CLEC2D

Preclinical data expand potential of IMT-009, confirming presence of CD161 expressing T cells in anti-PD1 non-responder tumors and demonstrating enhanced T cell mediated cytotoxicity with combination treatment of IMT-009 and anti-PD1 Results support clinical evaluation of IMT-009-anti-PD1 combination treatment approaches WALTHAM, Mass., April 8, 2024 /PRNewswire/ -- Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, today presented preclinical data supporting the combination potential of IMT-009 with anti-PD1 immunotherapy at the American Association for Cancer Research Annual Meeting (AACR 2024) in San Diego, California. "The need for new immuno-oncology approaches persists, with a significant proportion of patients unable to benefit from standard of care PD-1/PD-L1 checkpoint blockade treatment due to primary and acquired resistance. This need has fueled our work to develop IMT-009 as a differentiated cancer treatment option for patients," said Annalisa D'Andrea, Chief Scientific Officer at Immunitas. "The preclinical data presented at AACR build upon this innovation, supporting potential for clinical benefit through combination approaches featuring IMT-009 and anti-PD-1 treatments." Novel, anti-CD161 antibody IMT-009 has been shown to restore the anti-cancer activity of T and NK cells in preclinical studies by blocking interactions between CD161 and its ligand, CLEC2D, and is currently undergoing clinical evaluation for use in solid tumor and hematologic malignancies. The data presented at AACR 2024 build upon these preclinical data, reinforcing CD161 as a rational immunotherapy target with the potential to enhance T cell-mediated anti-tumor activity across a range of tumors. Single cell RNA sequencing analysis of published tumor datasets demonstrated the presence of CD161 expressing T cells in patients who have previously progressed on, or are refractory to, anti-PD-(L)1 therapy, indicating potential for benefit from treatment with IMT-009 as monotherapy or in combination with anti-PD-(L)1 therapy. In cancer cell models, combination of IMT-009 and anti-PD1 treatment significantly enhanced T cell mediated tumor killing. Transcriptomic changes upon treatment with IMT-009 also show robust T cell activation and cytotoxicity gene signatures which are further enriched in combination with anti-PD1 treatment. Together these data support clinical assessment of IMT-009 treatment in combination with anti-PD-(L)1 approaches in patients refractory to anti-PD-(L)1 treatment alone. Presentation Details for AACR 2024 Title: Abundance of KLRB1+ (CD161) T cells in anti-PD1 non responders coupled with enhanced tumor cytotoxicity of anti-CD161 (IMT-009) with anti-PD1 makes it a rational target for combination with anti-PD-(L)1 immunotherapy Abstract Number: 1375 Date/Time: Monday, April 8, 2024, 9:00am – 12:30pm PT About IMT-009 IMT-009 is a fully human, Fc-attenuated IgG1 monoclonal antibody that binds to CD161 and blocks its interaction with its ligand, CLEC2D. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. IMT-009 is under evaluation in a Phase 1/2a clinical trial for use as a monotherapy and combination treatment for solid tumor and hematological malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). About Immunitas Therapeutics Immunitas is a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated treatments for patients with cancer. A focus on human data, combined with fully integrated internal R&D capabilities and parallel discovery efforts, allows Immunitas to start with and stay closer to the most relevant and translatable biology for patients, accelerating the timeline from discovery to the clinic. The Immunitas discovery engine combines deep expertise in single-cell genomics with customized machine learning approaches to elucidate immune cell populations that are key actors in immuno-oncology. The company was founded by Longwood Fund with leading scientists from Dana-Farber, MGH, the Broad, and MIT. Since being founded in 2019, Immunitas has raised over $120 million from a strong syndicate of investors including Agent Capital, Alexandria Venture Investments, Evotec, Leaps by Bayer, Longwood Fund, M Ventures, Medical Excellence Capital, and Novartis Venture Fund. To learn more, visit . SOURCE Immunitas Therapeutics, Inc.

