Media Release Data from efti in combination with KEYTRUDA® in first line head and neck squamous cell carcinoma patients who do not express PD-L1 (TACTI-003, Cohort B) shows a preliminary 26.9% response rate, the primary endpoint of the study Data collection, cleaning, and analysis continues and additional data from TACTI-003 (Cohorts A & B), including complete response rate, will be released in H1 CY2024 SYDNEY, AUSTRALIA,... Read More

Media Release Centre for Human Drug Research (CHDR) will conduct Phase I trial to evaluate IMP761, a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system and address the underlying cause of autoimmune diseases CHDR will utilize its unique challenge model that enables insights into IMP761’s pharmacological activity early in clinical development Trial expected to begin mid-CY2024 SYDNEY,... Read More

SYDNEY, AUSTRALIA, April 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 it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III... Read More

Data from the safety lead-in of the AIPAC-003 trial shows 90mg efti in combination with paclitaxel is safe and well tolerated Encouraging initial efficacy in six metastatic breast cancer patients, who exhausted all endocrine therapy including CDK4/6 inhibitors, demonstrated by a 50% overall response rate, including one complete response, and a 100% disease control rate SYDNEY, AUSTRALIA, March 05, 2024 (GLOBE NEWSWIRE) --... Read More

Media Release Excellent clinical data reported from TACTI-002 Phase II trial, including median Overall Survival of 35.5 months in first line non-small cell lung cancer (1L NSCLC) patients expressing PD-L1 (TPS ≥1%) Promising efficacy and tolerability data reported from INSIGHT-003 Phase I trial, including a strong Overall Response Rate of 71.4% in 1L NSCLC patients Late-stage & registrational trial progress: 1L NSCLC:... Read More

SYDNEY, AUSTRALIA, Jan. 04, 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 that the first patient has been enrolled and safely dosed in the INSIGHT-005 Phase I trial. The investigator-initiated study jointly funded with Merck KGaA, Darmstadt,... Read More

SYDNEY, AUSTRALIA, Dec. 21, 2023 (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 constructive feedback has been received from the Paul-Ehrlich-Institut (“PEI”), a German regulatory authority and part of the Committee for Medicinal Products for Human Use... Read More

SYDNEY, AUSTRALIA, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep“ or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, is pleased to announce it has received a €1,595,475 (~ A$2,628,354 ) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt... Read More

SYDNEY, AUSTRALIA, Nov. 22, 2023 (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 that the INSIGHT-003 trial has been expanded to four sites across Germany including the University Clinic of Ruhr Universität Bochum and the Lung Clinic Cologne-Merheim. This... Read More

A total of 171 head and neck squamous cell carcinoma (HNSCC) patients enrolled in randomised, multicentre Phase IIb trial evaluating efti in combination with pembrolizumab Efti has FDA Fast Track designation for first-line treatment of HNSCC SYDNEY, AUSTRALIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3... Read More

No safety or tolerability issues in open-label, safety lead-in phase evaluating the higher 90mg dose of efti in combination with weekly paclitaxel in the first 6 patients Good safety profile allows for lead-in phase to be closed early and the randomized Phase II portion of study will now proceed SYDNEY, AUSTRALIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a... Read More

Media Release Statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes Early increase in absolute lymphocyte count is correlated with the positive Overall Survival results in non-small cell lung cancer patients recently reported at ESMO 2023, and is a potential... Read More

SYDNEY, AUSTRALIA, Nov. 02, 2023 (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 its management will participate in the following upcoming investor events in November: Baird’s Biotech Discovery Series Details: Marc Voigt (CEO), Dr. Frederic Triebel (CSO),... Read More

Excellent survival benefit in 1st line non-small cell lung cancer (1L NSCLC) in TACTI-002 trial: median Overall Survival of 35.5 months (TPS ≥1% patients) providing additional 12-18 months survival compared to historical data, reported post period Late-stage & registrational trial progress: 1st line head & neck squamous cell carcinoma (1L HNSCC) - Phase IIb TACTI-003 trial recruitment progressing and expected to be complete... Read More

SYDNEY, AUSTRALIA, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or the “Company”), is pleased to announce that it has received a A$1,134,882 cash rebate from the Australian Federal Government’s R&D tax incentive program. The cash rebate provided in respect of expenditure incurred on eligible R&D activities conducted in the 2022 fiscal year, mainly related to the Company’s TACTI-002... Read More

Media Release Promising efficacy and tolerability reported from efti plus anti-PD-1 therapy and doublet chemotherapy as first line therapy in metastatic non-squamous non-small cell lung cancer continues Strong 71.4% Overall Response Rate, 90.5% Disease Control Rate, 10.1-month median Progression Free Survival (PFS), and median Overall Survival (OS) that has not been reached, despite 81% of patients having low or negative... Read More

Media Release Median Overall Survival reaches 35.5 months in first-line treatment of metastatic non-small cell lung cancer patients expressing PD-L1 (TPS >1%), 23.4 months in patients with low PD-L1 expression (TPS 1-49%), and has not been reached in patients with high PD-L1 expression (TPS >50%), exceeding expectations Promising Overall Survival, Overall Response Rate, Progression Free Survival, and Duration of Response... Read More

New updated data from TACTI-002, including more mature Overall Survival data, will be presented during the Mini Oral session on Saturday, October 21st, at 9:05 CEST Immutep to host webcast to discuss ESMO 2023 clinical data on Monday, October 23rd, at 8AM AEDT (Sunday, October 22nd, at 5PM ET) SYDNEY, AUSTRALIA, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a... Read More

SYDNEY, AUSTRALIA, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease, today announces an abstract has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2023, taking place in San Diego, California and virtually from... Read More

SYDNEY, AUSTRALIA, Sept. 21, 2023 (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 the regulatory authorization of eftilagimod alpha (“efti”) manufactured at commercial 2,000L scale for use in clinical trials across multiple European countries including... Read More

SYDNEY, AUSTRALIA, Sept. 05, 2023 (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 its management will participate in the following upcoming investor conferences in September: The 18 th Annual Citi Biopharma Conference in Boston, MA on Thursday, September... Read More

SYDNEY, AUSTRALIA, Aug. 01, 2023 (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 it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the continued development... Read More

Mini Oral presentation will include data from TACTI-002 Phase II trial evaluating chemotherapy-free IO combination of efti plus KEYTRUDA® (pembrolizumab) Two additional posters on investigator-initiated trials evaluating efti will also be presented SYDNEY, AUSTRALIA, July 31, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel... Read More

Late-stage & registrational trial progress: TACTI-004 Phase III - Positive feedback received from US FDA for planned registrational trial in 1st line non-small cell lung cancer (1L NSCLC) TACTI-003 Phase IIb – Randomised study in 1st line head & neck squamous cell carcinoma (1L HNSCC) has reached ~91% patient recruitment and top-line results expected in H2 of CY2023 AIPAC-003 Phase II/III - First patient dosed in metastatic... Read More

SYDNEY, AUSTRALIA, July 28, 2023 (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 the first patient has been enrolled and safely dosed in EFTISARC-NEO, the Phase II investigator-initiated trial of eftilagimod alpha (efti), a soluble LAG-3 protein and MHC... Read More

SYDNEY, AUSTRALIA, June 27, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announced the grant of a new patent (number 11,684,654) entitled “Combined Preparations for the Treatment of Cancer or Infection” by the United States Patent Office. This United States patent was filed as a second... Read More

SYDNEY, AUSTRALIA, June 27, 2023 (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 diseases, today announces the successful completion of an A$80 million capital raise to support its late-stage and expanding clinical development pipeline. With this new capital, Immutep believes it... Read More

SYDNEY, AUSTRALIA, June 20, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announced the grant of a new patent (number 11,680,104) by the United States Patent Office. The granted claims are composition-of-matter type claims covering Immutep’s pre-clinical immunosuppressive product... Read More

SYDNEY, AUSTRALIA, June 07, 2023 (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 be presenting at the Jefferies Healthcare Conference being held on June 7-9, 2023 in New York City, NY. Event: Jefferies Healthcare Conference... Read More

Media Release Efti plus pembrolizumab led to deep, durable responses, regardless of PD-L1 expression levels, and median Duration of Response not reached despite median follow up of 39 months in TACTI-002 Phase II Promising efficacy in patients with a PD-L1 Combined Positive Score (CPS) of ≥1 with median Overall Survival of 12.6 months, a 12-month Overall Survival rate of 52.0%, and a response rate of 38.5% Patients with a... Read More

