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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Local – Amsterdam, the Netherlands: +31 (0)20 716 8295

Local – Copenhagen, Denmark: +45 32 71 16 60

Local – Frankfurt, Germany: +49 (0)69 2222 10625

Local – Zurich, Switzerland: +41 (0)44 580 7214

Local – London, U.K.: +44 (0)20 3427 1907

Local – New York City, U.S.A.: +1 646 254 3366

Local – Paris, France: +33 (0)1 76 77 22 23

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.

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.

On October 30, 2017 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) reported the initiation in Japan of a phase III clinical study of KHK 7580 (generic name: evocalcet) for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy (Press release, Kyowa Hakko Kirin, OCT 30, 2017, View Source [SID1234521287]).

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This phase III study is an open label study in Japan to evaluate the efficacy and safety of KHK7580 oral administration. “We are delighted to start the phase III study of evocalcet,” said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin.

“We believe evocalcet could provide more efficient treat ment for parathyroid carcinoma and primary hyperparathyroidism, in addition to secondary hyperparathyroidism.”

KHK7580 is a small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, “Mitsubishi Tanabe P harma”). Kyowa Hakko Kirin signed a license agreement of KHK7580 with Mitsubishi Tanabe Pharma for the rights to cooperative research, develop, market and manufacture the product in Japan and some parts of Asia in March 2008. The application for KHK7580 was submitted to Japan’s Ministry of Health, Labor and Welfare in April 2017, seeking approval for secondary hyperparathyroidism in maintenance dialysis patients.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

On October 30, 2017 Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MM-121, its investigational drug candidate, for the treatment of heregulin positive non-small cell lung cancer (Press release, Merrimack, OCT 30, 2017, View Source [SID1234521289]). MM-121 (seribantumab) is a fully human monoclonal antibody designed to block tumor survival signals and enhance the anti-tumor effect of combination therapies by targeting the cell surface receptor HER3 (ErbB3) in patients with high expression of the biomarker heregulin.

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“This is an important regulatory step forward for the clinical development of MM-121 in non-small cell lung cancer and we are pleased to have access to additional support from the FDA in this indication,” said Sergio Santillana, M.D., MSc, Chief Medical Officer. “Merrimack is dedicated to designing and developing novel precision therapeutics that shape treatment strategies for patients, and our randomized Phase 2 clinical trial of MM-121 in heregulin positive non-small cell lung cancer is well underway. We look forward to expanding the development of MM-121 to a biomarker-selected population of breast cancer patients later this year.”

The FDA’s orphan drug designation is granted to drugs and biologics intended to treat rare diseases or conditions with a prevalence of fewer than 200,000 people in the U.S. This designation includes eligibility for a seven-year period of marketing exclusivity for MM-121 upon approval, as well as other development assistance and financial incentives.

MM-121 is currently being evaluated in the SHERLOC study, a global randomized Phase 2 study that will assess progression-free survival of MM-121 in combination with docetaxel versus docetaxel alone. The study is enrolling patients with heregulin positive non-small cell adenocarcinoma of the lung who have progressed after a platinum-containing regimen and may have received anti PD-1 or anti-PD-L1 therapy. Top-line data for the SHERLOC study are expected in the second half of 2018.

In addition, Merrimack will be evaluating MM-121 in the SHERBOC trial, a global randomized Phase 2, double-blind, placebo-controlled clinical study of MM-121 added to standard of care in patients with heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer. The first patient is expected to be dosed in the SHERBOC study by the end of 2017.

About MM-121

MM-121, also known as seribantumab, is Merrimack’s wholly owned, fully human anti-HER3 (ErbB3) monoclonal antibody that targets phenotypically distinct heregulin positive cancer cells within solid tumors. Heregulin positive cancer cells are characterized by their ability to escape the effects of targeted, cytotoxic and anti-endocrine therapies and potentially contribute to rapid clinical progression in patients whose tumor cells test positive for heregulin as detected by RNA-ISH. When used in the combination setting, seribantumab is designed to block the heregulin/HER3 signaling axis to make tumor cells more sensitive to the effects of the combination therapy.

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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