Latest news with #Immutep
News.com.au
26-05-2025
- Business
- News.com.au
Health Check: The endo-metriosis? Proteomics is on the case
Having produced more positive diagnostics results, Proteomics plans to launch its Promarker Endo device locally this year Immutep posts more positive trial results, this time for soft tissue sarcoma Broker values EBR Systems share price at more than double current worth after capital raising Proteomics International Laboratories (ASX:PIQ) has come up with more positive data to support its endometriosis diagnosis test Promarker Endo, presented – aptly – to the World Congress on Endometriosis, held in Sydney over the weekend. Affecting one in nine women and girls, endometriosis is a common and painful disease that occurs when tissue similar to the lining of the uterus grows in other parts of the body. The condition takes on average seven years to diagnose, owing to the need for an invasive laparoscopy followed by histopathology (a camera is inserted into the pelvis through a small cut in the abdominal wall). The condition is often misdiagnosed. Promarker Endo is a non-invasive alternative, providing a 'traffic light' risk score of low, moderate to high. Derived from analysing 704 plasma samples, the latest results follow those of a 'breakthrough' study of 805 samples in December last year. The latest results showed an 83-98% ability to detect the disease and a 95% ability to rule it out. The company says the results shows that Promarker Endo 'demonstrates high diagnostic accuracy across all stages of endometriosis using a single universal test.' The company plans to launch Promarker Endo locally, in the September quarter. Immutep reports more promising cancer trial results When it comes to its lead compound dubbed 'efti', immuno-oncology drug developer Immutep (ASX:IMM) can't be accused of depriving investors of news flow. Immutep shares surged up to 11% after the company reported 'remarkable' patient response rates in a German lung cancer trial. Today, the company said a phase II soft tissue sarcoma trial hit its primary endpoint, when combining efti with radiotherapy and the standard of care checkpoint inhibitor, Keytruda. A rare cancer, soft tissue sarcoma starts in the soft tissues of the body, including muscle, fat, nerves, blood vessels, and tendons. The investigator-led trial exceeded the study's prespecified median of 35% tumour hyalinisation/fibrosis, versus 15% for historical data from radiotherapy alone in patients with resectable (operable) soft tissue sarcoma. Tumour hyalinisation/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival. Hyalinisation is a process where normal tissue degenerates into a translucent material called hyaline. So, while hyalinsation/fibrosis seems like a 'bad' thing, the presence of it leads to a heightened anti-cancer response. Enrolling 40 patients in January this year, the investigator-led trial was carried out at Warsaw's Maria SkÅ‚odowska-Curie National Research Institute of Oncology. Immutep is also trialling efti, a so-called Lag-3 protein, for other solid tumours including non-small cell lung cancer, head and neck squamous cell carcinoma and metastatic breast cancer. EBR shares find their groove Fresh from EBR Systems' (ASX:EBR) $56 million capital raising last week, broker Canaccord values the company's stock at $2.50 per share, more than double their current worth. By way of a placement, EBR's whip-'round was carried out to fund the US commercialisation of its Wise left-ventricle pacemaker, which the US Food & Drug Administration (FDA) approved in mid-April. Now comes the equally hard part of convincing surgeons and obtaining reimbursement. On the latter, Canaccord says EBR is on track to obtain full reimbursement by October 1, for both inpatients and outpatients. The firm believes some surgeons and hospitals won't wait until then, with the first procedures likely in early August. 