Swedish Orphan Biovitrum AB (Sobi) and France-based clinical-stage biotechnology company Innate Pharma have entered into a strategic partnership to advance lacutamab, an investigational therapy for cutaneous T-cell lymphoma (CTCL).
The partnership will enable the initiation of the TELLOMAK-3 confirmatory Phase 3 study, a key step toward a potential accelerated approval filing for lacutamab in Sézary syndrome, a rare and aggressive subtype of CTCL.
Under the agreement, Innate Pharma will conduct the TELLOMAK-3 Phase 3 trial in CTCL. The study is expected to support applications for accelerated approval in Sézary syndrome and, subsequently, full approvals in Sézary syndrome and mycosis fungoides, the most common subtype of CTCL.
Sobi will receive exclusive global commercialisation rights for lacutamab following a potential accelerated approval. The company will also be eligible to assume full global development rights following positive Phase 3 results.
The transaction remains subject to customary closing conditions, including receipt of the required antitrust clearance.
“This agreement is an important step in strengthening our portfolio and reflects our strategy of partnering with leading innovators to bring differentiated therapies to patients with rare diseases. We look forward to working with Innate Pharma to advance lacutamab and, subject to regulatory approvals, make it available to patients globally,” said Guido Oelkers, President and CEO of Sobi.
Jonathan Dickinson, CEO of Innate Pharma, said the partnership would enable the initiation of TELLOMAK-3, describing it as a “pivotal next step in advancing lacutamab toward a potential accelerated approval in Sézary syndrome.”
“Sobi is the ideal partner to help unlock the full potential of lacutamab. Their expertise in rare diseases, proven commercial capabilities and global reach perfectly complement Innate’s expertise in CTCL clinical development. Together, we share the ambition to bring lacutamab to patients globally as quickly as possible,” he said.
Under the terms of the agreement, Sobi will pay Innate Pharma USD 75 million upon closing. Innate will also be eligible to receive up to USD 40 million in near-term development milestones related to Sézary syndrome.
In addition, Innate could receive up to USD 465 million linked to Sobi’s option to obtain full development rights, as well as future regulatory and commercial milestones. Innate will also be eligible for tiered double-digit royalties on net sales.
Know More About Lacutamab
Lacutamab is a first-in-class anti-KIR3DL2 antibody being developed for CTCL, a group of rare non-Hodgkin lymphomas. CTCL includes Sézary syndrome, a rare and aggressive leukemic form of the disease, and mycosis fungoides, the most common CTCL subtype.
Lacutamab has received Fast Track designation from the US Food and Drug Administration (FDA), PRIME designation from the European Medicines Agency (EMA) for Sézary syndrome, and Orphan Drug designation in the US and EU for CTCL. The programme has also received FDA Breakthrough Therapy Designation for relapsed or refractory Sézary syndrome.
The programme is advancing toward the pivotal Phase 3 TELLOMAK-3 study, an open-label, multicenter, randomised trial evaluating patients with Sézary syndrome and mycosis fungoides who have received at least one prior systemic therapy. The study includes a confirmatory cohort in Sézary syndrome intended to support a potential accelerated approval and, following completion of the study, a full approval. A separate registrational cohort in mycosis fungoides is intended to support full approval, with progression-free survival (PFS) as the primary endpoint.
