Phase 1 Trial

The FDA has cleared Adagene Inc's (NASDAQ: ADAG) Investigational New Drug (IND) application to proceed with a Phase 1b/2 trial of ADG116, in combination with Merck & Co Inc (NYSE: MRK) Keytruda (pembrolizumab).  The global trial (ADG116-P001 / KEYNOTE-C97)...

Sigilon Therapeutics Inc (NASDAQ: SGTX) reported that fibrosed spheres were observed during a retrieval procedure in a patient in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A. The SIG-001 trial had been placed on FDA clinical hold following a serious...

The FDA has placed a clinical hold on Selecta Biosciences Inc's (NASDAQ: SELB) Phase 1/2 trial of SEL-302 (which consists of MMA-101 plus ImmTOR) for methylmalonic acidemia (MMA). MMA is a disorder in which the body cannot break down certain proteins and fats, resulting in...

The FDA has slapped a partial clinical hold on the early-stage program for one of Kura Oncology Inc’s (NASDAQ: KURA) cancer drugs following a patient’s death in a clinical trial. Kura reported that the Phase 1b study of KO-539 for acute myeloid leukemia would be...

Aptevo Therapeutics Inc (NASDAQ: APVO) has announced a clinical update for its Phase 1b Expansion trial evaluating APVO436 for acute myeloid leukemia (AML).  A high-risk AML patient treated in Cohort 1 with a combination of chemotherapy plus APVO436 achieved a complete remission...

Affimed NV (NASDAQ: AFMD) has announced interim clinical results from the investigator-initiated Phase 1/2 study evaluating cbNK cells pre-complexed with Affimed's innate cell engager (ICE) AFM13. Eighteen patients with CD30-positive relapsed or refractory Hodgkin and non-...

Dermata Therapeutics Inc (NASDAQ: DRMA) announced data from its Phase 1b proof of concept study evaluating a single treatment of DMT410 to treat multiple aesthetic skin conditions. DMT410 showed improvements in pore size, luminosity, brightness, and overall aesthetic appearance. The...

The European Commission (EC) has granted conditional marketing authorization to Roche Holdings AG's (OTC: RHHBY) Gavreto (pralsetinib) for treating adults with a form of non-small cell lung cancer. The approval covers pralsetinib as a monotherapy for treating adults with...

Enanta Pharmaceuticals Inc (NASDAQ: ENTA) has decided to discontinue the development of EDP-721, an oral Hepatitis B Virus (HBV) RNA destabilizer. The move follows safety signals observed in the single ascending dose part of a Phase 1 study in healthy volunteers. "Despite the...

Plus Therapeutics Inc (NASDAQ: PSTV) released interim data from Phase 1 ReSPECT-GBM trial in patients with recurrent glioblastoma (GBM) of Rhenium-186 NanoLiposome (186RNL). According to the interim data, 186RNL delivered via convection-enhanced delivery (CED) was well-tolerated...

Spark Therapeutics, a unit of Roche Holdings AG (OTC: RHHBY), has announced data from its Phase 1/2 trial of SPK-8011 in hemophilia A. At a median efficacy follow-up of 33.4 months, the study found that 16 of 18 study participants had sustained factor VIII (FVIII), which permitted prophylaxis...

Codiak BioSciences Inc (NASDAQ: CDAK) announced initial data for exoSTING currently in a Phase 1/2 trial as a single agent for the treatment of multiple solid tumors. ExoSTING is an engineered exosome therapeutic candidate. In the first three dose cohorts of the trial, participants...

Rocket Pharmaceuticals Inc (NASDAQ: RCKT) has announced updated data from the Phase 1 trial evaluating a single intravenous infusion of RP-A501, an investigational gene therapy, for Danon Disease.  Danon disease is characterized by weakening of the heart muscle, weakening of...

EyePoint Pharmaceuticals Inc (NASDAQ: EYPT) has announced six-month interim data from the Phase 1 trial of EYP-1901 in wet age-related macular degeneration (wet AMD). No reports of ocular SAEs or drug-related systemic SAEs were reported.  The data showed that 76% and 53% of...

Moderna Inc (NASDAQ: MRNA) announced interim data from Phase 1 study of mRNA-2752 (Triplet) in patients with accessible solid tumors and lymphomas.  The data showed that the mRNA Triplet program given in combination with AstraZeneca Plc's (NASDAQ: AZN) Imfinzi (durvalumab)...