Phase 1 Trial

Codiak BioSciences Inc (NASDAQ: CDAK) announced platform-validating clinical data from Phase 1 trials of exoSTING and exoIL-12, and it plans to advance both candidates into Phase 2 trials.  In an open-label Phase 1 trial, exoIL-12 demonstrated a differentiating favorable safety...

eFFECTOR Therapeutics Inc's (NASDAQ: EFTR) ongoing Phase 1/2 trial of zotatifin in solid tumors showed early signals of clinical activity in two patients with breast cancer.  As of the cutoff date of March 4, interim results showed that treatment-emergent adverse events...

BioNTech SE (NASDAQ: BNTX) announced initial data from the Phase 1 study of mRNA-based individualized neoantigen-specific immunotherapy (iNeST), autogene cevumeran. The study assesses cevumeran combined with Tecentriq (atezolizumab) and chemotherapy in patients with resected...

Keros Therapeutics Inc (NASDAQ: KROS) announced preliminary topline results from Part 1 of its Phase 1 trial evaluating single and multiple ascending doses of KER-012 in healthy postmenopausal volunteers. KER-012 was generally well tolerated in Part 1 at dose levels up to 5 mg/kg,...

Caribou Biosciences Inc (NASDAQ: CRBU) announced initial data from its ANTLER Phase 1 trial for CB-010 in relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). These initial data will be shared at the European Hematology Association (EHA) 2022 Hybrid Congress. The EHA...

The FDA has cleared Sorrento Therapeutics Inc's (NASDAQ: SRNE) investigational new drug application (IND) for intravenous (IV) STI-9167 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers.  STI-9167 is the IV formulation of the intranasal STI-...

Results from the Phase 1/2 dose-finding study evaluating Sanofi SA's (NASDAQ: SNY) rilzabrutinib in adults with heavily pre-treated immune thrombocytopenia (ITP) were published in the New England Journal of Medicine.  Results demonstrate that rilzabrutinib treatment led to...

Genmab A/S (NASDAQ: GMAB) and AbbVie Inc (NYSE: ABBV) announced topline results from the first cohort of the EPCORE NHL-1 phase 1/2 trial of epcoritamab (DuoBody-CD3xCD20).  Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's DuoBody...

Cocrystal Pharma Inc (NASDAQ: COCP) reported preliminary results of a Phase 1 study with CC-42344, a broad-spectrum oral antiviral to treat pandemic and seasonal influenza A. The ongoing Phase 1 trial, designed to evaluate CC-42344 administered in single-ascending and multiple-...

Repare Therapeutics Inc (NASDAQ: RPTX) presented updated data from its ongoing Phase 1/2 TRESR trial of RP-3500 for solid tumors with specific synthetic-lethal genomic alterations. The data were featured at the AACR Annual Meeting included monotherapy Phase 1 (Module 1) results from...

The FDA has signed off BioCardia Inc's (NASDAQ: BCDA) Investigational New Drug (IND) application for BCDA-04 to initiate Phase 1/2 trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. BCDA-04 is a proprietary allogeneic mesenchymal...

IO Biotech Inc (NASDAQ: IOBT) announced updated efficacy data and subgroup analyses from the MM1636 Phase 1/2 trial evaluating IO102-IO103 combined with Bristol Myers Squibb Co's (NYSE: BMY) Opdivo (nivolumab) in metastatic melanoma. The data showed that the three-year...

BioNTech SE (NASDAQ: BNTX) presented data from its ongoing Phase 1/2 trial of its CAR-T cell therapy candidate, BNT211, in advanced solid tumors.  The preliminary results demonstrated a favorable safety profile and antitumor activity in testicular cancer patients. BNT211...

AIM ImmunoTech Inc (NYSE: AIM) has announced the presentation of positive data from a Phase 1 study of Ampligen in metastatic triple-negative breast cancer. The pre-determined primary efficacy endpoint was met (increase in CD8⍺ in TME). A uniform increase of immune markers upon...

Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL) announced initial efficacy and safety data from the ongoing Phase 1b trial of ZN-c3 combined with chemotherapy in patients with platinum-resistant or -refractory ovarian cancer.  Data were reviewed at the American Association of...