Immutep publishes interim results for two ongoing studies, scoops $3.6 million in R&D grant

Immutep ASX IMM interim results cancer clinical studies R&D grant
Immutep is gradually progressing its phase 1 INSIGHT-004 and phase 2 TACTI-002 clinical trials in partnership with Merck.

Biotechnology company Immutep (ASX: IMM) has published results from two ongoing clinical studies, just days after revealing it received €2.1 million (A$3.6 million) in research and development tax incentive payments from the French Government under its Crédit d’Impôt Recherche scheme (CIR).

The funds are designated for developing the company’s lead drug eftilagimod alpha and the preclinical development of IMP761, primarily at Immutep’s laboratory at Châtenay-Malabry in south-western Paris.

In parallel news and as part of its interim data reporting, Immutep said that initial data from its INSIGHT-004 phase one clinical trial evaluating the combination of eftilagimod alpha with avelumab, a human anti-PD-L1 antibody, showed the drug was well tolerated with no dose-limiting toxicities.

The study was carried out on 12 patients with solid cancers as part of a broader “four-arm” investigator-initiated study called Insight, being conducted by the Institute of Clinical Cancer Research IKF in Frankfurt.

The entire project is being conducted in collaboration with global pharma giants Merck and Pfizer with Insight-004 now fully recruited and set to become the first combination trial of an approved and marketed anti-PD-L1 drug and efti.

According to the study, 33% of patients showed a partial response to the combination therapy with a further three patients still being assessed but without clinical signs of tumour progression.

Immutep also reported multiple encouraging single cases of unexpectedly good responses including one in esophagogastric junction carcinoma, one in colon adenocarcinoma, one in squamous cell anal carcinoma and one in pleural mesothelioma.

Further interim results

In a further batch of interim results, Immutep reported that new data from its ongoing phase 2 TACTI-002 study indicated “improving efficacy” when evaluating the combination eftilagimod alpha with Merch’s Keytruda drug in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma (HNSCC) or Non-Small Cell Lung Cancer (NSCLC).

According to Immutep, trial recruitment continues to “progress well”, with 77 of 109 patients enrolled at 12 clinical sites across Australia, Europe, the UK and the US.

The study’s trial investigator said results indicated a “promising new therapeutic option” with progression-free survival to be more than nine months for patients with 1st line NSCLC –significantly longer than the five-to-six months delivered by pembrolizumab monotherapy.

“TACTI-002 is generating increasingly promising data from both the NSCLC and HNSCC arms of study, as patients continue to receive efti in combination with Keytruda,” said Immutep chief scientific officer Dr Frederic Triebel.

“Remarkably, one HNSCC patient has even achieved a complete response, bringing the total response rate to an improved 39% in this arm. This is an early indication that the efti in combination with pembrolizumab may more than double the proportion of HNSCC patients that respond to pembrolizumab monotherapy, which is usually 18% or less,” he said.

Immutep shares edged up 8% to $0.20 in morning trade.

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