Drugs / Lacutamab
Lacutamab
English name lacutamab
also known as
IPH4102
Monoclonal antibody targets KIR3DL2 via depletion
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | primary cutaneous T-cell lymphoma | 2023-10-05 | “As a reminder, the FDA placed the TELLOMAK trial on partial hold due to GMP deficiencies at the Company’s manufacturing subcontractor site” innate-pharma.com ↗ “US FDA places lacutamab IND on partial clinical hold for new patient enrollment following one unexpected severe adverse reaction” innate-pharma.com ↗ “In October 2023, the US Food and Drug Administration (FDA) placed a partial clinical hold on the lacutamab IND” innate-pharma.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 missed | ||||||
| Phase 1 | NCT05321147 | Mar 2022 → Nov 2023 | peripheral T-cell lymphoma, not otherwise specified | Innate Pharma | Completed | Missed primary |
| Phase 1 | NCT02593045 | Oct 2015 → Apr 2020 | primary cutaneous T-cell lymphoma | Innate Pharma | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04984837 | Oct 2021 → Apr 2028 expected | peripheral T-cell lymphoma, not otherwise specified | The Lymphoma Academic Research Organisation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03902184 | May 2019 → Jan 2026 | mycosis fungoides and variants | Innate Pharma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2025-11-10 | Innate Pharma | Regulatory Innate Pharma announces FDA clearance to proceed with TELLOMAK 3, a confirmatory Phase 3 trial of lacutamab in CTCL innate-pharma.com ↗ |
| 2025-05-23 | Innate Pharma | Results Innate Pharma highlights durable responses to lacutamab in Sezary syndrome and mycosis fungoides innate-pharma.com ↗
Long-term follow-up data from TELLOMAK study confirms the meaningful clinical activity in heavily pretreated SS patients with a global overall response rate (ORR) of 42.9% and an impressive median duration of response of 25.6 months. |
| 2025-05-13 | Innate Pharma | Regulatory Innate Pharma reports first quarter 2025 business update and financial results innate-pharma.com ↗
FDA Breakthrough Therapy Designation granted to lacutamab for relapsed or refractory Sézary syndrome |
| 2025-03-27 | Innate Pharma | Regulatory Innate Pharma reports full year 2024 financial results and business update innate-pharma.com ↗
The FDA’s Breakthrough Therapy Designation for lacutamab highlights its potential to transform treatment for Sézary syndrome. |
| 2025-02-17 | Innate Pharma | Regulatory Innate Pharma announces U.S. FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary Syndrome innate-pharma.com ↗ |
| 2024-12-09 | Innate Pharma | Results Innate Pharma presents lacutamab improved health-related quality of life data at ASH 2024 from TELLOMAK Phase 2 study in patients with cutaneous T cell lymphoma innate-pharma.com ↗ |
| 2024-11-13 | Innate Pharma | Regulatory Innate Pharma reports Third Quarter 2024 Business Update and Financial Results innate-pharma.com ↗
We achieved notable regulatory milestones during the quarter including encouraging initial feedback from the FDA for lacutamab’s development plans and the IND approval for IPH4502, our nectin-4 ADC, which paves the way for its entry into clinical development. |
| 2024-06-04 | Innate Pharma | Results Innate Pharma presents positive results from TELLOMAK Phase 2 study with lacutamab in mycosis fungoides innate-pharma.com ↗ |
| 2024-05-24 | Innate Pharma | Results Innate Pharma highlights abstracts selected for ASCO 2024 Annual Meeting innate-pharma.com ↗
Top line results of TELLOMAK Phase 2 trial in mycosis fungoides confirming promising clinical activity of lacutamab |
| 2024-01-04 | Innate Pharma | Regulatory Innate Pharma announces U.S. FDA lifts partial clinical hold on lacutamab clinical program innate-pharma.com ↗ |
| 2023-12-10 | Innate Pharma | Results Innate Pharma presents positive results from TELLOMAK Phase 2 study with lacutamab in patients with Sézary syndrome at ASH 2023 innate-pharma.com ↗ |
| 2023-11-03 | Innate Pharma | Results Innate Pharma announces new clinical data for lacutamab and SAR443579/IPH6101 at ASH 2023 innate-pharma.com ↗
The oral presentation will highlight the results from Cohort 1, designed to evaluate safety and efficacy of single agent lacutamab in 56 patients with relapsed/refractory Sézary syndrome after at least two prior systemic therapies including mogamulizumab. |