Sydney, Australia, June 02, 2023 (GLOBE NEWSWIRE) - - Immutep Limited , an Australian company (ASX: IMM) (Nasdaq: IMMP) ( Immutep or the Company ), is pleased to announce the successful completion of an institutional placement ( Placement ) and the institutional component ( Institutional Entitlement Offer ) of its 1 for 7.6 pro rata accelerated non-renounceable entitlement offer ( Entitlement Offer and, together with the... Read More

Appointment of Charles River Laboratories ("Charles River") to run Immutep’s preclinical toxicology study evaluating the safety and toxicity of IMP761 Forms a key step prior to first-in-human trials for this first-in-class LAG-3 agonist antibody designed to treat the underlying cause of multiple autoimmune diseases Charles River is a highly respected, global provider of drug discovery and non-clinical development solutions... Read More

New data published from Part C of TACTI-002 Phase II Trial evaluating eftilagimod alpha plus pembrolizumab in metastatic 2nd line head and neck squamous cell carcinoma Deep, durable responses seen across all PD-L1 subgroups with a 13.5% Complete Response rate and median Duration of Response not yet reached (minimum follow-up of 17 months) In the overall patient population, regardless of PD-L1 expression, a strong response... Read More

SYDNEY, AUSTRALIA, May 25, 2023 (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 the first patient has been enrolled and safely dosed at a European clinical site for its integrated Phase II/III AIPAC-003 trial in metastatic breast cancer. AIPAC-003 is... Read More

Efti plus standard-of-care anti-PD-1 therapy and doublet chemotherapy in 1st line non-small cell lung cancer is well tolerated and continues to show promising initial signals of efficacy Triple combination therapy has achieved a 67% response rate and 91% disease control rate in metastatic 1st line non-small cell lung cancer patients (N=21) despite 81% of patients having low or negative PD-L1 expression SYDNEY, AUSTRALIA, May... Read More

Immuno-oncology combination of eftilagimod alpha (efti) and the leading anti-PD-1 therapy generates meaningful long-term survival in non-small cell lung cancer patients in Phase II TACTI-002 trial Initial median Overall Survival of 25 months in non-small cell lung cancer patients with >1% PD-L1 expression, a key area of focus for future development of efti Result is above reported rates of anti-PD-1 monotherapy and various... Read More

SYDNEY, AUSTRALIA, May 16, 2023 (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 it has received positive feedback from the US Food and Drug Administration (FDA), regarding the Company’s late-stage clinical development plans for its first-in-class soluble... Read More

SYDNEY, AUSTRALIA, May 09, 2023 (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 its management will present and be available for 1-on-1 meetings at the JMP Securities Life Sciences Conference, on Tuesday, May 16 th , 2023. Presentation details: The JMP... Read More

Webinar to take place on Tuesday, May 9, 2023, at 11:30 AM ET SYDNEY, AUSTRALIA, May 02, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces a Key Opinion Leader (KOL) event will be hosted by Ladenburg Thalmann & Co, Inc., on Tuesday, May 9, 2023, from 11:30 AM – 1:00 PM ET. The... Read More

Investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate dual immuno-oncology (IO) combination of eftilagimod alpha and BAVENCIO® in metastatic urothelial cancer Trial builds on strategy to cost-efficiently increase target indications for IO-IO combination approaches utilizing eftilagimod alpha in areas of high unmet need SYDNEY, AUSTRALIA, May 01, 2023 (GLOBE NEWSWIRE) -- Immutep... Read More

Media Release Initiation of integrated Phase II/III AIPAC-003 trial evaluating eftilagimod alpha (efti) and paclitaxel in HER2-neg/low metastatic breast cancer and triple-negative breast cancer Positive final data reported from patients with 2nd line non-small cell lung cancer refractory to anti-PD-(L)1 therapies, including Overall Survival rate of 39% at 21 months Randomised TACTI-003 Phase IIb trial has reached 75%... Read More

