Showing posts from October, 2019

Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date for [fam-] trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer is set for the first quarter of fiscal year 2020. “We are pleased that the FDA has accepted the application and granted Priority Review as we believe [fam-] trastuzumab deruxtecan has the potential to redefine the treatment of patients with HER2 positive metastatic breast cancer,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “Following the recent regulatory submission in Japan, we look forward to working closely with re

Glenmark spin-out aims to challenge Amgen, others in cancer bispecific field

A new spin-out of an Indian company best known for making generic drugs aims to compete with top biotechs like Amgen and Regeneron in one of oncology's biggest research areas. Officially launched Tuesday, Ichnos Sciences is an offshoot of Glenmark Pharmaceuticals, from which it will inherit five experimental medicines, two research laboratories and roughly 350 employees. While its pipeline encompasses autoimmune diseases and pain, Ichnos will focus foremost on a type of cancer drugs known as bispecific antibodies. For years a sideshow in oncology research, bispecifics are now at the center of efforts to find new ways to recruit the body's immune system in an attack on tumors. Amgen's widely considered a leader in the field, having won U.S. approval five years ago for the first cancer bispecific in its leukemia drug Blincyto. The biotech is advancing nearly a dozen more through clinical testing. Other large drugmakers, most notably Roche and Regeneron, are investing as well

GSK inks 5-year collaboration with Lyell Immunopharma to develop next generation of cancer cell therapies

GlaxoSmithKline plc announced a five-year collaboration with Lyell Immunopharma, a San Francisco biotechnology company, to develop new technologies to improve cell therapies for cancer patients. The collaboration will apply Lyell’s technologies to further strengthen GSK’s cell therapy pipeline, including GSK3377794, which targets the NY-ESO-1 antigen that is expressed across multiple cancer types. To date, two cell therapies have been approved for blood-borne cancers, but engineered T cells have not yet delivered strong clinical activity in common solid tumours. Improving the “fitness” of T cells and delaying the onset of T cell exhaustion could help engineered T cell therapies become more effective. Combining GSK’s strong cell and gene therapy programmes with Lyell’s technologies may allow the joint research team to maximise the activity and specificity of cell therapies in solid tumour cancers, where there is a high unmet medical need. Dr. Hal Barron, chief scientific officer and pr

Aethlon Medical gets US FDA nod to initiate early feasibility study of Hemopurifier in patients with head & neck cancer in combo Keytruda

Aethlon Medical, a therapeutic medical device and technology company focused on unmet needs in global health, announced that the US FDA has approved its Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the company's proprietary Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda). An EFS for a medical device is similar to a phase 1 study for a drug or biologic and as such this trial will enroll a small number of patients with advanced head and neck cancer who cannot be treated with surgery or radiation. In this patient population, pembrolizumab was recently approved for initial first line treatment. Non-clinical studies conducted by Aethlon Medical's collaborators and other investigators have suggested that a primary mechanism of resistance to pembrolizumab and other immuno-oncology drugs is the secretion by tumor cells of exosomes, which are small, sub-cellular partic

Janssen Pharma bags breakthrough designation for niraparib in prostate cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy. A Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.1 The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. [1] BRCA1/2 mutations are the most common DNA-repair gene defects (DRD) in patients with mCRPC.2 Patients with a DRD in BRCA1/2

Amgen reports positive results from two phase 3 Blincyto studies in pediatric patients with relapsed ALL

Amgen announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter phase 3 trial (20120215) showed that the primary endpoint of event-free survival was met. The study evaluated the efficacy, safety and tolerability of Blincyto (blinatumomab) compared to conventional consolidation chemotherapy in pediatric patients with high-risk, B-cell acute lymphoblastic leukemia (ALL) at first relapse. Enrollment was terminated early due to encouraging efficacy in the Blincyto arm and was based on a recommendation from the independent data monitoring committee (DMC). Follow up will continue as prescribed per protocol. In addition, a randomized, phase 3 trial (AALL1331) conducted by the children's oncology group (COG) using Blincyto in pediatric B-cell ALL patients at first relapse has closed to accrual for the high-risk and intermediate risk-arm based on the recommendation of the COG DMC. The DMC closure decision was based on a strong