Full Press Release Details
Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 25 January 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a
biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha
( efti ) and IMP761 for the quarter ended 31 December 2021.
Efti Development Program for Cancer
AIPAC - Phase IIb clinical trial - final data
reported final Overall Survival (OS) data from its Phase IIb AIPAC clinical trial evaluating efti in metastatic breast cancer (MBC) in November 2021, as a late breaker poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting.
The late-stage trial showed very encouraging OS data, including a statistically significant and clinically meaningful benefit in three patient predefined
subgroups representing a majority of patients. A survival benefit of +7.5 months was observed in patients < 65 years, reflecting a > 50% improvement compared to the control group. A +19.6 month survival benefit was seen in patients with low
monocytes, a benefit of > 150% compared to the control group. Lastly, a survival benefit of +4.2 months was reported in luminal B patients, reflecting a > 33% benefit compared to the control group. The data from these subgroups was improved
data versus the interim data presented by Immutep in December 2020.
In addition, a statistically significant Quality of Life preservation was
demonstrated in the first 6 months from patients in the efti group in the total population. A statistically significant increase in peripheral CD8 T cells in patients in the efti group of the total population was also observed and positively
correlated with improved OS.
These final results have given Immutep additional confidence efti can deliver a meaningful clinical improvement for diverse
sets of cancer patients, as the Company started its preparations for a larger clinical trial in MBC via its Phase III clinical trial, AIPAC-003.
AIPAC-003 - planned Phase III trial
In October 2021, Immutep received positive feedback from the European Medicines Agency (EMA) regarding its clinical development program for efti. Immutep has
also been interacting with the US FDA and is providing additional information relating to efti s unique mechanism of action as an agonist that leads to T cell expansion and proliferation (rather than all other
LAG-3 products in development which are antagonists that block an immune checkpoint). Interactions with the EMA, US FDA and other regulators are ongoing. The feedback from competent authorities, along with
insights from a rigorous engagement process with Key Opinion Leaders and other stakeholders will help Immutep generate a final study design.
Immutep Limited, Level 33, 264 George St, Sydney NSW 2000
TACTI-003 - Phase IIb clinical trial
During the quarter, Immutep continued recruitment of patients for the TACTI-003 clinical trial. At present, 6 of
approximately 154 patients with 1st line HNSCC have been enrolled into the trial at active clinical sites. The study is in its start-up phase and additional
sites are planned to be initiated in the first quarter of 2022.
Immutep also presented the trial design for
TACTI-003 via a poster at the SITC 2021 conference in November 2021. It is a Phase IIb multicentre, open label, randomised and controlled trial. Fast track designation for 1st line HNSCC by the US FDA was granted in April 2021.
TACTI-002 (also designated KEYNOTE-PN798) - Phase II clinical trial
Immutep also reported data from the 2nd line HNSCC patients (Part C) of
TACTI-002 at the SITC 2021 conference.
Part C is showing encouraging antitumor activity. An encouraging Overall
Response Rate (ORR) was reported, with 29.7% of patients responding to the combination therapy of efti and pembrolizumab. In addition, a favourable duration and depth of responses was observed, with 5 Complete Responses and a minimum duration of
response extended to > 9 months across all responding patients. The responses continue to be reported in PD-L1 low and high expressors.
During the quarter, Immutep enrolled and dosed the last patient in the expansion stage of Part A (1st
line non-small cell lung cancer (NSCLC)), completing the recruitment of all cohorts of the TACTI-002 study.
A total of 189 patients are now participating in TACTI-002 across Parts A, B, and C at approximately 20 clinical sites
in Australia, Europe, and the US. Additional data from TACTI-002, particularly in NSCLC, are planned to be reported in the first half of calendar year 2022. Data from the 114 patients in Part A (1st line NSCLC) is expected to inform potential late-stage development of efti in this important indication.
INSIGHT is an investigator-initiated Phase I
trial at the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) investigating different combination treatments with efti and a different route of administration for efti. INSIGHT consists of 5 different arms from stratums A to E.
