Zunsemetinib

FN Media Group Presents USA News Group News Commentary VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13%. Among the therapy developers that have garnered accolades and support from PanCAN is O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), which late last year took home a US$5 million Therapeutic Accelerator Award based on the promising results being delivered by its flagship asset, pelareorep. Since winning the award, Oncolytics has moved to make an amendment to its ongoing GOBLET gastrointestinal cancer study to include a new (fifth) cohort. This new cohort will evaluate the immunotherapy asset pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) both with and without atezolizumab (Tecentriq®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). "We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFOLFIRINOX as another combination that could improve outcomes for patients," said Dr. Matt Coffey, President and CEO of Oncolytics. "Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program. Last fall, we reported a 62% objective response rate for the GOBLET PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel. This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year." Oncolytics is conducting the GOBLET trial to investigate the effectiveness of pelareorep in enhancing the treatment of pancreatic cancer, a disease known for its poor 5-year survival rate. This is largely due to the cancer's ability to hide from the immune system and create an environment that suppresses immune response. In late 2022, the FDA granted pelareorep a fast track designation, acknowledging its potential to stimulate both the innate and adaptive immune systems and alter the tumor microenvironment. This makes pelareorep a promising candidate for combination therapy. "This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the most commonly used metastatic pancreatic cancer treatments," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients." After discontinuing development of its monoclonal antibody NIS793 for the treatment of patients with pancreatic cancer, Novartis AG (NYSE: NVS) has opened 2024 with positive data from its Lutathera asset. In a mid-January release, Novartis announced that Lutathera significantly reduced the risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors. "These positive results for Lutathera are practice-changing and offer new first-line treatment data for patients who have a significant unmet need," said Dr. Simron Singh, Associate Professor of Medicine at the University of Toronto and co-founder of the Susan Leslie Clinic for Neuroendocrine Tumours at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, Ontario, Canada. "This study confirms the clinical benefit of first-line radioligand therapy for newly diagnosed patients living with these types of advanced GEP-NETs. These findings should instill confidence among physicians in using Lutathera as a first-line treatment for patients with this life-threatening type of cancer." Back in early 2022, ImmunityBio, Inc. (NASDAQ: IBRX) showed promising results for its Nant Pancreatic Cancer Vaccine. Now, in February 2024, ImmunityBio has announced full accrual of its first two phases of a cancer vaccine trial in participants with Lynch Syndrome and the initiation of a randomized control phase of the trial. Lynch Syndrome is one of the most common hereditary cancer syndromes, occurring in 1 in every 300 Americans. People with Lynch Syndrome can not only develop colorectal cancer 20 years prior to the average age of diagnosis for that form of cancer but are also at an increased risk of developing many other types of cancers, including pancreatic. "We are encouraged by how rapidly this study has been able to enroll participants," said Asad Umar, D.V.M., Ph.D., a senior advisor to the Director for Translational Research in NCI's Division of Cancer Prevention (DCP) and a scientific lead for the trial. "It is a strong indication of an unmet need and of the willingness of participants to help science make new discoveries in the area of cancer prevention." Moving on from a disastrous year in 2023, Aclaris Therapeutics, Inc. (NASDAQ: ACRS) is resurrecting its asset zunsemetinib as a potential cancer treatment. As per the company's last corporate update of 2023, Aclaris now plans to explore zunsemetinib as a potential treatment for pancreatic cancer and metastatic breast cancer. "Throughout our history, Aclaris has remained focused on developing novel drugs where there is a lack of satisfactory treatment options," said Dr. Neal Walker, Co-Founder, Chairman, and Interim CEO of Aclaris in a January 2024 strategic business review. "We are well capitalized and we have recently taken the hard but necessary steps to streamline our operations to reduce costs and preserve capital in order to put Aclaris in an optimal position for the future." In early January 2024, the FDA cleared the investigational new drug (IND) application of Nuvation Bio Inc. (NYSE: NUVB) to evaluate its first clinical candidate from its novel drug-drug conjugate (DDC) platform, NUV-1511. "This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents," said David Hung, M.D., Founder, President, and CEO of Nuvation Bio. "We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the Phase 1/2 study." The initial part of the Phase 1/2 study will assess safety and tolerability and investigate the potential effectiveness in patients with advanced solid tumors. It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC). Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors. "We remain focused on strong clinical execution of our NUV-868 program for advanced solid tumors," said Hung in his company's Q3 2023 business update. Article Source: Article Source: USA News Group [email protected] DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. 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WAYNE, Pa., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year of 2023 and provided a corporate update. “As we enter 2024, we are financially strong, focused and motivated,” stated Dr. Neal Walker, co-founder and Interim Chief Executive Officer & President of Aclaris. “Returning to the CEO role, I look forward to building on our strong foundation and deep expertise in kinase discovery and development as we look to shape the future of Aclaris.” Research and Development Highlights: ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor In January 2024, Aclaris reported positive top-line results from its Phase 2b trial in atopic dermatitis, and is currently seeking a development and commercialization partner for this program. ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor Aclaris is assessing the most effective development pathway, including the lead indication, for ATI-2138. Aclaris reported positive results from its Phase 1 MAD trial of ATI-2138 in September 2023. Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor Aclaris plans to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib as a potential treatment for pancreatic cancer and metastatic breast cancer. Aclaris expects these trials to be primarily funded by grants awarded to Washington University.ATI-2231, Aclaris’ second MK2 inhibitor, was previously being developed for oncology and Aclaris was supporting Washington University in an investigator-initiated Phase 1a trial of ATI-2231 in patients with advanced solid tumor malignancies. However, Aclaris and Washington University agreed to instead study zunsemetinib in oncology in order to expedite the development timeline by eliminating the need to conduct the Phase 1a trial due to zunsemetinib’s more advanced clinical package. Discovery Aclaris plans to continue to advance discovery programs through KINect®, its proprietary drug discovery platform. Financial Highlights: Liquidity and Capital Resources As of December 31, 2023, Aclaris had aggregate cash, cash equivalents and marketable securities of $181.9 million compared to $229.8 million as of December 31, 2022. Financial Results Fourth Quarter 2023 Net loss was $1.5 million for the fourth quarter of 2023 compared to $27.6 million for the fourth quarter of 2022.Total revenue was $17.6 million for the fourth quarter of 2023 compared to $7.8 million for the fourth quarter of 2022. The increase was primarily driven by a one-time upfront payment under the license agreement with Sun Pharmaceutical Industries, Inc. (Sun Pharma) received in the fourth quarter of 2023. Research and development (R&D) expenses were $26.6 million for the quarter ended December 31, 2023 compared to $21.1 million for the prior year period. The $5.5 million increase was primarily the result of an increase in expenses associated with drug candidate manufacturing for zunsemetinib.General and administrative (G&A) expenses were $8.2 million for the quarter ended December 31, 2023 compared to $7.1 million for the corresponding prior year period. The increase was primarily due to an increase in personnel and stock-based compensation expenses. Licensing expenses were $5.7 million for the quarter ended December 31, 2023 compared to $0.6 million for the prior year period. The increase was primarily attributable to amounts payable to third parties in connection with amounts earned under the Sun Pharma license agreement. Revaluation of contingent consideration resulted in a $26.3 million gain for the quarter ended December 31, 2023 compared to a charge of $7.1 million for the prior year period. Intangible asset impairment charges were $6.6 million for the quarter ended December 31, 2023, representing the full balance of the in-process research and development (IPR&D) intangible asset. The impairment charge resulted from Aclaris’ decision to discontinue further development of the drug candidate for immuno-inflammatory diseases. Full Year 2023 Net loss was $88.5 million for the year ended December 31, 2023 compared to $86.9 million for the year ended December 31, 2022.Total