A Multi-center Phase Ib Trial Evaluating the Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2

This is a multi-center phase Ib study, which evaluates the safety and efficacy of lacutamab monotherapy in patients with relapsed/refractory peripheral T-cell lymphoma that express KIR3DL2.

开始日期2022-03-17

申办/合作机构

Innate Pharma SA

NCT04984837 / Recruiting临床2期IIT

A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL).
The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1).

开始日期2021-10-05

申办/合作机构

Le LYSARC

[+1]

EUCTR2020-003735-16-BE / Unknown status临床2期

A RANDOMIZED NON COMPARATIVE PHASE II STUDY OF LACUTAMAB WITH GEMOX VERSUS GEMOX ALONE IN RELAPSED/REFRACTORY PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA - KILT

开始日期2021-09-14

申办/合作机构

Le LYSARC

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项与拉可妥单抗相关的文献（医药）

2023-11-20·Cells

Histopathological Markers for Target Therapies in Primary Cutaneous Lymphomas.

Review

作者: Benedetta Sonego ; Adalberto Ibatici ; Giulia Rivoli ; Emanuele Angelucci ; Simona Sola ; Cesare Massone

In recent years, targeted (biological) therapies have become available also for primary cutaneous T-cell lymphomas (PCTCLs) including anti-CD30 (brentuximab vedotin) in mycosis fungoides, primary cutaneous anaplastic large T-cell lymphoma, lymphomatoid papulosis; anti-CCR4 (mogamulizumab) in Sezary syndrome; anti-CD123 (tagraxofusp) in blastic plasmocytoid cell neoplasm. Moreover, anti-PD1 (nivolumab), anti-PDL1 (pembrolizumab, atezolizumab), anti-CD52 (alemtuzumab), anti-KIR3DL2-CD158k (lacutamab), and anti-CD70 (cusatuzumab) have been tested or are under investigations in phase II trials. The expression of these epitopes on neoplastic cells in skin biopsies or blood samples plays a central role in the management of PCTCL patients. This narrative review aims to provide readers with an update on the latest advances in the newest therapeutic options for PCTCLs.

2022-06-10·Blood

KIR3DL2 contributes to the typing of acute-type adult T-cell leukemia and is a potential therapeutic target.

Article

作者: Morgane Cheminant ; Ludovic Lhermitte ; Julie Bruneau ; Helene Sicard ; Cécile Bonnafous ; Aurore Touzart ; Estelle Bourbon ; Nicolas Ortonne ; Laurent Genestier ; Philippe Gaulard ; Patricia Palmic ; Felipe Suarez ; Laurent Frenzel ; Louise Naveau ; Michaël Dussiot ; Laetitia Waast ; Veronique Avettand Fenoel ; Chantal Brouzes ; Claudine Pique ; Yves Lepelletier ; Vahid Asnafi ; Ambroise Marcais ; Olivier Hermine

Adult T-cell leukemia (ATL) is a lymphoid neoplasm caused by HTLV-1, that encodes the transcriptional activator Tax, which participates in the immortalization of infected T cells. ATL is classified into four subtypes (ie, smoldering, chronic, acute, lymphoma). We determined whether natural killer receptors (NKR) were expressed in ATL. NKR expression (KIR2DL1/2DS1, KIR2DL2/2DL3/2DS2, KIR3DL2, NKG2A, NKG2C, NKp46) was assessed in a discovery cohort of 21 ATL, and KIR3DL2 was then assessed in 71 ATL patients. KIR3DL2 was the only NKR among those studied frequently expressed by acute-type vs. lymphoma- and chronic/smoldering-type ATL (36/40, 4/16 and 1/15, respectively; p=0.001), although acute- and lymphoma-type ATL had similar mutation profiles by targeted exome sequencing. KIR3DL2 expression was correlated with promoter demethylation by microarray-based DNA methylation profiling. To explore the role of HTLV-1, KIR3DL2 and TAX mRNA expression levels were assessed by PrimeFlowTM RNA in primary ATL and in CD4+ T cells infected with HTLV-1 in vitro. TAX mRNA and KIR3DL2 protein expressions were correlated on ATL cells. HTLV-1 infection triggered KIR3DL2 by CD4+ cells but Tax alone did not induce KIR3DL2 expression. Ex vivo autologous antibody-dependent cell cytotoxicity using lacutamab, a first-in-class anti-KIR3DL2 humanized antibody, selectively killed KIR3DL2-positive primary ATL cells ex vivo. To conclude, KIR3DL2 expression is associated with acute-type ATL. Transcription of KIR3DL2 might be triggered by HTLV-1 infection and is correlated with hypomethylation of the promoter. The benefit of targeting KIR3DL2 with lacutamab is being further explored in a randomized phase 2 study in peripheral T-cell lymphoma, including ATL (NCT04984837).

2022-01-10·Presse medicale (Paris, France : 1983)4区 · 医学

New biotherapies for the treatment of cutaneous T-cell lymphomas.

