Sobi strikes US$580M lacutamab deal with Innate Pharma for CTCL

SWEDEN—Swedish Orphan Biovitrum (Sobi) has signed a licensing agreement worth up to US$580 million with Innate Pharma for lacutamab, an investigational treatment for cutaneous T-cell lymphoma (CTCL), as Innate prepares to seek accelerated approval for the therapy.

Under the agreement, Sobi will pay Innate US$75million upfront to support the launch of the Phase III TELLOMAK-3 trial in CTCL.

The study is designed to provide confirmatory evidence for lacutamab in two CTCL subtypes, Sézary syndrome and mycosis fungoides, potentially supporting full regulatory approval.

In return, Sobi will receive exclusive global commercialisation rights to lacutamab if the drug secures accelerated approval.

The agreement also gives Sobi worldwide development rights if positive Phase III results support continued development.

Beyond the upfront payment, Sobi has agreed to pay up to $40m in near-term development milestones linked to the Sézary syndrome programme.

The company could also pay up to US$ 465 million if it takes on full development rights, in addition to regulatory and commercial milestones.

Innate will also receive double-digit royalties on future lacutamab sales if the treatment reaches the market.

Path towards approval

The agreement comes as Innate prepares an accelerated approval submission for lacutamab in Sézary syndrome, a rare and aggressive form of CTCL.

The company is basing the submission on results from the Phase II TELLOMAK study (NCT03902184), in which the treatment produced durable responses and demonstrated a favourable safety profile among heavily pre-treated patients.

Lacutamab is a first-in-class antibody that targets killer-cell immunoglobulin-like receptor 3DL2 (KIR3DL2), a protein involved in regulating immune-cell activity.

KIR3DL2 is frequently overexpressed in patients with CTCL, making it a potential treatment target.

The therapy has already received Fast Track designation from the US Food and Drug Administration and PRIME designation from the European Medicines Agency, reflecting regulatory support for therapies addressing serious diseases with unmet medical needs.

Jonathan Dickinson, CEO of Innate Pharma, described the move into Phase III development as a “pivotal moment” for the company as it seeks to establish a position in oncology.

However, Dickinson said Innate’s pipeline extends beyond lacutamab.

The company also expects important milestones in 2026 for IPH4502, a Nectin-4-targeting antibody-drug conjugate (ADC), and monalizumab, an immune checkpoint inhibitor.

Competitive CTCL landscape

CTCL is a rare form of non-Hodgkin lymphoma in which abnormal T-cells accumulate in the skin.

The disease can cause itchy lesions that may resemble common skin conditions such as rashes, psoriasis or eczema.

Treatment options have expanded in recent years, including Adcetris (brentuximab vedotin), marketed by Pfizer-owned Seagen and Takeda, and romidepsin injection solution from Amneal Pharmaceuticals, which received regulatory approvals in 2024 and June 2026, respectively.

Nevertheless, several CTCL programmes have encountered setbacks. Karyopharm Therapeutics suspended a dedicated Phase II study of selinexor because of enrolment challenges.

Similarly, 4SC failed to obtain European Medicines Agency approval for Kinselby (resminostat), despite the treatment meeting its primary endpoint in the Phase II RESMAIN study (NCT02953301), after regulators determined that its benefit was insufficient to justify approval.

More recently, Soligenix terminated development of HyBryte, a topical treatment for CTCL, after an independent data monitoring committee concluded that the therapy was unlikely to meet the primary objectives of its pivotal Phase III trial.

Researchers estimate that primary cutaneous lymphomas, a group that includes CTCL, have a global incidence of approximately one case per 100,000 people.