palverafusp alpha (AXN-2510) / ImmuneOnco Biopharma - LARVOL DELTA

ImmuneOnco Biopharmaceuticals…announced that China’s National Medical Products Administration (NMPA) has approved a Phase II/III study for IMM2510 (palverafusp α), a PD‑L1×VEGF bispecific antibody, in primary advanced or recurrent endometrial cancer as monotherapy and in combination with chemotherapy (flcube.com) - "The company regained full global rights following the termination of its ex‑Greater China licensing agreement with Axion Bio, Inc. on 6 Jan 2026.....Global Development: ImmuneOnco plans ex‑China partnership discussions in H2 2026; US IND filing targeted for 2027 leveraging China data. Manufacturing: Shanghai GMP facility (capacity 2,000 L) already producing IMM2510 for NSCLC trials; scalable to 10,000 L by Q4 2026."

Commercial • IND • Licensing / partnership • New P2/3 trial • Endometrial Cancer • Non Small Cell Lung Cancer

A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=52 | Active, not recruiting | Sponsor: Axion Bio, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Solid Tumor • PD-L1

PD-L1/ VEGF Bispecific IMM2510 Combined with Chemotherapy in 1L NSCLC patients: A phase II study [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

IMM-2510, a novel bispecific antibody targeting PD-L1 and VEGF, exhibits cooperative binding, ADCC activity, and enhanced anti-tumor efficacy, with best-in-class potential (SITC 2025) - "This agent has unique capabilities to target multiple tumorigenic pathways, improving upon the class-specific functions of this drug class, with added anti-tumor effects. IMM-2510 is currently in clinical trials for multiple solid tumor indications, including front-line NSCLC.1"

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • VEGFB

…The first patient has been successfully dosed in the Phase IB/II clinical trial of IMM2510 in combination with IMM01 for the treatment of advance solid tumors (HKEXnews)

Trial status • Solid Tumor

…The Company is pleased to announce that the Group has submitted the application for Phase III clinical trial of IMM2510 for the treatment of immunotherapy (IO) resistant…NSCLC and has recently submitted two Phase III clinical trials targeting different lung cancer to the Center for Drug Evaluation of National Medical Products Administration of the People’s Republic of China (the 'NMPA') (HKEXnews)

New P3 trial • Non Small Cell Lung Cancer

IMM2510, an Anti-PD-L1/VEGF Bispecific Antibody Fusion Protein for Advanced IO-treated SQ-NSCLC: A Phase I Study (IASLC-WCLC 2025) - P1 | "IMM2510monotherapy demonstrated potent anti-tumor activity in advanced immunotherapy-treated squamous-NSCLC patients with tolerable and manageable safety profiles. Based on these findings, phase II studies of IMM2510 combined with chemotherapy in advanced NSCLC are in progress, to further explore its therapeutic potential."

Metastases • P1 data • Anemia • Hypertension • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Renal Disease • Solid Tumor • ALK • EGFR

A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Instil Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Solid Tumor • PD-L1

A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=104 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P1/2 trial • Solid Tumor

Second Quarter 2025 Financial and Operating Results: - "As of June 30, 2025, Instil had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $103.6 million, which consisted of $7.7 million in cash and cash equivalents, approximately $0.2 million in restricted cash, $84.1 million in marketable securities, and $11.7 million in long-term investments, compared to $115.1 million in cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024....Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of June 30, 2025 will enable it to fund its operating plan beyond 2026."

Commercial • Non Small Cell Lung Cancer

A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Instil Bio

Monotherapy • New P1 trial • Solid Tumor • PD-L1

Updated ‘2510 monotherapy data in squamous-NSCLC to be presented at IASLC’s 2025 World Conference on Lung Cancer (WCLC) by ImmuneOnco (GlobeNewswire)

Clinical data • Lung Non-Small Cell Squamous Cancer

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-line NSCLC in China (GlobeNewswire) - P2 | N=148 | NCT06746870 | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | "Instil Bio, Inc...announced preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510/AXN-2510 (‘2510) in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China by ImmuneOnco....Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the ‘2510 chemotherapy combination trial in front-line NSCLC at a future medical conference."

