InnoCare, a commercial-stage biopharmaceutical company, presented compelling clinical data for its robust oncology pipeline at two major medical conferences in 2025, showcasing promising results across multiple therapeutic areas and patient populations.
BCL2 Inhibitor Shows Strong Efficacy in B-Cell Malignancies
The company's BCL2 inhibitor mesutoclax (ICP-248) demonstrated remarkable efficacy in patients with relapsed or refractory B-cell malignancies. As of April 15, 2025, a total of 68 patients were enrolled in the dose escalation and dose expansion study, with 17 chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and 32 mantle cell lymphoma (MCL) patients treated with 125 mg of mesutoclax.
Among BTK-naïve patients, the overall response rate (ORR) for both R/R CLL/SLL and R/R MCL patients reached 100%, with complete response rates of 14.3% and 71.4% respectively. Notably, 43% of MCL patients achieved undetectable minimal residual disease (uMRD). Even in the challenging BTK-treated patient population, where 70% of CLL/SLL patients and 100% of MCL patients were resistant to BTK inhibitors, mesutoclax maintained strong efficacy with ORRs of 100% and 78.9% respectively.
Combination Therapy Advances to Phase III
Building on these promising results, InnoCare presented first-line combination data at the European Hematology Association (EHA) 2025 Congress. The combination of mesutoclax with BTK inhibitor orelabrutinib in treatment-naïve CLL/SLL patients showed exceptional promise, with 42 patients enrolled across two dose cohorts.
In the 125 mg dose cohort at week 24, the combination achieved a 100% ORR, 23.8% complete remission rate, and 48% peripheral blood uMRD rate. The favorable efficacy and safety profile prompted initiation of a registrational Phase III clinical study of mesutoclax (125 mg once daily) in combination with orelabrutinib for treatment-naïve CLL/SLL patients.
Pan-TRK Inhibitor Demonstrates Broad Efficacy
Zurletrectinib (ICP-723), InnoCare's next-generation pan-TRK inhibitor, showed significant efficacy across both pediatric and adult populations with NTRK fusion-positive solid tumors. In pediatric and adolescent patients, as of November 23, 2024, 18 patients were enrolled, with 6 TRK inhibitor treatment-naïve patients with central lab-confirmed NTRK+ tumors being efficacy evaluable.
The confirmed ORR assessed by independent review committee was 100%, with all patients achieving partial response at the first tumor assessment and maintaining remission as of the cutoff date. Median time to response was notably rapid at 1.0 month in adolescent patients and 0.9 month in pediatric patients. Importantly, one pediatric patient who had progressed on a prior first-generation TRK inhibitor achieved complete response after receiving zurletrectinib, demonstrating the drug's potential to overcome resistance.
In adult patients, zurletrectinib continued to show impressive results with 49 TRK inhibitor-naïve adult patients evaluable for efficacy across 12 different solid tumor types. The confirmed ORR by independent review committee was 83.7%, with a complete response rate of 10.2%. The duration of response rate and progression-free survival rate at 12 months were 92.0% and 90.5% respectively, with median values not yet reached.
Anti-CCR8 Antibody Targets Rare T-Cell Lymphoma
ICP-B05 (CM369), an anti-CCR8 antibody, represents the first and only reported preliminary efficacy data of anti-CCR8 targeted therapy for cutaneous T-cell lymphoma (CTCL) patients. As of January 6, 2025, 13 patients with relapsed/refractory CTCL were treated, with 12 patients receiving at least one skin lesion assessment.
The therapy achieved a 33.3% partial response rate, with 58.3% of patients assessed as stable disease with reduction in skin lesions. The 6-month progression-free survival rate was 82.5%, with a median PFS of 11.4 months. Among five patients with CCR8+ levels exceeding 10%, four (80%) achieved partial response, supporting the targeted approach.
Orelabrutinib Shows Versatility Across Multiple Indications
InnoCare's BTK inhibitor orelabrutinib demonstrated efficacy across multiple hematologic malignancies in combination regimens. In marginal zone lymphoma, orelabrutinib combined with bendamustine-rituximab or obinutuzumab achieved 100% ORR in untreated patients, with no BTK inhibitor-related adverse events such as atrial fibrillation or bleeding observed.
The drug also showed promise in primary central nervous system lymphoma (PCNSL), where the R-MTO regimen (rituximab, methotrexate, thiotepa, and orelabrutinib) achieved 93.34% complete response rate and 96.67% ORR in newly diagnosed patients, with 12-month progression-free survival and overall survival rates of 82.26% and 85.33% respectively.
Safety Profile Supports Clinical Development
Across all presented studies, InnoCare's pipeline candidates demonstrated manageable safety profiles. The anti-CCR8 antibody ICP-B05 was described as safe and well-tolerated, with its safety profile making it a good candidate for combination therapies. Similarly, mesutoclax showed a well-tolerated safety profile, and zurletrectinib demonstrated good safety across both pediatric and adult populations.
The comprehensive clinical data presented at both ASCO 2025 and EHA 2025 underscore InnoCare's commitment to developing innovative therapies for patients with unmet medical needs across various cancer types, with multiple candidates showing potential for regulatory advancement.
