Full Press Release Details
IMMUTEP QUARTERLY ACTIVITIES REPORT & APPENDIX 4C
SYDNEY, AUSTRALIA 22 January 2021 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
Following a succession of very
encouraging clinical trial results for efti reported throughout 2020, Immutep prioritised the process of scaling up the drug candidate s manufacturing, increasing the process from 200L to 2,000L capacity bioreactors. Manufacturing is taking
place at the WuXi Biologics manufacturing plant in Mashan, Wuxi, China. The major scale up steps are taking place throughout 2021.
Immutep reported first Overall Survival (OS) data (based on approximately 60% of patient events) from the AIPAC phase IIb trial
in a spotlight presentation at the San Antonio Breast Cancer Symposium 2020 in December. The results included a promising and improving overall trend in OS with a median survival benefit of +2.7 months from efti plus chemotherapy, compared to
chemotherapy plus placebo.
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.
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
In November 2020, Immutep presented very encouraging results from its TACTI-002 phase II trial of efti at the Society
for Immunotherapy of Cancer s (SITC) Congress. TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and
Canada) and is called Keynote-798 by MSD.
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 with 1st line NSCLC and three with 2nd line HNSCC) reported a complete disappearance of all lesions, known as a Complete Response.
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
Further data from TACTI-002 is expected in H1 2021.
Phase II Clinical Trial in Head and Neck Cancer
The encouraging results reported by Immutep at SITC in patients with 2nd line HNSCC prompted the Company to announce its intention to run a new randomised,
controlled phase II clinical study in approximately 160 1st line HNSCC patients which is a more commercially relevant indication. Patients will be 1:1 randomised to receive efti in combination with an anti-PD-1 treatment, or anti-PD-1 monotherapy. The trial is intended to take place across clinical trial sites in the United
States, Australia and Europe.
Immutep is continuing planning for this new trial and will announce further details in due course.
TACTI-mel - Phase I clinical trial
The results of Immutep s phase I TACTI-mel trial were recently published in the peer-reviewed Journal for
ImmunoTherapy of Cancer. TACTI-mel evaluated efti in combination with pembrolizumab in metastatic melanoma patients.
EAT COVID Phase II clinical trial
University Hospital Pilsen in the Czech Republic has commenced an investigator-initiated randomised phase II clinical trial evaluating efti in up to 110 hospitalised patients with COVID-19. Recruitment of
patients commenced in October 2020.
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, 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.
EOC Pharma - Phase II clinical
EOC Pharma announced its plans to conduct a new trial in December 2020, following Immutep s announcement of encouraging first OS data
from its Phase IIb study, AIPAC (see above).
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.
As announced today, GSK has
stopped its phase II clinical trial evaluating GSK2831781 (derived from Immutep s IMP731 antibody) in ulcerative colitis based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the
trial s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program. Immutep s collaboration
with GSK remains in place and GSK2831781 continues to be under an exclusive license with GSK. The discontinuation of the GSK trial has no impact on Immutep s three other product candidates all of which have different mechanisms of action,
including its lead product candidate eftilagimod alpha. Immutep s cash runway is also unimpacted.
Selected for its in-depth LAG-3 expertise and knowledge, Immutep entered into a
Licence and Collaboration Agreement with Laboratory Corporation of America Holdings, known as LabCorp, to support its development of immuno-oncology products or services in October 2020.
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
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
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.
A copy of the Appendix
4C -Quarterly Cash Flow Report for the quarter is attached.
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 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 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:
+61 (0)406 759 268; cstrong@citadelmagnus.com
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com
announcement was authorised for release by the board of Immutep Limited.