WOBURN, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Comera Life Sciences Holdings, Inc. (Nasdaq: CMRA), a life sciences company developing a new generation of bio-innovative biologic medicines to improve patient access, safety and convenience, today 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, Ph.D., 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.
About Comera Life Sciences
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.
To learn more about the Comera Life Sciences mission, as well as the proprietary SQore™ platform, visit https://comeralifesciences.com/.
This press release contains “forward-looking statements” within the meaning of the federal securities laws that reflect Comera's plans, estimates, assumptions and beliefs, including statements about the potential of the Company’s SQore™ platform to transform essential biologic medicines from IV to SQ forms based on the strength of preclinical results from the SEQURUS-2 study. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including, but not limited to: risks that the recently completed business combination disrupts the Company’s current plans and ability to retain its employees; the Company’s ability to maintain the listing of its securities on the Nasdaq Capital Market; the effect of the COVID-19 pandemic on the Company’s business; the price of the Company’s securities may be volatile due to a variety of factors, including changes in the competitive and highly regulated industries in which the Company plans to operate, variations in performance across competitors, changes in laws and regulations affecting the Company’s business and changes in the capital structure; the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities; the risk of downturns and the possibility of rapid change in the highly competitive industry in which the Company operates; the risk that the Company and its current and future collaborators are unable to successfully develop and commercialize the Company’s products or services, or experience significant delays in doing so; the risk that we will be unable to continue to attract and retain third-party collaborators, including collaboration partners and licensors; the risk that the Company may never achieve or sustain profitability; the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the risk that the Company experiences difficulties in managing its growth and expanding operations; the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations; the risk that the Company is unable to secure or protect its intellectual property; the risk that the Company is unable to secure regulatory approval for its product candidates; general economic conditions; and other risks and uncertainties indicated in the Current Report on Form 8-K filed with the SEC on May 25, 2022 under “Risk Factors” and in other filings that have been made or will be made with the SEC. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Comera’s Current Report on Form 8-K filed with the SEC on May 25, 2022 and other documents filed by Comera from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Comera assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Comera can give no assurance that it will achieve its expectations.