'Recent clinician discussions have suggested US hospitals are willing to absorb the cost of Wise pre reimbursement, for patients with a lack of alternative solutions.' In other words: 'if you can't pay, don't worry – we will spot you'. While the initial implants are likely to amount to only a handful, they will show the 'excitement about Wise among clinicians and patients'. Announced last Thursday, the placement was executed at $1 a share, a circa 18% discount on the frozen price of $1.215. The stock initially was sold down to $1.06 but is now trading above the pre-placement price. The shares were sold off sharply post FDA approval, partly reflecting expectations of a capital raise. EBR has US$84 million in the bank, but Canaccord's valuation assumes the issuance of a further 105 million shares in a follow-on raising, in 2025-26 or 2026-27. Medical devices 'safe haven' Canaccord notes that medical device makers generally have proved a haven in the US market turmoil, outperforming both the healthcare index and the S&P 500 index. US-listed device makers have gained 7.7% since the start of the year, compared with a 1.4% gain for the S&P 500 and a 3.3% decline for the proxy index, the Ishares US medical device ETF. ASX device makers have enjoyed a purple patch, with the FDA approving Orthocell's (ASX:OCC) Remplir nerve regeneration device in early April. In March the agency green-lit Nanosonics' (ASX:NAN) next-gen medical probe steriliser, Coris and Artrya's (ASX:AYA) AI-enabled coronary plaque detection tool. Medical devices don't tend to offer the same upside as an approved drug, but they are far less risky proposition. While-no one quite knows what's going on in the mind of Donald Trump, they are not in the firing line in the same way as overseas (notably European) drug makers. Rhythm nails it with 'poo test' alternative There's more on the diagnostics front, with Rhythm Biosciences (ASX:RHY) completing testing the second stage of testing of Colostat, its blood-based test for bowel cancer. Using banked patient samples, the second-generation (beta) kit generated around 23,000 data points 'to evaluate a variety of variables including inter and intraplate precision, interference and detection limits'. More than 96% of the total tests 'comfortably met the performance targets for their operational use.' The remaining 4% will be 'compensated for' in the final, manufactured product. In short, the test meets the 'performance required to meet or exceed the proposed clinical use as a triage test for patients symptomatic for bowel disease'. The next step involves Rhythm's partner Quansys producing pilot kits, followed by final testing with independent clinical samples. 'Following completion of the above, Rhythm will be able to make Colostat commercially available through Rhythm's commercial laboratory.' This would be by way of National Association of Testing Authorities verification, or through partner laboratories using their own accreditation. Ultimately, the assay aims to replace the current 'poo test', which many users find cumbersome, abhorrent for cultural reasons or simply unattractive.
News.com.au
15-05-2025
- Business
- News.com.au
Health Check: Amplia shares surge on pancreatic cancer trial results; Immutep offers hope
Amplia says it has reached the requisite level of 'partial responders' in its mid-stage pancreatic cancer study Immutep reports 'remarkable' response rates in a German-based lung cancer trial Paradigm wins US ethics approval for knee osteoarthritis trial Given it's National Palliative Care Week, it's apt that two drug developers have posted hopeful trial updates pertaining to two of the most deadly cancers. Amplia (ASX:ATX) reports the latest results from its ongoing phase Ib/IIa pancreatic cancer trial are 'superior to chemotherapy alone'. The trial, dubbed Accent, is testing Amplia's narmafotinib (AMP-945), a focus kinase (FAK) inhibitor. The study combines AMP-945 with two widely used chemotherapies. Amplia confirmed a 'partial response' in 15 patients. That's "a level of response sufficient to demonstrate that the combination of narmafotinib and chemotherapy is superior to chemotherapy alone'. A partial response means a tumour has shrunk more than 30%, with the benefit sustained for two months or more. 'As pancreatic cancer is highly aggressive, it is extremely rare for patients to achieve a complete response,' the company says. Under the open-label trial design, all patients receive narmafotinib and the standard of care chemo, with the results compared to historic data. Since January 2024, Amplia has enrolled 55 advanced pancreatic cancer in the study, with 21 patients still involved. The company says 15 out of 50 patients would be enough to demonstrate efficacy 'with reasonable confidence'. FAK inhibitors are especially relevant for fibrotic tumours such as pancreatic and ovarian cancer. Amplia expects to release top-line data from the fully recruited trial in around October this year. The trial is being conducted at seven sites in Australia and five sites in South Korea (which, not coincidentally, has a high rate of pancreatic cancer). Immutep's efti spurs hefty share surge Immutep (ASX:IMM) shares bounced up to 11% this morning after the cancer