MedicalResearch.com Interview with:
Dr. Mark Heffernan PhD
Dr. Mark Heffernan is a Nexvet co-founder, and has served as Chief Executive Officer and a member of the Nexvet board of directors since April 2011. In 2003, Dr. Heffernan co-founded Opsona Therapeutics Ltd., an Irish biotechnology company focused on human mAbs for inflammatory and oncology diseases. He also worked in R&D and business development roles for two Australia biotechnology companies, Antisense Therapeutics Limited and Metabolic Pharmaceuticals Pty Ltd., for a number of years. Dr. Heffernan has a BSc in Biochemistry and Pharmacology and a Ph.D. in Biochemistry from Monash University (Australia).
MedicalResearch.com: Tell me about Nexvet and its background? What is the company’s mission statement or goal?
Dr. Heffernan: Nexvet is a public (NASDAQ: NVET) clinical-stage biopharmaceutical company focused on developing and commercializing novel, species-specific biologics for companion animals (pets). We were founded five years ago and our mission has been to transform animal medicine by leading the introduction of biologic therapies (monoclonal antibodies and therapeutic proteins) into everyday veterinary practice. Many chronic conditions stand to benefit from biologic options, just as they have in human medicine, such as inflammation and cancer. Taking products with validation in human medicine is part of Nexvet’s development strategy, which leverages human data from these innovative therapies and rapidly advances the veterinary equivalents.
MedicalResearch.com: Can you tell us about the PETization™ platform? What is it designed to do?
Dr. Heffernan: PETization™ is Nexvet’s proprietary approach to monoclonal antibody (mAb) candidate design. It uses an algorithmic approach, ‘crunching’ libraries of natural antibody sequence data to rapidly design mAbs that are “100% species-specific” to a target species. This significantly reduces the risk of an immunogenic reaction, while preserving the parent (or ‘starting’) mAb’s affinity for its target.
PETization has demonstrated a reduction in the time and cost typically associated with the development of monoclonal antibodies using conventional methods, such as CDR grafting and its affinity maturation. Thus far Nexvet has used PETization to successfully convert human and rodent mAbs into canine, feline and equine mAbs. These candidates have demonstrated safety and efficacy across the clinical development spectrum including proof-of-concept (every species) right through to late-stage pivotal studies (in dogs).
MedicalResearch.com: Would you elaborate on the first three product candidates, NV-01, NV-02 and NV-08? What species and diseases are they designed to affect?
Dr. Heffernan: Nexvet’s chronic pain programs are led by NV-01 and NV-02, which are both mAb therapies in development for the control of osteoarthritis pain in dogs and cats, respectively. Both candidates work by inhibiting the activity of nerve growth factor (NGF), a potent mediator of pain signaling. Both candidates are being developed as monthly subcutaneous injectable therapies, a first in this therapeutic area.
NV-01 has successfully completed its pivotal safety and efficacy study, and NV-02 is currently the subject of a 90 cat pilot clinical study. The United States Adopted Name (USAN) Council has approved the generic name “ranevetmab” for NV-01.
Nexvet is also currently developing NV-08, aimed to treat canine inflammatory diseases, including atopic dermatitis, a common skin condition in dogs. It is an inhibitor of TNF- dogs, with TNF- being a potent inflammatory mediator in a number of inflammatory conditions.
MedicalResearch.com: : What future research are you planning?
Dr. Heffernan: Nexvet currently has 15 active programs at various stages of development, from lead candidate identification right through to completion of pivotal safety and efficacy studies required for regulatory approval. In the next quarter Nexvet expects results from a pilot study for NV-01 in osteoarthritic dogs investigating assessing various doses and dosing regimens, as well as a proof-of-concept study of NV-01 in canine pruritis (itch). In addition, in the first quarter Nexvet anticipates the completion of proof-of-concept studies for NV-08. In the second quarter of 2016 Nexvet expects to announce results from a pilot clinical study of NV-02 in approximately 90 cats with osteoarthritis.
Nexvet has also expanded its research into the area of immuno-oncology, which relies on harnessing the immune system to fight tumors, an area that has seen significant human clinical advances in recent years. This approach may provide therapies which have efficacy in a variety of tumor types, without the side-effects commonly associated with common chemotherapies. Epidemiological studies have indicated that cancer is the leading cause of death in dogs over 10 years of age, with 50 percent of older dogs developing cancer and approximately one in four dogs eventually dying from cancer.
MedicalResearch.com: Is there anything else you would like to add?
Dr. Heffernan: The Nexvet team was very pleased with the recent data from NV-01’s pivotal safety and efficacy study – which strongly supported its efficacy demonstrated in single monthly injections, a key advantage for monoclonal antibody therapies over small molecules. Additionally, NV-01 was found to be safe and well-tolerated with no significant adverse safety signals observed in the study.
Chronic pain is highly prevalent in companion animals and is caused by a number of conditions, and yet there are significant drawbacks to current standards-of-care including safety concerns, inconvenient dosing regimens, and non-species-specific drug design. New, safe and efficacious species-specific therapies would not only benefit pets and their owners but veterinarians as well, and we believe biologic therapies such as those Nexvet are developing have the potential to address this and many other health challenges in companion animals in the years ahead.
Our commitment to leading the biologics field through bringing innovative therapeutic medicines for companion animals has emerged from dedicated drug discovery, research and clinical development teams across the globe. We have recently expanded the global team to include a new division in Ireland that will manufacture our products for global markets. We strive to be recognized as the leader in animal health, bringing multiple biologic solutions to diseases in companions where there are unmet medical needs.