Innate Pharma and Sobi Partner to Advance Lacutamab into Phase 3 Development for Cutaneous T-Cell Lymphoma
Innate Pharma SA and Swedish Orphan Biovitrum AB (publ), widely known as Sobi®, have entered into a strategic partnership designed to accelerate the clinical development and potential commercialization of lacutamab, an investigational therapy being developed for patients with cutaneous T-cell lymphoma (CTCL). The agreement is expected to support the initiation of TELLOMAK-3, a confirmatory Phase 3 clinical study that could represent an important milestone in the development of lacutamab for Sézary syndrome, a rare and aggressive subtype of CTCL.
The partnership brings together Innate Pharma’s expertise in oncology research and clinical development with Sobi’s experience in rare diseases, global commercialization and late-stage product development. Under the agreement, Innate will conduct the planned TELLOMAK-3 Phase 3 study, while Sobi will receive exclusive worldwide commercialization rights to lacutamab following a potential accelerated approval. Subject to successful Phase 3 results, Sobi will also have the opportunity to assume full global development rights for the program.
The collaboration reflects the companies’ shared objective of advancing a potential new treatment option for patients living with CTCL, a group of rare lymphomas that can significantly affect quality of life and, in advanced cases, lead to serious complications.
Advancing Lacutamab Toward a Potential Accelerated Approval
Lacutamab is being developed as a targeted therapeutic approach for CTCL, with particular emphasis on Sézary syndrome. The planned TELLOMAK-3 study is intended to serve as the confirmatory Phase 3 trial supporting a potential accelerated approval filing in Sézary syndrome.
Accelerated approval pathways can provide an opportunity for promising therapies addressing serious diseases and unmet medical needs to reach patients sooner, provided that regulatory requirements are satisfied. For lacutamab, the planned development strategy is designed to build upon existing clinical evidence and advance the candidate into a confirmatory setting.
Following the planned study in Sézary syndrome, TELLOMAK-3 is also expected to provide data that could support applications seeking full regulatory approvals in important markets. The broader development objective includes both Sézary syndrome and mycosis fungoides, the most common form of CTCL.
CTCL is a type of non-Hodgkin lymphoma that primarily affects the skin. While some patients experience relatively slow disease progression, others develop more aggressive disease that can spread beyond the skin and become increasingly difficult to manage. Sézary syndrome is characterized by extensive skin involvement and the presence of malignant T cells in the blood, making it a particularly challenging form of the disease.
The limited treatment options available for patients with advanced CTCL underscore the importance of developing therapies with differentiated mechanisms and meaningful clinical activity.
Responsibilities Under the Strategic Partnership
Under the terms of the agreement, Innate Pharma will remain responsible for conducting the TELLOMAK-3 confirmatory Phase 3 clinical trial. The company will use its established expertise in CTCL clinical development to advance the study and support the planned regulatory strategy.
Sobi, meanwhile, will obtain exclusive global rights to commercialize lacutamab following a potential accelerated approval. This gives Sobi an opportunity to prepare for global commercialization while Innate continues to lead the near-term clinical development program.
The agreement also includes an option that could allow Sobi to assume full global development rights following positive Phase 3 results. This structure enables both companies to contribute their respective strengths throughout different stages of the program while maintaining a shared focus on advancing lacutamab toward patients.
The transaction remains subject to customary closing conditions, including the receipt of transaction-related antitrust clearance.
Jonathan Dickinson, Chief Executive Officer of Innate Pharma, said the company was pleased to establish the partnership with Sobi and move toward initiation of TELLOMAK-3. He described the Phase 3 program as a pivotal next step toward the potential accelerated approval of lacutamab in Sézary syndrome.
According to Dickinson, Sobi’s capabilities in rare diseases, commercial development and global reach complement Innate’s expertise in CTCL research and clinical development. The companies share the goal of making lacutamab available to patients around the world as efficiently as possible, subject to successful clinical development and regulatory review.
Sobi Expands Its Rare Disease Portfolio
For Sobi, the agreement represents another step in its strategy of expanding its portfolio through partnerships with innovative biotechnology companies. The Swedish biopharmaceutical company has built its business around therapies for rare diseases and conditions where significant unmet medical needs remain.
Guido Oelkers, President and Chief Executive Officer of Sobi, described the agreement as an important opportunity to strengthen the company’s portfolio. He emphasized Sobi’s strategy of collaborating with companies that have developed differentiated therapeutic approaches for rare diseases.
The partnership allows Sobi to leverage its global commercial infrastructure and rare disease expertise while working with Innate Pharma on the clinical advancement of lacutamab.
If the development program succeeds and regulatory approvals are obtained, Sobi would be positioned to commercialize lacutamab globally, potentially expanding access to the therapy for patients with CTCL in multiple regions.