| 2023-10-05 | Innate Pharma | Regulatory Innate Pharma provides update on lacutamab clinical program innate-pharma.com ↗
The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder. |
| 2023-09-22 | Innate Pharma | Results Innate Pharma announces encore presentation of interim results of Phase 2 TELLOMAK study with lacutamab with updated Olsen 2022 criteria at the EORTC cutaneous lymphoma tumour group annual meeting 2023 innate-pharma.com ↗
The data confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody. |
| 2023-06-16 | Innate Pharma | Results Innate Pharma highlights increased lacutamab clinical activity from interim results of Phase 2 TELLOMAK study with updated Olsen criteria innate-pharma.com ↗
Efficacy results presented at the 17th International Conference on Malignant Lymphoma, have been analysed according to updated lymph node involvement classification and confirm clinical activity and favorable safety profile of lacutamab in advanced Mycosis Fungoides |
| 2022-12-10 | Innate Pharma | Results Innate Pharma presents data from ongoing Phase 2 TELLOMAK trial demonstrating clinical activity of lacutamab in advanced Sézary syndrome at ASH 2022 innate-pharma.com ↗
In the ITT population, the global objective response rate (ORR) was 21.6% (8/37). |
| 2022-09-23 | Innate Pharma | Results Innate Pharma presents data from ongoing Phase 2 TELLOMAK trial demonstrating clinical activity of lacutamab in advanced mycosis fungoides innate-pharma.com ↗
Results showed that lacutamab produced a global objective response rate (ORR) of 28.6% (95% confidence interval [CI], 13.8-50.0) in the KIR3DL2-expressing MF patients (n=21), including 2 complete responses and 4 partial responses. |
| 2021-09-15 | Innate Pharma | Results Innate Pharma Reports First Half 2021 Financial Results and Business Update innate-pharma.com ↗
First data set from lacutamab TELLOMAK trial demonstrated encouraging 35% overall global response rate, including skin improvement in patients with mycosis fungoides that express KIR3DL2 |
| 2021-06-22 | Innate Pharma | Results Innate Pharma Presents Preliminary Data from TELLOMAK Trial Showing Clinical Response for Lacutamab in Mycosis Fungoides innate-pharma.com ↗ |
| 2021-02-09 | Innate Pharma | Results Innate Pharma advances lacutamab clinical development program innate-pharma.com ↗
This cohort reached the pre-determined number of responses needed to advance to stage 2, allowing the Company to recruit additional patients. |
| 2020-11-13 | Innate Pharma | Regulatory Innate Pharma receives PRIME designation from the European Medicines Agency for lacutamab in Sézary syndrome innate-pharma.com ↗
Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") today announced that the European Medicines Agency (EMA) has granted PRIME designation to lacutamab, the Company’s proprietary first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, for the treatment of patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. |
| 2020-06-24 | Innate Pharma | Regulatory U.S. Food and Drug Administration lifts partial clinical hold on lacutamab TELLOMAK trial in advanced T-cell lymphomas innate-pharma.com ↗
The Company can now resume recruitment of new patients in the US with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two prior systemic therapies. |
| 2020-01-13 | Innate Pharma | Regulatory French regulatory agency agrees lacutamab TELLOMAK trial can resume recruitment in Sezary syndrome and mycosis fungoides innate-pharma.com ↗
We are pleased that the ANSM agrees to resume enrollment of patients with Sézary syndrome and mycosis fungoides in the lacutamab TELLOMAK trial in France given the high medical need and lack of adequate treatment options currently available |
| 2020-01-09 | Innate Pharma | Regulatory Innate Pharma provides update from regulatory agencies on lacutamab TELLOMAK trial innate-pharma.com ↗
The US Food and Drug Administration (FDA) has placed the TELLOMAK trial on partial clinical hold. |
| 2019-12-13 | Innate Pharma | Regulatory Innate Pharma provides update on lacutamab TELLOMAK trial innate-pharma.com ↗
Lacutamab will not be administered to new patients in the TELLOMAK trial until additional feedback is received from the respective regulatory agencies overseeing our clinical trial. |
| 2019-06-26 | Innate Pharma | Results Innate Pharma announces publication of IPH4102 Phase I clinical trial results for CTCL in the Lancet Oncology innate-pharma.com ↗
