FDA Grants Breakthrough Status to Innate Pharma’s Lacutamab for Sézary Syndrome
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) announced today that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody, for the treatment of adult patients with relapsed or refractory (r/r) Sézary Syndrome (SS) who have undergone at least two prior systemic therapies, including mogamulizumab.
The BTD was awarded based on promising clinical results from both the Phase 1 trial and the Phase 2 TELLOMAK study. In these trials, lacutamab demonstrated notable efficacy and a favorable safety profile in heavily pretreated patients with advanced Sézary syndrome who had previously received mogamulizumab. The encouraging clinical outcomes highlight lacutamab’s potential to address an area of significant unmet medical need in this aggressive and rare cutaneous T-cell lymphoma (CTCL) subtype.
“Patients with Sézary syndrome face a severe and challenging disease that often leads to a very poor quality of life,” stated Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. “The Breakthrough Therapy Designation acknowledges lacutamab’s potential to provide a meaningful therapeutic advancement compared to existing treatment options. This designation is a crucial milestone in our strategic development plan for lacutamab. We look forward to collaborating closely with the FDA to expedite the development and regulatory review process, aiming to bring this therapy to patients as quickly as possible.”
The FDA grants Breakthrough Therapy Designation to drugs that demonstrate preliminary clinical evidence indicating substantial improvement over currently available treatments for serious or life-threatening conditions. This designation is designed to accelerate both the development and regulatory review of such therapies, providing benefits such as more intensive FDA guidance, rolling review, and potential eligibility for priority review.
In addition to receiving Breakthrough Therapy Designation, lacutamab was previously granted Fast Track designation by the FDA in 2019 for the treatment of adult patients with relapsed or refractory Sézary syndrome who have undergone at least two prior systemic therapies. Furthermore, the European Medicines Agency (EMA) awarded lacutamab PRIME (PRIority MEdicines) designation in 2020, recognizing its potential benefit for patients with high unmet medical needs.
Innate Pharma remains committed to advancing the clinical development of lacutamab. The company continues to engage with regulatory agencies to align on the design of a confirmatory Phase 3 trial in CTCL and is actively seeking a partner to support further development and commercialization efforts.
About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphoma (CTCL) is a heterogeneous group of non-Hodgkin’s lymphomas that primarily affect the skin and are characterized by malignant clonal mature T-cells. CTCL accounts for approximately 4% of all non-Hodgkin’s lymphomas, with an estimated median age at diagnosis of 55-65 years. The two most common subtypes of CTCL are mycosis fungoides and Sézary syndrome, the latter being its leukemic variant. Sézary syndrome is known for its aggressive nature, widespread skin involvement, and presence of malignant T-cells in the blood.
The prognosis for patients with Sézary syndrome remains poor, with an overall five-year survival rate of approximately 10%. Treatment options are limited, particularly for patients who have relapsed or become refractory to available therapies. This underscores the critical need for new targeted therapies that can improve outcomes and enhance the quality of life for affected individuals.
Each year, approximately 6,000 new cases of CTCL are diagnosed across Europe and the United States, reinforcing the urgency of developing innovative treatment solutions such as lacutamab.
With the FDA’s Breakthrough Therapy Designation, Innate Pharma is now well-positioned to accelerate the clinical and regulatory pathway for lacutamab, bringing hope to patients with advanced Sézary syndrome who are in desperate need of more effective treatment options.
About Sézary syndrome:
Sézary syndrome is the leukemic variant of CTCL. Patients often experience very poor quality of life with severe and debilitating pruritus (chronic itchy skin). Despite recent advancements, Sézary syndrome is associated with a high relapse rate with currently available therapies.
About Lacutamab:
Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have FDA a poor prognosis with few efficacious and safe therapeutic options at advanced stages.
KIR3DL2 is an inhibitory receptor FDA of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL FDA subtypes, in particular Sézary syndrome. FDA It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression FDA on normal tissues.
Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration FDA granted Fast Track designation and Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL.
About TELLOMAK:
TELLOMAK (NCT03902184) is a global, open-label, multi-cohort Phase 2 clinical trial in patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:
- Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.
- Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design.
- Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon-2 stage design.
- All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic.
The trial is fully enrolled. The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs).
Innate’s portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer.
Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.
Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.
Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.