INSIGHT-003 triple combination
In December 2021, the first five patients were enrolled and safely treated in the INSIGHT-003 study, also referred to
as stratum C of INSIGHT. No additional safety signals were observed in the study which is the first time a triple combination therapy consisting of efti and an existing approved standard of care combination of chemotherapy (carboplatin) and an anti-PD-1 therapy has been administered.
Patient recruitment is ongoing with 6
out of a total of 20 patients with various solid tumours now participating in the trial. Interim results are expected to be reported in 2022.
INSIGHT-005 combination with bintrafusp alpha
INSIGHT-005, known as
stratum E of INSIGHT, will include 12 patients with solid tumours and will evaluate efti in combination with bintrafusp alfa. In the light of the suboptimal results from Merck KGaA s bintrafusp alpha in other studies, this arm of the INSIGHT
study is currently under review.
Immutep Limited, Level 33, 264 George St, Sydney NSW 2000
EAT COVID - Phase II clinical trial - ongoing
The investigator-initiated EAT COVID study is continuing at the University Hospital Pilsen in the Czech Republic. Immutep will provide an update on the trial
IMP761 Development Program for Autoimmune Disease
During the quarter, Immutep appointed Northway Biotech, an end-to-end
biopharmaceutical contract development and manufacturing organisation (CDMO), to manufacture IMP761 ahead of clinical testing.
Northway has commenced
development of a GMP-compliant manufacturing process of IMP761 and will manufacture IMP761 in large scale bioreactors. After Immutep completes the required preclinical development evaluations, the material
will be used for clinical trials of IMP761. Planning for preclinical and clinical development is ongoing.
Intellectual Property
Immutep was granted two new patents by the Chinese Patent Office, protecting Immutep s intellectual property relating to combined therapeutic preparations
comprising efti and either a PD-1 pathway inhibitor or a chemotherapy agent. These new patents follow the grant of corresponding patents in other key global markets announced previously.
Financial Summary Q2 FY221
Cash receipts from customers for the quarter were $14k, compared to $56k in Q1 FY22 (i.e., the quarter ended 30 September 2021).
The net cash used in G&A activities in the quarter was $0.2 million compared to $1.0 million in Q1 FY22. The difference compared with the last
quarter is mainly due to capital raising expenses included in Q1 FY22. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $217k 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 $4.67 million, compared to $6.83 million in Q1 FY22. The higher cash outflows in Q1 FY2022 is mainly due to an upfront payment associated with the commencement of the TACTI-003 clinical trial.
Total net cash outflows used in operating activities in the quarter was $6.06 million. In comparison, total net cash outflows from operating activities in Q1 FY22 was $5.37 million, which was net of the $3.42m research and development
(R&D) tax incentive payment received in cash in Q1 FY22 from the French Government under its Cr dit d Imp t Recherche scheme (CIR).
The Company s cash and cash equivalent balance as at 31 December 2021 was $99.66 million compared to a balance of $106.39 million as at
30 September 2021. Immutep s cash balance puts the company in a strong financial position with an estimated cash reach of December 2023.
of the Appendix 4C - Quarterly Cash Flow Report for the quarter is attached.
Level 33, 264 George St, Sydney NSW 2000
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 maximise value to shareholders.
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.
Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
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.
