Full Press Release Details
Immutep Quarterly Activities Report & Appendix 4C Q2 FY26
29 January, 2026 - Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, provides an
update on its activities for the quarter ended 31 December 2025 (Q2 FY26).
EFTI DEVELOPMENT PROGRAM IN ONCOLOGY
IMMUTEP AND DR. REDDY'S STRATEGIC COLLABORATION
Most significantly, in December, Immutep and Dr. Reddy's announced that their respective wholly-owned subsidiaries, Immutep SAS and
Dr. Reddy's Laboratories SA, entered into a strategic collaboration and exclusive licensing agreement for the development and commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater
Immutep Limited, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90
first-in-class novel immunotherapy that directly activates the immune system to fight cancer, which is under evaluation in a Phase III trial, TACTI-004 (KEYNOTE-F91).
As per the agreement, and after the quarter's
end, Immutep has received from Dr. Reddy's the upfront payment of USD 20 million (~AUD 30.2 million). It is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million
(~AUD 528.4 million), plus royalties on commercial sales in these markets.
Immutep holds the global manufacturing rights to the product across all
markets and will supply the product to Dr. Reddy's in the licensed markets. Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan.
TACTI-004 (KEYNOTE-F91) - Ongoing Phase III Trial in 1L NSCLC
In December, Immutep reported strong operational progress in the TACTI-004
(KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA)
anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC), one of the largest indications in oncology.
The combination of efti with
KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC by expanding the number of patients who respond to anti-PD-1 therapy, across
all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients' survival.
mid-December, the registrational TACTI-004 trial had enrolled 289 patients (over 38% of the trial's targeted enrolment of 756 patients), and enrolment continues at
a robust pace. Additionally, the number of activated clinical sites exceeded 120 and 27 countries had received full regulatory approvals.
October 2025, TACTI-004 had enrolled the necessary number of patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Immutep anticipates reaching 50% of the patient
enrolment target for TACTI-004 soon.
Additionally, with the completion of Project Optimus as discussed
below, TACTI-004 has started to open sites in the United States.
INSIGHT-003 - Phase I Trial in Non-Squamous 1L NSCLC
In October, Immutep announced promising data from the investigator-initiated INSIGHT-003 trial, which is evaluating the
same immunotherapy/chemotherapy combination used in TACTI-004 (KEYNOTE-F91), was detailed in a poster presented by Dr. med. Akin Atmaca, Head of the Thoracic
Oncology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany at the ESMO Congress 2025.
Immutep Limited, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90
In this multi-centre study, the novel combination of efti with KEYTRUDA and chemotherapy
(carboplatin/pemetrexed) has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels.
Notably, the ORR and DCR reported in INSIGHT-003
outperforms historical controls irrespective of PD-L1 levels (e.g., TPS <1%, TPS 1-49%, and TPS >50%). This is particularly important for patients with low
and no PD-L1 (TPS <50%), who represent over two-thirds of the 1L NSCLC patient population and for whom PD-(L)1 inhibitors
typically perform suboptimally. In patients with TPS <50% (N=47), the combination with efti has achieved a strong and improved 61.7% ORR compared to historical control of 40.8%.1,2
Further to the strong efficacy data from INSIGHT-003, the combination with efti continues to have a favourable safety
EFTISARC-NEO - Phase II Trial in Soft Tissue Sarcoma
In October, Immutep announced that positive data from the
EFTISARC-NEO Phase II investigator-initiated trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) was shared in a Proffered Paper oral
presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland at the ESMO Congress 2025 in Berlin, Germany.
The EFTISARC-NEO trial met the primary endpoint and significantly exceeded the study's prespecified 35% tumour
hyalinization/fibrosis with a median 51.5% tumour hyalinization/fibrosis (p<0.001) in the evaluable patient population (N=38).3 This may hold significance in terms of future outcomes as tumour
hyalinization/fibrosis serves as an early surrogate endpoint correlated with improved survival in STS patients.4 Disease-free survival and overall survival data are immature at this stage and will
be presented in the future.
