On April 21, 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, as well as its response to the COVID-19 pandemic and its potential business impact (Press release, Immutep, APR 21, 2020, View Source [SID1234556461]).
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COVID-19 update
Immutep has welcomed recent guidance from the United States Food and Drug Administration ("FDA"), European Medicines Agency ("EMA") and other regulators on how to continue ongoing clinical trials during the COVID-19 pandemic. Cancer patients have been recognised by regulators as at risk and vulnerable to COVID-19 infection due to their weakened immune system. The FDA and other regulators are actively helping trial sponsors and hospitals continue critical clinical trials through the pandemic.
For Immutep, the safety and wellbeing of its clinical trial participants and investigators are its absolute priority. The Company is working closely with the clinical sites and regulators to monitor the situation, with the impact to date on treatment of patients being limited. Immutep also continues to work with its Clinical Research Organisation (CRO) partners to verify data remotely and review clinical trial processes according to the new guidance.
The Company anticipates that trial recruitment may slow down for its two actively recruiting trials, TACTI-002 and INSIGHT-004 over the coming months, due to the closure of hospitals in certain countries that have been most affected, such as Spain and the United Kingdom. However, INSIGHT has already recruited 91% of total patients and TACTI-002 has recruited 70% of total patients. Both its AIPAC and TACTI-mel trials are fully recruited.
Immutep is also implementing strategies to account for any impact of the pandemic on its ongoing trial data, related to potential patient infection. These strategies are under constant re-evaluation. As COVID-19 response restrictions are lifted, the Company will conduct an impact analysis to evaluate the overall effects of the pandemic.
Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000
ABN: 90 009 237 889
LOGO
The Company’s own operations are minimally affected with increased home office work and less travel for the staff.
Eftilagimod alpha Clinical Update
TACTI-002-Phase II clinical trial
In mid-February, Immutep reported highly encouraging first data from its ongoing TACTI-002 study of efti in combination with pembrolizumab, an anti-PD-1 therapy. The data showed an Overall Response Rate (ORR)of 47% for patients in Part A, first line non-small cell lung cancer (NSCLC) patients who are receiving the combination treatment of efti with pembrolizumab. This compared very favorably to patients in Part A who are receiving pembrolizumab monotherapy and reported an initial ORR of approximately just 20%.
Trial recruitment continues to progress well, with 76 patients out of up to 109 already enrolled at 12 clinical sites across Australia, Europe, the UK and US. Details of recruitment for each Part are below.
Study—Part* Stage 1 (N)
Actual/target Stage 2 (N)
target
Part A—1st line NSCLC
17/17 17/19
Part B—2nd line NSCLC
18/23 -/13
Part C—2nd line met. HNSCC
18/18 6/19
Immutep was selected to provide a poster short talk presentation of new TACTI-002 data as part of the high- impact paper presentation program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, scheduled for 27 and 28 April. In addition, further data will be reported throughout 2020.
AIPAC-Phase IIb clinical trial
In March 2020, Immutep reported first results from its randomised, placebo controlled AIPAC trial in metastatic breast cancer. Patients receiving efti showed a positive trend in Progression Free Survival (PFS) rate at the 6-month landmark, with 63% of those who received paclitaxel plus efti being progression-free. This compared favourably to 54% of patients who received paclitaxel plus placebo. The ORR in the efti group was 48.3%, compared to 38.4% in the placebo group.
In addition, analysis on the trial subgroups showed that patients with a low monocyte count at baseline received a remarkable benefit from efti, with a median PFS of 7.29 months, compared to just 5.45 months in the placebo group (Hazard Ratio 0.61). Similarly, patients with a more aggressive, more immunogenic luminal B type also benefitted from efti with a median PFS of 7.29 months, compared to just 5.45 months in the placebo group (Hazard Ratio 0.65). Patients with lower general performance status at baseline also had a median PFS of 7.13 months compared to of 6.67 months in the placebo group (Hazard Ratio 0.76). These interesting subgroups are being discussed with the Company’s clinical advisory board as well as other partners and will be investigated further.
Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000
ABN: 90 009 237 889
LOGO
Further building upon efti’s strong safety profile to date, the combination of efti and paclitaxel chemotherapy was overall safe and well tolerated. For further information please also view the webcast available at www.immutep.com.
