Comera Life Sciences (NASDAQ:CMRA) reported favorable results from its recently completed SEQURUS-2 study.
Together with the SEQURUS-1 study. the preclinical results showed that Comera’s caffeine-based SQore excipient did not result in local or systemic toxicity and had no impact on any measured pharmacokinetic parameters of ipilimumab when administered subcutaneously.
Comera is using its proprietary SQore formulation platform to enable subcutaneous (SQ) delivery of intravenous (IV) drugs, such as monoclonal antibodies (mAbs). The addition of excipients, such as caffeine, interrupts intermolecular interactions to reduce viscosity of high concentration mAb formulations.
“This new data represents another positive step in a broader development strategy to advance our lead SQore excipient,” Robert Mahoney, Ph.D. and CSO of Comera, said in a statement.
He said the SEQURUS-2 results confirm our initial safety and pharmacokinetic assessment and provide additional preclinical evidence of safety of Comera’s caffeine-based SQore excipient, when administered subcutaneously with a monoclonal antibody.
“Based on our four preclinical studies completed to date with our lead excipient, we believe that our technology has the potential to bring the freedom of self-administration to existing life-changing therapies,” Dr. Mahoney added.
Among other things, SEQURUS-2 data demonstrated rapid clearance of caffeine within eight hours, no evidence of caffeine impact on ipilimumab absorption, and established that caffeine had no impact on ipilimumab half-life and no effect on pharmacokinetic data for both the IV and SQ groups.
