lacutamab (IPH4102) / Innate, SOBI - LARVOL DELTA

KILT: A RANDOMIZED NON-COMPARATIVE PHASE II LYSA STUDY OF LACUTAMAB WITH GEMOX VERSUS GEMOX IN RELAPSED/REFRACTORY PERIPHERAL T-CELL LYMPHOMA (ICML 2023) - P2 | "A combination of lacutamab with gemcitabine and oxaliplatin (GemOx) enhances NK cell anti-tumor activity in vitro. The sponsor of the trial is the Lymphoma Academic Research Organisation (LYSARC) in collaboration with Innate Pharma. Trial registration: NCT04984837."

Clinical • P2 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • KIR3DL2

Lacutamab in patients with relapsed and refractory Sézary syndrome: Long term follow-up from the TELLOMAK phase 2 trial. (ASCO 2025) - P2 | "The long term follow-up data from TELLOMAK study in a R/R SS population previously treated with 2 or more prior systemic therapies including mogamulizumab, confirm that lacutamab shows promising clinical activity with ORR 42.9% (95% CI 31.4-55.1) and median duration of response of 25.6 months (11.0, NE) and an overall favourable safety profile. These data support the further development of lacutamab in an effort to bring improved treatments to patients with SS."

Clinical • P2 data • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Sezary Syndrome • KIR3DL2

Lacutamab in Patients with Relapsed and Refractory Sèzary Syndrome: Results from the Tellomak Phase 2 Trial (ASH 2023) - P2 | "Conclusion In this SS cohort from the TELLOMAK study, our data confirm that lacutamab monotherapy shows promising clinical activity in a R/R population previously treated with 2 or more prior systemic therapies including mogamulizumab, and an overall favourable safety profile. Continued evaluation of this new targeted treatment option for patients with SS is warranted."

Clinical • P2 data • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • KIR3DL2

Innate Pharma SA…announced that, subject to the closing of its strategic partnership with Sobi, it plans to initiate the TELLOMAK-3 confirmatory Phase 3 study of lacutamab in cutaneous T-cell lymphoma (CTCL) (Businesswire) - "The planned initiation of the TELLOMAK-3 confirmatory Phase 3 study marks an important step for Innate as the Company enters a new phase of late-stage clinical and regulatory execution. Under the agreement, Innate will conduct the TELLOMAK-3 Phase 3 confirmatory trial in cutaneous T-cell lymphoma, supporting a planned accelerated approval filing in Sézary syndrome (SS), based on TELLOMAK Phase 2 data. Alongside upcoming developments for IPH4502 and monalizumab, the Company is focused on executing its key clinical and regulatory priorities."

Licensing / partnership • Cutaneous T-cell Lymphoma • Sezary Syndrome

Innate Pharma SA…announced that the previously announced strategic partnership with Sobi is now effective following the expiration of applicable antitrust waiting periods and completion of other conditions. (Innate Pharma Press Release) - "Transaction closing triggers the USD 75 million upfront payment and marks the initiation of the TELLOMAK-3 confirmatory Phase 3 study, with first patient expected in Q1 2027." "

Licensing / partnership • New P3 trial • Cutaneous T-cell Lymphoma • Sezary Syndrome

Health-Related Quality of Life in Patients with Relapsed/Refractory Cutaneous T-Cell Lymphoma Treated By Lacutamab: Patient-Reported Outcomes from the Phase 2 Tellomak Trial (ASH 2024) - P2 | "Conclusion Meaningful improvements from baseline in CTCL overall HRQoL and in pruritus intensity were observed in the TELLOMAK trial assessing lacutamab monotherapy, with durable improvements from Week 5. These favorable HRQoL results compliment the established efficacy and safety profile of lacutamab, highlighting its potential as a compelling future treatment option for CTCL patients with unmet need."

Clinical • HEOR • P2 data • Patient reported outcomes • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Infectious Disease • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • KIR3DL2

Lacutamab in patients with relapsed and/or refractory mycosis fungoides: Long-term follow-up and translational data from the TELLOMAK phase 2 trial. (ASCO 2025) - P2 | "The long-term follow-up data from the heavily pre-treated MF population enrolled to the TELLOMAK study confirms promising clinical activity of lacutamab regardless of KIR3DL2 expression, with ORR 20.8%, a median duration of response of 13.8 m, a median PFS of 10.2 m and a favorable safety and tolerability profile. These data support the further development of lacutamab in an effort to bring improved treatments to patients with MF."

