Welcome to our dedicated page for Immutep news (Ticker: IMMP), a resource for investors and traders seeking the latest updates and insights on Immutep stock.
Overview of Immutep Ltd
Immutep Ltd is a globally active biotechnology company committed to advancing immunotherapy for both cancer and autoimmune diseases. Leveraging its expertise in immuno-oncology and innovative LAG-3 technology, the company has positioned itself as a specialized entity in personalized bio-therapeutic products. With dual listings on the Australian Stock Exchange and Nasdaq, Immutep demonstrates a robust international presence and a solid foundation in research and development.
Core Technology and Therapeutic Approach
The hallmark of Immutep’s approach is its focus on the LAG-3 immune control mechanism, a critical regulator of the T cell immune response. By modulating this pathway, Immutep aims to enhance the body’s natural ability to fight cancer and potentially address autoimmune conditions. This technology underpins the company’s strategic pipeline and sets a high standard for clinical precision and targeted therapy development.
Product Pipeline and Clinical Development
Immutep’s product portfolio is centered around its most advanced candidate, IMP321, which functions as a T cell immunostimulatory factor. This therapy is designed for integration into cancer chemoimmunotherapy protocols and has achieved significant clinical milestones in early phase trials. In addition to IMP321, the company is developing IMP701, a blocking anti-LAG-3 antibody candidate in early clinical evaluation, and CVac, a personalized immunocellular strategy under investigation for epithelial cancers. These development efforts illustrate a diverse and forward-looking approach that integrates both innovation and strategic collaboration.
Global Operations and Strategic Collaborations
Operating primarily from Australia, Immutep extends its influence across global markets, supported by strong regulatory compliance and research proficiency. Strategic partnerships with large pharmaceutical firms reinforce its pipeline development, enabling access to advanced clinical platforms and shared expertise. The company’s qualification for significant research tax incentives in both Europe and Australia underscores its commitment to high-caliber R&D and validates the commercial and scientific merits of its initiatives.
Industry Position and Business Model
Within the competitive landscape of biotechnology, Immutep differentiates itself by combining deep scientific expertise with a focused therapeutic strategy. Its business model hinges on collaborative partnerships, clinical innovation, and a targeted approach to harnessing LAG-3 mediated immune modulation. Investors and industry observers appreciate the rigorous clinical frameworks employed by the company, which underpin its potential to offer novel therapeutic modalities in the area of cancer treatment and beyond.
Research and Development Excellence
Immutep’s strategic emphasis on research and development is reflected in its participation in international R&D incentive programs. These initiatives not only provide substantial financial support for its clinical trials but also affirm the company’s adherence to high industry standards and scientific integrity. This relentless focus on innovation is at the core of Immutep’s operational ethos, ensuring that its immunotherapeutic solutions are developed in a rigorous and transparent environment.
Conclusion
In summary, Immutep Ltd stands as a key player in the biotechnology industry, with a specific focus on immunotherapy modalities for cancer and autoimmune diseases. Its reliance on advanced LAG-3 technology, comprehensive product pipeline, and robust global partnerships collectively fortify its standing in the competitive landscape. The company’s commitment to R&D excellence and transparent clinical strategies provides a rich source of insight for those seeking to understand a pioneering approach in modern biotechnology.
Immutep Limited (NASDAQ: IMMP) announced the initiation of the AIPAC-003 trial, combining eftilagimod alpha ('efti') with paclitaxel for metastatic breast cancer. The dual therapy targets HR+/HER2-neg/low and triple-negative breast cancer, covering about 78% of cases. Approvals received in the US and Spain, with patient enrollment expected in early Q2 CY2023. The trial design, reviewed by the FDA and EMA, aims to inform a Biologics License Application and Marketing Authorisation Application.
With a promising safety profile and earlier positive trial results showing a median overall survival increase, Immutep aims to enhance treatment outcomes in breast cancer.
