Immutep Limited

15/04/2026

Immutep Limited is pleased to announce that the U.S FDA has granted Orphan Drug Designation (ODD) for efti for the treatment of Soft Tissue Sarcoma (STS), a rare cancer with significant unmet medical need.

This designation supports development in a rare cancer with significant unmet need and is backed by Phase II EFTISARC-NEO data showing encouraging tumour response and a favourable safety profile in combination with radiotherapy and KEYTRUDA.

CEO of Immutep, Marc Voigt said: “We are pleased that the FDA has recognised the potential of efti for patients with soft tissue sarcoma, a rare and difficult to treat cancer. As previously communicated, the Company is currently undertaking a comprehensive review and analysis following the discontinuation of its Phase III TACTI-004 trial and the outcome will influence the decision regarding any potential future clinical trial with efti. The FDA’s designation, based on very encouraging data from the EFTISARC-NEO trial, provides us with a potential direct step forward into a late-stage study in the neoadjuvant setting for STS.”

08/04/2026

Immutep has provided an investor update following the recent discontinuation of the TACTI‑004 Phase III trial in first‑line non‑small cell lung cancer.

A thorough root cause analysis is underway to understand factors contributing to the trial’s futility outcome. This work is essential not only for interpreting TACTI‑004, but also for guiding future development decisions across the broader efti pipeline.

Immutep's portfolio continues to include multiple differentiated assets, including IMP761 with upcoming data in early June.

Read the full update here:

19/03/2026

CEO & Executive Director, Marc Voigt, appeared on FNN to discuss the Phase III TACTI-004 trial update following the interim futility analysis, and the decision to discontinue the study.

In the interview Marc outlines the Company’s next steps, including a detailed review of the data and ongoing strategic planning, and highlights continued progress across Immutep’s broader clinical pipeline, with multiple programs advancing and further key milestones ahead.

Link to the full video here:

Immutep (ASX: IMM) (NASDAQ : IMMP) CEO & Executive Director Marc Voigt discusses the TACTI-004 trial update and outlines the company’s next steps, including ...

05/02/2026

Immutep Limited announces today that the TACTI-004 trial in first line non-small cell lung cancer has enrolled 378 patients, representing 50% of the trial's target enrolment.

Marc Voigt, CEO of Immutep, said, “The excellent pace of enrolment globally in the TACTI-004 trial speaks to the promise of efti and the need for more efficacious therapies in the first line setting for patients with advanced/metastatic non-small cell lung cancer."

The futility analysis and completion of patient enrolment remain on track for the first quarter and third quarter of CY2026, respectively.

Announcement here: https://bit.ly/4ahX2ju

16/12/2025

Immutep Limited today reports strong operational progress in the global TACTI-004 Phase III trial evaluating efti in combination with MSD’s anti-PD-1 therapy, KEYTRUDA®, and chemotherapy as first-line therapy for advanced/metastatic non-small cell lung cancer.

Updates include:
- The TACTI-004 trial has enrolled 289 patients globally, representing over 38% of targeted enrolment
- Global progress continues, with more than 120 activated clinical sites and 27 countries having received full regulatory approvals, including the United States

Read the full announcement here: https://bit.ly/44r6rTV

12/12/2025

Great to be mentioned in The Australian today off the back of announcing our collaboration with Dr. Reddy's on Monday.

Scott Power, Senior Research Analyst at Morgans said: "That was a pretty big deal that Immutep announced with Dr.Reddy's and is providing them with important funding from an upfront payment and depending on clinical success there will be more milestone payments come through."

"The deal has put Immutep in a solid position and the share price has responded positively."

Thanks to Nadine McGrath & Scott Power for the mention.

Full article here:

Healthcare and life sciences expert Scott Power, who has been a senior analyst with Morgans Financial for 27 years, gives his take on the ASX healthcare sector for the week and his ‘Powerplay’ stock pick.

