VANCOUVER – USA News Group News Commentary – The potential threat of cancer looms for everyone, but now new studies are revealing an increased number of cancer cases in younger age groups than before. While researchers continue to search for a reason why this is happening, some are pointing towards increased rates of obesity, among other potential reasons. With the Global Oncology Drugs Market set to grow by 11.5% CAGR through 2033 to US$564.5 billion, according to Spherical Insights, the need for more effective therapies is becoming more apparent. The biotech sector continues to work diligently, spotlighted by several developments recently announced by companies, including: Oncolytics Biotech Inc.(NASDAQ: ONCY) (TSX: ONC), Mustang Bio, Inc. (NASDAQ: MBIO), Legend Biotech Corporation (NASDAQ: LEGN), Johnson & Johnson (NYSE: JNJ), and Nurix Therapeutics, Inc. (NASDAQ: NRIX).
The article continued: Last year, the FDA granted a total of 50 approvals for various oncology drugs. This year, the National Cancer Institute projects there will be an estimated 2,001,140 new cases of cancer diagnosed in the USA in 2024, with an expected 611,720 people projected to die from the disease.
Oncolytics Biotech® Doses First Patient in Study of Pelareorep/FOLFIRINOX Combination Therapy in Pancreatic Cancer
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the dosing of the first patient in the new GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The co-primary endpoints of the cohort are objective response rate (ORR) and safety. It’s supported by the US$5M Pancreatic Cancer Action Network (PanCAN) Therapeutic Accelerator Award, an innovative program established to accelerate the development of new treatments for pancreatic cancer patients. It will be conducted in collaboration with AIO-Studien-gGmbH (AIO), a clinical trial group within the German Cancer Society, as part of GOBLET, a Phase 1/2 multiple indication study evaluating pelareorep-based combinations in gastrointestinal cancers.
“Initiation of dosing in the mFOLFIRINOX cohort of the GOBLET study is an important milestone for Oncolytics, and we’re excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration program for the company,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “The combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy alone. That combination received Fast Track Designation from the FDA and is expected to be evaluated in an adaptive registration-enabling trial through the Global Coalition for Adaptive Research (GCAR). If the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, we could have two pancreatic cancer treatment regimens on the path to registration. I want to highlight PanCAN’s important support for this program with gratitude. The US$5M Therapeutic Accelerator Award has made it possible for us to broaden our evaluation of potential therapies that have the potential to improve outcomes for pancreatic cancer patients.”
Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN said, “Working toward our vision to create a world in which all patients with pancreatic cancer will thrive, PanCAN launched the Therapeutic Accelerator Award to speed the drug development process and bring new options to patients faster. Dosing the first patient in this new cohort of the GOBLET study is an important step toward further evaluation of this investigational immunotherapeutic approach.”
Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial commented, “I have been pleased to observe the strength of the clinical response data for pelareorep in multiple cohorts of the GOBLET gastrointestinal study, especially in pancreatic and anal cancer. mFOLFIRINOX is currently considered the best treatment option for many pancreatic cancer patients. Therefore, the evaluation of pelareorep and mFOLFIRINOX, with or without atezolizumab, presents an important opportunity to identify a novel therapeutic approach that may broaden the population of metastatic pancreatic cancer patients who could benefit from pelareorep-based therapies.”
“Oncolytics is in a favorable position as we prepare to advance multiple pelareorep programs toward registration track studies and continue to expand pelareorep’s potential as a backbone immunotherapy that can impact various tumor types. The collaboration with GCAR on a registration-enabling study for the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer, meeting with the FDA to align on next steps for our breast cancer program, expanded enrollment in the GOBLET anal cancer cohort, and now the initiation of dosing in the mFOLFIRINOX cohort of GOBLET, announced today, are all important elements of our corporate plan,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “The ability to improve the lives of cancer patients is something that motivates everyone at Oncolytics, and beginning to treat pancreatic cancer patients in the mFOLFIRINOX cohort of GOBLET is hopefully yet another step towards that goal.”
CONTINUED… Read this and more news for Avant Technologies at: https://equity-insider.com/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/
In other industry developments and happenings in the market this week include:
Mustang Bio, Inc. (NASDAQ: MBIO), a clinical-stage biopharmaceutical company, recently announced favorable efficacy and safety data from its Phase 1/2 trial of MB-106, a CD20-targeted CAR T-cell therapy for Waldenstrom macroglobulinemia (WM). The trial showed a 90% overall response rate (ORR), with one patient in complete remission for 31 months.
“We are very encouraged by the safety and efficacy data generated in WM, along with improvements in the quality of responses over time, which demonstrates MB-106 CAR T-cell expansion and persistence,” said Dr. Brian Till, M.D., Associate Professor and physician at Fred Hutch and University of Washington. Upon hearing the results of the study data, the market responded quickly and positively.
Legend Biotech Corporation (NASDAQ: LEGN), a global cell therapy leader, announced first-time results from the Phase 2 CARTITUDE-2 Cohort D study in multiple myeloma patients. Presented at ASCO 2024, findings showed deep and durable responses in patients with less than a complete response after front-line autologous stem cell transplant (ASCT) following a single infusion of CARVYKTI® (ciltacabtagene autoleucel) with or without lenalidomide maintenance. CARVYKTI® is the first B-cell maturation antigen (BCMA)-targeted therapy approved for treating relapsed/refractory multiple myeloma after the first relapse.
“Patients who achieve a less than complete response following ASCT may experience less durable response with future treatments,” said Melissa Alsina, M.D., Head Myeloma BMT-CI Program, H. Lee Moffitt Cancer Center, and Research Institute. “The outcomes from this study showed encouraging efficacy results and indicated the potential benefit of CARVYTKI in this patient population.”
Johnson & Johnson (NYSE: JNJ) has submitted a Biologics License Application (BLA) to the FDA for a subcutaneous (SC) version of amivantamab combined with recombinant human hyaluronidase. This application covers all current and pending indications of intravenous (IV) RYBREVANT® (amivantamab-vmjw) for certain non-small cell lung cancer (NSCLC) patients.
Data from the Phase 3 PALOMA-3 study, presented at ASCO 2024, showed that SC amivantamab had similar response rates to IV administration in NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations. Additionally, SC amivantamab offered significantly shorter administration time, a five-fold reduction in infusion-related reactions, and improved overall survival, progression-free survival, and duration of response.
“This subcutaneous option, administered in approximately five minutes, is a clinically important advancement that could transform the treatment experience for patients, oncologists and nursing staff,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. “We look forward to working with the FDA and global regulators in the review of these applications.”
Nurix Therapeutics, Inc. (NASDAQ: NRIX), a clinical-stage biopharma company, recently presented updated clinical data for NX-5948, an oral Bruton’s tyrosine kinase (BTK) degrader in a Phase 1a/b trial for relapsed/refractory B-cell malignancies like chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma. The trial showed a 69.2% objective response rate in heavily pretreated patients, including those with BTK inhibitor resistance mutations, leading to a positive market response.
“The current results from this study of advanced patients are very impressive for this early stage of development and we are optimistic that NX-5948 has the potential to be an exciting breakthrough for patients with relapsed CLL, particularly in light of the emerging patterns of resistance to the currently available targeted therapies,” said Dr. Kim Linton, M.B.Ch.B, MRCP, Ph.D., FRCP, senior lecturer at the University of Manchester, a consultant at The Christie NHS Foundation Trust and an investigator on the clinical trial. “As a clinical investigator, it is highly gratifying to be able to offer patients who are refractory to other therapies a once daily, oral drug that can address a range of CLL disease states.”
Source: https://equity-insider.com/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/
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