 13, 2019 BioInvent International AB (OMXS: BINV) reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance, informing the company that a patent application relevant to its F.I.R.S.T. platform has been allowed and can proceed to grant (Press release, BioInvent, MAR 13, 2019, http://www.bioinvent.com/media/press-releases/releases?id=A2FA3A84867D4C4E [SID1234534288]). The patent is expected to be issued once BioInvent has responded to the Notice. It covers methods for differential biopanning.

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This patent, once issued, strengthens the protection in the US for BioInvent’s unique, function-based F.I.R.S.T. platform, which allows for simultaneous identification of clinically relevant target structures and matching antibodies.

The now allowed application is a so called continuation application based on a US patent that was granted in 2013. A similar patent was granted some years earlier by the European patent office, and it is valid in 20 European countries.