Encouraging clinical results from TACTI-002 and INSIGHT-004 trials of eftilagimod alpha
completed recruitment for Stage 1 of Part B in TACTI-002 Study
Granted United States patent relating to eftilagimod alpha and LAG525
SYDNEY, Australia, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, today provided a business update for the quarter ended September 30, 2020, including for the ongoing development of its product candidates, eftilagimod alpha (“efti” or “IMP321”) and IMP761, and the activity of its new and existing partners.
“During the quarter, we continued to report supportive clinical data from our trials of efti in multiple cancers. These data have further bolstered our confidence in the therapeutic potential for these assets as we enter discussions with potential out licensing and collaboration partners. We already have committed partnerships in place with five of the world’s largest pharmaceutical companies: Merck, Pfizer, Merck MSD, Novartis and GSK, plus our partner in China, EOC Pharma, which give us confidence that we can build on our LAG-3 leadership position,” said Marc Voigt, CEO of Immutep.
Eftilagimod Alpha Clinical Updates
TACTI-002 - Phase II clinical trial
In September, Immutep presented encouraging interim results from its TACTI-002 Phase II trial in two poster presentations at the ESMO Virtual Congress 2020. These results showed three patients had complete responses (complete disappearance of all lesions) to the combination therapy of efti with KEYTRUDA® (pembrolizumab). Two of these patients had second-line head and neck squamous cell carcinoma (HNSCC) and one had first-line non-small cell lung cancer (NSCLC). Five partial responses were reported from patients (across both indications) with negative (< 1%) or moderate PD-L1 expression. Pembrolizumab monotherapy is typically less effective in these patients.
A median Progression Free Survival (PFS) of 4.3 months was achieved for patients with second-line HNSCC and 47% of these patients were progression free at the six-month landmark in this very aggressive late-stage disease. For first-line NSCLC patients, median PFS continues to improve and is 11.8 months. The combination treatment continues to be safe and well tolerated with no new safety signals reported thus far.
In August, Immutep enrolled and safely dosed the last patient for Stage 1 of Part B (second-line NSCLC) of the TACTI-002 study, completing recruitment of this stage. Recruitment is also complete for both stages of Part A (first-line NSCLC) and is ongoing for Stage 2 of Part C (second-line HNSCC). Pending the Data Monitoring Committee’s recommendation, Immutep will consider opening Stage 2 of Part B for recruitment. Overall, recruitment for the trial continues to progress well, with 92 out of up to 109 patients now enrolled.
The TACTI-002 study is evaluating the combination of efti with Merck & Co’s KEYTRUDA® (pembrolizumab) in up to 109 patients with second line HNSCC or NSCLC in first and second line.
INSIGHT-004 - Phase I clinical trial
In September, Immutep reported improving interim data from its INSIGHT-004 trial of efti at the ESMO Virtual Congress 2020. In the trial 41.7% of patients showed a Partial Response to the combination therapy of efti and avelumab, building on the previous interim data of 33%.
More importantly, the trial also reported encouraging early anti-tumour activity signals across a variety of cancer indications not typically sensitive to immune checkpoint inhibitor (ICI) therapy, including PD-L1-negative cervical cancer, squamous anal cell carcinoma, and mesothelioma. The combination of efti and avelumab continues to be safe and well tolerated.
INSIGHT-004 is evaluating the combination of efti with avelumab, a human anti-PD-L1 antibody, in 12 patients with different advanced solid malignancies, primarily gastrointestinal indications. The trial is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., as the fourth arm of the ongoing INSIGHT Phase I clinical trial. The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany (“IKF”) is the trial sponsor for INSIGHT-004.
IMP761 Preclinical Update
Immutep is continuing cell line development for IMP761, an immunosuppressive agonist antibody to LAG-3 for the treatment of autoimmune diseases, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis.
In August, Immutep and its research partner, Monash University, were awarded a A$671,427 grant under the Australian Research Council’s Linkage Project scheme to support their research collaboration into Lymphocyte Activation Gene-3 (LAG-3) for a further three years. The collaboration commenced in 2017.
Novartis has five clinical trials ongoing for LAG525 (Ieramilimab) in multiple cancer indications, including a Phase II clinical trial in triple negative breast cancer. According to the Novartis second quarter 2020 earnings call a regulatory submission is planned for LAG525 in 2023.
Immutep’s other partnerships with GlaxoSmithKline, EOC Pharma and CYTLIMIC continue to progress well.
In August, the United States Patent and Trademark Office granted Immutep a new patent entitled “Combined Preparations for the Treatment of Cancer”. The new patent relates to the use of efti in combined therapeutic preparations with a chemotherapy agent and follows the grant of similar European, Australian and Japanese patents in May 2019, June 2019 and May 2020, respectively. The expiry date of this United States patent is 25 January 2035.
In July, a new patent was granted by the United States Patent and Trademark Office entitled “Antibody molecules to LAG-3 and uses thereof”. The patent relates to embodiments of LAG525, a humanised form of Immutep’s IMP701 antibody, which is out-licensed to Novartis AG. The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 26 March 2035.
Financials for the First Quarter of FY2021 (Ended 30 September 2020)
Cash receipts from customers for the first quarter fiscal year 2021 were $23,000, compared to $128,000 in the fourth quarter of fiscal year 2020. Cash receipts from government grants and tax incentives for the quarter were $126,000, compared to $5.1 million in fourth quarter of fiscal year 2020.
The net cash used in G&A activities in the quarter was $350,000 compared to $360,000 in the fourth quarter of fiscal year 2020. G&A costs for the quarter includes $127,000 in payment of non-executive director’s fees and executive director’s salary.
Total net cash outflows used in operating activities in the quarter was $3.34 million. In comparison, total net cash inflows from the operating activities in the fourth quarter of fiscal year 2020 were $120,000.
The net cash used in Research and Development activities in the quarter was $2.10 million, compared to $3.77 million in fourth quarter of fiscal year 2020. R&D expenditure declined further as all patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase.
Interest paid of $6,000 is the interest component of the office lease under the application of AASB 16 Leases.
The Company reported a cash balance as at 30 September 2020 of $22.7 million, compared to a cash balance of $26.3 million as at 30 June 2020. The Company’s cash runway is expected to extend to the end of calendar year 2021, beyond several significant data read-outs.
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