{ "id": "ep68akzag0", "slug": "imm2510", "title": "IMM2510", "updated": "2026-10-21", "topic_path": [ { "id": "life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/topics/life" }, { "id": "life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health" }, { "id": "life.health.medicines", "label": "Medicines and therapeutics", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.medicines" }, { "id": "life.health.medicines.biologics-mabs", "label": "Biologics, monoclonal antibodies, and biosimilars", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.medicines.biologics-mabs" }, { "id": "life.health.medicines.biologics-mabs.car-t-and-engineered-cell-therapies", "label": "CAR-T and engineered cell therapies", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.medicines.biologics-mabs.car-t-and-engineered-cell-therapies" } ], "geo": [ { "id": "geo.chn.t2001.life.health.medicines.biologics-mabs", "label": "China · 2001 to 2020: Biologics, monoclonal antibodies, and biosimilars", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.chn.t2001.life.health.medicines.biologics-mabs", "path": [ { "id": "geo.chn", "label": "China", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.chn" }, { "id": "geo.chn.t2001", "label": "China · 2001 to 2020", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.chn.t2001" }, { "id": "geo.chn.t2001.life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.chn.t2001.life" }, { "id": "geo.chn.t2001.life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.chn.t2001.life.health" }, { "id": "geo.chn.t2001.life.health.medicines", "label": "Medicines and therapeutics", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.chn.t2001.life.health.medicines" }, { "id": "geo.chn.t2001.life.health.medicines.biologics-mabs", "label": "Biologics, monoclonal antibodies, and biosimilars", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.chn.t2001.life.health.medicines.biologics-mabs" } ] } ], "excerpt": "IMM2510 (palverafusp alfa, AXN-2510) is ImmuneOnco's PD-L1 x VEGF bispecific antibody fusion protein using a VEGFR1 trap and ADCC-enhanced Fc; RP2D 20 mg/kg Q2W, tested in NSCLC, sarcoma, and TNBC.", "snippet": "IMM2510 (palverafusp alfa, AXN-2510) is ImmuneOnco's PD-L1 x VEGF bispecific antibody fusion protein using a VEGFR1 trap and ADCC-enhanced Fc; RP2D 20 mg/kg Q2W, tested in NSCLC, sarcoma, and TNBC.", "node": "life.health.medicines.biologics-mabs.car-t-and-engineered-cell-therapies", "markdown": "# IMM2510\n\n**IMM2510** (palverafusp alfa; also known as AXN-2510) is a bispecific antibody fusion protein that targets both PD-L1 and vascular endothelial growth factor (VEGF), developed by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. for the treatment of solid tumors[1](https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0923/2025092300016.pdf) • [2](https://academic.oup.com/abt/article/9/1/86/8426273). It is built on ImmuneOnco's \"mAb-Trap\" platform, which fuses the second domain of VEGF receptor 1 (VEGFR1-D2), a VEGF-binding \"trap\", to the [N-terminus](https://www.edgepedia.org/n-terminus) of each heavy chain of an anti-PD-L1 antibody[2](https://academic.oup.com/abt/article/9/1/86/8426273). The drug has completed phase I dose-escalation and expansion testing in China, with a recommended phase II dose (RP2D) of 20 mg/kg every two weeks, and is in phase Ib/II combination studies for first-line non-small cell lung cancer (NSCLC), triple-negative breast cancer, and hepatocellular carcinoma[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506) • [1](https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0923/2025092300016.pdf).