Mesonephroma

– 23ME-00610 monotherapy demonstrates preliminary evidence of clinical benefit, including one confirmed partial response – 23ME-00610 monotherapy continues to demonstrate acceptable safety and tolerability, and achieves the prespecified targets for maximal pharmacology at 1400 mg dosed Q3W – Tumor CD200 is emerging as a potential biomarker associated with 23ME-00610 monotherapy efficacy SOUTH SAN FRANCISCO, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, announced positive preliminary Phase 2 safety and efficacy data from 23ME-00610, a first-in-class anti-CD200R1 antibody, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31-June 4. 23andMe presented two posters on 23ME-00610, one each from neuroendocrine and ovarian cancer patient cohorts in its ongoing Phase 1/2a clinical trial. Key takeaways: Confirmed partial response (PR) in patient with well-differentiated pancreatic neuroendocrine cancer (pNET) (> 24 cycles at data cut-off) and qualitative clinical benefit with durable treatment duration (> 12 cycles at data cut-off) and tumor shrinkage in patient with mesonephric adenocarcinoma (a form of ovarian cancer).23ME-00610 monotherapy demonstrates acceptable safety and tolerability, and achieves the prespecified targets for maximal pharmacology at 1400 mg dosed every three weeks.From archival tumor immunohistochemistry (IHC) analyses, over 70% of patients had detectable tumor cell CD200, and higher expression tended to trend with clinical benefit.In addition to CD200, histology data suggest that immunosuppressed (“cold”) tumors may be more likely to exhibit disease control with 23ME-00610.Emerging data shows preliminary evidence of clinical benefit from 23ME-00610 treatment associated with lower risk for chronic immune-mediated diseases (e.g., psoriasis, asthma, eczema), yet higher risk for acute immune reactivity and cancer. This aligns with the 23andMe Immuno-oncology Signature, which identifies promising IO targets by pinpointing areas of the genome associated with opposing risk for auto-immune disease and cancer. “We continue to be pleased with the progress of 23ME-00610 as monotherapy, which continues to demonstrate therapeutic potential for inhibiting CD200R1 in cancer patients,” said Jennifer Low, M.D., Ph.D, Head of Therapeutics Development. “We are also seeing evidence of CD200 emerging as a potential biomarker associated with 23ME-00610 monotherapy efficacy. Further, we are encouraged by the continued safety and tolerability profile of 23ME-00610 which, as presented at AACR earlier this year, points to potential combination strategies for added therapeutic benefit in cancer patients.” Further details - neuroendocrine cancers cohort Between February 23, 2023 and April 1, 2024, 16 adult patients with advanced neuroendocrine neoplasms who received a median of 3.5 prior treatment lines (range: 1 to 10), were enrolled and received ≥ 1 dose of 23ME-00610.A patient from the Phase 1 portion of the Phase 1/2a trial with well-differentiated pancreatic neuroendocrine cancer (pNET) and high tumor CD200 expression has a confirmed partial response (PR) and remains on treatment (> 21 months).Among the N=16 expansion cohort, the disease control rate was 50% (n=8), and 25.3% of patients were free from clinical progression at 6 months, per RECIST v1.1.The safety and tolerability profile remains acceptable and promising for potential anti-cancer combinations in neuroendocrine patients. No treatment-emergent adverse events (TEAEs) leading to 23ME-00610 discontinuation were reported.Related treatment-emergent adverse events (TRAEs) occurred in 8 patients (50%); all were G1/G2, and the most common were maculopapular rash (18.8%), pruritus (18.8%), nausea (12.5%), and fatigue (12.5%). Patients with moderate to high tumor CD200 expression tended to be more likely to derive clinical benefit (PR or durable SD) relative to patients with low or undetectable tumor CD200. Further details - ovarian cancer cohort Between March 27, 2023 and April 1, 2024, 16 adult patients with advanced ovarian cancer who received a median of 4 prior treatment lines (range: 1 to 12), were enrolled and received ≥ 1 dose of 23ME-00610.The safety and tolerability profile remains acceptable and promising for potential anti-cancer combinations in ovarian cancer patients. No TRAEs ≥ G4 or AEs leading to 23ME-00610 discontinuation or death were reported.Related TEAEs occurred in 7 patients (43.8%); most were G1 (12.5%) and G2 (25.0%), and the most common were maculo-papular rash (12.5%) and pruritus (12.5%). Immune-related AEs (irAEs) were ≤ G2 in severity and generally dermatologic and thyroid in nature. A patient with well-differentiated mesonephric adenocarcinoma progressing prior to study enrollment has shown qualitative clinical benefit and durable treatment duration (> 12 cycles), including decreasing CA-125, substantial decreases in malignant ascites, and tumor reduction while on 23ME-00610 treatment. Additional data from the 23andMe poster presentations at ASCO 2024 Eligible patients had histologically diagnosed locally advanced (unresectable) or metastatic 1) neuroendocrine cancers who had progressed on standard therapies, or 2) metastatic platinum-resistant epithelial ovarian, fallopian tube, or peritoneal carcinoma who have progressed on standard therapies.Exploratory biomarkers included CD200R1 and CD200 tumor expression, germline genotyping, and polygenic risk score calculation for immune-mediated and cancer phenotypes.Patients received 1400 mg given IV every 3 weeks until disease progression, and CT/MRI scans were conducted every ~ 8 weeks. Posters are available on the 23andMe Therapeutics and Investor websites. About 23ME-0061023ME-00610 binds to CD200R1 to prevent the interaction of CD200R1 with CD200. Using the world’s largest proprietary database of health and genetic information, 23andMe identified genetic variants of CD200R1, CD200, and DOK2, the downstream signaling protein, associated with higher