China-based Excalipoint Therapeutics announced a clinical trial collaboration with Roche to evaluate EXP011 (CTM012), its lead tri-specific T-cell engager, in combination with Roche’s atezolizumab (Tecentriq) in patients with DLL3-expressing solid tumors. The initial study will focus on small cell lung cancer, with potential expansion into neuroendocrine tumors. Financial terms were not disclosed.
EXP011 is a tri-specific antibody derived from Excalipoint’s proprietary EXCOPIA platform, formerly known as TOPABody, that simultaneously engages DLL3 on tumor cells and both CD3 and 4-1BB on T cells. The dual T-cell co-stimulatory design — engaging CD3 for cytotoxic activation and 4-1BB for costimulatory amplification — is intended to generate more potent and sustained anti-tumor immune responses than conventional bispecific T-cell engagers that engage CD3 alone. EXP011 is currently in a Phase I/II trial in solid tumors, with the first patient dosed in October 2025. Under the collaboration, Roche will supply atezolizumab for Excalipoint-sponsored combination studies; the clinical program will assess safety, tolerability, and preliminary anti-tumor activity of the combination regimen.
The agreement is structured as a clinical trial collaboration and supply arrangement, consistent with a narrowly scoped operational partnership rather than a licensing or co-development deal. Each party retains full commercial rights to its respective asset.
The DLL3 target has attracted substantial investment across modalities, while atezolizumab has become a common checkpoint inhibitor partner in DLL3-directed immunotherapy studies because PD-L1 blockade may enhance T-cell activity induced by T-cell engagers. In January 2025, Roche entered an exclusive global license agreement with Innovent Biologics to develop IBI3009, a DLL3-targeting ADC, in a deal that included an USD 80 million upfront payment and up to USD 1 billion in milestones — demonstrating Roche’s strategic commitment to DLL3-expressing solid tumors through both in-licensing and supply-based collaborations. The Excalipoint arrangement mirrors the structure Roche previously used with San Diego-based Phanes Therapeutics, which dosed the first patient in a combination study of peluntamig (PT217) with atezolizumab in SCLC and neuroendocrine carcinomas in May 2025 under an analogous clinical supply agreement. EXP011 is differentiated from peluntamig — a DLL3/CD47 bispecific — by its tri-specific format incorporating 4-1BB costimulation, a design shared with Merck and Daiichi Sankyo’s gocatamig (MK-6070), which is also in Phase I/II evaluation and being studied in combination with atezolizumab in SCLC. Amgen’s tarlatamab (Imdelltra), a DLL3×CD3 bispecific T-cell engager approved by the US FDA for previously treated extensive-stage SCLC, remains the only approved DLL3-targeted therapy and sets the competitive benchmark for the class.
Excalipoint closed a USD 68.7 million oversubscribed seed round in March 2026, one of the largest seed financings for a Chinese biotechnology company, with investors including MPCi, Centurium Capital, Lilly Asia Ventures, and Eisai Innovation. That round was intended to fund advancement of EXP011 and five additional pipeline programs across oncology and immunology. The Roche collaboration provides non-dilutive access to an approved PD-L1 checkpoint inhibitor for combination evaluation without requiring Excalipoint to procure atezolizumab independently, accelerating the company’s ability to generate combination immuno-oncology data at an early clinical stage.
This article was generated with AI assistance and reviewed and edited by the AllSci editorial team
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