PRO-203 / Keymed Biosciences, InnoCare, Prolium Bioscience - LARVOL DELTA

Prolium also announced today the completion of the last patient, last visit in a 26-week investigator-initiated study of PRO-203 in treatment-refractory lupus nephritis (LN) patients. (Yahoo Finance) - "Data...will be shared at an upcoming medical meeting....The investigator-sponsored study of PRO-203 (NCT07104344) enrolled five systemic lupus erythematosus (SLE) patients, all of whom had treatment-refractory lupus nephritis, at a single site in China."

Enrollment closed • Lupus Nephritis

Continued Breakthroughs Across Multiple Pipelines (The Manila Times) - "Prolium, InnoCare’s partner, expects to initiate a multinational Phase I/II trial in systemic sclerosis (SSc) in the second quarter of 2026, with additional studies in other severe B-cell-driven autoimmune diseases to start this year."

New P1/2 trial • Immunology • Systemic Sclerosis

InnoCare Releases 2025 Results and Business Highlights, Achieving First Annual Profit (The Manila Times) - "In March 2026, Prolium announced first dosing of healthy volunteers in an ongoing single ascending dose study of ICP-B02 (PRO-203) and expects to initiate a multinational Phase I/II study of ICP-B02 in systemic sclerosis (SSc) in the second quarter of 2026, with additional studies in B-cell-driven autoimmune disease expected to follow."

New P1/2 trial • Trial status • Systemic Sclerosis

InnoCare and KeyMed Jointly Announce the License Agreement with Prolium for CD20xCD3 Bispecific Antibody ICP-B02 (Businesswire) - "InnoCare Pharma...and KeyMed Biosciences...announced that the two companies, together with their joint venture, have jointly entered into an exclusive license agreement with Prolium Bioscience (Prolium) for the development and commercialization of ICP-B02 (CM355), a CD20xCD3 bispecific antibody....Under the terms of the agreement, Prolium will have the exclusive right to develop, register, manufacture and commercialize ICP-B02 in the non-oncology field globally and in the oncology field in ex-Asia regions. InnoCare and KeyMed will receive aggregate payments of up to $520 million, including upfront and near-term payments and other payments subject to the achievement of certain clinical, regulatory and commercial milestones, as well as a minority equity stake in Prolium. InnoCare and KeyMed are also eligible to receive tiered royalties on future net sales of any product resulting from the collaboration."

Licensing / partnership • Oncology

Keymed Biosciences Announces Interim Results for First Half of 2024 (PRNewswire) - "As of the date of this announcement...an international multi-center Phase III study comparing CMG901...monotherapy versus investigator's choice as second-line or later-line treatment in patients with advanced or metastatic gastric and gastroesophageal junction (G/GEJ) cancer expressing Claudin 18.2 was publicly announced on the drug clinical trial registration and information publicity platform in March 2024. The first patient has received the initial dose in April 2024....Continuously proceeded with a Phase I/II clinical trial in the first half of 2024 to assess the safety, tolerability, pharmacokinetics, and the preliminary anti-tumor activity of CM355 in relapsed or refractory non-Hodgkin's lymphoma (NHL). As of the date of this announcement, dose escalation of the intravenous infusion formulation (IV) was completed and the subcutaneous formulation (SC) is in the process of patient evaluation."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

InnoCare Releases 2024 Interim Results and Business Highlights (Businesswire) - P=NA | N=NA | "ICP-B02 is a CD20xCD3 bispecific antibody co-developed with Keymed. Data from both the intravenous infusion (IV) and the subcutaneous (SC) formulations have shown good efficacy of ICP-B02 in patients with follicular lymphoma (FL) and DLBCL. All 15 patients who were treated with ICP-B02 at doses ≥6mg achieved response, resulting in an ORR of 100%. All patients who achieved CR maintained the remission as of the cutoff date. Based on the encouraging results of ICP-B02 as a single agent, the Company is planning for a dose expansion study of ICP-B02 in combination with other immunochemotherapies targeting earlier lines of treatment in NHL patients."

Clinical data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase I/II Study of CM355 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL) (clinicaltrials.gov) - P1/2 | N=184 | Active, not recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

New P1/2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

InnoCare and Keymed Jointly Announce Dosing of First Patient in Clinical Trial of CD20xCD3 Bispecific Antibody CM355 (PRNewswire) - "InnoCare Pharma...and Keymed Biosciences...jointly announced today that the first patient in China has been dosed in clinical trial of CM355, a CD20xCD3 bispecific antibody developed by a joint venture between the two companies, for the treatment of CD20+ B-cell malignancies."

Trial status • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

InnoCare and Keymed Jointly Announce Approval of Clinical Trial of CD20xCD3 Bispecific Antibody CM355 (PRNewswire) - "InnoCare Pharma...and Keymed Biosciences...jointly announced today that the Investigational New Drug (IND) of CM355, a CD20xCD3 bispecific antibody developed by a joint venture between the two companies called Tiannuojiancheng Pharma, has been cleared by the China's National Medical Products Administration....CM355 binds to CD20 on the tumor cells and CD3 on the T cells, redirects and activates T cells to eradicate tumor cells through T-cell Directed Cellular Cytotoxicity (TDCC) in the treatment of CD20+ B-cell malignancies."

New trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology