MabVax Therapeutics and Boehringer Ingelheim Sign Asset Purchase and License Agreement and Related Agreements for an Antibody Development Program Targeting Multiple Solid Tumor Cancers

On July 9, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company and Boehringer Ingelheim reported they have signed an asset acquisition and related agreements centered on MabVax’s program targeting a glycan commonly overexpressed on multiple solid tumor cancers (Press release, MabVax, JUL 9, 2018, View Source [SID1234527613]). Boehringer Ingelheim has acquired all rights in and to the program.

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MabVax will receive a total of US $11 million in upfront and near-term milestones as well as downstream regulatory milestone payments plus further earn-out payments. The asset acquisition is separate and distinct from other programs under development at MabVax, enabling MabVax to retain all rights to its lead HuMab-5B1antibody program which is in Phase 1 clinical trials as a therapeutic product and as a diagnostic product, as well as other antibody discovery programs from the Company’s rich antibody discovery portfolio targeting other cancer antigens.

MabVax discovered the antibody series at the center of this transaction from biological samples, originally from patients who were vaccinated against their solid tumors with a glycan antigen-containing vaccine. The discovery of fully human antibodies directly from vaccinated cancer patients has potential advantages which include greater specificity and reduced toxicities. MabVax completed and has reported on early preclinical development activities to establish the utility of the program.

"We are very pleased to have Boehringer Ingelheim as a major industry partner to further develop one of our preclinical antibody assets based on our proprietary HuMab technology," said David Hansen, President and CEO of MabVax Therapeutics. "This agreement with Boehringer Ingelheim recognizes the value of our innovative approach to discovering novel antibodies to diagnose and treat cancer. We have been committed since the founding of the Company to discovering and developing unique fully human antibodies to diagnose and treat patients with cancers where there remain significant unmet medical needs."

Apollo Endosurgery, Inc. to Report Second Quarter Results on August 8, 2018

On August 6, 2018 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported that the Company is scheduled to release its financial results for the second quarter ended June 30, 2018 on Wednesday, August 8, 2018, after the U.S. stock markets close (Press release, Apollo Endosurgery, AUG 6, 2018, View Source [SID1234528448]).

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Apollo will hold a conference call on Wednesday, August 8, 2018 at 3:30 p.m. CT / 4:30 p.m. ET to discuss the results. The dial-in numbers are (800) 263-0877 for domestic callers and (646) 828-8143 for international callers. The conference ID number is 7723529. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.apolloendo.com.

A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, until Apollo releases its third quarter 2018 financial results. In addition, a telephonic replay of the call will be available until August 15, 2018. The replay dial-in numbers are (844) 512-2921 for domestic callers and (412) 317-6671 for international callers. Please use the replay conference ID number 7723529.

Halozyme To Host Second Quarter 2018 Financial Results Conference Call

On July 6, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the second quarter 2018 on Tues., Aug. 7 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call (Press release, Halozyme, JUL 6, 2018, View Source [SID1234527594]). On the same date, Halozyme will release financial results for the second quarter ended June 30, 2018 following the close of trading.

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The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 40189200.

Acceleron Appoints Robert K. Zeldin, M.D., Chief Medical Officer

On July 5, 2018 Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, reported the appointment of Robert K. Zeldin, M.D., as Chief Medical Officer (CMO) (Press release, Acceleron Pharma, JUL 5, 2018, View Source [SID1234527634]). Dr. Zeldin brings to Acceleron more than two decades of clinical, regulatory and industry experience, most recently serving as CMO of Belgium-based Ablynx NV.

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"Robert has built an impressive career, holding a variety of leadership positions across clinical development, regulatory, and medical affairs functions," said Habib Dable, Chief Executive Officer of Acceleron. "He’s joining us at a critical time for the company as we advance our lead product candidate, luspatercept, in multiple hematologic indications. Moreover, we have ongoing Phase 2 programs with our key, wholly-owned pipeline assets in neuromuscular and pulmonary diseases. Robert’s breadth and depth of experience should prove immensely valuable in executing on our clinical development goals."

As a member of the Executive Committee at Ablynx, Dr. Zeldin contributed to the development and implementation of the overall corporate strategy. He was responsible for the Medical, Regulatory, Pharmacovigilance, Clinical Operations, Biostatistics, and Data Management functions and led a team of 60. He joined Ablynx from French pharmaceutical firm Stallergenes SA, where he was Senior Vice President and Head of Global Clinical Development. Earlier, he worked for five years at Novartis Pharmaceuticals, the final three as Vice President and U.S. Medical Franchise Head, Respiratory and Dermatology. Dr. Zeldin’s career in industry began at Merck, where he spent seven years in progressively strategic roles in worldwide regulatory affairs and clinical development, rising to the position of Senior Director of Clinical Development with responsibility for products in the respiratory, cardiovascular, and infectious disease therapeutic areas.

"It’s a privilege to join the Acceleron team in the pursuit of novel therapies for serious and rare diseases with significant unmet medical need," said Dr. Zeldin. "Seldom does one have an opportunity to contribute to the development and potential launch of medicines in multiple therapeutic areas for diverse patient populations, all of whom are vastly underserved by current options."

Prior to his work in industry, Dr. Zeldin served as a Medical Officer at the U.S. Food & Drug Administration’s Center for Biologics Evaluation and Research, assessing efficacy and safety data from the clinical development of allergy-related therapies, vaccines, and orphan products. He also spent several years in clinical practice treating patients with allergic, asthmatic, and immunologic disorders. He holds a B.A. with honors from Johns Hopkins University and an M.D. from Tufts University School of Medicine. His postdoctoral training included Residency in Internal Medicine at University Health Center of Pittsburgh and Fellowship in Allergy and Clinical Immunology at Johns Hopkins University School of Medicine.

Dr. Zeldin succeeds longtime Acceleron CMO, Matthew Sherman, M.D., who earlier this year announced his planned retirement. Dr. Sherman will remain on staff until the anticipated mid-2018 release of topline Phase 3 data from the BELIEVE trial of luspatercept in beta-thalassemia patients, and will then serve in an advisory capacity for one year thereafter.

JHL Biotech Announces China Approves Phase I and Phase III Clinical Trial Application for Rituximab Biosimilar to Treat Non-Hodgkin Lymphoma

On July 5, 2018 JHL Biotech reported that the Center for Drug Evaluation (CDE), State Drug Administration of China (SDA) has approved JHL’s Phase I and Phase III Clinical Trial Application for a proposed rituximab biosimilar, JHL1101, to treat non-Hodgkin lymphoma (Press release, JHL Biotech, JUL 5, 2018, View Source [SID1234527700]). JHL will begin clinical trials of JHL1101 in the following months.

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Racho Jordanov, JHL’s Co-Chairman, and CEO stated, "This study adds to the data collected in the JHL1101 EU study and will differentiate JHL from many of its competitors. JHL Biotech is one of the few companies conducting clinical trials with biosimilars globally."