Phase 1 Trial

The FDA has cleared Lyell Immunopharma Inc's (NASDAQ: LYEL) Investigational New Drug (IND) application to initiate a Phase 1 trial for LYL132 in solid tumors. LYL132 is an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal...

The FDA has signed off TScan Therapeutics Inc's (NASDAQ: TCRX) investigational new drug (IND) application for TSC-100 in hematologic malignancies patients undergoing allogeneic hematopoietic cell transplantation (HCT).  The target of TSC-100 is the minor histocompatibility...

The FDA cleared the Masonic Cancer Center, University of Minnesota to evaluate HCW Biologics Inc's (NASDAQ: HCWB) lead drug candidate, HCW9218, in Phase 1 trial in patients with advanced solid tumors with progressive disease after prior chemotherapies.  HCW9218 is an...

Regulus Therapeutics Inc (NASDAQ: RGLS) has completed a pre-investigational new drug (Pre-IND) meeting with the FDA to obtain input on the Company's RGLS8429 for Autosomal Dominant Polycystic Kidney Disease (ADPKD).  ADPKD is a genetic disorder characterized by the growth...

The FDA has lifted the partial clinical hold on Kura Oncology Inc (NASDAQ: KURA) KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML).  The partial clinical hold was lifted following an agreement with the agency on the...

The FDA has signed off Turning Point Therapeutics Inc's (NASDAQ: TPTX) Investigational New Drug (IND) application for elzovantinib + aumolertinib combo therapy in EGFR mutant MET-amplified advanced non-small cell lung cancer (NSCLC).  The Company expects to initiate the...

The FDA has signed off Nuvation Bio Inc's (NYSE: NUVB) investigational new drug (IND) application to evaluate NUV-868 to treat advanced solid tumors. NUV-868 inhibits BRD4, a key member of the BET family that epigenetically regulates proteins that control tumor growth and...

Seagen Inc (NASDAQ: SGEN) announced data from a Phase 1 trial combining SEA-CD40 with chemotherapy and an anti-PD-1 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The data were shared at the ASCO GI annual meeting.  In the ongoing Phase 1 trial, SEA-CD40...

Cardiff Oncology Inc (NASDAQ: CRDF) posted new data from Phase 1b/2 trial of onvansertib combined with standard-of-care (SOC) FOLFIRI/bevacizumab for second-line KRAS-mutated metastatic colorectal cancer (mCRC). The data will be shared at the American Society of Clinical Oncology...

Vaxcyte Inc (NASDAQ: PCVX) priced its previously announced offering of common stock and pre-funded warrants at $20.00 per share, and $19.999 per underlying share, respectively. Vaxcyte is selling 2.5 million shares and pre-funded warrants to purchase 2.5 million shares of common...

The French National Agency for the Safety of Medicines and Health Products has signed off Phio Pharmaceuticals Corp's (NASDAQ: PHIO) clinical trial with its lead product candidate, PH-762 in melanoma. The Company expects to dose the first patient in Q1 of 2022.  PH-762 activates immune...

Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) posted results of the Phase 1 trial of Amilo-5MER in healthy volunteers. Amilo-5MER is a synthetic peptide consisting of 5 amino acids that significantly reduces symptoms and histopathological hallmarks of Inflammatory bowel disease (IBD) in...

Anavex Life Sciences Corp (NASDAQ: AVXL) announced topline results from its Phase 1 trial of ANAVEX3-71 in development for neurodegenerative diseases, including Frontotemporal Dementia (FTD). ANAVEX3-71 was well tolerated in all cohorts receiving single doses of the treatment...

Edgewise Therapeutics Inc (NASDAQ: EWTX) posted positive topline results from Phase 1b trial of EDG-5506, designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies such as Duchenne muscular dystrophy (DMD) and Becker Muscular Dystrophy (BMD) The seven...

Inhibrx Inc (NASDAQ: INBX) announced initial results from Part 3 (combination dose escalation) of the Phase 1 trial of INBRX-106 combined with Keytruda for solid tumors.  The dose of INBRX-106 was escalated in combination with Keytruda in 21 patients with locally advanced or...