CLM-022 Archives - Celloram

Celloram proudly highlights the remarkable advancements made by Genfit, a global leader in liver disease therapeutics, on CLM-022, an investigational first-in-class NLRP3 inflammasome inhibitor initially developed by Celloram and exclusively out-licensed to Genfit in 2023. During the American Association for the Study of Liver Diseases (AASLD) International Meeting, held in San Diego from November 15–19, 2024, Genfit presented compelling data showcasing the therapeutic potential of CLM-022 for Acute-on-Chronic Liver Failure (ACLF).

ACLF is a severe syndrome marked by hepatic and extrahepatic organ failure, often triggered by infections and carrying a short-term mortality rate of 23% to 74% within 28 days. The condition affects approximately 294,000 patients across the US, EU4, and UK, with the prevalence projected to rise to 300,000 by 2036 due to aging populations and lifestyle-related factors. Despite its gravity, ACLF currently lacks approved therapies beyond supportive care and limited liver transplant availability, leaving patients and clinicians with significant unmet needs.

Genfit’s presentation at AASLD focused on the critical role of the NLRP3 inflammasome in ACLF progression. The inflammasome drives inflammation by converting danger signals [CA1] into the release of IL-1β and IL-18, and triggering pyroptosis, a highly inflammatory form of cell necrosis.

Genfit showcased preclinical studies demonstrating the capacity of investigational drug CLM-022 to effectively suppress inflammasome complex formation, significantly reduce IL-1β secretion, and mitigate pyroptosis. In a preclinical animal model of acute liver failure, CLM-022 demonstrated substantial reductions in liver damage and inflammation, offering a strong foundation for its potential as a groundbreaking therapy in ACLF treatment.

“The data presented by Genfit highlights the transformative potential of CLM-022 as a potential novel therapeutic approach for ACLF,” said Dr. Seunghwan Lim, Vice President and Director of Scientific Programs at Celloram. “Celloram is proud to have partnered with Genfit in this endeavor, and their commitment to advancing this program has been exceptional.”

[CA1]Discretionary comment: consider alternative wording as it is not clear what ‘danger signals’ refers to.

Celloram Inc., a dynamic biotech startup based in Cleveland, Ohio and developing novel
medicines for cancer and immune disorders, announced today a groundbreaking licensing
agreement with French biotech GENFIT SA to advance Celloram’s first-in-class inflammasome
inhibitor, CLM-022. The agreement grants GENFIT exclusive global rights to develop CLM-022
in liver disease indications.
“This exclusive licensing agreement with GENFIT aims to expand our inflammasome inhibitor
platform into liver disease indications for the first time,” said Tej Pareek, Ph.D., Celloram CEO.
“We believe that GENFIT has the potential to rapidly advance the development of this class of
inhibitors, ultimately bringing therapies and hope to a large population of patients who
desperately need life-saving treatments. We are thrilled to work alongside GENFIT, a leading
biopharmaceutical company, to bring this potential life-saving treatment to patients worldwide.”
As part of this agreement, GENFIT will not only add to its arsenal of drug candidates for liver
disease, but also gain access to Celloram’s scientists and medicinal chemistry expertise to
help synthesize and validate CLM-022 as GENFIT advances on its goal to secure an IND for
future clinical trials.
In recognition of this transformative collaboration, Celloram Inc. is eligible to receive up to €160
million in clinical, regulatory, and commercial milestone payments, which will further fuel its
mission to deliver cutting-edge solutions for critical medical challenges. Celloram co-founders,
Dr. John Letterio and Dr. Seong-Jin Kim, jointly stated, “Our vision at Celloram Inc. has always
been driven by a passion for revolutionizing patient care by creating safer, more effective
therapies. With this licensing agreement, we are one step closer to realizing Celloram’s vision
and we are grateful for the opportunity to partner with GENFIT.”

About Liver Disease
Liver disease is a progressive deterioration of liver functions lasting more than six months,
involving synthesis of clotting factors, detoxification, and bile excretion. The process entails
inflammation, destruction, and regeneration of liver parenchyma, often leading to fibrosis and
cirrhosis. Etiologies are diverse, encompassing toxins, prolonged alcohol abuse, infections,
autoimmune diseases, and genetic/metabolic disorders. The global liver disease treatment
market size is predicted to be worth 25.8.3 billion USD by 2028 from 14.1 billion USD in 2023
to grow at a CAGR of 11.72% in forecasted period. Increasing cases of acute and chronic liver
diseases, including liver cancer, are driving the demand for advanced liver disease diagnostics
and treatments.

About Celloram Inc.
Celloram Inc. is a forward-thinking biotech startup based in Cleveland, Ohio, driven by the
vision to harness innovative science and revolutionize patient care. Their experienced
leadership team, including co-founders Dr. John Letterio and Dr. Seong-Jin Kim, CEO Dr. Tej
Kumar Pareek, VP and chief scientific Program Directors Dr. Seunghwan Lim and Dr. Liraz
Levi are committed to delivering cutting-edge solutions to unmet medical needs.
Celloram Inc. is also gearing up to open its Series A funding round in the coming months,
offering an opportunity for visionary investors to join forces in the pursuit of transformative
innovations. This funding will further catapult Celloram Inc.’s pioneering research and
development efforts, taking their pipelines to new heights.

About GENFIT.
GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients
with rare and severe liver diseases characterized by high unmet medical needs. GENFIT is a
pioneer in liver disease research and development with a rich history and strong scientific
heritage spanning more than two decades. Thanks to its expertise in bringing early-stage
assets with high potential to late development and pre-commercialization stages, today
GENFIT boasts a growing and diversified pipeline of innovative therapeutic and diagnostic
solutions. Its R&D pipeline covers acute on-chronic liver failure (ACLF), hepatic
encephalopathy (HE), cholangiocarcinoma (CCA), urea cycle disorders (UCD), organic
acidemias (OA) and primary biliary cholangitis (PBC). Beyond therapeutics, GENFIT’s pipeline
also includes a diagnostic franchise focused on NASH and ACLF. GENFIT has facilities in Lille
and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA).

Contact:
For further information, please contact:
Celloram Inc. Tej Kumar Pareek, CEO tejpareek@celloram.com, +1 (216) 375-6691

Disclaimer: This press release contains forward-looking statements regarding Celloram Inc.
and GENFIT’s potential collaboration and the development of CLM-022. These statements are
based on current expectations and assumptions and involve inherent risks and uncertainties,
which could cause actual outcomes to differ materially from those anticipated in these forwardlooking statements.
Note to Editors: This press release is provided for informational purposes only and should not
be construed as an offer or solicitation to buy or sell securities or engage in any other
transaction. Any reliance you place on such information is therefore strictly at your own risk.