Wael Fayad, who moved into the executive suite of Enumeral (OTCQB:ENUM) as chairman, president and CEO at the end of September, plans to reboot the company in the near term through partnering and collaborations.
“That’s why I’m here,” Mr. Fayad says in an interview with BioTuesdays.com, noting that collaborations would further validate the company’s technology platform and create value from its preclinical pipeline in cancer and other diseases mediated by the immune system.
The strategy, he points out, is to advance the company’s antibody assets to be “IND enabling ready,” with a data package that can attract partnering interest. IND enabling studies would then be done with a partner.
“We don’t need to be in the clinic to create value,” he contends, noting that significant value can be created at the preclinical stage. “There’s a race on in pharma and biotech to find the next breakthrough.”
Mr. Fayad has a 20-year record of executive and business experience in pharma. He spent 14 years at Forest Labs, most recently as corporate VP of global business development, until Actavis acquired Forest for $28-billion. He also assisted with the integration of the two companies. At Forest, he helped build and manage a broad network of corporate partnerships.
“My history at Forest was to work with the science and R&D teams to achieve our business goals,” he recalls. “I know how to value assets and how to create value. And I know an underappreciated asset when I see one, and I truly believe Enumeral is an underappreciated asset.”
In addition to Mr. Fayad, Enumeral’s new management team includes Robert Schaub, who is heading R&D. Mr. Schaub has 35 years of scientific and executive leadership in pharma and biotech, and is an expert in translational drug discovery and development of small molecules and biologics.
Enumeral licensed its discovery platform from MIT, Harvard University, Whitehead Institute for Biomedical Research and Massachusetts General Hospital.
Mr. Fayad explains that Enumeral has built a pipeline of preclinical immunotherapy antibodies from a platform targeting the study of immune cells and their response at high resolution.
“Our unique platform allows us to identify and characterize promising new drugs relevant to cancer, infectious and autoimmune diseases, giving us the potential to positively affect millions of patients who are underserved by current therapeutic alternatives,” he adds.
Initially, Enumeral’s immunomodulators are targeting checkpoint proteins, which the body uses to prevent runaway immune responses that can prove debilitating or even deadly.
Enumeral’s lead antibody, ENUM 244C8, is focused on targeting PD-1, or programmed cell death protein 1, which is a cell surface receptor that is expressed on T cells. Mr. Fayad says ENUM 244C8 binds differently to PD-1 and maintains its anti-tumor activity.
Cancer drugs on the market that now target PD-1 include Keytruda and Opdivo, which work with the immune system for the treatment of certain types of melanoma that can’t be treated with surgery or have metastasized. “ENUM 244C8 is differentiated at the fundamental level from these products,” Mr. Fayad contends.
ENUM 244C8 is a preclinical drug candidate and 15-to-18 months away from human clinical testing, he notes, adding the company is seeking a partner to advance the product, as well as another preclinical candidate, ENUM 388D4, which was developed as a backup program to ENUM 244C8.
In addition to PD-1, Enumeral is developing antibodies against a second generation checkpoint inhibitor, Tim-3, which also enables the immune system to attack cancer cells and is complimentary to PD-1, he adds.
Mr. Fayad points out that researchers are developing Tim-3 compounds as monotherapy and in combination with PD-1. “That’s why we picked these two targets to take advantage of their synergistic action.”
Enumeral’s preclinical studies are designed to further characterize the safety and efficacy of its antibodies and to “make them more attractive to potential collaborators,” he suggests. “Our Tim-3 antibodies are probably two years away from the clinic.”
Mr. Fayad says another opportunity for Enumeral is partnering its technology platform to discover antibodies, which could help other companies discover products against targets they are interested in.
“We are not limited by our three preclinical assets, but see an unlimited potential to enter into collaborations with our platform,” he adds. “We have some irons in the fire; some are more advanced than others.”
Noting that Enumeral is at its core a science company, Mr. Fayad also hopes to initiate discovery of at least one new antibody target in order to show potential partners the efficiency of the company’s discovery engine.
Enumeral already is collaborating with Pieris Pharmaceuticals, the NCI, Merck and MD Anderson Cancer Center, but Mr. Fayad figures his turnaround plan will position the company for more transformative deals. “Business development and collaborations are key value drivers for us,” he adds.