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CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Foundation Medicine, Inc. , a pioneer in molecular profiling for cancer, announced today that UnitedHealthcare commercial plans will cover FoundationOne®CDx as a companion diagnostic in all solid tumors for patients with unresectable or metastatic cancer being considered for treatment with an immune checkpoint inhibitor and meeting coverage criteria. Additionally, FoundationOne®Liquid CDx will be covered as a companion diagnostic for patients with advanced breast cancer, metastatic non-small cell lung cancer (NSCLC), recurrent ovarian cancer and metastatic castrate-resistant prostate cancer (mCRPC) meeting coverage criteria. Coverage is effective April 1, 2023. FoundationOne CDx, a tissue-based comprehensive genomic profiling (CGP) test, and FoundationOne Liquid CDx, a CGP liquid biopsy test, are used to identify patients who may benefit from treatment with specific FDA-approved targeted therapies. “We believe patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” said Foundation Medicine Chief Executive Officer Brian Alexander, M.D., M.P.H. “UnitedHealthcare’s coverage decision will improve patient access to molecular profiling and enable better outcomes for patients.” UnitedHealthcare’s planned coverage of FoundationOne CDx and FoundationOne Liquid CDx is in addition to coverage that Foundation Medicine already has for these tests from other national and regional commercial providers, as well as by Medicare and Medicare Advantage plans. About Foundation Medicine: Your Essential Partner in Cancer Care Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn . About FoundationOne CDx FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com . About FoundationOne Liquid CDx FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com . Source: Foundation Medicine

--To date, approximately 50% enrolled patients have completed 12-week treatment and all enrolled patients are expected to complete 12-week treatment by the end of February 2023 -- Clinical efficacy observed in patients who have completed 12-week treatment of ASC40 or placebo was comparable to that from two U.S. FDA approved acne drugs - WINLEVI® and TWYNEO® --In the previous Phase II clinical trial of non-alcoholic steatohepatitis (NASH) patients with 12-week treatment of 50 mg ASC40 once daily, 61% patients showed ≥ 30% relative decrease of liver fat HANGZHOU and SHAOXING, China, Nov. 30, 2022 /PRNewswire/ -- Ascletis, Inc. (HKEX: 1672, "Ascletis") announces today the completion of 180 patient enrollment for the Phase II clinical trial of ASC40 (denifanstat) for treatment of moderate to severe acne. The study is currently still blind. To date, approximately 50% enrolled patients have completed 12-week treatment and all enrolled patients are expected to complete 12-week treatment by the end of February 2023. Clinical efficacy observed in patients who have completed 12-week treatment of ASC40 or placebo was comparable to that from two recently approved acne drugs by U.S. Food and Drug Administration - WINLEVI® and TWYNEO® [1,2], in terms of percentage change from baseline in total lesion counts and percentage change from baseline in inflammatory and non-inflammatory lesion counts. To date, the preliminary data also indicated that ASC40 or placebo treatment in acne patients is safe and well tolerated, and majority of treatment-related adverse events are grade 1. In the previous Phase II clinical trial of non-alcoholic steatohepatitis (NASH) patients with 12-week treatment of 50 mg ASC40 once daily, 61% patients showed ≥ 30% relative decrease of liver fat[3]. The current Phase II clinical trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of ASC40 for the treatment of patients with moderate to severe acne. 180 enrolled patients have been randomized into three active treatment arms or one placebo control arm at the ratio of 1:1:1:1 to receive ASC40 (25 mg, 50 mg or 75 mg) or matching placebo orally once daily for 12 weeks. The primary outcomes include percentage change of total lesion count at week 12 compared with baseline and/or ratio of subjects, whose Investigator's Global Assessment (IGA) grades are decreased by ≥2 grades at week 12 compared with baseline. ASC40 is an oral, selective small molecule inhibitor of fatty acid synthase (FASN), a key enzyme which regulates de novo lipogenesis (DNL). Human sebum production requires de novo lipogenesis, which is increased in acne and can be suppressed by the FASN inhibitor ASC40. Acne is the eighth most prevalent disease in the world and affects more than 640 million people globally[4]. The onset of acne often coincides with pubertal hormonal changes, and the condition affects approximately 85% of adolescents and young adults aged 12 to 25 years[5]. However, acne can also persist into or develop during adulthood. Current first-line treatments for acne include topical creams such as topical retinoids, androgen receptor inhibitor, oral isotretinoin, and antibiotics, but still have various limitations. "Excess sebum production plays a significant role in the pathogenesis of acne and suppression of sebum production reduces acne incidence and severity. As a first-in-class drug with a novel mechanism, FASN inhibitor ASC40 has demonstrated exciting preliminary efficacy in Phase I clinical trial. We will continue to accelerate the Phase II study to provide more options for patients with moderate to severe acne." said Prof. Leihong Xiang, Chief Physician of Dermatological Department, Huashan Hospital, Fudan University, Executive Deputy Director of Institute of Dermatology, Fudan University, Deputy Director of Dermatology Division of Chinese Medical Doctor Association and principal investigator of ASC40 Phase II trial for moderate to severe acne. "Moderate to severe acne poses lasting impact on patients and remains a huge unmet medical needs globally. I'm very happy that FASN inhibitor ASC40 for acne has completed the patient enrollment for Phase II study, which marks a new milestone as Ascletis is exploring the market of consumer healthcare." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 22 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne). For more information, please visit . Company Codes: HongKong:1672