Human Trials

First HBV patient dosed in phase IIa clinical trial of ASC22

Ascletis Pharma announces the dosing of the first HBV patient in Phase IIa clinical trial of ASC22, which is a first-in-class, subcutaneously administered PD-L1 antibody.

FDA accepts Enzychem’s IND for trial of Covid-19 treatment candidate

The US Food and Drug Administration (FDA) has accepted Enzychem Lifescience’s investigational new drug application (IND) to assess its EC-18 therapeutic candidate for the prevention of acute respiratory disease syndrome (ARDS) due to Covid-19 pneumonia.

InPedILD trial enrols first patient to evaluate nintedanib in pediatric population with fibrosing ILD

Boehringer Ingelheim announced that the first patient has enrolled in InPedILD, a global Phase III trial assessing the dosing and safety profile of nintedanib in children and adolescents between six and 17 years old with clinically significant fibrosing interstitial lung disease (ILD).

CheckMate -577 trial for Opdivo meets primary endpoint of disease-free survival

Bristol Myers Squibb announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

SAB begins phase 1 trial of Covid-19 therapeutic candidate SAB-185

SAB Biotherapeutics, a US-based clinical-stage company, has dosed the first participant of a phase 1 study of SAB-185, its therapeutic candidate for Covid-19, in healthy volunteers.

FDA clears Appili Therapeutics to expand its trial of favipiravir for prrevention of Covid-19

Appili Therapeutics, a biopharmaceutical company focused on anti-infective drug development, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to proceed after Appili’s filing of an investigational new drug (IND) application for broad-spectrum antiviral favipiravir.

Omeros reports positive results for Narsoplimab in treatment of Covid-19-associated ARDS

Omeros Corporation reported the results of a compassionate-use study evaluating narsoplimab, Omeros’ investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), in the treatment of COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe and life-threatening symptom of COVID-19.

Daiichi Sankyo, AstraZeneca collaborate to evaluate patritumab deruxtecan in combination with TAGRISSO in EGFR-mutated NSCLC

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has entered into a clinical trial collaboration with AstraZeneca (LSE/STO/NYSE: AZN) to evaluate the combination of patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), and TAGRISSO (osimertinib), an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC).

LORBRENA significantly improves progression-free survival in first-line ALK-positive lung cancer

Pfizer announced that the Phase 3 CROWN study of LORBRENA (lorlatinib) in people with previously untreated advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) met its primary endpoint by demonstrating significantly improved progression-free survival (PFS), as compared to XALKORI (crizotinib).