Sobi Partners With Innate Pharma on Lacutamab in T-Cell Lymphoma

Swedish pharmaceutical company Sobi and Innate Pharma have entered into a strategic partnership to advance lacutamab, an investigational treatment for cutaneous T-cell lymphoma (CTCL), toward a potential regulatory approval.

The agreement will allow Innate Pharma to begin the TELLOMAK-3 confirmatory Phase 3 trial, a key step in the development of lacutamab for patients with Sézary syndrome, a rare and aggressive form of CTCL.

Under the partnership, Innate will be responsible for conducting the TELLOMAK-3 study. The trial is intended to support a potential accelerated approval application for lacutamab in Sézary syndrome. If successful, the study could also provide the clinical foundation for applications seeking full approval in Sézary syndrome and mycosis fungoides, the most common form of CTCL.

Sobi will receive exclusive global commercialization rights to lacutamab if the drug secures potential accelerated approval. The Swedish company will also have the opportunity to take over full global development responsibilities if lacutamab produces positive results in Phase 3.

The transaction remains subject to customary closing conditions, including regulatory clearance related to antitrust requirements.

CTCL is a group of rare cancers that develop in T cells, a type of white blood cell involved in the immune system. The disease primarily affects the skin but can become more aggressive and spread beyond the skin in advanced cases. Sézary syndrome is characterized by widespread skin involvement and malignant T cells circulating in the blood, making it a particularly difficult form of the disease to treat.

Lacutamab is being developed as a targeted therapy for CTCL. The planned Phase 3 program is expected to be an important test of whether the drug can deliver sufficient clinical benefit to support broader use in patients with Sézary syndrome and potentially other forms of CTCL.

For Innate Pharma, the partnership provides a path toward advancing lacutamab into a pivotal late-stage trial while bringing in Sobi’s commercial and rare-disease expertise. Innate has been responsible for the clinical development of the therapy and will continue to lead the TELLOMAK-3 study.

Jonathan Dickinson, Chief Executive Officer of Innate Pharma, said the agreement with Sobi would enable the company to move forward with TELLOMAK-3 and bring lacutamab closer to a potential accelerated approval. He said Sobi’s experience in rare diseases and international commercialization complements Innate’s expertise in CTCL development.

Sobi President and CEO Guido Oelkers said the partnership fits the company’s strategy of working with biotechnology companies and other innovators to expand its rare-disease portfolio. The company intends to use its global commercial infrastructure to support access to lacutamab if it receives regulatory approval.

The partnership marks another step in the development of lacutamab as companies look for new treatment options for patients with rare blood cancers. Starting the TELLOMAK-3 trial will be particularly important because positive Phase 3 results could determine whether the therapy can progress from an investigational treatment to a potential globally available option for patients with CTCL.

If the development program succeeds and regulators grant approval, Sobi would take a leading role in bringing lacutamab to patients worldwide, while Innate’s clinical development expertise would remain central to the program.