Immutep Quarterly Activities Report Q3 FY24
Immutep provides an update on its product candidates development, including positive clinical data in breast cancer and head and neck squamous cell carcinoma patients, progress in various phase II and III trials, appointment of a new director, and financial summary. The Company remains well-funded with a cash balance of approximately $95.4 million as of March 31, 2024.
Positive clinical data in metastatic breast cancer patients showing a 50% overall response rate and a 100% disease control rate with efti.
Positive preliminary results in first-line head and neck squamous cell carcinoma patients with a 26.9% overall response rate and a 57.7% disease control rate.
Excellent overall survival rates across all levels of PD-L1 expression in 1L NSCLC patients in the TACTI-002 trial.
Progress in various phase II and III trials for different cancer types, including NSCLC, HNSCC, urothelial carcinoma, and soft tissue sarcoma.
A new independent non-executive director, Anne Anderson, joined Immutep's Board bringing extensive experience in capital markets and governance.
Termination of the exclusive License and Research Collaboration Agreement with GSK for the development of GSK2831781, with no expected material impact on the financial statements.
Net cash outflows used in operating activities in the quarter increased to $9.0 million compared to $5.5 million in the previous quarter mainly due to the receipt of $3.8 million in R&D tax grants in the previous quarter.
The preliminary clinical outcomes, such as the reported 90mg dosing safety and efficacy in the AIPAC-003 trial for metastatic breast cancer, are promising. An overall response rate of 50%, including a patient with a complete response, is notable considering the disease's severity. These results could potentially lead to a paradigm shift in treatment approaches if the data remains consistent in larger trials and ultimately receives regulatory approval. The 100% disease control rate suggests that all patients experienced at least some benefit from the treatment, which is significant. However, investors should be cautious and look for the randomized Phase II outcomes to validate these initial findings and establish the treatment's efficacy definitively. It's also important to recognize that biotech companies like Immutep often have volatile stock prices that can be significantly impacted by the success or failure of their clinical trials.
Immutep's announcement of extending its cash reach into early CY2026 with a balance of approximately $95.4 million is a strong indicator of the company's financial health. This runway provides assurance to investors that the company can sustain its R&D activities without the immediate need for additional financing, which could dilute share value. Additionally, the consistent R&D expenses quarter over quarter reflect a steady investment in their product development. Any fluctuations in financials should be closely watched in subsequent quarters, as they could indicate changes in the company's operational efficiency or strategic direction. Investors should also monitor the consequences of the termination of the GSK collaboration agreement, ensuring the company's revenue streams are not overly dependent on any single partnership.
Media Release
- First clinical data from the safety lead-in of AIPAC-003 in metastatic breast cancer shows 90mg dosing of efti safe and well tolerated:
50% overall response rate, including one patient reporting a complete response (complete disappearance of all lesions), and a100% disease control rate - Subsequent to quarter end announced a positive preliminary response rate of
26.9% in first line metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression - Preclinical studies of IMP761 progressing to clinical trials mid-CY2024
- Anne Anderson joins as independent non-executive director on Immutep’s Board
SYDNEY, AUSTRALIA, April 29, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies 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 March 2024 (Q3 FY24).
EFTI DEVELOPMENT PROGRAM FOR CANCER
TACTI-002 (KEYNOTE-PN798) – Phase II clinical trial in 1L NSCLC
The TACTI-002 trial is ongoing with Immutep continuing to follow patients with 1L NSCLC (Part A) where, encouragingly, a median Overall Survival has not yet been reached in patients with high PD-L1 expression (TPS ≥
TACTI-003 (KEYNOTE-PNC34) – Phase IIb clinical trial in 1L HNSCC
The TACTI-003 multicenter Phase IIb trial evaluating efti in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) is ongoing with a total of 171 first line head and neck squamous cell carcinoma (1L HNSCC) patients enrolled. Cohort A evaluating efti in combination with KEYTRUDA® as compared to KEYTRUDA® monotherapy (randomised) involves 138 patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours and Cohort B (non-randomised) includes 33 patients with PD-L1 negative tumours.
Subsequent to quarter end Immutep announced positive preliminary topline results from Cohort B. The investigational immuno-oncology combination demonstrates an overall response rate (ORR) of
The final number of evaluable patients in Cohort B is expected to be higher and additional data, including complete response rate, is expected to be released together with Cohort A data. Data collection, cleaning, and analysis continue for TACTI-003, and the Company expects to report the primary endpoint (overall response rate according to RECIST1.1) from Cohorts A & B in H1 CY2024.
