Malignant Solid Neoplasm

Clinical Trials Showcased at Global Gathering FORT MYERS, Fla., April 5, 2024 /PRNewswire/ -- Clinical research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) will be highlighted at the American Association for Cancer Research 2024 Annual Meeting in San Diego as scientists, clinicians and other health care professionals and stakeholders from all over the world gather to share the latest advances in cancer science and medicine. Continue Reading Over a dozen FCS abstracts will be presented at the 2024 AACR annual meeting. "Finding cancer cures requires diligence and collaboration among the greatest minds in cancer research," noted Lucio N. Gordan, MD, FCS President & Managing Physician. "Through our extensive and growing clinical trials research program, FCS is proud to be part of global efforts that are saving lives and enhancing the quality of life for patients and their families." FCS provides ongoing access to more than 160 clinical trials within 32 FCS clinics and three Drug Development Units (early-phase) across Florida, in Sarasota, Lake Mary and Lake Nona. In recent years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation, prior to approval. FCS physician investigators will present findings during oral and poster sessions at the ACCR 2024 Annual Meeting. FCS abstracts at AACR 2024 Annual Meeting: 068, 075, 132, 141, 156, 163, 291, 6552, 7172, 099, 077, 2565 FCS Director of Drug Development Manish Patel, MD, co-author of nine abstracts: Interim results of the ongoing phase 1-2 clinical trial of KVA12123, an engineered IgG1 targeting VISTA, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors Phase 1 trial evaluating AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer Phase I/IIa clinical trial (TranStar101) to evaluate the safety, tolerability and pharmacokinetics of OSEMITAMAB administered as monotherapy or in combination with nivolumab or standard of care in patients with locally advanced or metastatic solid tumors mRNA-4157 (V940) individualized neoantigen therapy (INT) + pembrolizumab (pembro) in advanced unresectable HPV- head & neck carcinoma (HNSCC): Clinical & translational analysis Phase I study evaluating AC676, an innovative BTK chimeric degrader, in patients with relapsed and refractory B-cell malignancies Phase 1 clinical trial of the farnesyl transferase inhibitor KO-2806 alone or as part of combination therapy for advanced solid tumors Phase 1/2, first-in-human study of DS-3939a in patients with advanced solid tumors: A new DXd ADC targeting TA-MUC1 Intratumoral (ITu) delivery of mRNA-2752 encoding human OX40L/IL-23/IL-36γ in combination with durvalumab induces an immunostimulatory effect within the tumor microenvironment (TME) of patients with advanced solid tumors Pharmacokinetic/biomarker (PK/BMx) analysis of the toll-like receptor 7 and 8 (TLR7/8) agonist EIK1001 in phase 1 studies in participants (Pts) with solid tumors FCS Associate Director of Drug Development Judy Wang, MD first author: NGM707 in combination with pembrolizumab in advanced or metastatic solid tumors: Preliminary results from dose escalation FCS Scientific Director of Research and Associate Professor of Medicine, Wake Forest University School of Medicine Lowell Hart, MD, FACP, first author: Vitamin D deficiency and outcomes in prostate cancer patients-A real world database Co-authors include FCS Trial Match Specialist and Medical Oncologist and Hematologist (retired) James Reeves Jr., MD, FCS Nurse Specialist Stacey Garofalo RN and members of the FCS Real-World Evidence Team, IT Director Data Science Derek Hall and Informatics Data Scientist Parth Kothiya. FCS Director of Drug Development, Lake Nona DDU, Cesar Augusto Perez, MD, co-author: Open-label phase 1 study to investigate SGN-CEACAM5C in adults with advanced solid tumors "Our clinical trials research contributes daily to the discovery of ground-breaking new drugs and therapies that are accelerating our understanding of cancer and transforming the standard of care," said FCS Director of Late-Phase Clinical Research Bradley Monk, MD. Dr. Monk is co-author of a study conducted at HonorHealth University of Arizona College of Medicine and Creighton University School of Medicine prior to being named to his leadership position at FCS earlier this year, "Tumor microenvironment (TME) biomarkers of TIGIT and PD-L1 immune checkpoint blockade in cervical cancer: An exploratory biomarker analysis from SKYSCRAPER-04 (SKY04) study." Abstracts will be published in the AACR journal, Cancer Research, following the annual meeting. The American Association for Cancer Research (AACR), the first and largest cancer research organization dedicated to accelerating the conquest of cancer, represents 58,000 members residing in 141 countries. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Incendia Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), today announced that it will have three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place April 5-10, 2024 in San Diego, California. “We look forward to presenting these posters at AACR, which highlight our work to characterize immune exclusion in the TME,” said Laura Dillon, PhD, Vice President of Translational Medicine & Bioinformatics at Incendia Therapeutics. “The data continue to validate that Discoidin Domain Receptor 1 (DDR1), the target of Incendia’s PRTH-101 program that is currently in the clinic, is highly correlated with immune exclusion in the tumor microenvironment across epithelial tumors. Additionally, they demonstrate the power of applying H&E-based biomarkers, driven by machine learning, to better interrogate the TME. We look forward to further exploring the potential of this technology, combined with our novel class of anti-cancer therapies, to better treat cancer patients by targeting the tumor microenvironment.” Presentation details for AACR 2024 are as follows: Title: Discoidin Domain Receptor 1 (DDR1) expression is associated with degree of immune exclusion across epithelial tumors Abstract Number: 2916 / 24 Presenting Author: Laura Dillon, Ph.D., Vice President of Translational Medicine & Bioinformatics at Incendia Therapeutics Session: The Tumor Microenvironment as a Drug Target Date and Time: Monday, April 8 from 1:30 - 5:00 PM PDT (4:30 – 8:00 PM EDT) Key Highlights: DDR1 mRNA and protein expression levels are correlated with immune exclusion of lymphocytes, CD8+ T cells, and CD45+ immune cells across epithelial tumor types (R: 0.31-0.56, adjusted p values: 0.04-0.07). While the degree of the correlation varied by indication and immune cell type considered, pancreatic cancer exhibited the strongest correlation between the lymphocyte-based Immune Exclusion Scores (IES) and DDR1 mRNA and protein expression (R: 0.48-0.54, adjusted p values: 0.04-0.07). This work provides additional insight into the role of DDR1 in human cancers and has utility for selecting indications and stratifying patients for DDR1-targeted therapies. Title: Machine learning-based identification of H&E-derived morphologic features associated with CD8+ T cell immune exclusion Abstract Number: 7392 / 20 Presenting Author: Yanchao Wang, Ph.D., Data Scientist at Incendia Therapeutics Session: Artificial Intelligence and Machine/Deep Learning 4 Date and Time: Wednesday, April 10 from 9:00 AM - 12:30 PM PDT (12:00 PM – 3:30 PM EDT) Key Highlights: Morphologic features derived from H&E images can be effective predictors of CD8-defined immune exclusion, providing an option for patient stratification by immune phenotype using widely available H&E images. We developed an Ens-L1-SVM model that identified 6 H&E features predictive of CD8-defined immune phenotypes. CD8-based immune phenotypes were classified by the Ens-L1-SVM model with an estimated accuracy of 97% using only the H&E-based features as input. Details on Incendia’s poster which is a collaboration with Alpenglow Biosciences: Title: 3D spatial quantification of lymphocyte infiltration and collagen features in the tumor microenvironment using a novel assay: 3D I/O Pro™ Abstract Number: 2309 / 20 Presenting Author: Bonnie Phillips, Ph.D., Director, Commercial Development at Alpenglow Biosciences Session: Liquid Biopsy and Precision Oncology Date and Time: Monday, April 8 from 9:00 AM - 12:30 PM PDT (12:00 PM – 3:30 PM EDT) Key Highlights: An end-to-end 3D spatial biology workflow, Alpenglow’s 3D I/O Pro™, was applied to colorectal cancer (CRC) tissues stained with nuclear and general protein fluorescent dyes to quantify lymphocyte density in tumor parenchyma and stroma and analyze collagen features, including orientation, within 3D regions of interest in the TME. The ratio of stromal to parenchymal lymphocytes (lymphocyte infiltration ratio) varied from 1.4 up to 9.1 in 3D volumes and 1 to 25 in 2D virtual sections taken throughout all 5 CRC samples. Qualitatively, areas with perpendicular collagen had more lymphocyte infiltration into the tumor parenchyma than areas with parallel collagen orientation. This work highlights how the 3D I/O Pro™ workflow can characterize tumors based on complex spatial relationships within the tumor microenvironment, and could have broad applicability in research and development of novel cancer therapies that target tumor fibrosis or other features of the TME. About Incendia Therapeutics Incendia Therapeutics is discovering and developing a novel class of experimental therapeutics that reprogram the tumor microenvironment (TME). Incendia’s platform is based on rigorous, groundbreaking research involving spatial characterization of the tumor microenvironment, multi-omics data integration, and extensive preclinical testing. The Company’s most advanced experimental molecule, PRTH-101, is in a Phase 1 clinical trial for the treatment of patients with advanced solid tumors. For more information visit incendia.com and LinkedIn.

23ME-01473, antibody targeting ULBP6: Data will be presented on the discovery and biology of ULBP6, and the potential to restore natural killer and T cell-mediated anti-tumor immunity by targeting ULBP6 23ME-00610, antibody targeting CD200R1: Preclinical data will be presented on targeting the CD200R1 pathway in T cells and natural killer cells using 23ME-00610 as a single agent, or in combination with other anti-tumor therapies SAN DIEGO, April 05, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, will present data on its two clinical stage programs, 23ME-01473 targeting ULBP6, and 23ME-00610 targeting CD200R1, at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place in San Diego, CA, April 5-10, 2024. 23ME-001473 (‘1473) - Clinical-Stage Dual Mechanism Monoclonal Antibody Targeting ULBP6 Key takeaways: 23andMe used its proprietary database of human genetic and health information to discover germline variants of ULBP6 associated with higher risks of immune disease and lower risks of cancer, suggesting the potential of ULBP6 as a novel immuno-oncology (I/O) drug target. Data also show soluble ULBP6 is a dominant immunosuppressor compared to other soluble NKG2D ligands due to its highest binding affinity to NKG2D among all NKG2D ligands. ‘1473 is a high affinity, Fc effector-enhanced, anti-ULBP6 antibody that restores the activation and tumor cell killing capacity of natural killer (NK) and T cells through the dual mechanisms of NKG2D and FcγRIIIa activation. Key details: ULBP6 is a stress-induced ligand that is upregulated on the surface of cancer cells and binds to the activating immunoreceptor NKG2D found on NK and T cells. ULBP6 can be shed from the cell surface of tumor cells into a soluble form that acts as an immunosuppressive decoy to evade immune surveillance. Soluble ULBP6 is elevated in cancer patient plasma. Of all human NKG2D ligands, ULBP6 exhibits the highest binding affinity to NKG2D, which correlates with the high potency of soluble ULBP6 in suppressing PBMC-mediated interferon-gamma secretion and promoting tumor cell growth in vitro. Expression profiling of ULBP6 in various tumors using The Cancer Genome Atlas and immunohistochemistry reveals its elevated expression in squamous cell carcinomas and a subset of adenocarcinomas. ‘1473’s dual synergistic activation of NKG2D and FcγRIIIa leads to optimal activation of NK cells, which may reverse immune suppression and circumvent resistance to immune-checkpoint inhibitors due to the loss of neoantigen presentation in tumors. ‘1473 is currently being evaluated in a Phase I clinical trial for patients with advanced solid tumors (NCT06290388). 