KeyMed collaborates with Prolium for bispecific antibody agreement

Investment firm RTW Investments has introduced a new biotech entity named Prolium Bioscience, which will focus on developing the CD20×CD3 bispecific antibody, ICP-B02. This drug, initially created by China’s Keymed Biosciences in collaboration with InnoCare Pharma, is now set to be developed on a global scale by Prolium for non-oncology purposes and for oncology purposes outside of Asia.

The business arrangement grants Prolium exclusive rights to spearhead the development and commercialization of ICP-B02, with an initial payment of $17.5 million. Additionally, there are potential milestone payments that could amount to $502.5 million, as recorded in a Hong Kong Stock Exchange document. Keymed and InnoCare will retain a minority equity share in Prolium and will also receive tiered royalties linked to future net sales of the drug.

ICP-B02 functions as a bispecific antibody that targets CD20 on tumor cells and CD3 on T cells. This mechanism activates T cells to launch an attack on tumor cells, using a process known as T cell-directed cellular cytotoxicity (TDCC). Currently, the therapy is undergoing a Phase I/II clinical trial in China, aiming at treating relapsed or refractory non-Hodgkin lymphoma (NHL). Early data indicates that ICP-B02 shows promise in both intravenous and subcutaneous forms, especially for follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL).

A planned dose-expansion study will attempt to assess ICP-B02's effectiveness in combination with other immunochemotherapies, focusing on earlier stages of NHL treatment. Approval has been granted for the investigational new drug application for this combination therapy.

The Prolium agreement underscores a growing trend of experimental therapies developed in China entering the US market. Keymed Biosciences has emerged as a key player in this movement, frequently licensing its assets to international biotech startups. Recently, Keymed licensed novel candidates to the newly established Timberlyne Therapeutics and Ouro Medicines, which have successfully raised $180 million and $120 million in Series A funding rounds, respectively.

Timberlyne is concentrating its efforts on CM313, an IgG1 monoclonal antibody aimed at treating autoimmune disorders. In return for ex-China rights to CM313, Keymed received an unspecified upfront payment, alongside milestone payments, royalties, and a stake in Timberlyne.

Ouro has been launched with the purpose of developing antibody treatments for chronic inflammatory conditions, planning to advance a T cell engager, OM336, obtained from Keymed, into clinical trials this year. The company is also pursuing the development of other T cell engagers and treatments that target certain subsets of compromised B cells involved in autoimmune diseases.

In recent years, Keymed has secured several significant licensing agreements. In November 2024, Keymed licensed its bispecific antibody CM336 to Platina Medicines, a subsidiary of Ouro, for global rights excluding China, Hong Kong, Macau, and Taiwan, as part of an agreement involving a $16 million upfront payment and up to $610 million in milestone payments.

Furthermore, in February 2023, Keymed, through its partnership with Lepu Biopharma, procured $63 million from AstraZeneca for the early-stage antibody-drug conjugate CMG901, emphasizing the company’s expanding influence within the global biotech arena.