IMMUNEONCO-B (01541) announced after yesterday's market close that it has reclaimed the global rights (excluding Greater China) for IMM2510 (PD-L1/VEGF) and IMM27M (CTLA-4 ADCC+) from Instil Bio, signaling the company's proactive correction of its prior licensing strategy. When the overseas rights for these two assets were granted to Instil in August 2024 for a $50 million upfront payment, near-term payments, and up to $2 billion in milestones, the market already harbored doubts about Instil's execution capabilities. In hindsight, cutting losses promptly appears to be a wise decision. Progress under Instil was sluggish over 15 months, with the first US patient only enrolled in November 2025. Following the rights' return, the company not only regains full global control but also secures an opportunity to seek new partners, while simultaneously reclaiming主动权 over development strategy and clinical timelines.
Furthermore, the reclaimed rights also include those for IMM27M (CTLA-4 ADCC+). While CTLA-4 had received limited attention for some time due to safety concerns, the 2025 Nobel Prize in Physiology or Medicine brought the CTLA-4 target back into the spotlight. Recent data on Gotistobart (a next-generation CTLA-4 antibody) from BioNTech/OncoC4 showed significant positive results compared to the control group, with an overall survival (OS) curve displaying a characteristic plateau effect. Holding both VEGF/PD-L1 and CTLA-4 assets positions IMMUNEONCO-B with substantial potential for future combination therapies. Utilizing CTLA-4 as a monoclonal antibody in combinations offers greater flexibility in dosing and frequency, potentially mitigating its safety risks.
Another core highlight for IMMUNEONCO-B is its CD47-focused pipeline. Its cornerstone product, IMM01 (a SIRPα-Fc fusion protein), is advancing through a Phase III clinical trial for Chronic Myelomonocytic Leukemia (CMML), with an interim analysis expected within the year. Backed by substantial prior positive efficacy and safety data, it holds promise to fill a gap in the CD47 field. Additionally, IMM0306 (CD47/CD20), a Myeloid Cell Engager (MCE) molecule developed based on IMM01, is drawing significant attention. In 2025, Sanofi acquired an innovative MCE product, DR-0201, from Dren Bio for a $600 million upfront payment and up to $1.3 billion in milestones. Subsequent early-stage platform collaborations in this area have further validated the strategic value of MCEs. IMMUNEONCO-B's IMM0306 is one of the most advanced MCE molecules in development.
In the autoimmune disease arena, IMM0306 demonstrated promising Phase Ib data for treating Systemic Lupus Erythematosus (SLE) at the 2025 ACR conference, showing SRI-4 response rates of 71.4% and 80.0% in the 0.8 mg/kg and 1.2 mg/kg cohorts at 24 weeks, respectively, with no instances of Cytokine Release Syndrome (CRS). The dosing regimen requires only once-weekly administration for four consecutive weeks, followed by a six-month treatment-free period, highlighting its convenience. In oncology, Phase II data presented at the 2025 ASH conference showed that IMM0306 combined with lenalidomide achieved an Overall Response Rate (ORR) of 91.2% and a Complete Response (CR) rate of 67.6% in patients with relapsed/refractory follicular lymphoma. Even in patients resistant to CD20-targeted therapy, ORR and CR rates remained high at 88.9% and 66.7%, respectively. A Phase III clinical trial is scheduled to commence in the first quarter of 2026.
In summary, the recovery of these rights allows IMMUNEONCO-B to regain control over key assets (IMM2510 and IMM27M). Combined with the differentiated positioning of its IMM01 and IMM0306 pipelines in both oncology and autoimmune diseases, the company's future clinical progress and business development collaborations are highly anticipated.
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