Grok, write me a more positive PR:
Leronlimab Delivers Rapid, Deep ctDNA Reductions in Every Evaluable Patient With Heavily Pretreated Metastatic Colorectal Cancer in Phase 2 CLOVER Trial
Three patients advanced to curative-intent surgery. The combination was well tolerated with no leronlimab-related serious adverse events. Data presented at ESMO 2026.
VANCOUVER, Wash., October 26, 2026. CytoDyn Inc. (OTC: CYDY) today reported updated results from CLOVER, its Phase 2 trial of leronlimab combined with trifluridine/tipiracil (TAS-102) and bevacizumab in patients with microsatellite-stable metastatic colorectal cancer (MSS mCRC). The findings were presented as poster 820P at the European Society for Medical Oncology (ESMO) Congress 2026.
MSS mCRC accounts for most metastatic colorectal cancer and has historically responded poorly to immunotherapy. Patients who progress after standard therapy have few options.
Key findings
Molecular response in every evaluable patient: all 28 patients with evaluable circulating tumor DNA (ctDNA) data had a decline by week 2, with a median reduction of 86%.
Significantly deeper reductions than the standard of care: at weeks 4 and 8, ctDNA reductions were significantly greater than in matched real-world patients treated with TAS-102 plus bevacizumab (p=0.0005 and p=0.0006, Natera real-world database).
Tumor responses in a heavily pretreated population: blinded independent central review has confirmed 4 partial responses (6.3% response rate). Seven more investigator-reported partial responses are under central review; if all are confirmed, the response rate would be 17%. More than half of patients had received 3 or more prior lines of therapy, 71% had liver metastases, and 86% had already received bevacizumab.
Conversion to potentially curative surgery: three patients improved enough to leave the study for curative-intent surgery. Under the trial's rules, they are counted as non-responders.
Signs of a dose response: investigators observed greater activity at 700 mg than at 350 mg.
Target present in every tumor: CCR5 was expressed in all 91 archival tumor samples tested.
Favorable safety: there were no leronlimab-related dose-limiting toxicities, no related adverse events above Grade 2, and no discontinuations due to leronlimab.
"[CEO quote on what the data mean and next regulatory and partnering steps]," said Robert E. Hoffman, Chief Executive Officer of CytoDyn.
"[Investigator quote on the speed and depth of the ctDNA responses and the surgical conversions]," said [Dr. Benjamin Weinberg, Georgetown Lombardi Comprehensive Cancer Center, or Dr. Pashtoon Kasi, City of Hope].
Next steps
Eligible patients are now rolling over to an extension that adds pembrolizumab to leronlimab. CytoDyn expects central review of the pending responses, plus progression-free and overall survival data, by [timing]. The company plans to discuss these results with the FDA and potential partners.
About CLOVER
CLOVER is an open-label Phase 2 study that enrolled 66 patients with CCR5-positive MSS mCRC at 7 U.S. sites. It evaluates leronlimab at 350 mg and 700 mg weekly in combination with TAS-102 and bevacizumab.
About leronlimab
Leronlimab is a humanized monoclonal antibody that blocks CCR5, a receptor that drives tumor growth, metastasis and immune evasion.
Forward-looking statements: [standard CytoDyn safe-harbor language].
Leronlimab Delivers Rapid, Deep ctDNA Reductions in Every Evaluable Patient With Heavily Pretreated Metastatic Colorectal Cancer in Phase 2 CLOVER Trial
Three patients advanced to curative-intent surgery. The combination was well tolerated with no leronlimab-related serious adverse events. Data presented at ESMO 2026.
VANCOUVER, Wash., October 26, 2026. CytoDyn Inc. (OTC: CYDY) today reported updated results from CLOVER, its Phase 2 trial of leronlimab combined with trifluridine/tipiracil (TAS-102) and bevacizumab in patients with microsatellite-stable metastatic colorectal cancer (MSS mCRC). The findings were presented as poster 820P at the European Society for Medical Oncology (ESMO) Congress 2026.
MSS mCRC accounts for most metastatic colorectal cancer and has historically responded poorly to immunotherapy. Patients who progress after standard therapy have few options.
Key findings
Molecular response in every evaluable patient: all 28 patients with evaluable circulating tumor DNA (ctDNA) data had a decline by week 2, with a median reduction of 86%.
Significantly deeper reductions than the standard of care: at weeks 4 and 8, ctDNA reductions were significantly greater than in matched real-world patients treated with TAS-102 plus bevacizumab (p=0.0005 and p=0.0006, Natera real-world database).
Tumor responses in a heavily pretreated population: blinded independent central review has confirmed 4 partial responses (6.3% response rate). Seven more investigator-reported partial responses are under central review; if all are confirmed, the response rate would be 17%. More than half of patients had received 3 or more prior lines of therapy, 71% had liver metastases, and 86% had already received bevacizumab.
Conversion to potentially curative surgery: three patients improved enough to leave the study for curative-intent surgery. Under the trial's rules, they are counted as non-responders.
Signs of a dose response: investigators observed greater activity at 700 mg than at 350 mg.
Target present in every tumor: CCR5 was expressed in all 91 archival tumor samples tested.
Favorable safety: there were no leronlimab-related dose-limiting toxicities, no related adverse events above Grade 2, and no discontinuations due to leronlimab.
"[CEO quote on what the data mean and next regulatory and partnering steps]," said Robert E. Hoffman, Chief Executive Officer of CytoDyn.
"[Investigator quote on the speed and depth of the ctDNA responses and the surgical conversions]," said [Dr. Benjamin Weinberg, Georgetown Lombardi Comprehensive Cancer Center, or Dr. Pashtoon Kasi, City of Hope].
Next steps
Eligible patients are now rolling over to an extension that adds pembrolizumab to leronlimab. CytoDyn expects central review of the pending responses, plus progression-free and overall survival data, by [timing]. The company plans to discuss these results with the FDA and potential partners.
About CLOVER
CLOVER is an open-label Phase 2 study that enrolled 66 patients with CCR5-positive MSS mCRC at 7 U.S. sites. It evaluates leronlimab at 350 mg and 700 mg weekly in combination with TAS-102 and bevacizumab.
About leronlimab
Leronlimab is a humanized monoclonal antibody that blocks CCR5, a receptor that drives tumor growth, metastasis and immune evasion.
Forward-looking statements: [standard CytoDyn safe-harbor language].
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