Advocates Across the US: An advocate in all 50 States Challenge!

Hello advocates! We need you and your voice to help continue the momentum for change in Washington, DC. In order to do this, we’re looking for an advocate (or two!) in all fifty states.

Willing to help? Please let us know where you live and the names of your elected representatives.

Find your elected representatives in the United States by clicking here.

This advocacy activity is anonymous but will require a meeting with your elected representatives staff. Submit this form, and a member of the Herpes Cure Advocacy task force will follow up with you on next steps.

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INFORMATION SESSION:

Want to learn more about participation in the 50 State Challenge or being an effective advocate? Please register to learn more.

October 18th 6pm EST


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Highlights from the Herpes Cure Pipeline with Dr. Anna Wald

Highlights from the Herpes Cure Pipeline 3.0 w/ Dr. Anna Wald

September 20th 6pm EST 

Herpes Cure Advocacy Meet the Experts series returns this Fall with Dr. Anna Wald and an overview of the clinical pipeline for Herpes. Dr Anna Wald is Professor in the Department of Medicine, Epidemiology and Laboratory Medicine & Pathology at the University of Washington and in the Vaccine and Infectious Diseases Division at the Fred Hutchinson Cancer Research Center.  

Dr Wald co-directs the University of Washington Virology Research Clinic, a clinic dedicated to the study of epidemiology, natural history and therapeutics for viral infections.  Her research has focused on genital herpes infections, including infections in pregnant women and immunocompromised hosts.

Anna Wald, portrait at the Fred Hutchinson Cancer research Center, September 24, 2019, in Seattle, Washington

Dr. Wald has been an investigator in many clinical trials for novel antiviral agents and prophylactic and therapeutic vaccines for HSV infection, as well as vaccines for HPV, CMV and other viral pathogens.  Join us for a talk highlighting promising preclinical research and clinical trials for HSV, the release of Herpes Cure Pipeline 3.0, and hear Dr. Wald’s reflections on where the field has been and where it’s going. 

AGENDA:

Overview of Prior Efforts

Promising Clinical Research

Highlights from Herpes Cure Pipeline 3.0

The Path to a Cure

Live Q&A


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Updates from the Pipeline, IHW 2023 and more news!

Hello, The Latest News in Herpes Advocacy is here. Enjoy reading the latest news? Want to see progress faster? Support our work today.


Healthy Volunteers Needed for BNT163-01 Clinical Trial

Healthy volunteers sought for clinical trial for herpes vaccine candidate from BioNtech BNT-163-01.

Volunteers needed near The University of Pennsylvania Hospital in Philadelphia, PA.

This is Dr. Harvey Friedman’s work in partnership with BionNtech Group. 

Link


International Herpes Workshop Conference in Missoula, MT starts July 15

This week starts the International Herpes Workshop Conference in Missoula, MT. Patient advocates and some of Herpes Cure Advocacy medical advisory board are in attendance – please stay tuned for notes on promising new research!

Want to follow along on twitter?

Please use the hashtag #IHW2023

Follow our new Twitter list to follow and chat with the Herpes experts attending.

At IHW 2022 Herpes Cure Advocacy was on the agenda talking about federal advocacy for HSV!


STI & HIV World Congress 2023 in Chicago July 24-27

See you in Chicago July 24-27! Herpes Cure Advocacy and team will be exhibiting – find us in booth #11. If you haven’t yet – please shoot us a note if you want to schedule time to connect! Or stop by and say hello.

We’re excited to bring our message of cure, treatment and prevention for Herpes to Chicago.

Are you a patient advocate interested in attending the conference? Want to join us live and in person? Email us today!

Be ready to engage on twitter, ask questions and USE YOUR VOICE to ask for change.


HIV and Herpes: Related Epidemics

Did you know 30% of new HIV cases are directly attributable to herpes?

NEW on the website – more clinical data regarding the association between HIV and HSV. Check it out here: Herpes and HIV: Related Epidemics. Spread the word online with our social media toolkit!


GSK Patient Advisory Council

What we’re reading:

AiCuris Announces Strategic Shift to Focus Development and Commercialization of Anti-infectives for Immunocompromised Patients

The Many Faces of Neurological Neonatal Herpes Simplex Virus Infection

Incidence of Epstein-Barr virus reactivation is elevated in COVID-19 patients

Stacking the odds: Multiple sites for HSV-1 latency

 16th Mini-Herpesvirus Workshop in Germany, September 29, 2023



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Herpes Cure Pipeline 3.0 Release

Join the Party

Herpes Cure and Treatment News

At long last – the Herpes Cure Pipeline 3.0 is (almost) ready for release. To confirm your attendance, please join the wait list for the Pipeline Release Party.

The Herpes Cure Pipeline is the global resource for clinical research in cure and treatment for Herpes Simplex. Herpes Cure Advocacy monitors the clinical pipeline globally – including only preclinical studies that have expressed intent of commercialization.

The Pipeline Release Party will have special guests from the Herpes Cure Advocacy medical advisory board, scientists, and advocates!


LAST CALL:

Have a tip for the pipeline?

Are you or your colleagues involved in clinical research for herpes cure or treatment? Have other additions to the Herpes Pipeline 2.0? To drop us a pipeline tip, click here.



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Register: Herpes Advocates Town Hall Meeting June 1

Advocates Town Hall Meeting: Herpes advocates town hall meetings are open to patients, professionals, and those looking to get involved to make a difference. We’ll discuss Herpes Cure Advocacy urgent priorities, a 90 day action plan for new advocates, and ways to get more involved. Please submit questions in advance at info@herpescureadvocacy.com.

Thursday, June 1 at 6pm EST.

AGENDA:

  • About Herpes Cure Advocacy
  • Joining the Volunteer Task Force
  • Ways to Help and Getting Involved
  • Advocacy Question and Answer

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Progress for a Cure for Herpes Continues

person standing on hand rails with arms wide open facing the mountains and clouds

Herpes Clinical Pipeline

AiCuris Non-Confidential Slide Deck May 2023: AiCuris planning for commercial launch of Priteliver 2025. Launch prep for Priteliver is ongoing.

Innovative Molecules advances IM-250: The clinical trial center in Heidelberg, Germany has Phase 2 clinical trials are scheduled for 2024. The clinical phase 1 study investigates the safety, tolerability, and pharmacokinetics of a medication in development (IM-250) against infections with herpes simplex viruses in healthy test subjects. Participants: Healthy men and non-pregnant women aged 18-50 years.

Thyreos Inc. Receives NIH NIAID $1.6 Million Grant For Preclinical Development of R2® Herpes Simplex Type 2 Vaccine

EG 427 announces issuance of the first 2 patents for its HSV-based gene therapy treatment


Herpes Cure Advocacy News

Want to join the advocates volunteer task force? Join this information session to learn more. Interested volunteers can apply here.

REGISTER NOW

May 17th 6pm EST


What we’re reading…

Tired of ‘dead end’ approach, herpes patients mobilize to demand government action

Don’t ignore potential microbial causes of Alzheimer’s and other chronic diseases, researchers say

Chronic viral coinfections differentially affect the likelihood of developing long COVID

I Thought I Had A Headache. It Turned Out To Be Herpes (HSV-1) — In My Brain.


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Herpes Keratitis Cure advances to Phase 3 Clinical Trials in China

shallow focus photography of human eyes

BDGene Therapeutics is a Chinese biotech company based in Shanghai. BDgene now has approval to run Phase 3 trials (held in China) on their gene therapy cure for HSV-1 keratitis.

The gene editing treatment for viral keratitis (BD111), developed based on BDmRNA delivery patent technology, has completed 3 human clinical trials of IIT. It is the only technology of Cas9 mRNA delivery by lentivirus in the world, and also the second human clinical research project of CRISPR-Cas9 gene editing treatment in human body in the world. BDgene are currently advancing pre-clinical research in gene therapy for HSV-2.

BD111 was previously approved as an orphan drug by the US FDA in June 2022. BDGene representatives have now entered pre-IND meetings with the FDA and are in final submission stages. This implies to me that they will start trials in the US in the near future.

After IND approval, BDgene will start Phase 3 clinical trials in three Chinese hospitals.


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NIH forms Multi-Council Working Group for Herpes

person holding laboratory flask

Herpes Cure Advocacy celebrates a step forward on the path to the cure, treatment and prevention of Herpes. NIH has assembled a Multi-Council Working Group for Herpes Simplex Virus and are calling for input from field scientists and the general public. Herpes patients and field experts are excited to see this progress, an important win for advocates, who have been urgently calling on the federal government for a response. There is new momentum in the field of herpes, a common and important infectious disease area that has been stagnant for decades. There is currently an addendum for the cure treatment and prevention of Herpes being developed and incorporated into the 2020 National STI Strategic Plan at OASH. Additionally NIAID/CDC held a joint workshop for genital herpes in November 2022, the first federal meeting for Herpes in decades.

The new trans-NIH Herpes Simplex Virus (HSV) Working Group is engaged in the development of a strategic research plan on Herpes Simplex Virus. The working group is being led by the National Institute of Allergy and Infectious Diseases and includes representatives from the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, the National Institute on Aging, the National Institute on Minority Health and Health Disparities, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

The strategic research plan will be structured around four areas of research noted below. Working group leaders have also issued a request for information into the research plan from field experts and the general public.