immunotherapy developer reported 'remarkable' patient response rates in a German lung cancer trial testing its lead compound, efti. The trial, Insight 003, enrolled patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Proprietary to Immutep, efti (eftilagimod alfa) is a protein called Lymphocyte Activation Gene-3 (LAG-3), which stimulates the body's immune response to cancer. In a triple combo approach worthy of a Hungry Jack's menu, the subjects were delivered efti alongside the immune checkpoint inhibitor Keytruda and standard chemo. Admittedly, Immutep's dense announcements are too much for your scribe's frazzled synapses. Let's just say there's an interplay with PD-L1, a predictive biomarker expressed in cancers including lung and melanoma. PD-L1 is typically expressed on healthy cells and acts as the 'brake' preventing immune cells from attacking healthy tissues. High PD-L1 expression means the cancer cells can evade the immune system. While immune checkpoint inhibitors have revolutionised cancer treatment, as many as 80% of NSCLC patients do not respond to anti-PD-L1 monotherapy. The trial results showed a 60.8% response rate – the incidence of cancers shrinking or disappearing – compared with 48% for historical control data. Encouragingly, the triple combo worked best for patients with a PD-L1 score below 50% - a 59.6% response rate compared to 40.8% for the control data. 'These patients … have a high unmet need and represent over two-thirds of the NSCLC patient population,' the company says. The study is an adjunct to Immutep's main game: a pivotal phase III NSCLC combination trial, Tacti-004. 'Across two trials we have now efficacy data from 165 patients with NSCLC who have been treated with efti and Keytruda, either with or without chemotherapy,' Immutep chief Marc Voigt says. 'In multi-national settings, efti has generated consistent and remarkable improvements in response rates.' The investigator-led Insight-003 trial is being carried out at the Frankfurt Institute of Clinical Cancer Research and other German centres. Immutep is evaluating efti for other solid tumours including head and neck squamous cell carcinoma (HNSCC) and metastatic breast cancer. The US Food and Drug Administration (FDA) has bestowed fast track designation for efti, for first-line treatment of HNSCC and NSCLC. Paradigm gets the US go-ahead for pivotal knee trial Paradigm Biopharmaceuticals (ASX:PAR) has won US ethics approval to start its long-awaited phase III trial for knee osteoarthritis (OA), availing of a new streamlined procedure. The company plans to enrol 466 patients with moderate to severe OA in the pivotal trial, across 55 US sites. The first subject should enlist in the September quarter. Paradigm's treatment is an injected, repurposed drug candidate called pentosan polysulphate sodium, or iPPS. A central review board granted the ethics approval, which obviates the need for site-by-site clearance. The FDA approved the trial protocol in November last year. Australia's ethics gatekeeper also has granted approval, allowing Paradigm to initiate 10 clinical sites here. Patient recruitment is underway. The company cites a poultice of real-world evidence about iPPS's efficacy – notably former football with dodgy knees. But regulators want to see a randomised, double-blind, placebo-controlled effort, as per the Paradigm trial. Knee OA affects millions of people, yet there's no effective treatment. The company hopes an approved drug will reduce opioid use. With its anti-fibrotic action, iPPS may go further than just alleviating the symptoms and improve the fundamental condition of the joints. As at the end of March Paradigm had cash of $24.5 million – not enough to fully fund the trial. But in late January the company announced loyalty options, exercisable at 65 cents by February next year. Add-on 'piggyback' options are exercisable at $1 by February 2028. With Paradigm shares trading at just over 30 cents these options are not in the money, but if fully exercised would raise up to $112 million. Pause for thought Shares in HeraMED (ASX:HMD) and Chimeric Therapeutics (ASX:CHM) have entered trading halt today. The developer of foetal monitoring device, Heramed expects to issue a material update on its 'go-to-market strategy in the US due to changes in the business environment'. We'll know more on Monday. Cancer immunology player Chimeric has requested a 'temporary halt pending a further announcement'. Chimeric shares have been hammered by the healthcare upheaval in the US, where the company carries out third-party funded trials.