\n\n| Key fact | Detail |\n|---|---|\n| Other names | Palverafusp alfa (INN); AXN-2510 under Instil Bio/Axion Bio development[1](https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0923/2025092300016.pdf) • [4](https://cn.immuneonco.com/news/gsdynamics/594.html) |\n| Structure | VEGFR1 domain 2 fused to the N-terminus of each anti-PD-L1 heavy chain; Fc domain not silenced, retaining ADCC and ADCP activity[2](https://academic.oup.com/abt/article/9/1/86/8426273) |\n| Dosing | Intravenous infusion every 2 weeks; RP2D 20 mg/kg; half-life about 6.8 days at 20 mg/kg[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506) |\n| Key monotherapy result | In advanced IO-treated squamous NSCLC: ORR 27.3% (6/22), disease control rate 81.8%, median duration of response 11.1 months, median PFS 9.4 months[5](https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8580) |\n| Main safety findings | Infusion-related reaction is the most common treatment-related adverse event (72.7% in dose escalation, mostly grade 1–2); no dose-limiting toxicity; no treatment-related death[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506) • [5](https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8580) |\n| Developer | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX: 1541)[1](https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0923/2025092300016.pdf) |\n| Licensing history | Ex-Greater China rights licensed to Instil Bio in August 2024; rights reverted to ImmuneOnco in January 2026 after Axion Bio discontinued development[6](https://ir.instilbio.com/node/7911/pdf) • [4](https://cn.immuneonco.com/news/gsdynamics/594.html) |\n\n## Molecular design and mechanism\n\nIMM2510 combines two antitumor activities in one molecule. Blocking PD-L1 relieves inhibition of T cells, promoting T-cell activation and cytokine release; blocking VEGF inhibits tumor angiogenesis and reduces VEGF-mediated immunosuppression in the tumor microenvironment[2](https://academic.oup.com/abt/article/9/1/86/8426273). Because its Fc region carries no silencing mutations, the molecule also engages Fcγ receptors to mediate natural killer cell antibody-dependent cellular cytotoxicity (ADCC) against PD-L1-positive cells and macrophage antibody-dependent cellular phagocytosis (ADCP)[2](https://academic.oup.com/abt/article/9/1/86/8426273). This Fc-enhanced design differentiates it from other PD-L1 × VEGF bispecifics such as ivonescimab and BNT327/PM8002[2](https://academic.oup.com/abt/article/9/1/86/8426273).\n\nThe VEGF-binding arm uses the VEGFR1 trap rather than an antibody variable region, and the trap binds multiple VEGF receptor ligands beyond VEGF-A[6](https://ir.instilbio.com/node/7911/pdf). Laboratory work showed a cooperative binding effect: the presence of VEGF165 increased the apparent binding of IMM2510 to PD-L1 on tumor cells and on CD3+ T cells, and pre-binding with VEGF165 strengthened rescue of PD-1/PD-L1 signaling blockade in a reporter assay[2](https://academic.oup.com/abt/article/9/1/86/8426273). IMM2510 appeared less dependent on the presence of VEGF for this effect than ivonescimab[2](https://academic.oup.com/abt/article/9/1/86/8426273). [Size-exclusion chromatography](https://www.edgepedia.org/size-exclusion-chromatography) showed that IMM2510 forms a single complex with dimeric VEGF165, whereas bevacizumab and ivonescimab form larger immune complexes under the same conditions; large soluble complexes have been associated with Fc multimerization and platelet activation for those antibodies[2](https://academic.oup.com/abt/article/9/1/86/8426273).\n\n## Preclinical findings\n\nIn hPD-1 transgenic C57BL/6 mice bearing MC38-hPD-L1 syngeneic tumors, IMM2510 produced dose-dependent tumor growth inhibition, reaching about 70.24% at 12 mg/kg[2](https://academic.oup.com/abt/article/9/1/86/8426273). High-dose IMM2510 outperformed both atezolizumab and VEGFR1-Fc as single agents and showed a trend toward superior efficacy compared with the combination of VEGFR1-Fc plus atezolizumab[2](https://academic.oup.com/abt/article/9/1/86/8426273).