Significant Financial Commitments
The strategic agreement includes a series of upfront, development, regulatory and commercial payments that could provide Innate Pharma with substantial financial support as the lacutamab program advances.
Under the terms, Sobi will pay Innate Pharma $75 million upon closing of the transaction. This upfront payment provides immediate financial support for the program and reflects Sobi’s commitment to advancing lacutamab.
Innate will also be eligible to receive up to an additional $40 million in near-term development milestones associated with the development of lacutamab for Sézary syndrome.
Beyond these near-term milestones, Innate could receive substantially larger payments linked to Sobi’s potential exercise of its option to obtain full development rights, as well as future regulatory and commercial achievements. These potential payments could total as much as $465 million.
In addition, Innate is eligible to receive tiered double-digit royalties on net sales of lacutamab. This royalty structure would allow Innate to participate in the commercial success of the therapy if it reaches the market and generates sales.
Together, the financial terms provide Innate with potential near-term funding while also creating longer-term economic participation tied to the successful development, regulatory approval and commercialization of lacutamab.
A Potential New Treatment Option for CTCL
The development of lacutamab comes at a time when researchers and pharmaceutical companies continue to seek more targeted approaches for rare hematological cancers. CTCL can require prolonged treatment and management, particularly for patients with advanced or relapsed disease.
For patients with Sézary syndrome, treatment challenges can be particularly significant because the disease affects both the skin and circulating blood cells. New therapeutic strategies could therefore have an important role in improving disease control and addressing the needs of patients whose disease is difficult to manage with existing options.
The initiation of TELLOMAK-3 would mark a significant transition for lacutamab, moving the program into a confirmatory Phase 3 setting. Successful completion of the study could generate important evidence needed for regulatory submissions and potentially support the expansion of lacutamab development into additional CTCL populations.
The broader goal is to establish whether lacutamab can provide a meaningful therapeutic benefit across CTCL and ultimately become an important treatment option for patients with Sézary syndrome and mycosis fungoides.
The partnership between Innate Pharma and Sobi represents a strategic combination of clinical development expertise, rare disease capabilities and global commercial resources. Innate will focus on conducting the pivotal development work needed to advance lacutamab, while Sobi brings the infrastructure and experience needed to potentially commercialize the therapy internationally.
The immediate priority will be the planned initiation of the TELLOMAK-3 Phase 3 confirmatory study. The results of this trial will be important in determining the future regulatory pathway for lacutamab and its potential role in treating CTCL.
If the program achieves positive clinical and regulatory outcomes, lacutamab could potentially address an important unmet medical need among patients with Sézary syndrome and other forms of CTCL.
The agreement therefore represents an important development for both companies and for the broader field of rare hematological oncology. With the financial terms providing substantial potential support and Sobi positioned to assume commercialization responsibilities, the collaboration establishes a framework intended to move lacutamab through late-stage development and, if successful, toward potential availability for patients worldwide.
About Lacutamab
Lacutamab is a first-in-class anti-KIR3DL2 antibody, currently developed in cutaneous T-cell lymphoma (CTCL). CTCL is a group of rare non-Hodgkin lymphomas that includes Sézary syndrome, a rare and aggressive leukemic form, and mycosis fungoides, the most common subtype in CTCL.
The program has received Fast Track designation from the FDA, PRIME designation from the EMA for Sézary syndrome, Orphan Drug designation in both the U.S. and EU for CTCL, and Breakthrough Therapy Designation from the FDA for relapsed or refractory Sézary syndrome.
The program is advancing toward a pivotal Phase 3 TELLOMAK-3 study, an open-label, multicenter, randomized trial in patients with Sézary syndrome and mycosis fungoides who have failed at least one prior systemic therapy. The study includes a confirmatory cohort in Sézary syndrome intended to support a potential accelerated approval and upon study completion a full approval for Sézary syndrome, and a registrational cohort in mycosis fungoides intended to support full approval, with progression-free survival (PFS) as the primary endpoint.
About Sobi®
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 2,000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise in antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics.
Innate Pharma is advancing a portfolio of differentiated potential first- and/or best-in-class assets, focused on areas of high unmet medical need. Its proprietary pipeline is centered on antibody-drug conjugates (ADCs), led by IPH4502, a differentiated Nectin-4 ADC in clinical development for solid tumors, and supported by a preclinical portfolio of next-generation ADC candidates. In parallel, Innate is advancing two partnered late-stage assets: lacutamab, developed with Sobi for T-cell lymphomas, and monalizumab, developed with AstraZeneca for non-small cell lung cancer (NSCLC).
Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sobi, Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology.