On November 1, 2017 Mitsubishi Tanabe Pharma presented 2nd Quarter Results results for FY2017 (Press release, Mitsubishi Tanabe Pharma, NOV 1, 2017, View Source [SID1234521441])

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Tetraphase has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Tetraphase, 2017, NOV 1, 2017, View Source [SID1234521473]).

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On November 1, 2017 Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported that it has received the U.S. Food and Drug Administration’s (FDA) response to the NT219’s pre-IND meeting package (Press release, Kitov Pharmaceuticals , NOV 1, 2017, View Source [SID1234521402]). FDA has agreed to the proposed Chemistry Manufacturing and Controls (CMC), preclinical, and clinical development plans for NT219. For the clinical development plan, the FDA agreed with TyrNovo’s proposed development plan to test NT219 in combination with gemcitabine for the treatment of advanced pancreatic cancer. The FDA further agreed that the initial clinical trial with NT219 will be a Phase I/II clinical trial, and that "the overall design of proposed first-in-human trial appears reasonable". The FDA further agreed that one-month animal toxicology studies for NT219 would be sufficient to support the IND and that no toxicology studies of NT219 together with gemcitabine would be necessary.

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"We are very pleased that FDA’s Division of Oncology Products has accepted our chemistry, non-clinical, and clinical development plans for TyrNovo’s cancer drug, NT219, and we are moving forward with these development plans. We appreciate FDA’s helpful guidance and look forward to continuing to work with the FDA toward an IND submission, which based on our current development plans, we now expect to submit during the first half of 2019," said Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.

Dr. Hadas Reuveni, TyrNovo’s Founder and CTO added: "According to the National Cancer Institute, pancreatic cancer is the fourth leading cause of cancer death in the US and is known to be one of the most aggressive and difficult-to-treat cancer types. NT219 works by overcoming drug resistance and can be combined with various oncology drugs. Our drug’s efficacy was demonstrated in preclinical patient-derived xenograft (PDX) models with various oncology therapies such as chemotherapy agents, EGFR Antibodies, MEK and mTOR inhibitors, and also in combination with immuno-oncology agents such as Keytruda. We will initially be clinically testing NT219 in combination with gemcitabine on advanced pancreatic cancer patients, based on our consistent encouraging results in preclinical PDX models. Our long-term strategy is to develop NT219 in combination with other oncology drugs and for additional oncology indications in collaboration with potential strategic partners, who have expressed solid preliminary interest in NT219."

On November 1, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that it will present data on its Bruton’s Tyrosine Kinase (BTK) inhibitor at the upcoming 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, BeiGene, NOV 1, 2017, View Source [SID1234521450]). ASH (Free ASH Whitepaper) will take place December 9-12, 2017 in Atlanta, GA.

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Oral Presentation, Abstract #152

Title: Safety and Activity of the Highly Specific BTK Inhibitor BGB-3111 in Patients with Indolent and Aggressive Non Hodgkin’s Lymphoma

Presenter: Constantine Tam, MD

Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma – Clinical Studies: Mantle Cell Lymphoma, New Therapies
Date & Time: 12:15pm EST, Saturday, December 9, 2017
Location: Georgia World Congress Center, A411-A412

Poster, Abstract #1745

Title: BGB-3111 in Combination with Obinutuzumab in Patients with Chronic Lymphocytic Leukemia and Follicular Lymphoma

Presenter: Constantine Tam, MD

Session: 642. CLL: Therapy, excluding Transplantation: Poster I
Date & Time: 5:30pm-7:30pm EST, Saturday, December 9, 2017
Location: Georgia World Congress Center, Hall A2

Poster, Abstract #4057

Title: Safety and Activity of the Highly Specific BTK Inhibitor BGB-3111 in Combination with the PD-1 Inhibitor BGB-A317 in Patients with B-Cell Lymphoid Malignancies

Presenter: Gavin Cull, MD

Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma – Clinical Studies: Poster III
Date & Time: 6:00pm-8:00pm EST, Monday, December 11, 2017
Location: Georgia World Congress Center, Hall A2

About BGB-3111

BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib, a BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency, based on biochemical assays, higher exposure than ibrutinib based on their respective Phase 1 experience in separate studies, and sustained 24-hour BTK occupancy in both the peripheral blood and lymph node compartments.

About BGB-A317

BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for BGB-A317 for solid tumors.

On October 31, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the third quarter ended September 30, 2017, on Tuesday, November 7, 2017, after the close of U.S.-based financial markets (Press release, Nektar Therapeutics, OCT 31, 2017, View Source [SID1234521369]). Howard Robin, president and chief executive officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT).

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The press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast