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Cyclacel Pharmaceuticals Announces Appointment of Mark Kirschbaum, M.D., as Chief Medical Officer

On October 23, 2020 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC, Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported the appointment of Mark Kirschbaum, M.D. as Senior Vice President & Chief Medical Officer (CMO) (Press release, Cyclacel, OCT 23, 2020, View Source [SID1234568954]). Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care. He has management experience in both academic research and clinical and pharmaceutical settings. As CMO, he will be responsible for advancing Cyclacel’s pipeline and will lead clinical strategy, patient safety, and medical affairs.

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"We are delighted to welcome Mark to the Cyclacel team," said Spiro Rombotis, Cyclacel’s President & Chief Executive Officer. "Recent data with fadraciclib, our CDK2/9 inhibitor, and CYC140, our PLK1 inhibitor, support further clinical development of these agents in both liquid and solid cancers. Mark’s extensive hematology and oncology experience in clinical practice, experimental therapeutics and industry drug development will be essential as we advance these and our other clinical development programs with the aim of helping patients with unmet medical needs."

"Cyclacel’s biomarker-driven approach to drug development has produced a growing and diversified clinical pipeline with the potential to target a broad range of malignancies," said Dr. Kirschbaum. "I am excited to join the Cyclacel team at this point in its evolution to help build an innovative pipeline addressing the rising problem of cancer resistance and to achieve our clinical milestones."

Dr. Kirschbaum will report to Spiro Rombotis, President and Chief Executive Officer. He will be based in the Company’s Berkeley Heights, NJ office.

Most recently, Dr. Kirschbaum served as Vice President, Hematology/ Oncology at ArQule Inc., (recently acquired by Merck & Co.) where he managed the development of their BTK inhibitor ARQ531 for hematological indications, including CLL. Prior to ArQule, he was Senior Medical Director with global clinical development responsibilities at Daiichi-Sankyo, Taiho Pharmaceuticals and BeiGene, USA, where he led the clinical development of novel compounds including inhibitors of EZH2/1, HSP-90, HER2/3 and BTK in various solid tumors and hematological malignancies.

Before working in the biopharmaceutical industry, Dr. Kirschbaum served as Professor of Medicine, Director of Experimental Therapeutics, Hematology at the Monter Cancer Center/NSLIJHS; Professor of Medicine, Director Hematologic Malignancies at Penn State, Hershey Cancer Center, Director of Experimental Therapeutics, Nevada Cancer Institute, and Director, New Drug Development at the City of Hope National Cancer Center, and Attending Senior Physician, Department of Hematology and Department of Bone Marrow Transplantation, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

He has earned a B.A. from Yeshiva University in New York and his M.D. from SUNY–Health Sciences Center in Brooklyn. He did his Residency in Internal Medicine at Kings County Hospital Center in New York. He also held a Research Fellowship in Oncology at Fred Hutchinson Cancer Research Center in Seattle and worked as a physician scientist at Hadassah University Hospital and the Weizmann Institute of Science in Israel.

Cyclacel also announced that the Compensation Committee of its Board of Directors authorized the grant to Dr. Kirschbaum of non-qualified stock options to purchase up to 120,000 shares of the Company’s common stock, effective as of the first day of his employment as an inducement to Dr. Kirschbaum to commence employment with Cyclacel. The award was granted under Cyclacel’s 2020 Inducement Equity Incentive Plan which Cyclacel’s Board of Directors adopted to facilitate the granting of equity awards to new employees in accordance with NASDAQ Listing Rule 5635(c)(4).

The inducement grant is exercisable at a price of $3.77 per share, which is the closing price per share of Cyclacel’s common stock as reported by NASDAQ on October 23, 2020. The stock option shall vest over three years, with one third of the award vesting on October 23, 2021, and the remainder vesting ratably at the end of each subsequent month thereafter, subject to Dr. Kirschbaum’s continued employment with Cyclacel through each applicable vesting date. The option has a ten-year term and is subject to the terms and conditions of a stock option agreement.

KSQ boosts PARP inhibition in animal models of ovarian and breast cancers with USP1 inhibitor

On October 24, 2020 PARP inhibitors like Lynparza from Merck and AstraZeneca have been effective in some patients with ovarian and breast cancers, but many develop resistance to the drugs, and some people don’t respond at all (Press release, KSQ Therapeutics, OCT 24, 2020, View Source [SID1234568951]). KSQ Therapeutics hopes to provide hope for those patients with a first-in-class drug that may be able to boost Lynparza’s effectiveness when used in combination with it—and the company has rolled out promising animal data to back up that strategy.

KSQ’s drug inhibits ubiquitin specific peptidase 1, an enzyme that has been shown to promote the survival of cancer cells by facilitating DNA repair. The drug, dubbed KSQ-4279, inhibited tumor growth both on its own and when combined with Lynparza in mouse models of ovarian and triple-negative breast cancers, the company reported during a presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics.

KSQ discovered the drug using a technology platform it calls CRISPRomics, which allows its researchers to identify therapeutic targets by applying CRISPR-Cas9 gene editing to the whole genome. The company has used the platform to study 20,000 human genes in 600 cancer models.

RELATED: KSQ grabs $80M to move T-cell treatment for PD-1 resistance into the clinic

PARP inhibitors work by interrupting DNA repair, but KSQ’s researchers believe KSQ-4279 "inhibits different yet complementary DNA repair pathways," said the company’s chief scientific officer, Frank Stegmeier, Ph.D., in a statement.

In multiple animal models of ovarian cancer and triple-negative breast cancer, combining KSQ-4279 with Lynparza was more effective than either drug on its own. The combo approach prompted a complete response in some of the breast cancer models.

PARP inhibitor combinations are gaining steam in the oncology market. In May, the FDA approved a combination of Lynparza with Roche’s VEGF inhibitor Avastin to treat ovarian cancer with or without BRCA mutations.

Last year, Yale University researchers discovered that AstraZeneca’s experimental VEGF inhibitor cediranib also prevents DNA repair. The researchers suggested that cediranib could make tumors more responsive to Lynparza and other PARP inhibitors.

As for KSQ, it has grown quickly over the last few years, raising $76 million in 2017 and another $80 million a year later to advance its lead programs, one of which is a T-cell therapy for solid tumors that are resistant to PD-1 immune checkpoint inhibitors. KSQ-4279 is now its lead program, and the new data in ovarian and breast cancers give the company "confidence" to advance the drug into clinical trials "as a novel agent in a new class of targeted oncology treatment," Stegmeier said.

BerGenBio Virtual R&D Day – 06 November 2020

On October 23, 2020 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that it will host a virtual R&D Day on 06 November 2020 from 13.00 CET (Press release, BerGenBio, OCT 23, 2020, View Source;06-november-2020-301158567.html [SID1234568941]).

The event will feature independent experts highlighting the role of AXL kinase as an essential mediator of the biological mechanisms underlying life-threatening diseases. The presentations will focus on the role of AXL in specific disease areas including oncology, fibrosis and infectious disease such as COVID-19. Each presentation will be followed by a Q&A session.

A preliminary program for the event is outlined below. To register, please click here.

Preliminary Agenda