ROCKVILLE, Md.--(BUSINESS WIRE)--NeoImmuneTech, Inc., an immunotherapy drug development company focused on advanced cancer treatments, today announced the appointment of NgocDiep (‘Diep’) Le, M.D., Ph.D., as Chief Medical Officer (CMO). Dr. Le brings to NeoImmuneTech over 16 years of drug development experience across all phases of Oncology R&D, including discovery, early and late stage clinical development, and regulatory submission and approval, in both solid and liquid tumors.
“Dr. Le is a highly accomplished R&D leader with an exceptional track record of successful and efficient FDA review submissions. NeoImmuneTech will greatly benefit from her oncology and drug development background,” said Se Hwan Yang, Ph.D., Chief Executive Officer of NeoImmuneTech. “She will be instrumental to our team as we advance HyLeukin-7® through IND and clinical development in oncology and expand our pipeline to additional indications.”
“NeoImmuneTech’s approach to enhancing T cell functionality with HyLeukin-7 has the potential to be a transformative treatment for diseases in multiple therapeutic areas, including immuno-oncology,” said Dr. NgocDiep Le, NeoImmuneTech’s new CMO. “I am thrilled to join the NIT team and look forward to applying my experience in oncology and drug development to advance HyLeukin-7 efficiently through strategically important clinical trials while supporting pre-clinical development of NIT’s additional programs.”
Most recently, Dr. Le served as CMO at Verastem where she led the company’s first NDA submission and successful approval of the PI3K-δ/γ inhibitor duvelisib (COPIKTRATM) in multiple indications. Prior to Verastem, she was the Vice President in Immuno-Oncology Innovative Medicines at MedImmune, a subsidiary of AstraZeneca. In this executive role, she led the product development teams for several high-priority immuno-oncology assets. Prior to MedImmune, Dr. Le served as Global Clinical Program Head and Executive Medical Director at Novartis Oncology where she designed and implemented the development strategy for multiple oncology assets in late stage clinical evaluation. Prior to working at Novartis, she served as Senior Executive Medical Director at GSK, Oncology R&D, where she successfully led the clinical development program for the MEK inhibitor trametinib (MEKINISTTM) from the first-in-human study through FDA approval. Dr. Le began her industry career at Amgen, Inc. as Medical Sciences Medical Director in Early Development Oncology, where she led multidisciplinary teams to bring late stage research products through IND filing, Phase 1/Proof-of-Concept studies and position drugs for the late phase clinical development. Dr. Le received her B.S. in Biology from the California Institute of Technology, earned her MD and PhD in Cancer Biology from Stanford University School of Medicine. She completed a Medical Oncology Fellowship at the Duke Comprehensive Cancer Center and was promoted to a faculty member in the Divisions of Medical Oncology and Cellular Therapy/Bone Marrow Transplantation prior to the completion of her fellowship.
HyLeukin-7 (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell amplifier comprising a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform – hyFc™. IL-7 is known to be a critical factor for T cells, acting on increasing both the number and functionality of T cells. HyLeukin-7 could play a pivotal role in reconstitution and reinvigoration of T cell immunity for treatment of cancer patients and lymphopenia, providing unique opportunities for immuno-oncology (IO) combination strategies. HyLeukin-7 is being developed as an “IO enabling” therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy. NeoImmuneTech and Genexine are collaborating in three Phase 1b/2a clinical trials in advanced solid tumors and glioblastoma in the US and Korea.
NeoImmuneTech (NIT), a Genexine related company founded in 2014, is focused on leading the development efforts for its flagship immunotherapy product, Hyleukin-7, in the U.S. and EU. Based in Rockville, Maryland, NIT has the core competency of global clinical and business development with a strong scientific focus and a broad network of global leading R&D organizations. NIT is currently conducting Phase 1b/2a clinical trials of Hyleukin-7, aiming at developing not only the first-in-class treatment of lymphopenia but also a breakthrough cancer immunotherapy. www.neoimmunetech.com