Guardant Health Appoints Craig Eagle, MD as Chief Medical Officer

On May 3, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the appointment of Craig Eagle, MD as the company’s new Chief Medical Officer (CMO) (Press release, Guardant Health, MAY 3, 2021, View Source [SID1234579024]).

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As CMO, Dr. Eagle will play a vital role in furthering Guardant Health’s mission of transforming cancer care by unlocking data that will accelerate precision oncology for patients at all stages of the disease. "I am thrilled to welcome Dr. Craig Eagle, a respected leader in oncology, as our Chief Medical Officer," said AmirAli Talasaz, Guardant Health President. "Craig has a wealth of experience driving medical affairs, clinical development, and clinical trial operations at leading pharmaceutical companies, and he will undoubtedly make a great impact as we continue to develop and commercialize first-in-class products and scale the company for the future."

"I look forward to contributing to the ground-breaking work Guardant Health is doing to serve unmet medical needs by applying precision oncology across the continuum of cancer care," said Craig Eagle, MD. "Guardant Health is uniquely positioned to serve cancer patients at all stages of the disease, from advanced to early-stage cancers. I look forward to joining the team as the company continues to increase patient access to potentially life-changing diagnostics and testing."

Prior to joining Guardant Health, Dr. Eagle has most recently served as Vice President of Medical Affairs Oncology for Genentech where he oversaw the medical programs across the oncology portfolio, and developed innovative cancer trials and strategies in personalized health care. Prior to Genentech, Dr. Eagle has held several positions in the U.S. and internationally over his 19-year career at Pfizer including global head of the Oncology Medical and Outcomes Group. In this role, he oversaw the worldwide medical programs and development of numerous commercially successful drugs. Dr. Eagle currently serves on the Board of Directors for Generex Biotechnology and NuGenerex Immuno-Oncology.

Dr. Eagle attended medical school at the University of New South Wales in Sydney, Australia and received his general internist training at Royal North Shore Hospital in Sydney. Dr. Eagle completed his specialist training in hemato-oncology and laboratory hematology at Royal Prince Alfred Hospital in Sydney and was granted Fellowship in the Royal Australasian College of Physicians (FRACP) and the Royal College of Pathologists Australasia (FRCPA).

Synthekine Appoints Internationally Recognized Cancer Immunotherapy Leader Naiyer Rizvi, M.D., as Chief Medical Officer

On May 3, 2021 Synthekine Inc., an engineered cytokine therapeutics company, reported that it has appointed Naiyer Rizvi, M.D., as Chief Medical Officer, effective today (Press release, Synthekine, MAY 3, 2021, View Source [SID1234579023]). Dr. Rizvi is an internationally recognized leader in cancer immunotherapy drug development whose clinical research has helped deliver FDA approvals of several landmark immunotherapies, including nivolumab in squamous lung cancer and pembrolizumab in non-small cell lung cancer. He will lead Synthekine’s efforts in advancing its maturing pipeline through clinical investigation.

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"Naiyer is a physician scientist with a track record of success in the development of breakthrough oncology treatments. We are thrilled to have him join as our CMO as we move our first cytokine therapeutics into clinical development later this year," said Debanjan Ray, CEO of Synthekine. "Naiyer’s leadership and exceptional track record in immuno-oncology clinical development complement our deep cytokine expertise and will enable Synthekine to advance our broad pipeline of cytokine therapeutics and cytokine enabled cell therapies to clinical proof of concept."

As a medical oncologist and expert in clinical immuno-oncology, Dr. Rizvi’s research into mechanisms of sensitivity and resistance to immunotherapy has laid the foundation to the understanding of clinical responses to immune checkpoint inhibitors. Dr. Rizvi conducted clinical studies of novel immunotherapy drugs and immunotherapy combinations, including the landmark study to demonstrate a correlation between mutations and neoantigens with durable benefit to immune-checkpoint blockade. His work has been published in leading journals including Science, Nature, and the New England Journal of Medicine.

"Synthekine has assembled an impressive portfolio of cytokine therapeutic candidates that has the potential to address a spectrum of diseases, and I look forward to leading our clinical development and strategy to advance these promising medicines," said Dr. Rizvi. "I’ve treated patients with cytokine drugs and understand both the promise but also the toxicity that these potent therapeutics can deliver. Synthekine’s two lead programs, an IL-2 partial agonist (STK-012) and a CD-19 CAR-T with orthogonal IL-2 (SYNCAR-001 + STK-009), have demonstrated compelling efficacy, safety, and selectivity in preclinical models and I look forward to advancing them to clinical studies."

Dr. Rizvi most recently served as the Price Family Professor of Medicine, Director of Thoracic Oncology and Co-Director of Cancer Immunotherapy at Columbia University Medical Center. In addition, Dr. Rizvi was recently Research Director of the Price Family Comprehensive Center for Chest Care at New York-Presbyterian Hospital. Dr. Rizvi received his medical doctorate from the University of Manitoba Faculty of Medicine and completed his residency training at the University of Manitoba Affiliated Hospital and fellowship at Beth Israel Deaconess Medical Center/Harvard Medical School. He was a co-founder of Gritstone Oncology.

