Immutep Ltd (ASX: IMM), a biotechnology company, which develops immunotherapy treatments for cancer and autoimmune diseases, has “IMP 321” or “efti” eftilagimod alpha as the current lead product. IMP 321 is known to be a soluble LAG – 3 lg protein that has the LAG – 3 immune control mechanism; and regulation of the T cell immune response is dependent on this mechanism. IMP 321 has been highlighted to be in phase II B clinical trial under chemo-immunotherapy in relation to metastatic breast cancer termed AIPAC. Phase II clinical trials are termed as TACTI-002. In order to evaluate the effective results of the combination of Efti with KEYTRUDA these trials are being conducted. The combination results are done to evaluate its performance for varied solid tumors. [optin-monster-shortcode id=”swikrbu1d9j9aq0o4cko”]
Phase I clinical trial referred to as INSIGHT-004 was solely done to evaluate the combination effect of Efti with avelumab. The company in conjunction with key partners has been into the development of LAG – 3 products. These include antibodies and products driven towards immune response modulation in autoimmunity and cancer. IMP761, agonist of LAG-3 is also developed by IMM.
The interim data from TACTI-meI Phase I clinical trial has been positive as indicated by IMM and presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Washington D.C., U.S. on November 12, 2018. The group presented the data after conducting a closed study on 18 patients under part A and 6 patients under part B group; and Principal investigator and the Consultant Medical Oncologist, at Fiona Stanley Hospital, Prof. Adnan presented the data on the on-going TACTI-mel.
Under Part A, combination therapy was started after four cycles of KEYTRUDA monotherapy. Under part B, patients underwent the therapy with the combination i.e receiving efti with KEYTRUDA right from the first day of treatment. The data results from part A supported the previously disclosed response rates with a 33% overall response rate which was measured from the start of the combination at cycle 5 of KEYTRUDA.
When measured from the cycle 1, day 1, of the KEYTRUDA monotherapy treatment in an explorative analysis, 61% overall response rate was measured. Combination therapy has been well tolerated in both part A and part B and no signs of toxicities with the limit of dose and local erythema and injection site reactions which are the most common side effects have been noticed.
The dose scheduling of the Company’s planned Phase II TACTI-002 clinical study in collaboration with MSD is well supported by the safety data of part B.
As per the oral conversation made by the chief scientific officer of Immutep, Dr.Frederic Triebel, IMM is looking forward to the initiation of TACTI-002 during later part of the year and he believes that the new supply agreement and clinical trial collaboration with MSD during FY18 along with recent agreement announcement with Merck KGaA and Pfizer Inc. will help in the development of efti in combination with PD-1 and PD-L1 therapeutics. IMM slipped below its previous close of $0.05 and traded at the levels of $0.044, down 8.33% on November 12, 2018.
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