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CHMP delays decision on Kiadis’ GVHD immunotherapy

Medicines regulator issues out Day 180 List of Outstanding Issues

EMA

Kiadis Pharma will have to wait until next year to find out whether its lead cell therapy candidate ATIR101 has gained a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP), after the regulator issued a second round of outstanding issues.

ATIR101 is a novel cell therapy which aims to help improve outcomes in patients who receive  hematopoietic stem cell translation (HSCT) for certain types of blood cancer.

During the HSCT treatment, the patient’s bone marrow is completely destroyed and replaced by stem cells in the graft from a healthy donor.

It normally takes a patient up to a year to recover to near-normal blood cell levels and immune cell functions, and the patient is vulnerable to disease relapse along with infections caused by bacteria and viruses.

ATIR101 aims to target this, more specifically Graft-versus-Host-Disease (GVHD) along with cancer relapse.

It is administered as an adjunctive immunotherapeutic on top of HSCT, and the T cells in the therapy, which comes in the form of a single dose donor lymphocyte infusion, with immune cells from a donor, will help fight infections and remaining tumour cells.

The T-cells that would normally cause GVHD are depleted from the donor lymphocytes using Kiadis Pharma’s photodepletion technology, minimising the risk of GVHD and eliminating the need for prophylactic immune-suppression.

However, after an assessment from the CHMP and the Committee for Advanced Therapies (CAT), the regulators have demanded more data to back up its filing.

Kiadis has requested an extension to respond to the questions in order to gather additional analyses of existing clinical data.

Arthur Lahr, CEO of Kiadis Pharma, commented: “We are pleased with our continued clinical and regulatory progress and remain on track for the initial commercial launch of ATIR101 in a first EU country in the second half of 2019. We are confident that we can address the remaining questions from EMA, allowing for a CHMP opinion in the first half of 2019.”

The biopharma submitted a marketing authorisation application to the European Medicine Agency in April last year as an adjunctive treatment in HSCT for adult malignant disease.

It based this application on single dose phase 2 data, whereby the product demonstrated substantial and clinically relevant improvements over historical observational cohort data for a similar HSCT without ATIR101.

The company says it also shows an improvement over the Post-Transplant Cyclophosphamide (PTCy) and is currently conducting a phase 3 trial across Europe and North America against the protocol for PTCy.  The interim results of this study are expected in the second half of 2020.

Article by
Gemma Jones

12th October 2018

From: Regulatory

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