Unfortunately there's no such thing as immediate approval. This trial is a big deal. Very strong data, even interim data, could catapult the share price and the prospects for a partnership or buyout. However, we have to be realistic. 30% ORR wouldn't quite be revolutionary,as others have achieved that recently. That would turn heads in the industry, but a more or less standard development process would continue imo. 40? 50%? numbers like that would be a different story. That might make the FDA pro-active partner in the development process where there would be meetings to discuss the paths to approval. But that would still be a process, involving a complete BLA submission and proof of manufacturing readiness.
THIS IS ABOUT SHARE PRICE RESET, AND POTENTIAL PARTNERSHIP / BUYOUT.
FDA approval is not something any of us should think about too much. That will happen some day but that road could still be lengthy, We don;t need an approval for CYDY to be a profitable investment for most and for leronlimab to move forward towards that elusive approval. There ARE possibilities for "accelerated approval", but for now that resides with tnbc. But even "accelerated" isn't all that fast.
Best case for MSS is that the early results are extraordinary, and the DSMB is convened at cytodyn's request to consider stopping the trial early... but that would take more than just ORR in my opinion. There would need to be data showing some level of significant DOR (durability of response) and/or there would have to be a bunch of CRs (complete response = tumor gone). A PR is the typical response in oncology: >30% reduction in tumors. The FDA looks VERY VERY hard at DOR and mOS even when ORR is great and mPFS is great and safety is great. And that is also why a standard phase 3 trial will likely have to follow. cytodyn probably needs a trial with primary endpoint of mOS to seek approval.
*****
Believe it or not, beating SOC in major indications happens all the time. beating with safety doesn't change the timeline to approval, generally speaking. Safety just makes it more likely to be approved when the time comes. And more likely to attract partnership etc
there are other drugs that have already beat SOC for RR MSS-CRC. a few have crossed 30% ORR. none are seeking accelerated approval (one got rejected). they are all headed to further trials.
There are also a bunch of PD-L1 based therapies and combinations with PD-L1 inhibitors in development for MSS-CRC and some have promise. there are new assets that combine PD-L1 inhibition with other MOAs (bispecifics) in mss-crc.
*****
If cytodyn results are strong, then CytomX is the only real competitor for now, although other could emerge in the next 12 months. CytomX hit 30% and like cytodyn, they didnt exclude any subset of mss-crc patients. other successes below are limited to partial refractory mss-crc patient pools.
here's some confusing competitive environment info:
Therapy Combination / Eligibility "Filter" / % of MSS-CRC Patients / Liver Mets? / Best ORR / Next Steps (2026)
CytomX (Varseta-M) Broadest: KRAS Mutant or WT ~100% Yes 32% Finalizing FDA design for Registrational Phase 2/3
BeiGene Triplet Genetics-Locked: RAS Wild-Type ~40–50% Yes 33% Global Phase 3 vs. Standard Care
Adagene (ADG126) Anatomy-Locked: No Liver Mets ~25–30% No 31% Phase 2 dose selection; 2027 Phase 3 launch
Agenus (Bot/Bal) Anatomy-Locked: No Liver Mets ~25–30% No 24% Phase 3 BATTMAN (Active Enrollment)
Seagen (Tucatinib) Narrowest: RAS WT + HER2+ ~3–5% Yes 38% Expanding to 1st-Line (MOUNTAINEER-03)
BOT BAL from Agenus hit 19% (there are references to higher ORR but the 19% is the relevant one. BOT BAL was rejected for accelerated approval despite strong durability. they had design and dose dependency issues.
that's what i have found out after many hours of digging
*****
30% ORR for leronlimab would be as good as anything out there in development, but its still a dose finding p2 with a small higher dose cohort and will likely require the phase 2 to run all the way to the 12 month mark for all enrolled patients, followed by a phase 3 trial.
THIS IS ABOUT SHARE PRICE RESET, AND POTENTIAL PARTNERSHIP / BUYOUT.
FDA approval is not something any of us should think about too much. That will happen some day but that road could still be lengthy, We don;t need an approval for CYDY to be a profitable investment for most and for leronlimab to move forward towards that elusive approval. There ARE possibilities for "accelerated approval", but for now that resides with tnbc. But even "accelerated" isn't all that fast.
Best case for MSS is that the early results are extraordinary, and the DSMB is convened at cytodyn's request to consider stopping the trial early... but that would take more than just ORR in my opinion. There would need to be data showing some level of significant DOR (durability of response) and/or there would have to be a bunch of CRs (complete response = tumor gone). A PR is the typical response in oncology: >30% reduction in tumors. The FDA looks VERY VERY hard at DOR and mOS even when ORR is great and mPFS is great and safety is great. And that is also why a standard phase 3 trial will likely have to follow. cytodyn probably needs a trial with primary endpoint of mOS to seek approval.
*****
Believe it or not, beating SOC in major indications happens all the time. beating with safety doesn't change the timeline to approval, generally speaking. Safety just makes it more likely to be approved when the time comes. And more likely to attract partnership etc
there are other drugs that have already beat SOC for RR MSS-CRC. a few have crossed 30% ORR. none are seeking accelerated approval (one got rejected). they are all headed to further trials.
There are also a bunch of PD-L1 based therapies and combinations with PD-L1 inhibitors in development for MSS-CRC and some have promise. there are new assets that combine PD-L1 inhibition with other MOAs (bispecifics) in mss-crc.
*****
If cytodyn results are strong, then CytomX is the only real competitor for now, although other could emerge in the next 12 months. CytomX hit 30% and like cytodyn, they didnt exclude any subset of mss-crc patients. other successes below are limited to partial refractory mss-crc patient pools.
here's some confusing competitive environment info:
Therapy Combination / Eligibility "Filter" / % of MSS-CRC Patients / Liver Mets? / Best ORR / Next Steps (2026)
CytomX (Varseta-M) Broadest: KRAS Mutant or WT ~100% Yes 32% Finalizing FDA design for Registrational Phase 2/3
BeiGene Triplet Genetics-Locked: RAS Wild-Type ~40–50% Yes 33% Global Phase 3 vs. Standard Care
Adagene (ADG126) Anatomy-Locked: No Liver Mets ~25–30% No 31% Phase 2 dose selection; 2027 Phase 3 launch
Agenus (Bot/Bal) Anatomy-Locked: No Liver Mets ~25–30% No 24% Phase 3 BATTMAN (Active Enrollment)
Seagen (Tucatinib) Narrowest: RAS WT + HER2+ ~3–5% Yes 38% Expanding to 1st-Line (MOUNTAINEER-03)
BOT BAL from Agenus hit 19% (there are references to higher ORR but the 19% is the relevant one. BOT BAL was rejected for accelerated approval despite strong durability. they had design and dose dependency issues.
that's what i have found out after many hours of digging
*****
30% ORR for leronlimab would be as good as anything out there in development, but its still a dose finding p2 with a small higher dose cohort and will likely require the phase 2 to run all the way to the 12 month mark for all enrolled patients, followed by a phase 3 trial.
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