Skin Appendage Carcinoma

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Foundation Medicine, Inc ., today announced that the company and its collaborators will present 21 abstracts demonstrating the value of high-quality tumor profiling tests to inform cancer care at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6 in Chicago. Informing outcomes through ctDNA monitoring Circulating tumor DNA (ctDNA) has emerged as a promising tool to support oncologists in monitoring their advanced cancer patients’ response to therapy. Two studies being presented at ASCO further define the clinical application of ctDNA monitoring and demonstrate the value of FoundationOne ® Tracker to support and inform oncologists’ treatment planning. Circulating tumor DNA (ctDNA) monitoring to inform maintenance outcomes in patients (pts) with advanced NSCLC treated with induction atezolizumab+carboplatin+nab-paclitaxel ( Abstract 9075 ) Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death-ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo) ( Abstract 9022 ) New Capabilities of Liquid Biopsy Several studies to be presented by Foundation Medicine at ASCO demonstrate the unique capabilities of the company’s FDA-approved liquid biopsy comprehensive genomic profiling (CGP) test, FoundationOne ® Liquid CDx. Foundation Medicine is unique in its ability to report ctDNA tumor fraction in clinical reports for more confident clinical decision making, and along with its collaborators, is presenting two studies highlighting the clinical utility and differentiating factors of FoundationOne Liquid CDx’s tumor fraction reporting. Foundation Medicine will also present new data describing FoundationOne Liquid CDx’s robust ctDNA-based detection of rearrangements and fusions. It is the only company with companion diagnostics for fusions on both its tissue and blood-based CGP tests, and this research at ASCO continues to demonstrate the clinical utility of FoundationOne Liquid CDx’s regulatory-grade fusion detection and bioinformatics. Utility of ctDNA tumor fraction to inform negative liquid biopsy (LBx) results and need for tissue reflex in advanced non-small cell lung cancer (aNSCLC) ( Abstract 9076 ) The effect of ctDNA Tumor Fraction (TF) on overall survival and concordance between tissue genomics and ctDNA in Lung-MAP ( Abstract 9035 ) Liquid-biopsy detection of FGFR2 and other actionable rearrangements in GI malignancies ( Abstract 4085 ) Use of circulating tumor DNA (ctDNA) to complement tumor tissue homologous recombination repair (HRR) gene alteration testing in TALAPRO-2, a Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) ( Abstract 5056 ) 1 Mobocertinib efficacy in patients with NSCLC and EGFR exon 20 insertion mutations (ex20ins) identified by next-generation sequencing (NGS) of circulating tumor DNA (ctDNA) ( Abstract 9082 ) Driving innovation through development and validation of complex genomic biomarkers Multiple lines of evidence, including what will be communicated in an oral presentation, demonstrate the validity and utility of Foundation Medicine’s complex genomic biomarkers, including tumor mutational burden (TMB) and a signature for homologous recombination deficiency (HRDsig). Tumor Mutational Burden (TMB) Measurement from an FDA-Approved Assay and Real-World Overall Survival (rwOS) on Single-Agent Immune Checkpoint Inhibitors (ICI) in over 8,000 Patients across 24 Cancer Types ( Abstract 2503 ) Tumor Mutational Burden (TMB) in Real-world Patients with Pancreatic Ductal Adenocarcinoma (PDAC): Differences in Genomic Alterations (GA) and Predictive Value for Immune Checkpoint Inhibitor (ICI) Effectiveness ( Abstract 4146 ) Metastatic Breast Cancer (MBC) with Ultra-high Tumor Mutational Burden (UHTMB): A Comprehensive Genomic Profiling (CGP) Study ( Abstract 1036 ) HRD Signature and HRD Genomic Landscape of tumors from 896 Patients with Early-Stage Breast Cancer (BC) ( Abstract 539 ) Effectiveness of PARP inhibitor maintenance therapy (mPARPi) in advanced ovarian cancer (OC) by BRCA1/2 and HRD signature in real-world practice ( Abstract 5583 ) Addressing inequities in next generation sequencing for patients with NSCLC Additionally, in partnership with The West Cancer Center, OneOncology, Flatiron Health and Genentech, a member of the Roche Group, there will be an oral presentation of joint research examining inequities in next generation sequencing (NGS) testing for patients with advanced