lacutamab (IPH4102) / Innate - LARVOL DELTA

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 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

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

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

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

New nonchemotherapy treatment options for cutaneous T-cell lymphomas- an update. (PubMed, Expert Rev Anticancer Ther) - "Targeted therapies including brentuximab vedotin, lacutamab, denileukin diftitox, and mogamulizumab have shown activity in registrational trials. Novel agents which modulate tumor microenvironment and upregulate tumor-specific immune responses have been in clinical trials, including bispecific antibodies recruiting immune effectors, agents eradicating suppressive microenvironments, and engineered T cells targeting tumor epitopes. Checkpoint inhibitors may play a role in MF/SS but their role has not been well defined and they may induce hyper progression."

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

LACUTAMAB IN PATIENTS WITH RELAPSED AND REFRACTORY SéZARY SYNDROME: LONG TERM FOLLOW-UP FROM THE TELLOMAK PHASE 2 TRIAL (ICML 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 • Lymphoma • Sezary Syndrome • KIR3DL2

LACUTAMAB IN PATIENTS WITH RELAPSED AND/OR REFRACTORY MYCOSIS FUNGOIDES: LONG TERM FOLLOW-UP AND TRANSLATIONAL DATA FROM THE TELLOMAK PHASE 2 TRIAL (ICML 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%, amedian 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 • Lymphoma • Mycosis Fungoides • Oncology • 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/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

Characterizing malignant T cells in CTCL to inform personalized therapy: A scRNAseq study (SID 2025) - "High KIR3DL2 in MTC CM/N supports lacutamab trials, while metabolic and inflammatory pathways in other phenotypes suggest therapeutic targets. Investigation of cell types in the tumor environment is ongoing."

Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Metabolic Disorders • Oncology • T Cell Non-Hodgkin Lymphoma • EGR1 • FOXP1 • HMOX1 • KIR3DL1 • KIR3DL2 • NR4A1 • TWIST1

Innate Pharma Highlights Durable Responses to Lacutamab in Sezary Syndrome and Mycosis Fungoides (Yahoo Finance) - P2 | N=170 | TELLOMAK (NCT03902184) Sponsor: Innate Pharma | "Innate Pharma SA...announced the presentation of long-term follow-up data from the Phase 2 TELLOMAK clinical trial evaluating lacutamab, an anti-KIR3DL2 monoclonal antibody, in patients with Sézary syndrome (SS) and mycosis fungoides (MF), two rare and aggressive forms of cutaneous T-cell lymphoma (CTCL)....As of October 17, 2024, data cut-off, lacutamab demonstrated compelling and sustained clinical activity in heavily pretreated patients, with a global ORR of 42.9% for SS and 19.6% for MF. With longer follow-up, we observed improved median duration of response of 25.6 months in SS and 13.8 months in MF, highlighting the durability of responses in these challenging indications."

P2 data • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Sezary Syndrome

Innate Pharma Reports First Quarter 2025 Business Update and Financial Results (Businesswire) - "IPH4502: The study plans to enroll approximately 105 patients. A Trial in Progress Poster will be shared at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in June 2025....TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides....Long-term follow-up for Sezary syndrome and mycosis fungoides will be presented at the ASCO Annual Meeting in June 2025....AstraZeneca will present an update on the outcomes of the Phase 2 study NeoCOAST-2 at the upcoming ASCO Annual Meeting in June 2025."

P2 data • Trial status • Breast Cancer • Colorectal Cancer • Cutaneous T-cell Lymphoma • Esophageal Cancer • Gastric Cancer • Mycosis Fungoides • Non Small Cell Lung Cancer • Ovarian Cancer • Sezary Syndrome • Urothelial Cancer

Therapeutic advances for Cutaneous T Cell Lymphoma. (PubMed, Br J Dermatol) - "Brentuximab vedotin is very efficient for tumor and transformed MF. Mogamulizumab can induce long term remission in patients with SS. Lacutamab has recently completed an international trial, both in SS and MF...Kinase inhibitors and Chimeric Antigen Receptor (CAR)-T Therapy are promising new treatments. Finally, recent studies have demonstrated that allogeneic hematopoietic stem-cell transplantation can increase survival and quality of life in patients with advanced CTCL."

Journal • Bone Marrow Transplantation • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • Transplantation

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 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2025 ➔ Jan 2026

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

Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome (Businesswire) - "Innate Pharma SA...announced that the U.S. Food and Drug Administration (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) after at least 2 prior systemic therapies including mogamulizumab...The BTD is granted based on Phase 1 study results as well as results from the Phase 2 TELLOMAK study..."

Breakthrough therapy • Sezary Syndrome

Translational analysis of the TELLOMAK Phase 2 study (Innate Pharma Press Release) - P2 | N=170 | TELLOMAK (NCT03902184) | Sponsor: Innate Pharma | "The results show lacutamab induced early and deep depletion of KIR3DL2-expressing circulating tumor cells (CTCs) irrespective of the baseline blood tumor burden. Blood response correlated with the percentage of KIR3DL2 expression on CTCs. In addition, lacutamab induced depletion of skin KIR3DL2+ CD4+ cells regardless of their density and percentage among CD4+ T cells, which occur prior to the median time to skin response. The patients responding to lacutamab in skin have higher baseline CD68+ CD16+ macrophage density suggesting antibody-dependent cell phagocytosis is a mechanism of action of lacutamab in skin."

P2 data • Cutaneous T-cell Lymphoma

Health-related quality of life findings from the TELLOMAK Phase 2 study (Innate Pharma Press Release) - P2 | N=170 | TELLOMAK (NCT03902184) | Sponsor: Innate Pharma | "Sezary Syndrome Patients (n=56)...Improvement in Itch intensity: From Week 5, patients experienced a reduction in itch intensity, with a clinically significant 2-point decrease on the VAS scale to mild by Week 13 (VAS<4), which was sustained over time. Reduction in Skin-Related Symptoms: Patients reported notable improvements on the Skindex-29 scale, beginning as early as Week 5 (Skindex 38.7). Scores continued to decrease to mild then low score...Mycosis Fungoides Patients (n=107)...Improvement in Itch intensity: from Week 5 (VAS 5), with a deeper improvement observed from Week 37 (<4) onward. Reduction in Skin-Related Symptoms: Skindex-29 scores also showed early reductions from Week 5 with less severe score (Skindex 46.3), with more pronounced decreases to moderate score by Week 29 (Skindex 38.8) then low score, reflecting gradual yet meaningful improvement in symptoms affecting daily life."

P2 data • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Sezary Syndrome

Innate Pharma Highlights Abstracts Selected for the ASH Annual Meeting 2024 (Businesswire) - "Innate Pharma SA...today announced that abstracts related to lacutamab health-related quality of life and translational data from the TELLOMAK trial and SAR443579, Sanofi-partnered ANKET® asset, have been selected for the American Society of hematology (ASH) Annual Meeting."

Clinical data • P2 data • Mycosis Fungoides • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma