CD24

REDWOOD CITY, CA, USA I April 14, 2025 I Pheast Therapeutics , a private biotechnology company developing novel therapies to unleash the power of macrophages on aggressive, difficult-to-treat cancers, today announced that the first patient has been treated in its Phase 1 clinical trial evaluating PHST001, an anti-CD24 macrophage checkpoint inhibitor, in patients with advanced solid tumors. “The start of this Phase 1 trial is an important milestone for Pheast and for the advancement of next generation macrophage checkpoint therapies,” said Roy Maute, Ph.D., Cofounder and CEO, Pheast Therapeutics. “We believe PHST001 has the potential to provide new treatment options for patients, particularly in cancers where other immunotherapies have not been effective.” The multicenter, open-label Phase 1 study will enroll up to 80 patients with advanced relapsed and/or refractory solid tumors (ClinicalTrials.gov Identifier: NCT06840886 ). The study’s primary objectives include evaluating safety and tolerability of PHST001 and establishing the recommended Phase 2 dose, with secondary endpoints assessing pharmacokinetics and early signs of anti-tumor activity. Raphaël Rousseau, M.D., Ph.D., Chief Medical Officer, Pheast Therapeutics, said, “PHST001 has demonstrated robust activity across tumor types and a favorable safety profile in preclinical studies. Furthermore, these data suggest that PHST001 may overcome tumor immune evasion through a differentiated approach to macrophage activation. We are pleased to have initiated this study as a first step in understanding the clinical potential of PHST001 to improve patient outcomes across multiple cancer types.” Irving Weissman, M.D., scientific co-founder of Pheast Therapeutics added, “CD24 is a key mechanism that tumors use to evade macrophage-mediated immune responses. PHST001 was developed based on foundational research into this pathway, and I’m encouraged to see this science progressing into the clinic. It’s a meaningful step toward harnessing the full potential of the innate immune system in cancer.” Preclinical data presented at SITC 2024 highlight PHST001’s potential across multiple cancer types, and its differentiation as a novel macrophage checkpoint inhibitor uniquely designed to target all glyco-variants of CD24. By binding CD24 with high affinity and specificity, PHST001 promotes macrophage-induced phagocytosis in a variety of cancer cell types and significantly shrinks tumors in in vivo models. Additionally, PHST001 has a favorable pharmacokinetic profile in non-human primates and does not induce immune-mediated toxicity in in vitro studies. About CD24 CD24 is a cell surface protein that plays a key role in tumor immune evasion by engaging Siglec-10, an inhibitory receptor on macrophages. This interaction suppresses macrophage-mediated clearance of cancer cells, allowing tumors to escape destruction by the innate immune system. CD24 was identified as a novel macrophage checkpoint through foundational work by Dr. Amira Barkal, principal founder of Pheast. Along with other co-founders, Drs. Irving Weissman, Ravi Majeti, and Roy Maute, Pheast’s research opened the door to therapeutic strategies targeting CD24 to drive innate immune responses against cancer. About PHST001 PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed by many human cancers, including ovarian and triple negative breast cancer (TNBC), and high expression of CD24 is a negative prognostic factor in multiple cancer indications. Pheast has engineered PHST001 to be a best in class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response. About Pheast Therapeutics Pheast is a clinical-stage immuno-oncology company focused on activating the innate immune system in the fight against cancer. Founded as a spinout from Stanford University and led by scientific experts in innate immunity and cancer immunotherapy, Pheast is developing novel therapies for some of the most difficult-to-treat and aggressive cancers. Pheast is backed by leading life sciences investors, Catalio Capital Management and ARCH Venture Partners. For more info, visit Pheast.com and connect on LinkedIn . SOURCE: Pheast Therapeutics

