Innate Pharma Presents Preliminary Data from TELLOMAK Trial Showing Clinical Response of Lacutamab in Mycosis Fungoid


  • TELLOMAK’s First Data Set Establishes Safety, Clinical Responses, and Skin Improvement in Mycosis Fungoid Patients Who Express KIR3DL2
  • Data support continued development of lacutamab for T lymphomas expressing KIR3DL2
  • Results presented at 16e International Conference on Malignant Lymphoma; Innate will host the investor event tomorrow, June 23, at 2:00 p.m. CEST / 8:00 a.m. EDT

MARSEILLE, France, June 22, 2021 (GLOBE NEWSWIRE) – Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate“or the”Company”) Today announced preliminary data from the mycosis fungoid (MF) cohort of the TELLOMAK Phase 2 clinical trial, evaluating lacutamab, an anti-KIR3DL2 cytotoxicity inducing antibody, in an oral presentation at 16e International Conference on Malignant Lymphoma (16-ICML).

Lacutamab has demonstrated clinical responses in patients with MF who express KIR3DL2 (cohort 2), reaching the predetermined threshold to progress to stage 2.1

At the data cut-off date of May 10, 2021, in the cohort expressing KIR3DL2 (n = 17), complete (n = 1), partial (n = 3) and unconfirmed partial (n = 2) responses were observed. . After the data was cut, the two unconfirmed partial responses were confirmed.

When assessing skin responses, one patient had a complete response, eight patients had a partial response, and two patients had an unconfirmed partial response. Of seven patients with blood loss, four had a complete response in the blood, and of eight patients with lymph node involvement, one had a partial response. After the data was cut, the two unconfirmed partial responses in the skin were confirmed.

All patients (n = 19) from the cohort without KIR3DL2 expression (cohort 3) were recruited. The response threshold required to proceed to stage 2 has not been reached and follow-up is ongoing.

“We are delighted with the response demonstrated to date in patients with mycosis fungoides who express KIR3DL2, which has enabled us to move this cohort forward sooner than expected”, mentionned Joyson Karakunnel, MD, MSc, FACP, Medical Director of Innate Pharma. “These data confirm our initial hypothesis that lacutamab may be of benefit for patients with T lymphomas expressing KIR3DL2, and support our data-driven approach in pursuing a new standard of care in this population. For the future, we continue to recruit patients in the mycosis fungoides and Sézary syndrome cohorts of our TELLOMAK study. In addition, we plan to launch our peripheral T-cell lymphoma program for lacutamab, with our Phase 1b monotherapy study scheduled to begin mid-year and an investigator-sponsored combination study scheduled for the second half of this year. year. “

Consistent with previous observations, lacutamab has demonstrated a favorable safety profile in MF. Grade 1-2 treatment-related adverse events (AEs) were observed, with one patient (out of 36) exhibiting a grade 3 AE. No relevant dermal toxicity was observed.

“Mycosis fungoides, and cutaneous T cell lymphomas more generally, are associated with poor clinical outcomes, particularly in advanced stages” mentionned Prof. Martine Bagot, Head of the dermatology department, Hôpital Saint Louis, Paris, and a study researcher. “The clinical responses and favorable safety profile observed in the TELLOMAK study have been quite encouraging so far. I am particularly pleased with the preliminary skin responses, as relapsed / refractory patients require new treatment options that can improve their quality of life and slow disease progression. I look forward to seeing more data on lacutamab as this trial progresses with the recruitment of additional patients into this cohort. ”

Innate will provide additional information on these results tomorrow, June 23, 2021, at an investor event scheduled for 2:00 p.m. CEST / 8:00 a.m. EDT. Details for accessing the live event are available in the investors section of Innate’s website, where a replay of the webcast will also be archived for 90 days after the event.

