SYN-27M / ImmuneOnco Biopharma, Instil Bio - LARVOL DELTA

IMM27M, a humanized Fc-engineered anti CTLA-4 antibody, in patients with advanced solid tumors: A phase I dose-escalation and dose-expansion study. (ASCO 2025) - P1 | "The pre-clinical results showed IMM27M induced significantly stronger anti-tumor activity than ipilimumab and resulted in complete tumor remission even at a low dose. IMM27M monotherapy was well-tolerated, with preliminarily single agent activity could be seen in patients with late line advanced solid tumors especially with HR+/HER2- mBC."

Clinical • Metastases • P1 data • Breast Cancer • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CTLA4 • HER-2

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

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

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

IMM27M, a humanized Fc-engineered anti CTLA-4 antibody, in patients with advanced solid tumors: A phase I dose-escalation study (AACR 2024) - P1 | "The pre-clinical results showed IMM27M induced a significantly stronger anti-tumor activity than ipilimumab and resulted in complete tumor remission even at a low dose. This study is an open-label, multi-center, phase I dose-escalation study to evaluate the safety, tolerability, maximum tolerated dose/recommended dose for expansion, PK and anti-tumor activity in patients with advanced solid tumors. IMM27M monotherapy in general was well-tolerated at the dose levels evaluated and preliminarily single agent activity was seen in patients with heavily pretreated advanced solid tumors. The dose escalation study of IMM27M in advanced solid tumors is ongoing.Clinical trial information: NCT05235438."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • CTLA4 • HER-2

IMM27M, a humanized Fc-engineered anti CTLA-4 antibody, in patients with advanced solid tumors: A phase I dose-escalation study. (ASCO 2023) - P1 | "The pre-clinical results showed IMM27M induced a significantly stronger anti-tumor activity than ipilimumab and resulted in complete tumor remission even at a low dose. IMM27M monotherapy in general was well-tolerated at the dose level evaluated and preliminarily anti-tumor activity in patients with advanced solid tumors. The dose escalation study of IMM27M in advanced solid tumors is ongoing. Clinical trial information: NCT05235438."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pulmonary Disease • Renal Cell Carcinoma • Respiratory Diseases • Solid Tumor • CTLA4

Safety and Toxicity Study of IMM27M in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2023 ➔ Aug 2024 | Trial primary completion date: Apr 2023 ➔ Aug 2023

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer