On May 6th, Dr. Shan Lu gave a presentation on behalf of the HVTN124 protocol team during a plenary session that was part of the larger 2021 HVTN Full Group Meeting. He shared a summary of the excellent immunogenicity data obtained from the multi-center phase 1a study testing the investigational HIV vaccine candidate PDPHV, a polyvalent DNA/Protein HIV Vaccine. To read the whole press release, click on the link below.
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Iris Benhayoun joins WHV as an Independent Consultant
It is our great pleasure to announce that Iris Benhayoun has joined our team as an independent consultant. Iris will assist in WHVs HIV vaccine development including the upcoming WHV138 clinical trial study.
Iris holds a Master of Science in Epidemiology from the University of Massachusetts Amherst and comes with an extensive background in trial studies. Most recently, Iris worked as a clinical research coordinator for both the Specialty Retina Center and the Specialty Gastro Center where she was responsible for patient recruitment and retention, as well as the preparation of clinical offices to comply with sponsor requirements for study site selections.
Previously, Iris worked at the Global HIV Vaccine Enterprise assisting in the Timely Topics in HIV Vaccine initiative. She helped create print and online guidance materials for researchers working on the development of a safe and effective HIV Vaccine.
Iris’ experience at the HIV Enterprise and in clinical trial studies makes her a perfect match for WHVs 138 trial and we are extremely excited to have her on board.
WHV completes release testing of the four-valent gp120 protein vaccine
Working with Waisman Biomanufacturing, WHV is pleased to announce today the completion of testing and release of two clinical lots of a novel 4-valent gp120 protein vaccine.
Previously, the laboratory of Dr. Shan Lu at the University of Massachusetts Medical School (UMMS) developed the HIV vaccine candidate PDPHV including polyvalent DNA and protein components. In recently completed phase I clinical trial HVTN124 supported by US NIH/NIAID, four gp120 proteins from the four major clades of HIV-1 (A, B, C, and AE) were individually vialed. The proteins had to be mixed with each other and with the GLA-SE adjuvant at bedside prior to administration.
Over the past year, WHV has launched a major program to establish the production of a final drug product with four gp120 proteins mixed in the same vial. The four previously produced gp120 proteins were tested for stability and then mixed in equal amounts to produce and vial the 4-valent protein mixture.
Extensive pilot tests were conducted to ensure the proteins can be characterized using existing and new analytical assays. Now WHV and Waisman used these analytical approaches to characterize two lots of the vialed 4-protein mixture vaccine and released it for clinical use.
This novel 4-valent formulation will greatly simplify storage, transportation, and administration of the protein vaccine. Having both DNA and protein vaccine components positions WHV for rapid advancement toward the next stages of clinical testing of the PDPHV vaccine candidate.
The Scientist discusses heterologous prime-boost vaccines
The article in The Scientist titled “COVID-19 Vaccine Combos Aim to Boost Immunity” discusses the plans to test combinations of different vaccine modalities to boost immunity to SARS-CoV-2, an approach similar to the one being advanced by WHV for prevention of HIV infection.
Over the past year, multiple vaccines have been approved for use around the world utilizing very different platforms, including mRNA, adenoviral vectors, recombinant proteins, and whole killed vaccines. The limited supply of these vaccines is driving discussions on whether different vaccine platforms can be mix-and-matched for both practical and scientific reasons. WHV’s advisor, Dr. Shan Lu has been working on such an approach for many years and is quoted multiple times in the article discussing his experience and the future prospects for such an approach.
Specifically, Dr. Lu points out in the article: “The order matters,” says Lu. “We found that DNA first, protein after is better than protein first, DNA after. You cannot reverse that.”, referring to the work that his laboratory conducted over the past 20 years. These discoveries lie at the heart of WHV’s approach of using DNA priming and recombinant protein boosting to stimulate very robust antibody responses to HIV’s gp120 protein.
Coronavirus vaccine research is taking advantage of the multiple discoveries made in the HIV vaccine field, allowing it to accelerate discovery and development of preventive vaccines.
HVTN 124 study conclusion supports advancement to WHV 138 clinical trial
The HVTN 124 clinical trial is wrapping up while the stability of the used vaccines is confirmed.
HVTN 124 is a phase 1 clinical trial conducted by NIH-funded HIV Vaccine Trials Network, testing the safety and immunogenicity of PDPHV-201401, WHV’s preventive HIV vaccine candidate. The trial has now been formally concluded with the lock of the database. Volunteers and researchers will be unblinded to the treatment group assignment in the near future. The preliminary data from the peak immunogenicity analyses are very encouraging and support the advancement of this vaccine candidate to further clinical testing. The data will be presented at the HVTN’s annual 2021 Full Group Meeting on May 5-7, 2021.
