Sobi adds rare lymphoma drug with $580m Innate tie-up

 Sobi chief executive Guido Oelkers is preparing to depart the company, but the deals keep coming under his watch, with the latest an alliance with Innate Pharma for a lymphoma drug.

The Sweden-headquartered group is paying $75 million upfront to France's Innate in order to partner lacutamab, which is vying to become a first-in-class anti-KIR3DL2 antibody for cutaneous T-cell lymphoma (CTCL), a group of rare non-Hodgkin lymphomas.

The deal – which includes another $505 million in development milestones, regulatory, and commercial milestones – will allow Innate to start a phase 3 trial of lacutamab in Sézary syndrome, one of the most difficult-to-treat forms of CTCL that causes skin reddening and a rash that can often be mistaken for eczema or psoriasis.

Although Sézary syndrome impacts a small patient population – estimated at one per million people in the US – more than 90% of patients express KIR3DL2, a coinhibitory receptor found on the malignant T-cells in the disorder that promotes resistance to activation-induced cell death.

There is currently only one treatment specifically approved for this form of CTCL – Kyowa Kirin's Poteligeo (mogamulizumab) – but other drugs like HDAC inhibitors and retinoids, which are cleared for other forms of CTCL, are used off-label.

"Sobi is the ideal partner to help unlock the full potential of lacutamab," commented Jonathan Dickinson, Innate's CEO. "Their expertise in rare diseases, proven commercial capabilities and global reach perfectly complement Innate's expertise in CTCL clinical development."

The planned TELLOMAK-3 trial of lacutamab is designed as a confirmatory study that will be used to back up a planned accelerated filing for the antibody in Sézary syndrome, based on the phase 2 TELLOMAK-2 study.

Completed in 2024, that trial involved heavily pre-treated patients with the disease and achieved an overall response rate (ORR) of 42.9%, with a median duration of response of 25.6 months, along with a manageable safety profile and improvements in patients' quality of life.

It also showed efficacy for lacutamab in mycosis fungoides, another form of CTCL, which will be a follow-up indication for the antibody.

Running TELLOMAK-3 – which will include a mycosis fungoides arm – will be the responsibility of Innate's just-appointed new chief medical officer, Markus Jensen, who will replace Sonia Quaratino on 1st September.

Sobi will receive exclusive global rights to commercialise lacutamab upon potential accelerated approval and will be eligible to assume full global development rights if the phase 3 trial delivers as hoped.

"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," said Oelkers, who is leaving Sobi to take up the leadership of German mRNA company BioNTech early next year.

https://pharmaphorum.com/news/sobi-adds-rare-lymphoma-drug-580m-innate-tie