4区 · 医学

Review

作者: A de Masson

Most cutaneous lymphomas are cutaneous T-cell lymphomas, and the most common form is mycosis fungoides. Sézary syndrome is a leukemic form of cutaneous T-cell lymphoma which is characterized by erythroderma and the presence of blood tumor cells. The only potential cure of cutaneous T-cell lymphomas remains allogeneic stem cell transplantation. However, monoclonal antibodies have led to a substantial progress in the treatment of advanced-stage cutaneous T-cell lymphomas. Some of them, such as mogamulizumab (anti-CCR4 monoclobal antibody) or brentuximab vedotin (anti-CD30 coupled to monomethylauristatin E, antibody drug conjugate) have shown efficacy in international randomized controlled studies. Lacutamab, an anti-KIR3DL2 monoclonal antibody, is currently tested in an international, prospective phase 2 trial in cutaneous T-cell lymphomas and peripheral T-cell lymphomas. Finally, immune checkpoint inhibitors have shown clinical benefit in open-label phase 2 studies in cutaneous T-cell lymphomas. This review focuses on the new biotherapies currently used in cutaneous T-cell lymphomas.

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2024-04-05

·BioSpace

Innate Pharma Files Its 2023 Universal Registration Document (Document d’enregistrement Universel) and 2023 Annual Report on Form 20-F

MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the filing of its 2023 Universal Registration Document (Document d’enregistrement universel) for the year ending December 31, 2023 with the French market authority “Autorité des Marchés Financiers” (“AMF”) on April 4, 2024. It can be downloaded (in French) on the Company’s website and on the AMF’s website. The Company also announced today the filing of its annual report on Form 20-F for the year ending December 31, 2023 with the United States Securities and Exchange Commission (“SEC”). It can be also be accessed on the Company’s website and on the SEC’s website. 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 therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types. 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 and follow us on X and LinkedIn. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country. View source version on businesswire.com: Contacts For additional information, please contact: Investors Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88 Henry.wheeler@innate-pharma.fr Media Relations NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15 innate@newcap.eu Source: Innate Pharma SA View this news release online at:

免疫疗法临床研究

2024-03-22

·Pharmaceutical Technology

Innate shelves lacutamab monotherapy plans in peripheral T cell lymphoma

Innate announced the decision to not reopen the trial’s recruitment in its full-year earnings report. Image credit: Shutterstock/CI Photos. Innate has dropped plans to evaluate lacutamab as a monotherapy in KIR3DL2-expressing refractory/relapsing peripheral T cell lymphoma (r/r PTCL) following disappointing data from a Phase Ib trial. The French biotech, which has both PTCL and cutaneous T cell lymphoma (CTCL) programmes for its anti-KIR3DL2 antibody, highlighted the “prespecified threshold for meaningful activity not being reached” as the reason for the trial’s (NCT05321147) termination. Innate announced the decision to not reopen the trial’s recruitment in its full-year earnings report released on 21 March. Lacutamab has had a bumpy clinical journey. The US Food and Drug Administration (FDA) placed a partial clinical hold on the drug’s trials in December 2023, following a death from a rare haematologic disorder in one of Innate’s CTCL trials evaluating lacutamab. The hold was lifted a month later after an analysis found that Innate’s compound was not to blame. Whilst it is the end of the road for lacutamab as a monotherapy in PTCL, Innate is still investigating its potential use in the cancer type as a combination with the chemotherapy GEMOX – gemcitabine in combination with oxaliplatin. The Phase II KILT trial (NCT04984837) is being led by the Lymphoma Study Association (LYSA). See Also: AnGes files patent for crispr-based method for modifying mutant lRRK2 gene in cells Cellectis files patent for engineered T-cells for immunotherapy with inhibited B2M expression Innate will also press ahead with its CTCL programme as planned. In December 2023, the biotech reported positive final data for its Phase II TELLOMAK study (NCT03902184) in patients with Sézary syndrome, a type of CTCL. The results included a 37.5% objective response rate in patients treated with a median of five prior lines of therapy. Innate has also reported positive interim data from a Phase I trial investigating the drug in patients with mycosis fungoides (MF), also a type of CTCL. The company expects to present topline results from the study later this year. In the financial results release, Innate’s CEO Hervé Brailly also pointed towards recent successes in its natural killer (NK) cell engager programme. Innate has become somewhat of a specialist in NK cell engagers through its ANKET platform. The biotech has a range of NK-targeting therapies in clinical trials being tested as cancer treatments via a collaboration with Sanofi . The big pharma has licensed four NK cell engagers from Innate through a €400m ($437.5m) initial deal and a €15m ($16.4m) expansion . With a view to Innate’s plans for 2024, Brailly said: “We expect notable milestones including final results from the TELLOMAK Phase II trial with lacutamab in mycosis fungoides, and progressing our first proprietary ADC programme, IPH45 towards an IND filing.”

