Comera Life Sciences Announces Favorable Preclinical Results of Lead SQore Excipient in SEQURUS-2 Study
Comera Life Sciences Holdings, Inc. recently announced 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 (PK) parameters of ipilimumab when administered subcutaneously.
Comera is using its proprietary formulation platform SQore 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,” said Robert Mahoney, PhD, Chief Scientific Officer of Comera. “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.”
SEQURUS-2 data demonstrate no evidence of local or systemic toxicity of caffeine in animals when administered subcutaneously with ipilimumab. Furthermore, a rapid clearance of caffeine was seen within eight hours. The data also reveal no evidence of caffeine impact on ipilimumab absorption. Additionally, the results establish that caffeine had no impact on ipilimumab half-life and no effect on pharmacokinetic data for both the IV and SQ groups.
The SEQURUS-2 study was designed to provide a statistically robust evaluation of caffeine on the PK of SQ-administered ipilimumab, and it expanded on the exploratory PK analysis completed in SEQURUS-1 by increasing sample sizes and including formulations with different caffeine concentrations. The study evaluated three different SQ test formulations, including two concentrations of caffeine-containing ipilimumab formulations and an ipilimumab-only formulation (no caffeine). The monoclonal antibody ipilimumab (branded as Yervoy) was chosen for evaluation as a representative example of a commercially successful, widely used monoclonal antibody for which no SQ formulation is commercially available. Two control IV ipilimumab formulations, one with caffeine and one without, were included as reference groups. Local toxicity was assessed by visualization and palpation of the injection site and systemic toxicity was assessed by body weight and viability. PK data were collected on ipilimumab to assess impact of caffeine on ipilimumab absorption, distribution, and clearance.
Leading a compassionate new era in medicine, Comera Life Sciences is applying a deep knowledge of formulation science and technology to transform essential biologic medicines from intravenous (IV) to subcutaneous (SQ) forms. The goal of this approach is to provide patients with the freedom of self-injectable care, reduce institutional dependency and to put patients at the center of their treatment regimen. For more information, visit https://comeralifesciences.com/.
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