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 Admera Health reported that will present in the PMWC 2020 Clinical Diagnostics Showcase for selected organizations, to exhibit their latest advancements, insights, applications, and technologies to an audience of clinicians, leading investigators, academic institutions, pharma and biotech, investors, and potential clients (Press release, Admera Health, JAN 16, 2020, View Source [SID1234553273]).

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Event | Location: Precision Medicine World Conference 2020 | Santa Clara Convention Center
Presenter: Ruben Bonilla-Guerrero, MD, FACMG, FAACC, Medical Director, Admera Health
Date | Time: Friday, January 24th, 2020 | 11:30 a.m. Pacific Time
Program | Track: Silicon Valley Program | Track 6

On January 16, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biopharmaceutical company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported new findings in its collaboration with Univo Pharmaceuticals (TASE:UNVO) characterizing the effects of cannabinoids on diseases mediated through the A3 adenosine receptor (A3AR) (Press release, Can-Fite BioPharma, JAN 16, 2020, View Source [SID1234553257]). Joint research shows that certain cannabinoid-based formulations exert a highly potent beneficial effect on diseased cells by binding to A3AR, and these findings present new opportunities for the development of cannabinoids in the treatment of a variety of diseases in which there is an overexpression of A3AR. Can-Fite filed a patent application titled "Cannabinoids for use in treating A3 adenosine receptor-associated conditions" based on these findings, and covering all the clinical indications in which A3AR is overexpressed.

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Can-Fite, a global leader in discovering and developing drugs which target A3AR, is collaborating with Univo Pharmaceuticals and utilizes its platform technology within the framework of this collaboration to develop cannabinoids for the treatment of large unmet medical needs. Can-Fite announced a strategic partnership with Univo Pharmaceuticals, a medical cannabis company, in September 2019, and Univo’s CEO Golan Bitton joined Can-Fite’s Board of Directors in December 2019.

Dr. Ilan Cohen, Co-Founder and Chairman of the Board at Can-Fite, and a senior partner of Reinhold Cohn & Partners the largest IP firm in Israel, stated, "This new patent application is an important addition to the different patent families containing issued patents and pending patent applications relating to the use of ligands that target the A3 adenosine receptor and which bind and activate the target to yield different therapeutic effects. If issued, we expect this patent will be a very valuable addition to Can-Fite’s patent portfolio. We believe Can-Fite and Univo together are ideally positioned to lead in the invention and development of cannabinoid-A3AR drugs and the companies are establishing foundational IP assets for these inventions."

Can-Fite CEO Dr. Pnina Fishman added, "Our unique approach to developing cannabis derived pharmaceuticals, utilizing the A3 adenosine receptor as a filter, serves as an additional barrier of protection of our innovative findings for the use of cannabinoids for a variety of clinical applications. As the medical community is now recognizing the opportunities within this exciting area, it is important that we protect our innovative approach and the investments that we made along the way. In addition to our small molecule drugs, Piclidenoson and Namodenoson, which are currently in Can-Fite’s advanced stage clinical pipeline, we now have the opportunity to develop a whole new class of cannabinoid-A3AR drugs in partnership with Univo."

Golan Bitton, Univo’s CEO commented, "We are very pleased with the first success from the strategic partnership between Univo and Can-Fite. The new discovery and its potential is a testament to the research and development capabilities of both companies. We look forward to accelerating our collaboration to develop promising cannabinoid-based drugs."

According to Adroit Market Research, the medical cannabis market is projected to grow at a CAGR of 29% to $56.7 billion by 2026.

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 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."