On January 16, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that its wholly-owned Seattle-based subsidiary company Just – Evotec Biologics, Inc. has established a collaborative relationship with OncoResponse, Inc., a biotech company developing human antibodies as product candidates for multiple high value targets associated with immunosuppressive myeloid biology (Press release, Evotec, JAN 16, 2020, View Source;announcements/press-releases/p/just—evotec-biologics-announces-product-development-and-manufacturing-agreement-with-oncoresponse-5899 [SID1234553255]). OncoResponse’s lead antibody product candidate, OR2805, is a fully human antibody derived from an elite responder that reverses immunosuppression in the tumour microenvironment and promotes greater cancer killing that will lead to higher response rates and more cures.

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Under the agreement, Just – Evotec Biologics will leverage its integrated technology platform, J.DESIGN, to provide OncoResponse with services to accelerate OR2805 into the clinic. The services include cell line development, process development, and Phase I/II cGMP clinical manufacturing of a selected drug candidate for use in human clinical trials.

Clifford Stocks, Chief Executive Officer of OncoResponse, commented: "We are thrilled to have Just – Evotec Biologics develop and manufacture our lead therapeutic antibody. Just – Evotec Biologics’ background, expertise and guidance combined with their track record and unique technology platform will play a critical role in the successful production of our molecule for clinical studies."

Dr James Thomas, EVP Global Head Biotherapeutics, President U.S. Operations at Just – Evotec Biologics, commented: "We are delighted to be working with the experienced and dynamic team at OncoResponse on the development and manufacturing of this exciting immunotherapy approach to cancer."

On January 16, 2020 BioNTech and Neon Therapeutics reported that they have entered into a definitive merger agreement under which BioNTech will acquire Neon in an all-stock transaction valued at approximately $67.0 million (Press release, BioNTech, JAN 16, 2020, View Source [SID1234553275]). Neon is a biotechnology company developing novel neoantigen-based T cell therapies. Upon closing, it will operate as a subsidiary of BioNTech, a global clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases. The transaction will combine two organizations with a common culture of pioneering translational science and a shared vision for the future of cancer immunotherapy.
Neon has deep expertise in the development of neoantigen therapies, with both vaccine and T-cell capabilities. Neon’s most advanced program is NEO-PTC-01, a personalized neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor. Neon is also advancing a precision T cell therapy program targeting shared neoantigens in genetically defined patient populations. The lead program from this approach, NEO-STC-01, is a T cell therapy candidate targeting shared RAS neoantigens. In addition, Neon has assembled libraries of high-quality TCRs against various shared neoantigens across common HLAs.

Neon’s pipeline is underpinned by its platform technologies including RECON, its machine-learning bioinformatics platform, and NEO-STIM, its proprietary process to directly prime, activate and expand neoantigen-targeting T cells ex vivo.

Transaction Details

Under the terms of the definitive agreement, Neon will, following consummation of the acquisition, merge with Endor Lights, Inc., a Delaware corporation and a direct, wholly-owned subsidiary of BioNTech and become a wholly-owned subsidiary of BioNTech. At closing, BioNTech will issue, and Neon shareholders will receive 0.063 American Depositary Shares (ADS) (each ADS representing one ordinary share of BioNTech) in exchange for each of their shares of Neon. The exchange ratio implies a deal value of $67 million, or $2.18 per share of Neon, based on the closing price of BioNTech’s ADSs of $34.55 on Wednesday, January 15th, 2020.

The transaction was unanimously approved by both BioNTech’s and Neon’s boards of directors. The transaction, which is expected to close during the second quarter of 2020, is subject to approval of Neon’s shareholders and the satisfaction of customary closing conditions. Certain stockholders of Neon owning approximately 36% of the outstanding Neon shares have entered into voting agreements, pursuant to which they have agreed, among other things, and subject to the terms and conditions of the agreements, to vote in favor of the Neon acquisition.

Ondra Partners is acting as the exclusive financial advisor to Neon and Goodwin Procter LLP is acting as legal counsel to Neon. Duff & Phelps LLC provided a fairness opinion to Neon’s board of directors in connection with the transaction. Covington & Burling LLP is acting as legal counsel to BioNTech.

On January 16, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX), dedicated to the early detection of skin cancer, reported that a total of 5,990,000 stock options have been granted to directors (2,020,000 options), Officers (1,580,000 options) and employees and consultants (2,390,000 options) (Press release, MedX Health, JAN 16, 2020, View Source [SID1234553293]). The options are all exercisable at the price of $0.17 per share, valid for a period to December 31, 2024, and vest immediately. The Company notes that a total of 7,150,000 stock options previously granted in 2014 expired unexercised on November 26, 2019. At this time there are a total of 21,200,000 options available for grant under the Company’s Incentive Stock Option Plan, of which a total of 17,765,000 are currently subject to grants, at a weighted average exercise price of $0.197, and 3,435,000 remain available for grant under the Plan.

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On January 16, 2020 AI Therapeutics is a clinical-stage biopharmaceutical company that has created an artificial intelligence-driven drug development platform for matching drugs to new indications (Press release, AI Therapeutics, JAN 16, 2020, View Source [SID1234553256]). The company has made significant recent progress with its four clinical assets and proprietary Guardian Angel algorithm.

