Clinical development strategy & plan for novel small molecule

Challenge:

For a leading university with an early stage novel small molecule to treat prostate cancer, Alacrita was asked to validate a development plan in order to support activities for securing investor, translational grant-funder and/or pharma partner confidence.

Solution:

Alacrita reviewed all the documentation already provided by the academic inventor and any available publications validating the target. We held a teleconference with the core team to get a detailed understanding of the project, the nature of the ‘hit’ generation work and the ‘hit’ molecules generated to date, available in vitro and cell-based assays and in silico models, and the basis for the projected costings for discovery, pre-clinical development and Phase I and II clinical trials, as prepared by the team. We found that although evidence to date had been generated for metastatic prostate cancer, this particular target was known to be over-expressed in other cancers and therefore our consultants proposed exploration of small molecule in a range of tumor types, both in vitro and later in vivo. We developed a clinical development strategy and plan, costings and timelines, based on our experience and appropriate industry standard metrics, for:

• Hit-to-lead medicinal chemistry, computational chemistry and screening (in vitro activity and preliminary ADME screens);
• Lead optimization medicinal chemistry, computational chemistry and screening (in vitro and in vivo activity and ADME/DMPK screening);
• Pre-clinical development, including non-GMP then GMP, pharmacology and toxicology;
• CMC (process development, non-GMP and GMP batch manufacture, formulation development and trial supplies); and
• Early clinical development to clinical proof-of-concept (Phase I safety trial and Phase IIa study).

Clinical Development Expertise

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