Pelareorep

Pipeline Progress: Over 25 New Therapies in Development for Metastatic Liver Cancer

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 20 companies developing 25+ therapies for metastatic liver cancer, offering new hope for patients with limited treatment options. • Several promising clinical trials are underway in 2025, including studies evaluating novel combinations such as AK104 plus lenvatinib, tislelizumab with lenvatinib, and triplet therapy of nivolumab, relatlimab and bevacizumab. • Key emerging therapies include exoASO-STAT6 targeting tumor-associated macrophages, STP705 dual TGF-ß1/COX-2 inhibitor, and ONCR-177, an oncolytic viral immunotherapy expressing five transgenes to fight tumors through multiple mechanisms.

Japan Approves Groundbreaking Viral Therapy Teserpaturev for Glioblastoma Treatment

3 months ago

• Japan's health ministry committee has approved Teserpaturev, the country's first virotherapy drug developed by Daiichi Sankyo, marking a significant breakthrough in cancer treatment. • The novel therapy, which uses modified herpesvirus to selectively target and destroy brain cancer cells, demonstrated a remarkable 92.3% one-year survival rate in clinical trials. • The treatment, designed for malignant glioma patients with recurring tumors, showed a median survival period of 20 months, substantially exceeding traditional treatment outcomes.

Pelareorep Plus FOLFIRINOX Shows Acceptable Safety in Metastatic Pancreatic Cancer

4 months ago

• The GOBLET study's safety run-in showed that pelareorep with modified FOLFIRINOX, with or without atezolizumab, is acceptably safe in metastatic pancreatic ductal adenocarcinoma (PDAC). • The combination therapy demonstrated manageable adverse events, consistent with the known safety profiles of the individual drugs, allowing the study to continue full enrollment. • While efficacy results are pending, the safety data supports further investigation of this combination in patients with newly diagnosed metastatic PDAC. • The study continues to enroll patients to evaluate tumor response to pelareorep plus mFOLFIRINOX with or without atezolizumab.

Oncolytics Biotech's Pelareorep Advances in Pancreatic Cancer Trial with Regulatory Approval

4 months ago

• The Paul-Ehrlich-Institute (PEI) in Germany has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. • Cohort 5 is evaluating pelareorep in combination with mFOLFIRINOX with or without atezolizumab in newly diagnosed PDAC patients. • Early safety data will be presented at the upcoming ASCO Gastrointestinal Cancers Symposium, with initial efficacy results expected in the second half of the year.

Pancreatic Cancer: Advances in Treatment and Research Bring Hope in 2024

5 months ago

• The five-year relative survival rate for pancreatic cancer has risen to 13%, marking the third consecutive year of improvement, yet it remains the lowest among major solid tumors. • Four new drug approvals for pancreatic cancer occurred in 2024, including one first-line treatment and three targeted agents for previously treated advanced disease. • A Phase 3 clinical trial demonstrated an overall survival benefit using Tumor Treating Fields (TTFields) in combination with chemotherapy for unresectable, locally advanced pancreatic cancer. • Precision medicine is advancing with the FDA approval of Bizengri for NRG1 fusion-positive pancreatic cancer and the ongoing RASolute 302 trial evaluating RMC-6236, a RAS inhibitor.

Oncolytics' Pelareorep Shows Promise in Pancreatic Cancer Trial, GOBLET Cohort 5 Enrollment Continues

6 months ago

• The Data Safety Monitoring Board (DSMB) has recommended continued enrollment in Cohort 5 of the GOBLET study, which is evaluating pelareorep in pancreatic cancer. • Cohort 5 is assessing pelareorep combined with mFOLFIRINOX, with or without atezolizumab, in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). • Initial safety data from the trial's safety run-in phase support the continued evaluation of pelareorep in combination with chemotherapy and immunotherapy. • Updates from the trial, including safety and efficacy data, are expected in 2025, offering potential advancements in PDAC treatment.

Oncolytics Biotech and Bio-Path Holdings Announce Promising Cancer Therapy Advancements

6 months ago

• Oncolytics Biotech presented data at the ASCO GI Symposium, highlighting pelareorep's potential in treating relapsed anal and metastatic pancreatic cancers. • A GOBLET study cohort showed a 33% objective response rate in relapsed anal cancer patients treated with pelareorep and atezolizumab, including a complete response lasting over 15 months. • Bio-Path Holdings reported a meaningful patient response in a Phase 1/1b trial of BP1002 for refractory/relapsed AML, with stable disease and reduced blast count after one treatment cycle. • Bio-Path Holdings' BP1001-A demonstrated continued tumor reduction and stable disease in a solid tumor patient, alongside durable remissions in AML patients treated with prexigebersen.

Oncolytics Biotech's Pelareorep Shows Promising Survival Benefit in Breast Cancer

6 months ago

• BRACELET-1 trial data reveals a significant overall survival benefit with pelareorep plus paclitaxel in HR+/HER2- metastatic breast cancer, supporting further registrational study. • Oncolytics Biotech anticipates updated efficacy data from the GOBLET study's anal cancer cohort and safety data from the modified FOLFIRINOX pancreatic cancer cohort in H1 2025. • The company reported $19.6 million in cash reserves as of September 30, 2024, projecting a cash runway through key milestones into 2025.

Pancreatic Cancer Market to Reach $11.5 Billion by 2033, Driven by Targeted Therapies and Early Detection

7 months ago

• The global pancreatic cancer market is projected to reach $11.5 billion by 2033, driven by a 14.1% CAGR from 2024, fueled by advancements in treatment and understanding of the disease. • Targeted therapies, including those directed at KRAS mutations and DNA damage, are shifting the treatment paradigm from traditional chemotherapy, enhancing precision medicine approaches. • Innovations in diagnostic techniques, such as AI-enhanced CT scans, are improving early detection, while novel chemotherapy combinations like NALIRIFOX offer improved survival rates. • The development of pancreatic cancer vaccines and personalized treatment plans based on genomic profiling are emerging as promising strategies to combat this aggressive disease.

Oncolytics Biotech Pursues Accelerated Approval for Pelareorep in Breast and Pancreatic Cancers

8 months ago

• Oncolytics Biotech plans to submit a pelareorep and paclitaxel combination therapy trial to the FDA in early 2025 for HR+/HER2- metastatic breast cancer, seeking accelerated approval. • The planned Phase 2 study will enroll approximately 180 patients who have progressed on or are ineligible for antibody-drug conjugates (ADCs), addressing a significant unmet need. • Oncolytics is collaborating with GCAR and PanCAN to advance pelareorep in gastrointestinal cancers, with key milestones expected in 2025, including updates from the GOBLET study in pancreatic cancer. • BRACELET-1 study results showed a 5.7-month PFS benefit for the pelareorep + paclitaxel arm compared to chemotherapy alone, supporting the accelerated approval pathway.

FDA Approves New Cancer Treatments Amidst Rising Global Cancer Rates

8 months ago

• The FDA issued 16 oncology approvals between July and September 2024, addressing the global surge in cancer cases, particularly among individuals under 50. • Oncolytics Biotech is advancing pelareorep, with plans to submit a clinical trial for HR+/HER2- breast cancer to the FDA in early 2025, following positive BRACELET-1 trial results. • AbbVie has submitted a BLA for telisotuzumab vedotin for previously treated non-small cell lung cancer (NSCLC) with c-Met protein overexpression. • HUTCHMED's partner, Takeda, received approval in Japan for FRUZAQLA (fruquintinib) for previously treated metastatic colorectal cancer (CRC).

Drug Development Updates