In a significant development for bispecific antibody therapeutics, InnoCare Pharma and KeyMed Biosciences have jointly announced an exclusive licensing agreement with Prolium Bioscience for their investigational CD20xCD3 bispecific antibody, ICP-B02 (also known as CM355). The deal, potentially worth up to $520 million, includes upfront payments, milestone-based compensation, and tiered royalties on future sales.
The agreement grants Prolium exclusive rights to develop, manufacture, and commercialize ICP-B02 globally for non-oncology applications. Additionally, Prolium receives rights to pursue oncology indications in regions outside Asia. As part of the transaction, InnoCare and KeyMed will receive a minority equity stake in Prolium, a Delaware-based company backed by RTW Investments, LP.
Mechanism of Action and Clinical Progress
ICP-B02 employs a novel mechanism of action, simultaneously targeting CD20 on tumor cells and CD3 on T cells. This dual targeting approach facilitates T-cell Directed Cellular Cytotoxicity (TDCC), enabling the body's immune system to more effectively eliminate tumor cells.
The drug is currently undergoing a Phase I/II clinical trial in China, evaluating its safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with relapsed or refractory Non-Hodgkin lymphoma (NHL). Early results have been encouraging, particularly in patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), with both intravenous and subcutaneous formulations showing promise.
Expanding Therapeutic Applications
Building on these positive initial findings, researchers have already secured regulatory approval to begin dose expansion studies combining ICP-B02 with other immunochemotherapies. These combination trials aim to evaluate the drug's potential in earlier treatment lines for NHL patients.
The licensing agreement's scope, which includes non-oncology applications, suggests potential therapeutic opportunities beyond cancer treatment, though specific indications have not been disclosed.
Strategic Implications
For Prolium, backed by New York-based RTW Investments, this agreement represents a significant addition to their portfolio in transformational biopharmaceutical innovations. The deal structure, including substantial milestone payments and royalties, reflects confidence in ICP-B02's potential across multiple therapeutic areas.
The partnership leverages InnoCare's and KeyMed's strong presence in Asia with Prolium's development and commercialization capabilities in other global markets, potentially accelerating the drug's path to market in multiple regions and indications.
