On January 8, 2020 HUYA Bioscience International CEO & Executive Chair, Dr. Mireille Gillings reported the appointment of Meiji Seika Pharma (Meiji) as an exclusive distributor for its lymphoma product, HBI-8000, in Japan (Press release, HUYA Bioscience, JAN 8, 2020, View Source [SID1234552850]). Meiji also acquired exclusive rights for HBI-8000 in Japan, South Korea, Thailand, Malaysia, Indonesia, Philippines, Vietnam and Singapore. The drug, an epigenetic immunomodulator, is the first approved oral class I-selective histone deacetylase inhibitor which is now in various stages of development globally for Peripheral T-Cell Lymphoma (PTCL) and Adult T-Cell Leukemia (ATL) in Japan and solid tumors in the United States. Increased excitement has been generated by studies that show that HBI-8000 produces cumulative effects over time that increase the receptivity of cancer cells to immunologic therapy.

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The product has orphan drug designation for PTCL granted by Japan’s Ministry of Health, Labor and Welfare. HUYABIO will complete the development of HBI-8000 for PTCL and ATL in Japan for commercialization by Meiji who will hold exclusive sales and marketing rights. Meiji will pay HUYABIO an upfront and milestones plus royalties on net sales. HUYABIO will manufacture and supply the product to Meiji for initial commercialization.

"This collaboration aligns with Meiji’s R&D commitment to oncology to develop new drugs to fulfil unmet needs of patients worldwide. By continually improving our R&D process with innovation, Meiji brings high-value and high-quality drugs to market quickly. Meiji and HUYABIO will cooperate to commercialize HBI-8000, for the benefit of cancer patients" said Daikichiro Kobayashi, President and Representative Director of Meiji Seika Pharma Co, Ltd.

"We are delighted to enter into this partnership with Meiji to bring HBI-8000 to patients with PTCL or ATL. We also look forward to advancing the development of our drug based on its immunomodulatory properties" said Dr. Mireille Gillings. "The agreement reinforces our vision to leverage assets licensed from China for global development and commercialization. Meiji Seika Pharma’s strong position in hematologic malignancy will help ensure the drug’s success in the Japanese market."

About HBI-8000
The novel epigenetic drug, HBI-8000, is a member of the benzamide class of histone deacetylase inhibitors, which regulate gene expression through histone modification, which enables the efficacy of increasing other cancer agents such as checkpoint inhibitors.

The company was the first to leverage the Tripartite Agreement between China, Japan and South Korea, which allowed Chinese clinical data to be leveraged in the other two countries. Based on clinical results, the Japanese Pharmaceutical and Medical Devices Agency allowed accelerated development of this drug in lymphoma.

On January 8, 2020 KIYATEC, Inc. reported that it has secured an investment from life sciences venture investment company Esperante (Press release, KIYATEC, JAN 8, 2020, View Source [SID1234552867]). Investment funds will be used primarily to support KIYATEC’s pivotal 3D-PREDICT study (NCT03561207), designed to validate clinical assays that predict pre-treatment response to cancer drug therapies for ovarian cancer and glioblastoma. Both cancer types are characterized by poor progression-free and overall survival, despite aggressive administration of approved and experimental drug therapies.

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While significant advances in the field of personalized medicine have been made over the last 20 years, the industry has made very little headway in its ability to help clinicians optimize cancer drug selection and patient outcomes through the accurate stratification of patients according to predicted response and/or non-response to specific, approved drug therapies. KIYATEC’s ex vivo 3D cell culture platform is optimized to use a patient’s primary tumor tissue to create microtumors, or tumor spheroids, that can be treated with drug therapies outside the body, to potentially inform and guide pre-treatment therapeutic decision-making. The company’s 3D-PREDICT clinical study is currently enrolling patients and Esperante’s investment will help support those efforts.

"In vitro clinical diagnostics is a field of particular investment focus for us due to its potential to positively impact clinical decision making, therapeutic selection and patient outcomes," said Dean Slagel, Managing Director at Esperante. "Investing in KIYATEC dovetails very well with our investment strategy. We believe their clinical assays, once validated, have the potential to transform the manner in which these two cancer types are treated."

The catalyst for Esperante’s investment in KIYATEC was the National Cancer Institute’s (NCI) Investor Initiatives program, which brings together emerging biotechnology companies with targeted investors and strategic partners to advance their research and commercialization efforts. KIYATEC and the NCI have enjoyed a longstanding, productive research collaboration that has centered on multiple clinical applications of KIYATEC’s proprietary ex vivo 3D cell culture technology platform. KIYATEC’s participation in the NCI Investor Initiatives program was a natural extension of this mutually beneficial relationship.