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announced the online publication in The Lancet Oncology of the results from the completed Phase I dose-escalation and expansion clinical trial of IPH4102 in advanced CTCL patients. |
| 2019-06-12 | Innate Pharma | Results Innate Pharma to present IPH4102 “TELLOMAK” clinical trial design and preclinical PTCL data at the 2019 ICML innate-pharma.com ↗
New preclinical data show IPH4102 and chemotherapy combination enhances KIR3DL2 expression and has superior anti-tumor activity, providing rationale for peripheral T-cell lymphoma (PTCL) cohort |
| 2019-01-29 | Innate Pharma | Regulatory Innate Pharma receives FDA fast track designation for IPH4102 in relapsed or refractory Sézary syndrome innate-pharma.com ↗
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to IPH4102 for the treatment of adult patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. |
| 2018-12-03 | Innate Pharma | Results Innate Pharma announces updated results that support advancement of IPH4102 in refractory Sézary syndrome at the American Society of Hematology (ASH) 2018 annual meeting innate-pharma.com ↗
Mogamulizumab pretreated patients (n=7) showed an ORR (42.9%), median DoR (13.8 months) and median PFS (16.8 months) similar to the entire group. |
| 2018-09-29 | Innate Pharma | Results Innate Pharma reports IPH4102 results in advanced Cutaneous T Cell Lymphoma (CTCL) innate-pharma.com ↗
IPH4102 showed encouraging clinical activity, demonstrated by high response rate and long progression-free survival (PFS) |
| 2017-10-16 | Innate Pharma | Results Final results of the dose-escalation part from the phase I trial evaluating IPH4102 in patients with advanced cutaneous T-cell lymphomas presented at the EORTC CLTF meeting innate-pharma.com ↗
These data confirm the good safety profile and promising activity of IPH4102 in this elderly and heavily pretreated patients population (n=25). |
| 2017-06-15 | Innate Pharma | Results Dose-escalation data show favorable safety profile and promising clinical activity for IPH4102 innate-pharma.com ↗
The data from the trial indicate that IPH4102 was well tolerated with no dose-limiting toxicity. |
| 2017-05-22 | Innate Pharma | Results IPH4102: Completion of the dose escalation part of the Phase I trial - Data to be presented at International Conference on Malignant Lymphoma in June 2017 in Lugano innate-pharma.com ↗
No dose-limiting toxicity was reported and the maximum tolerated dose (MTD) was not reached. |
| 2016-12-05 | Innate Pharma | Results Further clinical data for lirilumab and IPH4102 presented at ASH annual meeting reinforcing confidence in our programs innate-pharma.com ↗
They showed that the drug candidate is well tolerated in patients with relapsed/refractory CTCL (2) and a preliminary global objective response rate (ORR) of 38% in the evaluable population across all dosage levels. |
| 2016-10-26 | Innate Pharma | Results Encouraging initial results for IPH4102 presented at the Third World Congress of Cutaneous Lymphomas innate-pharma.com ↗
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH), today announces encouraging preliminary safety and clinical activity results from the dose-escalation part of the Phase I study testing IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (“CTCL”), an orphan disease. |
| 2014-11-03 | Innate Pharma | Results IPH 4102 preclinical data published in “cancer research” innate-pharma.com ↗
Potent antitumor properties of IPH4102 were shown against human cutaneous T-cell lymphoma (CTCL) cells in vitro and in vivo in a mouse model of KIR3DL2+ tumors, in which IPH4102 reduced tumor growth and improved survival. |
| 2014-08-27 | Innate Pharma | Regulatory Orphan drug designation in the European Union for IPH4102 innate-pharma.com ↗ |
All press releases naming this drug 53 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lacutamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05321147 ↗ |
| Known as | IPH4102 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03902184 ↗ |
| Action | Inhibit | “Anti-KIR3DL2 Therapy” NCT03902184 ↗ |
| Modality | Monoclonal antibody | “IPH4102 is a first-in-class monoclonal antibody” PMID 31253572 ↗ Jun 2019 |
| Route | Intravenous | “administered as an intravenous infusion” PMID 31253572 ↗ Jun 2019 |
| Target | KIR3DL2 | “targeting KIR3DL2” PMID 31253572 ↗ Jun 2019 |