On April 14, 2020 Case Western Reserve University reported a new $6 million, five-year grant from the National Institutes of Health extends funding for the Silvio O. Conte Cleveland Digestive Diseases Research Core Center (DDRCC), a cross-institutional collaboration of digestive disease investigators (Press release, Case Western Reserve University, APR 14, 2020, View Source [SID1234556299]).

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In 2015, an initial $6 million, five-year NIH grant established the DDRCC as one of only 17 in the country. (There are now 18.)

The Cleveland collaborative, which includes the Case Western Reserve University School of Medicine, Cleveland Clinic, University Hospitals Cleveland Medical Center (UH) and the Louis Stokes Cleveland VA Medical Center (LSCVAMC), works to develop and advance research on digestive inflammation, gastrointestinal cancer and liver and metabolic diseases.

"The overall objective of the Cleveland DDRCC," said Fabio Cominelli, professor of medicine and pathology and associate dean for program development at the School of Medicine and the center’s director, "is to increase the availability of resources for center members and foster research, collaborations and new directions in digestive disease research, leading to important scientific discoveries."

Cominelli, the Herman Menges, MD Professor in Internal Medicine at the School of Medicine and chief scientific officer of the Digestive Health Institute at UH, is an internationally recognized expert in such conditions as inflammatory bowel disease, Crohn’s disease, gastrointestinal cancer and ulcerative colitis.

The Cleveland DDRCC’s mission is to:

Enhance the research capabilities of its investigators;
Develop and implement programs to support young investigators;
Attract established investigators not currently involved in digestive disease research;
Facilitate the translation of basic research discoveries to the clinical arena.
The center currently includes 47 full members and 35 associate members from 25 academic departments across Case Western Reserve, Cleveland Clinic, UH and LSCVAMC, representing a steady expansion during the previous funding cycle.

Together, these investigators comprise the center’s research base, which consists of $17.3 million in peer-reviewed federal and foundation grants for two specific focus research areas—digestive inflammation and tumorigenesis, and liver disease and metabolism.

On April 14, 2020 Hansoh Pharma (3692:HK), a leading biopharmaceutical company in China, and Atomwise, the leader in artificial intelligence (AI) for drug discovery, reported the expansion of their strategic partnership for AI-accelerated drug discovery (Press release, Atomwise, APR 14, 2020, View Source [SID1234556296]). Expansion of the partnership immediately follows completion of their first hit-discovery collaboration, which successfully identified and experimentally confirmed several novel hit compounds for a previously challenging oncology target in only 4 months.

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The collaboration began in November 2019, focusing on identifying hit compounds that are specific towards an intractable drug target. Atomwise performed AI-based molecular screening using their proprietary AI technology, AtomNet, to generate compound hits with predicted activity against multiple mutant forms of the oncology targets for Hansoh. With AtomNet, the collaboration was able to screen an ultra-large and diverse virtual library of over 12 billion compounds, finding 200 predicted candidates displaying specificity for the targets in only 2 weeks from a single virtual screen.

"We are really impressed by Atomwise’s capability to deliver potential candidates," said Rudi Bao, M.D. Ph.D., SVP of Hansoh R&D. "Our expanded partnership will accelerate major initiatives to discover innovative medicines for patients."

"It is a privilege to partner with Hansoh Pharma to develop their first-in-class or best-in-class portfolio of novel small molecule therapies," said Dr. Abraham Heifets, CEO of Atomwise. "Therapies with high specificity and potency are urgently needed for oncology, infectious diseases, and personalized medicine. We look forward to expanding our work with Hansoh on additional challenging targets."

On April 14, 2020 Intensity Therapeutics reported it has entered into a clinical trial collaboration agreement with Bristol Myers Squibb Company (NYSE: BMY) (Press release, Intensity Therapeutics, APR 14, 2020, View Source [SID1234556294]). The program will evaluate the safety and efficacy of Intensity’s lead product INT230-6, an investigational, novel and potent anti-cancer drug designed to directly kill cancer cells through intratumoral injection and improve immune cell recognition of cancer, when dosed in combination with Bristol Myers Squibb’s Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) immune checkpoint inhibitor Yervoy (ipilimumab). The combination will be evaluated in patients with breast cancer, liver cancer and advanced sarcoma in a series of new cohorts within IT-01, Intensity’s ongoing Phase 1/2 clinical trial. Intensity will sponsor and conduct the clinical trial and Bristol Myers Squibb will supply Yervoy for use in the study.

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"We are excited to have entered into this clinical collaboration with Bristol Myers Squibb, a global leader and pioneer in immuno-oncology," said Lewis H. Bender, President and CEO of Intensity Therapeutics. "This new collaboration builds upon our other partnerships to evaluate the potential of INT230-6 in combination with immunotherapy. A joint publication with the National Cancer Institute last year, showed remarkable synergy with the combination of INT230-6 and CTLA-4 antibodies in nonclinical in vivo models. The ability to combine our drug in the clinic with Yervoy, may benefit patients with cancers that have high unmet medical need. Results from this collaboration could accelerate the timeline for clinical development and approval of our drug."

Ian. B. Walters, M.D., Intensity’s Chief Medical Officer, added, "We will be able to evaluate the combination of INT230-6 and Yervoy in a variety of difficult-to-treat tumor types. To date, our Phase 1/2 study has produced solid evidence of activity with INT230-6 as a single agent, as well as a favorable safety profile, in patients with a variety of highly refractory, advanced cancers. In our studies we have also shown systemic immune activation and local recruitment of immune cells in treated tumors. The combination cohorts should enable further expansion of the immune response."

