mCRC abstract link

 What the abstract signifies to me

• All of the trial participants had locally advanced or metastatic solid tumors.
• All of the trial participants had 1-3 prior systemic therapy lines for mCRC
• None of the trial participants had Serious Adverse Events
• 60% (3 of 5) had partial responses
• 20% (1 of 5) have no evidence of disease and is alive at 57 months
• mOS (median overall survival) from the first dose of leronlimab in this trial as 2^(nd) – 4^(th) therapy, was 15.8 months (range 4.2-57 with a patient still alive at 57 months), compared to approved therapies having 7.5 months mOS for 2nd or 3rd therapies.      

My thoughts

• Due to the abstract submission deadline being April 8, 2025, I think it is likely that the 5-year anniversary for survival will arrive in July 2025. See ESMO GI 2025 abstract guidelines
• Based on the safety profile in this and other trials with leronlimab, IMO the 700 dosage level seems reasonable.
• The Phase 2 CRC trial recently underway would benefit CytoDyn if it measures PD-L1 and more. This is glaringly obvious I think from the mTNBC data released in this poster May 15, 2025. See more here:
  • "Immunotherapy For All" https://www.linkedin.com/posts/maxlataillade_tnbc-immunotherapy-leronlimab-activity-7338662267086905344-DftX/
  • "Turning Cold Tumors Hot: Leronlimab’s Transformative Potential in TNBC" https://www.linkedin.com/feed/update/urn:li:activity:7329189660927102976/
    • see Ken Chowder question about adding the possibility of Checkpoint Inhibitors to the new CRC trial
    • see Max Lataillade (SVP CytoDyn) response which indicates the option has been added to the new CRC trial
    • https://www.reddit.com/r/Livimmune/comments/1kp0r4g/option_for_checkpoint_inhibitors_in_crc_trial/
• IMO the mTNBC data on May 15 and the additional MOA of synergy with Immune Checkpoint Inhibitors inevitably means that big things are coming. In TNBC it could be a BTD, partnership, P2-3 trial or any/all of these in combination.