In November, early translational data from the EFTISARC-NEO trial were detailed in an
oral presentation by Pawe Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida. Results from the
initial twenty patients who underwent surgery in the trial show a strong immune system activation in line with efti's mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral
blood - specifically CXCL9, CXCL10, IL-23, and IFN- .
The increase on treatment of immune response biomarkers like IFN-
correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery.
Immutep Limited, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90
Additionally, during the quarter, the EFTISARC NEO trial was awarded second place in the distinguished
Golden Scalpel Award competition in Poland. 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. EFTISARC-NEO was the only oncology project to receive this accolade, underscoring its leadership and breakthrough potential in cancer treatment.
AIPAC-003 - Phase II/III Trial in Metastatic Breast Cancer
Immutep continues to execute the AIPAC-003 trial, which has enrolled 71 metastatic hormone receptor positive (HR+),
HER2-negative/low patients resistant to endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or triple-negative breast cancer patients.
Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients
across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30 mg or 90 mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA's Project Optimus
initiative and prior regulatory interaction with FDA.
In October, Immutep announced that positive feedback had been received from the US Food and Drug
Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30 mg as the optimal biological dose for efti. The agreement with the FDA on efti's optimal biological dosing carries
strategic importance in the ongoing and future clinical development of efti, including the global TACTI-004 (KEYNOTE-F91) Phase III trial.
In December, Immutep announced that new data from the AIPAC-003 trial was presented by Dr. Nuhad Ibrahim,
Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas.
The data presented shows that both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a
median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64).
New Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer
Immutep continues to progress with a new investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy
prior to surgery in early-stage HR+/HER2-negative breast cancer patients. The trial aims to assess pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC).
Immutep Limited, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90
The study will treat up to 50 evaluable patients in a two-stage
design and will be primarily funded by grants and The GW University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget.
The investigator-initiated INSIGHT-005 Phase I study, conducted
by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) to evaluate the safety and efficacy of efti in combination with avelumab in up to 30 patients with metastatic urothelial cancer, was discontinued by IKF after the end of the
quarter. This decision was made, as significant changes in the treatment landscape created challenges with patient recruitment. Only 3 patients were recruited in total.
IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE
IMP761 - Phase I Trial
In December, Immutep
announced a positive update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases.
The single-ascending dose escalation portion of the trial successfully completed the 2.5 and 7 mg / kg dosing levels of IMP761 with continued positive safety
and efficacy data. IMP761 was tolerated well with no treatment-related adverse reactions beyond mild intensity. Additionally, evidence of dose dependent immunosuppressive effects with IMP761 was observed with significant, long-lasting inhibition of
the three T-cell-mediated intradermal reactions to a strong foreign antigen on day 2, 9 and 23.
encouraging efficacy and safety to date, the trial will continue as planned and additional updates are anticipated in the first half of CY2026 including a planned presentation of data at a major medical conference.
INTELLECTUAL PROPERTY
During the quarter, Immutep was
granted four patents.
The New Zealand Patent Office granted a new patent protecting Immutep's intellectual property for a binding assay for
determining MHC Class II binding activity of LAG-3 protein. The assay is used in the characterisation of efti in GMP-grade manufacturing.
Three new patents directed to IMP761 were also granted. Two were granted in Brazil and one in Japan.
Immutep Limited, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90
CORPORATE & FINANCIAL SUMMARY
Annual General Meeting
Immutep successfully held its
Annual General Meeting (AGM) during the quarter, with all resolutions put forward to shareholders strongly approved. The Company appreciates the continued support and engagement of its shareholders as it advances its strategic and operational
Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761.
The Company is well funded with
a strong cash and cash equivalent, and term deposit balance as at 31 December 2025 of approximately A$99.1 million, which is in line with budget as at the beginning of FY2026, while progressing our clinical programs within announced