08/12/2025

Immutep Limited is pleased to announce a new strategic collaboration and exclusive licensing agreement with Dr. Reddy's Laboratories Ltd. for the development and commercialisation of efti in all countries outside North America, Europe, Japan, and Greater China.

Marc Voigt, CEO of Immutep said: “The license agreement with Dr. Reddy’s is a major commercial milestone for Immutep and further validates the significant potential of efti, our first-in-class cancer immunotherapy.”

“Dr. Reddy’s is a global pharmaceutical company with proven capabilities in the markets they have licensed for efti. This makes them an ideal partner for us to maximise the commercial benefits from efti outside of North America, Europe, Japan and China. Having recently launched Zytorvi® (toripalimab) as the first and only immunotherapy for nasopharyngeal cancer in Australia, Dr. Reddy’s has a strong track record of bringing cancer therapies to patients.”

“In addition to the upfront payment, we stand to earn substantive future milestone and royalty payments. Importantly, we preserve full commercial rights in the world’s largest pharmaceutical markets so we are very well-positioned for future value creation while also maintaining full control of efti’s manufacturing globally, including to Dr. Reddy’s.”

Full announcement here: https://bit.ly/3KNPQmu

13/11/2025

Immutep has announced positive data from the EFTISARC-NEO Phase II trial evaluating efti in combination with radiotherapy and pembrolizumab for resectable soft tissue sarcoma (STS).

The novel combination achieved a significant 51.5% median tumour hyalinization/fibrosis across multiple STS subtypes, including rare and aggressive tumours with poor prognosis.

The promising results warrant further investigation of this novel combination in registrational settings.

Click here to see the ASX: https://bit.ly/4p5Pkid

10/11/2025

Immutep Limited is pleased to share that the EFTISARC-NEO clinical trial evaluating neoadjuvant efti in soft tissue sarcomas has been awarded second place in the distinguished Golden Scalpel Award competition.

This competition recognises the most innovative solutions in Polish medicine and is presented by independent experts to initiatives that set new standards in advancing healthcare.

This year, EFTISARC-NEO was the only oncology project to receive this accolade, underscoring its leadership and breakthrough potential in cancer treatment.

To learn more visit: https://bit.ly/43W9jaZ

Immutep extends its gratitude to the patients and dedicated team at MSCNRIO whose efforts made this achievement possible.

Nasze badanie w zasadzie zmienia myślenie o mięsakach. To absolutnie nowy kierunek w terapii, który realnie poprawia rokowanie pacjentów – mówi dr n. med. Paulina Jagodzińska-Mucha z Zespołu Narodowego Instytutu Onkologii, który zajął drugie miejsce w konkursie Złoty Skalpel 2025.

20/10/2025

Immutep Limited is pleased to share positive clinical data presented at the Congress 2025

Key highlights:
- EFTISARC-NEO Phase II: Met primary endpoint, with the novel combination including efti achieving 51.5% tumour hyalinization/fibrosis in soft tissue sarcoma (p < 0.001). https://bit.ly/3IVVQsF

- INSIGHT-003 trial: Generated strong response rates across all PD-L1 expression levels 1L NSCLC, including 61.7% in low & no PD-L1 (TPS

12/10/2025

Immutep Limited is pleased to complete another productive meeting with the FDA regarding the eftilagimod alfa (efti) program. We welcome the positive feedback and the agreement on efti's optimal biological dose is another important building block for future potential BLA filings.

Announcement here: http://bit.ly/4ogdyWA

09/10/2025

Immutep Limited announces update for pivotal TACTI-004 Phase III in 1L NSCLC.

Immutep has now enrolled & randomised over 170 patients, an important milestone as this is above the # required to conduct the futility analysis, which remains on track for Q1 2026.

Additionally, the # of activated clinical sites continues to expand at a strong pace, now exceeding 100 across 24 countries.

Read more here: http://bit.ly/42wziFq