[PDF]Kyowa Hakko Kirin Announces Initiation of the Phase III Clinical Study of KHK7580 (evocalcet) for Hypercalcemia in Patients with Parathyroid Carcinoma or Primary Hyperparathyroidism

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.

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.

Intellia Therapeutics to Hold Conference Call to Discuss Third Quarter 2017 Earnings

On October 31, 2017 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology, reported it will present third quarter 2017 results to investors and analysts in a conference call on October 31, 2017 at 8:30am EDT, hosted by Nessan Bermingham, Ph.D., Chief Executive Officer and Founder, John Leonard, M.D., Executive Vice President, R&D, and Graeme Bell, Chief Financial Officer (Press release, Intellia Therapeutics, OCT 30, 2017, View Source [SID1234521356]). The analyst and investor presentation can be downloaded starting at 8:00am EDT from the Investor Relations section of the company’s website at www.intelliatx.com. A replay of the call will be available on Intellia’s website, beginning on October 31 at 11:00am EDT, 2017.

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To participate on the day of the call:

U.S. callers should dial 888-752-0423 and use Conference ID# 9089048, approximately five minutes before the call.
International callers should dial +1 918-398-4936 and use Conference ID# 9089048, approximately five minutes before the call.
To listen to the replay:

U.S. callers should dial 855-859-2056, Conference ID# 9089048.
International callers should dial +1 404-537-3406, Conference ID# 9089048.

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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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.

Endocyte Announces Third Quarter 2017 Earnings Conference Call

On October 30, 2017 Endocyte, Inc., (NASDAQ:ECYT) reported that the company will host a conference call on Monday, Nov. 6th, at 4:30 p.m. EST to discuss its third quarter financial results and provide an operational update (Press release, Endocyte, OCT 30, 2017, View Source [SID1234521315]).

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Investors and the general public are invited to listen to a live webcast of the call, which can be accessed in the Investors & News section of the Company’s website at www.endocyte.com or by dialing (877) 845-0711 (U.S./Canada) or (760) 298-5081 (International).

The webcast will be recorded and available on the Company’s website for 90 days following the call.