Repare Therapeutics Doses First Patient in Phase 1 Clinical Trial of RP-6306, a First-in-Class, Selective, Oral Inhibitor of PKMYT1

On May 3, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality (SL) approach to the discovery and development of novel therapeutics, reported the first patient has been dosed in the Company’s Phase 1 clinical trial of RP-6306, a first-in-class small molecule product candidate targeting PKMYT1, which is a novel target that Repare discovered to be synthetic lethal with CCNE1 amplification and other genomic mutations to treat CCNE1-amplified, FBXW7-altered and other PKMYT1 inhibitor-sensitive cancers (Press release, Repare Therapeutics, MAY 3, 2021, View Source [SID1234579022]).

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"The dosing of the first patient in this RP-6306 trial marks a key milestone in Repare’s development of targeted cancer therapeutics. We are pleased to have initiated this trial six months ahead of what we projected at our IPO launch last June," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Patients with tumors carrying CCNE1, FBXW7 and certain other genetic alterations we have identified as sensitive to PKMYT1 inhibition have few treatment options available, and the incidence of these cancers is rising. This Phase 1 trial will assess the safety and tolerability of RP-6306, as well as dosing schedule, to inform Repare’s planned Phase 2 program."

The Phase 1 multi-center clinical trial is expected to enroll approximately 70 patients with recurrent tumors characterized by specific genomic alterations predicted by Repare’s SNIPRx platform to render sensitivity to RP-6306. The primary goal of the Phase 1 clinical trial is to assess preliminary safety and tolerability in patients and to establish the recommended Phase 2 dose and dosing schedule for RP-6306 for evaluation in further trials. Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other treatment modalities, into proof-of-concept studies in 2022, targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other alterations identified through Repare’s proprietary STEP2 screens.

About RP-6306

RP-6306 is a first-in-class, selective, orally available inhibitor of PKMYT1 that was discovered and developed entirely in-house by Repare. Through Repare’s SNIPRx screen campaign for targets that are SL with CCNE1 amplification, the Company identified and validated this novel SL gene that has the characteristics of a therapeutic target. Repare has developed novel and selective inhibitors against PKMYT1, which demonstrated compelling pre-clinical anti-tumor activity alone and in combination with certain anticancer agents, and subsequently announced the advancement of a clinical candidate to this potential, first-in-class program.

Vivacitas Oncology and IAG Partner to Integrate Novel Imaging Markers in the Development of AR-67 in Recurrent Glioblastoma Patients

On May 3, 2021 Vivacitas Oncology, Inc. ("Vivacitas" or the "Company"), a clinical stage biopharmaceutical company focused on tough to treat cancers, and Image Analysis Group ("IAG"), a leading global medical imaging company, reported that iare collaborating to apply Artificial Intelligence (AI) technology and advanced imaging strategies to further the development of AR-67, a third generation Camptothecin, in patients with recurrent glioblastoma multiforme (reGBM) (Press release, Vivacitas Oncology, MAY 3, 2021, View Source [SID1234579021]).

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Advanced imaging techniques could play a critical role in response assessment in developing new and innovative cancer therapies. Multiparametric magnetic resonance imaging (mpMRI) provides quantitative non-invasive imaging markers of early therapy-related changes. IAG is deploying its proprietary, cloud-based imaging approach to provide scientific evidence of early therapy response.

Tina Runk, Vivacitas co-founder and Executive Vice President of Clinical Operations stated, "Working with IAG, we performed a retrospective analysis of imaging data from our Phase 2 clinical study of AR-67 activity in recurrent GBM, in which their technology was applied to assess pseudoprogression from true progression of disease. This assessment capability demonstrates the benefit of potentially including this technology in future pivotal clinical trials and treatment regimens to ensure patient retention based on more detailed and objective criteria."

Dr. Diana Dupont-Roettger, the Chief Scientific Alliance Officer at IAG stated, "We are excited to bring the latest and most impactful imaging strategies to Vivacitas to ensure a scientific excellence and efficient drug development process."

CohBar to Announce 2021 First Quarter Financial Results and Provide Business Update on May 17, 2021

On May 3, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that the company will release its first quarter 2021 financial results after the market closes on Monday, May 17, 2021 (Press release, CohBar, MAY 3, 2021, View Source [SID1234579020]). Management will host a conference call with a slide presentation at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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Details for the Conference Call and Slide Presentation:

Please visit View Source and enter password CWBR, or
Go to www.cohbar.com and click on Q1 2021 Shareholder Presentation at the top of homepage.
Please note, the conference audio will only be available by dial-in and not through Zoom.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Zoom approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on May 17, 2021, through 11:59 p.m. Eastern Time on June 7, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13718702. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.