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Priovant Therapeutics, a clinical-stage biotechnology company headquartered in Durham, North Carolina, and a subsidiary of Roivant Sciences (Nasdaq: ROIV), announced that the US FDA has accepted its New Drug Application (NDA) for brepocitinib and granted Priority Review for the treatment of dermatomyositis (DM). Brepocitinib is an oral, once-daily small molecule that functions as a dual selective inhibitor of tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q3 2026, and Priovant expects a US launch at the end of September 2026. If approved, brepocitinib would be the first targeted therapy cleared for dermatomyositis. Notably, Priovant was established by Pfizer and Roivant in 2021 and licensed global development rights and US and Japan commercial rights to brepocitinib. Pfizer retains a 25% equity stake in Priovant. Priority Review reduces the FDA’s target review clock from the standard 10 months to approximately 6 months from the date of filing acceptance. The designation is reserved for applications where the proposed drug, if approved, would provide improvements in the safety or effectiveness of treating a serious condition relative to available therapies. In addition to Priority Review, brepocitinib has previously received both Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) from the FDA for dermatomyositis. The Priority Review designation was supported by results from the Phase III VALOR study (NCT05437263), a global, placebo-controlled trial that enrolled 241 adults with dermatomyositis across 90 sites comparing brepocitinib to placebo. The primary endpoint was the myositis Total Improvement Score (TIS) evaluated at Week 52. Brepocitinib 30 mg met the primary endpoint, demonstrating a statistically significant difference versus placebo on TIS at Week 52 (mean TIS 46.5 vs. 31.2; p=0.0002). Separation from placebo was observed as early as Week 4 and sustained at every subsequent visit through the end of the 52-week double-blind period. The 30 mg dose also met all nine key secondary endpoints, which spanned measures of skin disease, muscle disease, and steroid sparing. VALOR is the longest and largest interventional trial conducted in dermatomyositis and the first to produce a positive result over a 52-week placebo-controlled period. On safety, serious infections were increased in the brepocitinib 30 mg arm compared to placebo; these events resolved with medical management, and treatment was completed in most cases. Brepocitinib was originally discovered by Pfizer, where it carried the internal designation PF-06700841. In December 2021, Roivant Sciences acquired global development and commercialization rights to the molecule from Pfizer through a licensing deal involving upfront and milestone payments. Priovant Therapeutics, a dedicated Roivant subsidiary, assumed responsibility for clinical development and regulatory filings. Beyond dermatomyositis, brepocitinib is being evaluated in a Phase III program in non-infectious, non-anterior uveitis (NCT06431373), with 371 subjects enrolled and a primary endpoint of time to treatment failure up to Week 48. The company also reported positive Phase II data in cutaneous sarcoidosis (BEACON study), with a Phase III study planned to begin in calendar year 2026. Through dual TYK2/JAK1 inhibition, brepocitinib suppresses cytokines linked to autoimmunity, including type I interferon (IFN), type II IFN, interleukin-6 (IL-6), IL-12, and IL-23, via a single oral agent. Dermatomyositis is an autoimmune condition characterized by muscle weakness, skin disease, and chronic inflammation. Patients frequently depend on high-dose corticosteroids and broad immunosuppressants, which carry cumulative organ toxicity and contribute to comorbidities. No targeted therapies are currently approved for the condition.

GW Cancer Center to initiate Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in HR+/HER2-neg breast cancer patientsSecond investigator-initiated trial to evaluate efti in earlier stage disease where its unique activation of a broad anti-cancer immune response may drive optimal benefit and high pathologic response rates SYDNEY, AUSTRALIA, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces the initiation of an investigator-initiated Phase II trial evaluating neoadjuvant eftilagimod alfa (efti) administered subcutaneously as monotherapy and then in combination with standard-of-care chemotherapy prior to surgery in patients with early-stage HR+/HER2-negative breast cancer. The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The George Washington (GW) University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget. The trial will be led by Principal Investigator, Pavani Chalasani, MD, MPH, Division Director of Hematology and Medical Oncology at the GW Cancer Center and a leader of the GW Cancer Center Breast Cancer clinical research team. Dr. Chalasani stated, “Given my clinical experience with efti in the AIPAC-003 study coupled with promising data from additional trials evaluating efti in metastatic breast cancer settings, we look forward to evaluating this unique immunotherapy at earlier stage disease in patients with HR+/HER2 -ve breast cancer. As a novel neoadjuvant immunotherapy option, efti’s powerful and safe activation of a broad anti-cancer immune response in combination with chemotherapy may lead to high rates of pathologic complete responses, the primary endpoint of this study. Additionally, we are hopeful that efti’s immune activation in these patients with early stage cancer who have stronger immune systems may lead to improved disease free survival.” Efti’s targeting and unique activation of powerful antigen-presenting cells via MHC Class II leads to a broad anti-cancer immune response. This includes the activation and proliferation of cytotoxic CD8+ T cells that can be armed in vivo with chemotherapy-induced tumour antigens, as well as numerous other immune cells and cytokines enhancing the immune system’s ability to fight cancer. This novel immunotherapy has yielded encouraging clinical results in metastatic disease and earlier stage disease in its initial trial as a neoadjuvant treatment in soft tissue sarcoma. Immutep CEO, Marc Voigt added, “We are thankful for the interest and investment by academia in the United States and elsewhere to evaluate the promise of efti at earlier-stage disease. This trial helps us cost-efficiently expand our clinical pipeline for neoadjuvant efti in areas of high unmet need. Our belief is this novel immune system activator can play a meaningful role in metastatic settings and in the ongoing expansion of immunotherapy into neoadjuvant settings to fight cancer.” The goal of this multi-center study led by the GW Cancer Center is to determine pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC). This is a single-arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for NAC. Enrolled patients will be treated with efti monotherapy for three weeks and then start NAC in combination with efti. For more information, visit clinicaltrials.gov (NCT07102940). About Eftilagimod Alfa (efti)Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About Immutep Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. Australian Investors/Media:Eleanor Pearson, Sodali & Co.+61 2 9066 4071; eleanor.pearson@sodali.com U.S. Investors/Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

SYDNEY, AUSTRALIA, July 29, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces an upcoming poster presentation for the pivotal TACTI-004 (KEYNOTE-F91) Phase III trial at the IASLC 2025 World Conference on Lung Cancer (WCLC), taking place in Barcelona, Spain, from 6-9 September 2025. The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s antigen presenting cell (APC) activator, eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA® (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression (Tumour Proportion Score or TPS of 0-100%) and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Immutep CMO, Stephan Winckels M.D., Ph.D, said, “Our engagement to date with physicians in the lung cancer community, including at ELCC in Paris and ASCO in Chicago, has yielded encouraging feedback with a shared view of efti as a safe, easy-to-administer immunotherapy with strong efficacy across two 1L NSCLC trials. We look forward to continuing our investigator discussions at WCLC and ESMO around the pivotal TACTI-004 Phase III, which has the potential to change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression.” Details for the poster presentation:Title: TACTI-004, a Phase 3 trial of Eftilagimod Alfa plus Pembrolizumab (P) + Chemotherapy (C) vs Placebo + P + C in 1st line NSCLC Presenter: Dr. Martin Sebastian, University Hospital of Frankfurt, GermanySession: Clinical Trials in ProgressDate and Time: Tuesday, 9 September 2025 at 10:00 AM CEST The poster will be available on the Posters & Publications section of Immutep’s website following the presentation. About Eftilagimod Alfa (efti)Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About ImmutepImmutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Eleanor Pearson, Sodali & Co.+61 2 9066 4071; eleanor.pearson@sodali.com U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com