Latest Data of InnoCare’s Robust Oncology Pipelines Presented at the 2025 ASCO Annual Meeting

Latest data of InnoCare’s robust oncology pipelines were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, involving the anti-CCR8 antibody ICP-B05 (CM369), the BCL2 inhibitor mesutoclax (ICP-248) and the pan-TRK inhibitor zurletrectinib (ICP-723).

Oral Presentation

Title: Preliminary results from the dose-escalation stage of a phase I trial of an anti-CCR8 antibody in patients with relapsed/refractory cutaneous T-cell lymphoma (R/R CTCL) (Abstract No.: 2514)

The current study is the first and only report on the preliminary efficacy data of anti-CCR8 targeted therapy for CTCL patients. The efficacy of ICP-B05 was supported by the PD effects in both skin lesions and peripheral blood in the depletion of CCR8+ cells. ICP-B05 is safe and well tolerated and its safety profile made it a good candidate for combo therapies for CTCL patients with lymph node and other organ involvement.

As of Jan. 6, 2025, a total of 13 patients with R/R CTCL were treated. There were 12 patients received at least one skin lesion assessment followed the mSWAT. 33.3% of patients achieved PR, and 58.3% of patients were assessed as SD with reduction in skin lesion. The 6-month PFS rate was 82.5%, and the median PFS was 11.4 months.

Among the five patients with CCR8+ levels exceeding 10%, four (80%) achieved PR. PK analysis showed that serum exposure (Cmax and AUC0-14D) increased with dose escalation. PD analysis demonstrated significant depletion of CCR8-expressing cells in CTCL skin lesions.

Poster 1:

Title: Preliminary safety and efficacy data of ICP-248, a novel BCL2 inhibitor, in patients with relapsed or refractory B-cell malignancies (Abstract No.: 7038)

The results of ICP-248 monotherapy suggests a well-tolerated safety profile and an exciting efficacy in BTK failed, heavily treated, 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. 17 R/R CLL/SLL and 32 R/R MCL patients were treated with 125 mg of ICP-248, including 10 CLL/SLL and 25 MCL patients were previously treated with BTK inhibitors, and 70.0% of CLL/SLL patients and 100% of MCL patients were resistant to BTK inhibitors.

17 CLL/SLL and 26 MCL patients had at least one response assessment. Among the BTK naïve patients, the ORR for R/R CLL/SLL and R/R MCL patients were both 100%, and the CRR was 14.3% and 71.4% respectively, of which 43% of MCL patients reported undetectable minimal residual disease (uMRD). Among the BTK treated patients, the ORR for R/R CLL/SLL and R/R MCL patients were 100% and 78.9% respectively, and the CRR were 30.0% and 26.3% respectively, of which uMRD was reported in 20% of CLL/SLL and 16% of MCL patients.

The median PFS of R/R MCL patients who had received treatment of BTK inhibitors before was 8.3 months. The PFS was not reached among BTK naïve R/R CLL/SLL and R/R MCL patients and BTK-treated R/R CLL/SLL patients.

Poster 2:

Title: Efficacy, safety and pharmacokinetics (PK) of zurletrectinib, a next-generation pan-TRK inhibitor, in pediatric and adolescent patients with NTRK fusion-positive (NTRK+) solid tumors (Abstract No.: 10048)

The integrated analysis demonstrated that zurletrectinib had significant efficacy and good safety profile in pediatric and adolescent patients with NTRK+ solid tumors. Zurletrectinib also showed the potential to overcome the resistance to first generation TRK inhibitors. These findings support zurletrectinib is a better treatment option for NTRK+ pediatric and adolescent patients.

As of Nov. 23, 2024, 18 patients in total were enrolled, including 8 pediatric patients and 10 adolescent patients. Among the 18 patients, 6 TRK inhibitor treatment-naïve patients with central lab confirmed NTRK+ were efficacy evaluable. The confirmed ORR assessed by IRC was 100%.

All patients achieved partial response (PR) at the first tumor assessment and maintained the remission as of the cutoff date. Median time to response were 1.0 month in adolescent patients and 0.9 month in pediatric patients. It is worth noting that one pediatric patient who progressed on prior first-generation TRK inhibitor achieved complete response after receiving zurletrectinib.

Poster 3:

Title: Updated efficacy and safety of zurlectrectinib in adult patients (pts) with locally advanced or metastatic NTRK fusion-positive (NTRK+) solid tumors (Abstract No.: 3112)

In line with previously reported results, zurletrectinib continued to demonstrate a deep and durable responses in adult patients with NTRK+ advanced solid tumors with or without brain metastasis. Zurletrectinib was also well-tolerated and showed favorable safety profile in adult patients with various tumor types.

As of Nov. 23, 2024, a total of 49 TRK inhibitor naïve adult patients were evaluable for efficacy representing 12 different solid tumor types. Among the efficacy population, the distribution of NTRK1, NTRK2 and NTRK3 fusions was 53.1%, 2.0% and 44.9% respectively.

The confirmed ORR by IRC was 83.7%, with CR of 10.2%. Median duration of response (DOR) and median progression-free survival (PFS) by IRC were not reached. The DOR rate and PFS rate by IRC at 12 months was 92.0% and 90.5% respectively. Two of the three patients who had brain metastasis at the baseline achieved intracerebral ORR, which is consistent with the good brain penetration and strong intracranial activity of zurletrectinib.

The 2025 ASCO Annual Meeting is held from May 30 to June 3, 2025 in Chicago, U.S. The ASCO annual meeting is the most important and professional academic event in the global oncology field, which showcases the international cutting-edge clinical oncology research results and tumor treatment technologies.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

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