Working with Waisman Biomanufacturing, WHV also formally completed the studies initiated by Dr. Shan Lu’s laboratory at UMass as part of the IPCAVD program to test the stability of all vaccine components used in the HVTN 124 trial. The results of these studies indicate that DNA vaccine, gp120 Env recombinant protein vaccine, and the GLA-SE adjuvant are all stable after 4-5 years and can be used in the planned WHV 138 clinical trial. To support the use of these vaccines in the WHV 138 trial, WHV extended the stability studies for all components.
WHV 138 Expedited Adverse Event Reporting Form
Download the form by clicking on the link below
WHV to present HVTN 124 results at the HVTN Full Group meeting
Safety and immunogenicity results from the HVTN 124 study will be presented by WHV at the Full Group meeting of HVTN.
HVTN 124 is a phase 1 clinical trial conducted by NIH-funded HIV Vaccine Trials Network, testing the safety and immunogenicity of PDPHV-201401, WHV’s preventive HIV vaccine candidate. The trial recently completed and immunogenicity is being assessed by both HVTN and WHV. The preliminary data from these analyses supports the advancement of this vaccine candidate to further clinical testing.
HVTN leadership invited WHV to present the results of the trial at its annual 2021 Full Group Meeting. The meeting will be held virtually on May 5-7, 2021 and will cover the progress in immune-mediated HIV prevention approaches including vaccines and passive immunizations.
FDA Clears Worcester HIV Vaccine Investigational New Drug Application for Vaccine to Prevent HIV Infections
Worcester HIV Vaccine (WHV) has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (IND) application for a novel polyvalent DNA/prime-protein boost vaccine to prevent HIV, called PDPHV. The IND calls for the Worcester-based start-up to explore different vaccination designs in a phase 1b clinical trial to be launched in February 2021. A phase II clinical trial is expected to follow.
Based on discoveries by Shan Lu, MD, PhD, professor of medicine, and licensed from UMass Medical School, WHV’s vaccine employs a polyvalent DNA-prime/protein-boost technology to target multiple subtypes of HIV-1. PDPHV is a novel vaccine composed of five DNA plasmids and four gp120 recombinant proteins. The DNA component is used to prime the immune system to receive a boost of HIV proteins, which stimulate the body to produce potent antibodies against HIV.
“In a little over two years since the founding of WHV, we have filed our first IND. This is a major achievement and a true milestone for WHV,” said Yegor Voronin, PhD, chief operating officer of WHV. “The excellent safety results of PDPHV and positive preliminary immunogenicity data we have from earlier clinical trials give us confidence to rapidly develop our own clinical program.”
An earlier version of this vaccine was tested in a single-site clinical trial conducted at UMass Medical School, and the second generation of the vaccine has been recently tested at six US sites by the HIV Vaccine Trials Network (HVTN) under protocol HVTN 124. HVTN is funded by the National Institute of Allergy and Infectious Diseases (NIAID). Dr. James Kublin, Executive Director of HVTN, commented on the news: “I am very encouraged by the safety data and preliminary immunogenicity results of the HVTN124 trial and excited to see WHV’s further progress in advancing this promising vaccine candidate.”
PDPHV is the first and only vaccine formulation that includes natural viral antigens from all four major circulating HIV subtypes to advance to safety and efficacy trials in humans. Full immunogenicity results from HVTN 124 will be released later this year.
Over the last two decades, Dr. Lu’s lab has received more than $50 million in NIAID funding to oversee the development and manufacturing of PDPHV. WHV licensed PDPHV from UMass Medical School in early 2018 for development.
WHV has worked with Waisman Biomanufacturing, a contracted manufacturing organization, to use their proprietary technology to manufacture DNA plasmids with purer quality and higher yields than previously. Recently, Target Health, LLC, a New York-based CRO with many years of regulatory experience, joined the WHV team to help prepare and file the IND.
WHV is also collaborating with the Infectious Disease Research Institute (IDRI) in Seattle, which developed and manufactured the adjuvant used to stimulate responses to the protein component of the PDPHV vaccine. Adjuvants can be broadly leveraged to develop vaccines against many viruses, and are components of several COVID-19 vaccine candidates to broaden and lengthen the duration of protection against the SARS-CoV-2 virus.
“HIV remains a leading infectious cause of death worldwide, and is one of the most challenging viruses to protect against with a vaccine,” said Corey Casper, M.D., chief executive officer of IDRI. “IDRI is excited to contribute its immune-enhancing adjuvant, GLA-SE — with a proven safety and immunogenicity profile in thousands of humans to date — to this critical vaccine effort.”