Clinical • P2 data • Cutaneous T-cell Lymphoma • Dermatology • Fatigue • Musculoskeletal Pain • Mycosis Fungoides • Oncology • KIR3DL2

KILT: Study of Lacutamab in Peripheral T-cell Lymphoma (clinicaltrials.gov) - P2 | N=49 | Active, not recruiting | Sponsor: The Lymphoma Academic Research Organisation | Recruiting ➔ Active, not recruiting

Enrollment closed • Follicular Lymphoma • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • KIR3DL2

Pipeline highlights: Lacutamab (anti-KIR3DL2 antibody) (Innate Pharma Press Release) - "The TELLOMAK Phase 2 trial is completed, and patients still on treatment at the end of the study continue to receive lacutamab through a Post Trial Access program. An abstract authored by ZS Associates entitled 'Cutaneous T-Cell Lymphoma Epidemiology in the United States: A Real-World Data Analysis of Administrative Claims' has been accepted for publication in the official Abstract Book of the European Hematology Association Congress 2026....Lacutamab TELLOMAK-3 confirmatory Phase 3 trial in cutaneous T-cell lymphoma (CTCL) remains planned for initiation in H2 2026, subject to non-dilutive financing options currently under negotiation, including pharma partnering and royalty structures."

New P3 trial • Real-world evidence • Trial completion • Cutaneous T-cell Lymphoma

TELLOMAK: IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma (clinicaltrials.gov) - P2 | N=170 | Completed | Sponsor: Innate Pharma | Active, not recruiting ➔ Completed | Trial primary completion date: Oct 2023 ➔ Jan 2026

Trial completion • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • KIR3DL2

KILT: Study of Lacutamab in Peripheral T-cell Lymphoma (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: The Lymphoma Academic Research Organisation | Trial completion date: Jan 2028 ➔ Apr 2028 | Trial primary completion date: Jan 2026 ➔ Apr 2028

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • KIR3DL2

Targeting Cutaneous T-cell lymphoma in non-hodgkin lymphoma: What's new for investigational agents? (PubMed, Expert Opin Investig Drugs) - "Recent years have seen a shift away from chemotherapy with the approval of targeted therapies like mogamulizumab, brentuximab vedotin, and denileukin diftitox-cxdl. Though these novel agents have improved outcomes for patients with advanced-stage CTCL, most patients will continue to experience relapses. Emerging agents, including lacutamab, resminostat, and immune checkpoint inhibitors and biomarkers including CD5, CD70, and CD47/Sirpα represent the next frontier in maintaining durable remissions and improving quality of life (QoL) for these patients."

IO biomarker • Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD5 • CD70 • SIRPA

Innate Pharma…to showcase oncology pipeline at AACR event (StockTitan.net) - "The April 16, 2026 showcase session will allow Innate to highlight its oncology pipeline, including key assets such as IPH4502, a Nectin4 antibody-drug conjugate for solid tumors, lacutamab for cutaneous and peripheral T cell lymphomas, and monalizumab, developed with AstraZeneca, for non-small cell lung cancer."

Clinical data • Cutaneous T-cell Lymphoma • Non Small Cell Lung Cancer • Peripheral T-cell Lymphoma • Solid Tumor

Emerging Therapeutic Strategies in Cutaneous T-Cell Lymphoma: A Comprehensive Review of Clinical Trials. (PubMed, Am J Clin Dermatol) - "The 2020-2025 period brought meaningful therapeutic advances for CTCL, including new FDA approvals, breakthrough designations, and emergence of cellular therapy. Future development should prioritize patient-reported outcomes as co-primary endpoints, prospective biomarker validation, and combination strategies with non-overlapping toxicity profiles."

IO biomarker • Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • Skin Cancer • T Cell Non-Hodgkin Lymphoma • CD70

KILT (anti-KIR in T-Cell Lymphoma) Phase 2 trial, an investigator-sponsored, randomized study led by the Lymphoma Study Association (LYSA) evaluating lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL, is ongoing. (Innate Pharma Press Release)

Trial status • Peripheral T-cell Lymphoma

The planned confirmatory Phase 3 TELLOMAK-3 trial is an open-label, multi-center, randomized, comparative study evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides, who have failed at least one prior systemic therapy. (Innate Pharma Press Release) - "...the trial is planned for initiation in H2 2026; The TELLOMAK Phase 2 trial is completed, and patients who were receiving treatment will continue to receive lacutamab through a Post Trial Access program."

