Immutep Stock Price, News & Analysis

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.

Immutep Limited (ASX: IMM; NASDAQ: IMMP) has reported encouraging clinical results from its Phase II TACTI-002 trial. The overall response rate (ORR) for the combination therapy of eftilagimod alpha (efti) and KEYTRUDA® in treating first-line non-small cell lung cancer (NSCLC) increased to 40.4%, with notable improvements across all PD-L1 expression groups. Median duration of response was 21.6 months, showing efficacy irrespective of PD-L1 status. The trial, which included 114 patients, demonstrated a favorable safety profile, with only 9.6% discontinuation due to adverse effects.