Full Press Release Details
Immutep Quarterly Activities Report & Appendix 4C
SYDNEY, AUSTRALIA 27 April 2023
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune
diseases, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for the quarter ended 31 March 2023 (Q3 FY23).
EFTI DEVELOPMENT PROGRAM FOR CANCER
progress during the quarter to advance its clinical development strategy to position the company, or a potential partner, to fully exploit efti s broad potential.
AIPAC-003 Phase II/III trial in Metastatic Breast Cancer (MBC)
In March, Immutep initiated AIPAC-003 (Active Immunotherapy PAClitaxel), its integrated Phase
II/III trial evaluating efti in combination with paclitaxel for the treatment of HER2-neg/low metastatic breast cancer and triple-negative breast cancer. These two indications account for ~78% of breast cancer
cases. The trial commenced following the regulatory approval in the United States and Institutional Review Board (IRB) approval in Spain. Immutep anticipates enrolling the first patient in Q2 CY2023.
As a first-in-class soluble LAG-3
protein targeting MHC Class II ligands on antigen-presenting cells (APC), efti is well positioned to improve clinical outcomes from standard-of-care chemotherapy
due to its unique mechanism of action. Its activation of APC triggers a broad immune response that includes significant increases in cytotoxic CD8+ T cells armed with chemo-induced tumour antigens
The AIPAC-003 trial employs an integrated clinical design agreed to with the FDA to help inform
a potential Biologics License Application (a request for permission to sell a biologic product) and a potential Marketing Authorisation Application with the European Medicines Agency (EMA). This trial design also allows for a risk-balanced approach
with the Phase III portion dependent on the Phase II results, among other items.
Immutep Limited, Level 33, Australia Square
264 George Street, Sydney NSW 2000
TACTI-002 (also designated KEYNOTE-PN798) Phase II clinical trial
Positive final data on safety and efficacy was reported from Part B of the TACTI-002 trial in patients with
2nd line non-small cell lung cancer (NSCLC) refractory to anti-PD-(L)1 therapies in a Mini Oral presentation at ESMO s
European Lung Cancer Congress (ELCC) 2023. These patients have few therapeutic options, and the addition of efti to pembrolizumab may help these patients by reverting the confirmed
anti-PD-(L)1 therapy resistance.
The Company reported encouraging
clinical results, including an Overall Survival (OS) rate of 39% at 21 months. In addition, 83% of patients studied for Tumour Growth Kinetics showed deceleration (50%) in tumour growth or shrinkage (33%) of target lesions. Responses were confirmed
and durable with responders participating in the study for more than 19 months.
The ORR, PFS, and OS were more pronounced in patients with high PD-L1 expression (N=6) or who were secondary resistant (N=25). For patients with 50% PD-L1 TPS expression, median OS was not yet reached, overall response rate (ORR)
was 33.3%, and 6-month progression-free survival (PFS) was 50%. Efti plus pembrolizumab was well tolerated without any new safety signals, and there was no treatment discontinuation due to adverse reactions.
TACTI-003 Phase IIb clinical trial in 1st line HNSCC
In early 2023 Immutep announced it has successfully enrolled over 50% of the planned 154 patients into the randomised Phase IIb
TACTI-003 trial. Subsequent to quarter end TACTI-003 has reached 75% enrolment, and Immutep expects to complete enrolment by
mid-year positioning the Company to report top-line results in H2 of CY2023.
Planned late-stage trial in 1st line NSCLC
continuing its preparations for a late-stage trial evaluating efti in 1st line NSCLC in combination with anti-PD-1 therapy. The NSCLC program will be shaped by the
maturing data from the Company s ongoing TACTI-002 and INSIGHT-003 trials. Current activity is focused on trial design and engagement with regulatory authorities
and other stakeholders. The Company obtained US FDA Fast Track designation late last year for this indication.
INSIGHT-003 Phase I in 1st line NSCLC
In February, the investigator-initiated INSIGHT-003 trial reached its enrolment target of 20 patients with 1st line
NSCLC for this first triple combination therapy study of efti with standard-of-care combination of
anti-PD-1 therapy and chemotherapy. INSIGHT-003 has been now extended to include a total of 50 patients. The expansion of INSIGHT-003 will further inform planning for registrational studies.
