Syndax Pharmaceuticals Announces Appointment of Kate Madigan, M.D., as Chief Medical Officer

On March 1, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the appointment of Kate Madigan, M.D., to the role of Chief Medical Officer, effective immediately (Press release, Syndax, MAR 1, 2022, View Source [SID1234609265]). Dr. Madigan, who brings to Syndax over 20 years of clinical hematology expertise and broad experience in the design and execution of early to late-stage clinical programs across oncology and rare diseases, will lead the Company’s clinical development strategy. She will succeed Michael Meyers, M.D., Ph.D., who will continue with the Company through June before transitioning to serve in a consulting capacity.

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"Dr. Madigan has a proven track record of driving the design and execution of late-stage clinical programs," said Briggs W. Morrison, M.D., President, Head of Research and Development at Syndax. "Her demonstrated acumen in oncology development in both the academic and industry settings will be invaluable as we continue to expand our pipeline. Her appointment is the result of a thorough succession planning process as we lay the groundwork for our evolution into a fully-integrated oncology company. I would like to thank Dr. Meyers for his dedication to Syndax over the years, having played an essential role in advancing both SNDX-5613 and axatilimab from Investigational New Drug filing to the pivotal stage. We look forward to his continued contributions as we work to bring innovative cancer therapies to patients in areas of high unmet need."

"With two ongoing pivotal programs for two first-in-class and potentially best-in-class medicines and subsequent U.S. Food and Drug Administration filings expected next year, Syndax is well positioned to make a meaningful impact in the treatment of some of the most underserved therapeutic areas," said Dr. Madigan. "The talented team at Syndax has already made impressive progress advancing the pipeline, and I look forward to building on that momentum to further advance the mission of realizing a future in which people with cancer live longer and better than ever before."

Dr. Madigan most recently served as Vice President, Head of Clinical Development at Syros Pharmaceuticals, where she oversaw the development and execution of clinical strategy across multiple solid and hematologic tumor programs. Prior to joining Syros, she served as Senior Medical Director at Alnylam Pharmaceuticals, and was a Medical Director in Biogen’s Rare Disease Innovation Unit. Before moving into industry, Dr. Madigan held various academic positions of increasing responsibility at University of California San Diego/ Rady Children’s Hospital San Diego. Dr. Madigan received a B.A. in Asian Studies from Dartmouth College and an M.D. from the Keck School of Medicine of the University of Southern California.

Long term study confirms efficacy of our T-cell activating immunotherapy in combination with checkpoint inhibitor

On March 1, 2022 ISA reported the publication of extension data from a key study using lead product ISA101b in the Journal of ImmunoTherapy of Cancer (Press release, ISA Pharmaceuticals, MAR 1, 2022, View Source [SID1234609264]). The study, ISA101 and nivolumab for HPV-16+ cancer: updated clinical efficacy and immune correlates of response, is performed by Guimaraes Sousa, Michael Curran, Bonnie Glisson et al. in collaboration with the MD Anderson Cancer Center in Houston, Texas .

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The initial study by Massarelli et al. was published in 2018*. It investigated ISA101b in combination with anti-PD1 checkpoint inhibitor nivolumab (OPDIVO) in head-and-neck cancer. In this open-label study, 22 patients with recurrent/metastatic Human Papilloma Virus type 16-positive (HPV16+) OroPharyngeal Cancer (OPC) were treated. The Objective Response Rate (ORR) in this difficult to treat patient population was 36%, with a median Overall Survival (mOS) of 17.,5 months.

Two patients in the first study displayed a Complete Response to treatment. This follow-up study shows they survived disease-free for more than 44 months.

Prof. Dr. Cornelis Melief, Chief Scientific Officer of ISA Pharmaceuticals, said: "We are delighted to see the results of this key study published as we continue to develop an exciting pipeline of cancer vaccines. Our work shows that a combination of ISA101b and anti-PD-1 remains a promising treatment vastly improving patient prognosis and long-term responses."

ISA’s product portfolio consists of multiple synthetic long peptide (SLP) therapeutics for cancer and infectious diseases. The SLP approach is designed to unleash a durable and broad T cell immune response to specific diseases. It enables a patient’s own immune system to attack and destroy tumour cells or viruses for significant clinical benefit. ISA101b is based on this technology and is currently being studied in HPV16+ cancers in combination with Libtayo (cemiplimab) in three phase 2 clinical trials under a strategic collaboration with Regeneron. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.

*Massarelli et al, JAMA Oncology 2018

G1 Therapeutics to Participate in the 42nd Annual Cowen Health Care Conference and the 34th Annual Roth 2022 Conference

On March 1, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will participate in two upcoming investor conferences in March 2022 (Press release, G1 Therapeutics, MAR 1, 2022, View Source [SID1234609261]).

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On Tuesday March 8, 2022, G1’s Chief Executive Officer Jack Bailey will participate in a New Drug Launches panel at 2:10PM ET during the virtual 42nd Annual Cowen Health Care Conference.

On Tuesday March 15, 2020, Jack Bailey and Raj Malik, M.D., G1’s Chief Medical Officer, will participate in a fireside chat at 8:00AM PT during the 34th Annual Roth Conference.
The webcast and replay of both events will be accessible on the Events & Presentations page of View Source

G1 Therapeutics to Participate in the 42nd Annual Cowen Health Care Conference and the 34th Annual Roth 2022 Conference

On March 1, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the Company will participate in two upcoming investor conferences in March 2022 (Press release, G1 Therapeutics, MAR 1, 2022, View Source [SID1234609261]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On Tuesday March 8, 2022, G1’s Chief Executive Officer Jack Bailey will participate in a New Drug Launches panel at 2:10PM ET during the virtual 42nd Annual Cowen Health Care Conference.

On Tuesday March 15, 2020, Jack Bailey and Raj Malik, M.D., G1’s Chief Medical Officer, will participate in a fireside chat at 8:00AM PT during the 34th Annual Roth Conference.
The webcast and replay of both events will be accessible on the Events & Presentations page of View Source

StemPrintER Demonstrates Prognostic Utility in TransATAC Cohort

On March 1, 2022 Tiziana Life Sciences Ltd.’s (Nasdaq: TLSA) former subsidiary, AccuStem Sciences, Inc. (OTC PINK: ACMSY) (formerly AccuStem Sciences Ltd.), reported publication of new data in the European Journal of Cancer (Press release, Tiziana Life Sciences, MAR 1, 2022, View Source [SID1234609260]). Results demonstrate that StemPrintER is highly prognostic for risk of distant recurrence in women with breast cancer.

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Investigators from the European Institute of Oncology (IEO) in Milan and The Royal Marsden Hospital in London evaluated 776 tumor samples from the TransATAC cohort, a subgroup of estrogen receptor positive (ER+), post-menopausal patients from the prospective, randomized ATAC trial. The pivotal TransATAC study has been used to evaluate many of the commonly used breast cancer risk scoring assays, including OncotypeDX, Prosigna, EndoPredict and Breast Cancer Index.

In this analysis, investigators demonstrated that patients with a StemPrintER Risk Score (SPRS) Low result had significantly better outcomes than patients with a SPRS High result. Patients with a SPRS Low result had a 5.8% risk of distant recurrence at 10 years versus 23.2% risk of distant recurrence in patients with a SPRS High result.1

"Many genomic classifiers have been evaluated in the TransATAC cohort," said Salvatore Pece, Full Professor at the Milan University Medical School and Director of the Hormone-Related Cancers and Stem Cell Pathobiology Lab at IEO. "It is exciting that StemPrintER appears to perform as well as other commercially-available tests and indicates the potential for this novel test to inform clinical decision making."