\n\n## Phase I dose escalation\n\nThe first-in-human study, IMM2510-01 (NCT05972460), was a multicenter, open-label trial of IMM2510 monotherapy in patients with advanced solid tumors, using accelerated titration followed by a 3+3 design across nine dose levels from 0.007 to 20.0 mg/kg given intravenously every two weeks[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506). As of December 21, 2023, 33 patients had been treated; the median age was 57 years and the median prior line of therapy was 3[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506). Treatment-related adverse events occurred in 32 patients (97.0%), most of grade 1 or 2; the most common were infusion-related reaction (72.7%), decreased platelet count (39.4%), anemia (33.3%), and diarrhea (21.2%)[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506). Grade 3 or higher treatment-related adverse events occurred in 11 patients (33.3%), no dose-limiting toxicity was observed, and three patients discontinued treatment for related events[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506). Among 25 response-evaluable patients there were three confirmed partial responses, including two in squamous NSCLC patients who had previously failed immunotherapy[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506). Circulating VEGF-A was completely blocked at doses of 3.0 mg/kg or greater from the first administration until the end of treatment[7](https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.2535). The RP2D was set at 20.0 mg/kg[3](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506).\n\n## Squamous NSCLC after immunotherapy\n\nThe squamous NSCLC expansion cohort enrolled patients whose disease had progressed after a PD-1/PD-L1 inhibitor plus platinum-based chemotherapy[8](https://cn.immuneonco.com/upload/file/20260601/594aa7e377f677d366e94626b3d9a749.pdf). Data presented at the 2025 World Conference on Lung Cancer, covering 17 efficacy-evaluable patients, showed an objective response rate (ORR) of 35.3% (6/17), disease control rate (DCR) of 76.5%, median duration of response of 7.59 months, and median progression-free survival (PFS) of 9.4 months[9](https://www1.hkexnews.hk/listedco/listconews/sehk/2026/0429/2026042900035.pdf).\n\nThe updated analysis reported at the 2026 ASCO Annual Meeting included 32 patients treated as of December 31, 2025, of whom 22 were evaluable for efficacy[5](https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8580). The ORR was 27.3% (6/22) and the DCR was 81.8% (18/22); the median duration of response was 11.1 months, the median PFS was 9.4 months at a median follow-up of 8.3 months, and the median overall survival had not been reached[5](https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8580). All 32 patients experienced treatment-emergent adverse events; grade 3 or higher events occurred in 53.1%, grade 3 or higher treatment-related events in 37.5%, one patient (3.1%) discontinued for a treatment-related adverse event, and no treatment-related death occurred[5](https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8580). Exposure-response analysis across the 3 to 20 mg/kg range found that higher exposure corresponded to higher ORR and DCR while the exposure relationship for grade 3 or higher toxicity was relatively flat, supporting 20 mg/kg every two weeks as the RP2D[5](https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8580). A phase III study was being planned as of the 2026 report[5](https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8580).\n\n## Other monotherapy cohorts and combinations\n\n**Soft tissue sarcoma.** In the phase Ib expansion, 29 patients with relapsed or refractory soft tissue sarcoma had been treated as of December 24, 2024, including alveolar soft part sarcoma, [undifferentiated pleomorphic sarcoma](https://www.edgepedia.org/undifferentiated-pleomorphic-sarcoma) (UPS), leiomyosarcoma (LMS), and synovial sarcoma[10](https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.11545). Among 27 efficacy-evaluable patients the ORR was 7.4% and the DCR 55.6%; partial responses occurred in the UPS and LMS cohorts, with ORRs of 20% and 14.3% respectively[10](https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.11545). Treatment-related adverse events of grade 3 or higher occurred in 3 of 29 patients (10.3%), and none led to discontinuation[10](https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.11545).