non-small cell lung cancer being treated in the community setting in the United States. Practice- and provider-level inequities in Next Generation Sequencing (NGS) by race/ethnicity for advanced non-small cell lung cancer (aNSCLC) patients ( Abstract 6508 ) “Our data at ASCO demonstrates the expanded and differentiated capabilities of our monitoring and liquid biopsy tests, reinforces our leadership in detection of complex genomic biomarkers, and supports increased confidence and ease in our tests’ use by doctors and researchers,” says Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “Much of this research was conducted in collaboration with our partners across the oncology ecosystem, underscoring our commitment to working together in order to make faster, more impactful progress for patients.” The following is a list of abstracts that will be presented at the meeting. To access all abstracts being presented at ASCO, please visit ASCO.org . Follow Foundation Medicine on Twitter and LinkedIn for more updates from #ASCO23 and visit us in person at Booth #19081. Abstract # Title Collaborators Product Orals 2503 Sunday, June 4 9:45 AM – 12:45 PM Tumor Mutational Burden (TMB) Measurement from an FDA-Approved Assay and Real-World Overall Survival (rwOS) on Single-Agent Immune Checkpoint Inhibitors (ICI) in over 8,000 Patients across 24 Cancer Types UC Davis Comprehensive Cancer Center, Flatiron Health and others Foundation Medicine and Flatiron Health’s Joint Clinico-Genomic Database (CGDB) 6508 Tuesday, June 6 8:00 – 11:00 AM Practice- and provider-level inequities in Next Generation Sequencing (NGS) by race/ethnicity for advanced non-small cell lung cancer (aNSCLC) patients The West Cancer Center, OneOncology, Genentech Inc., Flatiron Health, Tennessee Oncology Flatiron Health Database Poster Discussions 9022 Sunday, June 4 4:30 – 6:00 PM Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death-ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo) Third-party poster generated by Regeneron Pharmaceuticals, Inc., MD Anderson Cancer Center and others featuring results obtained through collaboration with Foundation Medicine, Natera Inc., and others FoundationOne®Tracker Posters 5056 Saturday, June 3 8:00 – 11:00 AM Use of circulating tumor DNA (ctDNA) to complement tumor tissue homologous recombination repair (HRR) gene alteration testing in TALAPRO-2, a Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer) Peter MacCallum Cancer Centre, Institute Gustave Roussy, Pfizer and others FoundationOne ® CDx FoundationOne ® Liquid CDx 11541 Saturday, June 3 1:15 – 4:15 PM Clinical Utility of Liquid-based Comprehensive Genomic Profiling (CGP) in Gastrointestinal Stromal Tumors (GIST) Boston University Medical Campus, OHSU Knight Cancer Institute, Boston Medical Center FoundationOne ® CDx FoundationOne ® Liquid CDx TPS3166 Saturday, June 3 8:00 – 11:00 AM SPARK, Studying Pathways of Resistance in KRAS-driven Cancers: A remote plasma ctDNA participation study to identify mechanisms of resistance to KRAS inhibitors Dana-Farber Cancer Institute, Lowe Center for Thoracic Oncology, KRAS Kickers, GO2 Foundation for Lung Cancer, Addario Lung Cancer Medical Institute, Bonnie J Addario Lung Cancer Foundation, Addario Lung Cancer Medical Institute (ALCMI) FoundationOne ® Liquid CDx 9587 Saturday, June 3 1:15 – 4:15 PM Comprehensive Genomic Profiling (CGP) of Clinically Advanced and Metastatic Cutaneous Adnexal Carcinomas (CAs; MCADCA): A Genomic Landscape Study SUNY Upstate Medical University, Upstate University Hospital FoundationOne ® CDx 5044 Saturday, June 3 8:00 – 11:00 AM Penile Squamous Cell Carcinoma (PSCC) with Elevated Tumor Mutational Burden (TMB): A Genomic Landscape Study SUNY Upstate Medical University, H. Lee Moffitt Cancer Center and Research Institute, University of Washington; Fred Hutchinson Cancer Center, The University of Texas MD Anderson Cancer Center, Vita-Salute San Raffaele University FoundationOne ® CDx 4587 Saturday, June 3 8:00 – 11:00 AM CDH1-Mutated Clinically Advanced Urothelial Bladder Cancer (UBC): A Genomic Landscape and Real-World Clinical Outcome Study (RWCOS) Moffitt Cancer Center and Research Institute, Vita-Salute San Raffaele University, Saint Louis University Hospital, University of Washington; Fred Hutchinson Cancer Center, SUNY Upstate Medical University FoundationOne ® CDx CGDB 9075 Sunday, June 4 8:00 – 11:00 AM Circulating Tumor DNA (ctDNA) Monitoring to inform