Immutep was one of the Benzinga Biotech Small Cap Conference held virtually on March 24 & 25, 2021. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.
Immutep Limited (ASX: IMM) (NASDAQ: IMMP) is an innovative biotechnology company that develops novel immunotherapy treatments for cancer, infectious disease and autoimmune disease. The company is setting the global standard for the development of therapeutics that modulate Lymphocyte Activation Gene-3 or LAG-3, a cell surface molecule that plays a vital role in regulating T cells.
The LAG-3 protein controls the signaling between specific immune cells, T cells and antigen-presenting cells (APCs), which are responsible for the adaptive immune response. Immutep not only leads the way with its LAG-3 research but sets the research standard because it was discovered by its Chief Scientific Officer and Chief Medical Officer Dr. Frederic Triebel. This alone has put Immutep as a global leader of immunotherapy drugs for cancer and autoimmune diseases.
“It’s really what we do. We are a LAG-3 company. We have more programs built around LAG-3 than even anyone, including in the Pharma space,” said Immutep CEO Marc Voigt. “The reality is, there has not been a new, approved or validated checkpoint in the past six years. LAG-3 is our opportunity to be the next big thing in immunization technology.”
Immutep’s objective is to harness and strengthen the power of the body’s own immune system through therapeutic intervention for the benefit of patients’ health — and how immunotherapy fights cancer and autoimmune diseases. The company now has one preclinical and three clinical LAG-3 product candidates under development, including two antibodies for modulating immune responses in autoimmunity and cancer, through pharmaceutical partnership, with Novartis and GlaxoSmithKline.
In addition, Bristol Myers Squibb (BMS) just announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. The trial met its primary endpoint of progression-free survival (PFS). Follow up for overall survival, a secondary endpoint, is ongoing.
The fixed-dose combination was well-tolerated and there were no new safety signals reported in either the relatlimab and Opdivo combination arm or the Opdivo arm. These are the first Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody. Relatlimab is the 3rd distinct checkpoint inhibitor (anti-PD-1, anti-CTLA-4 and anti-LAG-3) for BMS and, with Opdivo, the 1st fixed-dose combination to demonstrate a benefit for patients.
Immutep continues to look for innovative ways to advance its market share in immunotherapy treatments including new clinical trials such as:
AIPAC (Active Immunotherapy PAClitaxel) — Active Immunotherapy PAClitaxel (AIPAC) is Immutep’s most advanced and largest clinical trial. It is a Phase IIb trial evaluating eftilagimod alpha (known as “efti” or IMP321) in combination with a taxane-based chemotherapy called paclitaxel in patients with hormone receptor-positive metastatic breast cancer (MBC) as an immunotherapy.
TACTI-002 — Two ACTive Immunotherapies-002 (TACTI-002) are being conducted in collaboration with Merck & Co., Kenilworth, New Jersey, (known as MSD outside the U.S. and Canada). The study evaluates the combination of efti with MSD’s KEYTRUDA® (or pembrolizumab, an anti-PD-1 therapy) for up to 183 patients. The trial is a Phase II, noncomparative, open-label, single-arm, multicenter clinical study that is taking place in up to 13 study centers across the U.S., Europe and Australia.
TACTI-Mel — Two ACTive immunotherapeutics in melanoma (TACTI-mel) is a Phase I safety and dose-finding clinical trial of efti given in combination with pembrolizumab (Keytruda) in patients with locally-advanced (unresectable Stage III) or metastatic (Stage IV) melanoma. The study combined two immunotherapies to enhance the immune response by activated T cells. Patients having a suboptimal response or having had disease progression with pembrolizumab as a monotherapy were eligible for the study and received the combination of pembrolizumab, plus efti.
Insight-004 — Insight-004 is the 4th arm of the INSIGHT Phase I clinical trial. It is being conducted under Immutep’s new clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The trial evaluates the combination of efti with avelumab, a human anti-PD-L1 antibody, in 12 patients with advanced solid malignancies. It will assess the safety, tolerability and recommended Phase II dose of efti when combined with avelumab.
Immutep also recently announced the extension of its partnership with Merck to develop an eilagimod alpha ("ei") pembrolizumab ("pembro") combination as a 1st-line therapy for HNSCC (head and neck cancer). The planned randomized-controlled TACTI-003 trial involving 160 patents builds on impressive Phase 2 TACTI-002 data (also with MSD), which showed a doubling of the overall response rate with ei-pembro in normally unresponsive PD-1 and PD-L1 2nd-line HNSCC patients, including 3 complete responses, as well as encouraging data in 1st- and 2nd-line NSCLC (nonsmall-cell lung cancer).
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