Level 33, Australia Square
264 George Street, Sydney NSW 2000
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASES
During the first quarter, our preclinical development continued for IMP761, including preparations to begin the toxicology study. As the first
immunosuppressive agonist antibody to LAG-3 acting upstream on activated T cells to target the root cause of self-antigen-specific T cell induced disease, IMP761 is a potential game-changer in how autoimmune
diseases are treated. The Company currently anticipates that clinical development will begin in the first half of CY2024.
INTELLECTUAL PROPERTY
During the quarter, Immutep was granted three new patents directed to efti. The first is a United States patent drawn to methods of treating cancer
with a combination of efti and chemotherapy, where the efti is administered in a dose of more than 6 mg. This is the third United States patent granted from this family.
The second patent is an Indian patent that protects Immutep s intellectual property relating to combined preparations of efti with a PD-1/PD-L1 therapy for the treatment of cancer or infection. The third patent is an Australian patent which relates to a potency assay for release testing of efti. The assay
is used in Immutep s commercial-scale (2,000L) manufacturing process. This new Australian patent follows the grant of a similar patent in South Korea in 2022.
BOARD AND MANAGEMENT CHANGES
On 11 April, Lis Boyce
was appointed as Non-Executive Director replacing Lucy Turnbull, who re-joined the board after the sudden and untimely death of Grant Chamberlain in January 2022. The
Board is grateful to Lucy for stepping in under such tragic circumstances and for her boundless energy and valued insights.
Ms Boyce is a highly
experienced corporate lawyer and currently a partner at Piper Alderman. She has extensive experience in the Life Sciences and Healthcare sectors as well as in capital raisings, strategic collaborations, commercial contracts and mergers and
acquisitions. Lis is currently deputy chair of AusBiotech s AusMedtech Advisory Group and a member of AusBiotech s State Committee for NSW.
26 April, Immutep announced that it expanded its leadership team with the appointment of Florian D. Vogl, M.D., Ph.D., MSc., as Chief Medical Officer (CMO) with effect from 1 May 2023. Dr. Vogl has over a decade of experience in the
biopharmaceutical industry with extensive clinical development expertise in the field of oncology. Most recently, he was CMO of Cellestia Biotech where he focused on delivering new treatments to patients with cancer and autoimmune disorders that had
limited therapeutic options. Prior to Cellestia, Dr. Vogl held senior management roles in Europe and the United States, including Head of Clinical Development Europe at Rainier Therapeutics, Senior Global Medical Leader, Oncology Development at
Novartis, and as Early Development Leader, Oncology Pipeline at Amgen.
Dr. Vogl assumes the CMO role from Fr d ric Triebel, M.D.,
Ph.D., who previously acted as both Chief Scientific Officer (CSO) and CMO of Immutep. Dr. Triebel s foremost focus will be on his responsibilities as CSO and as a member of Immutep s Board.
Immutep continued to focus on prudent
cash management during the past quarter (Q3 FY23). The Company remains well funded with a cash runway extending to the end of FY24.
Level 33, Australia Square
264 George Street, Sydney NSW 2000
Cash receipts from customers in the quarter increased to $30k, compared to $8k in Q2 FY23. The net cash used
in G&A activities in the quarter was $1.12million compared to $734k in Q2 FY23. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter, includes $257k in payments for
Non-Executive Director s fees and Executive Director s remuneration.
The net cash used in R&D
activities in the quarter was $11.52 million, compared to $5.87 million in Q2 FY23. The increase was mainly due to the increased clinical trial and manufacturing activities.
Total net cash outflows used in operating activities in the quarter were $14.17 million compared to $7.02 million in Q2 FY23.
Immutep s cash and cash equivalent balance at 31 March 2023 was approximately $55.2 million, giving the Company an expected cash reach based on
current estimates to June 2024. Immutep will continue to manage its solid cash balance carefully as it pursues its overall clinical development strategy.
