Innate Pharma to host key opinion leader call on IPH4102 “TELLOMAK” clinical trial design and rationale
Источник: Nasdaq GlobeNewswire / 20 июн 2019 01:00:29 America/New_York
INNATE PHARMA TO HOST KEY OPINION LEADER CALL ON IPH4102 “TELLOMAK” CLINICAL TRIAL DESIGN AND RATIONALE
Marseille, France, June 20, 2019, 07:00 AM CEST
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH), today announced that it will host a key opinion leader (KOL) call focused on the topic of IPH4102 “TELLOMAK” clinical trial design and rationale in T-cell lymphoma, including preclinical data in peripheral T-cell lymphoma (PTCL) today, Thursday, June 20, at 2pm CEST / 8am ET.
The call will feature a presentation by Dr. Pierluigi Porcu, MD, key opinion leader and Principal Investigator of the TELLOMAK study. He will discuss the cutaneous T-cell lymphoma (CTCL) and PTCL treatment landscapes and rationale of the TELLOMAK trial design. Innate's Chief Medical Officer, Pierre Dodion, MD, will also provide strategic perspectives on IPH4102’s development.
Prof. Pierluigi Porcu is Director of the Division of Medical Oncology and Hematopoietic Stem Cell Transplantation at the Jefferson University Hospital in Philadelphia, PA, USA. Prof. Porcu is a Lymphoma-focused hematologic oncologist with a long track record of advocacy and education for patients with cutaneous lymphoma.
To view the presentation and posters presented at the International Conference on Malignant Lymphoma (“ICML”) visit: https://www.innate-pharma.com/en/actus/evenements/icml-2019-lugano-switzerland
KOL webcast and conference call on Thursday, June 20, at 2pm CEST (8am ET)
The presentation and access to the live webcast will be available at this link: https://edge.media-server.com/m6/p/sq5czucf
Participants can also join the conference call using the following dial-in numbers:
+33 (0) 176700794
United Kingdom, International
+44 (0) 2071 928000
+41 (0) 315800059
The participation code is: 9493234
An audio replay will be made available a few hours after the session via Innate Pharma’s website: https://www.innate-pharma.com/en/actus/evenements/icml-2019-lugano-switzerland
TELLOMAK is a global, open-label, multi-cohort Phase II clinical trial conducted in the United States and Europe. In this trial, IPH4102 is being evaluated alone and in combination with chemotherapy in patients with advanced TCL. TELLOMAK is expected to recruit up to 250 patients, with IPH4102 evaluated:
- As a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior treatments, including mogamulizumab,
- As a single agent in approximately 90 patients with MF who have received at least two prior treatments, and
- In combination with standard chemotherapy (gemcitabine and oxaliplatin) in approximately 100 patients with PTCL who have received at least one prior treatment.
In patients with MF and PTCL, the study is designed to evaluate the benefit of IPH4102 according to KIR3DL2 expression. The study will comprise two cohorts for each of the 2 indications, testing IPH4102 in KIR3DL2 expressing and non-expressing patients. These cohorts will follow a Simon 2-stage design that will terminate if treatment is considered futile. The Sézary syndrome arm of the study could enable the registration of IPH4102 in this indication.
The primary endpoint of the trial is objective response rate. Key secondary measures include incidence of treatment emergent adverse events, quality of life, overall response rate, progression-free survival and overall survival.
IPH4102 is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, designed for treatment of CTCL, an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few 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 to 85% of them with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It has a restricted expression on normal tissues.
IPH4102 was granted orphan drug status in the European Union and in the United States for the treatment of CTCL. In January 2019, the US Food and Drug Administration (FDA) granted Innate Pharma Fast Track designation for IPH4102 for the treatment of adult patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.
About 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.
MF, 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 Peripheral T-Cell Lymphoma:
PTCL represents a group of non-Hodgkin lymphomas of mature T-cell origin with generally aggressive clinical behavior. The three predominant aggressive PTCL subtypes in the Western countries are: PTCL not otherwise specified (NOS); angioimmunoblastic T cell lymphoma (AITL); and anaplastic T cell lymphoma (ALCL). In the aggregate, PTCL accounts for approximately 10% of all non-Hodgkin’s lymphomas and has a median age at diagnosis around 65 years.
Multi-agent chemotherapy is the recommended first line treatment for the majority of patients with PTCL (NCCN guidelines). Brentuximab vedotin has been approved by the US FDA in combination with first line chemotherapy for patients with CD30 positive PTCL in November 2019. Stem cell transplantation (SCT) is a potentially curative option but is rather restricted to a minority of patients who are young, fit and achieve complete response to systemic therapy. Hence a high proportion of patients need second line therapy. Belinostat, pralatrexate and romidepsin have been approved by the FDA in this setting, but efficacy is generally limited. None of these treatments have been approved by the EMA. Brentuximab vedotin is also approved in the 2nd line setting, but if used in the first line, it may no longer be an option for 2nd line patients.
About Innate Pharma:
Innate Pharma S.A. is a commercial stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.
Innate Pharma’s commercial-stage product, Lumoxiti, in-licensed from AstraZeneca, was approved by the FDA in September 2018. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia (HCL). Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.
Innate has been a pioneer in the understanding of NK cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca.
Based in Marseille, France, Innate Pharma is listed on Euronext Paris.
Learn more about Innate Pharma at www.innate-pharma.com
Information about Innate Pharma shares:
This press release contains certain 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. For a 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 Document de Reference prospectus filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website www.amf-france.org or on Innate Pharma’s website.
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:
Dr. Markus Metzger / Danielle Spangler /
Tel.: +33 (0)4 30 30 30 30
Consilium Strategic Communications
Mary-Jane Elliott / Jessica Hodgson
Tel.: +44 (0)20 3709 5700
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