News.com.au
05-05-2025
- Business
- News.com.au
Health Check: Biotechs recover as peace descends on the FDA
The US health sector shows signs of stabilising as chaos subsides Immutep will meet with the FDA following 'excellent' follow-on trial results When it comes to its sagging share price, Immuron leaves blame-shifting to the defeated Liberals Has the US healthcare scene reached peak mayhem? After the tariff uncertainties, Food & Drug Administration (FDA) staff cuts and the gutting of the National Institutes of Health, conditions appear to be settling. This is reflected in the Nasdaq biotech index, which has recovered 15% from its April 8 nadir – then a 33% decline from August 2021 peak levels. Year to date the index has fallen 1.6%. Bell Potter notes new FDA Marty Makary has stressed the agency's staff cuts – 3500 out of an 18,000 strong workforce – have not involved case reviewers and other science-y roles. 'This corroborates feedback from many ASX companies advising FDA engagements in recent months have been conducted per agreed timelines,' the firm says. After announcing the company's US partnership worth up to $940 million, Dimerix (ASX:DXB) chief Dr Nina Webster said a meeting with the FDA to discuss the use of surrogate endpoints in a trial was 'held on time and the review team was intact.' Makary has also flagged streamlining the post-marketing review process for rare disease drugs, to enable them to be approved faster in the first place. This benefits Dimerix, which is eyeing potential fast-track approval for its rare kidney disease drug. Bell Potter describes Makaray as a 'relatively pragmatic Commissioner unlikely to plunge the FDA into chaos.' Alterity is in the fast lane As if on cue, the FDA has also granted fast-track designation to Alterity Therapeutics (ASX:ATH) for its investigational drug to treat multiple system atrophy (MSA). This follows positive results from the company's phase II trial, which showed a 'statistically significant' improvement in how patients go about their daily lives. A so-called Parkinsonian disorder, MSA results in similar gait problems, shuffling and tremors. On January Alterity shares more than doubled after the company released the phase II results – and they perked up about 10% on this morning's news. Fast-track status enables more frequent and earlier communication with the FDA, with any new drug application reviewed on a quicker rolling basis. Alterity's therapy also has orphan drug designation, which confers benefits such as marketing exclusivity and higher pricing. Immutep shares surge on cancer trial results Still on cancer immunotherapy, Immutep (ASX:IMM) will seek a meeting with the FDA after reporting 'excellent' results for its phase IIb head and neck cancer trial. Aimed at head and neck squamous cell carcinomas (HNSCCs), the trial combines the company's Efti therapy with the standard of care Keytruda. The company reports the combination resulted in median overall survival of 17.6 months, in a 31-patient cohort with a low incidence of the biomarker PD-L1. Overall survival is how long a patient lives from the time of diagnosis or treatment until their death, regardless of the cause. The data 'compares favourably' with standard of care approaches resulting in overall survival between 7.9 months and 11.3 months. Earlier, the company reported multiple complete responses (the cancer had gone away). The company says these patients have a high unmet medical need, given the lack of available treatment options without chemotherapy. 'We will meet with regulators to discuss next steps and potential paths to approval,' says CEO Marc Voigt. The company is also evaluating the protein eftilagimod – Efti to friends – for non-small cell lung cancer (NSCLC) and metastatic breast cancer. The FDA has accorded fast-track status to Efti as a first-line treatment for HNSCC and NSCLC. Last week, the Nasdaq-listed ALX Oncology said its combination trial for HNSCC failed to meet primary endpoints in a phase II trial. The company has abandoned the program. Imugene explains share rout The US chaos has resulted in radical share moves for US-exposed ASX biotechs over the last month, such as cancer drug developer Imugene's (ASX:IMU) 23% sell-off. In a missive to shareholders, Imugene executive chair Paul Hopper and CEO Leslie Chong last week offer 'transparent explanations' as to why the company is worth $200 million today, compared to $3 billion in late 2021. They must have missed the memo about blaming challenging macro conditions and short-term investors, etcetera. They acknowledge slower than expected progress on Imugene's two key trial programs, CF33 and Oncarlytics. Another likely culprit is the lack of licensing deal, especially for the company's legacy program, Her Vaxx. The duo says the market perceives the company as a high cash-burn business – which is kinda right because drug development inherently is not cheap. In the meantime, short sellers account for an elevated 5.2% of the company's share register. 'We think this has had a knock-on effect to other sellers/investors who view a short position as an expectation that the share price will fall, and possibly this has dragged other sellers in.' Management has no control over that one. Health winners from Alban-easy victory Given he brandished his well-worn Medicare card during his victory speech, Anthony Albanese is expected to deliver swiftly on Labor's promise to expand the availability of bulk-billing doctors. If more patients visit their doc, there will be an expected rise in flow-on referrals to pathology and radiology providers. While the overall market opened slightly lower this morning, shares in Sonic Healthcare (ASX:SHL), Healius (ASX:HLS), Australian Clinical Labs (ASX:ACL) and Integral Diagnostics (ASX:IDX) enjoyed a faint Albo glow. But it remains to be seen whether subdued volumes return to historical levels.
