On August 28, 2025, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as "ImmuneOnco," with the stock code 01541.HK on the Hong Kong Stock Exchange) reported that, in accordance with the collaboration development plan, it has received the third clinical development milestone payment of $5 million from Instil Bio, Inc (Nasdaq: TIL, "Instil") as scheduled, in relation to the licensing and collaboration on IMM2510 and IMM27M (Press release, ImmuneOnco Biopharma, AUG 28, 2025, View Source [SID1234655713]).
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The receipt of this $5 million payment marks significant progress in the clinical development of the collaboration project. It not only reflects ImmuneOnco’s strength in innovative drug research and development but also demonstrates the efficient cooperation between the two parties, providing strong financial support for the further advancement of the project. With the arrival of this milestone payment, the total amount received from the collaboration project has reached as high as $35 million, indicating the rapid progress of the collaboration and the positive and sincere attitude of both parties in their cooperation.
Key Terms of the Licensing Agreement
On August 1, 2024, ImmuneOnco entered into a business development (BD) collaboration worth over $2 billion with Axion Bio, Inc., a wholly-owned subsidiary of Instil Bio, Inc. (formerly known as SynBioTx). Axion Bio, Inc. obtained the rights to develop and commercialize two products, IMM2510 and IMM27M, from ImmuneOnco’s pipeline outside the Greater China region. In addition to retaining the rights to these two products within the Greater China region, ImmuneOnco received an upfront payment and recent payments totaling $50 million, as well as over $2 billion in subsequent development, registration, and commercial milestone payments, and single-digit to low double-digit sales royalties outside the Greater China region.
Clinical Trial Updates
The Phase I clinical study of IMM2510 in Chinese patients with solid tumors has shown positive efficacy signals and good safety, especially in patients with squamous non-small cell lung cancer (SQ-NSCLC) who had previously failed treatment with PD-1 or PD-L1 inhibitors. These results will be presented at the 2025 World Conference on Lung Cancer (WCLC).
The Phase II clinical trial of IMM2510 in combination with chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC) is recruiting patients smoothly in China. As of July 1, 2025, the overall best objective response rate (ORR) in the evaluable population was 62%, with an ORR of 80% in patients with squamous NSCLC. The safety of this therapy is tolerable and controllable, supporting further clinical development. Plans are underway to initiate a Phase III clinical trial. More relevant research results will be published at future international academic conferences.
A Phase I clinical trial of IMM2510 monotherapy for recurrent/refractory solid tumors is scheduled to be launched in the United States in the second half of 2025.
(The above Phase II clinical data for IMM2510 in combination with chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC) has been previously disclosed by the company.)
Statement from ImmuneOnco’s Founder, Chairman, CEO, and CSO
Dr. Tian Wenzhi, Founder, Chairman, CEO, and CSO of ImmuneOnco, stated: "We are very pleased that our collaboration with Instil Bio has achieved another clinical development milestone. This not only recognizes our strength in innovative drug research and development but also reflects the close cooperation and efficient progress between the two parties. We will continue to work closely with Instil Bio to accelerate the global development of IMM2510 and IMM27M, striving to bring new treatment hopes to cancer patients worldwide as soon as possible. At the same time, ImmuneOnco will continue to be committed to the research and development of innovative drugs, providing more high-quality treatment options for patients globally."