Immutep Limited American Depositary Shares - IMMP STOCK NEWS

Immutep, a biotechnology company specializing in LAG-3 immunotherapies for cancer and autoimmune diseases, will present new clinical data at the European Society for Medical Oncology (ESMO) Virtual Plenary session on July 11, 2024. The presentation will feature results from the TACTI-003 Phase IIb trial, focusing on Cohort B with negative PD-L1 expression in first-line head and neck squamous cell carcinoma patients. Dr. Robert Metcalf from The Christie NHS Foundation Trust will present the data, which shows a substantially improved overall response rate. Additionally, Immutep will host a webcast to discuss these clinical results on July 12, 2024, at 9am AEST.

Immutep has signed an exclusive License Agreement with Cardiff University to develop and commercialize anti-LAG-3 small molecules for cancer treatment. Under this collaboration, several promising compounds have been identified that block LAG-3, a key immune checkpoint. These small molecules could offer a more convenient and cost-effective oral treatment for cancer patients compared to existing monoclonal and bi-specific antibodies. The agreement builds on a relationship that began in 2019 and includes upfront and milestone payments, as well as royalties on future sales.

Immutep has announced the successful completion of its institutional placement and the institutional component of its 1 for 16 pro rata accelerated non-renounceable entitlement offer, raising approximately A$89.6 million. The offer price was A$0.38 per new share, and it saw strong support from institutional investors, achieving a 100% take-up rate. The total expected to be raised by the offer is A$100.2 million, including the upcoming retail entitlement offer set to open on June 7, 2024. New shares are expected to be issued and commence trading by mid-June 2024. The funds raised will support Immutep's late-stage clinical programs in lung, breast, and head and neck cancers.

Immutep announced a Phase III clinical trial collaboration with MSD to evaluate eftilagimod alfa (efti) combined with KEYTRUDA® (pembrolizumab) and chemotherapy in treating first-line metastatic non-small cell lung cancer (NSCLC).

The TACTI-004 trial will involve 750 patients regardless of PD-L1 expression. Under the agreement, Immutep will conduct the trial, and MSD will supply KEYTRUDA. Immutep retains commercial rights to efti.

Past trials have shown promising efficacy and safety of the combination therapy. This trial aims to confirm these benefits and potentially set a new standard of care for NSCLC.

Immutep presented promising data from the safety lead-in phase of their AIPAC-003 Phase II/III trial at the ESMO Breast Cancer Congress 2024. The trial, combining 90mg efti with paclitaxel, showed a 50% overall response rate and a 100% disease control rate in six metastatic breast cancer patients. Notably, one patient achieved a complete response which is ongoing with efti monotherapy. The combination has been well tolerated with no severe adverse events. Higher efti concentrations were observed, remaining pharmacologically active up to 96 hours post-administration. The randomized Phase II portion continues, with more data expected in 2024.

Immutep has reported positive initial clinical data from the Phase II EFTISARC-NEO trial, combining efti with radiotherapy and pembrolizumab in soft tissue sarcoma patients. The trial showed very good pathologic responses rarely seen with standard therapies, with 67% of patients having near-complete responses. This novel triple combination was well tolerated, with no new safety concerns.

Immutep provides an update on its product candidates development, including positive clinical data in breast cancer and head and neck squamous cell carcinoma patients, progress in various phase II and III trials, appointment of a new director, and financial summary. The Company remains well-funded with a cash balance of approximately $95.4 million as of March 31, 2024.

Immutep announces positive preliminary topline results from Cohort B of the TACTI-003 Phase IIb trial, showing a 26.9% response rate in first-line head and neck squamous cell carcinoma patients who do not express PD-L1. The investigational combination of eftilagimod alpha and KEYTRUDA® demonstrates promising overall response and disease control rates, expanding treatment options for this challenging cancer type. The data suggests that efti's unique activation of antigen-presenting cells enhances the immune system's response to anti-PD-(L)1 therapies, potentially benefiting patients with negative PD-L1 expression. The study continues to collect and analyze data, with full results expected in H1 CY2024.

Immutep partners with CHDR for a Phase I trial of IMP761, a LAG-3 agonist antibody to treat autoimmune diseases. The trial will utilize a unique challenge model to assess pharmacological activity. IMP761 aims to restore immune system balance and target autoimmune disease causes. The study is set to begin in mid-CY2024 with 49 healthy volunteers.