Therapy Areas: Vaccines
HDT Bio Corp and SENAI CIMATEC launch second international study in Brazil to help partners in historically underserved nations fight COVID-19 pandemic
18 January 2022 -

Oncology immunotherapies company HDT Bio Corp said on Monday that it has dosed the first healthy volunteers in Brazil under a Phase 1 trial of its RNA COVID-19 vaccine, HDT-301, in partnership with SENAI CIMATEC, a Brazilian educational institute.

Under the partnership, SENAI CIMATEC will conduct the clinical trial under the name Vaccine RNA MCTI-CIMATEC-HDT. The vaccine uses HDT Bio's proprietary lipid nanoparticle RNA-delivery technology.

Additionally, HDT Bio has other partnerships for its RNA COVID-19 vaccine. It plans to transfer its unique technology to historically underserved nations to provide them local control over development, manufacturing and distribution of COVID-19 RNA vaccine.

As part of SENAI CIMATEC's double-blind, placebo-controlled, dose-ranging Phase 1 clinical trial, it will enroll 90 healthy adult volunteers. The trial will assess the safety, tolerability and immunogenicity of the vaccine at three dose levels, 1 µg, 5 µg and 25 µg. Safety and tolerability will be the primary endpoints assessed by incidence of adverse events for each dose through 12 months after the vaccination.

HDT Bio's vaccine uses its proprietary lipid nanoparticle carrier system for delivery of RNA. The RNA-based vaccine offers simpler manufacturing, easier deployment without the need for ultra-low freezers and requires lower dosing than current RNA COVID-19 vaccines.