Cambridge, Mass. — Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TP-1287, an investigational oral CDK9 inhibitor, for the treatment of Ewing sarcoma. “We are delighted to have received this designation for TP-1287...
treatment News
Mesalazine plus somatostatin and bifid triple viable capsules can effectively improve the clinical symptoms of patients with ulcerative colitis, according to a study in BMC Gastroenterology. Investigators sought to determine the effect of mesalazine plus somatostatin and bifid triple viable capsules on plasma inflammatory factors and T cell frequency in patients...
HONG KONG — Akeso Inc. announced the China National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) of cadonilimab (开坦尼®, PD-1/CTLA-4 bispecific antibody, AK104) in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ)...
CAMBRIDGE, Mass. – Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for GSK4381562 (formerly SRF813) to proceed into a first-in-human clinical trial. GSK4381562 is a...
Ingelheim am Rhein, Germany – Boehringer Ingelheim today announced that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase II trial [response difference: 64.8% (CI 51.1% – 78.6%), p<0.0001]. The trial met its...
SOUTH SAN FRANCISCO, Calif. — Sutro Biopharma, Inc (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that the randomized portion (Part 2) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), is now open for enrollment, and...
PHILADELPHIA – SwanBio Therapeutics, a gene therapy company advancing AAV-based therapies for the treatment of devastating, genetically defined neurological conditions, today announced the initiation of the CYGNET study with the enrollment of the first two participants. CYGNET is a natural history study of adrenomyeloneuropathy (AMN), a form of adrenoleukodystrophy (ALD)...
Zurich, Switzerland – Hydrogels have a variety of use cases, including contact lenses, delivering doses of medication within the body, moisturisers, water storage in soil, cleaning polluted water and as gelling and thickening agents. A hydrogel is a gel made of a type of plastic that can bind water. Researchers...
WALTHAM, Mass. — Syndax Pharmaceuticals Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101 pivotal trial cohort of patients with relapsed/refractory (R/R) mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML). Topline data is expected in the fourth...
CAMBRIDGE, Mass. – Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that it has initiated the Phase 1 clinical trial of SYNB1934, an investigational Synthetic Biotic™ medicine for the treatment of Phenylketonuria (PKU). “We are delighted to have so quickly advanced...