The Swedish Orphan Biovitrum, or Sobi, has inked a licensing deal worth up to $580m with Innate Pharma for its cutaneous T-cell lymphoma (CTCL) hopeful, lacutamab, amid an accelerated approval submission.
Under the terms of the deal, Sobi will hand $75m upfront to help Innate begin the confirmatory Phase III TELLOMAK-3 study in CTCL, which the latter hopes will back lacutamab’s potential full approval in two CTCL subtypes: Sézary syndrome and mycosis fungoides. In exchange, Innate will offer Sobi the exclusive global rights to commercialise lacutamab provided it secures accelerated approval, as well as the worldwide development rights to the drug if Phase III results are positive.
On top of the upfront sum, Sobi has also committed to hand over $40m in potential near-term development milestones associated with lacutamab’s Sézary programme, as well as up to $465m if the company chooses to secure the full development rights to the drug alongside future regulatory and commercial milestones. Sobi will offer Innate double-digit royalties on any resulting lacutamab sales if the drug makes it to market.
This comes as Innate eyes an accelerated approval for lacutamab in Sézary syndrome, a rare and aggressive variant of CTCL, based on a win from the Phase II TELLOMAK study (NCT03902184). In the trial, lacutamab prompted durable responses and favourable safety in a heavily pre-treated patient population.
Lacutamab, a first-in-class medicine, acts as an anti-killer-cell immunoglobulin-like receptor 3DL2 (KIR3DL2), which helps to control immune cell activity and is often overexpressed in patients with CTCL. The therapy has already received Fast Track and PRIME designations from US and European regulators, respectively.
According to Innate’s CEO, Jonathan Dickinson, the advancement of lacutamab into a Phase III study marks a “pivotal moment” for the company as it looks to secure a place on the oncology market.
However, the company is not just pinning its hopes on lacutamab, Dickinson notes, as it is also expecting key milestones for its Nectin-4-targeting antibody-drug conjugate (ADC), IPH4502, and its immune checkpoint inhibitor, monalizumab, which he says represent “important developments” for Innate in 2026.
Treating CTCL
CTCL is a rare form of non-Hodgkin lymphoma caused by the accumulation of abnormal T-cells in the skin – leaving patients with itchy skin afflictions that often look like rashes, psoriasis or eczema.
In recent years, there have been multiple advancements in the treatment of CTCL, with the approval of drugs like Pfizer-owned Seagen and Takeda’s Adcetris (brentuximab vedotin), as well as Amneal Pharmaceuticals’ romidepsin injection solution in 2024 and June 2026, respectively.
However, several drugs have failed to cross the line to regulatory approval in CTCL, with a dedicated Phase II trial for Karyopharm Therapeutics’ selinexor being put on ice due to challenges around enrolment.
Meanwhile, 4SC also failed to secure the European Medicines Agency’s (EMA) blessing despite its drug, Kinselby (resminostat), meeting its primary endpoint in the Phase II RESMAIN study (NCT02953301), due to the drug’s perceived lack of benefit to warrant approval.
Most recently, Soligenix opted to terminate its development programme for topical CTCL therapy, HyBryte, after a data monitoring committee deemed it unlikely the drug would meet its primary goals in a pivotal Phase III trial.
Currently, researchers estimate that the global incidence of primary cutaneous lymphomas (PCL), a category which includes CTCL, is one in 100,000.
