Sosei Heptares and Cancer Research UK Have Initiated a Phase I/IIa Trial, Marking the Administration of the First Dose of the Cancer Immunotherapy Drug HTL0039732
Friday, August 11, 2023
Sosei Group Corporation (TSE: 4565) and Cancer Research UK have jointly initiated a Phase I/IIa clinical trial to assess a novel cancer immunotherapy drug known as HTL0039732. Developed by Sosei Heptares, a prominent player in structure-based drug design, this small molecule drug aims to target advanced solid tumors. Notably, the trial has successfully administered the drug's first dose to a patient.
HTL0039732 operates by inhibiting signaling through a specific receptor known as the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4). Within the context of cancer, PGE2 prompts tumor cells to evade the immune response within the tumor microenvironment. The distinctive mechanism of HTL0039732 involves blocking EP4, thereby enhancing the immune system's capacity to recognize and combat cancer cells. This drug holds promise for treating cancers that typically display limited response to existing immunotherapies, including colorectal, gastroesophageal, head and neck, and castrate-resistant prostate cancers.
Overseeing the Phase I/IIa trial is Cancer Research UK's Centre for Drug Development (CDD), which has outlined several key objectives. These objectives encompass evaluating the drug's toxicity, tolerability, and pharmacokinetics, as well as determining the optimal dosage for subsequent Phase II studies. Additionally, the trial seeks to appraise the anti-tumor activity of HTL0039732 both when administered alone and in combination with the PD-L1 inhibitor atezolizumab. The Phase IIa stage of the trial will further delve into identifying the most effective combination dosages for specific cancer types. As a result of the trial's outcomes, Sosei Heptares holds the rights to continue advancing the clinical development and commercialization of HTL0039732.
Leading the trial are Dr. Bristi Basu from the University of Cambridge and Dr. Debashis Sarker from King’s College London, both serving as Chief Investigators. The trial's recruitment efforts have commenced within the UK, with patient enrollment initiated at Cambridge University Hospitals and Guy’s and St Thomas’ NHS Foundation Trusts. There are also plans to extend the trial's reach to other medical centers within the Experimental Cancer Medicine Centre (ECMC) network.
Matt Barnes, President of Heptares Therapeutics and Head of UK R&D, expressed his enthusiasm for the collaborative partnership with Cancer Research UK and the potential impact of HTL0039732 in augmenting cancer immunotherapies. Dr. Bristi Basu from the University of Cambridge emphasized the significance of targeting EP4 as a potential avenue for enhancing treatment options across a broad spectrum of cancers.
Dr. Nigel Blackburn, Director of Cancer Research UK’s CDD, highlighted the pivotal nature of this milestone within their collaboration with Sosei Heptares. Furthermore, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted HTL0039732 an Innovation Passport, a recognition that underscores its potential in addressing life-threatening conditions and expediting its path to market. This designation ultimately seeks to enhance patient access to groundbreaking treatments.
