TC Biopharm adds Bree Harlin as Chief Clinical Officer to Lead Global Clinical Division
TC BioPharm Announces Hiring of Chief Clinical Officer Bree Harlin to Lead Global Clinical Division
Former Loxo@Lily will oversee expansion of U.S. FDA Clinical Trials
TC BioPharm (NASDAQ: TCBP), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, today announced the appointment of Bree Harlin as Chief Clinical Officer (CCO).
Ms. Harlin brings more than twenty years of experience in research, oncology and clinical stage drug development to TC BioPharm. Most recently she was with Loxo at Lilly, where she worked on the clinical development of targeted therapies for various types of solid and hematologic cancers. She has worked in clinical development and operations across multiple therapeutic areas at large pharma and small biotech companies for the majority of her career which began in academia working on clinical trials at Mass General and Brigham and Women's Hospital. She will be based in New York, NY.
“Having worked at Loxo Oncology and then Eli Lilly post the acquisition of Loxo, Bree brings a wealth of experience and knowledge to TC BioPharm," said Bryan Kobel, Chief Executive Officer. “As we look to expand our clinical trial efforts into the United States her expertise will be vital in building strong clinical teams and spearheading successful trials globally.
Harlin will oversee TC Biopharm’s U.S. Food and Drug Administration clinical trials around TCBiopharm’s OmnImmune unmodified allogeneic gamma delta T cell product initially anticipated for use for the treatment of Acute Myeloid Leukaemia (AML).The aim is to treat patients who have not responded well to first-line therapy with the aim of delaying or preventing the need for human bone-marrow transplant. Kobel said TC Biopharm expects to file a first Investigational New Drug (IND) in the second half of 2023 with additional potential IND submittals for collaborative trials in combination with TCB-008.
“We pursued an exhaustive search to find the best candidate and Bree certainly checks all the boxes. Her experience at similar-sized biotechs as well as transitioning to big pharma provides us with a breadth of insight rarely seen in a candidate,” Kobel said. We are excited that Bree has seen the promise of TCBP and our platform technology around allogeneic gamma delta t-cells and our CAR program and we look forward to her leadership.”
"I look forward to joining the talented team at TC BioPharm as they enter a key inflection point in the clinical trial stage of their potential breakthrough therapies," Harlin said. "Cell therapies continue to present new promise with exciting breakthroughs happening throughout the vertical and TC BioPharm continues as a leader in the allogeneic gamma delta t-cellspace. The Company's robust clinical trial plans for TCB-008 and development of the CAR program offer multiple shots on goal in various indications and leading the design and management of future trials and seeing them to fruition was exceptionally compelling when I was presented the opportunity to join."
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer.
TC BioPharm is developing gamma-delta T cell therapies as the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.