Final results from Part C of the Phase II TACTI-002 trial in 2nd line head and neck squamous cell carcinoma patients to be presented SYDNEY, AUSTRALIA, April 26, 2023 (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 two abstracts have been selected for... Read More

SYDNEY, AUSTRALIA, April 26, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, today announces that Florian D. Vogl, M.D., Ph.D., MSc, has been appointed as Chief Medical Officer (CMO) with effect from 1 May 2023. Dr. Vogl brings to Immutep over a decade of experience in the biopharmaceutical... Read More

Media Release Soft tissue sarcoma, an orphan disease, represents a high unmet medical need with a poor prognosis First time efti will be studied in neoadjuvant, non-metastatic cancer setting Novel triple combination of efti with radiotherapy and anti-PD-1 therapy has potential to generate a robust anti-tumour immune response SYDNEY, AUSTRALIA, April 17, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP)... Read More

Media Release Efti plus pembrolizumab achieved mOS of 9.9 months and a 39% OS rate at 21 months, which compare favourably to typical 6-9 months mOS and a 10-15% OS rate for standard-of-care chemotherapy 83% of patients studied for Tumour Growth Kinetics showed deceleration of tumour growth or shrinkage of tumours, previously increasing under PD-(L)1 monotherapy or in combination with chemotherapy ORR of 8.3%, DCR of 33.3%,... Read More

Media Release Expanding INSIGHT-003 trial evaluating efti with standard-of-care combination of anti-PD-1 therapy and chemotherapy to 50 patients Expansion based on safety and strong initial efficacy results Data updates expected throughout CY2023 and cost-efficient approach through investigator-initiated trial will further inform options related to 1L NSCLC development Clinical data to date shows efti uniquely positioned to... Read More

Media Release 2 nd line NSCLC patients refractory to anti-PD-(L)1 treatment have few therapeutic options, and the addition of efti to pembrolizumab may help these patients by reverting anti-PD-(L)1 therapy resistance 83% of patients that were studied for Tumor Growth Kinetics showed deceleration (50%) in tumour growth or shrinkage (33%) of target lesions Overall Response Rate (ORR) of 8.3% and Disease Control Rate (DCR) of... Read More

Media Release Integrated Phase II/III trial design incorporates feedback from the FDA and EMA and will help inform a BLA and MAA HR+/HER2-neg/low metastatic breast cancer (MBC) patient population has been expanded to include triple-negative breast cancer, which together account for ~78% of breast cancer cases Approval for study start received in US and IRB approval in Spain, with more countries to follow shortly First... Read More

Media Release 20 patients with 1st line non-small cell lung cancer (1L NSCLC) now enrolled in the first triple combination therapy study of efti with standard-of-care combination of anti-PD-1 therapy and chemotherapy Promising initial efficacy results showing a 72.7% response rate and 90.9% disease control rate reported at SITC 2022 Additional data is expected throughout calendar year 2023 and will further inform our next... Read More

Media Release Second US FDA Fast Track designation granted to eftilagimod alpha (efti) supporting planned late-stage development in 1st line non-small cell lung cancer (1L NSCLC) Compelling Phase II results in 1L NSCLC, including Overall Response Rate (ORR) of 40.4% in all-comer PD-L1 TACTI (Two ACTive Immunotherapies trial)-002 trial combining efti and pembrolizumab, showcased at SITC 2022 press briefing Successful meeting... Read More

SYDNEY, AUSTRALIA, Jan. 04, 2023 (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 that it has enrolled and randomised over 50% of the planned 154 patients in the TACTI-003 Phase IIb trial. TACTI-003 is evaluating Immutep’s first-in-class soluble LAG-3... Read More

Agreement with FDA on Phase II/III trial design positions the Company to exploit eftilagimod alpha’s potential to address high unmet need for metastatic breast cancer patients Patient population expanded to include patients with triple-negative breast cancer Late-stage clinical development efforts remain focused on frontline non-small cell lung cancer (NSCLC) in combination with anti-PD-1 therapy Immutep’s cash runway... Read More

first 2,000L Manufacturing Run of its First-in-Class Soluble LAG-3 Protein Completed by WuXi Biologics SYDNEY, AUSTRALIA, Dec. 08, 2022 (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 the successful scale-up of the manufacturing of its lead product... Read More