Possible herpes keratitis cure takes another step: BDGene of China applies for Orphan Drug Designation at the FDA

Chinese company BDGene from Shanghai continues to lead in the global race for a herpes keratitis cure. The highly anticipated treatment, BD111 has reached a big milestone as it applied for Orphan Drug designation from the US FDA. Previously, BD111 has received international attention for its progress with a gene editing cure for herpes keratitis. We reported on its progress – which it has published in the top international academic journals Nature Biotechnology and Nature Biomedical Engineering.

BD Gene has (in collaboration with the Eye and ENT Hospital of Fudan University) carried out 3 cases of IIT human clinical trials, and has reported pre-clinical results where study subjects were cleared of the virus. The potential to change the landscape for Herpes treatment has patient advocates very excited.

Orphan drugs, also known as rare disease drugs, refer to drugs used for the prevention, treatment and diagnosis of rare diseases. The orphan drug designation granted by the FDA applies to drugs and biologics for rare diseases that affect less than 200,000 people in the United States each year, and provides policy support for related products. Therefore, obtaining orphan drug designation is of great advantage for manufacturers bringing new medicines to market.

Possible herpes cure takes another important step

According to the U.S. FDA Orphan Drug Act, new drugs that have obtained orphan drug qualification allows for a series of advantages for BDGene including quicker, easier processes to get to market in the US. Supports include tax credit for clinical research expenses, Exemption of NDA/BLA application fees, access to special R&D funds, special approval channels, exemption from the declaration of some clinical data, and a seven-year market exclusivity period after the drug is approved. Orphan Drug Designation can also bring investment as the company continues to lead the market.

About Herpes Keratitis: Herpes virus keratitis is caused by herpes simplex virus (HSV-1) infection and is the most common infectious blindness disease. Current first-line antiviral drugs can only inhibit viral replication by interfering with viral DNA synthesis. These drugs can inhibit HSV-1 DNA replication, but cannot clear the latent viral genome in the cornea and trigeminal ganglion, which leads to the disease. Repeated attacks can lead to blindness in severe cases.

About BD111: CRISPR-based gene editing technology can directly degrade the viral genome, providing the possibility of fundamentally curing the disease. BD111 gene editing drugs get rid of the drawbacks of traditional related drugs that need to be repeatedly administered, and only need to be injected once. The drug uses the original delivery technology of VLP to transduce the CRISPR gene editing tool to directly target and cut the HSV-1 genome, so as to achieve the purpose of removing the HSV-1 virus genome, thereby realizing the treatment of herpes virus keratitis. The characteristics of the BD111 drug are: (1) Cas9 mRNA is delivered, and the gene enzyme stays in the body for a short time, which can reduce the risk of immune response and gene editing off-target; (2) It cuts the viral genome and does not need to change anyone’s genes, not detected to off-target effects on the human genome.


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New Clinical Trial for Herpes Vaccine from Biontech + UPenn

The BioNTech team and UPenn have previously partnered on pre-clinical study of an mRNA-based vaccine candidate to prevent genital herpes. This work is led by lead investigator Dr. Harvey Friedman and team at the University of Pennsylvania.

A new clinical trial A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions is now testing the BioNTech/UPenn formulation, BNT163, and it is recruiting as of today.

The clinical trial, posted on ClinicalTrials.gov on June 27th, is enrolling HSV negative individuals to test the effectiveness of a vaccine candidate to prevent genital herpes. Trials are set to begin in September 2022 with a completion date of 2025. Locations for the study are to be determined and will be posted when finalized.

This clinical trial is for HSV negative, healthy participants to test safety and efficacy in a two-part study. Part A will be multiple doses of vaccine, The highest dose that is well tolerated will be studied in a larger number of subjects in part B.

Regarding a therapeutic to treat those living with genital herpes: Within the next 1-2 months, Dr. Friedman and his lab will be turning energies towards a therapeutic, plans for an experimental approach are underway.

HSV- patients interested in participation can contact: patients@biontech.de


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New Clinical Trial for Herpes Simplex Virus

GlaxoSmithKline Pipeline Update

GSK has officially updated its clinical research pipeline to include a vaccine for HSV-2! Their therapeutic vaccine for HSV-2 isn’t mRNA (or what they called SAM technology) but an adjuvanted therapeutic vaccine.

The trial (currently recruiting) is a Phase 1/2 combined trial that ends in 2024. GSK will test 9 different formulations as a prophylactic, the one that has the highest efficacy will then be tested in Part 2 as a therapeutic. Ultimately, advocates assume, that GSK will make one vaccine as both a prophylactic/therapeutic.

GSK Formulation: GSK3943104A: Therapeutic HSV (Immunomodulator): Active Immunization to suppress recurrence of genital herpes in adults aged 18 years and older.

GSK is the manufacturer of Shingrix (shingles vaccine released in 2017) and is perfectly positioned to leverage their knowledge from this very effective vaccine for another herpes virus for a new formulation to treat Herpes Simplex. Shingrix is also a recombinant protein adjuvanted vaccine with 90-97% efficacy over 7 years with one 2-dose regimen.

GSK has a proven platform for developing a highly effective recombinant protein – adjuvanted herpes vaccine. They are now simply tweaking it slightly for a new target in HSV-2. HSV and VZV (VZV = Varicella-zoster virus the virus that causes chickenpox and shingles) are both alpha herpes viruses. They are genetically very closely related, are latent viruses that live in the body for life, and when reactivated exhibit symptoms in the body similarly. Both herpes simplex and zoster are viruses that hide in the nerve ganglia and reactivate on the skin in the same manner with blisters, prodrome, etc.

