Directors’ Report (Continued)
In July 2021, Immutep completed its share purchase plan (SPP) which opened to eligible shareholders the previous month. The Company received total SPP funds of A$7,175,720, exceeding the targeted amount sought to be raised under the SPP of A$5m. The SPP followed a A$60m two-tranche institutional placement (Placement) also conducted in June 2021, with the second tranche receiving shareholder approval at Immutep’s EGM held in late July.
The funds raised from the SPP and Placement are being applied to support the Company’s ongoing and planned immuno-oncology clinical development programs, its pre-clinical program in autoimmune disease, manufacturing and for general working capital purposes. Importantly, they have improved Immutep’s financial flexibility and extended its cash runway to the end of calendar year 2023.
Regrettably, following the close of the half-year, Immutep announced Non-Executive Director Grant Chamberlain had passed away suddenly and unexpectedly in late January 2022. Grant was a valued member of the Immutep team, having served on the Board since August 2017. The Company recognises the significant contribution he made, as well as his passion for Immutep and extensive corporate and financial insights.
Clinical Trials with Eftilagimod Alpha
AIPAC - Phase IIb - Positive Final Data Reported
Immutep reported positive final Overall Survival (OS) data from its Phase IIb AIPAC clinical trial evaluating efti in MBC in November 2021 as a late breaker poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2021.
AIPAC is the Company’s Phase IIb clinical trial evaluating efti in combination with paclitaxel, a standard of care chemotherapy, as a chemo-immunotherapy combination. The trial was a randomised, double blinded, placebo-controlled clinical study in 227 HR+/HER2- metastatic breast cancer patients and was conducted across more than 30 clinical sites in Germany, UK, France, Hungary, Belgium, Poland, and the Netherlands. The combination therapy aims to boost the body’s immune response against tumour cells compared to chemotherapy plus placebo.
This late-stage trial showed very encouraging OS data, including a statistically significant and clinically meaningful benefit in three prespecified subgroups representing a majority of patients. A survival benefit of +7.5 months was observed in patients < 65 years, reflecting a > 50% improvement compared to the control group. A +19.6 month survival benefit was seen in patients with low monocytes, a benefit of > 150% compared to the control group. Lastly, a survival benefit of +4.2 months was reported in luminal B patients, reflecting a > 33% benefit compared to the control group.
In addition, a statistically significant Quality of Life preservation was demonstrated in the first 6 months from patients in the efti group in the total population. A statistically significant increase in peripheral CD8 T cells in patients in the efti group was observed and significantly correlated with improved OS.
The results from AIPAC are particularly encouraging as HR+/HER2- metastatic breast cancer is typically a non-immunogenic cancer and therefore less responsive to modern immune checkpoint inhibitor (ICI) therapies. As such, there continues to be a large unmet medical need in this population of patients.
These encouraging final results have formed the basis for the Company’s planned AIPAC-003 clinical trial (see below).
AIPAC-003 - Phase III - Planned Registrational Trial
In October 2021, Immutep received positive feedback from the European Medicines Agency (EMA) regarding its clinical development program for efti which includes AIPAC-003. Interactions with the EMA, US FDA and other regulators are ongoing. Feedback from competent authorities, along with insights from a rigorous engagement process with Key Opinion Leaders and other stakeholders will inform about next steps for the program.
AIPAC-003 is Immutep’s planned Phase III trial evaluating efti in MBC. The study will be conducted across multiple countries and will be based on the Company’s Phase IIb AIPAC trial, which reported encouraging final OS results in key patient subgroup populations in November 2021 (see above).
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