A copy of the Appendix 4C Quarterly Cash Flow Report for the quarter is attached.
Immutep is a clinical stage biotechnology
company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its
expertise to bring innovative treatment options to market for patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com or contact:
Australian Investors/Media:
+61 (0)406 759 268; cstrong@citadelmagnus.com
U.S. Media/Investors:
Chris Basta, VP, Investor Relations
and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
This announcement was authorised for release by the Board of Immutep Limited.
Level 33, Australia Square
264 George Street, Sydney NSW 2000
Quarterly 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 March 2023 |
| Consolidated statement of cash flows | Current quarter $A 000 | Year to date (9 months) $A 000 | ||||||||
| 1. | Cash flows from operating activities | |||||||||
| 1.1 | Receipts from customers | 30 | 71 | |||||||
| 1.2 | Payments for | |||||||||
| (a) research and development | (11,524 | ) | (24,560 | ) | ||||||
| (b) product manufacturing and operating costs | ||||||||||
| (c) advertising and marketing | (83 | ) | (305 | ) | ||||||
| (d) leased assets | ||||||||||
| (e) staff costs | (1,666 | ) | (4,408 | ) | ||||||
| (f) administration and corporate costs | (1,117 | ) | (2,446 | ) | ||||||
| 1.3 | Dividends received (see note 3) | |||||||||
| 1.4 | Interest received | 196 | 499 | |||||||
| 1.5 | Interest and other costs of finance paid | (2 | ) | (32 | ) | |||||
| 1.6 | Income taxes paid | |||||||||
| 1.7 | Government grants and tax incentives | 3,645 | ||||||||
| 1.8 | Other (provide details if material) | |||||||||
| 1.9 | Net cash from / (used in) operating activities | (14,166 | ) | (27,536 | ) | |||||
| 2. | Cash flows from investing activities | |||||||||
| 2.1 | Payments to acquire or for: | |||||||||
| (a) entities | ||||||||||
| (b) businesses | ||||||||||
| (c) property, plant and equipment | (1 | ) | (44 | ) | ||||||
| (d) investments | ||||||||||
| (e) intellectual property | ||||||||||
| (f) other non-current assets |
| 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 (9 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 | 16 | |||||||||
| 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 | (1 | ) | (28 | ) | |||||
| 3. | Cash flows from financing activities | |||||||||
| 3.1 | Proceeds from issues of equity securities (excluding convertible debt securities) | |||||||||
| 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 | |||||||||
| 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) | (46 | ) | (150 | ) | |||||
| 3.10 | Net cash from / (used in) financing activities | (46 | ) | (150 | ) | |||||
| 4. | Net increase / (decrease) in cash and cash equivalents for the period | |||||||||
| 4.1 | Cash and cash equivalents at beginning of period | 68,376 | 79,995 | |||||||
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (14,166 | ) | (27,536 | ) |
| 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 (9 months) $A 000 | ||||||||
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | (1 | ) | (28 | ) | |||||
| 4.4 | Net cash from / (used in) financing activities (item 3.10 above) | (46 | ) | (150 | ) | |||||
| 4.5 | Effect of movement in exchange rates on cash held | 1,038 | 2,920 | |||||||
| 4.6 | Cash and cash equivalents at end of period | 55,201 | 55,201 | |||||||
| 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 | 32,023 | 45,179 | |||||||
| 5.2 | Call deposits | 19,625 | 22,895 | |||||||
| 5.3 | Bank overdrafts | |||||||||
| 5.4 | Other (provide details if material) | |||||||||
| -Term deposit | 3,553 | 302 | ||||||||
| -Restricted cash (Advance payment from shareholder for SPP) | ||||||||||
| 5.5 | Cash and cash equivalents at end of quarter (should equal item 4.6 above) | 55,201 | 68,376 | |||||||
| 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 | 257 | ||||||||
| 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 Non-Executive Directors fees and Executive Directors remuneration. |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 3 | |
| + See chapter 19 of the ASX Listing Rules for defined terms. |