Immutep Limited (IMMP) Company Overview

Media Release Marking Immutep's transition to a Phase III biotech, the Company's pivotal TACTI-004 trial in first-line non-small cell lung cancer (1L NSCLC) received first regulatory approval Mature data from INSIGHT-003 in 1L NSCLC demonstrates an excellent 32.9-month median overall survival (OS) and 81.0% 24-month OS rate, significantly outperforming historical controls Promising new results in first line head & neck cancer with PD-L1 CPS

Immutep Limited remains a “Buy” due to promising pipeline updates and strong financials, despite inherent high-risk/high-reward dynamics. Key trials for eftilagimod show encouraging results, particularly in non-small cell lung cancer and soft tissue sarcoma, enhancing the drug's potential. Financially, IMMP has a cash runway at least to 2026, supporting ongoing and future clinical trials without immediate funding concerns.

SYDNEY, AUSTRALIA, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces favourable initial safety data from the placebo-controlled, double-blind first-in-human Phase I study evaluating IMP761. Through the first three of five single ascending dose cohorts in healthy participants, there have been no treatment related adverse events.

SYDNEY, AUSTRALIA, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces positive clinical results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This study evaluates eftilagimod alpha (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in first line recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with negative PD-L1 expression.

Positive results from phase 1 INSIGHT-003 study, using eftilagimod alpha in combination with KEYTRUDA and chemotherapy in treating first-line metastatic non-squamous NSCLC patients. Additional data from the phase 1 INSIGHT-003 study is expected in 2025, with plans to initiate a phase 3 TACTI-004 study targeting the same patient population. The global non-small cell lung cancer market size is projected to reach $36.9 billion by 2031.

Media Release Mature data in patients with a minimum follow-up of 22 months (N=21) shows excellent results, well above historical controls and exceeding expectations: Median Overall Survival is 32.9 months, with median Progression Free Survival reaching 12.7 months, and a 24-month Overall Survival rate of 81.0% Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate compared to historical controls Safety continues to be favourable with no new safety signals INSIGHT-003, which is nearing completion of enrolment, evaluates efti with the most widely used immunotherapy-chemo combination today in a similar population to upcoming TACTI-004 Phase III trial  SYDNEY, AUSTRALIA, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces positive data from the investigator-initiated INSIGHT-003 Phase I trial evaluating eftilagimod alpha (efti) in combination with KEYTRUDA® (pembrolizumab) and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer (1L NSCLC) patients. Prof. Dr. Salah-Eddin Al-Batran of the Frankfurt Institute of Clinical Cancer Research (IKF) and project lead stated, “The strength of these mature survival results coupled with a favourable safety profile in first-line treatment of patients with non-squamous NSCLC, the vast majority of whom have negative or low PD-L1 expression, is very encouraging.

SYDNEY, AUSTRALIA, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on its activities for the quarter ended 30 September 2024 (Q1 FY25).

Media Release SYDNEY, AUSTRALIA, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces Marc Voigt, CEO of Immutep, will participate in a fireside chat at the Maxim Healthcare Virtual Summit on Wednesday, October 16, 2024 at 9:30 am ET. The fireside chat will be live on M-Vest.

Immutep Limited (IMMP) has shown underwhelming results in their TACTI-003 trial, raising questions about the efficacy of their lead drug, eftilagimod. Despite the disappointing data, IMMP has a strong cash position, giving them a 3-4 year runway to continue their development efforts. The company remains a speculative investment with potential, especially with upcoming results from the AIPAC-003 breast cancer study expected in 2025.