revenue was $31.2 million for the year ended December 31, 2023 compared to $29.8 million for the year ended December 31, 2022. The increase was primarily driven by a one-time upfront payment under the license agreement with Sun Pharma received in the year ended December 31, 2023. The increase was partially offset by both a one-time upfront payment received under a license agreement with Eli Lilly and Company and a one-time upfront payment received under a license agreement with Pediatrix Therapeutics, Inc. in the year ended December 31, 2022. R&D expenses were $98.4 million for the year ended December 31, 2023 compared to $77.8 million for the prior year period. The $20.6 million increase was primarily the result of higher: Zunsemetinib development expenses, including costs associated with clinical activities for the Phase 2b trial for rheumatoid arthritis and drug candidate manufacturing costs;ATI-2138 development expenses, including costs associated with the Phase 1 MAD trial and other preclinical activities; andCompensation-related expenses due to an increase in headcount. G&A expenses were $32.4 million for the year ended December 31, 2023 compared to $25.1 million for the prior year period. The $7.3 million increase was primarily the result of higher compensation-related costs due to increased headcount and the impact of equity awards granted during the year ended December 31, 2023.Bad debt expense recorded from Aclaris’ determination that collection of amounts due from EPI Health are uncertain as a result of their filing for Chapter 11 bankruptcy protection also contributed to the increase. Revaluation of contingent consideration resulted in a $26.9 million gain for the year ended December 31, 2023 compared to a charge of $4.7 million for the corresponding prior year period. Intangible asset impairment charges were $6.6 million for the year ended December 31, 2023, representing the full balance of the IPR&D intangible asset. The impairment charge resulted from Aclaris’ decision to discontinue further development of the drug candidate for immuno-inflammatory diseases. 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 “anticipate,” “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 its development plans for its development programs, including its plans to seek a development and commercialization partner for ATI-1777 and its strategic review of its business. 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 strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment 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, 2023, 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 Therapeutics, Inc.Consolidated Statements of Operations(unaudited, in thousands, except share and per share data) Three Months Ended Year Ended December 31, December 31, 2023 2022 2023 2022 Revenues: Contract research $566 $866 $3,035 $4,395 Licensing 17,004 6,722 28,214 25,100 Other — 165 — 257 Total revenue 17,570 7,753 31,249 29,752 Costs and expenses: Cost of revenue (1) 725 877 3,423 4,023 Research and development (1) 26,646 21,072 98,384 77,813 General and administrative (1) 8,214 7,146 32,412 25,133 Licensing 5,703 637 14,658 7,937 Revaluation of contingent consideration (26,300) 7,100 (26,900) 4,700 Intangible asset impairment 6,629 — 6,629 — Total costs and expenses 21,617 36,832 128,606 119,606 Loss from operations (4,047) (29,079) (97,357) (89,854)Other income, net 2,189 1,444 8,509 2,946 Loss before income taxes (1,858) (27,635) (88,848) (86,908)Income tax benefit (367) — (367) — Net loss $(1,491) $(27,635) $(88,481) $(86,908)Net loss per share, basic and diluted $(0.02) $(0.41) $(1.27) $(1.33)Weighted average common shares outstanding, basic and diluted 70,866,315 66,685,580 69,808,855 65,213,944 (1) Amounts include stock-based compensation expense as follows: Cost of revenue $337 $314 $1,456 $1,151 Research and development (2,367) 1,517 6,801 3,745 General and administrative 3,296 2,982 12,285 10,143 Total stock-based compensation expense $1,266 $4,813 $20,542 $15,039 Aclaris Therapeutics, Inc.Selected Consolidated Balance Sheet Data(unaudited, in thousands, except share data) December 31, 2023 December 31, 2022 Cash, cash equivalents and marketable securities $181,877 $229,813 Total assets $197,405 $254,596 Total current liabilities $30,952 $21,938 Total liabilities $40,226 $56,975 Total stockholders' equity $157,179 $197,621 Common stock outstanding 70,894,889 66,688,647 Aclaris Therapeutics, Inc.Selected Consolidated Cash Flow Data(unaudited, in thousands) Year EndedDecember 31, 2023 Year EndedDecember 31, 2022 Net loss $(88,481) $(86,908) Depreciation and amortization 863 797 Stock-based compensation expense 20,542 15,039 Revaluation of contingent consideration (26,900) 4,700 Intangible asset impairment charge 6,629 — Deferred taxes (367) — Changes in operating assets and liabilities 9,389 (1,195) Net cash used in operating activities $(78,325) $(67,567) Aclaris Therapeutics Contact: investors@aclaristx.com