risks of immune disease and lower risks of cancer, pinpointing CD200R1 as a promising immuno-oncology target. Additional preclinical data validated the CD200-CD200R1 pathway as an immune checkpoint, and potential target for reversing immune tolerance in cancer as a monotherapy, or in combination with other therapies. Clinical data from the dose escalation cohort of patients with advanced solid tumors has shown 23ME-00610 has favorable pharmacokinetics (PK) for dosing once every three weeks, expected on-target pharmacologic activity, and a promising safety and tolerability profile at the preliminary recommended phase 2 dose of 1400 mg. About 23andMe23andMe is a genetics-led consumer healthcare and biopharmaceutical company empowering a healthier future. For more information, please visit www.23andMe.com. Forward-Looking StatementsThis 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. All statements, other than statements of historical fact, included or incorporated in this press release 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.comMedia Contact: press@23andMe.com

CAMBRIDGE, Mass., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Cytovia Therapeutics an emerging biopharmaceutical company focusing on Natural Killer cells in cancer, announced today that it has signed a licensing agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, to apply its gene-edited iPSC-derived NK cell technology to develop GPC3 CAR NK cell therapeutics. Dr Mitchell Ho, PhD, Director of the Antibody Engineering Program and Deputy Chief of the Laboratory of Molecular Biology at the NCI Center for Cancer Research has developed novel antibodies and chimeric antigen receptors (CAR) binding to glypican-3 (GPC3) on liver cancer cells. Dr. Ho has published data on the humanized GPC3 antibody in scientific reports (nature research) in 2016 as well as on the GPC3 CAR in Gastroenterology in 2020. GPC3 is an oncofetal antigen involved in Wnt-dependent cell proliferation. It is highly expressed in Hepatocellular Carcinoma tumor cells as well as multiple other solid tumors, including ovarian cancer and lung cancer, but not expressed in adult normal tissues. Cytovia has also signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. Under the CRADA, Cytovia will collaborate with Dr. Ho’s laboratory to develop and evaluate gene-edited iPSC-derived GPC3 CAR NK cells. Cytovia expects to initial new drug application (IND) for its GPC3 CAR NK cells in the first half of 2022. Dr. Daniel Teper, Chairman and CEO of Cytovia Therapeutics commented: “GPC3 is an exciting new validated target for Hepatocellular Carcinoma, an area of major unmet medical need, as well as other solid tumors. We look forward to collaborating with Dr. Ho, a pioneer in GPC3 research, to develop a novel gene-edited, iPSC-derived GPC3 CAR NK that will advance toward a cure for liver cancer.” Dr. Ho added: “Natural Killer cells play a major role in the immuno-surveillance of liver cancer. GPC3 is expressed in more than 70% of Hepatocellular Carcinoma cells but not on healthy cells. We look forward to investigating whether GPC3 CAR-NK therapy could provide a new safe and effective off-the-shelf option for patients with liver cancer.” ABOUT GENE-EDITED, IPSC-DERIVED NK CELLS Chimeric Antigen Receptors (CAR) are fusion proteins that combine an extracellular antigen recognition domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified genetically to allow insertion of a CAR. CAR-NK cell therapy has demonstrated initial clinical relevance without the limitations of CAR-T, such as Cytokine Release Syndrome, neurotoxicity or Graft vs Host Disease (GVHD). In addition, CAR-NKs are naturally allogeneic, available off-the-shelf and may be able to be administered on an outpatient basis. Recent innovative developments with the induced pluripotent stem cell (iPSC)-derived CAR-NKs, an innovative technology, allow large quantities of homogeneous genetically modified CAR NK cells to be produced from a gene-edited iPSC master cell bank, and thus hold promise to expand access to cell therapy for many patients. ABOUT HCC Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and a leading cause of death worldwide, with 800,000 new cases diagnosed globally every year. The incidence in Asia is amongst the highest in the world (75%) with 400,000 in China alone. In the US, it is estimated to reach upwards of 30,000 by the end of 2020 and continues to be on the rise. Despite advances in immunotherapy, with current treatment options including multi-kinase inhibitors (TKI) and checkpoint inhibitors, life expectancy for patients diagnosed with HCC remains very low. The disease is often diagnosed at an advanced stage, with a median survival of approximately 6 to 20 months following diagnosis, and a 5-year survival rate below 10% in the US. Fortunately, new options including cell therapy and bispecific antibodies offer promise towards a cure for liver cancer. ABOUT GPC3 Glypican-3 (GPC3) is a cell-surface heparan sulfate proteoglycan expressed in the liver and the kidney of fetuses but is hardly expressed in adults, except in the placenta. However, it is highly expressed in HCC, ovarian clear cell carcinoma, squamous cell carcinoma of the lung, melanoma, hepatoblastoma, nephroblastoma (Wilms tumor), yolk sac tumor, and some pediatric cancers. GPC3 promotes Wnt-dependent cell proliferation and has been strongly suggested that it is related to the malignant transformation. Therefore, GPC3 is a promising target for cancer immunotherapy and can serve as a biomarker for predicting tumor recurrence and treatment efficacy. About Cytovia Therapeutics Cytovia Therapeutics Inc is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, INSERM, and CytoImmune Therapeutics. Learn more at and follow Cytovia Therapeutics on Social Media (Facebook, LinkedIn, Twitter, and Youtube). Contact for investor enquiries: Anna Baran-Djokovic Vice President, Investor Relations Anna@cytoviatx.com 1 (646) 355 1787