On February 3, 2020 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported the appointment of Rajiv Patni, M.D., as executive vice president and chief medical officer, effective immediately (Press release, Portola Pharmaceuticals, FEB 3, 2020, View Source [SID1234553790]). Dr. Patni brings to his new role two decades of clinical development and approval experience as a biopharmaceutical industry leader. As a member of the Executive Committee, Mr. Patni will report to Scott Garland, president and chief executive officer, and will be responsible for leading Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance, and Data Management.

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"Rajiv brings deep clinical development experience to Portola that will be invaluable as we work to establish Andexxa as the standard of care for Factor Xa patients with life-threatening or uncontrolled bleeding," said Scott Garland, Portola’s president and chief executive officer. "He will focus on leading our post-market clinical studies, including label expansion, along with driving our European regulatory activities. These are key elements of our long-term growth strategy, and we look forward to his leadership in strengthening our healthcare community engagement in the U.S. and Europe further establishing the clinical and economic differentiation of Andexxa."

During his career, Dr. Patni has contributed to 8 approvals, across multiple therapeutic areas, including cardiology and neurology, in both established and growing companies. Before joining Portola, Dr. Patni was chief medical officer at Adamas Pharmaceuticals, Inc., a fully-integrated, development and commercial company focused on neurological diseases. In this role, he built out the R&D and medical affairs departments. These efforts resulted in the FDA approval of GOCOVRI. Prior to Adamas, Dr. Patni was Chief Development Officer at Ocera Therapeutics. Earlier in his career, he held senior roles in clinical development and medical affairs in Actelion Pharmaceuticals (US affiliate), Roche and Pfizer.

"I am excited to join Portola at this pivotal time of growth," said Dr. Patni. "The Company is uniquely positioned with the first and only reversal agent for Factor Xa inhibitors, a large and rapidly growing class of medications. I am eager to contribute to Portola’s mission and further enhance awareness of the potential life-saving benefits and value of Andexxa."

Dr. Patni received his M.D. from the Mount Sinai School of Medicine, and completed his training in internal medicine and cardiology at the Albert Einstein College of Medicine, where he remained as an attending physician before joining industry.

Jeff Myers, M.D., Ph.D., who has served as Portola’s interim chief medical officer since May 2019, will continue in his role as the Company’s senior vice president of medical affairs.

On February 3, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Gritstone Oncology, Inc. for semi-mechanistic systems pharmacology modeling (Press release, Applied BioMath, FEB 3, 2020, View Source [SID1234553789]). Applied BioMath created a semi-mechanistic pharmacokinetic, receptor occupancy model for a Gritstone Oncology, Inc. bispecific antibody. Gritstone plans to leverage this model for clinical candidate selection for its work in treating solid tumors. "Our collaboration with Applied BioMath helped us explore the impact of various drug properties such as affinity and half life," said Jonah Rainey, Vice President of Antibody Therapeutics at Gritstone Oncology, Inc. "Their modeling efforts provided a framework for identifying optimal bispecific design for lead selection."

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Applied BioMath employs a rigorous fit-for-purpose model development process which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for mechanistic PK/PD modeling. "When you are designing a bispecific therapeutic, or any complex therapeutic, it’s extremely difficult to assess ideal drug properties without the aid of modeling," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Specifically, it’s the mechanistic component of our systems pharmacology modeling that enables us to closely replicate therapeutic and disease biology which in turn helps our clients quickly answer critical questions about their project."

On February 3, 2020 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the CE-marking and launch of its therascreen PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation (Press release, Qiagen, FEB 3, 2020, View Source [SID1234553788]). Last year the therascreen PIK3CA test was approved by the FDA and launched as a companion diagnostic test for Piqray (alpelisib) in the US.

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The therascreen PIK3CA test is a new diagnostic assay for detection of activating mutations in the phosphatidyl 3-kinase catalytic subunit alpha (PIK3CA) gene, and the first to enable testing of both DNA from FFPE tissue or plasma specimens. All QIAGEN therascreen PIK3CA tests leverage QIAGEN’s worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on detection of mutations in the PIK3CA gene.

