Human Trials

Sage Therapeutics’ SAGE-217 shows positive effect in phase 1/2 insomnia trial

Sage Therapeutics’ sleep disorder drug SAGE-217 has yielded positive results from a phase 1/2 trial in healthy adult volunteers using a 5-hour phase advance model of insomnia using polysomnography.

SillaJen initiates phase 1/2 trial of Pexa-Vec in metastatic colon cancer

SillaJen has initiated a phase 1/2 clinical trial of pexastimogene devacirepvec (Pexa-Vec) in combination with checkpoint inhibitor therapy for the treatment of metastatic colon cancer.

AstraZeneca’s PT010 triple combination therapy shows significant effect in COPD trial

AstraZeneca has reported top-line results from the Phase III KRONOS trial, which showed significant effect of PT010 triple combination therapy in chronic obstructive pulmonary disease (COPD).

Allergy Therapeutics completes patient recruitment in PQ Birch phase III clinical trial

Allergy Therapeutics has completed recruitment of patients in the PQ Birch phase III clinical trial.

BerGenBio meets first efficacy endpoint in phase II trial with selective AXL inhibitor BGB324 in NSCLC

BerGenBio announced that it met the first efficacy endpoint in the phase II clinical trial evaluating BGB324 (bemcentinib), a selective AXL inhibitor, in combination with erlotinib in patients with advanced non-small cell lung cancer (NSCLC) who have progressed on an approved EGFR inhibitor.

Inovio, Parker Institute to jointly evaluate cancer immunotherapy combinations

Inovio Pharmaceuticals and the Parker Institute for Cancer Immunotherapy have signed a clinical collaboration agreement to assess novel combination regimens within the field of immuno-oncology.

Atara gets FDA approval to start two phase 3 studies to assess tabelecleucel in patients with EBV+PTLD

Atara Biotherapeutics has received clearance from the US Food and Drug Administration (FDA) to initiate two phase 3 clinical studies with tabelecleucel (formerly known as ATA129) in patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD).

AbbVie’s upadacitinib succeeds in phase 3 rheumatoid arthritis study

AbbVie says that its investigational oral JAK1-selective inhibitor upadacitinib (ABT-494) has demonstrated positive results as monotherapy in phase 3 rheumatoid arthritis study, meeting all primary and key secondary endpoints.

Regeneron and ISA Pharmaceuticals form immuno-oncology collaboration

Regeneron Pharmaceuticals and ISA Pharmaceuticals have formed a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab (REGN2810), a PD-1 (programmed cell death protein 1) antibody.