TACTI-004 – Phase III registrational trial in 1L NSCLC
Immutep continued to advance the necessary preparations for the Phase III TACTI-004 trial in first line non-small cell lung cancer (1L NSCLC) during the quarter. Productive interactions with regulatory agencies as well as with other stakeholders and potential partners are ongoing. Immutep expects to announce the trial design for TACTI-004 in H1 CY2024.
AIPAC-003 – Integrated Phase II/III trial in MBC
Immutep announced the first clinical data from the 90mg dosing of efti, the highest dose ever administered to patients, from patients participating in the safety lead-in of the AIPAC-003 trial in metastatic breast cancer (MBC). Data from the six patients in the safety lead-in showed the 90mg dose of efti in combination with paclitaxel is safe and well tolerated. The initial efficacy data was also encouraging, with a
INSIGHT-003 – Phase I in non-squamous 1L NSCLC
The investigator-initiated INSIGHT-003 trial continued to enrol patients throughout the quarter, with 38 out of a total of 50 patients enrolled and safely dosed across six sites in Germany. INSIGHT-003 evaluates a triple combination therapy consisting of efti and an approved standard of care combination of chemotherapy (carboplatin and pemetrexed) and anti-PD-1 therapy (pembrolizumab) in patients as first line treatment in non-squamous NSCLC adenocarcinomas.
INSIGHT-005 – Phase I trial in Urothelial Carcinoma
The first patient in the investigator-initiated INSIGHT-005 trial was enrolled and safely dosed, as announced in January 2024. The study is evaluating efti and the anti-PD-L1 therapy BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial cancer and is jointly funded with Merck KGaA, Darmstadt, Germany.
EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma
The investigator-initiated EFTISARC-NEO trial is ongoing with 14 patients now enrolled and safely dosed. The study evaluates efti in combination with pembrolizumab and radiotherapy in up to 40 soft tissue sarcoma (STS) patients in the neoadjuvant (prior to surgery) setting.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
IMP761 is the Company’s proprietary preclinical candidate and world’s first LAG-3 agonist that aims to treat the underlying cause of multiple autoimmune diseases. Throughout the quarter, Immutep progressed its pre-clinical development and IND-enabling toxicology studies for IMP761 to evaluate the safety and toxicity of its product candidate before entering first-in-human trials.
Subsequent to quarter end, Immutep entered into an agreement with the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands specializing in cutting-edge early-stage clinical drug research, to perform a first-in-human clinical study of IMP761, which it expects to begin mid-CY2024.
GLAXOSMITHKLINE (GSK) - IMP731 (GSK2831781)
As detailed in Immutep’s half year report in February 2024, Immutep received from GSK a written notice of termination of its exclusive License and Research Collaboration Agreement with GSK entered into in 2010 for the development of GSK2831781, a LAG-3 depleting antibody derived from Immutep’s IMP731 antibody, targeting autoimmune disease, with an effective termination date of 30 May 2024. The Company expects no material impact on the financial statements due to the termination.
CORPORATE & FINANCIAL SUMMARY
Board Appointment
In February 2024, Anne Anderson was appointed as an independent non-executive director of Immutep Limited. Ms Anderson has extensive board and leadership experience serving Australian and international companies and brings considerable capability across capital markets, risk management and governance to Immutep’s Board.
Cash Flow Summary
During the quarter, Immutep continued to fund the advancement of its clinical trial programs for efti and preclinical program for IMP761 to create value for shareholders. The Company is well funded with a strong cash and cash equivalent balance as at 31 March 2024 of approximately
Cash receipts from customers in Q3 FY24 were
The net cash used in R&D activities in the quarter was
Total net cash outflows used in operating activities in the quarter was
About Immutep
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 patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
+61 (0)406 759 268; cstrong@citadelmagnus.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
What positive clinical data was reported in metastatic breast cancer patients?
What were the positive preliminary results in first-line head and neck squamous cell carcinoma patients?
Who is the new director that joined Immutep's Board?
What is Immutep's cash balance as of March 31, 2024?
What agreement was terminated with GSK?
What was the net cash outflows used in operating activities in the quarter?
