Worcester HIV Vaccine

News

WHV is moving into M2D2 biotech incubator

WHV is proud to join the Massachusetts Medical Device Development Center (M2D2), a biotech incubator located at the University of Massachusetts Medical School in Worcester, MA.

M2D2 is a highly successful accelerator and incubator, which over the years supported more than 100 small companies. It is sponsored by 15 partner organizations, including major pharmaceutical and medical devices companies such as Johnson & Johnson, Boston Scientific, and Amgen.

The 1,200 square foot facility in Worcester opened in 2018 and is the newest of the three M2D2 locations. It includes open concept lab space with a range of shared equipment as well as conference rooms and offices. M2D2 companies receive access to and preferred rates for nearly 50 state-of-the-art core facilities at the UMMS and Lowell campuses. Mentoring program provides companies with advice on IP, corporate structure, deal-making, therapeutic areas, product development, and commercialization.

In joining M2D2, WHV is planning to take full advantage of the various facilities and UMMS resources being made available through this program and to further strengthen its operational capacity and scientific excellence.

Mollie Ockene joins WHV as an intern

WHV researchers believe in the need to train the next generation of leaders to tackle health challenges around the world. Thus, it is our great pleasure to announce that Mollie Ockene joined our team as an intern looking to learn more about HIV vaccine development and to assist with a variety of projects at the company.

Mollie is a rising senior from Boston studying Environmental Policy, Global Health, and pre-medical sciences. At Middlebury College in Vermont she gained experience as a volunteer EMT, joined the leadership board of her sailing team, and is the president of Middlebury Nutrition Outreach and Mentorship, a student organization focused on community engagement with local youth. She has also served on the Environmental Advisory Committee and worked as a research assistant for professors there.

Mollie spent last fall in New Zealand sailing on a tall ship, studying climate science and the health impacts of climate change on the local Māori population. Her academic interests focus on the intersection between medicine and social issues, making her particularly interested in our mission of developing a vaccine to prevent HIV infections worldwide.

Drs. Lu and Voronin are interviewed by MassTERi

Dr. Lu and Dr. Voronin spoke with Anna Wortman and Dr. Karthik Dhatchinamoorthy from MassTERi about their experience in launching and running the Worcester HIV Vaccine.

MassTERi is an Entrepreneurship Club bringing together UMMS students and postdocs interested in pursuing careers in biotech and pharmaceutical industry. The conversation centered on the skills and personal qualities needed to succeed in industry, as well as on the current trend in biotech and pharma to use geographically distributed workforce and the challenges and opportunities of this approach.

Read the full interview here or download it as pdf by clicking below.

2020-07-08-MassTERi-interviewDownload

WHV Advances Toward Filing IND for the Next Clinical Trial

WHV cleared the path toward filing its own IND and hired Target Health to assist with preparing and filing the necessary documents with US FDA.

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 the next several months. 

The Division of AIDS (DAIDS) of 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.  DAIDS expressed support for WHV’s plans to file its own IND and will facilitate the process by transferring several key documents to WHV.

Target Health, LLC, a New York-based CRO with many years of regulatory experience, joined the WHV team and will assist in preparing and filing the IND with the US FDA.

WHV advances with an Exploratory Study of Immune Responses in HVTN 124

HVTN approved WHV proposal to conduct an exploratory study to better characterize the immune responses observed in volunteers in the HVTN 124 clinical study testing WHV’s PDPHV vaccine candidate.

HIV Vaccine Trials Network is conducting immunogenicity assays to assess the peak immune responses observed two weeks after the last immunization in the HVTN 124 trial. At the same time, WHV plans to supplement HVTN’s work by conducting its own investigation into the dynamics of immune responses, as well as conducting additional assay to better assess the breadth and potency of antibodies elicited by the PDPHV vaccine candidate. WHV formally applied to HVTN to request the samples from volunteers needed for the study and the request has been approved.

This work will be conducted in collaboration with Dr. Shan Lu’s Laboratory of Nucleic Acid Vaccines (LNAV) at the UMMS in Worcester, MA. Dr. Lu is the co-inventor of the PDPHV vaccine candidate and his laboratory has extensive expertise in assessing immune responses to the DNA/protein vaccines. Another co-inventor, Dr. Shixia Wang, will lead the studies. The results from both the HVTN study and the exploratory study by WHV will be available later this year.

2020 HIV Vaccine Awareness Day

Right now, the world is focused on COVID-19, which already claimed hundreds of thousands of lives and paralyzed the economies of many countries. The low- and medium-income countries are less prepared to deal with the public health and economic challenges associated with the COVID-19 spread. Many of these countries are already struggling with diseases like malaria, tuberculosis, and HIV and will be severely impacted by the additional strain on their healthcare systems.

The pandemic of SARS-CoV-2 virus once again highlights the need to prepare for potential zoonotic infections that my spread around the world, just like HIV did 40 years ago. The worldwide response to HIV pandemic brought together scientists, doctors, advocates, and public health experts, just like COVID-19 pandemic has been met with international response. Indeed, many of the experts now working on COVID-19 have come from the HIV field. They are bringing the experience and the valuable lessons to accelerate the discovery of preventive measures and treatments for COVID-19.

In these challenging times, WHV remains committed to the development of a preventive HIV vaccine to reduce HIV infections around the world. HIV remains a major public health challenge around the world and a safe and effective vaccine is the best way to stop the virus.

WHV researchers are actively working to better understand the immune responses observed in the HVTN 124 trial, to advance our vaccine manufacturing, and to plan further clinical trials of our vaccine candidate.

WHV collaborates with UMMS to conduct preclinical vaccine studies

In preparation for further clinical testing of its PDPHV vaccine candidate, WHV is working closely with Dr. Shan Lu’s Laboratory of Nucleic Acid Vaccines (LNAV) at the University of Massachusetts Medical School to conduct immunogenicity studies of the vaccine in small animal models. The studies will test the immunogenicity of newly manufactured vaccine products for a planned Phase IIa study and help refine the design of the next clinical trials by exploring different vaccine formulation, dosing, and administration schedules.

Phase I clinical study HVTN 124 is testing safety and immunogenicity of WHV’s DNA-prime/protein-boost vaccine candidate PDPHV in healthy volunteers. The results of the trial will be available later this year, but WHV is already planning the next steps in its clinical program. Additional questions about vaccine formulation, dosing, and schedule will be answered in the follow-up clinical trials.

Testing in small animal models can be extremely helpful in down-selecting among many potential avenues of vaccine improvement. Because the PDPHV vaccine candidate has been developed at LNAV, the researchers there, including Drs. Shan Lu and Shixia Wang have extensive expertise in assessing immunogenicity of this vaccine in preclinical models. Several animal studies are being conducted to investigate immune responses to the current vaccine candidate, to help better interpret the expected results of the current HVTN 124 trial, and to bridge the findings to future clinical trials.

WHV creates DNA reference standards to facilitate future manufacturing

Working with its partner, Waisman Biomanufacturing, researchers at WHV created dedicated lots of vialed individual DNAs from its DNA vaccine to be used as reference standards in the future.

Reference standards of clinical-grade vaccine allow cross-comparison between products from different manufacturing campaigns. With their well-defined characteristics, they help ensure that the vaccine produced for a clinical trial or for commercial distribution is equivalent to the vaccine used previously to establish safety and immunogenicity.

The advances in DNA manufacturing accomplished by WHV and Waisman in their latest plasmid production resulted in substantial improvements in yield and purity of PDPHV DNA vaccine. After generating sufficient DNA final product to support its planned Phase 2a clinical trial, WHV used the remaining material to generate reference standards.

The investment in reference standards highlights WHV’s commitment to the long-term development of its PDPHV vaccine candidate. These standards will be useful in the next manufacturing campaign that will be needed to provide vaccine for the large efficacy trial, and can even be used in the future to support the licensed vaccine manufacturing.

WHV plans an ancillary study of immune responses in HVTN 124 volunteers

WHV scientists will conduct a study to better characterize the immune responses observed in volunteers in the HVTN 124 clinical study testing its PDPHV vaccine candidate.

With the completion of immunizations in all volunteers in the ongoing HVTN 124 Phase I clinical study, HIV Vaccine Trials Network recently advanced to assessing the peak immune responses observed two weeks after the last immunization. At the same time, WHV plans to supplement HVTN’s work by conducting its own investigation into the dynamics of immune responses, as well as conducting additional assay to better assess the breadth and potency of antibodies elicited by the PDPHV vaccine candidate. This proposal has been met positively by HVTN, who agreed to share the necessary samples from the HVTN124 study volunteers.

This work will be conducted in collaboration with Dr. Sha Lu’s Laboratory of Nucleic Acid Vaccines (LNAV) at the UMMS in Worcester, MA. Dr. Lu is the co-inventor of the PDPHV vaccine candidate and his laboratory has extensive expertise in assessing immune responses to the DNA/protein vaccines. Another co-inventor, Dr. Shixia Wang, will lead the studies.

In preparation for this work, LNAV recently obtained an approval for this project from UMMS’ Institutional Review Board (IRB) and is currently working with HVTN to identify and transfer the required samples for the study. The results from the study will be available later this year.

FDA provides positive feedback on WHV’s new manufacturing strategy

In preparation for IND submission, WHV requested FDA’s opinion on its approach to manufacturing protein and DNA vaccines for the planned Phase 2a clinical trial. The request included plans for improved plasmid DNA production, advancement of protein vaccine formulation, and corresponding changes to analytical assays that will be used to release the vaccine for clinical studies.

The response from FDA experts was generally positive and did not identify any major challenges to the proposed improvements in the GMP manufacturing process and testing of WHV’s vaccine components. This confirmation clears the path for advancing WHV’s vaccine candidate PDPHV to the next stage of clinical testing.

Currently, PDPHV candidate is being tested in HVTN 124, a Phase I clinical trial run by HIV Vaccine Trials Network, based in Seattle and funded by the National Institute of Allergy and Infectious Diseases. WHV recently announced its commitment to launching a Phase 2a trial to optimize the immunization approach and to further characterize the safety and immunogenicity of its vaccine candidate.