Immutep Limited - IMMP STOCK NEWS

Immutep (ASX: IMM; NASDAQ: IMMP) has received regulatory clearance in the Netherlands to initiate a Phase I study of IMP761, the world's first therapeutic LAG-3 agonist antibody for autoimmune diseases. The study, expected to enroll 49 healthy volunteers starting Q3 CY2024, will assess safety, pharmacokinetics, and pharmacodynamics.

IMP761 aims to restore immune system balance by enhancing LAG-3's 'brake' function to silence self-antigen-specific memory T cells, which cause many autoimmune diseases. The antibody has shown promise in preclinical studies for suppressing T cell-mediated immune responses and reducing inflammatory cytokines.

The trial, conducted by the Centre for Human Drug Research in Leiden, will use a unique KLH challenge model to evaluate IMP761's pharmacological activity. First data is anticipated before the end of 2024.

Immutep has announced positive results from Cohort B of their TACTI-003 Phase IIb trial, which evaluates the combination of eftilagimod alfa (efti) and KEYTRUDA® (pembrolizumab) as a first-line treatment for head and neck squamous cell carcinoma (HNSCC) patients with negative PD-L1 expression. The combination achieved a 35.5% response rate and a 58.1% disease control rate, significantly higher than historical controls for anti-PD-1 monotherapy.

Additionally, the combination showed a high complete response rate of 9.7%, with over 50% of patients receiving treatment for at least six months. No new safety signals were observed, making the treatment favorable in terms of safety.

Immutep will discuss the path forward with regulatory agencies based on these promising results. The company has received FDA Fast Track designation for efti in 1L HNSCC regardless of PD-L1 expression.

A webcast to discuss the clinical data will be held on July 12, 2024, at 9am AEST.

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.