Gemcovac (HDT-301) / HDT Bio Corp, Emcure, Quratis, SENAI CIMATEC - LARVOL DELTA

Cellular immune breadth of an Omicron-specific, self-amplifying monovalent mRNA vaccine booster for COVID-19. (PubMed, NPJ Vaccines) - "In summary, while ChAdOx1 nCoV-19 showed some cross-reactivity, GEMCOVAC-OM induced a more targeted immune response. GEMCOVAC-OM offers a broader, longer-lasting immunity, making it a promising candidate for future vaccine development and global distribution."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of HDT-301 Targeting a SARS-CoV-2 Variant Spike Protein (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: HDT Bio | Active, not recruiting ➔ Completed | Trial completion date: Nov 2023 ➔ May 2024 | Trial primary completion date: Jul 2023 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Characterization and Process Development of Serine Protease Inhibitor (Sj-B6): A Next Generation Transmission-Blocking Veterinary Vaccine for Asiatic Schistosomiasis (ASM Microbe 2024) - "A pilot study evaluating the efficacy of a novel Sj-B6 mRNA vaccine using a proprietary technology (HDT-301) invented by our partners at HDT Bio is now underway...The repRNA/ LION™ vaccine stabilizes the RNA in vivo allowing it to persist longer. A successful veterinary vaccine would play a major role in reducing pathogen transmission to humans by interrupting the parasite life cycle and improving quality of life for people living in endemic countries."

Infectious Disease • ELANE

Characterization and Process Development of Serine Protease Inhibitor (Sj-B6): A Next Generation Transmission-Blocking Veterinary Vaccine for Asiatic Schistosomiasis (ASM Microbe 2024) - "A pilot study evaluating the efficacy of a novel Sj-B6 mRNA vaccine using a proprietary technology (HDT-301) invented by our partners at HDT Bio is now underway...The repRNA/ LION™ vaccine stabilizes the RNA in vivo allowing it to persist longer. A successful veterinary vaccine would play a major role in reducing pathogen transmission to humans by interrupting the parasite life cycle and improving quality of life for people living in endemic countries."

Infectious Disease • ELANE

An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial. (PubMed, Nat Med) - "Here we conducted a multicenter open-label, randomized phase 2 and 3 study to assess the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron-specific (BA.1/B.1.1.529), monovalent, thermostable, self-amplifying mRNA vaccine, GEMCOVAC-OM, when administered intradermally as a booster in healthy adults who had received two doses of BBV152 or ChAdOx1 nCoV-19. These results demonstrate that GEMCOVAC-OM is safe and boosts immune responses against the B.1.1.529 variant. Clinical Trial Registry India identifier: CTRI/2022/10/046475 ."

Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Leveraging the immunoinformatics approach for designing the SARS-CoV-2 omicron-specific antigenic cassette of mRNA vaccine. (PubMed, Vaccine) - "Finally, the protein was reverse translated, codon-optimized, and encoding mRNA sequence was checked for its stability by predicting the secondary structures. A comprehensive examination of in-silico data revealed 628.2 as a potent antigenic candidate that was finally used in Gemcovac®-OM, a heterologous booster mRNA vaccine for COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Characterization and Process Development of Serine protease inhibitor: A Next Generation Transmission-Blocking Veterinary mRNA Vaccine for Asiatic Schistosomiasis (ASTMH 2023) - "A pilot study evaluating the efficacy of a novel Sj-B6 m RNA vaccine using a proprietary technology (HDT-301) invented by our partners at HDT Bio is now underway...The rep RNA/ LION™ vaccine stabilizes the RNA in vivo allowing it to persist longer. A successful veterinary vaccine would play a major role in reducing pathogen transmission to humans by interrupting the parasite life cycle and improving quality of life for people living in endemic countries."

Infectious Disease • ELANE

Evaluation of self-amplifying mRNA platform for protein expression and genetic stability: Implication for mRNA therapies. (PubMed, Biochem Biophys Res Commun) - "The consecutive launch of mRNA vaccines like mRNA-1273, BNT 162b2, and GEMCOVAC®-19 against COVID-19 has triggered the debate of long-term expression, safety, and genomic integration of the mRNA vaccine platforms. Furthermore, we have generated high-quality 3D structures of non-structural proteins (nsPs) in silico and the genes encoding for the nsPs were cloned and expressed using the T7 system. Findings from the current study have strengthened the fact that the alphavirus-based SAM platform has the potential to become a modality in the upcoming years."

Journal • Infectious Disease • Novel Coronavirus Disease

Study to Assess Safety, Reactogenicity and Immunogenicity of the repRNA(QTP104) Vaccine Against SARS-CoV-2(COVID-19) (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Quratis Inc.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety And Immunogenicity Of HDT-301 Targeting A SARS-CoV-2 Variant Spike Protein (clinicaltrials.gov) - P1 | N=63 | Active, not recruiting | Sponsor: HDT Bio | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Nov 2023

Enrollment closed • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (clinicaltrials.gov) - P2b | N=300 | Not yet recruiting | Sponsor: Azidus Brasil

New P2b trial • Infectious Disease • Novel Coronavirus Disease

Safety And Immunogenicity Of HDT-301 Targeting A SARS-CoV-2 Variant Spike Protein (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: HDT Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Single Dose SARS-CoV-2 Replicon RNA Vaccine Induces Cellular and Humoral Immune Responses in Simian Immunodeficiency Virus Infected and Uninfected Pigtail Macaques. (PubMed, Front Immunol) - "Here, we evaluated the immunogenicity of a single dose COVID-19 replicon RNA vaccine expressing Spike protein (A.1) from SARS-CoV-2 (repRNA-CoV2S) in immunocompromised, SIV infected and immune competent, naïve pigtail macaques...Furthermore, vaccine immunogenicity was elicited even among the animals with the highest SIV viral burden or lowest peripheral CD4 counts prior to immunization. This study provides evidence that a SARS-CoV-2 repRNA vaccine could be employed to induce strong immunity against COVID-19 in HIV infected and other immunocompromised individuals."

Journal • Human Immunodeficiency Virus • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Safety And Immunogenicity Of HDT-301 Targeting A SARS-CoV-2 Variant Spike Protein (clinicaltrials.gov) - P1; N=63; Not yet recruiting; Sponsor: HDT Bio

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 1 Study to Assess Safety, Reactogenicity and Immunogenicity of the HDT-301 Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=78; Not yet recruiting; Sponsor: SENAI CIMATEC

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

DBT seed funds Gennova Biopharmaceuticals’ novel mRNA-based COVID-19 vaccine candidate (ExpressPharma) - "DBT-BIRAC has facilitated the establishment of ‘first-of-its-kind’ mRNA-based vaccine manufacturing platform in India. It has provided seed funding for the development of Gennova’s novel self-amplifying mRNA-based vaccine candidate for COVID19. In collaboration with HDT Biotech Corporation, Seattle, US, Gennova has developed an mRNA vaccine candidate (HGCO19)....The company is working aggressively to ensure first human injection by the end of the year, subject to Indian regulatory approvals, informed a release from the Ministry of Science & Technology."

Financing • New molecule • Infectious Disease • Novel Coronavirus Disease