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Posted On: 04/23/2025 12:47:50 PM
Post# of 154593
The Cytodyn URL updates are definitely telegraphing a full court press on oncologic indications whilst not ignoring the sweep of indications under the pipeline page, which also leads with oncology. Dr Jay stated outright they see it is the shortest timeline to approval or partnership. More coming with the announcements at ESMO in Munich, but this from the last shareholders letter I think is already spelled out on your “our-science” sub-page. The oncology rationale and mechanism is not news to our group here but I expect they are going to bring it into focus at ESMO and with results that should startle, provide hope to anyone with TNBC (along with other high CCR5 expressing solid tumors), and likely a partnership which will put a floor under the company.
“we are excited to share more about the clarity forming around the putative mechanism of action of leronlimab in solid tumors…”
“The exciting survival outcomes announced in February 2025 provide early clinical evidence of leronlimab’s potential impact across the field of solid-tumor oncology. As previously announced, we’ve submitted our findings as an abstract to the European Society for Medical Oncology meeting in Munich, Germany in May 2025. We are eager to share additional insights into the apparent mechanism behind the survival outcomes and will do so once appropriate and in compliance with pre-conference publication and announcement allowances.”
Certainly not expecting this, however, per new FDA directors interview comments in some instances he can envision provisional approval based on sound mechanism of action, with the proviso of confirmatory data from patients that are treated. The FDA directors comments were related to rare diseases, TNBC is not rare but is in the spirit of devastating diagnosis with current regimens that are approved falling woefully short of anything tantamount to a “cure”. Strong case here for breakthrough therapy designation and some compelling action on the part of the agency.
“we are excited to share more about the clarity forming around the putative mechanism of action of leronlimab in solid tumors…”
“The exciting survival outcomes announced in February 2025 provide early clinical evidence of leronlimab’s potential impact across the field of solid-tumor oncology. As previously announced, we’ve submitted our findings as an abstract to the European Society for Medical Oncology meeting in Munich, Germany in May 2025. We are eager to share additional insights into the apparent mechanism behind the survival outcomes and will do so once appropriate and in compliance with pre-conference publication and announcement allowances.”
Certainly not expecting this, however, per new FDA directors interview comments in some instances he can envision provisional approval based on sound mechanism of action, with the proviso of confirmatory data from patients that are treated. The FDA directors comments were related to rare diseases, TNBC is not rare but is in the spirit of devastating diagnosis with current regimens that are approved falling woefully short of anything tantamount to a “cure”. Strong case here for breakthrough therapy designation and some compelling action on the part of the agency.
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