Siglec x 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

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 .

Merger expands OncoC4’s wholly owned immunotherapy pipeline and establishes in-house clinical manufacturing capabilities Adds IND-ready AI-081, a PD-1/VEGF bispecific antibody with best-in-class potential and clinical-stage assets including next-generation siglec agonist AI-071 Both companies are co-founded by CEO, Yang Liu and CMO, Pan Zheng and have a similar shareholder base ROCKVILLE, Md., Sept. 25, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, and AcroImmune, a biopharmaceutical company developing immunotherapy drugs for malignant tumor and inflammatory disease, today announced that the companies, which are under common control, have entered into a definitive merger agreement to combine in an all-stock transaction (the Merger). Under the terms of the agreements, OncoC4 will acquire 100% of the outstanding equity interests of AcroImmune. Upon completion of the Merger, the combined company is expected to operate under the name OncoC4, Inc., will be headquartered in Rockville, Maryland, and led by Yang Liu, PhD, Co-Founder, Chief Executive Officer (CEO). Both OncoC4 and AcroImmune were co-founded by Drs. Yang Liu and Pan Zheng and have a similar shareholder base. “This Merger seamlessly bolsters OncoC4’s wholly owned immunotherapy pipeline and adds investigational new drug (IND)-ready PD-1/VEGF bispecific antibody AI-081 with best-in-class potential and clinical stage assets with near-term catalysts including next-generation siglec agonist AI-071,” said Yang Liu, PhD, Co-Founder, CEO and Chief Scientific Officer (CSO) of OncoC4. “Additionally, the Merger will also expand OncoC4’s geographical footprint and establish in-house clinical manufacturing capabilities including R&D, clinical, and manufacturing sites in China.” Dr. Liu continued, “Collectively, these synergies further strengthen the potential of OncoC4 to deliver differentiated and novel immunotherapies spanning multiple modalities for difficult to treat solid tumors and hematological malignancies. We look forward to continued advancement across our innovative pipeline with several upcoming early and late-stage clinical milestones over the next 12 months.” Dr. Pan Zheng, MD, PhD, OncoC4’s Chief Medical Officer (CMO) and cofounder of OncoC4 and AcroImmune added, “A bispecific targeting PD-1 and VEGF holds potential to broaden the horizon of checkpoint therapy across cancers. AI-081 consists of fully owned and high affinity binding motifs to PD-1 and VEGF that are designed to be best in-class among an emerging class of potentially transformative cancer therapies. We are very excited to file an IND application for AI-081 in the fourth quarter of the year.” OncoC4’s Pipeline Programs and Expected Upcoming Milestones Newly Added Wholly Owned Programs AI-081 – A potentially best-in-class bispecific antiboy against PD-1 and VEGF that has demonstrated high potency and in vivo anti-tumor activity in preclinical models IND filing expected in Q4 2024 AI-071 – A Phase 2 ready, next-generation siglec agonist that is designed for broad siglec coverage with potential application across immunotherapy treated indications. Siglec is a novel innate immune checkpoint discovered by OncoC4 founders with broad application for cancer and excessive inflammation. Initiation of Phase 2 trial for acute respiratory failure expected in Q4 2024Initiation of Phase 2 trial for immune related adverse events expected in Q1 2025 Legacy OncoC4 Wholly Owned Programs CD24 Siglec Program – Novel innate immune checkpoint discovered by OncoC4 founders with broad application for the treatment of cancer and excessive inflammation. ONC-841 – First-in-class anti-Siglec 10 mAb designed for broader impact across innate and adaptive immunity in tumor microenvironment Initiated Phase 1 trial in solid tumors in Q3 2024 Cancer Specific CD24 Platform Program – CD24 is a potent ‘don’t eat me’ signal used by tumors to evade innate immune destruction and an oncogene overexpressed in 70% of all human cancers. OncoC4’s cancer-specific mAb targets a neo-CD24 epitope with application across multiple therapeutic modalities. ONC-782 – CAR-T cell therapy for solid and hematological malignancies Initiation of Phase 1 Investigator Initiated Trial in China expected in 2H 2024 ONC-783 – Bispecific mAb for hematological malignancies IND enabling studies initiated in Q2 2024 ONC-784 – ADC for solid tumors IND enabling studies to be initiated in Q1 2025 Partnered Programs Gotistobart (BNT316/ONC392) is a next-generation anti-CTLA-4 antibody candidate in joint late-stage clinical development with BioNTech as a monotherapy and in combination in multiple ongoing solid tumor indications. Designed for improved toxicity and ability to overcome immune suppression in the tumor microenvironment by depleting regulatory T cells to turn immunologically cold tumors hot. About OncoC4 Based in Rockville, Maryland, OncoC4 is a privately held, late-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. Its lead clinical candidate is gotistobart (BNT316/ONC-392), a next generation anti-CTLA-4 antibody that allows CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In March 2023, OncoC4 announced a strategic collaboration with BioNTech to co-develop and commercialize ONC-392 in multiple solid tumor indications. OncoC4 received $200M upfront and is eligible to receive development, regulatory, and commercial milestone payments in addition to double digit royalties. In addition, OncoC4 has a pipeline of first-in-class and best-in-class assetstargeting both novel and well validated oncology targets. For more information, please visit www.oncoc4.com. Investor Contact: Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.com Media Contact: Kristin Politi, Ph.D. LifeSci Communicationskpoliti@lifescicomms.com