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LAM-002 is a first-in-class, PIKfyve kinase inhibitor that activates transcription factor EB (TFEB), the master regulator of lysosomal biogenesis (1). TFEB activation clears toxic aggregates that drive neurodegenerative disorders (2-4). Dr. Murat Gunel, Nixdorff-German Professor of Neurosurgery and Professor of Genetics and of Neuroscience at Yale University and a member of AI Therapeutics’ Scientific Advisory Board indicated, "A wealth of new data points to the accumulation of toxic proteins as a common mechanism in neurodegenerative conditions disorders including amyotrophic lateral sclerosis (ALS), Parkinson’s disease and Alzheimer’s disease. We look forward to bringing the most advanced PIKfyve inhibitor into clinical development for patients suffering from ALS. We are pleased that our Guardian Angel platform made the connection of LAM-002 to ALS and that the finding was validated in our laboratories and with our collaborators, as well as in independent research published in Nature Medicine (5)."

Through its action on the lysosome, LAM-002 also selectively kills tumor cells. AI Therapeutics has recently completed enrollment in a clinical trial with patients previously treated for follicular lymphoma. Efficacy has been observed with LAM-002 as a single agent and when combined with rituximab or atezolizumab. LAM-002 appears to be well-tolerated with patients on continuous treatment for well over a year. Dr. Sarah Rutherford, Assistant Professor at Weill Cornell Medicine noted "LAM-002 represents a novel targeted approach to treat patients with follicular lymphoma. Our patients have shown durable objective responses while on LAM-002 therapy without the adverse effects often associated with other drugs."

AI Therapeutics is also pleased to announce that it had a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the registrational program for LAM-002 in patients with previously treated follicular lymphoma. At this meeting, AI Therapeutics reached concurrence on the design of a pivotal trial that could support accelerated approval. The clinical data to support full approval in patients with previously treated follicular lymphoma was also discussed and a path forward was detailed.

LAM-002 has received Fast Track status and Orphan Drug Designation from the FDA for the therapy of follicular lymphoma. The safety and clinical data for LAM-002 are expected to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference in 2020.

On January 16, 2020 Syndivia, a biotechnology company focused on the development of new therapeutic modalities for solid cancers based on specific targeting of the tumor microenvironment and anatomical hallmarks, reported that it has been granted an exclusive, worldwide sublicense by SATT Sud-Est to the immunoconjugates of the anti‑CD146-ts antibody (excluding diagnosis), which binds a tumor-specific form of CD146 found on a number of solid cancers (Press release, Syndivia, JAN 16, 2020, View Source [SID1234553294]). CD146-ts has a central role in the mechanism of tumorigenesis and has the potential to address a current unmet need in cancer therapy. The development of novel biologic entities (NBE) targeting CD146-ts will be undertaken by Syndivia in Strasbourg, France.

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Commenting on this deal, Dr. Sasha Koniev, Syndivia’s CEO, said "We are excited to have been granted the sole and exclusive sublicense to commercialize the immunoconjugates against this tumor-specific form of CD146. We are enthusiastic about the addition of this candidate to the Syndivia discovery pipeline and will leverage our expertise in bioconjugation to rapidly progress its preclinical development."

"We are extremely pleased that Syndivia shares our excitement for the CD146-ts mAb project and look forward to the next stages of development with great enthusiasm," said Dr. Marcel BLOT-CHABAUD, inventor of anti-CD146-ts antibody and leader of the "New Molecular Targets" team at C2VN, Aix-Marseille Université, INSERM, INRA, Marseille, France.

"We could not be any happier when transferring such a first-in-class opportunity for the treatment of solid cancers, with the sole aim of transforming the invention into an innovation – especially when the nature of the identified target makes it possible to identify a relevant lead for the most aggressive and refractory forms to current treatments," concluded Laurent BALY, President of SATT Sud-Est.

Syndivia will undertake further development and commercialization of anti-CD146-ts immunoconjugates in exchange for undisclosed upfront, milestone and royalty payments to SATT Sud-Est.

About CD146-ts

CD146-ts represents a novel target in a number of the deadliest therapeutic indications in oncology, including melanoma and pancreatic cancer. Due to its important role in tumorigenesis and confirmed tumor-specific expression in patient-derived samples, anti-CD146-ts immunoconjugates have the potential to become new therapeutic modalities in a number of solid cancer indications.

About C2VN (Aix-Marseille Université, INSERM, INRA)

The Cardiovascular and Nutrition Research Centre (C2VN, UMR_S 1263, UMR 1260, Aix-Marseille Université, INSERM, INRA) shows expertise in all pathways and targets involved in pathologies with a vascular component, including cancer pathology, with the aim of identifying innovative biomarkers and biotherapies. To support its studies, the C2VN has developed many platforms, tools and experimental models related to the targeted pathologies. For more information, visit View Source

About SATT Sud-Est ­| From dream to reality, from lab to market

A researcher and his/her team make an extraordinary discovery. But how can an idea be transformed into a solution, and how can an invention be turned into an innovation? This is the start of a race against time to find the partner company capable of upholding that ambition. Fortunately, SATT Sud-Est is there to help in this undertaking and make this great story come true. Transforming an invention into an innovation is a wonderful experience. And we’re fortunate, it is our job. Find out how SATT Sud-Est accelerates technology transfer by bringing together research and business players. From the patent to the operating license agreement, SATT Sud-Est stands out in France’s South and Corsica regions as an essential innovation player. Visit www.sattse.com and Twitter @SATTse_.