Bristol-Myers Squibb Announces European Commission Approval of Pending Acquisition of Celgene

On July 29, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that the European Commission (EC) has granted unconditional approval of Bristol-Myers Squibb’s pending acquisition of Celgene Corporation (NASDAQ:CELG) (Press release, Bristol-Myers Squibb, JUL 29, 2019, View Source [SID1234537840]).

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"Clearance from the European Commission is an important milestone toward completing our combination with Celgene and moves us one step closer to creating a leading biopharma company that is well positioned to develop and deliver innovative, meaningful medicines to patients," said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb.

The transaction remains subject to additional customary closing conditions and other regulatory approvals. Bristol-Myers Squibb intends to close the Celgene transaction at the earliest possible date, which it currently expects to be by the end of 2019 or the beginning of 2020.

Anixa Biosciences Announces VA North Texas Health Care System to Join Cchek™ Prostate Cancer Study

On July 29, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that the VA North Texas Health Care System and its non-profit affiliate, the Dallas VA Research Corporation, have joined Anixa’s ongoing prostate cancer Cchek study (Press release, Anixa Biosciences, JUL 29, 2019, View Source [SID1234537839]). Study enrollment will be led by Dr. Manoj Reddy, Radiation Oncologist, and Dr. Jeffrey Gahan, Chief of Robotic Surgery.

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"We are pleased to see the continued expansion in Cchek collaboration partners to now include the VA North Texas Health Care System. We look forward to working with Dr. Reddy and Dr. Gahan as we further the development of our artificial intelligence based prostate cancer diagnostic test," stated Dr. Amit Kumar, CEO of Anixa.

Inovio’s Cancer Immunotherapy (INO-5151) Targeting Prostate Cancer in Innovative Cancer Combination Trial

On July 29, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that as part of its clinical collaboration agreement with Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), Inovio’s prostate cancer immunotherapy INO-5151 will be combined with an immune modulator (CDX-301, FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint inhibitor (nivolumab) targeting metastatic castration resistant prostate cancer (mCRPC) in a PICI sponsored platform study (Press release, Inovio, JUL 29, 2019, View Source [SID1234537835]).

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This innovative combination trial is an open-label, non-randomized, exploratory platform study designed to assess the safety and antitumor activity of multiple immunotherapy based combinations in participants with mCRPC who have received prior secondary androgen inhibition. Evaluating biomarkers of immune activity and clinical outcomes using a multi-omic, multi-parameter approach is an important aspect of the study. INO-5151 is a combined formulation of INO-5150 (with SynCon antigens encoding for PSA and PSMA) and INO-9012 (DNA vector expressing interleukin 12). Inovio’s immunotherapy is one arm (Cohort C) of this broad PICI-supported study which is a multi-arm, multi-stage platform design (called PORTER Study: ClinicalTrials.gov Identifier: NCT03835533).

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "Inovio is pleased that PICI selected our novel DNA-based immunotherapies to join in this unique combination trial targeting a major unmet medical need. This study demonstrates how Inovio is working with top cancer immunotherapy pioneers to investigate the potential significance of Inovio’s T cell activating immunotherapy in an innovative immuno-oncology combination regimen. Our collaboration with PICI allows us to leverage strategic partnerships with academia, non-profits, and pharma while working with PICI’s team of world-renowned experts from leading cancer centers at the forefront of cancer research."

Metastatic castration resistant prostate cancer, the lethal form of prostate cancer, has shown limited benefit from immune checkpoint inhibition as a monotherapy, with two randomized Phase 3 trials with ipilimumab failing to show a clinically meaningful survival benefit, and a large Phase 2 trial with pembrolizumab demonstrating a modest rate of objective responses.

Under the agreement, PICI will design and execute the clinical study, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers, and with funding support from CRI. Based on PICI’s novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio’s product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

Corporate Presentation

On July 29, 2019 Bellicum Pharmaceuticals presented the corporate presentation (Presentation, Bellicum Pharmaceuticals, JUL 29, 2019, View Source [SID1234537834]).

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Arvinas Appoints Ronald Peck, M.D. as Chief Medical Officer

On July 29, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported the appointment of Ronald Peck, M.D. to the newly created position of Chief Medical Officer (CMO) (Press release, Arvinas, JUL 29, 2019, View Source [SID1234537833]). Dr. Peck brings to Arvinas more than twenty years of clinical and drug development experience, most recently serving as Senior Vice President, Clinical Research at Tesaro, where he oversaw all clinical development efforts for the company’s entire pipeline, including Zejula (niraparib) and Tesaro’s immuno-oncology programs.

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"Dr. Peck arrives at the right time for our company, as we advance ARV-110 through a Phase 1 clinical trial and expect to initiate a Phase 1 clinical trial of ARV-471 in the third quarter of 2019," said John Houston, Ph.D., President and CEO of Arvinas. "Ron is a highly accomplished clinician with a strong track record of successful drug development, leading novel oncology programs from the earliest phases through to registration. His experience is strongly aligned with our goals at this pivotal time for the company."

"Arvinas is leading the industry with its new and exciting technology platform of PROTAC targeted protein degraders," said Dr. Peck. "The company has tremendous momentum. With one clinical program, which also received Fast Track designation from FDA, and another program entering the clinic soon, I anticipate Arvinas will be the first company in the field to have clinical data with a targeted protein degrader. I am excited to be joining Arvinas, and look forward to pursuing the development of PROTAC protein degraders to benefit patients and address unmet medical needs in oncology and in other devastating and life-threatening diseases."

Prior to his work at Tesaro, Dr. Peck served as the CMO of Kolltan Pharmaceuticals, a privately-held clinical-stage biotechnology company where he oversaw the clinical development of monoclonal antibodies targeting receptor tyrosine kinases. Dr. Peck began his industry career at Bristol Myers Squibb (BMS), where he spent 15 years in drug development, eventually serving as Vice President, YERVOY (ipilimumab) Global Development Lead. At BMS, he played a key role in the approval and commercialization of YERVOY (ipilimumab) across all indications and contributed to the successful development of multiple other oncology assets, including IXEMPRA (ixabepilone). Early in his BMS career, Dr. Peck contributed to the life cycle development of ABILIFY (aripiprazole) within the neuroscience clinical research organization. Dr. Peck received his bachelor’s degree in chemistry from Georgetown University in Washington, D.C., his M.D. from Thomas Jefferson University Medical College in Philadelphia, PA., and completed a residency and hematology/oncology fellowship at Georgetown University in Washington, D.C before serving as Assistant Professor of Medicine at the University of Virginia.

About PROTAC Protein Degraders

Arvinas’ PROTAC protein degraders harness the body’s own natural protein disposal system to degrade disease-causing proteins. PROTAC protein degraders recruit an E3 ligase to tag the target protein with ubiquitin, which directs its degradation through the proteasome, a large protein complex that breaks down the ubiquitinated target protein into small peptides and amino acids. As the target protein is degraded, the PROTAC protein degrader is released and acts iteratively to destroy additional target protein.

PROTAC protein degraders offer numerous potential advantages as therapeutics, including broad tissue distribution, routes of administration that include oral delivery, and simpler manufacturing than other new modalities, such as cell-based therapies. Arvinas has developed and optimized a proprietary library of protein targeting ligands, E3 ligase ligands, and linkers, which allow the company to rapidly identify and optimize efficient protein degraders with favorable characteristics for successful drug development.