Biotechnology company Immutep (ASX: IMM) has brought out a flurry of developments over the past few days including new data from its ongoing TACTI-mel Phase 1 clinical trial as well as two distinct new patents, granted by the European Patent Office.
On Monday, Immutep unveiled new data from its ongoing trial at the 4th Annual ICI Europe Summit, held in Berlin, Germany.
The data followed up results presented earlier this month at the 33rd annual meeting of the Society for Immunotherapy of Cancer (SITC) in Washington, D.C.
The study is evaluating the combination of eftilagimod alpha (efti), Immutep’s lead drug candidate, in combination with anti-PD-1 therapy KEYTRUDA in 24 patients with unresectable or metastatic melanoma.
Part A of the study includes escalating dosages in three cohorts of six patients with a treatment duration of 6 months. Part B of the study is expected to take 12 months and includes an additional cohort of 6 patients at 30mg of efti in combination with KEYTRUDA.
As part of the company’s presentation, Immutep’s chief scientific and chief medical officer Dr Frédéric Triebel said that after 3 months of the trial, 3 out of 6 patients experienced a “partial response” alongside a 50% overall response rate.
Mr Triebel confirmed that Immutep’s trial observed long-lasting and durable responses with 13 patients – 72% of the total – confirmed as “progression-free” at 6 months into the trial.
Mr Triebel said he was very pleased by this initial data which further supports the company’s hypothesis that the combination of efti and pembrolizumab may be a hopeful solution for cancer patients, although more data is still required.
“Based on these encouraging results we are looking forward to the start of our TACTI-002 trial where exactly this combination will be tested in three different cancer indications,” he said.
First of two new patents now granted
Immutep has also confirmed that it has seen two distinct patents granted.
Yesterday, the biotechnology company said it had received word from the European Patent Office that a patent titled “Compositions comprising LAG-3 and therapeutic antibodies and their uses in treating cancer” was now granted, thereby securing intellectual property rights until January 2036 and ensuring the company can be secure in conducting further development in view of future commercialisation.
The new patent relates to combined preparations comprising its lead product candidate eftilagimod alpha and a PD-1 or PD-L1 inhibitor, and also the use of the combined preparations for the treatment of cancer or infection.
The new patent is significant as it covers the combination of active ingredients being evaluated in the company’s “TACTI-mel, TACTI-002 and INSIGHT-004” clinical trials.
The TACTI-002 trial will be conducted in collaboration with US pharmaceutical giant Merck, first announced in March this year.
Meanwhile, INSIGHT-004 will be conducted in collaboration with Merck’s German subsidiary Merck KGaA and one of the world’s most prominent pharmaceutical companies Pfizer in Darmstadt, Germany, first announced in September 2018.
“We are very pleased that our European patent application has been granted covering our lead product candidate, efti, in combination with either a PD-1 or PD-L1 inhibitor,” said Marc Voigt, CEO of Immutep.
Mr Voigt added that “this is particularly important for Immutep as PD-1 and PD-L1 inhibitors are the standard of care for a broad range of cancers, an area where the Company is actively pursuing the development of combined therapies.”
“This European patent grant represents an important milestone for Immutep and is consistent with our long-held hypothesis that combining efti with a PD-1 or PD-L1 checkpoint inhibitor should result in a combinatory therapeutic benefit to patients, by both pushing the accelerator and releasing the brake of the immune system,” said Mr Triebel.
More patent news
In addition to yesterday’s patent that combines efti with a PD-1 or PD-L1 inhibitor, earlier today Immutep announced the receipt of another patent for its leading drug candidate.
The biotechnology company said it has also received a patent that covers efti being combined with “therapeutic antibodies” such as rituximab, cetuximab, or trastuzumab – treatments that kill tumour cells through what’s known as “antibody dependent cell-mediated cytotoxicity” (ADCC) for the treatment of cancer.
The patent has been granted for 10 years until October 2028, significantly shorter than the one granted yesterday.
According to the patent claim, efti elicits a monocyte-mediated immune response which enhances ADCC with the treatment administered either before, with, or subsequent to administration of the therapeutic antibody.
“The new patent points to the broad potential of efti as an immunostimulant and provides patent protection in Europe for an additional range of combination therapies,” Immutep said.