P2 data • Non Small Cell Lung Cancer

MILESTONE PAYMENT RECEIVED UNDER THE LICENSE AND COLLABORATION AGREEMENT WITH AXION BIO (HKEXnews) - "The board (the 'Board') of directors ('Directors', and each a 'Director') of the Company is pleased to announce that the Company has received a milestone payment of US$10 million (the 'Milestone Payment') from Instil following the FDA clearance of IMM2510/AXN-2510 to initiate a Phase I clinical trial in the United States. As of the date of this announcement, the total payments received under the License and Collaboration Agreement have reached US$30 million (including the Milestone Payment), demonstrating continued progress and strong commitment between the Company and Instil."

Financing • Solid Tumor

Instil Bio Announces U.S. F.D.A. Clearance of Investigational New Drug (IND) Application for AXN-2510, a PD-L1xVEGF Bispecific Antibody, for a Phase 1 Trial in Relapsed/Refractory Solid Tumors (GlobeNewswire) - "Instil Bio, Inc...announced the clearance of an Investigational New Drug (IND) application for AXN-2510 ('2510') by the U.S. Food and Drug Administration. Instil expects to initiate a phase 1 trial of ‘2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025....Additionally, Instil continues to anticipate that initial safety and efficacy results from the ongoing phase 2 study of ‘2510 in combination with chemotherapy in first-line NSCLC in China will be shared in the second half of 2025 by ImmuneOnco."

IND • New P1 trial • P2 data • Non Small Cell Lung Cancer • Solid Tumor

IMM2510, an anti-PD-L1/VEGF bispecific antibody fusion protein, in patients with R/R STS: A phase Ib expansion study. (ASCO 2025) - P1 | "IMM2510 monotherapy demonstrated active anti-tumor activity in R/R STS patients with tolerable toxicity."

Clinical • P1 data • Alveolar Soft Tissue Sarcoma • Leiomyosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • Undifferentiated Pleomorphic Sarcoma

Other ‘2510 Clinical and Preclinical Updates (GlobeNewswire) - "Instil’s Phase 1b/2 trial of ‘2510 in the United States is expected to be initiated before the end of 2025, assuming the necessary regulatory approvals are obtained. The trial is expected to be a monotherapy dose optimization trial in relapsed/refractory solid tumors, which is intended to bridge the doses to the ongoing China trials and replaces the previously planned US ‘2510 and chemotherapy combination trial in first-line NSCLC....Preclinical assays demonstrate cooperative binding of ‘2510 to PD-L1 in the presence of VEGF in vitro. Further preclinical datasets demonstrating the unique and potentially best-in-class mechanism of action of ‘2510 are anticipated to be presented at future medical or scientific conferences."

New P1/2 trial • Preclinical • Non Small Cell Lung Cancer

‘2510 Monotherapy Data in Relapsed/Refractory NSCLC (China) (GlobeNewswire) - P1/2 | N=108 | NCT05972460 | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | "The objective response rate (ORR) is similar to datasets from competitor PD-(L)1xVEGF bispecific antibodies at a similar stage of development in patients with previously treated NSCLC, showing ORR of 23% (efficacy evaluable n=13)."

P1/2 data • Non Small Cell Lung Cancer

Instil Bio and ImmuneOnco Announced the Phase 2 Trial in First-line NSCLC of IMM2510/AXN-2510 (‘2510), a PD-L1xVEGF Bispecific Antibody, in Combination with Chemotherapy in China is on Track to Complete Enrollment in Q3 2025; Initial Results Anticipated in 2H 2025 (GlobeNewswire) - "ImmuneOnco expects to complete enrollment of approximately 60 patients in Q3 2025 in its Phase 2 trial of ‘2510 in combination with chemotherapy in patients with NSCLC in the first-line setting in China. Among more than 30 NSCLC patients enrolled (including the safety run-in), more than 20 first-line NSCLC patients have been treated since the end of March. ImmuneOnco anticipates sharing initial safety and efficacy results from this Phase 2 trial in the second half of 2025."