\n\n**First-line NSCLC with chemotherapy.** China's NMPA approved an investigational new drug application in November 2023 for a phase II trial of IMM2510 plus chemotherapy in first-line NSCLC and triple-negative breast cancer (TNBC); the first NSCLC patient was dosed in December 2024[1](https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0923/2025092300016.pdf). As of July 1, 2025, 33 patients had been dosed at 10 mg/kg and 21 were efficacy-evaluable, with an ORR of 61.9% (13/21); in squamous NSCLC the ORR reached 80% (8/10)[11](https://www.globenewswire.com/news-release/2025/7/31/3124761/0/en/ImmuneOnco-Announced-Preliminary-Safety-Efficacy-Data-from-the-Clinical-Trial-Studying-IMM2510-AXN-2510-a-PD-L1xVEGF-Bispecific-Antibody-in-Combination-with-Chemotherapy-in-Front-l.html). By December 31, 2025, 69 first-line NSCLC patients were efficacy-evaluable[9](https://www1.hkexnews.hk/listedco/listconews/sehk/2026/0429/2026042900035.pdf). In the TNBC cohort, whose safety run-in began on June 10, 2025, 4 patients with relapsed or refractory disease had been enrolled by August 15, 2025, with 2 partial responses and 1 stable disease at first assessment, including responses in patients with PD-L1 CPS below 1[1](https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0923/2025092300016.pdf).\n\n**Combination with IMM27M.** IMM2510 is also tested with [IMM27M](https://www.edgepedia.org/imm27m) (tazlestobart), an ADCC-enhanced anti-CTLA-4 antibody from the same company; the phase Ib/II study for relapsed or refractory solid tumors began in July 2024, and a phase II trial of the pair in first-line advanced hepatocellular carcinoma dosed its first patient in 2026[1](https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0923/2025092300016.pdf) • [12](https://cn.immuneonco.com/news/gsdynamics/625.html).\n\n## Partnership history\n\nOn August 1, 2024, [ImmuneOnco](https://www.edgepedia.org/immuneonco) licensed ex-[Greater China](https://www.edgepedia.org/greater-china) development and commercialization rights for IMM2510 and IMM27M to [Instil Bio](https://www.edgepedia.org/instil-bio), Inc. through its subsidiary Axion Bio, Inc., with an upfront and near-term payment of up to $50 million, potential milestones exceeding $2 billion, and single-digit to low double-digit royalties on ex-China sales[6](https://ir.instilbio.com/node/7911/pdf). ImmuneOnco received FDA investigational new drug clearance for IMM2510 in July 2025, enabling a phase Ib/II trial in the United States[13](https://financialfilings.com/filings/immuneonco-biopharmaceuticals-shanghai-inc/earnings-release/2026/33040674/). On January 6, 2026, ImmuneOnco announced that Axion had decided to discontinue clinical development of IMM2510/AXN-2510; all rights outside Greater China reverted to ImmuneOnco, and the $35 million already received was not affected[4](https://cn.immuneonco.com/news/gsdynamics/594.html).\n\n## Position in its class\n\nIMM2510 belongs to an emerging class of PD-(L)1 × VEGF bispecific antibodies that includes ivonescimab and BNT327/PM8002, several of which have reached phase 3 testing[14](https://pmc.ncbi.nlm.nih.gov/articles/PMC12876227/). Within this class it is distinguished by its fusion-protein (VEGF trap) architecture, its unsilenced Fc with ADCC activity, and the cooperative binding behavior in which VEGF engagement strengthens PD-L1 blockade[2](https://academic.oup.com/abt/article/9/1/86/8426273). As of December 31, 2025, 183 patients had been enrolled in the monotherapy phase Ib/II program in China[9](https://www1.hkexnews.hk/listedco/listconews/sehk/2026/0429/2026042900035.pdf).