NKG2D

23andMe to give an oral presentation on the genetic signature of ULBP6, the target of 23ME-01473, along with poster presentations of the biology of ULBP6 and mechanism of 23ME-01473, and new non-clinical insights for 23ME-00610, targeting the CD200R1 pathwaySOUTH SAN FRANCISCO, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company, today announced an oral presentation and two poster presentations on two of the Company’s immuno-oncology programs that will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place in San Diego, CA, April 5-10, 2024. The oral presentation will detail the use of the 23andMe genetic and health survey database to discover ULBP6, the highest affinity ligand of the NK and T-cell activation receptor, NKG2D. ULBP6 is the primary target for 23ME-01473 (‘1473), a dual mechanism monoclonal antibody. The Company will also present a poster on the biology of ULBP6, and how ‘1473 reinvigorates anti-tumor NK cell function through NKG2D and FcγRIIIa activation. These presentations will be the first scientific communications the Company has prepared on ‘1473 since announcing its pursuit of this novel, genetically-validated target. The FDA recently cleared the IND application for ‘1473, which targets ULBP6. Cancers escape immune cell recognition by shedding ULBP ligands from their cell surface, which act as immunosuppressive molecular decoys. Blocking the binding of soluble ULBP6 to NKG2D with ‘1473 may restore immune cell recognition and killing of cancers. Further, ‘1473 is Fc-effector enhanced, which provides an additional mechanism for NK cells to induce cell death of ULBP6-expressing cancer cells. 23andMe will also present a non-clinical poster on 23ME-00610, an inhibitor of the CD200R1 receptor, which will include new insights into targeting the CD200R1 pathway in T and NK cells using 23ME-00610 as a single agent or in combination with other anti-tumor therapies. 23ME-00610 is currently in Phase 2a of a Phase 1/2a clinical study. The presentations will be available on the 23andMe Investor Relations and Therapeutics websites on April 5, 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 databaseSession Type: MinisymposiumSession Category: Experimental and Molecular TherapeuticsSession Title: Drug Discovery 1: New Targets and ApproachesSession Date and Time: Monday, April 8, 2024, 2:30 - 4:30 PM PTPublished 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 activationSession Category: Clinical ResearchSession Title: Antibodies 1Session Date and Time: Monday, April 8, 2024, 9:00 AM - 12:30 PM PTLocation: Poster Section 38Poster Board Number: 21Published 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 combinationSession Category: Clinical ResearchSession Title: Antibodies 1Session Date and Time: Monday, April 8, 2024, 9:00 AM - 12:30 PM PTLocation: Poster Section 38Poster Board Number: 5Published Abstract Number: 2359 About 23ME-01473 (‘1473)‘1473 targets ULBP6 to restore anti-tumor immunity through NK and T cells. ULBPs are stress-induced ligands found on the surface of cancer cells that bind to their receptor, NKG2D, on NK and T cells. Cancers escape immune cell recognition by shedding ULBP ligands from their cell surface, which act as immunosuppressive molecular decoys. Blocking the binding of soluble ULBP6 to NKG2D may restore immune cell recognition and killing of cancers. Further, ‘1473 is Fc-effector enhanced, which provides an additional mechanism for NK cells to induce cell death of ULBP6-expressing cancer cells. 23andMe plans to evaluate ‘1473 in participants with advanced solid tumors in a Phase 1 clinical study beginning in the first half of 2024. Clinical trials registry (clinicaltrials.gov): NCT06290388. About 23ME-0061023ME-00610 is a high-affinity, fully humanized monoclonal antibody that is designed to bind to CD200R1 and prevent the interaction of CD200R1 with CD200. The CD200–CD200R1 axis is an immunological checkpoint that plays a pivotal role in maintenance of immune tolerance. CD200R1 is an inhibitory receptor expressed on T cells and myeloid cells while CD200, the ligand for CD200R1, is highly expressed on certain tumors. In preclinical studies, binding of tumor-associated CD200 to CD200R1 leads to immune suppression and decreased immune cell killing of cancer cells. Preclinical data indicate that this mechanism has the potential to restore the ability for both T-cells and myeloid cells to kill cancer cells. Clinical trials registry (clinicaltrials.gov): NCT05199272. 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, without limitation, statements regarding the future 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.comMedia Contact: press@23andMe.com

