Shares in Immutep (IMMP) are surging 10% in Monday’s pre-market trading after the company announced first interim data from its ongoing INSIGHT-004 Phase I clinical trial at the 2020 American Society of Clinical Oncology’s (ASCO) Annual Meeting.
The Frankfurt-based study is a phase I trial evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha (“IMP321” or “efti”) with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers. Avelumab is co-developed and co-commercialized by Merck KGaA (MRK), Darmstadt, Germany and Pfizer Inc (PFE).
Patients in cohort 1 receive 6mg doses of efti every two weeks with the standard dose of avelumab (800mg every two weeks), while patients in cohort 2 receive a higher dose of efti, 30mg, with avelumab.
According to the presentation, 33% of patients (4 out of 12) showed a partial response (PR) to the combination therapy. In cohort 2, 3 patients out of 6 have not yet had their response assessed but are still under therapy without clinical signs of tumour progression, the company said, while noting a number of encouraging single PR cases.
INSIGHT-004 reached full recruitment in April 2020 and has recruited patients in different solid tumors, primarily with gastrointestinal indications. It is the first combination trial of an approved and marketed anti-PD-L1 drug and efti.
Trial investigator, Prof Salah-Eddin Al-Batran, commented: “It is good to see a number of patients are responding to the combination therapy of efti and avelumab, particularly as three patients in cohort 2 are still very early on in their treatment and haven’t yet been assessed… These patients typically are heavily pretreated and do not have any good therapy options.”
Interim results from the first cohort in the trial show that the combination treatment is well tolerated with no dose limiting toxicities, while safety data from the second cohort will be reported at a later date.
Two analysts have recently published buy recommendations on IMMP, giving the stock a Moderate Buy analyst consensus. Meanwhile the average analyst price target of $3.50 indicates a further 184% lies ahead. (See IMMP stock analysis on TipRanks). Shares are currently trading down 31% year-to-date, after the company announced disappointing top-line data from the P2b AIPAC study in metastatic breast cancer (mBC).
“Is all lost for Immutep? Not at all, in our view… The mBC data is a disappointment, but efti and the other LAG3s in the pipeline still have a path forward. Overall, in our view, the damage has been done to IMMP shares” wrote Maxim Group’s Jason McCarthy at the time.