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responses in animals with long-term, protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity’s collaborative research, published in July 2019 in the Journal OncoImmunogy, showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.

On April 14, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC QB: IPATF), a global leader in therapeutic antibody discovery and development, reported that it, through its subsidiary Talem Therapeutics, has entered into a research license agreement (the "Agreement") with Janssen Research & Development, LLC ("Janssen"), providing Janssen exclusive access to a panel of novel, monoclonal antibodies against an undisclosed target (Press release, ImmunoPrecise Antibodies, APR 14, 2020, View Source [SID1234556293]). Pursuant to the Agreement, Janssen holds an option to acquire all commercial rights to the antibodies. The financial details of the transaction have not been disclosed.

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"This Agreement validates Talem’s business concept in early antibody discovery and development," said Ilse Roodink, Chairwoman of Talem’s Scientific Advisory Committee and Scientific Director at IPA Europe. "It is a significant milestone to see this exclusive agreement through Talem finalized with Janssen, a company so well positioned to further develop and maximize the potential of these lead candidates for clinical applications."

"Talem continues to build a therapeutic program pipeline for commercial partnering, thus optimizing shareholder value creation based on IPA’s infrastructure across Europe and North America," added Jennifer Bath, President and CEO of IPA.

On April 14, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) reported that the companies have entered into a global license, development and commercialization agreement to further develop and commercialize MEI’s ME-401, an oral, once-daily, investigational drug-candidate, selective for phosphatidylinositol 3-kinase delta (PI3Kδ), in clinical development for the treatment of B-cell malignancies (Press release, MEI Pharma, APR 14, 2020, View Source [SID1234556292]). MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S., with MEI booking all revenue from U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

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ME-401 is being studied in the ongoing Phase 2 TIDAL clinical trial evaluating patients with relapsed or refractory follicular lymphoma which, subject to results, may support an accelerated approval of a marketing application with the U.S. Food and Drug Administration (FDA). An ongoing Phase 1b study is evaluating ME-401 as a monotherapy and in combination with rituximab (Rituxan) or zanubrutinib (Brukinsa) in patients with B-cell malignancies. Also, a Phase 1 study was initiated in 2019 evaluating ME-401 as a monotherapy in patients with indolent B-cell malignancy in Japan.

"This global partnership with Kyowa Kirin is a key step to achieving our goal of broadly developing and commercializing ME-401, optimizing the opportunity to benefit patients across multiple B-cell malignancies inside and outside the U.S., and also building value for our shareholders," said David M. Urso, J.D., chief operating officer & general counsel of MEI Pharma. "The decision to expand our alliance with Kyowa Kirin is based on the successful relationship we’ve built working together to date under our 2018 Japan license agreement, and the respect we have for Kyowa Kirin and their ability to jointly execute our shared vision of ME-401 in the U.S. and around the world."

"I am delighted to expand our agreement with MEI Pharma for the development and commercialization of ME-401 all over the world," said Tomohiro Sudo, Executive Officer, Director of Strategic Product Planning Department for Kyowa Kirin. "We believe that ME-401 may be an important new treatment option for patients and further enhances our global oncology pipeline."

About the Global License, Development and Commercialization Agreement

Under the terms of the agreement, which substantially retains and consolidates the terms of the 2018 license agreement between MEI and Kyowa Kirin to develop and commercialize ME-401 in Japan, MEI will receive a $100 million upfront payment from Kyowa Kirin. MEI is also eligible to receive up to $582.5 million in additional payments from Kyowa Kirin depending on the achievement of certain U.S. and ex-U.S. development, regulatory and commercial milestones.

If approved by FDA in the U.S., MEI and Kyowa Kirin will co-promote ME-401, with MEI booking all revenue from sales. MEI and Kyowa Kirin will share U.S. profits and costs (including development costs) on a 50-50 basis.

Outside the U.S., Kyowa Kirin will have exclusive commercialization rights, lead commercialization and book all revenues from sales of ME-401. Kyowa Kirin will pay MEI escalating tiered royalties on ex-U.S. sales starting in the teens. Kyowa Kirin will be responsible for all incremental ex-U.S. clinical development costs and all ex-U.S. regulatory, CMC and commercial costs.

The companies have agreed to a development plan designed to broadly evaluate ME-401 in patients with various B-cell malignancies, including in combination with other agents.

Conference Call & Webcast Information (Conducted by MEI)
When: April 14, 2020, 8:00 a.m. ET
Dial-in: 1-877-879-1183 (International Toll: 1-412-902-6703)
Conference ID: 0809665

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived under events and webcasts for at least 30 days after the call.

About ME-401

MEI-401 is an investigational treatment and not approved by the U.S. Food and Drug Administration (FDA) or other Health Authorities. Clinical development of ME-401 as an oral, once-daily, selective PI3Kδ inhibitor for the treatment of B-cell malignancies is ongoing. The U.S. FDA recently granted ME-401 Fast Track designation.

MEI is currently conducting two ongoing studies evaluating ME-401. The first is a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, ME-401 is planned to be submitted with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H. The second study is a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies or investigational agents in patients with relapsed or refractory B-cell malignancies. Additionally, a Phase 1 study was initiated by Kyowa Kirin in 2019 evaluating ME-401 as a monotherapy in patients with indolent B-cell malignancy in Japan.