Company will initiate Phase 1 study of CLN-619 for relapsed or refractory multiple myeloma, first MICA/B antibody clinical study in hematologic malignancies Follows ongoing clinical study of CLN-619 alone and in combination with pembrolizumab in solid tumors, with anticipated updated clinical data in Q2 2024 March 01, 2024 -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that binds to stress-induced ligands, MICA and MICB, which are expressed on a wide variety of solid tumors and hematologic malignancies. The company will commence a Phase 1 dose-escalation and dose-expansion trial of CLN-619. “Multiple myeloma remains incurable, and most patients experience sequential relapses. The response to treatment is typically shorter with each relapse, so novel treatments are still needed,” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology. “Multiple myeloma is another example of a malignancy where MICA/B shedding from tumor cells allows for immune evasion. As we shared at SITC 2023, CLN-619 restores MICA/B expression on tumor cells, enabling immune recognition. This Phase 1 trial will assess CLN-619 in patients with multiple myeloma, and, given the safety profile shown to date for CLN-619, we believe there is an opportunity to combine the monoclonal antibody with multiple standard therapies. With clinical studies in both solid tumors and hematologic malignancies, we look forward to assessing the full potential of CLN-619 to address multiple areas of unmet clinical need.” CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that binds to the stress-induced ligands MICA and MICB, which are expressed on a wide variety of solid tumors and hematologic malignancies. Engagement of MICA/B by the activating receptor NKG2D, present on both cytotoxic innate and adaptive immune cells, results in target cell lysis. However, tumor cells can shed MICA/B via proteases they release into the tumor microenvironment, resulting in evasion of immune-mediated destruction. CLN-619 functions by restoring MICA/B expression on the surface of tumor cells, enhancing the interaction between MICA and NKG2D, and inducing antibody-dependent cellular toxicity (ADCC), together promoting anti-tumor activity via multiple immune-mediated mechanisms. CLN-619 is being studied in an ongoing Phase 1 clinical trial (NCT05117476) both as a monotherapy and in combination with pembrolizumab in patients with solid tumors. The study design allows dose level extensions as well as expansion in tumor-specific cohorts. CLN-619 will also be studied in a Phase 1 clinical trial in patients with relapsed/refractory multiple myeloma. Cullinan Oncology, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients with cancer. We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners. Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications. Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization. As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class. Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer. Learn more about our Company at www.cullinanoncology.com, and follow us on LinkedIn and Twitter. The content above comes from the network. if any infringement, please contact us to modify.

Daiichi Sankyo's expansion in Germany, Astellas and Kelonia's deal, and Novartis' strategic review of an Indian unit made our news this week. Daiichi Sankyo is building additional antibody-drug conjugate capacity at its German site. Astellas partnered with Kelonia on cell therapy tech. Novartis launched a strategic review of a subsidiary in India that's focused on older meds. And more. 1. Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany Daiichi Sankyo is doubling down on the production of antibody-drug conjugates by directing about 1 billion euros ($1.08 billion) into expanding its facility near Munich, Germany. The expansion is expected to create at least 350 new jobs by 2030 when Daiichi plans to wrap up the project. Aside from cancer-treating ADCs, the expansion will also boost capacity for cardiovascular medicines. 2. Astellas-owned Xyphos offers more than $800M for Kelonia's in vivo delivery know-how Astellas, through its subsidiary Xyphos, has penned a deal worth more than $800 million with Kelonia to combine the companies' expertise on up to two cell therapy programs. Kelonia’s lentiviral particle offers targeted delivery of genetic material, whereas Xyphos boasts a convertible CAR platform that modifies the NKG2D receptor. The goal is to make the CARs more adaptable and able to reach multiple targets. 3. Novartis, zeroing in on innovative meds, launches strategic review of India outfit Novartis unveiled a strategic review of its 70.68% position in Novartis India Limited, a locally-listed unit that handles some old, off-patent meds in bone and pain, immunology and neuroscience. The shares owned by Novartis were worth about $161 million as of the end of 2023. The review doesn’t affect Novartis Healthcare Private Limited, which has its own commercial and R&D teams. 4. AstraZeneca touts 'overwhelming' Tagrisso win among 3 lung cancer portfolio advancements The second antibody-drug conjugate in AstraZeneca and Daiichi Sankyo’s partnership is getting closer to the market. The FDA has accepted the pair’s application for TROP2-targeted datopotamab deruxtecan in previously treated nonsquamous non-small cell lung cancer and assigned a target decision date in December. The drug didn’t benefit patients with squamous tumors in a phase 3 trial. 5. Daiichi blasts 'malicious and defamatory' marketing complaints but still gets hit with serious violation Daiichi Sankyo’s marketing communications around its cholesterol-lowering drugs, Nilemdo and Nustendi, have run afoul of the U.K.’s Prescription Medicines Code of Practice Authority. The issue came from complaints alleging that Daiichi failed to announce a contraindication in its public materials. But Daiichi noted that the complaints featured “somewhat malicious and defamatory” wording. 6. Everest to continue mRNA ascent alone after shedding Providence partnership China’s Everest Medicines has terminated an mRNA COVID vaccine collaboration with Providence Therapeutics. Everest plans to develop its own products utilizing the mRNA platform that it accessed through the partnership. Everest needs to cough up $4 million to end the deal, and Providence will be eligible for milestones and royalties related to the rabies and shingles vaccines the companies have been working on. Other News of Note:  7. Innovent's Tepezza rival one step closer to Chinese approval after phase 3 eye disease win 8. Following FDA rejection, Sanofi and Regeneron's Dupixent gains Japanese approval in hives condition 9. Biocytogen offers Gilead antibody capabilities in 3-year research pact (release) 10. FDA slams Chinese API maker with warning letter on heels of issuing Form 483