Challenge:

A late pre-clinical biotech company engaged in the development of antibody drug conjugates (ADCs) targeting GPCRs for treatment of solid tumors asked Alacrita to conduct an internal due diligence & reality check of its investment proposition and plans. The most advanced asset was an ADC with a preclinical data set in the treatment of melanoma. The target was a cell-surface expressed receptor located both on the tumor cell and in the stroma of the tumor microenvironment (TME) and in melanoma has the highest absolute expression level and the highest differential expression between tumor and normal cells. Expression was also increased in melanoma cells upon combination  therapy and is a prognostic marker of poor outcomes.  

Solution:

We interviewed company management and reviewed all relevant documents describing the lead program, its characteristics and development status, including: 

  • Reports and publications about the pharmacology;
  • Toxicology and preclinical study reports;
  • Documentation relating to indication selection, clinical development plans and data;
  • High-level budgets and timelines;
  • Intellectual property position and documentation (not a freedom-to-operate nor a patent expiry analysis, rather a strategic assessment of the IP position).
We then identified the risks associated with the program across melanoma and other possible indications and quantify their impact (high – medium – low), and suggested, where possible, actions to mitigate these risks. Finally, we assessed the competitive landscape as it relates to the indications under development as well as the class of molecule/mechanism of action. As a result of the DD component of our assessment, the client decided to pivot to a new ADC toxin and linker combination and reoriented the program to address a different, niche, indication.


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.

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