Immutep Limited has announced the successful enrollment of 20 patients in the INSIGHT-003 trial, evaluating its lead product candidate, eftilagimod alpha (efti), in combination with standard anti-PD-1 therapy and chemotherapy for first-line non-small cell lung cancer (1L NSCLC). Initial results showed a promising 72.7% response rate and 90.9% disease control rate. The trial aims to assess the safety and efficacy of this triple therapy approach. Further data will be released throughout 2023 to guide the next steps in 1L NSCLC treatment.
Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced significant advancements in its product development for efti and IMP761. The US FDA granted a second Fast Track designation for efti in non-small cell lung cancer (1L NSCLC), following positive Phase II results showcasing an Overall Response Rate (ORR) of 40.4%. A successful FDA meeting allowed for a combined Phase II/III trial design for metastatic breast cancer (MBC), including triple-negative patients. Additionally, the company reported a strong cash balance of $68.38 million, extending its cash runway until FY24, while also scaling manufacturing for efti.
Immutep Limited (NASDAQ: IMMP) announced that it has successfully enrolled over 50% of its target of 154 patients in the TACTI-003 Phase IIb trial, which evaluates its soluble LAG-3 protein, eftilagimod alpha (efti), in combination with Merck's KEYTRUDA® for treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The trial is ongoing across the U.S., Australia, and Europe, with full recruitment expected by mid-2023. The Independent Data Monitoring Committee has recommended trial continuation without modifications, reinforcing the potential efficacy of efti.
Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced a successful Type C meeting with the FDA, paving the way for a Phase II/III trial of eftilagimod alpha (efti) for metastatic breast cancer (MBC). The trial’s design includes an expanded patient population to include triple-negative breast cancer. Efti aims to improve standard-of-care chemotherapy by stimulating the immune system. The company’s cash runway is secured until mid-2024, supporting ongoing clinical development efforts.
Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced the successful completion of a 2,000L manufacturing run for its lead product candidate, eftilagimod alpha (efti), in partnership with WuXi Biologics. This achievement ensures readiness for late-stage clinical trials and potential commercial production. The manufacturing process was scaled up from 200L to 2,000L to meet demand for ongoing and future trials. Efti, a first-in-class soluble LAG-3 protein, is being developed for various cancer indications and has received Fast Track Designation from the FDA.
Immutep Limited (ASX: IMM; NASDAQ: IMMP) announced the successful establishment of a GMP compliant manufacturing process for its autoimmune disease candidate, IMP761. Developed by Northway Biotech, this 200L scale production will facilitate IND-enabling studies in the first half of 2023 and subsequent clinical trials. IMP761 is projected to be a groundbreaking treatment by targeting self-reactive T cells in autoimmune diseases. Pre-clinical studies have shown significant reductions in cytokine levels, marking promising advancements in immunotherapy.
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced that CEO Marc Voigt will present at The JMP Securities Hematology and Oncology Summit on December 7, 2022, at 11:20 am EST. The event is virtual, offering one-on-one meetings with Mr. Voigt. A live webcast of the presentation will be accessible via their website and archived for later viewing. Immutep focuses on developing LAG-3 immunotherapies for cancer and autoimmune diseases, with lead candidate eftilagimod alpha being tested in various clinical trials.
Immutep Limited (NASDAQ: IMMP) announces a new collaboration with Merck KGaA and Pfizer for the Phase I clinical study INSIGHT-005, focusing on metastatic urothelial cancer. This study builds on positive results from previous trials with eftilagimod alpha (efti) and avelumab, targeting patients who have limited treatment options. The first patient is anticipated to be enrolled in H1 2023. Urothelial cancer is prevalent in the US, with an estimated 81,180 new cases in 2022. This collaboration intends to enhance the potential of efti in various cancer types and improve patient outcomes.
Immutep (ASX: IMM; NASDAQ: IMMP) announced it has secured a cash rebate of A$986,286 (~US$659,303) from the Australian Federal Government's R&D tax incentive program for eligible R&D activities in the 2021 fiscal year, particularly for its TACTI-002 clinical study involving eftilagimod alpha (efti). This follows a previous EU tax incentive of €1,804,341 (~US$1,862,143). The funds will support ongoing clinical trials, with cash flow expected to last into the first half of 2024.
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