Positive high-level results from the TOPAZ-1 Phase III trial showed Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer (BTC). At a predefined interim analysis, the Independent Data Monitoring...
treatment News
WILMINGTON, Del. — AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted by the Food and Drug Administration (FDA) after securing...
WILMINGTON, Del. — Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared to TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolization....
LUND, Sweden — Hansa Biopharma today announced full results from the 16-HMedIdeS-12 phase 2 trial in patients with antibody mediated rejection (AMR) episodes following a kidney transplant demonstrating that imlifidase significantly reduced donor-specific antibodies (DSAs) within the first five days of treatment. In the trial, the primary endpoint was the...
LOS ANGELES, Calif. — Immix Biopharma, Inc (Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of multiple myeloma. “Frail patients, heavily represented in our NEXICART-1 clinical trial, remain an area...
Los Angeles, Calif. — Immix Biopharma, Inc, a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis. “European Union orphan drug designation for NXC-201 represents an important milestone in our...
LOS ANGELES — Immix Biopharma, Inc. (Nasdaq:IMMX), a clinical-stage biopharmaceutical company advancing personalized therapies for oncology and immunology, today announced that it will host a virtual KOL event to discuss its BCMA-Targeted CAR-T cell therapy candidate NXC-201, in development for relapsed/refractory AL amyloidosis (R/R ALA) and relapsed/refractory multiple myeloma (R/R...
LOS ANGELES, Calif. — ImmPACT Bio USA Inc. (ImmPACT Bio), a clinical-stage biopharmaceutical company developing a new generation of cellular therapies that have the potential to bring transformational benefits to patients, today announced the United States Food and Drug Administration (FDA) has cleared an investigational new drug application (IND) for...
PALO ALTO, Calif. — Immune-Onc Therapeutics Inc., a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IO-202 for the treatment of chronic myelomonocytic leukemia (CMML). IO-202...
CAMBRIDGE, Mass. — Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its lead clinical-stage program, IMM-1-104, for the treatment of patients with...