Innate Pharma SA 6-K, filed Nov 27, 2023
Innate Pharma SA (IPHA)
About this 6-K
Innate Pharma SA filed this 6-K on November 27, 2023.
| Exhibit | Description |
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| 99.1 | [Press Release dated November 27, 2023] |
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INNATE PHARMA S.A.
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| Date: November 27, 2023 |
By: | /s/ MONDHER MAHJOUBI |
| Name: | Mondher Mahjoubi | |
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Title: |
Chairman of the Executive Board and Chief Executive Officer
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| Exhibit 99.1 |
Innate Pharma to Host Virtual KOL Event on Lacutamab
- The event will highlight positive results from the TELLOMAK Phase 2 Trial with lacutamab in heavily pretreated patients with relapsed and refractory Sézary syndrome which have been selected for oral presentation at the American Society of Hematology (ASH) Annual Meeting
- Virtual KOL event will be held on Tuesday, December 12, 2023 at 7:00AM PST (4:00PM CET)
MARSEILLE, France--(BUSINESS WIRE)--November 27, 2023--Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that it will host a virtual KOL (Key Opinion Leader) event on lacutamab, a first-in-class anti-KIR3DL2 antibody currently in development for cutaneous T-cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL), on Tuesday, December 12, 2023, at 7:00AM PST (4:00PM CET).
The event will feature Prof. Pierluigi Porcu, M.D., Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia, United States, and principal investigator in the TELLOMAK Phase 2 study, who will discuss Sézary syndrome data from the TELLOMAK trial following oral presentation at the American Society of Hematology (ASH) 2023 Annual Meeting. Prof. Porcu is a Lymphoma-focused hematologic oncologist with a long track record of advocacy and education for patients with cutaneous lymphoma. Sonia Quaratino, M.D., PhD, Chief Medical Officer of Innate Pharma, will host the call.
As disclosed in the abstract release on November 3, positive data from the Phase 2 TELLOMAK study in Sézary syndrome will be reported at the ASH 2023 Annual Meeting on December 9. The ASH abstract states that lacutamab showed promising clinical activity and an overall favorable safety profile in the heavily pre-treated post-mogamulizumab patient population with a median of six prior lines of therapy. In the Intention to treat population (ITT), the global confirmed objective response rate (ORR) was 37.5% (21/56). ORR in the skin was 46.4% (26/56) and ORR in the blood was 48.2% (27/56). Median progression-free survival was 8.0 months (95% CI 4.7-21.2). Additional data will be presented at the ASH 2023 Annual Meeting.
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Virtual KOL Event Details |
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Tuesday, December 12, 2023 at 7:00AM PST (4:00PM CET) |
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The live webcast will be available at the following link: |
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https://events.q4inc.com/attendee/341836372 |
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Participants may also join via telephone using the following registration link: |
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https://registrations.events/direct/Q4I90753 |
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This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event. |
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 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 recruiting 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 now 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 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 www.innate-pharma.com and follow us on Twitter and LinkedIn.
Information about Innate Pharma shares
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ISIN code |
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 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, 2022, 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.
Contacts
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