New clinical collaboration with SCRI in immune-oncology

On October 30, 2017 Boehringer Ingelheim and Sarah Cannon Research Institute reported an expansion of their strategic partnership to bring innovative treatments to cancer patients by developing novel immuno-oncology therapies (Press release, Boehringer Ingelheim, OCT 30, 2017, View Source [SID1234521329]). The new effort combines Boehringer Ingelheim’s oncology research and Sarah Cannon’s expertise in clinical trial design and recruitment to evaluate BI 891065, a novel and potent SMAC mimetic, alone and as a potential combination partner with PD-1-directed cancer therapy.

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SMAC mimetics are a new class of targeted, small molecules that trigger tumor cell death and immune system activation that may enhance the activity of immunotherapies in the treatment of cancer. Through this collaboration, Boehringer Ingelheim’s BI 891065 will be studied in a Phase I clinical trial [NCT03166631] (link is external) alone and in combination with BI 754091 (anti-PD-1) in patients with advanced metastatic solid tumors. The first patient has been enrolled in the Phase I study, which aims to include approximately 100 patients. Previously, the partners had announced a joint clinical development program to study Boehringer Ingelheim’s BI 754091 (anti-PD-1) and BI 754111 (anti-LAG 3) monoclonal antibodies for the combination treatment of multiple cancers with high unmet medical needs. More immune-oncology combination studies are planned moving forward.

Mehdi Shahidi, M.D.
“Ground-breaking advances in immuno-oncology are expected to transform cancer treatment paradigms. We are significantly expanding our efforts in this area including a broad research program focusing on the development of rational combinations of novel immuno-oncology approaches,” said Mehdi Shahidi, M.D., Global Medical Head Oncology, Boehringer Ingelheim. “As part of these ongoing efforts to transform the lives of cancer patients, we are extremely proud to be one of the first companies to bring this innovative combination therapy of an immune checkpoint inhibitor and a small molecule targeted treatment to the clinical stage of development,” added Shahidi.

Preclinical data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the Keystone Symposia Conference on Molecular and Cellular Biology earlier this year, suggest that BI 891065 is a promising combination partner for checkpoint inhibitors and, when used together, may provide a new approach to cancer therapy.

“We look forward to continuing our research to find more effective therapies for patients across tumor types through novel immune therapies and combinations of therapies,” said Howard A. “Skip” Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon. “This expanded collaboration furthers our mission to provide access to the latest treatments in the community for our patients.”

Through Sarah Cannon Development Innovations, a full-service, oncology-focused contract research organization (CRO), Sarah Cannon is providing comprehensive clinical development services and operational delivery of Boehringer Ingelheim’s early stage development programs. Expansion of the collaboration with Sarah Cannon, will enable rapid patient enrollment and expand access to Boehringer Ingelheim’s investigational oncology treatments through Sarah Cannon’s extensive network across the U.S. and UK.

About Sarah Cannon Research Institute
Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 300 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.

Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations. For more information, visit sarahcannon.com (link is external).

About Boehringer Ingelheim in Oncology
Boehringer Ingelheim’s oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for non-small-cell lung cancer (NSCLC) that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.

10-Q – Quarterly report [Sections 13 or 15(d)]

Vertex Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Vertex Pharmaceuticals, 2017, OCT 30, 2017, View Source [SID1234521308]).

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Affimed Announces Third Quarter 2017 Financial Results and Corporate Update Conference Call

On October 30, 2017 Affimed N.V. (Nasdaq:AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that on November 7, 2017, the Company will release its financial results for the quarter ended September 30, 2017 (Press release, Affimed, OCT 30, 2017, View Source [SID1234521338]). The Company’s management team will host a conference call to discuss the Company’s financial results and recent corporate developments on Tuesday, November 7, 2017 at 8:30 a.m. ET. The call can be accessed by dialing one of the numbers listed below five minutes prior to the start of the call and providing the confirmation code 3213767.

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An audio webcast of the conference call can be accessed in the “Events” section on the “Investors & Media” page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.

Daiichi Sankyo and Glycotope Announce Option Agreement for Antibody Drug Conjugate Strategic Collaboration and Licensing

On October 30, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Glycotope GmbH (hereafter, Glycotope) have signed an option agreement for future strategic collaboration and licensing to develop an antibody drug conjugate (ADC) by combining Daiichi Sankyo’s proprietary ADC technology with Glycotope’s investigational tumor-associated TA-MUC1 antibody PankoMab-GEX (Press release, Daiichi Sankyo, OCT 30, 2017, View Source [SID1234521286]).

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Under the terms of the agreement, once a feasibility study has been successfully completed, Daiichi Sankyo has the right to exercise its option for worldwide exclusive rights to develop and commercialize PankoMab-GEX ADC. If Daiichi Sankyo exercises these rights, Glycotope will receive an upfront payment as well as development and sales milestone payments plus royalties. Specific financial terms have not been disclosed.

"This strategic partnership is part of our overall strategy to maximize the potential of our ADC technology by seeking partnerships where our proprietary linker and payload as well as our unique protein engineering capabilities can be applied to new antibodies and targets," said Tom Held, Vice President, Global Head, Antibody Drug Conjugate Task Force, Daiichi Sankyo. "We look forward to working with Glycotope to combine our scientific expertise to develop a new ADC that can deliver smart chemotherapy to cancer cells."

"Entering into this agreement with such a renowned partner as Daiichi Sankyo is an important achievement for Glycotope’s core expertise of tumor-targeted monoclonal antibodies," said Roland Sand, Chairman of the Board, Glycotope.

"We are excited about the opportunity to enter into this collaboration with Daiichi Sankyo, which without doubt adds great value to our glycoepitope-targeting program as well as the oncological pipeline," added Henner Kollenberg, Managing Director, Glycotope.

ADCs are a type of targeted cancer medicine that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Daiichi Sankyo’s proprietary ADC technology is designed to deliver enhanced cancer cell destruction upon release inside the cell and reduce systemic exposure to the chemotherapy payload compared to the way chemotherapy is commonly delivered. PankoMab-GEX is an investigational monoclonal antibody that enables tumor-specific binding to a novel carbohydrate-induced conformational epitope, the TA-MUC1, which is extensively expressed in many tumor types including ovarian, lung and breast.

10-K/A [Amend] – Annual report [Section 13 and 15(d), not S-K Item 405]

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