Dr. D'Andrea brings more than 25 years of research and development experience to the company, expanding executive leadership team to advance pipeline WALTHAM, Mass., Jan. 18, 2024 /PRNewswire/ -- Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, today announced the appointment of Annalisa D'Andrea, Ph.D., as Chief Scientific Officer (CSO). Dr. D'Andrea has more than 25 years of basic and translational research and development expertise in both large and small pharmaceutical and biotech settings. Dr. D'Andrea brings to Immunitas a strong history of success in immunology therapeutic development, having led products from target selection through clinical evaluation. Her expertise will accelerate Immunitas' pipeline of highly differentiated, antibody-based therapeutics, including lead candidate IMT-009 which is currently dosing in the clinic and the company's second program, an antibody oligonucleotide conjugate designed to stimulate Toll-like receptor 9. Dr. D'Andrea has been an advisor for the Company and served as Acting CSO since September 2023. "Annalisa's leadership and deep drug development expertise has proven invaluable as we advanced our growing pipeline of novel precision immuno-oncology therapeutics over the past several months," said Amanda Wagner, Chief Executive Officer of Immunitas. "We are excited to welcome her as our full-time Chief Scientific Officer. Annalisa will spearhead translational development and progression of our research and discovery programs. Her experience will play a key role in shaping our scientific strategy as the company continues to bring novel differentiated therapies to patients." Dr. D'Andrea brings nearly three decades of experience leading drug discovery and development. In addition to her role at Immunitas, Dr. D'Andrea is also a Venture Partner at Longwood Fund, supporting the identification and advancement of promising biotechnology companies, and an independent board member for Engimmune Therapeutics. Most recently, Dr. D'Andrea served as President and CSO at ImmuneID, CSO at Kiniksa Pharmaceuticals and Vice President and Global Head of Discovery for Immunology and Inflammation at Roche, where she oversaw the discovery pipeline of drug candidates from inception to the clinic. She also previously held multiple roles at SRI International and at Chiron Vaccines. Dr. D'Andrea earned her doctoral degree from the University of Florence while training at the Wistar Institute at the University of Pennsylvania. She completed her postdoctoral studies at the DNAX Research Institute in Palo Alto, California. "I look forward to collaborating with this talented team to build on the foundation of strong science underpinning Immunitas' expanding portfolio and realize novel therapeutic options for people living with cancer," said Dr. D'Andrea. "Immunitas' unique approach to drug discovery and fully integrated research and development capabilities differentiate the organization and offer opportunity to translate innovative science into broad patient impact." About IMT-009 IMT-009 is a fully human, Fc-attenuated IgG1 monoclonal antibody that binds to CD161 and blocks its interaction with its ligand, CLEC2D. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. IMT-009 is under evaluation in a Phase 1/2a clinical trial for use as a monotherapy and combination treatment for solid tumor and hematological malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). The trial will then transition into Phase 2 with multiple expansion cohorts to assess the safety and efficacy of IMT-009 alone or in combination with another antineoplastic agent. About Immunitas Therapeutics Immunitas is a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated treatments for patients with cancer. A focus on human data, combined with fully integrated internal R&D capabilities and parallel discovery efforts, allows Immunitas to start with and stay closer to the most relevant and translatable biology for patients, accelerating the timeline from discovery to the clinic. The Immunitas discovery engine combines deep expertise in single-cell genomics with customized machine learning approaches to elucidate immune cell populations that are key actors in immuno-oncology. The company was founded by Longwood Fund with leading scientists from Dana-Farber, MGH, the Broad, and MIT. Since its founding in 2019, Immunitas has raised a total of $97 million in venture funding from a strong syndicate of investors including Agent Capital, Alexandria Venture Investments, Evotec, Leaps by Bayer, Longwood Fund, M Ventures, Medical Excellence Capital, and Novartis Venture Fund. To learn more, visit .