maintenance outcomes in patients (pts) with advanced NSCLC treated with induction atezolizumab+carboplatin+nab-paclitaxel H. Lee Moffitt Cancer Center and Research Institute, Natera, Inc., Genentech Inc., AdventHealth Cancer Institute FoundationOne ® Tracker 9076 Sunday, June 4 8:00 – 11:00 AM Utility of ctDNA tumor fraction to inform negative liquid biopsy (LBx) results and need for tissue reflex in advanced non-small cell lung cancer (aNSCLC) Icahn School of Medicine at Mount Sinai, UC San Diego Moores Cancer Center FoundationOne ® CDx FoundationOne®Liquid CDx CGDB 9082 Sunday, June 4 8:00 – 11:00 AM Mobocertinib efficacy in patients with NSCLC and EGFR exon 20 insertion mutations (ex20ins) identified by next-generation sequencing (NGS) of circulating tumor DNA (ctDNA) Third-party poster generated by Takeda Pharmaceuticals USA and others featuring FoundationOne ® Liquid CDx results obtained through collaboration with Foundation Medicine FoundationOne ® Liquid CDx 9035 Sunday, June 4 8:00 – 11:00 AM The effect of ctDNA Tumor Fraction (TF) on overall survival and concordance between tissue genomics and ctDNA in Lung-MAP Mount Sinai Health System and others FoundationOne ® CDx FoundationOne ® Liquid CDx 9094 Sunday, June 4 8:00 – 11:00 AM Characterization of diverse targetable alterations in ERBB2 and ERBB3 in 93,465 non-small cell lung cancers (NSCLC) Memorial Sloan Kettering Cancer Center, University of California San Diego, Moores Cancer Center FoundationOne ® CDx FoundationOne ® Liquid CDx 539 Sunday, June 4 8:00 – 11:00 AM HRD Signature and HRD Genomic Landscape of tumors from 896 Patients with Early-Stage Breast Cancer (BC) Yale School of Medicine, Yale Cancer Center CGDB 1036 Sunday, June 4 8:00 – 11:00 AM Metastatic Breast Cancer (MBC) with Ultra-high Tumor Mutational Burden (UHTMB): A Comprehensive Genomic Profiling (CGP) Study Lifespan Health System, Ohio State University Comprehensive Cancer Center, SUNY Upstate Medical University, Upstate University Hospital, Yale Cancer Center, Yale School of Medicine FoundationOne ® CDx 4085 Monday, June 5 8:00 – 11:00 AM Liquid-biopsy detection of FGFR2 and other actionable rearrangements in GI malignancies Weill Cornell Medicine, Englander Institute of Precision Medicine, New York Presbyterian Hospital, Vanderbilt University Medical Center, The University of Texas MD Anderson Cancer Center FoundationOne ® CDx FoundationOne ® Liquid CDx 4146 Monday, June 5 8:00-11:00 AM Tumor Mutational Burden (TMB) in Real-world Patients with Pancreatic Ductal Adenocarcinoma (PDAC): Differences in Genomic Alterations (GA) and Predictive Value for Immune Checkpoint Inhibitor (ICI) Effectiveness University Hospital Seidman Cancer Center, Case Western Reserve University, Mayo Clinic FoundationOne ® CDx CGDB 5593 Monday, June 5 1:15 – 4:15 PM Gynecologic-Cancer Analysis of ARID1A Alterations Detected in Both Tissue and Liquid Biopsies National Cancer Institute FoundationOne ® CDx FoundationOne ® Liquid CDx 5583 Monday, June 5 1:15 – 4:15 PM Effectiveness of PARP inhibitor maintenance therapy (mPARPi) in advanced ovarian cancer (OC) by BRCA1/2 and HRD signature in real-world practice Stephenson Cancer Center/University of Oklahoma Health Sciences Center and Sarah Cannon Research Institute, University of Oklahoma, Flatiron Health FoundationOne ® CDx CGDB 4088 Monday, June 5 8:00 – 11:00 AM ASCO Merit Award Characterizing KRAS Allele Variants Within Biliary Tract Cancers Princess Margaret Cancer Centre, MD Anderson Cancer Center University Health Network, University of Toronto, SUNY Upstate Medical University FoundationOne ® CDx 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 . Foundation Medicine ® and FoundationOne ® are registered trademarks of Foundation Medicine, Inc. __________________________ 1 FoundationOne ® Liquid CDx is not FDA-approved as a companion diagnostic for talazoparib. Source: Foundation Medicine