Priority 1: Improve fundamental knowledge of HSV biology, pathogenesis, and epidemiology

  • Enhance fundamental knowledge of HSV biology, including but not limited to: viral interactions with host cells and mechanisms of replication and transport; fundamental aspects of innate and adaptive immune response to HSV; HSV disease pathogenesis in multiple organ systems, including the skin, reproductive tract, eye, and the peripheral and central nervous systems; and the key drivers of disease transmission.
  • Characterize host and pathogen drivers that underlie dynamics of HSV latency and reactivation
  • Improve understanding of diverse pathophysiology of HSV infection including neonatal infection and the role of mucosal immunity to reduce genital and orolabial infection and disease; and a deeper understanding of the neurologic impact of HSV infection, including herpes simplex encephalitis, post-herpetic neuropathic pain, post-herpetic autoimmune encephalitis (i.e., post-HSV NMDARE), and potential associations with neurodegenerative disorders such as Alzheimer’s disease.
  • Explore epidemiology of and co-morbidities associated with HSV infection
  • Improve and develop new in vitro and in vivo models that reflect human disease

Priority 2: Accelerate research to improve diagnosis

  • Develop improved biomarkers and technologies for herpes diagnosis
  • Improve sensitivity and specificity of serologic tests that can be made commercially
  • Support research to improve point-of-care diagnostics

Priority 3: Improve strategies treat and cure HSV

  • Identify candidates for elimination of virus or functional cure
  • Advance the development of novel treatment strategies, including strategies for preventing HSV entry into the central nervous system and for reducing sequelae of HSV encephalitis.                                                           
  • Evaluate the safety and efficacy of treatment strategies in diverse populations and age groups
  • Optimize therapy to reduce shedding and transmission

Priority 4: Advance research to prevent HSV infection

NIH Request for Information

On April 21, a notice with a Request for Information (RFI) was shared, inviting comments and suggestions on National Institutes of Health’s (NIH) key strategic approaches to develop a Herpes Simplex Virus Strategic Plan.

This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding the above proposed framework. Learn more and respond to the RFI here.


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Latest Updates on Herpes Cure Treatment and Prevention

Herpes Cure Advocacy News

HHS Listening Sessions: Two listening sessions were held this past week in an effort to gather insights for an addendum to the HHS 2020 STI Strategic Plan. Both patients and providers spoke with OIDP, NIH, and CDC stakeholders about their experiences and ideas for how to help cure, treat and prevent herpes in America. HCA is supporting our federal partners in this effort. There will be future opportunities for input including a listening session at the STD Engage conference in New Orleans May 16-18.

Herpes Cure Advocacy will exhibiting at STI/HIV World Congress in Chicago, IL.

Fundraising continues with industry partners, foundations, and individuals. Want more updates? Want to change the field faster? Please donate what you can to help advance this work!

Corporate and industry partners interested in sponsoring our work? Want to host a patient workshop or speak on Meet the Experts? Email us at info@herpescureadvocacy.com for sponsorship opportunities.

Dr. Harvey Friedman has joined the Herpes Cure Advocacy Medical Advisory Board.

NEXT UP on Meet the Experts Series: April 26th 6pm EST Terri Warren from Westover Clinic. Register now!


Industry and News from the Pipeline

AiCuris Establishes US Subsidiary – Appoints New CEO

Promising Progress with Pritelivir

GSK Updates Phase 1 Clinical Trial End Date – changed to two weeks earlier!

GSK recruitment for Phase 2 expected to begin in June 2023 in the following locations: USA, Spain, UK, Belgium, Germany for HSV-2 positive people.

BD Gene Makes Progress towards possible Herpes Keratitis Cure in China

Dr. Gerald Kleymann presented an update on the HSV helicase-primase inhibitor IM-250, with potent in-vitro and in-vivo activity against HSV including nucleoside-resistant mutants due to its different mechanism of action. Clinical Trials are planned soon.

Rational Vaccines starts clinical trial in UK with a survey

A team from Fred Hutch published promising results from clinical research on HSV-2.


Funding News

NIH/NIA Infectious Etiology of Alzheimer’s Disease (R01 Clinical Trial Optional) RFA-AG-21-034


Advocacy Alerts

Ask NIH Leaders: What is the status of Multi-Council Working Group for HSV?

Advocacy Alert Archive


What we’re reading


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Advocacy Alert: Registration Open for OASH Listening Sessions

Mark your calendars! The HHS Office of Infectious Disease and HIV/AIDS Policy (OIDP) wants to hear from members of the STI community during two virtual listening sessions on April 4th and April 6th, 2023.

OIDP is developing an addendum to the STI National Strategic Plan to include herpes simplex virus (HSV) types 1 and 2 in the United States. The STI Plan provides a roadmap toward a nation where STIs are prevented and where every person has high-quality STI prevention, care, and treatment while living free from stigma and discrimination. To help inform the HSV addendum to the STI Plan, OIDP will host two separate listening sessions for provider and community audiences.  These listening sessions are geared for US residents only.

Providers Session: 

Tuesday, April 4, 2023, from 3:00pm-4:30pm (EST)

  • National, state, local, and tribal health departments and organizations
  • Health care providers
  • Scientists/researchers

Community and Patient Session

Thursday, April 6, from 1:00pm- 2:30pm (EST)

  • National STI Coalition Members
  • Advocacy groups
  • Community- and faith-based organizations
  • People with or at risk for HSV