Talimogene laherparepvec

FN Media Group Presents USA News Group News Commentary VANCOUVER, British Columbia, Sept. 22, 2023 /PRNewswire/ -- USA News Group - Despite the potential federal funding challenges due to the recent debt ceiling deal, optimism in the battle against cancer persists, thanks in large part to the audacious "Cancer Moonshot" initiative. This ambitious plan, aimed at halving cancer rates within the next quarter-century, continues to fuel hope even as concerns about the stability of National Institutes of Health (NIH) funding arise. In these turbulent times, the resilience and ingenuity of the biotech sector provide a beacon of hope. For instance, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Zymeworks Inc. (NASDAQ: ZYME), Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Protagonist Therapeutics, Inc. (NASDAQ: PTGX), and Amgen Inc. (NASDAQ: AMGN), have each demonstrated inspiring progress and unwavering commitment in advancing cancer treatments, highlighting their vital role in the future of cancer therapy. At the 2023 ASCO Annual Meeting Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) shared exciting results from its important study, called BRACELET-1, with results that caught the eye of RBC Capital. The oral presentation shared at the event described how they've been testing a treatment for advanced breast cancer, and it's looking very promising. The treatment combines Oncolytics' flagship drug, pelareorep, with a well-known cancer medicine, paclitaxel. Pelareorep is a unique drug that targets and kills cancer cells by making them self-destruct while leaving healthy cells unharmed. The results of BRACELET-1 showed that this mixture could slow down the cancer significantly. It even lowered the risk of the cancer getting worse by a significant 71% compared to just using paclitaxel. For people battling cancer, this means more quality time before the cancer might get worse. Specifically, people getting the combined treatment had about 9.5 good months before the disease advanced, compared to just 6.3 months with only paclitaxel. Moreover, the new treatment was better at shrinking or even eliminating the cancer. An impressive 37.5% of patients responded to the combined treatment, as opposed to just 13.3% with paclitaxel alone. "BRACELET-1's positive results complement prior phase 2 data showing a statistically significant increase in overall survival when pelareorep was combined with paclitaxel by demonstrating similar robust improvements in PFS and ORR in less heavily pre-treated patients," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Given this exciting finding, our next step is to discuss our data with the FDA to investigate incorporating dual PFS and OS endpoints into our breast cancer program's registrational study. Including a PFS endpoint will substantially reduce the time to a pivotal readout from the registrational trial, thereby accelerating pelareorep's path to potential approval as we work to address the urgent needs of HR+/HER2- breast cancer patients." Following these encouraging results, Oncolytics Biotech is now ready to take the next steps in advancing its breast cancer program. They're planning to talk to the FDA and push forward with more registrational studies, having already received Fast Track Designation for pelareorep in the treatment of advanced/metastatic pancreatic cancer, in late 2022. This could make pelareorep an approved treatment for breast cancer sooner than expected. Another highlight from the ASCO presentations was that of Jazz Pharmaceuticals plc (NASDAQ: JAZZ) and Zymeworks Inc. (NASDAQ: ZYME). Together the two companies presented promising data from a pivotal Phase 2b trial, evaluating the bispecific antibody, zanidatamab, in HER2-amplified biliary tract cancers (BTC), a particularly aggressive group of cancers that currently lack HER2-targeted treatment options. The results were not only presented at ASCO but also concurrently published in The Lancet Oncology. They demonstrated meaningful clinical benefit, including antitumor activity, a confirmed objective response rate (cORR) of 41.3%, a median duration of response (DOR) of 12.9 months, and a median progression-free survival (PFS) of 5.5 months. "The HERIZON-BTC-01 trial advances an exciting field of oncology research where we can leverage next-generation sequencing on BTC patients to understand genomic markers of the disease and choose the appropriate targeted therapies for these patients," said Shubham Pant, M.D., professor of Gastrointestinal Medical Oncology and Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. The data clearly outshines current chemotherapy treatments for BTC, which offer only a 5 to 15 percent ORR and median PFS of 1.4 to 4 months. The Zymeworks-Jazz partnership showcased an oral presentation on the pivotal HERIZON-BTC-01 study results demonstrating zanidatamab's meaningful clinical benefit and tolerable safety profile in patients with HER2-amplified BTC. Zanidatamab has already been granted Breakthrough Therapy designation and two Fast Track designations by the FDA, making it an exciting contender in the fight against these tough-to-treat cancers. These exciting results suggest a potential future where targeted treatments like zanidatamab transform the lives of patients in critical need. With three oral presentations