23ME-00610 - Clinical-Stage Monoclonal Antibody Targeting CD200R1 Key Takeaways: CD200R1 is a dominant immune checkpoint and differentiated from PD-1, based on both the pattern of expression on tumor infiltrating immune cells from patient tumors and the pattern of activation on patient peripheral mononuclear blood cells. 23andMe preclinical results support the potential for 23ME-00610 to combine with anti-PD-1 and antiangiogenics. Key Details: Prevalence of CD200R1 and its ligand CD200 was characterized on tumor samples from patients with clear cell renal cell and serous ovarian carcinomas. CD200R1 is broadly expressed on tumor-infiltrating immune cells, including T cells and NK cells, whereas expression of PD-1 is predominantly restricted to T cells. 23ME-00610 differentially enhanced interferon-gamma secretion from cancer patient peripheral blood mononuclear cells relative to anti-PD-1, and 23ME-00610 enhanced both T and NK cell anti-tumor activity. CD200/R1 is an independent immunosuppressive pathway from PD/L-1, with potential for synergism in patients with cancer based on preclinical combination data with primary human T cells. CD200, the ligand of CD200R1, is expressed on both tumor cells and endothelial cells, and combination anti-CD200 with anti-VEGF led to tumor growth inhibition relative to single agents in a preclinical mouse model. 23ME-00610 is currently in the Phase 2a portion of a Phase 1/2a clinical trial (NCT05199272). The presentations will be available on the 23andMe Investor Relations and Therapeutics websites on April 8, 2024. Presentation details - 23ME-01473: Oral presentation Title: Discovery of ULBP6 as a novel immuno-oncology target using pleiotropic signals from 23andMeʼs genetic and health survey database Session Type: Minisymposium Session Category: Experimental and Molecular Therapeutics Session Title: Drug Discovery 1: New Targets and Approaches Session Date and Time: Monday, April 8, 2024, 3:20-3:35 PM PT Location: Room 30, Upper Level of the San Diego Convention Center Published Abstract Number: 3903 Poster presentation Title: 23ME-01473, a novel anti-ULBP6/2/5 monoclonal antibody, reinvigorates anti-tumor NK cell function through NKG2D and FcγRIIIa activation Session Category: Clinical Research Session Title: Antibodies 1 Session Date and Time: Monday, April 8, 2024, 9:00 AM - 12:30 PM PT Location: Poster Section 38 Poster Board Number: 21 Published Abstract Number: 2375 Presentation Details: 23ME-00610: Poster presentation Title: New insights into targeting the CD200R1 pathway in T and NK cells using 23ME-00610 as a single agent or in combination Session Category: Clinical Research Session Title: Antibodies 1 Session Date and Time: Monday, April 8, 2024, 9:00 AM - 12:30 PM PT Location: Poster Section 38 Poster Board Number: 5 Published Abstract Number: 2359 About 23andMe 23andMe is a genetics-led consumer healthcare and biopharmaceutical company empowering a healthier future. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding its future clinical trials and plans of 23andMe’s therapeutics business. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding 23andMe’s strategy, the plans for and results of its clinical trials and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," “predicts,” "continue," "will," “schedule,” and "would" or, in each case, their negative or other variations or comparable terminology, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on 23andMe’s current expectations and projections about future events and various assumptions. 23andMe cannot guarantee that it will actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements and you should not place undue reliance on 23andMe’s forward-looking statements. These forward-looking statements involve a number of risks, uncertainties (many of which are beyond the control of 23andMe), or other assumptions that may cause actual results or performance to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission, and as revised and updated by our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The statements made herein are made as of the date of this press release and, except as may be required by law, 23andMe undertakes no obligation to update them, whether as a result of new information, developments, or otherwise. Contacts: Investor Relations Contact: investors@23andMe.com Media Contact: press@23andMe.com