New P3 trial • Trial status • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Sezary Syndrome

KIR3DL2-directed CAR T cell therapy for T cell malignancies (ASH 2025) - "Lacutamab, a first-in-class humanized monoclonal antibody targeting KIR3DL2, has demonstrated potent antitumor activity in vitro via antibody-dependent cell-mediated cytotoxicity (ADCC) and encouraging early clinical efficacy in relapsed/refractory CTCL...Studies in additional xenograft models are ongoing. If confirmed, this approach holds promise for treating aggressive and therapy-resistant T cell lymphomas including SS, tMF, HSTCL, MEITL, and PTCL-NOS which, despite their rarity, have dismal survival outcomes and represent a major unmet clinical need."

CAR T-Cell Therapy • IO biomarker • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Lymphoma • Multiple Myeloma • Mycosis Fungoides • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • KIR2DS2 • KIR3DL2

Following FDA clearance for confirmatory Phase 3 trial TELLOMAK-3, lacutamab is progressing toward Phase 3 initiation in H1 2026 and potential accelerated approval in Sézary syndrome (Businesswire)

New P3 trial • Sezary Syndrome

Strategies to Develop Anti-KIR Mab Lacutamab in Patients with Peripheral T-Cell Lymphoma: Preliminary Monotherapy Clinical Data and Pre-Clinical Combinability Data (ASH 2023) - P1, P2 | "To further develop novel-lacutamab combinations, the combinability of lacutamab with therapies used in R/R or frontline PTCL e.g., pralatrexate or CHOP, respectively, was tested. These data inform the future development of lacutamab to provide additional therapeutic options that may improve outcomes for PTCL patients, including those who relapse or are refractory to available therapies. A Phase 2 study evaluating the combination of lacutamab with GemOx is ongoing (NCT04984837) based on pre-clinical observations that GemOx improves lacutamab-induced ADCC by NK cells."

Clinical data • Monotherapy • Preclinical • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • KIR3DL2

Lacutamab in Patients with Relapsed and/or Refractory Sézary Syndrome: Translational Analysis from the Tellomak Phase 2 Trial (ASH 2024) - P2 | "Conclusion Lacutamab monotherapy shows promising clinical activity in a R/R SS population previously treated with 2 or more prior systemic therapies including mogamulizumab. In skin, while no association was observed between response to lacutamab and KIR3DL2-expression in biopsies or KIR3DL2+ cell density at baseline, higher baseline infiltration by CD16-expressing cells, in particular CD16-expressing CD68+ macrophages was associated with better response in this compartment, consistent with lacutamab mechanism of action. These data confirm at a translational level the activity of lacutamab in the clinical trial setting, and its potential as a compelling future treatment option for CTCL patients with unmet need."

Clinical • P2 data • Cutaneous T-cell Lymphoma • Dermatopathology • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD68 • CTCs • KIR3DL2

Innate Pharma Announces FDA Clearance to Proceed With TELLOMAK 3, a Confirmatory Phase 3 Trial of Lacutamab in CTCL (Businesswire) - "The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy....The Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway."

FDA event • New P3 trial • Mycosis Fungoides • Sezary Syndrome

Innate Pharma to Host Analyst and Investor Event on Lacutamab on October 28, 2025 (Businesswire) - "Leading KOL Pierluigi Porcu, M.D., a world expert in T-cell lymphomas, will discuss results from the TELLOMAK Phase 2 trial; ZS Associates, leading experts in life sciences and healthcare markets, will describe the eligible U.S. CTCL patient population based on real-world claims data; Innate Pharma’s management will provide updates on the planned Phase 3 trial, the regulatory pathway in CTCL, and will outline the commercial opportunity for lacutamab."

P2 data • Real-world • Cutaneous T-cell Lymphoma • Sezary Syndrome

Lacutamab in patients with relapsed and/or refractory mycosis fungoides: long term follow-up and translational data from the TELLOMAK phase 2 trial (EORTC-CLTG 2025) - No abstract available

Clinical • P2 data • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Oncology

Lacutamab in patients with relapsed and refractory Sézary Syndrome: long term follow-up from the TELLOMAK Phase 2 Trial (EORTC-CLTG 2025) - No abstract available

Clinical • P2 data • Cutaneous T-cell Lymphoma • Oncology • Sezary Syndrome

Advancements in Cutaneous T-Cell Lymphoma Treatment: Unveiling Novel Therapeutic Avenues and Clinical Implications. (PubMed, Am J Clin Oncol) - "This review emphasizes the necessity for ongoing research and individualized treatment plans while highlighting the promise of these cutting-edge techniques to enhance outcomes for patients with advanced CTCL."

Journal • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CCR4 • IL15 • IL9 • TNFRSF8