and two poster discussions, and over 25 abstracts, Amgen's (NASDAQ: AMGN) presence at ASCO included new scientific and clinical research across its diverse oncology portfolio and pipeline, featuring data in hard-to-treat tumor types like non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and small cell lung cancer (SCLC). "Our presentations at ASCO… illustrate how we're advancing novel approaches to address the toughest thoracic and colorectal cancers with limited treatment options," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We're focused on expanding the reach and impact of our transformative, first-in-class medicines to help more people living with cancer." Highlights from Amgen's presentations included data on LUMAKRAS® (sotorasib) from the first study evaluating its intracranial efficacy as a KRAS G12C inhibitor versus docetaxel in treated KRAS G12C-mutated advanced NSCLC. Additional analyses from DeLLphi-300 highlighted the safety and clinical efficacy of Tarlatamab, an investigational first-in-class BiTE® immunotherapy, in patients with SCLC with treated and stable brain metastases. Other studies presented novel combinations showing encouraging safety and efficacy in pre-treated KRAS G12C-mutated metastatic CRC and first-line NSCLC. These presentations showed advances in several therapeutic areas, including hematologic malignancies, melanoma/skin cancers, and gastrointestinal cancers. Some of the key clinical studies presented include the IKEMA study for KYPROLIS®, the PARADIGM trial for VECTIBIX®, and a phase 2 study on IMLYGIC® in advanced sarcoma. One company also potentially (yet indirectly) making significant strides in the oncology sector is Protagonist Therapeutics, Inc. (NASDAQ: PTGX), a Newark, California-based biopharmaceutical firm. Although not traditionally labeled as a cancer biotech firm, their innovative approach towards blood disorders, notably Polycythemia Vera, a slow-growing blood cancer, underscores their contribution to the broader oncology landscape. Protagonist's leading drug candidate, rusfertide (PTG-300), is currently under the microscope. The company recently announced that additional data from the REVIVE study of rusfertide in polycythemia vera would be presented at the annual Congress of the European Hematology Association (EHA). This study holds immense promise as it explores the ability of rusfertide to improve symptoms related to this blood disorder. The Moffitt Cancer Center and the Department of Malignant Hematology have taken a keen interest in this study, suggesting rusfertide's potential broader application in the field of hematology and possibly in other forms of cancer. An assistant member of the Department, Dr. Andrew Kuykendall, will present the study results, further demonstrating the deep links between Protagonist's work and oncology professionals. Moreover, Protagonist is also advancing their peptide-based new chemical entity, JNJ-2113 (formerly PN-235), which recently showed positive topline results in treating moderate-to-severe plaque psoriasis. While psoriasis is not a form of cancer, the advancement of these biological drugs signals a new direction in treating various human conditions, including cancers. Article Source: Article Source: USA News Group [email protected] DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. 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Bronchopulmonary dysplasia is a rare disease impacting premature infants. Credit: Ro_Ma_Li / Shutterstock.com. Advent Therapeutics has received a small business innovation research grant worth $3m from the US National Institutes of Health (NIH) to develop a non-invasive inhaled bronchopulmonary dysplasia (BPD) therapy. The Phase IIB grant will aid the company in developing an aerosolised formulation of vitamin A for the prevention of BPD, a rare but major respiratory condition impacting premature infants. Treatment is expensive, with no therapies yet approved. Recommended Reports Reports LOA and PTSR Model - Paclitaxel in Metastatic Adenocarcinoma of The Pancreas GlobalData Reports LOA and PTSR Model - Talimogene Laherparepvec in Metastatic Adenocarcinoma of The Pancreas GlobalData View all Companies Intelligence Advent LLC Advent Therapeutics Inc ODD View all Advent plans to commercialise the new formulation in 2025. The company will also use the grant to conclude preclinical requisites and scale up the production of inhalable retinol palmitate products to enter clinical trials in humans. This will aid in obtaining marketing approvals in the US and other regions. The vitamin A formulation has received orphan drug designation (ODD) in the US and Europe. The granting of ODD provides incentives including support to develop drugs and user fee exemption. Advent Therapeutics CEO David Lopez stated: “This NIH award will allow us to greatly accelerate the development and advance towards approval of our optimised vitamin A drug product. “Advent’s novel, precisely optimised products are intended to address the unmet medical needs of premature infants [with BPD] and reduce morbidity and mortality in this fragile patient population. “Our primary focus is to accelerate the path to commercialisation, first in the US, then EU and worldwide.” The latest funding takes the NIH grant received by Advent to more than $6m for its neonatal programmes.