Worcester HIV Vaccine

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HVTN to assess peak immune responses in HVTN 124

WHV’s vaccine candidate PDPHV is currently being tested in the HVTN 124 clinical trial. The trial sites recently completed all scheduled vaccinations and collected samples to assess the peak immune responses elicited by the vaccine. On November 20, 2019, WHV convened with HVTN to discuss the priorities and the timelines of conducting laboratory assays. The immediate focus was placed on the magnitude and quality of the antibody responses, including binding to Env proteins from a wide diversity of viral variants, as well as neutralization of viruses and ADCC functionality of antibodies. The results are expected in 3 months. Later this year, the volunteers will return to provide samples at 6 months after the last vaccination, which will be used to assess the durability of the responses.

WHV Researchers Poised to Advance HIV Vaccine Candidate – Previously Tested Proteins Prove Promising

Researchers at WHV tested proteins previously manufactured for the ongoing HVTN 124 Phase I trial of PDPHV, its investigational DNA-prime/protein-boost vaccine, to determine their utility for future use.  They confirmed that these proteins continue to demonstrate an excellent stability profile, which indicates they will be effective for use in WHV’s next Phase IIa clinical trial of PDPHV.

PDPHV is the first and only HIV vaccine candidate to use four recombinant HIV Env proteins. This multivalent approach is important because it is designed to protect against the diverse HIV strains around the world. It is hoped that PDPHV will enter a Phase IIa clinical trial in 2020.

The validation of PDPHV proteins shows that the timeline and cost to advance to the Phase IIa trial will be significantly reduced. Typically, the manufacturing of proteins for HIV vaccines is quite cumbersome and expensive given relatively low yields of recombinant HIV Env and the complexities of the process to purify the proteins for the vaccine.

For more information on WHV’s vaccine approach, please visit Our Approach.

WHV Researchers Advance Production of Investigational HIV Vaccine

WHV researchers showed that they can improve the manufacturing of the DNA component of their candidate HIV vaccine PDPHV to allow a faster and more effective path to Phase II clinical trials.  These biomanufacturing advances have the potential to inform the way HIV vaccine candidates are manufactured in the future.

WHV researchers together with Waisman Biomanufacturing, a non-profit biomanufacturing partner, confirmed that by using DH5a, E. coli strain, with a proprietary technology, they can manufacture DNA plasmids that are purer and result in higher yields than previously thought.  This development shows a  more robust and effective approach to making the essential components of the PDPHV vaccine and could accelerate manufacturing of the candidate vaccine for future clinical trials and eventual manufacturing of the vaccine after its approval.

PDPHV is WHV’s investigational DNA-prime/protein-boost vaccine, which is comprised of five DNA plasmids and four gp120 recombinant proteins and is being tested as a prime-boost regimen or co-administered in repeated doses, in healthy adult volunteers.

Specifically, researchers completed manufacturing of five plasmid constructs for the DNA vaccine, which included the creation of new cell banks for all five plasmids. Plasmid constructs are essential because they make up the DNA prime component of the vaccine. This is an important step toward the planned Phase IIa trial of PDPHV and demonstrates a new level of advancement in biomanufacturing.

Historically, protein HIV vaccines have been poorly immunogenic because of a number of immune escape mechanisms deployed by the viral Env protein. Using a DNA delivery of HIV Env to prime the immune response ensures high magnitude and high quality of antibodies elicited by boosting with recombinant HIV Env proteins.

PDPHV is the first and only HIV vaccine candidate to use a multivalent approach with HIV Env proteins from the four major clades or strains of HIV.  The PDPHV vaccine is currently being tested by the HIV Vaccine Trials Network (HVTN) in a Phase I clinical trial HVTN 124.

For more information, visit Our Approach.

WHV Prepares to File Investigational New Drug (IND) Application to the U.S. FDA to Test its Candidate HIV Vaccine in a Phase IIa Clinical Trial

WHV is preparing to file a new IND for PDPHV, its investigational DNA-prime/protein-boost vaccine.  PDPHV is comprised of five DNA plasmids and four gp120 recombinant proteins and is being tested in a Phase I clinical trial (HVTN 124) as a prime-boost regimen or co-administered in repeated doses, in healthy adult volunteers. Results of the HVTN 124 trial are expected in early/mid 2020.  If the vaccine is proven safe and immunogenic, the IND will allow WHV to rapidly advance PDPHV through to Phase IIa clinical testing.

The National Institutes of Allergy and Infectious Diseases (NIAID) holds the current IND for the vaccine candidate and NIAID-supported HVTN is running the Phase I HVTN 124 trial.  WHV will work with NIAID, the U.S. FDA, and other regulatory partners to clarify the regulatory pathway for PDPHV.

For more information on the HVTN124 trial, please visit HVTN 124 Trial.

WHV hires Dr. Yegor Voronin as its Chief Operating Officer

WHV hired Dr. Yegor Voronin to manage the day-to-day operation of the company and to develop the strategy for development of its PDPHV preventive HIV vaccine candidate. Dr. Voronin previously served as the Senior Science Officer at the Global HIV Vaccine Enterprise in New York. He brings over 15 years of HIV research and vaccine development expertise. Dr. Voronin holds a Ph.D. from the West Virginia University and did his postdoctoral fellow training in the laboratories of Dr. Michael Emerman and Dr. Julie Overbaugh at the Fred Hutchinson Cancer Research Center, Seattle.