TMCnet News
Immutep Quarterly Activities ReportHighlights
Sydney, AUSTRALIA, April 19, 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 for the quarter ended March 31, 2021. “We continue to lead the world in the development of different LAG-3 related therapies, with a robust pipeline of exciting clinical stage programs and promising data. Throughout the quarter ended 31 March 2021, we have been extremely active advancing and expanding upon these clinical programs, building upon our data generated last year” said Marc Voigt, CEO of Immutep. “We are well-positioned for long-term success, as we have a steady stream of positive data advancing our clinical studies, and decades of experience across our clinical team, which includes the discoverer of the LAG-3 immune control mechanism, as well as a strengthened balance sheet.” “There has recently been broad industry coverage of positive Phase II/III data from another company’s LAG-3 program to treat melanoma, which we’re pleased to say further validates targeting the LAG-3 pathway to enhance the immune response. While they have additional data to announce, what has been discussed to-date further supports our knowledge of the LAG-3 mechanism and is in line with our MSD collaboration to develop a combination of KEYTRUDA® with efti. This year is shaping up to be an exciting period for the clinical development of LAG-3 therapies,” added Dr. Frederic Triebel, CSO/CMO of Immutep. Efti Development Program Updates Intellectual Property TACTI-002 (Two Active Immunotherapies, also designated KEYNOTE-798) - Phase II clinical trial Patients participate in one of three parts: Part A - First Line NSCLC, PD-X naive Part B - Second Line NSCLC, PD-X refractory Part C - Second Line HNSCC Additional data from TACTI-002 is expected in H1 2021. TACTI-003 (Two Active Immunotherapies) - Phase IIb clinical trial - First Line HNSCC This is Immutep’s second collaboration with MSD for a combination of KEYTRUDA® and efti. EAT COVID - Phase II clinical trial In January 2021 Immutep reported that the independent Data Safety Monitoring Board (DSMB) had completed a safety run-in data review of the first six patients from the Phase II clinical trial of Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease (EAT COVID). Following this data review, the DSMB recommended that the study advance with enrolment for the randomised portion of the study. All six patients (age range, 50-83 years; 2 women and 4 men) received the three planned 10 mg efti injections and were since discharged from hospital with no adverse events reported. Partner Updates GlaxoSmithKline Other Partners LabCorp co-authored with Bristol Myers Squibb an abstract released in March 2021 on the distribution and prevalence of LAG-3 expression in samples of melanoma and gastric/gastroesophageal junction cancer for the American Association for Cancer Research Annual Meeting 2021. Immutep’s other licensing partnerships with Novartis, EOC Pharma and CYTLIMIC continue to progress well. Financial Summary - Q3 FY21 Cash receipts from customers for the quarter was $59k, compared to $336k in Q2 (i.e. the quarter ended 31 December 2020). The net cash used in G&A activities in the quarter was $242k compared to $1.82 million in Q2. The significant decrease compared with last quarter is mainly due to the prepayment of certain annual expenses in Q2. G&A costs for the quarter includes $125k in payment of Non-Executive Director’s fees and Executive Director’s remuneration. The net cash used in Research and Development activities in the quarter was $1.74 million, compared to $3.18 million in Q2. Year to date cash flow used in R&D activities for the 9 months from July 2020 to March 2021 was $7.0 million compared to $16.1 million for the 9 months from July 2019 to March 2020. The decline is mainly due to the declining AIPAC expenses since patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase. The cash used in R&D activities is expected to increase with the commencement of the new Phase IIb TACTI-003 clinical trial. Total net cash outflows used in operating activities in the quarter was $3.05 million. In comparison, total net cash outflows from operating activities in Q2 was $5.58 million. The cash and cash equivalent balance as at 31 March 2021 was $51.7 million compared to a balance of $54.9 million as at 31 December 2020. Immutep is in an excellent financial position with a cash runway into calendar year 2023 and beyond several significant data read-outs. About Immutep Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer, infectious disease and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States. Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein, 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:
|