Seasoned biotech executive James Wooldridge, M.D., named Chief Medical Officer to support advancement of immuno-oncology pipelineNew preclinical data to be presented at the American Society of Hematology 2023 Annual Meeting supports therapeutic potential of IMT-009 in hematological malignancies WALTHAM, Mass., Dec. 4, 2023 /PRNewswire/ -- Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, today announced the appointment of James Wooldridge, M.D., as Chief Medical Officer (CMO). The company also announced it will present new data supporting continued clinical development of its lead program IMT-009 for solid tumors and hematological malignancies at the 65th American Society of Hematology Annual Meeting and Exposition (ASH 2023). Continue Reading Immunitas Therapeutics Announces Appointment of James Wooldridge as Chief Medical Officer and Upcoming Presentation at ASH 2023 Annual Meeting In the CMO role, Dr. Wooldridge will leverage his extensive oncology therapeutic development experience to support clinical advancement strategy for Immunitas' pipeline of highly differentiated, antibody-based immuno-oncology assets, including lead candidate IMT-009. Dr. Wooldridge has served as Acting CMO since June 2023 and has been an advisor to the Company since October 2022. "We are pleased to announce Jim's appointment as our Chief Medical Officer as we continue progressing toward our goal of providing groundbreaking therapeutic solutions for patients with cancer," said Amanda Wagner, Chief Executive Officer of Immunitas. "Over the past year advising Immunitas he has provided invaluable expertise, drawing from his extensive breadth of experience in immuno-oncology development to support advancement of our evolving pipeline. We are delighted to have him on board as our CMO as we continue clinical development of IMT-009 and progress our portfolio of highly differentiated immuno-oncology biologics." Dr. Wooldridge has more than 20 years of experience in clinical oncology research and drug development spanning the biotechnology, pharmaceutical, and academic sectors. He previously served as the Chief Medical Officer at Checkmate Pharmaceuticals leading up to the company's acquisition by Regeneron. Additionally, he held the role of Chief Medical Officer at Aeglea BioTherapeutics, where he oversaw development of enzyme-based treatments for rare genetic diseases and cancer. "I am excited to continue working with this team to further advance the Immunitas pipeline. Our lead program, IMT-009, targets the CD161/CLEC2D axis and is currently dosing in the clinic with key data expected in 2024. The talented Immunitas team has built on our unique expertise in this area to progress a second compelling program for tumors that have traditionally not responded to immune-therapy, and the company's approach to target discovery is deeply rooted in human biology," said Dr. Wooldridge. "I'm particularly excited by Immunitas' strategy to develop novel therapeutics using a biomarker-driven approach early in development, and I greatly look forward to continuing my work with this team to bring new therapies to patients." The data to be presented at ASH 2023 further supports the therapeutic potential of IMT-009 in hematological malignancies. IMT-009 is a monoclonal, Fc silent, fully human Immunoglobulin G1 (IgG1) antibody that binds to CD161 with high affinity, selectively blocking interactions with its ligand CLEC2D. Previously reported preclinical data confirm that blocking CD161 with IMT-009 restores activation of effector functions of both CD161+ T and NK cells, enhancing cytotoxicity toward target tumor cells. IMT-009 is currently being evaluated in a Phase 1/2a clinical trial for use as monotherapy and combination treatment in both solid tumors and heme malignancies (NCT05565417). "The new data to be shared at ASH 2023 adds to the growing body of evidence supporting IMT-009's potential as a differentiated treatment approach for hematologic malignancies, in addition to the strong data we have generated in solid tumors. Together with data presented at SITC 2023 that demonstrated proof-of-concept for our second program, a myeloid and B cell modulating anti CLEC2D-Toll-like receptor 9 (TLR9) agonist conjugate, these data provide further compelling support for our approach targeting the CLEC2D/CD161 axis as a novel ligand-receptor pathway for immunotherapeutic intervention," said Amanda Wagner, Chief Executive Officer of Immunitas. Presentation Details for ASH 2023: Title: Anti CD161 antibody IMT-009 is a novel immunotherapeutic agent that effectively blocks the inhibitory CLEC2D/CD161 axis in CLEC2D+ B Cell hematological malignancies reinvigorating T and NK cell function leading to anti-tumor benefit Abstract Number: 2815 Date/Time: Sunday, December 10, 2023, 6:00 – 8:00 pm PT About IMT-009 IMT-009 is a fully human, Fc-attenuated IgG1 monoclonal antibody that binds to CD161 and blocks its interaction with its ligand, CLEC2D. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. IMT-009 is under evaluation in a Phase 1/2a clinical trial for use as a monotherapy and combination treatment for solid tumor and hematological malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). The trial will then transition into Phase 2 with multiple expansion cohorts to assess the safety and efficacy of IMT-009 alone or in combination with another antineoplastic agent. About Immunitas Therapeutics Immunitas is a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated treatments for patients with cancer. A focus on human data, combined with fully integrated internal R&D capabilities and parallel discovery efforts, allows Immunitas to start with and stay closer to the most relevant and translatable biology for patients, accelerating the timeline from discovery to the clinic. The Immunitas discovery engine combines deep expertise in single-cell genomics with customized machine learning approaches to elucidate immune cell populations that are key actors in immuno-oncology. The company was founded by Longwood Fund with leading scientists from Dana-Farber, MGH, the Broad, and MIT. Since its founding in 2019, Immunitas has raised a total of $97 million in venture funding from a strong syndicate of investors including Agent Capital, Alexandria Venture Investments, Evotec, Leaps by Bayer, Longwood Fund, M Ventures, Medical Excellence Capital, and Novartis Venture Fund. To learn more, visit . SOURCE Immunitas Therapeutics, Inc.