The proposed supplement funds participation of a 3-member team from Elf Zone, Inc. in the I-Corps? at NIH training program. The team will receive training in commercialization that will facilitate the successful development of a research discovery to a commercially available therapy for the treatment of high-risk pediatric and adult leukemia. It will also serve to extend the national innovation ecosystem to the team members? respective academic institutions and companies. The Project: Current standard of care treatments show poor efficacy against B cell acute lymphoblastic leukemia with overexpression of the cytokine receptor, CRLF2 (CRLF2 B-ALL). Using a cell-mediated delivery system, the Principal Investigator?s (PI?s) laboratory at Loma Linda University (LLU) identified a cytokine that essentially eliminates CRLF2 B-ALL cells in vivo in preclinical patient-derived xenograft models of CRLF2 B-ALL. A recombinant form of the cytokine is proposed as a novel biologic to treat CRLF2 B-ALL. LLU filed a provisional patent application (April 2017) covering the use of the cytokine as a biologic to treat CRLF2 B-ALL. Elf Zone, Inc. has secured an option to license exclusively this technology from LLU. The use of this biologic is anticipated to be in combination with standard of care therapy. Current therapies used to augment standard of care therapy to treat high-risk leukemia, like CRLF2 B-ALL, typically cost $400,000-$800,000 per case. In the United States alone, there is a total of ~2012 new cases per year of CRLF2 B-ALL with larger numbers in Central and South America due to the five-fold increased incidence in the Hispanic population. The Team: The three team members selected for participation in I-Corps? have a demonstrated history of successful scientific collaboration as evidenced by co-authored publication. The team brings the C-level decision making ability, technical expertise, and industry expertise that will allow us to leverage I-Corps? training to commercialize the results of our research discoveries to benefit patients. Kimberly Payne, PhD. Dr. Payne is the Chief Executive Officer (CEO) of Elf Zone, Inc. and owns 60% of the company. She is an Associate Professor at LLU and serves as the university PI for the parent SBIR. The therapeutic activity of the cytokine biologic was discovered in her laboratory at LLU. Dr. Payne brings C-level decision-making ability to the team. Jacqueline S. Coats, BS, MPH candidate. Ms. Coats serves as the Chief Scientific Officer (CFO) of Elf Zone, Inc., and led the patient-derived xenograft studies that identified the therapeutic activity of the cytokine biologic in Dr. Payne?s LLU laboratory. She brings scientific expertise to the team. Ben Van Handel, PhD. Dr. Van Handel has co-founded two start-up companies and is currently the CEO of a company that is developing small inhibitors to modulate cytokine signaling. He has overseen company formation, licensing of technology from UCLA, developing management and advisory teams and successful seed funding. He brings industry expertise to the team. Each member of the team is committed to the time requirements of the program.
The proposed supplement will fund participation of a 3-member team from Elf Zone, Inc. in the I-Corps? at NIH training program. The team will receive training in commercialization that will facilitate the successful development of a research discovery to a commercially available therapy for the treatment of high-risk pediatric and adult leukemia. It will also serve to extend the national innovation ecosystem to the team members? respective academic institutions and other collaborating companies.