Immutep expects to report Overall Survival (OS) and immuno-monitoring results from AIPAC later in 2020. Together with the already reported data, this will inform the Company’s future strategy for efti in metastatic breast carcinoma.
In early March 2020, Immutep received approval for its second Investigational New Drug ("IND") application from the United States FDA for efti. The IND enables the Company to initiate a clinical study in metastatic breast cancer patients. It also enables Immutep to further interact with the FDA regarding the use of efti in metastatic breast cancer.
INSIGHT-004 -Phase I clinical trial
Patient recruitment is continuing for Cohort 2 (30 mg efti) of the INSIGHT-004 study with 5 out of 6 patients participating. Cohort 1 is already fully recruited, bringing total recruitment to 11 out of 12 patients. As previously reported, the study is showing encouraging, positive initial activity.
The INSIGHT-004 is being conducted as the 4th arm of the INSIGHT trial and evaluates the combination of efti with avelumab in 12 patients with advanced solid malignancies.
TACTI-mel-Phase I clinical trial
Immutep is preparing a clinical study report for its TACTI-mel trial which reported positive final efficacy data in late 2019. The study showed deep and durable responses to the combination of efti and pembrolizumab in patients with metastatic melanoma. 12 patients (50%) reported a decrease of ³ 75% in the target lesions and 9 patients (38%) were treated for ³ 12 months.
IMP761 Preclinical Update
Since the end of the quarter, Immutep has reported significant progress in the cell line development of its IMP761 immunosuppressive product candidate. A pharmaceutical-grade, stable CHO cell line has been developed that produces significantly high product yields of IMP761. Immutep will complete its preparations for the Good Manufacturing Practice (GMP) process compliance development phase, ahead of potential clinical testing of the compound in autoimmune disease.
Partner Updates
EOC Pharma
Following the recent APIAC results, Immutep discussed the analysis of the reported PFS data (including subgroup analysis) with its Chinese partner for efti, EOC Pharma. Subsequently, EOC confirmed it plans to continue advancing efti (designated as EOC202 in China) in metastatic breast cancer.
Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000
ABN: 90 009 237 889
CYTLIMIC
At the end of the quarter, Immutep’s partner, CYTLIMIC reported positive results from its YNP01 phase I clinical trial which is evaluating the combination immunotherapy of a HSP70 derived peptide, a GPC3 derived peptide, Immutep’s IMP321 (efti) and Hiltonol in patients with advanced or metastatic solid cancer.
The results showed that approximately 70% of patients showed an immune response to each peptide. Further notable results were observed at the recommended dose (which has been adopted in CYTLIMIC’s Investigator-Initiated Phase I Trial CRESCENT1), including a significant reduction of lymphocyte population expressing an exhaustion marker in the peripheral blood and an overall survival of 18 months or more in 5 out of 11 patients.
The results were published in the scientific peer-reviewed journal, Cancer Immunology, Immunotherapy.
Financials
Cash receipts for the quarter were $0.22 million, compared to $7.28 million in Q2 FY2020. Q2 FY2020 was boosted by a milestone payment of £4 million from GSK related to the first patient being dosed in GSK’S Phase II clinical trial evaluating GSK2831781 in ulcerative colitis.
The net cash used in G&A activities in the quarter was $0.49 million compared to $1.43 million in Q2 FY2020. The decrease reflected a return to normalised levels, after the Company prepaid some annual corporate expenses related to the 2020 calendar year in Q2. G&A costs for the quarter includes $136K in payment of Non-Executive Director’s fees and Executive Director’s salary.
Total net cash outflows related to operating activities in the quarter was $6.09 million. In comparison, total net cash inflows in Q2 FY2020 were $1.22 million.
The net cash used in Research and Development activities in the last quarter was $4.71 million, compared to $6.19 million in Q2 FY2020. R&D expenditure is expected to continue to decline further over the remaining three 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.
The cash balance as at 31 March 2020 was $16.1 million compared to a balance of $20.5 million as at 31 December 2019. Immutep’s cash position gives the Company an expected cash runway beyond multiple upcoming data catalysts in 2020 and into the beginning of CY 2021.
A copy of the Appendix 4C – Quarterly Cash Flow Report for the quarter is attached.