Comera Life Sciences Announces Favorable Preclinical Results of Lead SQore Excipient in SEQURUS-2 Study
18 October 2022 - 11:00PM
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
SciencesLeading 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/.
Forward-Looking StatementsThis
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.
Contacts
Comera Investor John Woolford ICR Westwicke
John.Woolford@westwicke.com
Comera Press Karen Chase ICR
WestwickeKaren.Chase@westwicke.com
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