Case Studies Archive - Alacrita

Clinical due diligence of an NK cell therapy

Written by Cort | Nov 15, 2023 5:18:18 PM

Challenge:

A leading NK cell research group had developed a novel process for manufacturing NK cells with highly differentiated properties. The technology had been licensed to a start-up company that was investigating the possibility of establishing a partnership with a larger company. The client hired Alacrita to conduct an assessment of the clinical data that had been generated in physician-initiated trials in AML.

Solution:

An Alacrita pharmaceutical hematologist reviewed the properties of the differentiated NK cells and concluded that there was indeed material differentiation that had the potential to translate into superior clinical performance. Furthermore, the manufacturing process appeared feasible using current technologies, providing no barriers to clinical adoption. However, we concluded that the current clinical dataset was not strong enough to engage major partners given the very high competitive intensity in the field, and we recommended an outline design for a trial that, if positive, would prove attractive.



Due Diligence Consulting

Alacrita due diligence consultants have been a trusted DD source for close to fifteen years, conducting assignments for large pharma, biotech, universities and investors. Every due diligence we perform is underpinned by our ability to incorporate individuals into each project who have the exact matching expertise required for a complete, thorough and accurate assessment.