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Immutep Quarterly Activities ReportHighlights
Sydney, AUSTRALIA, Jan. 22, 2021 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha (“efti” or “IMP321”) and IMP761, and the activities of its partners. “Immutep has entered calendar year 2021 in a very strong financial and operational position, following the encouraging clinical results announced for our lead product candidate, efti, last year. We have increasing confidence in efti and accordingly, three new efti trials or trial extensions with up to 386 patients in different cancer indications were announced or started in the quarter. We advanced our business development activity with MSD and signed a new LAG-3 agreement with LabCorp. Our engagement with regulatory bodies has continued and our IP position has been significantly strengthened; in addition, we are upscaling the manufacturing of efti to prepare for the future. Immutep is advancing strongly towards another step change in calendar year 2021,” said Marc Voigt, CEO of Immutep. Eftilagimod Alpha Updates AIPAC - Phase IIb clinical trial In addition, a statistically significant OS benefit was observed in the efti group in key pre-defined patient groups. In patients under 65 years of age, a +7.1 months survival benefit was observed in the efti group which reported a median OS of 21.9 months vs. 14.8 months in the placebo group, reflecting nearly 50% longer survival. Similarly, in patients with a low starting monocyte count, a +9.4 months survival benefit was observed in the efti group, with a median OS of 22.4 months vs. 12.9 months in the placebo group, 74% longer. Importantly there was a statistically significant increase of cytotoxic CD8 T-Cells in the efti arm versus the control arm and patients with those increased cells had, in general, a better OS. It is the first time that an antigen presenting cell activator (APC activator) has delivered meaningful OS data in a randomised, double blind setting. The proportion of patient events has advanced to ~ 68% currently and Immutep is on track to report final OS data and Overall Response Rates (ORR) by mid calendar year 2021. TACTI-002 - Phase II clinical trial More mature ORRs for Parts A and C were reported at SITC and continued to be very favourable. Immutep reported a 39.4% ORR in patients with 1st line Non-small Cell Lung Cancer (NSCLC) and 43.5% in patients with 2nd line head and neck squamous cell carcinoma (HNSCC), on an evaluable patient basis. Five patients (two wih 1st line NSCLC and three with 2nd line HNSCC) reported a complete disappearance of all lesions, known as a Complete Response. First data from patients with 2nd line NSCLC (Part B) who are PD-1 resistant was also reported at SITC. This group showed encouraging efficacy for low PD-L1 expressing patients who do not typically respond to immune checkpoint (PD-L1) therapy. Following the encouraging results presented at SITC, Immutep and MSD expanded the TACTI-002 study by 74 additional patients with 1st line NSCLC, creating a stage 3 for Part A. Recruitment for this new stage opened in late December 2020. In addition, Immutep completed recruitment of 2nd line HNSCC patients for Part C of the trial in early January 2021. Further data from TACTI-002 is expected in H1 2021. Phase II Clinical Trial in Head and Neck Cancer Immutep is continuing planning for this new trial and will announce further details in due course. TACTI-mel - Phase I clinical trial EAT COVID – Phase II clinical trial Initial results from the safety run in of the trial are expected to be reported in early 2021 with initial interim efficacy results in 2021. IMP761 Update IMP761, a LAG-3 agonist antibody, is Immutep’s preclinical candidate for autoimmune disease. The Company is continuing cell line and other preclinical development for IMP761 in preparation for clinical trials. Partner Updates EOC Pharma - Phase II clinical trial Approximately 152 patients will participate in EOC Pharma’s clinical trial which evaluates efti in combination with chemotherapy and is fully funded by EOC. EOC Pharma is the exclusive licensee of efti for the Chinese market. The ethics committee of the leading clinical site has already approved the study. GlaxoSmithKline Other Partners Immutep’s other licensing partnerships with Novartis and CYTLIMIC continue to progress well. Intellectual Property During the quarter, Immutep was granted a new US patent for efti in combination with a PD-1 pathway inhibitor, such as pembrolizumab or nivolumab. The Company was also granted a new European patent for its pre-clinical candidate IMP761 and a new Australian patent for LAG525, a humanised form of Immutep’s IMP701 antibody which is out-licensed to Novartis. Financial Summary – Q2 FY21 Cash receipts from customers for the quarter was $336k, compared to $23k in Q1 (i.e. the quarter ended 30 September 2020). Cash receipts from government grants and tax incentives for the quarter was $34k, compared to $126k in Q1. The net cash used in G&A activities in the quarter was $1.82 million compared to $0.35 million in Q1. The significant increase compared with last quarter is mainly due to the prepayment of certain annual expenses. G&A costs for the quarter includes $248k in payment of Non-Executive Director’s fees and Executive Director’s remuneration. Total net cash outflows used in operating activities in the quarter was $5.58 million. In comparison, total net cash outflows from the operating activities in Q1 was $3.34 million. The net cash used in Research and Development activities in the quarter was $3.18 million, compared to $2.10 million in Q1. Year to date cash flow used in R&D activities for the 6 months from July to December 2020 was $5.3 million compared to $11.4 million for the 6 months from July to December 2019; the decline is mainly due to the declining AIPAC expenses since almost all patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase. In November 2020, the Company successfully raised $29.57 million via a placement which was supported by high-quality institutional investors in Australia and offshore. In December 2020, the Company received $10.66 million from the exercise of warrants over American Depository Shares. The cash and cash equivalent balance as at 31 December 2020 was $54.9 million compared to a balance of $22.7 million as at 30 September 2020. Immutep is in an excellent financial condition with a cash runway beyond end of calendar year 2022 and beyond several significant data read-outs. Its cash position is currently at its strongest since it started the LAG-3 developments. About Immutep Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners. Further information can be found on the Company’s website www.immutep.com or by contacting: Australian Investors/Media: U.S. Media:
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