Clinical Trials

HiFiBiO completes first cohort of phase 1 study of SARS-CoV-2 neutralising antibody

HiFiBiO Therapeutics, a multinational biotherapeutics company with unique expertise in immune modulation and single-cell science, announced the successful completion of the first cohort of the Phase I study (NCT04590430) of HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment and prevention of COVID-19.

FDA authorises restart of the COVID-19 AZD1222 vaccine US phase 3 trial

Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.

Gilead announces new data on Biktarvy for the treatment of HIV in Black Americans

Gilead Sciences announced 48-week data from the BRAAVE 2020 study, a Phase 3 clinical trial evaluating the safety and efficacy of switching to Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults living with HIV who self-identified as Black or African American.

ImmunityBio, NantKwest dose first patient in novel Covid-19 vaccine candidate trial

ImmunityBio and NantKwest have dosed the first patient in phase I clinical study of a novel Covid-19 vaccine candidate called hAd5-Covid-19.

VelosBio announces first patient dosed in phase 2 trial of VLS-101 in solid tumours

VelosBio announced that the first patient has been dosed in a Phase 2 trial of VLS-101 in patients with solid tumors. VLS-101, the company’s lead product candidate, is an antibody-drug conjugate (ADC) that targets ROR1.

Dr. Reddy’s, RDIF secure DCGI’s approval for Sputnik V vaccine trial in India

Russian Direct Investment Fund (RDIF), along with Dr. Reddy’s Laboratories, has secured approval from the Drug Control General of India (DCGI) to carry out clinical trials of Sputnik V vaccine in India.

ImmunityBio gets FDA authorisation to begin trial of novel Covid-19 vaccine candidate

ImmunityBio has secured authorisation from the US Food and Drug Administration (FDA) to commence a phase I clinical study of its novel Covid-19 vaccine candidate, called hAd5-Covid-19.

Seagen, Astellas report positive results from PADCEV phase 2 trial in advanced urothelial cancer

Seagen and Astellas Pharma announced positive topline results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial known as EV-201.

J&J halts Covid-19 vaccine trials after unexplained illness in participant

Johnson & Johnson (J&J) has halted further dosing in all Janssen’s Covid-19 vaccine candidate clinical trials, as a result of unexplained illness in a study participant.