About lacutamab:

Lacutamab (IPH4102) is a first-class anti-KIR3DL2 cytotoxicity inducing humanized antibody currently in clinical trials for the treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease. This group of rare cutaneous T-cell lymphomas has a poor prognosis with few effective and safe treatment options in the advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% ​​of patients in all CTCL subtypes and expressed by up to 90% of patients with certain aggressive CTCL subtypes, particularly CTCL syndrome. Sézary. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T cell lymphoma (PTCL). It has restricted expression on normal tissue.

About TELLOMAK:

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial enrolling patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:

  • Cohort 1: lacutamab being evaluated as monotherapy in approximately 60 patients with Sézary syndrome who have received at least two previous systemic treatments, including mogamulizumab.
  • Cohort 2: Lacutamab is being evaluated as monotherapy in up to approximately 50 patients with FM who express KIR3DL2, as determined at baseline.
  • Cohort 3: Lacutamab is being evaluated as monotherapy in up to 38 patients with MF who do not express KIR3DL2, as determined at baseline.

The MF cohorts follow a 2-step Simon design that will end early if treatment is considered futile. The Sézary syndrome cohort of the study could allow the registration of lacutamab in this indication.

The primary endpoint of the trial is the objective overall response rate. The main secondary endpoints are progression-free survival, duration of response, quality of life and adverse events.

The overall response in cutaneous lymphoma is measured by the guidelines published by Olsen et. al in the Journal of Clinical Oncology in 2011.2

About Innate Pharma:

Innate Pharma SA is a global clinical-stage oncology-focused biotechnology company dedicated to improving treatments and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.

Innate Pharma’s large antibody portfolio includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.

Innate is a pioneer in understanding Natural Killer cell biology and has extended its expertise in the tumor microenvironment and tumor antigens, as well as in antibody engineering. This innovative approach has resulted in a diverse proprietary portfolio and major alliances with leaders in the biopharmaceutical industry, including Bristol-Myers Squibb, Novo Nordisk A / S, Sanofi, and a multi-product collaboration with AstraZeneca.

Based in Marseille, France, with a US office in Rockville, Maryland, Innate Pharma is listed on Euronext Paris and Nasdaq in the United States.

Find out more about Innate Pharma on www.innate-pharma.com

Information on Innate Pharma shares:

ISIN code
Ticker code
LEI
FR0010331421
Euronext: IPH Nasdaq: IPHA
9695002Y8420ZB8HJE29

Disclaimer regarding 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 that 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 others, the uncertainties inherent in research and development, in particular relating to the safety, progress and results of its ongoing and planned clinical and preclinical trials, review and approvals by the regulatory authorities of its product candidates, the Company’s marketing efforts, the Company’s continued ability to raise capital to finance its development, and the overall impact of the COVID-19 epidemic on the global health system as well as the business, financial condition and results of operations of the Company. For further discussion of the risks and uncertainties that could cause the actual results, financial condition, performance or achievements of the Company to differ from those contained in forward-looking statements, please refer to the Risk Factors section ( “Risk factors”) of the Universal Registration Document filed with the Autorité des Marchés Financiers (“AMF”), available on the AMF website http://www.amf-france.org or on the Innate Pharma website, and public records and statements filed with the US Securities and Exchange Commission (“SEC”), including the Company’s annual report on Form 20-F for the year ended December 31 2020, and subsequent filings and reports filed with the AMF or the SEC, or otherwise made public, by the Company.

This press release and the information it contains do not constitute an offer to sell or a solicitation of an offer to purchase or subscribe for Innate Pharma shares in any country whatsoever.

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1 In this assay, expression of KIR3DL2 is defined as tumors in which KIR3DL2 staining is detected in ≥1% of mononuclear cells by immunohistochemistry using central assessment.
2 Olsen EA, Whittaker S, Kim YH, et al. Clinical endpoints and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement from the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium and the Cutaneous Lymphoma Task Force of the European Organization for cancer research and treatment. J Clin Oncol. 2011; 29 (18): 2598-2607. doi: 10.1200 / JCO.2010.32.0630

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