Immutep Limited American Depositary Shares - IMMP STOCK NEWS

Immutep Limited (ASX: IMM; NASDAQ: IMMP) has received FDA and IRB approval to launch the TACTI-003 trial, assessing the efficacy of its lead product candidate, eftilagimod alpha, in combination with KEYTRUDA in first-line treatment for Head and Neck Squamous Cell Carcinoma (HNSCC). Recruitment for the trial, which will include around 154 patients, is set to begin this quarter, with locations across Australia, Europe, and the U.S. Immutep aims to evaluate overall response rates and other efficacy metrics in this pivotal study.

Immutep announced a successful A$60 million private placement of new ordinary shares to professional and institutional investors. The first tranche will be completed without shareholder approval, while the second tranche awaits approval. Funds will support the expansion of clinical programs and manufacturing processes for eftilagimod alpha. New Shares will be issued at A$0.52 each, reflecting a 12.9% discount. Settlement dates are set for late June and July 2021. Additionally, a share purchase plan targeting A$5 million will be offered to eligible shareholders.

Immutep Limited has announced the initiation of a new Phase I clinical trial, INSIGHT-003, aimed at evaluating the combination of its lead product candidate, eftilagimod alpha (efti), with chemotherapy and anti-PD-1 therapy in patients with various solid tumors. The trial will recruit up to 20 patients, with the expected first patient enrollment in Q3 2021 and interim results anticipated in 2022. All regulatory approvals are in place for the trial, marking a significant step in enhancing treatment options for cancer patients.

Immutep Limited (NASDAQ: IMMP) announced a significant update on its collaboration with Cardiff University to develop a new generation of small molecule anti-LAG-3 therapies aimed at providing affordable oral treatments for cancer patients. This project, leveraging Immutep's expertise in LAG-3 biology and Cardiff's medicinal chemistry skills, aims to produce compounds with lower costs compared to existing antibodies. The joint venture will result in shared intellectual property, enabling Immutep exclusive rights to develop these novel therapeutic molecules commercially.

Immutep Limited announced positive final data from its Phase I INSIGHT-004 study, revealing a 41.7% objective response rate and 50% disease control rate among 12 patients with various solid tumors. Notably, 75% of patients remain alive. The study evaluated the combination of eftilagimod alpha and avelumab, demonstrating encouraging activity even in patients with low PD-L1 expression. The treatment maintained a good safety profile with no dose-limiting toxicities, supporting further clinical evaluation of this novel therapy.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced positive interim data from the Phase II TACTI-002 study, demonstrating a 41.7% overall response rate (ORR) for first-line non-small cell lung cancer (NSCLC) and 29.7% ORR for second-line head and neck squamous cell carcinoma (HNSCC). The study showed significant tumor responses across PD-L1 subgroups, with safe and well-tolerated results. The median progression-free survival (PFS) was 8.2 months for NSCLC and 12.6 months for HNSCC. Further recruitment into the trial is ongoing, promising advancements in treatment.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced the grant of a new European patent (EP3473263) for combined preparations in cancer treatment. This patent follows previous grants in November 2018 and early 2021, enhancing the protection of their lead candidate eftilagimod alpha (IMP321) alongside PD-1/PD-L1 inhibitors. Valid until January 8, 2036, this patent reinforces Immutep's commitment to clinical development and commercialization of innovative therapies. CEO Marc Voigt highlighted the patent's importance for ongoing trials, especially those presented at the upcoming ASCO 2021 Annual Meeting.

Immutep Limited (NASDAQ: IMMP) announced a collaboration with Merck KGaA for a Phase I/IIa clinical trial named INSIGHT-005, focusing on eftilagimod alpha in combination with bintrafusp alfa in previously treated patients with solid tumours. This new trial builds on previous encouraging data from the INSIGHT trial. The first patient is set to be enrolled in mid-2021, with initial data expected by early 2022. The study aims to investigate the safety and efficacy of this combination therapy, enhancing Immutep's ongoing relationship with Merck.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced the grant of a new patent by the Chinese Patent Office for its combination therapy involving eftilagimod alpha and chemotherapy agents like oxaliplatin. This adds to existing patents in Europe, Australia, Japan, and the U.S., enhancing Immutep's intellectual property rights in China until December 19, 2034. EOC Pharma, Immutep's partner in China, will develop this therapy, highlighting increasing collaboration in the oncology sector.