临床2期临床结果临床1期免疫疗法

2024-03-21

·FierceBiotech

Innate drops monotherapy plans for lacutamab in one type of lymphoma after hold lift

Innate said a phase 2 trial of lacutamab in combination with the chemotherapy GEMOX—a combination of gemcitabine and oxaliplatin—is ongoing. Just two months after the FDA lifted a clinical hold on trials of Innate Pharma’s lymphoma drug, the biotech has now dropped plans to pursue the anti-KIR3DL2 antibody as a monotherapy for a specific form of that cancer. The French drug developer has been investigating the potential of lacutamab to treat both cutaneous T cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL). In October, Innate revealed a fatal case of hemophagocytic lymphohistiocytosis, a severe systemic inflammatory syndrome, in a patient in the phase 2 CTCL study that prompted the FDA to impose a partial hold on studies of lacutamab. After an analysis suggested the death was related to aggressive disease progression, not the study drug, the agency agreed to lift the hold in January. But now it sounds like lacutamab’s PTCL program has run into problems. Despite “objective responses observed,” Innate has decided not to reopen the phase 1b trial evaluating lacutamab as a monotherapy for PTCL. “The prespecified threshold for meaningful clinical activity was not reached,” the biotech explained in a full-year earnings report this morning. It’s not the end of the road for lacutamab in PTCL, however. Innate said a phase 2 trial of the antibody in combination with the chemotherapy GEMOX—a combination of gemcitabine and oxaliplatin—is ongoing. Preclinical data presented at last year’s American Society of Hematology conference showed a “synergistic effect between lacutamab and chemotherapy” that supported the “rationale for combination strategy in this clinical indication,” Innate added. Innate shared phase 2 data for lacutamab in Sézary syndrome, a type of CTCL, at the same conference. The biotech expects to read out mid-stage data on patients with mycosis fungoides, another type of CTCL, later this year. Talking to investors in December 2023, Chief Medical Officer Sonia Quaratino said the plan is to talk to the FDA once the mycosis fungoides data are in. The Marseille-based biotech entered 2024 with cash, equivalents and assets amounting to 102.3 million euros ($111.6 million). This should pave a cash runway to the end of 2025, said interim CEO Hervé Brailly, Ph.D., who also used his statement to highlight the company’s recent Big Pharma collaborations. “We reported positive data with lacutamab in Sézary syndrome, began phase 1 testing of our proprietary, second-generation ANKET IPH6501 and secured further validation of our ANKET platform with Sanofi having licensed four ANKET candidates for hematologic malignancies and solid tumors,” Brailly said. “The phase 3 trial for monalizumab in non-small lung cancer that is being led by AstraZeneca continues to advance,” the CEO added. “Looking ahead to 2024, we expect notable milestones including final results from the TELLOMAK phase 2 trial with lacutamab in mycosis fungoides, and progressing our first proprietary ADC program, IPH45, towards an IND filing.”

临床2期临床结果临床1期临床3期

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KEGG	Wiki	ATC	Drug Bank
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研发状态

适应症	最高研发状态	国家/地区	公司
T细胞淋巴瘤	临床2期	奥地利更多	Innate Pharma SA 更多
外周T细胞淋巴瘤	临床2期	比利时更多	Innate Pharma SA 更多
塞扎里综合征	临床2期	比利时更多	Innate Pharma SA 更多
蕈样真菌病	临床2期	比利时更多	Innate Pharma SA 更多
难治性外周T细胞不明淋巴瘤	临床1期	韩国更多	Innate Pharma SA 更多

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03902184 (Tellomak, ASH2022) 人工标引	临床2期	塞扎里综合征	37	lacutamab	(鑰願鏇鹹積觸壓憲範蓋) = 壓廠繭製簾襯鹹積廠憲齋積窪廠壓獵築選鑰獵 (衊憲積鹹艱齋廠鹽壓窪, 11.4 ~ 37.2) 更多	积极	2022-11-15
NCT03902184 (TELLOMAK, Corporate Publications) 人工标引	临床2期	蕈样真菌病	36	Lacutamab (KIR3DL2-expressing cohort)	(築顧願鏇艱顧鹹積繭遞) = 1 CR，10 PR 選顧顧繭襯夢積願衊醖 (艱製艱艱夢鏇壓艱觸構 ) 更多	积极	2021-06-22
NCT03902184 (TELLOMAK, Corporate Publications) 人工标引	临床2期	蕈样真菌病	36	Lacutamab	(築顧願鏇艱顧鹹積繭遞) = 1 CR，10 PR 選顧顧繭襯夢積願衊醖 (艱製艱艱夢鏇壓艱觸構 ) 更多	积极	2021-06-22
NCT02593045 (Pubmed \| Lancet Oncol) 人工标引	临床1期	皮肤T细胞淋巴瘤	44	IPH4102	(糧廠觸選衊繭夢齋蓋願) = 餘積壓簾齋簾繭憲壓壓襯獵糧蓋襯網衊廠願構 (餘夢獵網齋製膚淵淵窪 ) 更多	积极	2019-08-01
NCT03902184 (Tellomak Phase 2 Trial, ASH2023)	临床2期	塞扎里综合征	56	Lacutamab 750 mg	(窪遞觸廠築鏇蓋窪遞壓) = 壓簾衊壓艱衊鑰獵築積糧膚壓築選鬱鏇鑰觸觸 (廠鏇艱壓觸醖夢遞壓網, 26.0 ~ 50.6) 更多	-	2023-12-09