On July 23, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported an update on the ongoing development of its product candidates, eftilagimod alpha ("efti" or "IMP321") and IMP761, the activity of its partners, and the minimal impacts to the business from the COVID-19 pandemic (Press release, Immutep, JUL 24, 2020, View Source [SID1234562316]).
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Protecting the health of patients recruited into our clinical trials and our employees continues to be a focus for Immutep during the COVID-19 pandemic. Pleasingly, none of our employees have been infected with the virus. We have also been working closely with the clinical sites and regulators to monitor the situation and make any necessary adjustments to trial protocols to diminish risks to patients.
To date, the Company has not seen a significant impact on the pace of trial recruitment for its two actively recruiting trials: TACTI-002 and INSIGHT-004. TACTI-002 is now 74% recruited and INSIGHT-004 reached full recruitment during the quarter. AIPAC has been fully recruited since June 2019.
Eftilagimod Alpha Clinical Update
TACTI-002 – Phase II clinical trial
TACTI-002 is evaluating the combination of efti with KEYTRUDA (pembrolizumab) in up to 109 patients with second line HNSCC or NSCLC in first and second line.
During the quarter, Immutep has continued to report consistently encouraging findings from its TACTI-002 study. The most recent results presented at ASCO (Free ASCO Whitepaper) in June reported the first Complete Response (complete disappearance of target lesion) from a patient with second line HNSCC (Part C). The Overall Response Rate according to iRECIST (iORR) of this group is 38.9% and 44% of patients were still under therapy. For patients with first line NSCLC (Part A) progression-free survival (PFS) is estimated to be more than 9 months, which is a very encouraging achievement for patients with such advanced cancer. The iORR for this group is 53% and 71% of patients had tumour shrinkage. Most importantly, responses have been observed regardless of the PD-L1 expression status. The trial continues to report a good safety profile from the combination. Recruitment for Part A of the study has recently been completed, while recruitment is ongoing for Part B (second line NSCLC) and for stage 2 of Part C (second line HNSCC). In total, 81 patients out of up to 109 patients (74%) are already enrolled and participating in the trial.
Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000
ABN: 90 009 237 889
LOGO
Further results are expected to be reported throughout calendar year 2020.
AIPAC – Phase IIb clinical trial
AIPAC is evaluating efti in combination with paclitaxel, a standard of care chemotherapy, in patients with metastatic breast cancer. Following the read out of PFS data from AIPAC in March 2020, Immutep has continued to explore the favourable results demonstrated in multiple predefined patient subgroups in greater detail. Overall, the PFS results showed that efti provided an improvement for patients compared to the placebo group at the 6-month landmark and an increase in ORR of 48.3% compared to 38.4% in the placebo group.
Importantly, Overall Survival (OS) results are expected to be reported from AIPAC by the end of calendar year 2020.
INSIGHT-004 – Phase I clinical trial
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. It is the 4th arm of the ongoing INSIGHT Phase I clinical trial which is being conducted by trial sponsor, the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany ("IKF").
In April 2020, INSIGHT-004 reached full recruitment and first data was reported in May 2020. Encouraging early efficacy signals have been observed in a variety of cancer indications and, overall, Partial Responses have been reported in 4 of the 12 patients. Importantly, thus far, the combination treatment of efti and avelumab is safe and well tolerated.
Further data from the study is expected to be reported throughout calendar year 2020.
Efti Manufacturing
The Company plans to manufacture two new 200L batches of efti in FY21 which will provide sufficient material to complete the current clinical program. During the quarter, Immutep postponed its efti up-scaling manufacturing program at the WuXi Biologics manufacturing plant (Wuxi, China). The program aims to upscale the manufacturing process from 200L to 2,000L single-use bioreactors to prepare for potential commercial manufacturing and additional registration trials in multiple indications. Immutep will recommence the 2000L manufacturing program as its clinical development program for efti advances.
Separately, Immutep’s partner in China, EOC Pharma, has started upscaling manufacturing for efti to 2,000L.
IMP761 Preclinical Update
IMP761 is an immunosuppressive agonist antibody to LAG-3 for the treatment of autoimmune diseases, such as inflammatory bowel diseases, rheumatoid arthritis, and multiple sclerosis. The Company’s manufacturing partner for IMP761, Batavia Biosciences, reported significant progress in the cell line development of IMP761, delivering a pharmaceutical-grade, stable CHO cell line that produces sufficient yields for clinical development. The program is now working on the completion of the cell line development.
Partner Updates
EOC Pharma
Immutep’s partner and Chinese licensee, EOC Pharma, is evaluating efti (designated as EOC202 in China) in patients with metastatic breast cancer in a Phase I study in China, called EOC202A1101.
During the quarter, EOC Pharma confirmed its plans to continue advancing efti through clinical trials following its analysis of the PFS data, including subgroup analysis, from Immutep’s Phase IIb AIPAC study, detailed above. This includes manufacturing scale up work, also detailed above.
CYTLIMIC
CYTLIMIC is evaluating efti in two Phase I clinical trials as part of a therapeutic vaccine, known as CYT001, in patients with advanced or metastatic solid cancer.
In June 2020, CYTLIMIC reported interim results from its second Phase I study in the neoadjuvant setting before surgery, called YCP02, showing that tumour cell death and infiltration of CD8 T cells into hepatocellular carcinoma surgical samples was observed in 6 out of 9 patients.
GSK
Clinical Proof-of-Concept data is expected in 1H of calendar year 2021 from GSK’s ongoing Phase II trial of GSK’781 in ulcerative colitis.
Financials
Cash receipts from customers for the quarter were $0.13 million, compared to $0.22 million in Q3 FY2020. Cash receipts from government grants and tax incentives for the quarter were $5.1 million, compared to nil in Q3 FY2020.
The net cash used in G&A activities in the quarter was $0.36 million compared to $0.49 million in Q3 FY2020. G&A costs for the quarter includes $171K in payment of Non-Executive Director’s fees and Executive Director’s salary.
Total net cash inflows from operating activities in the quarter was $0.12 million. In comparison, total net cash outflows used in the operating activities in Q3 FY2020 were $6.09 million.
The net cash used in Research and Development activities in the last quarter was $3.77 million, compared to $4.71 million in Q3 FY2020. R&D expenditure is expected to continue to decline further over the remaining two quarters of this calendar year as almost all patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase.
Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000
ABN: 90 009 237 889
In April 2020, Immutep raised A$12 million before transaction costs via a Placement. The proceeds are being used to continue the LAG-3 related programs, including the ongoing clinical development of efti and the development of IMP761.
The cash balance as at 30 June 2020 was $26.3 million compared to a balance of $16.1 million as at 31 March 2020. The Company’s cash runway is expected to extend beyond several significant data catalysts to the end of calendar year 2021.
A copy of the Appendix 4C – Quarterly Cash Flow Report for the quarter is attached.