Home Product listing Comera Life Sciences announces favorable preclinical results on the safety of the excipient Lead SQore

Comera Life Sciences announces favorable preclinical results on the safety of the excipient Lead SQore

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WOBURN, Mass., July 13. 10, 2022 (GLOBE NEWSWIRE) — Comera Life Sciences Holdings, Inc. (Nasdaq: CMRA), a life sciences company developing a new generation of bio-innovative biologic drugs to improve patient access, safety and security convenience, announced favorable initial results from its recently completed SEQURUS-1 study. The results of this preclinical study provide supporting evidence for the safety of Comera’s caffeine-based SQore™ primary vehicle when administered as a subcutaneous (SQ) biologic drug formulation with a monoclonal antibody (mAb).

Many mAb therapies are administered by intravenous (IV) injection because the solutions exhibit high viscosity at high concentrations, preventing the manufacture and injection of concentrated drug to the volumes needed for SQ administration. Using its proprietary formulation platform, SQore, Comera is developing excipients that enable the delivery of SQ. The addition of excipients, such as caffeine, interrupts intermolecular interactions to reduce the viscosity of high concentration mAb formulations.

The SEQURUS-1 study was designed to assess the safety of caffeine when given SQ in combination with ipilimumab, an mAb therapy that acts to activate the immune system by targeting CTLA-4 to treat melanoma, as a model protein. SEQURUS-1 demonstrated no evidence of local or systemic caffeine toxicity when administered subcutaneously with ipilimumab in animals. Additionally, rapid caffeine clearance was observed within eight hours in test animals, consistent with modeled predictions. Initial data also show no evidence of impact of caffeine on ipilimumab absorption.

“Our previously published data on this SQ drug product showed favorable viscosity reduction and stability,” said Robert Mahoney, Ph.D., Chief Scientific Officer of Comera. “The first positive results of this SEQURUS-1 study validate the safety in animal models of our main SQore excipient, caffeine. The product demonstrated rapid caffeine clearance and no impact on ipilimumab absorption. We look forward to further evaluation liveto further support the potential value of our proprietary excipient technology platform to provide alternative options to patients.

The study evaluated three different SQ test formulations, including a caffeine-containing ipilimumab formulation, an ipilimumab-only (caffeine-free) formulation, and a caffeine-only (ipilimumab-free) formulation. A control formulation of ipilimumab IV without caffeine was included as a reference group. Local toxicity was assessed by visualization and palpation of the injection site and systemic toxicity was assessed by body weight and viability. Additional exploratory data were collected on ipilimumab pharmacokinetic (PK) parameters to assess the impact of caffeine on ipilimumab absorption, distribution, and clearance.

A larger study, SEQURUS-2, was initiated to provide a statistically robust assessment of caffeine on the PK of ipilimumab administered by SQ, and was designed to extend the exploratory PK analysis performed in SEQURUS-1. Comera plans to present the first results of the SEQURUS-2 study during the 14e Annual Bioprocess Summit to be held in Boston August 14-18, 2022.

The live the data generated by the two SEQURUS studies complement those previously published by Comera in vitro analytical results in the Journal of Pharmaceutical Sciences demonstrating achievement of favorable viscosity reduction and stability meeting the criteria for a viable SQ drug product formulation. The monoclonal antibody ipilimumab (brand Yervoy®) was chosen for evaluation as a representative example of a commercially successful and widely used monoclonal antibody for which no SQ formulation is commercially available.



About Comera Life Sciences
Leading a compassionate new era in medicine, Comera Life Sciences applies deep knowledge of science and formulation technology to transform essential biological medicines from intravenous (IV) to subcutaneous (SQ) forms. The goal of this approach is to offer patients the freedom of self-injectable care, reduce institutional dependency, and put patients at the center of their treatment regimen.

To learn more about the Comera Life Sciences mission, as well as the exclusive SQore™ platform, visit https://comeralifesciences.com/.

Forward-looking statements
This press release contains “forward-looking statements” within the meaning of the federal securities laws. These forward-looking statements are generally identified by the words “believe”, “project”, “expect”, “anticipate”, “estimate”, “intend”, “strategy”, “future”, “opportunity “, “plan,” “may,” “should,” “will,” “would,” “will,” “will,” “will likely,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, therefore, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements contained herein, including, but not limited to: the risks that the recently completed business combination will disrupt the Company’s current plans and its 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 among competitors, changes in laws and regulations affecting the Company’s business and changes in capital structure; the ability to implement business plans, forecasts and other expectations and to identify and realize additional opportunities; the risk of downturn 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 associates may not be able to successfully develop and market the Company’s products or services, or experience significant delays in doing so; the risk that we may not be able to continue to attract and retain third-party collaborators, including collaboration partners and licensors; the risk that the Company will never achieve or maintain profitability; the risk that the Company needs 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 may experience difficulty managing its growth and expanding its business; the risk that third-party suppliers and manufacturers may not be able to fully and timely fulfill their obligations; the risk that the Company may not be able to secure or protect its intellectual property; the risk that the Company may not be able to obtain regulatory approval for its product candidates; general economic conditions; and other risks and uncertainties noted 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 or will be filed 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 near the second. 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 place undue reliance on forward-looking statements, and Comera undertakes no obligation and does not intend to update or revise such forward-looking statements, whether as a result of new information, future events or otherwise. Comera cannot guarantee that it will meet its expectations.

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Comera Investor
John Woolford
ICR Westwicke
[email protected]

Comera Press
Karen Chase
ICR Westwicke
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