Immutep Limited, Level 33, 264 George St, Sydney NSW
cash flow report for entities
subject to Listing Rule 4.7B
| Name of entity | ||||
| Immutep Limited | ||||
| ABN | Quarter ended ( current quarter ) | |||
| 90 009 237 889 | 31 December 2021 |
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (6 months) $A 000 | ||||||||
| 1. | Cash flows from operating activities | |||||||||
| 1.1 | Receipts from customers | 14 | 70 | |||||||
| 1.2 | Payments for | (4,672 | ) | (11,502 | ) | |||||
| (a) research and development | ||||||||||
| (b) product manufacturing and operating costs | ||||||||||
| (c) advertising and marketing | (111 | ) | (210 | ) | ||||||
| (d) leased assets | ||||||||||
| (e) staff costs | (1,135 | ) | (2,141 | ) | ||||||
| (f) administration and corporate costs | (214 | ) | (1,189 | ) | ||||||
| 1.3 | Dividends received (see note 3) | |||||||||
| 1.4 | Interest received | 67 | 130 | |||||||
| 1.5 | Interest and other costs of finance paid | (5 | ) | (9 | ) | |||||
| 1.6 | Income taxes paid | |||||||||
| 1.7 | Government grants and tax incentives | 3,422 | ||||||||
| 1.8 | Other (provide details if material) | |||||||||
| 1.9 | Net cash from / (used in) operating activities | (6,056 | ) | (11,429 | ) | |||||
| 2. | Cash flows from investing activities | |||||||||
| 2.1 | Paymentsto acquire or for: | |||||||||
| (a) entities | ||||||||||
| (b) businesses | ||||||||||
| (c) property, plant and equipment | (5 | ) | (6 | ) | ||||||
| (d) investments | ||||||||||
| (e) intellectual property | ||||||||||
| (f) other non-current assets | (25 | ) | (25 | ) |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 1 | |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (6 months) $A 000 | ||||||||
| 2.2 | Proceeds from disposal of: | |||||||||
| (a) entities | ||||||||||
| (b) businesses | ||||||||||
| (c) property, plant and equipment | ||||||||||
| (d) investments | ||||||||||
| (e) intellectual property | ||||||||||
| (f) other non-current assets | ||||||||||
| 2.3 | Cash flows from loans to other entities | |||||||||
| 2.4 | Dividends received (see note 3) | |||||||||
| 2.5 | Other (provide details if material) | |||||||||
| 2.6 | Net cash from / (used in) investing activities | (30 | ) | (31 | ) | |||||
| 3. | Cash flows from financing activities | |||||||||
| 3.1 | Proceeds from issues of equity securities (excluding convertible debt securities) | 52,975 | ||||||||
| 3.2 | Proceeds from issue of convertible debt securities | |||||||||
| 3.3 | Proceeds from exercise of options | |||||||||
| 3.4 | Transaction costs related to issues of equity securities or convertible debt securities | (2,427 | ) | |||||||
| 3.5 | Proceeds from borrowings | |||||||||
| 3.6 | Repayment of borrowings | |||||||||
| 3.7 | Transaction costs related to loans and borrowings | |||||||||
| 3.8 | Dividends paid | |||||||||
| 3.9 | Other (provide details if material) -Payment for the finance lease liability under AASB 16) | (34 | ) | (97 | ) | |||||
| 3.10 | Net cash from / (used in) financing activities | (34 | ) | 50,451 | ||||||
| 4. | Net increase / (decrease) in cash and cash equivalents for the period | |||||||||
| 4.1 | Cash and cash equivalents at beginning of period | 106,385 | 60,593 | |||||||
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (6,056 | ) | (11,429 | ) |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 2 | |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (6 months) $A 000 | ||||||||
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | (30 | ) | (31 | ) | |||||
| 4.4 | Net cash from / (used in) financing activities (item 3.10 above) | (34 | ) | 50,451 | ||||||
| 4.5 | Effect of movement in exchange rates on cash held | (609 | ) | 72 | ||||||
| 4.6 | Cash and cash equivalents at end of period | 99,656 | 99,656 | |||||||
| 5. | Reconciliation of cash and cash equivalents at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts | Current quarter $A 000 | Previous quarter $A 000 | |||||||
| 5.1 | Bank balances | 39,947 | 26,505 | |||||||
| 5.2 | Call deposits | 59,407 | 71,251 | |||||||
| 5.3 | Bank overdrafts | |||||||||
| 5.4 | Other (provide details if material) -Term deposit -Restricted cash (Advance payment from shareholder for SPP) | 302 | 8,629 | |||||||
| 5.5 | Cash and cash equivalents at end of quarter (should equal item 4.6 above) | 99,656 | 106,385 |
| 6. | Payments to related parties of the entity and their associates | Current quarter $A 000 | ||||
| 6.1 | Aggregate amount of payments to related parties and their associates included in item 1 | 217 | ||||
| 6.2 | Aggregate amount of payments to related parties and their associates included in item 2 |
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
The amount at 6.1 includes payment of