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Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome

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Innate Pharma announced that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to lacutamab for treating adult patients with relapsed or refractory Sézary Syndrome after at least 2 prior systemic therapies including mogamulizumab. The designation is based on Phase 1 and Phase 2 TELLOMAK study results, which showed encouraging efficacy and favorable safety profile in heavily pretreated patients.

The BTD aims to accelerate development and regulatory review of drugs treating serious conditions. This adds to lacutamab's previous Fast Track designation (2019) and PRIME designation by European Medicines Agency (2020). The company is currently aligning with regulatory agencies regarding a confirmatory Phase 3 trial in Cutaneous T Cell Lymphoma and seeking a partnership.

Innate Pharma ha annunciato che la FDA degli Stati Uniti ha conferito la Designazione di Terapia Innovativa (BTD) a lacutamab per il trattamento di pazienti adulti con Sindrome di Sézary in recidiva o refrattaria dopo almeno 2 precedenti terapie sistemiche, compreso il mogamulizumab. La designazione si basa sui risultati degli studi TELLOMAK di Fase 1 e Fase 2, che hanno mostrato un'efficacia promettente e un profilo di sicurezza favorevole in pazienti con precedenti trattamenti intensivi.

La BTD mira ad accelerare lo sviluppo e la revisione normativa di farmaci che trattano condizioni gravi. Questo si aggiunge alla precedente designazione Fast Track di lacutamab (2019) e alla designazione PRIME da parte dell'Agenzia Europea dei Medicinali (2020). L'azienda sta attualmente collaborando con le agenzie regolatorie riguardo a uno studio di conferma di Fase 3 nel Linfoma Cutaneo a Cellule T e cerca una partnership.

Innate Pharma anunció que la FDA de EE. UU. ha otorgado la Designación de Terapia Innovadora (BTD) a lacutamab para el tratamiento de pacientes adultos con Síndrome de Sézary en recaída o refractario después de al menos 2 terapias sistémicas previas, incluyendo mogamulizumab. La designación se basa en los resultados de los estudios TELLOMAK de Fase 1 y Fase 2, que mostraron una eficacia alentadora y un perfil de seguridad favorable en pacientes con tratamientos previos intensivos.

La BTD tiene como objetivo acelerar el desarrollo y la revisión regulatoria de medicamentos que tratan condiciones graves. Esto se suma a la anterior designación Fast Track de lacutamab (2019) y a la designación PRIME por parte de la Agencia Europea de Medicamentos (2020). La compañía está actualmente alineándose con las agencias regulatorias respecto a un ensayo de confirmación de Fase 3 en Linfoma Cutáneo de Células T y busca una asociación.

Innate Pharma는 미국 FDA가 혁신 치료제 지정(BTD)을 lacutamab에 부여했다고 발표했습니다. 이는 최소 2회의 이전 전신 치료 후 재발 또는 불응성 세자리 증후군 성인 환자를 치료하기 위한 것입니다. 이 지명은 Fase 1 및 Fase 2 TELLOMAK 연구 결과를 기반으로 하며, 심한 선행 치료를 받은 환자에서 유망한 효능과 우호적인 안전성 프로필을 보여주었습니다.

BTD의 목적은 심각한 질환을 치료하는 약물의 개발 및 규제 검토를 가속화하는 것입니다. 이는 lacutamab의 이전 패스트 트랙 지정 (2019) 및 유럽 의약품청의 PRIME 지정 (2020)에 추가됩니다. 회사는 현재 피부 T 세포 림프종에 대한 확인 Fase 3 시험과 관련하여 규제 기관과 조율하고 있으며, 파트너십을 모색하고 있습니다.

Innate Pharma a annoncé que la FDA des États-Unis a accordé la Désignation de Thérapie Innovante (BTD) à lacutamab pour le traitement des patients adultes atteints du syndrome de Sézary en rechute ou réfractaire après au moins 2 traitements systémiques antérieurs, y compris le mogamulizumab. La désignation est basée sur les résultats des études TELLOMAK de Phase 1 et Phase 2, qui ont montré une efficacité encourageante et un profil de sécurité favorable chez les patients ayant subi de nombreux traitements antérieurs.

La BTD vise à accélérer le développement et l'examen réglementaire des médicaments traitant des conditions graves. Cela s'ajoute à la précédente dénomination Fast Track de lacutamab (2019) et à la dénomination PRIME par l'Agence Européenne des Médicaments (2020). L'entreprise s'aligne actuellement avec les agences réglementaires concernant un essai de confirmation de Phase 3 dans le lymphome cutané à cellules T et recherche un partenariat.

Innate Pharma gab bekannt, dass die FDA der USA lacutamab die Breakthrough Therapy Designation (BTD) für die Behandlung von erwachsenen Patienten mit rezidivierendem oder refraktärem Sézary-Syndrom nach mindestens 2 vorherigen systemischen Therapien, einschließlich Mogamulizumab, zuerkannt hat. Die Auszeichnung basiert auf den Ergebnissen der Phase-1- und Phase-2-Studien TELLOMAK, die eine vielversprechende Wirksamkeit und ein günstiges Sicherheitsprofil bei stark vorbehandelten Patienten zeigten.