Enrollment status • P2 data • Non Small Cell Lung Cancer

Instil Bio Reports First Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "ImmuneOnco’s Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC in China is ongoing and ImmuneOnco anticipates initial clinical data from first-line NSCLC patients in 2H 2025; Instil anticipates initiating a U.S. clinical trial of AXN-2510/IMM2510 in combination with chemotherapy for 1L NSCLC patients before the end of 2025, assuming the necessary regulatory approvals are obtained."

P1/2 data • Trial status • Non Small Cell Lung Cancer

FURTHER PAYMENT RECEIVED UNDER THE LICENSE AND COLLABORATION AGREEMENT WITH AXION BIO FOR IMM2510 (PALVERAFUSP α) AND IMM27M (TAZLESTOBART) (HKEXnews) - "The board (the 'Board') of directors ('Directors', and each a 'Director') of the Company is pleased to announce that the Company has received the second near-term payment of US$5 million from Axion Bio in accordance with the License and Collaboration Agreement. As of the date of this announcement, the Company has received an aggregate of US$20 million in upfront and near-term payments under the License and Collaboration Agreement, marking a significant milestone in its collaboration with Axion Bio and laying a solid foundation for further advancement. Pursuant to the License and Collaboration Agreement, the Company expects to receive the remaining potential near-term payments of up to US$30 million in the future."

Financing • Solid Tumor

APPROVAL BY THE NMPA FOR CLINICAL TRIAL OF IMM01 (TIMDARPACEPT) COMBINED WITH IMM2510 (PALVERAFUSP α) AND WITH OR WITHOUT CHEMOTHERAPY FOR ADVANCED MALIGNANT TUMORS (HKEXnews) - "The board (the 'Board') of directors ('Directors', and each a 'Director') of the Company is pleased to announce that the Group has received approval from the National Medical Products Administration of the People’s Republic of China (the 'NMPA') for a clinical trial of IMM01 (Timdarpacept) in combination with IMM2510 (palverafusp α) and with or without chemotherapy, for the treatment of advanced malignant tumors."

New trial • Solid Tumor

Instil Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Clinical data for AXN-2510/IMM2510 monotherapy in relapsed/refractory NSCLC in China by ImmuneOnco, as well as additional safety data in other solid tumors, anticipated in 1H 2025; Enrollment of 1L NSCLC patients in trial of AXN-2510/IMM2510 and chemotherapy by ImmuneOnco in China anticipated to begin in Q2 2025 with initial clinical data by ImmuneOnco expected in 2H 2025; Initiation of U.S. clinical study of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC anticipated before the end of 2025, assuming receipt of necessary regulatory approvals."

New trial • P1 data • P1/2 data • Trial status • Non Small Cell Lung Cancer

Instil Bio Announces Clinical Progress in China for IMM2510/SYN-2510, a Clinical-Stage PD-L1xVEGF Bispecific Antibody (GlobeNewswire) - "ImmuneOnco announced that the first patient has been dosed in its phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) in China. ImmuneOnco announced it plans to enroll first-line patients in this trial and anticipates presenting initial clinical data, including data for first-line NSCLC patients, from this trial as soon as the second half of 2025. Additionally, Instil announced that for its anticipated initial U.S. clinical trial of SYN-2510/IMM2510 in lung cancer, it plans to target enrollment of first-line patients with NSCLC in combination with chemotherapy with an expected initiation in the second half of 2025, assuming the necessary regulatory approvals are obtained."

P1/2 data • Trial status • Non Small Cell Lung Cancer

A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor