ADC Digest - August 2020

ADC Digest - August 2020

Mersana Therapeutics received FDA fast track designation (FTD) for XMT-1536 for the treatment of patients with platinum-resistant ovarian cancer

11 Aug 2020

XMT-1536 (NaPi2b antibody; Mersana Therapeutics/Recepta Biopharma)

  • FDA has granted fast track designation for XMT-1536 for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have:
    • Received up to three prior lines of systemic therapy or
    • Have received four prior lines of systemic therapy regardless of platinum status
  • XMT-1536 is in an ongoing Phase 1 proof-of-concept clinical trial in patients with tumors expressing NaPi2b, including ovarian cancer and NSCLC adenocarcinoma

Mersana bags FDA Fast Track Designation for XMT-1536

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Our outlook: 

  • This FTD will be an important milestone in the development of XMT-1536. XMT-1536 appears to be well tolerated, with promising responses shown in high grade serous ovarian cancer
  • With unmet need in platinum-resistant ovarian cancer and designation in hand, the product upon showing promising results can rapidly advance in development

– Dr. Kowndinya, CI Scientists

Background:

  • XMT-1536 is lead product candidate, composed of XMT-1535, a proprietary, humanized monoclonal antibody against human sodium-dependent phosphate transport protein 2B (NaPi2b), site-specifically linked, via a protease cleavable linker, to the proprietary cytotoxic aurastatin derivative auristatin F-HPA (auristatin F-hydroxypropylamide), with potential antineoplastic activity
  • XMT-1536 is in the expansion portion of a Phase 1 proof-of-concept clinical study in patients with ovarian cancer and NSCLC adenocarcinoma

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