U.S. Food and Drug Administration lifts partial clinical hold on lacutamab TELLOMAK trial in advanced T-cell lymphomas - Seite 2

The Company expects to start sharing data from the TELLOMAK trial for mycosis fungoides in 2021 and Sézary syndrome in 2022.

Analyst webcast and conference call will be held today at 4:00pm CEST (10:00am EST)

Innate Pharma will host a live webcast and conference call today to discuss its lacutamab clinical trial program, including the Company’s PTCL strategy.

The presentation and live webcast details are available on Innate Pharma’s web site at www.innate-pharma.com, and below:

Webcast: https://edge.media-server.com/mmc/p/e65nrsvu

Conference call dial in details:

 France: [phone] | US: + 1 877 870 9135 | International: [phone]

Conference ID: 20679317

A replay will be available on Innate Pharma’s website after the conference call.

About the GMP Deficiency:

This situation is related to GMP deficiencies put forward by the Company’s manufacturing subcontractor, Rentschler Fill Solutions GmbH or “RFS” (now known as Impletio Wirkstoffabfüllung GmbH). RFS was granted a GMP certificate by the Austrian regulatory agency in August 2018, which was further confirmed in October 2019 after two on-site inspections. In November, RFS unilaterally withdrew the Certificate of Conformity of batches they have produced, including the lacutamab batch currently used in the TELLOMAK trial. RFS also filed for bankruptcy.          

The Company’s utmost priority is to ensure patient safety. An extensive internal and third-party analysis concluded that there was no evidence that the integrity of the product was questioned.

About Lacutamab:

Lacutamab 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.