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

IMM2510, an anti-PD-L1/VEGF bispecific antibody fusion protein, in patients with R/R STS: A phase Ib expansion study. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05972460 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • P1 data • Oncology • Sarcoma • Solid Tumor

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

A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer (clinicaltrials.gov) - P2 | N=148 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P2 trial • Breast Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

ImmuneOnco's Phase Ib/II clinical study application for IMM2510 combined with IMM01 has been accepted by the National Medical Products Administration (NMPA) | Project Progress [Google translation] (bydrug.pharmcube.com) - "On December 16, 2024, ImmuneOnco Biopharmaceutical Technology (Shanghai) Co., Ltd. ('ImmuneOnco', Hong Kong Stock Exchange stock code: 01541.HK) announced that the Phase Ib/II clinical research application (IND) for the PD-L1xVEGF bispecific antibody IMM2510 combined with Timdarpacept (IMM01) was accepted by the National Medical Products Administration (NMPA)....Currently, it has entered Phase Ib/II clinical research for further development in multiple solid tumor indications, both as a monotherapy and in combination with different treatment modes."

New P1/2 trial • Solid Tumor

A novel anti-PD-L1/anti-VEGF bispecific VHH antibody exhibits a synergistic anti-tumor effect compared to the monospecific VHH antibodies (SITC 2024) - "BB-203 also exhibited higher potency in blocking human PD-L1 compared to Avelumab, IMM2510, and PM8002 in PD1/PD-L1 blockade assay. The potency of BB-203 in blocking human VEGFA was similar to Avastin, IMM2510, and PM8002 in VEGF bioassay.BB-203 showed remarkable stability in both accelerated stability tests and serum stability tests...Conclusions The novel anti-PD-L1/anti-VEGF bispecific VHH antibody BB-203 has potent target-blocking activities in vitro and strong anti-tumor efficacy in vivo. Together with its excellent developability, BB-203 potentially is the best-in-class anti-PD-L1/anti-VEGF bispecific antibody drug candidate."

Oncology • Solid Tumor

Instil Bio Reports Third Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "ImmuneOnco expects to provide a clinical data update for SYN-2510/IMM2510 monotherapy in multiple solid tumors in China in the first half of 2025....Initiation of Phase 1b/2 IMM2510/SYN-2510 studies expected in late 2024 and 1H 2025 in China by ImmuneOnco...Instil is targeting initiation of a U.S. study of SYN-2510 in NSCLC in 2H 2025....Today, ImmuneOnco announced initial clinical results for patients with estrogen receptor positive (ER+) advanced breast cancer treated in the Phase 1 dose escalation of SYN-27M/IMM27M and the initiation of a Phase 2 clinical trial of SYN-27M/IMM27M for patients with ER+ breast cancer that failed after endocrine therapy or have recurred."

New P1/2 trial • New trial • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Solid Tumor

Instil Bio and ImmuneOnco Announce Global Registrational Strategy for PD-L1xVEGF Bispecific Antibody, SYN-2510/IMM2510, in Non-Small Cell Lung Cancer and Triple-Negative Breast Cancer (GlobeNewswire) - "Instil Bio, Inc...announced today the global registrational strategy for the PD-L1xVEGF bispecific antibody SYN-2510/IMM2510 in combination with chemotherapy in front-line non-small cell lung cancer (NSCLC) and in front-line triple-negative breast cancer (TNBC). In China, ImmuneOnco is accelerating the development of IMM2510/SYN-2510 in front-line NSCLC by targeting initiation in late 2024 of a Phase 1b/2 front-line chemo combination study. This study is expected to enroll patients with driver gene mutation-negative non-squamous and squamous NSCLC. ImmuneOnco is also accelerating development of IMM2510/SYN-2510 in front-line TNBC with initial Phase 1b/2 chemotherapy combination studies targeted to begin in early 2025. In the United States, Instil is prioritizing development of SYN-2510/IMM2510 in NSCLC and TNBC. US IND submission is targeted for late 2024, starting with a Phase 2 trial of SYN-2510/IMM2510 monotherapy in second-line non-squamous and squamous NSCLC."

IND • New P1/2 trial • New P2 trial • Breast Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Instil Bio and ImmuneOnco Announce License and Collaboration Agreement for Development of IMM2510, a Potentially Best-in-Class PD-L1xVEGF Bispecific Antibody, and IMM27M, a Novel Next-Generation Anti-CTLA-4 Antibody (GlobeNewswire) - "Instil Bio...and ImmuneOnco Biopharmaceuticals...announced a definitive agreement pursuant to which Instil is in-licensing ex-China development and commercial rights to ImmueOnco’s proprietary PD-L1xVEGF bispecific antibody, IMM2510, as well as its next-generation anti-CTLA-4 antibody, IMM27M....Under the terms of the agreement, a wholly owned subsidiary of Instil will receive global development and commercialization rights for IMM2510 and IMM27M outside of Greater China, while ImmuneOnco will retain development and commercialization rights in Greater China including Taiwan, Macau, and Hong Kong. ImmuneOnco will receive an upfront payment and potential near-term payments of up to $50 million as well as potential additional development, regulatory, and commercial milestones exceeding $2 billion plus single digit to low double-digit percentage royalties on global ex-China sales."

Licensing / partnership • Solid Tumor

ImmuneOnco's Phase IB clinical trial of IMM2510 combined with IMM27M completes first patient dosing (iis.aastocks.com) - "Immune Onco (01541) announced that the first patient was successfully dosed in the Phase Ib clinical trial of IMM2510 combined with IMM27M for the treatment of advanced solid tumors."

Trial status • Solid Tumor

IMM2510, an anti-PD-L1/VEGF bispecific antibody fusion protein, in patients with advanced solid tumors: A phase I dose-escalation study. (ASCO 2024) - P1 | "IMM2510 is well tolerated in general and preliminary anti-tumor activity in solid tumors is encouraging. The phase Ib/II is ongoing to enroll patients. Clinical trial information: NCT05972460."

Clinical • Metastases • P1 data • Anemia • Cervical Cancer • Hematological Disorders • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma

IMM2510, a PD-L1 and VEGF Bispecific Fusion Protein, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Metastases • New P1 trial • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Preliminary results of a phase I dose escalation study of IMM2510, a PD-L1 and VEGF bispecific fusion protein, in patients with advanced tumors. (ASCO 2023) - "These data indicated that IMM2510 is well tolerated at the dose levels evaluated, and preliminary anti-tumor efficacy in solid tumors is encouraging. The phase I/II is ongoing. Clinical trial information: chictr20211203."

Clinical • Metastases • P1 data • Anemia • Cervical Cancer • Hematological Disorders • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pain • Solid Tumor • Squamous Cell Carcinoma • CRP • PD-L1 • VEGFA

ImmuneOnco ‘s VEGF/PD-L1-targeted BsAb under clinical review in China (GBI Health) - "The Center for Drug Evaluation (CDE) website indicates that a clinical trial filing by ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd for its Category 1 biological injectable IMM2510 has been accepted for review, aiming to start trials for solid tumors...IMM2510 is a bispecific-antibody (BsAb) targeting vescular endothelium growth factor (VEGF) and programmed cell death-ligand 1 (PD-L1) developed via ImmuneOnco’s proprietary mAb-Trap technology."

Non-US regulatory