Swedish Orphan Biovitrum AB (Sobi) and Innate Pharma have entered into a strategic partnership to advance lacutamab, an investigational therapy for Cutaneous T-Cell Lymphoma (CTCL), toward a potential regulatory approval.

The collaboration will enable the initiation of TELLOMAK-3, a confirmatory Phase 3 clinical trial evaluating lacutamab in CTCL. The study is expected to support a planned accelerated approval filing for lacutamab in Sézary syndrome, a rare and aggressive subtype of CTCL.

Under the agreement, Innate Pharma will be responsible for conducting the TELLOMAK-3 Phase 3 confirmatory study. The trial is also intended to support applications for full regulatory approval in key markets for Sézary syndrome and mycosis fungoides, the most common form of CTCL.

Sobi will receive exclusive worldwide commercialisation rights to lacutamab upon a potential accelerated approval. The company will also be eligible to assume full global development rights following positive results from the Phase 3 programme.

The completion of the transaction remains subject to customary closing conditions, including receipt of transaction-related antitrust clearance.

Guido Oelkers, President and CEO of Sobi, said, the partnership strengthens the company’s rare disease portfolio and reflects its strategy of collaborating with innovative companies to develop differentiated treatments for patients with rare diseases. He added that Sobi looks forward to working with Innate Pharma to advance lacutamab and potentially make the therapy available to patients worldwide, subject to regulatory approvals.

Jonathan Dickinson, CEO of Innate Pharma, said the partnership marks an important step toward initiating TELLOMAK-3 and advancing lacutamab toward a potential accelerated approval in Sézary syndrome. He highlighted Sobi’s rare disease expertise, commercial capabilities and global reach as complementary to Innate Pharma’s clinical development expertise in CTCL.

The planned TELLOMAK-3 study represents a key development milestone for lacutamab, with the companies aiming to advance the investigational therapy toward regulatory submissions and broader availability for patients with CTCL.

Lacutamab remains an investigational therapy and its safety and efficacy have not been established for any indication. Any potential approval will be subject to review and authorisation by the relevant regulatory authorities.