Regulus dumps first-gen ADPKD treatment in favor of second iteration; Sutro joins BioNova in $200M deal
Regulus Therapeutics just finished dosing in IND-enabling toxicity studies for its second-generation autosomal dominant polycystic kidney disease (ADPKD) candidate RGLS8429.
Based on FDA discussions and data from a Phase Ib trial on original ADPKD candidate RGLS4326, Regulus is shifting away from the first-generation candidate and prioritizing the newer candidate, according to a statement.
“We have determined that advancing our next-generation compound RGLS8429 is more compelling than further development of RGLS4326,” said Regulus CEO Jay Hagan. “The extensive work and investment we have made in RGLS4326 will directly inform the advancement of RGLS8429, and we believe will make this transition both expeditious and productive.”
The California biotech is expecting to meet with the FDA pre-IND by the end of the year — and pending an FDA decision on their IND, they anticipate starting a Phase I study on their candidate in Q2 next year. By early 2023, Regulus expects to be able to report top-line data in the first cohort of RGLS8429-treated patients.
Sutro and BioNova launch option agreement for anti-CD74 ADC worth $200M
The San Francisco biotech Sutro Biopharma and Shanghai-based BioNova jointly announced an option agreement for BioNova to develop and commercialize anti-CD74 ADC STRO-001 for patients with hematologic cancers. The commercialization deal is for certain Asian markets, including China, Hong Kong, Macau and Taiwan.
As part of the agreement, BioNova has the option to receive exclusive rights to develop and commercialize the ADC in those specific Asian markets. In the meantime, BioNova will pursue clinical development, regulatory approval, and commercialization of STRO-001 in multiple indications, including non-Hodgkin’s lymphoma, multiple myeloma, and leukemia.
Sutro will retain both development and commercial rights of STRO-001 globally outside of those Asian markets, including the US.
BioNova will pay Sutro an initial licensing option payment of $4 million, with potential milestone payments totaling up to $200 million. Sutro will also receive tiered and double-digit royalties based on annual net sales in those Asian markets.
Sutro will provide STRO-001 to BioNova under appropriate clinical and commercial supply service agreements.
“This strategic partnership of STRO-001 at this stage of its clinical development demonstrates the shared vision of Sutro and BioNova of the potential for this promising ADC,” said Sutro CEO Bill Newell in a statement.
Bristol Myers Squibb shows interim results from five-year extension trial on Zeposia
Bristol Myers Squibb unveiled interim results today from the Phase III open-label extension trial Daybreak, showing five years of data on the approved MS drug ozanimod in patients with relapsing multiple sclerosis.
In the extension study, safety was consistent with prior findings. Treatment with ozanimod, also known as Zeposia, lead to a low relapse rate — 0.103. According to a Bristol Myers statement, 75% and 71% of patients were relapse-free when tested at the 3- and 4-year mark, respectively.
“Early and effective intervention can significantly impact physical and cognitive results over time, with low relapse rates an important indicator of patient outcomes,” said study investigator and clinical research director for the UCSF MS Center in San Francisco Bruce Cree. “These data from the DAYBREAK trial provide a clear picture of the long-term safety and efficacy profile of Zeposia, and reinforce its potential when used early in the treatment process for people living with relapsing forms of MS.”
This story has been corrected to clarify that RGLS8429 has not yet reached clinical testing.