GERMANTOWN, Md. and SUZHOU BIOBAY, China, Dec. 14, 2022 /PRNewswire/--Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today the interim results of part-one of an ongoing Phase IIb clinical trial of STP705 for the treatment of Cutaneous Squamous Cell Carcinoma In Situ (isSCC). The interim results showed that the majority (78%) of 32 patients with STP705 treatment achieved histological clearance. One of the three treatment cohorts achieved 89% histological clearance. STP705 is an siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down bothTGF-β1 and COX-2 gene expression. The two-part, double-blind, randomized, placebo-controlled Phase IIb study is designed to evaluate the safety and efficacy of various doses of STP705, administered as an intralesional injection in subjects with isSCC. In the part-one of the study, we have treated 32 patients with 30 μg/ml, 60 μg/ml and 90 μg/ml of STP705, respectively, and 12 patients with 0 μg/ml placebo weekly. After six-week repeated dosing, we collected tissue samples from the treatment sites followed by histological analysis. This interim report is specifically for part-one of the study results with a total of 44 patients. Based on our Phase IIb study plan, part-two of this study will include 60 additional subjects who will receive selected doses or placebo for a total of more than 100 subjects. Enrolled subjects will be randomly allocated to receive STP705 or placebo injection once a week for a total of six weeks. In the seventh week, the lesion will be excised. "The positive clinical readouts of the part-one study of this Phase IIb trial provide a further validation of our STP705 for treatment of non-melanoma skin cancers." said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "With more clinical results from this study and the cutaneous Basal Cell Carcinoma (BCC) study (Sirnaomics News Release at PR Newswire, August 29, 2022), we feel more enthusiastic about this novel RNAi cancer therapeutics for treatment of Squamous Cell Carcinoma (SCC), addressing a broader unmet patient need." "In our study thus far, patients who received various doses of STP705 over six weeks achieved better histological clearance of isSCC excised lesions than the patients who received a placebo," said Dr. Michael Molyneaux, M.D., Executive Director and Chief Medical Officer of Sirnaomics. "As we move into the latter phase of the clinical trial, we will use this information to determine which doses we deem most effective for treating SCC, which is a type of nonmelanoma skin cancer that affects millions of people in the U.S. Currently, there are only a small number of approved non-surgical treatments that exist for SCC." This interim report of unblinded results of part-one of the Phase IIb study showed that 25 of 32 subjects with STP705 treatment resulted in a high ratio (78%) of histological clearance. Among three treatment cohorts, the 30 μg treatment group (N = 9) achieved the highest histological clearance (89%), while the 60 μg treatment group (N = 12) achieved 75%, and the 90 μg group (N = 11) achieved 73%, which are clearly higher than the placebo group (N = 12) which achieved 58%. There were no treatment-related AE's or SAE's and Local Skin Response Scores were stable or improved across all treatment groups. About Non-melanoma Skin Cancer Non-melanoma skin cancers (NMSC) are the most common forms of human neoplasia. NMSC constitute a large group of skin cancers that are not melanoma, including squamous cell carcinoma (SCC), basal cell carcinoma (BCC), Extramammary Paget's Disease (EMPD), Merkel cell carcinoma (MCC), and skin adnexal carcinomas. Among these, BCC and SCC account for the majority of NMSC with more than 5 million newly diagnosed cases estimated to occur in the U.S. every year. Along with BCC, SCC is one of two major subtypes of NMSC. NMSC treatment market in the U.S. is expected to increase from US$6.5 billion in 2020 to US$22 billion in 2030. In China, the market size of NMSC treatment was US$38 million in 2020 is also expected to grow faster in the coming years, reaching US$149 million in 2030. A World Health Organization authorized report from "International Agency for Research on Cancer" (2019) has demonstrated that the number of deaths in 2018 globally for both men and women from NMSC is 65,155, where the mortality of Asia NMSC subjects represents 41.9% of the global total, which is significantly more than other individual areas. Surgery is currently the most common treatment option for the treatment of NMSC. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection and bleeding. As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective. About STP705 Sirnaomics' leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in seven clinical trials for different indications: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical aesthetics treatment. About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutic for its core product, STP705. Learn more at www.sirnaomics.com.