Die BTD zielt darauf ab, die Entwicklung und die behördliche Prüfung von Arzneimitteln zu beschleunigen, die ernsthafte Erkrankungen behandeln. Dies ergänzt die vorherige Fast Track-Designierung von lacutamab (2019) und die PRIME-Designierung durch die Europäische Arzneimittel-Agentur (2020). Das Unternehmen stimmt sich derzeit mit den Regulierungsbehörden über eine bestätigende Phase-3-Studie im kutanen T-Zell-Lymphom ab und sucht eine Partnerschaft.

Positive
  • Received FDA Breakthrough Therapy Designation for lacutamab
  • Demonstrated encouraging efficacy in Phase 1 and Phase 2 TELLOMAK studies
  • Potential accelerated regulatory review pathway in the U.S.
  • Multiple regulatory designations (BTD, Fast Track, PRIME) supporting development
Negative
  • Still requires partner for development
  • Phase 3 trial yet to be initiated
  • to specific patient subset (post-mogamulizumab treatment)

Insights

The FDA's Breakthrough Therapy Designation for lacutamab marks a pivotal advancement in Innate Pharma's commercialization strategy. This anti-KIR3DL2 cytotoxicity-inducing antibody has now secured a regulatory trifecta with BTD, Fast Track, and PRIME designations, significantly de-risking its development pathway and potentially accelerating time to market.

The designation's timing is particularly strategic as it's based on both Phase 1 and Phase 2 TELLOMAK study results, demonstrating clinical efficacy in a heavily pretreated patient population. This positions lacutamab as a potential late-line therapy option in an indication with treatment alternatives. Sézary Syndrome, while rare, represents a high-value opportunity due to its serious nature and current lack of effective treatments.

The company's active pursuit of a partnership signals a important inflection point. This strategy suggests Innate Pharma is prioritizing speed to market and seeking to leverage a partner's commercial infrastructure rather than building its own. This approach could significantly reduce commercialization costs and accelerate market penetration, particularly important given the orphan indication status.

The confirmatory Phase 3 trial planning, coupled with regulatory agency alignment, indicates a well-structured development pathway. However, investors should note that while BTD status enhances the probability of approval, it doesn't guarantee success. The company's market capitalization of $163.4 million suggests the market hasn't fully priced in lacutamab's potential, possibly due to the pending partnership announcement and Phase 3 trial initiation.

  • Designation is based on TELLOMAK Phase 2 results demonstrating efficacy and a favorable safety profile in patients with advanced Sézary syndrome heavily pre-treated, post- mogamulizumab.
  • Breakthrough Therapy Designation is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition; adding to a Fast Track designation by the U.S. FDA received in 2019 as well as a PRIME designation by European Medicines Agency in 2020
  • Innate continues to align with regulatory agencies around the confirmatory Phase 3 trial in Cutaneous T Cell Lymphoma and is actively seeking for a partner

MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today 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, where lacutamab demonstrated encouraging efficacy and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sézary syndrome.

There is a high unmet medical need for patients with Sézary syndrome. In this aggressive and rare form of cutaneous T-cell lymphoma, patients in advanced disease often experience very poor quality of life and are in strong need of new, targeted treatment options,” commented Sonia Quaratino, MD, Chief Medical Officer of Innate Pharma. “The Breakthrough Therapy Designation underscores lacutamab’s potential to transform the patient’s care by achieving clinically meaningful efficacy and favorable safety profile compared to available therapies. This is an important step in Innate’s strategy for lacutamab. We are excited to work with the U.S. FDA to accelerate the development of this therapy.”

A Breakthrough Therapy Designation by the FDA is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically significant endpoint over available medicines.

Lacutamab previously received a Fast Track designation by the FDA in 2019 for the treatment of adult patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies as well as a PRIME designation by European Medicines Agency in 2020.

Innate continues to align with the regulatory agencies around the confirmatory Phase 3 trial in CTCL and is actively seeking for a partner.

About Cutaneous T-Cell Lymphoma:

Cutaneous T-Cell Lymphoma (CTCL) is a heterogeneous group of non-Hodgkin’s lymphomas which arise primarily in the skin and are characterized by the presence of malignant clonal mature T-cells. CTCL accounts for approximately 4% of all non-Hodgkin’s lymphomas and has a median age at diagnosis of 55-65 years. Mycosis fungoides, and Sézary syndrome, its leukemic variant, are the most common CTCL subtypes. The overall 5-year survival rate, which depends in part on disease subtype, is approximately 10% for Sézary syndrome. There are approximately 6,000 new CTCL cases in Europe and the United States per year.

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 a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor 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 subtypes, in particular Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression 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.

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 applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these 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 reliance on third parties to manufacture 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 http://www.amf-france.org 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. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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.

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

FAQ

What is the significance of FDA's Breakthrough Therapy Designation for IPHA's lacutamab?

The BTD will accelerate development and regulatory review of lacutamab in the U.S. for treating relapsed or refractory Sézary Syndrome, indicating its potential for substantial improvement over existing therapies.

What clinical trial results supported IPHA's lacutamab BTD application?

The designation was based on Phase 1 study results and Phase 2 TELLOMAK study, which showed encouraging efficacy and favorable safety profile in heavily pretreated, post-mogamulizumab patients.

What regulatory designations has IPHA's lacutamab received as of 2023?

Lacutamab has received FDA Breakthrough Therapy Designation, FDA Fast Track designation (2019), and EMA PRIME designation (2020).

What are IPHA's next steps for lacutamab development?

Innate Pharma is aligning with regulatory agencies for a confirmatory Phase 3 trial in Cutaneous T Cell Lymphoma and actively seeking a development partner.

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