LHC165 is a Toll-like receptor 7 (TLR-7) agonist, developed as a suspension for IT administration. Here, we present the technical development and characterization of a novel sustained release formulation for administration into the tumor tissue. An early and common understanding of the Target Product Profile (TPP) with the clinical team helped identify the desired product attributes for Clinical Manufacturing and Control. Salt and polymorph screening was performed to ensure sufficient solubility and fast dissolution enabled a focused formulation screening. As intratumoral injection is a novel route of administration, testing syringeability at extreme needle length and gauge as well as dose accuracy confirmation according to Ph. Eur. Guidelines are vital to ensuring a robust dosing strategy in the clinic. Innovative experiments using pork meat synringeability testing with statistical rigor resulted in an efficient and effective early product development approach.<br/>LHC165 as a single agent and in combination with PDR001 is currently enrolling patients with advanced malignancies in CLHC165X2101.

Development and characterization of LHC165, a TLR7 agonist designed for localized intratumoral injection

2019 Spring National Meeting

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