Challenge:
A European biopharma company focused on immuno-oncology therapeutics was developing small molecule and monoclonal antibody agents for three targets of high interest in the I/O field. The company had a sudden departure of their Chief Medical Officer and needed interim support while recruiting for a permanent replacement. Alacrita was engaged to provide this.
Solution:
Alacrita provided Chief Medical Officer support to the client, assisting them on key related activities. We provided clinical development input on the design of an FIH trial and clinical development plan for a differentiated small molecule that targeted a receptor of high interest in the I/O field. This study included dose-escalation for the novel agent as monotherapy and in combination with the anti-PD-1 antibody Keytruda (pembrolizumab). The agent was being developed in collaboration with a non-profit cancer research organization. The phase 1 trial was to be conducted at a prominent U.S. academic center.
We contributed to joint team meetings regarding the FIH trial and IND preparation, as well as meetings with the KOL-lead investigator. We also provided input on the clinical development plan and FIH study design for the next-most advanced agent in the company’s portfolio. In addition to the above, we joined the company’s executive team members in meetings with U.S. venture investors during due diligence, which led to a successful Series B financing. Finally, we assisted in evaluating and interviewing candidates for the permanent CMO position.
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