Challenge:
For a university with an early stage novel inhibitor of the JAK2/STAT5 pathway intended to treat hematologic malignancies, Alacrita was asked to validate a development plan to support activities for securing investment.
Solution:
The work was led by one of our pharmaceutical oncologists who reviewed the data and hypothesis developed by the university, including the proposed primary indication label and endpoints. Our consultant advised against pursuing the initial proposed label because of the associated requirement of lengthy and costly clinical trials with a low probability of success. Furthermore, while the theory behind the approach was indeed scientifically sound, the program was high risk given its very early stage compared to more advanced competitors. Our consultant proposed further research to develop POC data including mechanistic studies. This was followed by development of a map of the most appropriate product positioning of the inhibitor based on competitiveness, clinical relevance and unmet need. Our consultant advised on more practical primary endpoints for subsequent pivotal studies that would support more suitable indication labels, including solid tumors which the client had not considered.
Overall, we recommended that the scientific rationale and clinical settings under consideration for the inhibitor warranted further funding.