Celcuity was on an apparently unstoppable march with gedatolisib – posting phase 3 wins in PIK3CA-mutant and wild-type breast cancer, and scoring a last-minute ASCO late-breaker – but there was one fly in the ointment. This was the limited patent life of gedatolisib, a PI3K/mTOR inhibitor Pfizer had worked on for years before discarding it. Now Celcuity appears to have found the answer, on Thursday revealing that it had filed for a US patent covering a subcutaneous formulation of gedatolisib. A SC form could enable longer durations of treatment, but importantly it would represent an entirely new chemical entity with a brand new patent life – and the only clinical requirement on Celcuity would be to demonstrate bioequivalence between the SC and IV forms. IV gedatolisib, which Celcuity bought from Pfizer for just $5m in cash and $5m in equity, has a composition-of-matter patent expiring in 2029, according to SEC filings, plus the possibility of a five-year extension. Celcuity’s shares closed up 8% on Thursday, as the group also said the first-line Viktoria-2 gedatolisib study would be overhauled, splitting enrolment and analysis by patients’ endocrine sensitivity/resistance, instead of by the PIK3CA status (mutated or wild type) of their breast cancer.
Celcuity was on an apparently unstoppable march with gedatolisib – posting phase 3 wins in PIK3CA-mutant and wild-type breast cancer, and scoring a last-minute ASCO late-breaker – but there was one fly in the ointment. This was the limited patent life of gedatolisib, a PI3K/mTOR inhibitor Pfizer had worked on for years before discarding it. Now Celcuity appears to have found the answer, on Thursday revealing that it had filed for a US patent covering a subcutaneous formulation of gedatolisib. A SC form could enable longer durations of treatment, but importantly it would represent an entirely new chemical entity with a brand new patent life – and the only clinical requirement on Celcuity would be to demonstrate bioequivalence between the SC and IV forms. IV gedatolisib, which Celcuity bought from Pfizer for just $5m in cash and $5m in equity, has a composition-of-matter patent expiring in 2029, according to SEC filings, plus the possibility of a five-year extension. Celcuity’s shares closed up 8% on Thursday, as the group also said the first-line Viktoria-2 gedatolisib study would be overhauled, splitting enrolment and analysis by patients’ endocrine sensitivity/resistance, instead of by the PIK3CA status (mutated or wild type) of their breast cancer.
