Genprex, Inc. (NASDAQ:GNPX) said it has strengthened its leadership team with the appointments of Dr Mark S. Berger to the newly-created position of chief medical officer and Dr Hemant Kumar to the newly-created position of chief manufacturing and technology officer, with both to report to Genprex chief executive officer Rodney Varner.
In a statement. Varner commented: “It is my privilege and pleasure to welcome Mark and Hemant to our management team. Their collective accomplishments and deep domain expertise in clinical development and gene therapy manufacturing, respectively, will be of great value as they help guide Genprex and advance our important Acclaim-1 and Acclaim-2 clinical trials in non-small cell lung cancer this year.
"As we continue to make progress with these studies, and to expand our technology pipeline, it is more important than ever to have medical affairs and manufacturing in such capable hands.”
READ: Genprex gears up for patient enrollment in its Acclaim-1 REQORSA trial after FDA feedback
Dr Berger said: “I am delighted to join the growing team at Genprex, confident that my experience designing and managing pivotal clinical trials in oncology will provide valuable insight and oversight for Genprex’ novel gene therapy pipeline."
“Advancing the first systemic gene therapy in oncology is a uniquely exciting opportunity to transform cancer care for patients with limited treatment options and I am looking forward to working with Genprex’ leadership team to help develop this new approach to cancer treatment.”
Dr Berger is an oncologist and senior executive with 25 years of biotech and pharmaceutical company experience in the development of oncology therapeutics. The company noted that he has successfully brought two drugs through the regulatory process to approval and excels in strategic development, team management and collaborative leadership.
He joins Genprex from Actinium Pharmaceuticals, Inc. where since January 2017 he served as chief medical officer and was responsible for clinical strategy and development of radioisotope-labeled antibodies for therapy in oncology, including the company’s Phase 3 SIERRA trial. Before that, Dr Berger was senior vice president-Clinical Research at Kadmon Corporation from 2013 through 2017, where he led all aspects of the company’s new drug development, including clinical trial design and management of the oncology programs in non-small cell lung cancer and breast cancer, among others.
Prior to that, Dr Berger was chief medical officer of Deciphera Pharmaceuticals from June 2011 to September 2013. Before Deciphera, he was vice president for Clinical Development at Gemin X Pharmaceuticals, where he led the clinical strategy, design and management of clinical trials for two novel oncology agents including obatoclax. Based on the results of a randomized Phase 2 clinical trial of obatoclax, Gemin X was acquired by Cephalon (NASDAQ:CEPH) in March of 2011.
Before his work with biotechnology companies, Dr Berger held key positions in two global pharmaceutical companies. He served as group director, Medicine Development Centre-Oncology for GlaxoSmithKline. In this position, Dr Berger managed the development of Tykerb (lapatinib) in lung and breast cancer where he designed and led two Phase 2 clinical trials before planning and leading a 399 patient pivotal Phase 3 trial that resulted in the FDA approval of Tykerb in breast cancer. In addition, he managed the Lapatinib Expanded Access Program that enrolled over 4000 patients on a global basis.
Dr Berger began his career in drug development at Wyeth Research where he led the planning and execution of the pivotal Phase 2 trial for Mylotarg, which was the first antibody-targeted chemotherapy agent. He presented the Mylotarg clinical data at the US Food & Drug Administration's (FDA) Oncology Drug Advisory Committee meeting, after which Mylotarg received accelerated FDA approval for patients with relapsed AML.
Global expert in Chemistry, Manufacture and Controls
Dr Kumar is a recognized global expert in Chemistry, Manufacture and Controls (CMC) Technical Development and GMP manufacturing. He has a more than 25-year track record leading global CMC and regulatory approval strategy for accelerated development of innovative vaccines, biologics, advanced cell & gene therapy drug process and product development (Ph1 to Ph3 and commercialization) under current GMP, and licensing processes.
He joins Genprex from Arcturus Therapeutics (NASDAQ:ARCT), Inc., where he served as Strategic Advisor and then vice president, Global Head of Manufacturing, Supply Chain, and Strategy. Prior to that, Dr Kumar was vice president of CMC Technical Development & Manufacturing Operations at Oncoimmune Therapeutics, Inc., a private company that was acquired by Merck & Co. during his tenure there.
Before that, he was vice president, Head of Global Process Sciences and Clinical Manufacturing Operations at Rentscher BioPharma, SE, and prior to that, Dr Kumar was with AnaptysBio (NASDAQ:ANAB), Inc., where he served as senior vice president, head of Global CMC, Technical Development and Manufacturing Operations. Before that, Dr. Kumar held senior-level positions of increasing manufacturing and technical operations leadership in global biopharmaceutical companies including Merck & Co., Inc. (NYSE:MRK), Sanofi Genzyme (NASDAQ:GENZ), Inc., Lonza Biologics, Inc., Sanofi Pasteur, Janssen Biotech (a Johnson & Johnson (NYSE:JNJ) company) and Wyeth Lederle Vaccines, Inc.
Dr Kumar commented: “I am excited to join the management team at Genprex and to work alongside this group of seasoned executives to realize the potential for its novel systemic gene therapy to improve outcomes for cancer patients.
“I am eager to apply my expertise and technical background in accelerated development of innovative biologics and advanced cell and gene therapies to support Genprex’ already impressive work and drive its technologies to commercialization.”
Inducement Grants
Genprex said it has granted 550,000 options to Dr Berger at an exercise price equal to $2.85, the closing price of its common stock on September 27, 2021, the date of grant. The company added that it has granted 400,000 options to Dr Kumar also at an exercise price equal to $2.85.
While these options were not granted under the company's 2018 Equity Incentive Plan, the awards will incorporate the terms of the plan. The options vest as to one-third of the shares over the next three years and are exercisable for a period of ten years subject to continued service to the company.
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. The company’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options.
Contact the author at jon.hopkins@proactiveinvestors.com