1 in 8 women in Europe will develop breast cancer before the age of 85, making it the most common form of cancer in female patients. The therascreen assay detects 11 clinically actionable PIK3CA mutations, which are estimated to be present in approximately 40% of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+ HER2-) advanced breast cancer cases.

"This launch in Europe further underscores our commitment to support patients with breast cancer, the most common cancer in female cancer patients, with an estimated incidence of 562,500 in Europe in 2018 according to the WHO" said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics. "We are convinced that our therascreen PIK3CA Kit, which expands our market-leading therascreen portfolio of companion diagnostics, will provide a valuable testing option for those seeking new ways to combat advanced breast cancer. We are committed to making the therascreen PIK3CA Kit available immediately so that leading laboratories in Europe can provide patients with the test as soon as possible."

On February 3, 2020 Alliance for Cancer Gene Therapy (ACGT) reported that it will host its inaugural ACGT 2020 Cancer Summit on April 16, 2020 at the Alexandria Center for Life Science in New York City (Press release, ACGT Alliance For Cancer Gene Therapy, FEB 3, 2020, View Source [SID1234553787]). The ACGT 2020 Cancer Summit — which launches ACGT’s 20th anniversary — will bring together researchers, companies, investors and advocates in cancer cell and gene therapy to discuss the latest advances, with a focus on combating solid tumors .

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A partial list of ACGT 2020 Cancer Summit speakers includes:

Dara Richardson-Heron, MD – Chief Patient Officer, Pfizer
David Weinreich – Senior Vice President, Global Clinical Development, Regeneron
Maria Fardis, PhD, MBA – President and CEO, Iovance
Gavin Thurston – Vice President, Oncology & Angiogenesis, Regeneron
Mitchell H. Finer, PhD – Chief Scientific Officer, ElevateBio, Executive Partner MPM Capital
Peter Dudek, PhD – Partner, MRL Ventures Fund
Bruce Levine, PhD – Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania
Noriyuki Kasahara, MD, PhD – Professor, Neurological Surgery, UCSF
Tom Whitehead – Co-Founder, Emily Whitehead Foundation
Marc Hurlbert, PhD – Chief Scientific Officer, Melanoma Research Alliance
Kerri Kaplan – President & CEO, Lustgarten Foundation
Robert Levis – Director, CLL Society
Presenting sponsors include Alexandria Real Estate Equities, Inc./Alexandria Venture Investment. Additionally, STAT will be a media partner for the ACGT 2020 Cancer Summit. For more sponsorship information and early bird registration, please visit View Source

Media Registration

Media registration is free of charge for all valid press card holders or via provision of formal journalist credentials. Register early by contacting [email protected] to begin receiving advance meeting materials, media alerts, and access to meeting presenters.

On February 3, 2020 Calidi Biotherapeutics, Inc., a clinical‐stage immuno-oncology company at the forefront of cell-based oncolytic virus immunotherapies for cancer, reported the acceptance of an abstract for presentation at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, which is being held February 6 to February 8, 2020, at the Rosen Shingle Creek Resort in Orlando, Florida (Press release, Calidi Biotherapeutics, FEB 3, 2020, View Source [SID1234553786]).

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"We look forward to sharing our data evidencing the ability of Calidi’s proprietary cell-based delivery platform to address a major obstacle in oncolytic virotherapy – the quick elimination of oncolytic viruses by the patient’s immune system," said Boris Minev, MD, President, Medical and Scientific Affairs, Calidi Biotherapeutics. "Calidi’s platform not only protects, amplifies, and delivers the oncolytic viruses, but it also modifies the tumor microenvironment and activates the immune system to actively seek, and destroy distant tumor sites."

ASCO-SITC Presentation Details Are As Follows:

Board C3
Abstract 21: A cell-based platform to potentiate oncolytic virus therapies.

Date: Thursday, February 6, from 11:30 AM – 1:00 PM and 6:00 PM – 7:00 PM
Location: Rosen Shingle Creek, Orlando, FL
Key Words: oncolytic virus, cancer, cancer therapies, cell-based delivery platform