#Sweden #Stockholm #Sobi #Lacutamab #Innate Pharma

Sobi and Innate Pharma Join Forces to Advance Lacutamab for T-Cell Lymphoma

In a significant move within the pharmaceutical industry, Swedish Orphan Biovitrum AB, widely known as Sobi, has announced a strategic partnership with Innate Pharma SA to further the development of lacutamab, a promising treatment for cutaneous T-cell lymphoma (CTCL). This collaboration aims to initiate the TELLOMAK-3 confirmatory Phase 3 study focused on Sézary syndrome, a severe subtype of CTCL.

The partnership marks a pivotal point for both companies as they seek to address the urgent need for effective therapies for rare cancers. As part of the agreement, Innate Pharma will oversee the TELLOMAK-3 trial, which is essential for the potential accelerated approval of lacutamab in the treatment of Sézary syndrome. If successful, this study will not only solidify the path for accelerated approval but will also lay the groundwork for applications aimed at achieving full approvals in crucial markets.

Guido Oelkers, President and CEO of Sobi, expressed his enthusiasm about the partnership, emphasizing its importance in enhancing Sobi's portfolio. He stated, "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." Oelkers highlighted the hope of making lacutamab accessible to patients worldwide, contingent upon regulatory approvals.

Innate Pharma's CEO, Jonathan Dickinson, also echoed a positive sentiment about this collaboration, describing Sobi as an ideal partner. He added, "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."

Financial Aspects of the Agreement

Under the terms of this partnership, Sobi is set to pay Innate Pharma an initial fee of $75 million, with the potential for an additional $40 million contingent on near-term development milestones related to Sézary syndrome. Furthermore, Innate stands to earn up to $465 million tied to the attainment of full development rights for Sobi and additional regulatory and commercial milestones. The agreement also includes provisions for Innate to receive tiered royalties from future net sales.

A Breakthrough in Oncology

Lacutamab is distinguished as a first-in-class anti-KIR3DL2 antibody that specifically targets CTCL. This condition encompasses rare non-Hodgkin lymphomas, which include both Sézary syndrome and the more prevalent mycosis fungoides. The potential of lacutamab is underscored by the various designations it has received: Fast Track designation from the FDA, PRIME designation from the EMA, and Orphan Drug designation in both the U.S. and EU for CTCL, as well as Breakthrough Therapy Designation from the FDA for relapsed or refractory Sézary syndrome. The upcoming TELLOMAK-3 study will play a critical role, focusing on patients who have not responded to at least one previous systemic therapy.

About Innate Pharma and Sobi

Innate Pharma, a clinical-stage biotech firm, specializes in developing innovative immunotherapies for cancer. The company has a promising product pipeline that includes IPH4502, an antibody-drug conjugate targeting solid tumors, and other differentiated therapeutics.

Sobi, on the other hand, is a global biopharmaceutical company dedicated to unleashing the potential of breakthrough innovations, striving to transform lives for those with rare diseases. With a dedicated workforce across several continents and a significant revenue stream, the company's commitment to enhancing its therapeutic offerings is clear.

As both companies embark on this transformative journey for lacutamab, the medical community and patients await the results of the TELLOMAK-3 study, hoping for a new viable treatment option in the fight against T-cell lymphoma.