\n\n## References\n\n1. [ImmuneOnco Biopharmaceuticals (Shanghai) Inc., Management Discussion and Analysis, September 2025](https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0923/2025092300016.pdf)\n2. [IMM2510, a novel anti-PD-L1/VEGF bispecific antibody for cancer immunotherapy, Antibody Therapeutics (2026)](https://academic.oup.com/abt/article/9/1/86/8426273)\n3. [IMM2510 in patients with advanced solid tumors: A phase I dose-escalation study, J Clin Oncol 42 (2024), abstr e14506](https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.16_suppl.e14506)\n4. [ImmuneOnco Regains Global Rights to IMM2510/AXN-2510 and IMM27M/AXN-27M Following Axion Bio's Discontinuation, January 6, 2026](https://cn.immuneonco.com/news/gsdynamics/594.html)\n5. [Phase I study of IMM2510 in participants with advanced IO-treated SQ-NSCLC, J Clin Oncol 44 (2026), abstr 8580](https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.8580)\n6. [Instil Bio and ImmuneOnco Announce License and Collaboration Agreement, August 1, 2024](https://ir.instilbio.com/node/7911/pdf)\n7. [Preliminary results of a phase I dose escalation study of IMM2510, J Clin Oncol 41 (2023), abstr 2535](https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.2535)\n8. [ImmuneOnco ASCO 2026 poster: Phase I study of IMM2510 in advanced IO-treated SQ-NSCLC](https://cn.immuneonco.com/upload/file/20260601/594aa7e377f677d366e94626b3d9a749.pdf)\n9. [ImmuneOnco Biopharmaceuticals (Shanghai) Inc., Management Discussion and Analysis, April 2026](https://www1.hkexnews.hk/listedco/listconews/sehk/2026/0429/2026042900035.pdf)\n10. [IMM2510 in patients with R/R STS: A phase Ib expansion study, J Clin Oncol 43 (2025), abstr 11545](https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.11545)\n11. [ImmuneOnco Announced Preliminary Safety & Efficacy Data for IMM2510/AXN-2510 with Chemotherapy in Front-line NSCLC, July 31, 2025](https://www.globenewswire.com/news-release/2025/7/31/3124761/0/en/ImmuneOnco-Announced-Preliminary-Safety-Efficacy-Data-from-the-Clinical-Trial-Studying-IMM2510-AXN-2510-a-PD-L1xVEGF-Bispecific-Antibody-in-Combination-with-Chemotherapy-in-Front-l.html)\n12. [ImmuneOnco Doses First Patient in Phase II Trial of Palverafusp Alfa (IMM2510) with Tazlestobart (IMM27M) in First-Line Advanced HCC](https://cn.immuneonco.com/news/gsdynamics/625.html)\n13. [ImmuneOnco Biopharmaceuticals (Shanghai) Inc., Earnings Release 2025](https://financialfilings.com/filings/immuneonco-biopharmaceuticals-shanghai-inc/earnings-release/2026/33040674/)\n14. [Anti-angiogenic therapies in cancer: from endogenous inhibitors to bispecific VEGF x PD-(L)1 antibodies, Frontiers in Immunology (2026)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12876227/)\n\n---\n*Topic: Encyclopedia › Life and health › Human health and medicine › Medicines and therapeutics › Biologics, monoclonal antibodies, and biosimilars › CAR-T and engineered cell therapies*\n\n*Initially written Oct 21, 2026*\n\n*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*\n\nLicense: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license\n", "same_as": [], "url": "https://www.edgepedia.org/imm2510", "markdown_url": "https://www.edgepedia.org/imm2510.md", "license": { "name": "Edgepedia Community License 1.0", "url": "https://www.edgepedia.org/edgepedia/license", "summary": "Free with credit, commercial use included. AI training is open to everyone. For other uses, organizations over USD 100M in revenue or 100M monthly users license separately.", "spdx": "LicenseRef-Edgepedia-Community-1.0" }, "credit": "\"IMM2510\", Edgepedia (EdgeChat), https://www.edgepedia.org/imm2510. Edgepedia Community License 1.0.", "credit_md": "\"[IMM2510](https://www.edgepedia.org/imm2510)\", Edgepedia (EdgeChat), [https://www.edgepedia.org/imm2510](https://www.edgepedia.org/imm2510). [Edgepedia Community License 1.0](https://www.edgepedia.org/edgepedia/license).", "credit_html": "\"IMM2510\", Edgepedia (EdgeChat), https://www.edgepedia.org/imm2510. Edgepedia Community License 1.0.", "speakable": "IMM2510 is ImmuneOnco's PD-L1 x VEGF bispecific antibody fusion protein using a VEGFR1 trap and ADCC-enhanced Fc; RP2D 20 mg/kg Q2W, tested in NSCLC, sarcoma, and TNBC." }