On February 1, 2016 Dana-Farber Cancer Institute reported an immuno-oncology collaboration with potential applicability in a wide range of oncology indications with Array BioPharma (NASDAQ: ARRY)(Press release, Array BioPharma, FEB 1, 2016, View Source;p=RssLanding&cat=news&id=2134177 [SID:1234508930]).

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The research team at Dana-Farber’s Robert and Renée Belfer Center for Applied Cancer Science will work with Array scientists on novel immune-oncology targets with the goal of bringing innovative medicines to patients. The collaboration will leverage the Belfer Center’s proprietary immuno-oncology platform. Combining Dana Farber’s oncology expertise with the Array’s proficiency in drug discovery provides a unique opportunity to accelerate drug discovery of effective medicines for patients with unmet medical need.

"We are very enthusiastic about working with Array to develop novel immune-oncology drugs because their team has a strong track record of drug discovery success yielding innovative cancer therapies. Together we have the potential to deliver novel molecules that target unique mechanisms to harness the immune system and result in durable efficacy," said Kwok-Kin Wong, MD, PhD, scientific co-director of the Belfer Center for Applied Cancer Science and Dana-Farber Cancer Institute, and professor of medicine at Harvard Medical School.

"We are excited to partner with the Dana-Farber scientists at the Belfer Center. Their capabilities perfectly synergize with the capabilities and drug discovery track record of Array. Specifically, their expertise in target validation, pre-clinical models of immunotherapeutic activity and translational medicine will greatly enable Array’s ability to deliver innovative therapeutics in this area," said Nick Saccomano, PhD, chief scientific officer, Array BioPharma.

Financial terms of the agreement are not being disclosed.

On February 01, 2016 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that the company received $22.4 million in clinical development milestone payments from Janssen Biotech, Inc., the company’s license partner for ADU-214, ADU-741 and other products using Aduro’s LADD technology platform for the treatment of specific cancers(Press release, Aduro BioTech, FEB 1, 2016, View Source;p=RssLanding&cat=news&id=2133977 [SID:1234508932]). Janssen is responsible for all clinical development for the product candidates within the license agreements.

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"Our relationship with Janssen has been exceptionally productive, with ADU-214 for the treatment of lung cancer and ADU-741 for the treatment of prostate cancer advancing in clinical studies," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We believe these therapeutics may offer important alternatives for patients suffering from these aggressive cancers."

In May 2014 and October 2014, Aduro entered into two separate agreements with Janssen, granting exclusive, worldwide licenses to ADU-741 and other product candidates engineered for the treatment of prostate cancer, and ADU-214 and other product candidates engineered for the treatment of lung cancer and certain other cancers, based on its novel LADD immunotherapy platform.

(Filing, 10-K, HedgePath Pharmaceuticals, FEB 1, 2016, View Source [SID:1234508943])

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On February 1, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that Eisai has entered into an exclusive license agreement with HUYA Bioscience International, LLC (Headquarters: San Diego, California, United States, President, CEO, Executive Chairman & Founder: Dr. Mireille Gillings, "HUYA") to develop and market the oral histone deacetylase (HDAC) inhibitor HBI-8000 in Japan, South Korea, Thailand, Malaysia, Indonesia, Philippines, Vietnam and Singapore (Press release, Eisai, FEB 1, 2016, View Source [SID:1234508935]).

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HBI-8000 is an oral HDAC inhibitor approved in China for use in the treatment of peripheral T-cell lymphoma (PTCL). Non-clinical data suggest HBI-8000 has epigenetic properties that work to regulate tumor cell growth, and the agent is believed to have immunomodulatory properties as well. HBI-8000 is at the clinical stage of testing in Japan as a treatment for PTCL, a type of non-Hodgkin’s lymphoma, under orphan drug designation from the regulatory authority in Japan. Meanwhile, a Phase I clinical study of the agent in solid tumors has been completed in the United States.

Under the agreement, Eisai has exclusive rights to develop and market HBI-8000 in the licensed territories. However, for PTCL and adult T-cell leukemia-lymphoma, HUYA will complete development of the agent for these indications and Eisai will be responsible for commercialization. According to the agreement, Eisai will pay HUYA upfront, development and commercial milestone payments as well as royalties over the term of the license, respectively.

Eisai positions oncology as a key franchise area, and is committed to providing new treatment options for patients with cancer in order to further contribute to addressing unmet medical needs that exist in the treatment of cancer as well as increase the benefits provided to patients and their families.

2About HBI-8000
HBI-8000 is a member of the benzamide class of histone deacetylase (HDAC) inhibitors designed to block the catalytic pocket of Class I HDACs. HBI-8000 is an orally bioavailable, low-nanomolar inhibitor of cancer-associated HDAC enzymes with favorable pharmacology and safety profiles. HBI-8000 inhibits cancer-associated Class I HDAC1, HDAC2, HDAC3, as well as Class IIb HDAC10 at nanomolar concentrations and stimulates accumulation of acetylated histones H3 and H4 in tumor cells. Studies with human-derived tumor cell lines suggest that HBI-8000 inhibits the growth of many tumor cell lines via multiple mechanisms of action, including epigenetic regulation of tumor cell growth and apoptosis as well as immunomodulatory effects regulating antitumor activity.
To date, HBI-8000 has been dosed in various types of hematological and solid tumors in several clinical trials, including a Phase I trial completed in the United States. HBI-8000 is approved for the treatment of peripheral T-cell lymphoma (PTCL) in China. A Phase I clinical study of the agent in non-Hodgkin’s lymphoma is underway in Japan under orphan drug designation as a treatment for PTCL by the regulatory authority in Japan.

About HDAC
Removing acetyl groups from lysine amino acids on histones to encourage stronger binding of chromatin structures to suppress gene transcription, and adding acetyl groups to weaken binding of chromatin structures to promote transcriptional activity play an important role in regulation of gene transcription on histones. HDAC are enzymes that remove acetyl groups from lysine amino acids on histones, and it is thought that by inhibiting HDAC to allow acetyl groups to accumulate on histones and relax chromatin structures promotes gene transcription activity. In tumor cells, inhibiting HDAC suppresses tumor growth by facilitating the transcriptional activity of cancer suppressing genes and inducing both apoptosis in tumor cells as well as cell cycle arrest.

On January 21,2016 ENB Therapeutics reported that the FDA awards ENB lead product ENB001 Orphan Drug Designation for Stage IIB- Stage IV melanoma (Press release, ENB Therapeutics, JAN 30, 2016, View Source [SID1234634052]). This represents a major milestone in our development program for ENB001 which now qualifies for various development incentives including tax credits for clinical trials, seven year marketing exclusivity in the US following approval, and a fast track for the FDA to evaluate registration files.

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