ICP-B05 / InnoCare, Keymed Biosciences - LARVOL DELTA

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). (ASCO 2025) - P1 | "The current study is the first and only report on the preliminary efficacy data of anti-CCR8 targeted therapy for CTCL patients. The effectiveness 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."

Clinical • P1 data • Anemia • Cardiovascular • Congestive Heart Failure • Cutaneous T-cell Lymphoma • Dermatology • Heart Failure • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Neutropenia • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • CCR8

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) (Businesswire) - P1 | N=146 | NCT05690581 | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | "Latest data of InnoCare’s robust oncology pipelines presented at the 2025 ASCO Annual Meeting....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."

P1 data • Cutaneous T-cell Lymphoma

Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies (clinicaltrials.gov) - P1 | N=146 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Trial completion date: Apr 2025 ➔ Feb 2026 | Trial primary completion date: Jun 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

InnoCare Releases 2023 Results and Business Highlights (Businesswire) - P1 | N=146 | NCT05690581 | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | "The Phase I trial is ongoing, showing good tolerability with no DLT observed. The preliminary results demonstrate favorable PK profile and PD biomarker, Treg depletion, was observed; Dose escalation in solid tumors has been escalated up to 150 mg, which is also the initial dose designated for NHL. Preliminary efficacy was observed in NHL."

P1 data • Trial status • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies (clinicaltrials.gov) - P1 | N=146 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | N=82 ➔ 146

Enrollment change • Metastases • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

InnoCare and Keymed Jointly Announce First Subject Dosed in Clinical Trial of CCR8 Monoclonal Antibody ICP-B05 (Businesswire) - "InnoCare Pharma...and Keymed Biosciences...jointly announced today that the first subject has been dosed in clinical trial of ICP-B05 (CM369), an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody, developed by a joint venture between the two companies called Tiannuojiancheng Pharma in China. ICP-B05 is a potential first-in-class drug co-developed by InnoCare and Keymed as a monotherapy or in combination with other therapies for the treatment of various cancers."

Trial status • Oncology • Solid Tumor

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=82 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

InnoCare and Keymed Jointly Announce Approval of Clinical Trial of CCR8 Monoclonal Antibody CM369 (Businesswire) - "InnoCare Pharma...and Keymed Biosciences...jointly announced today that the Investigational New Drug (IND) of CM369, an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody, developed by a joint venture between the two companies called Tiannuojiancheng Pharma, has been approved by the China’s National Medical Products Administration (NMPA). CM369 is a potential first-in-class drug co-developed by InnoCare and Keymed as a monotherapy or in combination with other therapies for the treatment of various cancers."

New trial • Oncology • Solid Tumor