Innate Pharma SA and Swedish Orphan Biovitrum AB have entered a strategic partnership to enable initiation of the TELLOMAK-3 confirmatory phase 3 study in Cutaneous T-Cell Lymphoma (CTCL), a key step toward filing for accelerated approval of lacutamab in Sézary syndrome, a subtype of CTCL.

Under the agreement, Innate will conduct the TELLOMAK-3 phase 3 confirmatory trial in CTCL, supporting a planned accelerated approval filing in Sézary syndrome. The planned TELLOMAK-3 study will subsequently support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides, the most common subtype. Sobi will receive exclusive global rights to commercialise lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive phase 3 results. Closing of the transaction is subject to closing conditions, including the receipt of transaction related anti-trust clearance.

Jonathan Dickinson, CEO, Innate Pharma, said, “We are thrilled to partner with Sobi and enable TELLOMAK-3 initiation, the 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.”

According to the agreement, Sobi will pay Innate Pharma USD 75 million, payable on closing. Innate will be eligible to receive up to a further USD 40 million in respect of near-term development milestones connected to Sézary syndrome. Additionally, Innate will be eligible to receive up to USD 465 million related to the option for Sobi to get full development rights and to future regulatory and commercial milestones. Innate will be eligible to receive tiered double-digit royalties on net sales.

Guido Oelkers, President and CEO, Sobi, said, “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.”