Mireya Wesselossky joins WHV as Medical Officer
In preparation for its upcoming launch of a Phase 1b clinical trial, WHV engaged a well-known expert Dr. Mireya Wesselossky as our Medical Officer.
To follow up on the HVTN 124 phase 1 clinical trial, WHV is preparing to launch a phase 1b clinical trial WHV138 to further explore the safety and immunogenicity of its polyvalent PDPHV vaccine candidate. Different administration approaches and schedules will be explored in that study and the company is preparing to file an IND with the US FDA in the near future. As a Medical Officer, Dr. Wesselossky will join the Protocol Leadership team and will oversee the regular safety reports in WHV 138.
Dr. Wesselossky has been Associate Professor of Medicine at University of Massachusetts Medical School and an Infectious Disease Attending Physician at UMass Memorial Health Care since 2001. She has extensive experience with HIV, previously working with a >700 HIV-infected patients in the HIV Associated Neurocognitive Disorders (HAND) cohort in Central Massachusetts. In January 2018, she participated in opening a walk-in clinic in AIDS Project Worcester to diagnose, treat, and prevent many infectious disease conditions including sexual transmitted diseases, HIV, and HCV in a population with no easy access to medical care due to extreme poor socio-economic status.
Dr Wesselossky’s experience and unique strengths as an infectious diseases clinician and researcher will be invaluable for the conduct of the WHV 138 trial.
WHV Reaffirms Commitment to Advance Development of Novel HIV Vaccine
As the world commemorates World AIDS Day this week and grapples with a second pandemic in COVID-19, Worcester HIV Vaccine (WHV) reaffirms its commitment to developing a preventive vaccine to reduce HIV infections around the world as it advances its candidate vaccine toward more safety and efficacy trials.
“The progress we have made this year is remarkable, especially considering the challenges posed by the COVID-19 pandemic,” said Yegor Voronin, Ph.D., chief operating officer of WHV. “The fact that we stand poised to advance our HIV vaccine candidate to additional safety and efficacy testing is a testament to our commitment to developing a vaccine to protect against one of the world’s most elusive viruses.”
WHV’s investigational HIV vaccine candidate, PDPHV, is completing safety and immunogenicity testing in a Phase I clinical trial (HVTN 124) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN). If proven immunogenic, PDPHV would be the first and only vaccine formulation that includes viral Env antigens from all four major circulating HIV subtypes to advance to safety and efficacy trials in humans. Immunogenicity results are being analyzed and will be shared in early 2021.
Earlier this year, WHV announced plans to investigate the dynamics of the immune responses seen in the HVTN124 trial, and conduct additional testing to better assess the breadth and potency of antibodies elicited by the PDPHV vaccine candidate, which will be critical to advancing vaccine manufacturing, and to planning further clinical trials.
PDPHV is a nucleic acid vaccine composed of five DNA plasmids and four gp120 recombinant proteins. The DNA vaccine is used to prime the immune system to receive a boost of HIV proteins, which stimulate the body to produce antibodies against HIV. WHV researchers have optimized the manufacturing of the DNA component of PDPHV in the last two years and are continuing to ensure the gp120 proteins remain stable throughout the development process, all while setting a clear path toward regulatory review. WHV is expected to file a new Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for PDPHV before the end of 2020 in partnership with Target Health, LLC, a New York-based CRO with many years of regulatory experience.
“The work we are doing to understand the types of immune responses induced by PDPHV is not only important to the HIV field, but is yielding important insights for the development of nucleic acid vaccines, which are also being tested for the novel SARS CoV-2 virus,” said Shan Lu, M.D., Ph.D., professor of Medicine at UMMS, who created PDPHV and who is also conducting COVID-19 vaccine research. “We know that science—and an effective vaccine—requires us to persist, to test every concept, to be innovative and fearless in our discovery efforts, to find new ways of working together, and to persevere. The recent progress of mRNA-based COVID-19 vaccines, which is another type of nucleic acid vaccine similar to DNA vaccines, just proved that this technology platform has very promising potential.”
Much of WHV’s progress in early research and development has been the result of collaborations within UMass Medical School (UMMS). In the last two decades, Dr. Lu’s group at UMMS received more than $50 million to oversee the development and manufacturing of PDPHV, which allowed WHV to license PDPHV from UMMS in early 2018 for its further development. WHV is also establishing broad collaboration with academic and industry partners including the Infectious Disease Research Institute (IDRI) in Seattle, Washington, which developed and manufactured the adjuvant used to stimulate responses to the protein component of the PDPHV vaccine. This World AIDS Day, we thank our HIV researchers, many who are now working on COVID-19 and are bringing valuable lessons to accelerate the discovery of preventive measures and treatments for COVID-19 while continuing to set the stage for an HIV vaccine.
