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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
27-03-2025
- Business
- Yahoo
J&J says Rybrevant/Lazcluze outperforms osimertinib OS in Phase 3 study
Johnson & Johnson announced results for the 'gold standard endpoint in cancer treatment' of overall survival from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed Rybrevant plus Lazcluze significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or L858R substitution mutations. Median OS is projected to exceed one year beyond the median of three years observed with osimertinib and has not yet been reached. 'This is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib. New compelling data were presented during a proffered paper session at the 2025 European Lung Cancer Congress,' the company stated. At a median follow-up of 37.8 months, patients treated with the chemotherapy-free regimen of first-line Rybrevant plus Lazcluze had a significantly longer OS compared to those receiving osimertinib. Median OS for Rybrevant plus Lazcluze has not yet been reached, indicating that survival benefits continue to extend beyond the measured follow-up period. Comparatively, median OS for osimertinib-treated patients was 36.7 months and consistent with prior studies with osimertinib. Fifty-six percent of patients treated with Rybrevant plus Lazcluze were alive at three and a half years compared to 44 percent of patients on osimertinib. Projections based on survival data suggest Rybrevant plus Lazcluze could extend median OS by at least 12 months compared to osimertinib, J&J stated. Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on JNJ: Disclaimer & DisclosureReport an Issue U.S. to end funding for child vaccines in developing countries, NY Times reports Large pharma M&A deals stalling amid volatile policies, Reuters reports Needham medtech & diagnostics analyst holds analyst/industry conference call Pharma Giant Johnson & Johnson (JNJ) Boosts U.S. Investments by 25% J&J (JNJ) Commits $55B to U.S. Manufacturing Expansion as Trump's Tariffs Pressure Mounts Sign in to access your portfolio
Bloomberg
26-03-2025
- Health
- Bloomberg
J&J Passes AstraZeneca in Blockbuster Cancer Race — For Now
Johnson & Johnson has pulled ahead of rival AstraZeneca Plc in a race to dominate the blockbuster market for lung cancer treatment, but data from a forthcoming study could quickly shake up the competition again. J&J's combination therapy helped patients live significantly longer than those who received Astra's Tagrisso, according to detailed data from a head-to-head study presented Wednesday at the European Lung Cancer Congress in Paris. Expanding on results disclosed in January, researchers said they expect J&J's treatment to extend patients' median survival by a year or more compared to Astra's drug, the current standard of care.
Associated Press
25-03-2025
- Business
- Associated Press
Nuvation Bio to Present Matching-adjusted Indirect Comparison Data for Taletrectinib vs. Crizotinib During Mini Oral Presentation at the European Lung Cancer Congress 2025
NEW YORK--(BUSINESS WIRE)--Mar 25, 2025-- Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus crizotinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be reported in a mini oral presentation at the European Lung Cancer Congress taking place March 26–29, 2025 in Paris, France. Mini Oral Presentation Overview: Title: Taletrectinib vs crizotinib in ROS1-positive non-small cell lung cancer: A matching-adjusted indirect comparison Presenter: Misako Nagasaka, M.D., Ph.D., Associate Professor – Division of Hematology and Oncology, UCI School of Medicine Date: Thursday, March 27, 2025 Session Time: 4:00 p.m. – 5:05 p.m. CET / 11:00 a.m. – 12:05 p.m. ET Session: Mini Oral Session 1 Presentation Number: LBA2 The materials will be made available in the Publications section of Nuvation Bio's website after the presentation. About Taletrectinib Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio's NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China's NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. About Nuvation Bio Nuvation Bio is a global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio's programs include taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, please visit or follow the Company on LinkedIn and X (@nuvationbioinc). INDUSTRY KEYWORD: BIOTECHNOLOGY GENERAL HEALTH HEALTH PHARMACEUTICAL ONCOLOGY SOURCE: Nuvation Bio Inc. Copyright Business Wire 2025. PUB: 03/25/2025 08:00 AM/DISC: 03/25/2025 08:00 AM
Yahoo
20-03-2025
- Business
- Yahoo
BioAtla Announces Two Poster Presentations at Upcoming Medical Meetings
SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced two abstracts accepted for poster presentations at the upcoming European Lung Cancer Congress (ELCC) 2025 Scientific Committee and Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025, to be held in Paris, France from March 26–29, 2025 and in Scottsdale, AZ from March 27–29, 2025, respectively. Presentation Details: Venue: ELCC 2025 Title: Exploratory Analysis of Overall Survival among Non-Small Cell Lung Cancer (NSCLC) Patients with Mutated KRAS in a Phase 2 Trial of Mecbotamab Vedotin (CAB-AXL-ADC) Presenter: Karen Reckamp (Los Angeles, CA, United States of America) Poster Number: 98P Session Topic: Advanced NSCLC Date and Time: Wednesday–Saturday, March 26–29, 2025; presenter available at poster on Friday, March 28, 2025 from 13:00 – 13:45 CET Venue: Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025 Title: Ozuriftamab Vedotin (BA3021), a Conditionally Binding ROR2-ADC; Phase 2 experience in Patients with Heavily Pretreated Squamous Cell Carcinoma of the Head and Neck Presenter: Winston Wong (New York City, NY, United States of America) Date and Time: Thursday, March 27, 2025 at 10:55a MST A copy of the presentation materials can be accessed on the 'Publication' section of the Company's website at once the presentations have concluded. About BioAtla®, Inc. BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vedotin, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 2 stage CAB-CTLA-4 antibody, evalstotug, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. The Company's first dual CAB bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development. BA3182 targets EpCAM, which is highly and frequently expressed on many adenocarcinomas while engaging human CD3 expressing T cells. To learn more about BioAtla, Inc. visit Internal Contact:Richard WaldronChief Financial OfficerBioAtla, 858.356.8945 External Contact:Bruce MackleLifeSci Advisors, LLCbmackle@ in to access your portfolio
