Innate pharma enrolls first patient in IPH4102 TELLOMAK phase II study
- Category: Antibodies
- Published on Thursday, 06 June 2019 10:40
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- TELLOMAK is a Phase II study to evaluate the efficacy of IPH4102 in different subtypes of T-cell lymphoma
- The TELLOMAK trial design and preclinical data in PTCL will be presented at the International Conference on Malignant Lymphoma (ICML), June 18-22
MARSEILLE, France I June 6, 2019 I Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announced that it has enrolled the first patient in the TELLOMAK Phase II study of IPH4102 in patients with different subtypes of T-cell lymphoma (TCL). IPH4102 is Innate Pharma’s wholly-owned first-in-class anti-KIR3DL2 antibody, developed for the treatment of T-cell lymphoma.
“The start of the TELLOMAK study is an important milestone in advancing IPH4102 towards potential registration in Sézary syndrome. The Phase I results demonstrated strong clinical activity, a favorable safety profile and a substantial improvement in quality of life. Based on these data, IPH4102 has the potential to become the treatment of choice in later lines of Sézary syndrome therapy, where there are currently limited effective treatment options and where toxicity is remaining an area of great concern with currently approved drugs“, said Pierre Dodion, Chief Medical Officer of Innate Pharma. “Moreover, we are excited about exploring the activity of IPH4102 in larger subsets of T-cell lymphoma, such as Mycosis fungoides (MF) and Peripheral T-cell lymphoma (PTCL) where patients suffer from a significant medical need and to broaden the potential use of IPH4102.”
TELLOMAK is a global, open-label, multi-cohort Phase II clinical trial conducted in the United States and Europe. In this trial, IPH4102 is evaluated alone and in combination with chemotherapy in patients with advanced TCL. We expect to recruit up to 250 patients, with IPH4102 evaluated:
- As a single agent in approximately 60 patients with Sézary syndrome (Sézary) 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 and arms in the two indications will be comprised of two cohorts each, testing IPH4102 in KIR3DL2 expressing and non-expressing patients. These cohorts will follow a 2-staged protocol that will terminate if treatment is considered futile. Under certain conditions, the Sézary 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”):
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. There are approximately 6,000 new CTCL cases in Europe and the United States per year.
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 and less than 15% for transformed mycosis fungoides. CTCL is an orphan disease and patients with advanced CTCL have a poor prognosis with few therapeutic options and no standard of care.
About Peripheral T-Cell Lymphoma (“PTCL”):
PTCL represents a group of non-Hodgkin lymphomas of mature T-cell origin with generally aggressive clinical behavior (Armitage, 2015). 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 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 (Horwitz et al., The Lancet 2019, ECHELON-2 Study Group). Autologous stem cell transplantation (autoSCT) is a potentially curative option but is rather restricted especially to patients who achieve complete response to systemic therapy (Wilhelm, Smetak et al. 2016). 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 (O'Connor, Zcan et al. 2015). None of these treatments have been approved by EMA. Thus, single agent and combination chemotherapy remains to be widely used in the relapsed setting albeit with unsatisfactory results. The expected median overall survival of the different treatment options in the relapsed setting is in the range of 1 year (O’Connor O et al; JCO 2019). Brentuximab vedotin is also approved in the 2nd line setting (Pro, Advani et al. 2017), but if used in the first line, it may no longer be an option in 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.
Pioneer in the biology of NK cell, Innate Pharma 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
SOURCE: Innate Pharma