Oxford, UK, April 1st, 2016 – Replimune announced today the expansion of its management team and the opening of new product development facilities and offices in the UK and US. The expanded management team includes five senior appointments, Dr. Colin Love as Chief Operating Officer, Dr. Pamela Esposito as Chief Business Officer, Annie Woodland as Senior Vice President of Regulatory Affairs and Quality, Susan Doleman as Vice President of Clinical Development, and Dr. Tess Schmalbach as Executive Medical Director.
Replimune is developing next generation oncolytic immunotherapy products intended to maximise both the direct anti-tumor effect of oncolytic therapy, and the induction of a systemic immune response to tumor antigens, including neoantigens. The new team has considerable expertise in this area, as each previously led their respective functions at BioVex Inc, the original developer of talimogene laherparepvec (T-VEC; Imlygic) up until acquisition by Amgen in 2011. T-VEC is the first in the class of oncolytic immunotherapy drugs to receive marketing approval anywhere in the world, and is now approved for the treatment of advanced melanoma in the US, EU and Australia.
Colin Love comes to Replimune having most recently provided consultancy support to a range of companies from small gene therapy start-ups to large established biotech companies. He has over 30 years experience developing and launching biotechnology products and led development teams for Medeva, Serono and Amersham, prior to joining BioVex. Colin was SVP of Product Development at BioVex from 2000 until it was acquired by Amgen in 2011. Following the acquisition, he remained at Amgen as VP of R&D Operations working on T-VEC until it was approved in 2015.
Pamela Esposito joins Replimune from Ra Pharmaceuticals, where she served as Chief Business Officer. As a member of Ra’s senior management team, Pamela played a leadership role in strategy, helping Ra transform from a discovery platform to a clinical stage company and raising approximately $58 million in a Series B funding round. Prior to Ra, she was VP of Business Development at Biovex and played a lead role in negotiating the acquisition of the company by Amgen.
Anne Marie Woodland joins Replimune from uniQure where she had regulatory responsibility for all early stage and commercial products. Prior to joining uniQure, Annie was Executive Director and Global Regulatory Lead for T-VEC at Amgen/Biovex. She has extensive regulatory and quality expertise in the biopharmaceutical industry, specifically the areas of gene therapy and biologics and has held positions at CombinatoRx, Inc, Dyax Corp., Curis, Inc. (previously Reprogenesis), T-Cell Diagnostics and Baxter Dade.
Susan Doleman was most recently Senior Director, Clinical Operations at Epizyme, following, from 2006-2015, ultimately leading clinical operations for the pivotal Phase 3 program with T-VEC until BLA filing at BioVex/Amgen. Previously Susan has held clinical operations roles at a number of biotechnology companies including Critical Therapeutics Inc, ToleRX Inc and Genzyme Corp.
Tess Schmalbach has held multiple senior clinical positions at biotechnology and healthcare companies, including Chief Medical Officer at Dyax Inc, Vice President, Clinical Development at Coley Pharmaceuticals, and Director, Clinical Research at Vertex Pharmaceuticals. Previously she was a Fellow in Clinical Pharmacology at Harvard Medical School and received her medical training at the University of Medicine and Dentistry of New Jersey. She is currently an independent consultant, having previously provided consulting services to BioVex, and will also provide services to Replimune on a consultancy basis.
Replimune also announced the opening of its product development facilities in Abingdon, UK and corporate offices in Woburn, MA. The development facilities will house Replimune’s research, pre-clinical development, and CMC teams (currently housed in a smaller facility in Oxford, UK).
“Both the expanded team and the new facilities will help us accelerate our research and development efforts towards the intended initiation of clinical trials with our first next generation oncolytic immunotherapy product in 2017,” said Robert Coffin, Ph.D., CEO and co-founder of Replimune. He concluded, “We are excited that we were able to bring our uniquely experienced management team back together to develop our proprietary new platform and to rapidly transform Replimune into a clinical stage biotechnology company at the cutting edge of immuno-oncology.”
Replimune, headquartered in Oxford UK and with offices in the UK and MA, was founded in April 2015 to develop the next generation of ‘oncolytic immunotherapies’ for the treatment of cancer. Replimune is developing novel, proprietary products intended to improve both the direct anti-tumor effects of selective virus replication and the potency of the immune response to the tumor antigens released. Replimune intends to progress these therapies rapidly through clinical trials and to combine these with other immuno-oncology products with complementary mechanisms of action at an early stage.
About Oncolytic Therapy
Oncolytic immunotherapy is an emerging class of cancer therapeutics which exploit the ability of viruses to selectively replicate in and kill tumor tissue, while at the same time induce a potent, patient-specific, anti-tumor immune response. Oncolytic viruses have the unique ability to generate an autologous vaccine to the patient’s particular complement of tumor antigens, including neoantigens, in situ in the patient with a truly off-the-shelf approach. While clear single agent clinical activity has been achieved with oncolytic immunotherapy, it is anticipated that particular synergy may be observed in combination with immune checkpoint blockade and other immune-modulatory approaches.