On January 13, 2025 ImmuneOnco Biopharma reported that the Phase Ib/II clinical trial of its PD-L1xVEGF bispecific antibody IMM2510 combined with chemotherapy for the treatment of first-line non-small cell lung cancer (NSCLC) has completed the enrollment of its first patient (Press release, ImmuneOnco Biopharma, JAN 13, 2025, View Source [SID1234655707]). This marks another significant milestone in the rapid clinical advancement of IMM2510. Following a safety run-in, the Company plans to enroll first-line patients in the aforesaid clinical trial and anticipates releasing initial clinical data, including data from the first-line patients with NSCLC, as early as the second half of 2025.
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Results from the dose-escalation stage of the Phase I study of IMM2510 have demonstrated promising therapeutic signals: partial tumor response (PR) was observed in several patients with advanced solid tumors who had failed multiple lines of treatment. As of December 31, 2024, over 100 patients have been enrolled in the Phase I/II monotherapy clinical trials of IMM2510, showing good tolerability and encouraging initial tumor remission signals in multiple solid tumor indications (including NSCLC, triple-negative breast cancer, and soft tissue sarcoma) after repeated treatment failures. Currently, Phase Ib/II clinical trials are being actively developed in various solid tumor indications, exploring both monotherapy and combination treatment modalities.
Immune Onco is accelerating the development of IMM2510 for first-line NSCLC treatment in China, while also advancing the launch of the Phase Ib/Il project of IMM2510 combined with chemotherapy for first-line triple-negative breast cancer (TNBC). Based on the results of the Phase II clinical trial, ImmuneOnco and Instil Bio, Inc. are expected to initiate global clinical registration studies for IMM2510 combined with chemotherapy targeting first-line non- squamous and squamous NSCLC and/or first-line TNBC.
Dr. Tian Wenzhi, Founder and Chairman of ImmuneOnco, stated:
"We are delighted to announce that the Phase Ib/Il clinical trial of IMM2510 combined with chemotherapy for first-line NSCLC has successfully enrolled its first patient. This progress is not only a testament to our team’s hard work and commitment but also brings us one step closer to providing more effective treatment options for patients. IMM2510, as a bispecific antibody-receptor recombinant protein targeting PD-L1 and VEGF, has the potential to modulate the tumor microenvironment and significantly improve therapeutic outcomes. We will continue to advance research on the IMM2510 project to bring hope to cancer patients as soon as possible."
Dr. Lu Qiying, Chief Medical Officer and Senior Vice President of ImmuneOnco, commented:
"Today, we have reached a significant milestone with the successful enrollment of the first patient in the Phase Ib/II clinical trial of IMM2510 combined with chemotherapy for first-line NSCLC. In the Phase I clinical trial, tumor remission was observed in both squamous cell carcinoma and adenocarcinoma patients after repeated treatments with IMM2510 monotherapy, demonstrating a favorable response regardless of cancer subtype. This provided the rationale for advancing the development of IMM2510 combined with chemotherapy for newly diagnosed NSCLC. We are confident in IMM2510’s potential and look forward to its significant role in treating newly diagnosed NSCLC patients."
About IMM2510
IMM2510 is a bispecific antibody developed by ImmuneOnco’s proprietary "mAb- Trap" platform. It blocks the binding of PD-L1 to PD-1, relieving tumor immune evasion, and enhances immune response through Fc-mediated ADCC/ADCP, activating NK cells and macrophages for robust anti-tumor effects. Additionally, it inhibits VEGF/VEGFR signaling pathways, suppressing tumor angiogenesis, growth, and metastasis. Preclinical studies have demonstrated that IMM2510 achieves superior therapeutic outcomes compared to single-target or dual-target combination therapies, with a significant safety advantage. Its main indications include various advanced solid tumors.