ImmuneOnco Biopharmaceuticals started a phase 3 trial of its lead asset late last year.\n ImmuneOnco Biopharmaceuticals has shown Chinese biotechs are far from immune to the pressures to prioritize pipelines. Eighteen months after listing in Hong Kong, the company has stopped development of two clinical programs and abandoned plans to build a manufacturing facility.Shanghai-based ImmuneOnco raised 319 million Hong Kong dollars ($41 million) to fund a broad pipeline of drug candidates when it went public in 2023. ImmuneOnco allocated a chunk of the money for the development and planned launch of IMM2520, a CD47×PD-L1 bispecific that it named as a key product. The biotech set aside a further 10% of its IPO haul for a planned trial of anti-CD24 antibody IMM47.ImmuneOnco revealed (PDF) a shift in its plan after the Hong Kong stock market closed Tuesday. The biotech has “strategically terminated” development of IMM2520 and IMM47, it said.“In light of evolving industry dynamics, the group continues to optimize the use of existing resources,” the biotech said in a statement. “We are refocusing and reallocating these resources to expedite the clinical development of our most promising candidates. This strategic realignment will enable us to maximize our impact and effectively address the needs of patients.” ImmuneOnco received clearance to test IMM2520 in humans in China and the U.S. late in 2022. A study started in China in March 2023 and had enrolled 26 solid tumor patients across six dose cohorts by the end of 2024. One patient had a partial response. ImmuneOnco designed the bispecific to simultaneously activate macrophages and T cells. CD47 programs at other biotechs have failed to live up to expectations, with Gilead Sciences\' $4.9 billion bet on Forty Seven the highest-profile casualty. ImmuneOnco retains a strong interest in CD47. A fusion protein and bispecific that hit the “don’t eat me” target remain part of the biotech’s plans.IMM47, the other program terminated by ImmuneOnco, entered the clinic in 2023. The biotech bet on the antibody in the belief hitting CD24 would suppress immune inhibitory signals that tumor cells send to macrophages, natural killer cells and T cells. ImmuneOnco saw the candidate’s potential to increase the number of macrophages in tumors as a good fit for PD-1/L1 combinations.Backing away from that vision frees up resources to spend on assets including IMM01, which the biotech has designated as its core product. The fusion protein is designed to activate macrophages by blocking a CD47 interaction. ImmuneOnco started a phase 3 trial in chronic myelomonocytic leukemia late last year.

PALO ALTO, Calif.--( BUSINESS WIRE )-- Pheast Therapeutics (“Pheast”), a biotech developing novel macrophage checkpoint therapies to defy cancer, today announced the presentation of new preclinical data for PHST001, an anti-CD24 antibody drug candidate that is designed to block a key macrophage "don't eat me" signal on cancer cells. The data were presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) taking place both virtually and at the George R. Brown Convention Center in Houston from November 6-10, 2024. The presented data show that PHST001, through potent CD24 binding, promotes macrophage-induced phagocytosis in a number of cancer cells and significantly shrinks tumors in vivo. In addition, PHST001 has a favorable PK profile in non-human primates and does not induce immune-mediated toxicity in vitro. “These data build on the results we presented earlier this year at PEGS showing that PHST001 can powerfully induce an anti-cancer immune response and drive therapeutic efficacy in challenging mouse model systems,” said Roy Maute, Ph.D., Cofounder and CEO, Pheast Therapeutics. “Macrophage checkpoint therapies such as PHST001 have the potential to expand clinical options for patients in high unmet need oncology indications where other immunotherapies have not yet been successful.” CD24 is highly expressed by many human cancers, including ovarian and triple negative breast cancer (TNBC), and high expression of CD24 is a negative prognostic factor in multiple cancer indications. CD24 interacts with the macrophage receptor Siglec-10, and shields cancer cells from attack by macrophages. Pheast has engineered PHST001 to bind CD24 on the surface of cancer cells with high affinity and specificity and to block Siglec-10 binding. “The preclinical data demonstrate the potential of PHST001 to address multiple cancer types, and its differentiation as a novel macrophage checkpoint inhibitor with potent inhibition of CD24," said Suzana Kahn, Ph.D., Senior Director, Biology at Pheast Therapeutics. "PHST001 does not have a toxic preclinical profile, which, combined with its superior efficacy in our preclinical models, supports the initiation of first-in-human clinical trials.” Dr. Kahn presented these data in a poster presentation entitled, “PHST001, a humanized anti-CD24 antibody, induces phagocytosis of human tumor cells in vitro and tumor clearance in vivo.” About Pheast Therapeutics Pheast is a preclinical stage immuno-oncology company focused on targeting immune evasion pathways to activate the innate immune system to defy cancer and help patients thrive. Founded and led by scientific experts in innate immunity and cancer immunotherapy, Pheast is developing novel immunotherapies for some of the most difficult-to-treat and aggressive cancers, including ovarian cancer and triple negative breast cancer. For more info, visit www.pheast.com .