OncoSec Medical Incorporated (OncoSec) (ONCS), a company developing intratumoral cancer immunotherapies, today announced the appointment of Robert W. Ashworth, Ph.D. as Vice President, Regulatory. With more than 35 years of experience in the pharmaceutical industry, Dr. Ashworth is well-versed in the development of global regulatory strategies and has made significant contributions to the FDA approval of 12 new drugs.
As Vice President, Regulatory, Dr. Ashworth will oversee regulatory interactions involving the company’s intratumoral IL-12 immunotherapy (TAVO) clinical programs, bringing his expertise to OncoSec as the company anticipates multiple development milestones during the remainder of 2018 and throughout 2019. OncoSec has built a diverse clinical pipeline utilizing TAVO as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading anti-PD-1 checkpoint inhibitors. OncoSec’s combination studies include the rapidly advancing PISCES/KEYNOTE-695 Phase 2 clinical trial, which is evaluating the use of TAVO in combination with KEYTRUDA® (pembrolizumab) for the treatment of metastatic melanoma.
“Over the past year, OncoSec has significantly expanded and accelerated its clinical development activities requiring an individual of Bob’s expertise and experience to manage the overall regulatory processes here and around the world,” said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. “As Vice President, Regulatory, Bob will be responsible for leading our global regulatory strategy as we advance our PISCES/KEYNOTE-695 study and other clinical programs. Bob will direct all regulatory activities supporting the product registration strategy, lead interactions with health authorities on behalf of OncoSec, and coordinate joint submissions with OncoSec’s strategic partners as necessary.”
Dr. Ashworth’s career is highlighted by executive and senior-level regulatory positions at several influential pharmaceutical and biotechnology companies spanning multiple drug strategies and therapeutic indications. His extensive drug development and regulatory experience includes small molecules, therapeutic proteins and antibodies. Importantly, Dr. Ashworth was instrumental in securing a groundbreaking investigational new drug application (IND) for a personalized medicine, neo-epitope program.
Prior to joining OncoSec, Dr. Ashworth served as Vice President, Regulatory Affairs, Quality & Compliance for Advaxis, Inc., where he developed and executed the global regulatory strategy for the company’s immunotherapy platform and served as the company’s regulatory representative for clinical development programs involving Amgen, Bristol-Myers Squibb and Merck. Before Advaxis, Dr. Ashworth was Vice-President, Global Regulatory Affairs at NPS Pharmaceuticals, Inc., where he built the company’s international regulatory department and was instrumental in negotiating the approval of NATPARA (PTH) for hypoparathyroidism. As Vice-President, Global Regulatory Affairs for Otsuka Pharmaceutical Development, Inc., Dr. Ashworth was responsible for the regulatory strategy for the company’s flagship product, ABILIFY®.
Dr. Ashworth’s career experience also includes regulatory positions at Biovail Corporation, Forest Laboratories, Inc., Knoll Pharmaceutical Company (BASF), and CIBA-Geigy Corporation.
Dr. Ashworth earned a B.S. in Chemistry from St. John’s University and his Ph.D. in Organic Chemistry from MIT.
In connection with his appointment, Dr. Ashworth received a one-time inducement award of 100,000 stock options, of which 25,000 (25%) are fully vested as of the grant date. The remaining options vest monthly over a three-year period. The Company approved the award as an inducement material to Dr. Ashworth entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).
About OncoSec Immunotherapies
OncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer. OncoSec’s lead immunotherapy platform – TAVO (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach. In addition to TAVO, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its ImmunoPulse® platform. For more information, please visit www.oncosec.com.