Opportunity analysis of an antibody-cleaving enzyme in oncology & autoimmune diseases

Challenge:

A biopharmaceutical company with a focus on immunomodulatory compounds was looking to expand the application of its lead product in oncology, specifically, by adapting the product to increase the potency of therapeutic antibodies that act via antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP), when used in combination with mAbs. It was understood that this would entail overcoming several technical hurdles and potential immunogenicity issues. Alacrita was asked to address several scientific and clinical questions regarding the possibilities of this new product in oncology to further characterize the opportunity.

Solution:

To address these questions, we assembled a high-powered multidisciplinary group of experts who explored the following themes:

• Efficacy/safety trade-offs and challenges when treating cancer patients with therapeutic antibodies (considering the different mechanisms of action, ADCC, ADCP and CDC).
  
  
• Oncology settings where the product could have a material impact (balancing the fact that the approach causes a window of vulnerability to infectious disease). For example, specific patient groups/indications; hematologic malignancies vs. solid tumors; primary vs. metastatic disease; therapeutic mAb treatment responders vs. non-responders.
  
  
• Competing approaches to the same objective i.e., enhancing the potency of ADCC or ADCP-dependent mAb therapies.
  
  
• Rationale for targeting pipeline antibodies or established antibodies with respect to partnering the clinical development.

Our recommendations were submitted to the company in the form of a report, which was presented to the senior leadership in a workshop format.

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