Yahoo
29-04-2025
- Business
- Yahoo
Immutep Quarterly Activities Report Q3 FY25
Media Release First patient safely dosed in TACTI-004 Phase III lung cancer trial, marking a significant milestone Pivotal TACTI-004 trial design presented at the European Lung Cancer Congress (ELCC) 2025 Patient enrolment completed for the EFTISARC-NEO Phase II trial evaluating efti with radiotherapy and KEYTRUDA® in resectable soft tissue sarcoma Patient enrolment completed for the INSIGHT-003 Phase I trial evaluating efti with KEYTRUDA® and chemotherapy as first-line treatment of advanced or metastatic 1L NSCLC Strong cash position of A$146.25 million, providing an expected cash reach to the end of CY2026 SYDNEY, AUSTRALIA, April 29, 2025 (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 31 March 2025 (Q3 FY25). EFTI DEVELOPMENT PROGRAM FOR CANCER TACTI-004 – First Patient Successfully Dosed in Pivotal Phase III Trial in 1L NSCLCIn March 2025, Immutep announced the first patient in the Company's pivotal TACTI-004 Phase III trial was successfully dosed at Calvary Mater Newcastle Hospital in Australia. TACTI-004 evaluates eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and chemotherapy as first line treatment of patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global Phase III trial with efti will randomize approximately 756 patients at more than 150 clinical sites and trial results will inform a potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology. Immutep also presented the pivotal TACTI-004 Phase III trial as a Trial-in-Progress poster at the European Lung Cancer Congress (ELCC) 2025, in Paris, France, in late March. The poster included an overview and study design of the TACTI-004 Phase III trial. Informed by the Company's AIPAC-003 study, Immutep has determined to move forward with 30 mg efti dosing as the optimal biological dose. We have observed encouraging support from the investigators participating in the study in our meetings to date including those held at ELCC 2025 and after quarter end at the investigator meeting in Budapest, Hungary. Consistent feedback has been that the efficacy and safety data collected thus far from the TACTI-002 and INSIGHT-003 trials are impressive and address the unmet medical needs seen by many key opinion leaders. Recruitment in TACTI-004 is underway at a growing number of activated clinical sites and countries with approvals from regulatory authorities expanded to now 19 countries including Australia, Austria, Belgium, Bulgaria, Canada, Germany, Greece, Hungary, India, Ireland, Italy, Latvia, Lithuania, Portugal, Spain, and the United Kingdom. TACTI-003 (KEYNOTE-C34) – Phase IIb Trial in 1L HNSCCImmutep continued to follow patients in the TACTI-003 (KEYNOTE-C34) Phase IIb trial, which is evaluating efti in combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC), during Q3 FY25. Immutep most recently reported positive results from Cohort B of the trial in 1L HNSCC patients with PD-L1 negative tumours (CPS <1) who typically do not respond well to anti-PD-1 therapy alone, at the ESMO Immuno-Oncology Annual Congress in December 2024. Immutep will continue to follow the maturing data from TACTI-003 and plans to engage with regulatory authorities regarding potential paths forward by mid of this year. AIPAC-003 – Phase II/III Trial in Metastatic Breast CancerImmutep continues to execute the AIPAC-003 trial, which enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. 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 30mg or 90mg 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. Patient follow up, data cleaning and analysis is ongoing and an update is anticipated in CY2025. INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLCIn January 2025, Immutep announced that patient enrolment has been completed for the ongoing investigator-initiated INSIGHT-003 trial. INSIGHT-003 is evaluating efti in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and doublet chemotherapy as first line treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC). The Phase I trial has reached its enrolment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF. Positive first Overall Survival results and other data points from INSIGHT-003 were reported in late 2024. Data updates from INSIGHT-003 are expected in CY2025. EFTISARC-NEO – Phase II Trial in Soft Tissue SarcomaIn January 2025, Immutep announced that patient enrolment has been completed in the ongoing investigator-initiated EFTISARC-NEO trial. EFTISARC-NEO is evaluating efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS). The Phase II trial being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, reached its enrolment target of 40 patients. Encouraging data from EFTISARC-NEO was presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024. Data updates from EFTISARC-NEO are expected in CY2025. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASEImmutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class agonist LAG-3 antibody designed to restore balance to the immune system by enhancing the 'brake' function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. Following previously reported favourable initial safety data in December 2024, additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships are expected to be reported in CY2025. INTELLECTUAL PROPERTY During the quarter, Immutep was granted two new patents for LAG525 in in the Philippines and the United States. Immutep was also granted a Russian patent directed to an assay for use in measuring the potency of IMP761, for example, as part of a quality control step in production of the agonist LAG-3 antibody. CASH FLOW SUMMARYDuring the quarter, Immutep continued to advance its clinical trial programs for efti and for IMP761 with prudent cash management. The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 31 March 2025 of approximately A$146.25 million, which is greater than budgeted as at the beginning of the current financial year, whilst delivering on our announced goals. The total balance consists of: 1) a cash and cash equivalent balance of A$92.45 million and 2) bank term deposits totaling A$53.80 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months. In Q3 FY25, cash receipts from customers were A$12k. The net cash used in G&A activities in the quarter was A$704k, compared to A$566k in Q2 FY25. Payments to Related Parties comprises Non-Executive Directors' fees and Executive Directors' remuneration of A$363k. The net cash used in R&D activities during the quarter was A$13.6 million, compared to A$16.2 million in Q2 FY25. The decrease is mainly due to: the prepayment of TACTI-004 clinical trial related 'kick-off costs' to initiate the trial in the previous quarter; and the completion of enrolment in the Phase II portion of the AIPAC-003 trial and the cost-efficient investigator initiated EFTISARC-NEO and INSIGHT-003 trials, which like TACTI-003 are all now focused on patient follow up. As such the Company is incurring significantly lower burn rates from those trials. Payment for staff costs was A$2.5 million in the quarter, which was the same as for Q2 FY25. Total net cash outflows used in operating activities in the quarter were A$16.26 million compared to A$19.0 million in Q2 FY25. Total cash inflow from investing activities for the quarter was A$32.34 million, mainly due to the maturity of short-term investments. The short-term investments are comprised of term deposits with maturities of greater than 3 months and less than 12 months. During the quarter, the company transferred back A$32.34 million from short-term investments that had matured to cash at bank, resulting in a positive cashflow in investing activities. About ImmutepImmutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique 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 Australian Investors/Media:Catherine Strong, Sodali & Co+61 (0)406 759 268; U.S. Investors/Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; in to access your portfolio
Yahoo
20-03-2025
- Business
- Yahoo
Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the European Lung Cancer Congress 2025
SYDNEY, AUSTRALIA, March 20, 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 Phase III trial. The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025. The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company's MHC Class II agonist, 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 and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Immutep CSO, Frédéric Triebel, M.D., Ph.D, said, 'We look forward to engaging with physicians in the lung cancer community at the ELCC conference to discuss our TACTI-004 Phase III study that is actively recruiting patients. Efti in combination with KEYTRUDA may change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression, and we hope to see this registrational trial confirm the promising safety and efficacy achieved to date.' Details for the poster presentation:Title: TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + CPresentation number: 131TiPPresenter: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant PauSession Date and Time: 26 March 2025, 13:50 CET The poster will be available on the Posters & Publications section of Immutep's website following the presentation. About Eftilagimod Alpha (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 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Catherine Strong, Sodali & Co.+61 (0)406 759 268; U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000;
