Dual-listed biotechnology company Immutep (ASX: IMM) has published new data from its ongoing TACTI-mel phase 1 clinical trial and presented its findings at the 33rd annual meeting of the Society for Immunotherapy of Cancer (SITC) in Washington, D.C.
The biotech company is actively developing novel immunotherapy treatments for cancer and autoimmune diseases and is gradually moving through a rigorous clinical trial program in part supported by its ongoing working relationship with pharma giants Merck KGaA and Pfizer.
In a presentation to a packed audience, consultant medical oncologist at Fiona Stanley Hospital and a principal investigator of the on-going TACTI-mel study, Professor Adnan Khattak, presented efficacy and safety data from 18 patients in part A (the dose escalation part of the study) and first safety data from 6 patients in part B.
Mr Khattak said that Immutep’s “positive” interim data indicates that the trial is matching its previous overall response rate (ORR) of 61% when measured from the start of its KEYTRUDA monotherapy treatment and has reached a disease control rate of 66% from its combination treatment.
Interim data on track
The TACTI-mel study is evaluating the use of eftilagimod alpha, also known as “efti” or “IMP321” – a soluble fusion protein based on a specific “immune control” mechanism, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab) for metastatic melanoma.
Immutep also confirmed that in both parts A and B, combination therapy has been “well tolerated with no dose-limiting toxicities and local erythema and injection site reactions as the most common side effects.”
Importantly, the safety data of part B supports the dose scheduling of Immutep’s planned phase 2 TACTI-002 clinical study in collaboration with MSD. Progress to phase 2 would be a significant milestone for the company and would mean recruiting more patients and more thorough testing of its treatment.
Immutep’s chief scientific officer Dr Frédéric Triebel said that the newly-published data further supports the company’s hypothesis that combining efti with a checkpoint inhibitor results in a combinatory therapeutic benefit to patients, akin to “pushing the accelerator and releasing the brake of the immune system.”
Dr Triebel also confirmed that the data highlights the excellent safety profile of efti, when combined with an anti-PD-1 therapy – a key factor that underpins Immutep’s ongoing work towards developing a range of applications for its drug candidate, and ultimately, progressing the fight against metastatic melanomas.
“We are looking forward to the initiation of TACTI-002 later this year and I believe the clinical trial collaboration and supply agreement that we entered into with MSD earlier this year, as well as the recently announced agreement with Merck KGaA and Pfizer, further supports the development of efti in combination with PD-1 and PD-L1 therapeutics,” said Dr Triebel.
In September this year, Immutep announced a clinical trial collaboration and supply agreement with Merck KGaA and Pfizer.
The agreement meant the emergent biotech company would be tasked with evaluating a combination of its own lead immunotherapy product candidate “eftilagimod alpha”, with Avelumab, a human anti-PD-L1 antibody, in patients with advanced solid malignancies.
Merck and Pfizer first announced a strategic alliance to co-develop and co-commercialise Avelumab in November 2014, with the antibody undergoing over 30 different clinical programs and seven separate phase 3 trials over the past few years.