"As a growing biotech company with a promising technology platform, KIYATEC has been a beneficiary of the NCI’s guidance in both supporting our efforts to advance our technology across multiple solid tumor types and cancer drug classes while at the same time enabling relationships with potential investors and strategic partners. We gratefully welcome Esperante to a growing body of KIYATEC investors as we advance our mission to provide response-predictive testing services to the scientists and clinicians at the forefront of cancer drug development and patient care," said Matthew Gevaert, CEO and co-founder of KIYATEC.

On January 8, 2020 Roivant Sciences reported that Vivek Ramaswamy, Founder and Chief Executive Officer of Roivant, reported that it will present an overview of recent developments and future directions for the business at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Roivant Sciences, JAN 8, 2020, View Source [SID1234552885]).

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The company’s presentation is scheduled to begin at 10:30 a.m. PT on Tuesday, January 14, 2020 at the Westin St. Francis.

Roivant recently announced the close of its transaction forming a strategic alliance with Sumitomo Dainippon Pharma. The company will discuss this transaction and other business updates during its presentation.

On January 8, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the first patient has been dosed in the Phase III GEMSTONE-304 study of the Company’s anti-PD-L1 antibody CS1001 in combination therapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC) (Press release, CStone Pharmaceauticals, JAN 8, 2020, View Source [SID1234552811]). The GEMSTONE-304 trial is a multicenter clinical study designed to evaluate the efficacy and safety of CS1001 in combination with 5-fluorouracil plus cisplatin (FP) doublet chemotherapy in the first-line treatment of unresectable locally advanced, relapsed, or metastatic ESCC.

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According to the GLOBOCAN data released in 2018, there are approximately 307,000 new incidences of esophageal cancer and 283,000 cases of esophageal cancer-related deaths in China annually. The incidence and mortality rates of esophageal cancer are ranked 5th and 4th respectively among all tumor types nationwide. Epidemiological data indicate that 90% of all esophageal cancer cases in China are ESCC, and around 70% of ESCC cases were locally advanced or metastatic at the time of diagnosis. The platinum-based doublet chemotherapy is the current standard of care first-line treatment for patients with advanced ESCC, but it has limited efficacy. Existing data on this first-line treatment for advanced ESCC suggest an objective response rate (ORR) of 35%, a median progression-free survival (PFS) of less than six months, and a median overall survival (OS) of less than one year. There are no alternative treatments for ESCC patients who have failed the first-line treatment.

CS1001 is an investigational anti-PD-L1 antibody developed by CStone. Results released at the 2019 Chinese Society of Clinical Oncology (CSCO) Annual Meeting have shown that, as of July 1, 2019, the Phase Ib trial of CS1001 in combination with the FP chemotherapy regimen in first-line treatment of ESCC achieved an ORR of 77.8% with durable response as well as good overall safety and tolerability.

"Esophageal cancer is one of the tumor types that are particularly prevalent in China, with over 50% of the world’s new esophageal cancer cases and related deaths occurring in the country. Furthermore, the lack of more effective treatments for this patient population has long represented an urgent unmet clinical need," said Dr. Frank Jiang, Chairman and CEO of CStone. "I am glad that we have dosed the first patient in the GEMSTONE-304 trial. I hope CS1001 will continue to demonstrate its clinical promise in its development programs, and soon be proven as a new treatment option for ESCC patients in China."

"Early symptoms of esophageal cancer are relatively silent; as a result, esophageal cancer patients are commonly diagnosed at advanced stages for which there are very limited treatment options. Furthermore, no immunotherapy has been approved for the first-line treatment of ESCC. Recent results from the Phase Ib trial of CS1001 have already demonstrated promising preliminary antitumor efficacy in advanced ESCC. We will continue accelerate this Phase III trial with our best effort. Should this clinical program lead to successful outcomes, it will be a major breakthrough for advanced ESCC patients who are in urgent need of effective therapies," noted Dr. Jason Yang, Chief Medical Officer of CStone.

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase 1 dose-escalation study in China, in which the drug showed good tolerability. During Phase 1a and 1b stages of the study, CS1001 produced sustained clinical benefits in multiple tumor types.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase 1 bridging study in the U.S. In China, its clinical program includes one multi-arm Phase 1b study, two pivotal Phase 2 studies, and four Phase 3 studies for several tumor types.

On January 8, 2020 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary intratumoral immunotherapy products to kill tumors and increase immune system recognition of solid cancers, reported that Lewis H. Bender, President and CEO, will be a featured panelist on the "Developments in The Oncology Landscape" panel at East/West CEO (Press release, Intensity Therapeutics, JAN 8, 2020, View Source [SID1234552851]). The conference will take place January 11-12, 2020, the weekend before the 38th Annual J.P. Morgan Healthcare Conference, at the Four Seasons Hotel in San Francisco.
The panel, which will examine the next wave of innovations and developments in oncology, will be held on Sunday, January 12, 2020 from 1:45 p.m. to 2:15 p.m. PST.

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