Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the publication of preclinical research of zunsemetinib in pancreatic cancer in the peer-reviewed journal Science Translational Medicine, on December 1, 2021.

The article, entitled “The MK2/Hsp27 axis is a major survival mechanism for pancreatic ductal adenocarcinoma under genotoxic stress,” presents the results from a preclinical study using patient-derived cell lines and an autochthonous pancreatic ductal adenocarcinoma mouse model that evaluated the role of MK2, as well as the impact of zunsemetinib (ATI-450), Aclaris’ investigational oral MK2 inhibitor, in pancreatic cancer. This study was a multi-year collaboration between Aclaris and Washington University School of Medicine, led by the laboratory of Dr. Kian-Huat Lim, MD, PhD, Associate Professor in Oncology and Dr. Patrick Grierson, MD, PhD, Assistant Professor in Oncology.

In the study, Dr. Lim and his team identified the MK2/HSP27 axis as an important resistance mechanism resulting in pancreatic tumor cell survival following exposure to components of FOLFIRINOX chemotherapy - the current standard-of-care treatment for pancreatic cancer. His team also demonstrated that DNA damage induced by FOLFIRINOX chemotherapy components upregulated tumor necrosis factor alpha (TNFa) in pancreatic cancer cells, which had the dual effect of impacting cell death and cell survival, and that the selective inhibition of MK2 downstream of TNFa signaling abrogated survival through blocking HSP27 activation and beclin1 mediated autophagy, which allowed TNFa to execute its pro-death mechanism. With this understanding, his team then showed that mouse survival in an autochthonous KPPC model of pancreatic cancer was statistically significantly (p<0.001) extended when dosed with zunsemetinib in combination with FIRINOX (a murine version of FOLFIRINOX).

“This study introduces a new MK2-targeted approach for the treatment of pancreatic cancer,” said Dr. Lim. “We are very excited about the potential of this therapeutic combination and believe it should be advanced into clinical trials to determine whether MK2 inhibition can strengthen the effect of mainstay FOLFIRINOX chemotherapy in patients with pancreatic cancer without incurring additional side effects.”

Based on these results and clinical data generated from Aclaris’ clinical development program with zunsemetinib, Aclaris is considering a future clinical program for the treatment of patients with pancreatic cancer using one of Aclaris’ other MK2 inhibitor drug candidates.

The authors of the article are Patrick M. Grierson, Paarth B. Dodhiawala, Yi Cheng, Timothy Hung-Po Chen, Iftikhar Ali Khawar, Qing Wei, Daoxiang Zhang, Lin Li, John Herndon, Joseph B. Monahan, Marianna B. Ruzinova, and Kian-Huat Lim, and the article can be accessed here: https://www.science.org/doi/10.1126/scitranslmed.abb5445.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Aclaris’ drug candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into research collaborations on commercially reasonable terms, the uncertainty regarding the COVID-19 pandemic and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2020 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Contact

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