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."

On January 15, 2020 CoImmune, Inc. and Formula Pharmaceuticals, Inc. announced today the merger between the two companies, bringing together two therapeutic immuno-oncology platforms (Press release, CoImmune, JAN 15, 2020, View Source [SID1234638183]).

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Upon completion of the merger of Formula Pharmaceuticals into CoImmune, bringing forth access to all of Formula Pharmaceuticals’ tangible and intangible assets, the merged company will continue to focus on running a Phase 2b trial for lead asset, CMN-001, in advanced renal cell carcinoma and a Phase 1 trial for CAR-CIK (cytokine-induced killer cells) in acute lymphoblastic leukemia. This proprietary non-viral, allogeneic CAR-CIK technology platform has the potential to overcome commercial limitations related to existing CAR-T approaches that require autologous blood and viral transfection. The close of the deal will be accompanied by a $6MM investment in the combined entity to fund the CAR-CIK program.

"We are excited about the opportunity of bringing together two therapeutic immuno-oncology platforms to maximize our clinical and commercial value as a result of merger," said Charles Nicolette, Chief Executive Officer of CoImmune. He continued that "CoImmune has a compelling Phase 2b program with lead candidate, CMN-001, and a strong team to advance its pipeline. We evaluated numerous potential merger and acquisition opportunities and believe that Formula has a best-in-class allo CAR-based technology and a solid base of investors which can deliver significant value. We believe that both companies complement each other, and together, this relationship will enable us to continue to advance our therapies toward US FDA approval in the near future."

Additionally, CoImmune intends to execute sponsored research contracts with the M. Tettamanti Research Center, University of Milano-Bicocca and MBBM Foundation, San Gerardo Hospital to conduct non-clinical research and other necessary work for the development of CAR-CIK in Monza, Italy. CoImmune plans to establish a Joint Steering Committee to organize its activity in Monza and offer Dr. Andrea Biondi, Scientific Director of the M. Tettamanti Research Center, a role on CoImmune’s Clinical Advisory Board.

Dr. Lucio Rovati, CEO of Rottapharm Biotech S.r.l. will join the Board of Directors of the post-merger combined company.

On January 15, 2020 Artisan Bio, Inc., a stealth cell therapy engineering company, reported that it has entered into a global research and collaboration agreement with Takeda Pharmaceutical Company Limited ("Takeda") for the discovery, development, and commercialization of novel cell therapy products (Press release, Artisan Bio, JAN 15, 2020, View Source [SID1234572330]).

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"Many limitations that exist in current generation cell therapies can be addressed through the precision engineering of cells for enhanced performance."
– Ryan T. Gill, CEO, Artisan Bio

Under the terms of the agreement, Artisan Bio will deploy its STAR platform and synthetic biology expertise to construct customized and precisely engineered cell therapies. Artisan will lead discovery efforts, including gene editing, and Takeda will be responsible for the development, manufacturing, and commercialization of the resulting cell therapy products

"We are thrilled to collaborate with Takeda and combine our advanced cell engineering capabilities with Takeda’s visionary cellular therapy programs," said Ryan T. Gill, CEO of Artisan Bio. "Many limitations that exist in current generation cell therapies can be addressed through the precision engineering of cells for enhanced performance. This collaboration will accelerate the availability of more effective next-generation cellular therapies for patients with high unmet needs."

On January 15, 2020 Bloom Science, a biopharmaceutical company focused on the discovery and development of precision living medicines for currently untreatable neurological diseases, reported signing of an agreement with Duke University, granting the Company an option to an exclusive license to intellectual property and technology related to unique strain isolates and libraries of genetic variants of Akkermansia genus bacteria developed in the laboratory of Raphael H. Valdivia, Ph.D (Press release, Bloom Science, JAN 15, 2020, View Source [SID1234556211]). The underlying principle of Dr. Valdivia’s approach is to isolate, characterize and genetically alter Akkermansia to understand how this beneficial microbe’s genes contribute to promoting immunological health. Bloom will leverage the technology to develop heirloom strain Akkermansia therapeutics, genetically optimized strains and discover novel chemical composition of the Akkermansia metabolome.

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"Multiple reported animal studies have demonstrated the high therapeutic potential of Akkermansia muciniphila in amyotrophic lateral sclerosis, epilepsy, multiple sclerosis, immune oncology, progeroid syndrome and metabolic diseases," said Christopher Reyes, PhD, CEO of Bloom Science. "Dr. Valdivia and his team’s extensive research will be foundational to our therapeutic development platform and furthers our strategy of investing in and expanding our multi-faceted approach to leveraging the gut-brain axis to discover and develop breakthrough therapies for the largest number of patients."

"We are very excited for the opportunity to generate Akkermansia strains with the most beneficial activities and accelerate their application as potential therapeutics, " said Dr. Valdivia, who will be joining Bloom as a scientific founder.

The financial terms of the agreement have not been disclosed.