Advocates are excited that GSK is taking this approach and hopeful that as one of the largest pharma companies globally, and entering clinical studies for herpes simplex for the second time, they’re confident about the safety and efficacy of this formulation. The new formulation is estimated to reduce viral shedding to the extent that the infection would be non-transmissible to partners or what is known as a functional cure.

For other projects in the Herpes Cure Pipeline, see here.

For more details on the new GSK clinical trial for Herpes and to apply to participate please visit here.


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Testing and Diagnosis for Herpes: A Dialogue

Herpes Cure Advocacy is proud to offer a 2-part webinar series in partnership with NCSD.

STI Testing and Diagnosis for Herpes is Challenging

Testing for HSV, especially of asymptomatic infection, is complex and can be challenging for both patient and clinician alike. Join our two-part workshop for an open and safe dialogue to learn, ask questions, and discuss the nuances and best practices of testing for herpes simplex virus in clinical practice.

What about Herpes?
Part 1: Dialogue on Patient-Centered Care for HSV Diagnostic Testing and Diagnosis
May 26th, 2022, 2-3:00pm ET

Join us to learn more from an advocates’ and clinical perspective about the landscape of HSV diagnostic tools, what is currently available and where there is opportunity to develop new tools. We will hear patient experiences during herpes testing and diagnosis and discuss ways to improve outcomes during clinical care. There will also be opportunities to speak with advocates about what patient-centered care for HSV looks like and advocate-preferred language for clinical counseling during herpes screening and diagnosis.

Guests:
Terri Warren, RN, ANP

Westover Clinic

Part 2: Dialogue on Implementation of HSV Testing and Treatment Guidelines in Clinical Practice
June 2nd, 2022, 2-3:00pm ET

Join us for a safe and non-judgmental discussion on complications of testing for genital herpes in clinical practice. We will also learn about new updates to testing for herpes according to the CDC 2021 STI Treatment guidelines as well as how to implement them in practice, how to handle patients who are asymptomatic, when to order a confirmatory test, and best tips for counseling a newly-diagnosed patient. 

Guests:
Dr. Christine Johnston

University of Washington


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Help HCA ask for Federal Funding for Treatment and Prevention of HSV!

The landscape for Herpes treatment and prevention is, while the are glimmers of hope, very ugly. There are no public health interventions to stop transmission and no accurate test to diagnose asymptomatic infection. The treatment pipeline is slim, improving – yet slim. And NIH is investing less than 10 million a year in clinical research for HSV with commercial viability.

Help advocate for federal investment for treatment and prevention of Herpes

Herpes Cure Advocacy is asking the federal government for 225+ million in the FY 2023 budget. To increase our chances of getting this federal funding – we need to show the American people want this!

Contact your elected reps at the links below. Call. Email. Better yet, ask them for a meeting. Have a meeting scheduled? Let us know. We’d love to join!

Sample email is here!
Senate
House

Here’s what we’re asking for specifically:

DHHS: HSV Strategic Plan Implementation Funds

In 2022, OASH has a $250,000 budget for a National Strategy and Strategic Plan for the treatment and prevention of HSV types 1 and 2. This was HCA big win in 2021! In 2023, we want to make sure they have funding to implement this plan.

NIH: Clinical research for HSV treatment

The NIH has a 30+ billion budget. Yet they are spending less than 10 million a year on translational research for HSV, or clinical research with intention of bringing a product to market. They have indicated Herpes treatment and vaccine are a priority. The funding strategy tells another story. We urgently need these funds for clinical research at NIH, with a focus on clinical research projects with commercial viability.

NIH: Interagency working group

NIH has 21 agencies focusing on different disease areas. Herpes is primarily addressed by NIAID with the Division of Microbiology and Infectious Diseases. It’s also neuropathic, impacts primarily women and minorities, is a recognized driver of HIV/AIDS, has mental health implications, and is being studied for association with Alzheimer’s Disease. This working group will bring together various NIH agencies that Herpes may impact, to approach treatment from an interdisciplinary perspective, and ensure a coordinated effort.

NIH: Clinical research on neurological complications

Herpes has a suspected association with Alzheimer’s Disease, and proven links to neurological complications such as encephalitis, meningitis, and Bells Palsy. Medical knowledge on neurological complications is not complete – these funds will support clinical research specifically to assess risk of potential known or unknown neurological complications as a result of the infection.

CDC: Interagency testing development working group

There is no accurate diagnostic test (that is commercial available or FDA-approved) to diagnose asymptomatic infection. Without one, the prevention strategy for Herpes is fundamentally flawed. This working group, led by CDC, will outline next steps for the advancement of HSV diagnostic tests.


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Monoclonal Antibodies: What’s in the pipeline for Herpes treatments?

What new treatments are coming for Herpes?

In the Herpes Cure Pipeline, there are several monoclonal antibody treatments. What kind of advantages do monoclonal antibody (MAB) treatments have over anti-virals or therapeutic vaccines? What makes monoclonals work?

In simple terms, monoclonal antibodies are lab developed antibodies that are directly injected into the body. The antibodies support the immune system by responding to viral pathogens, like herpes, preventing them from entering cells and infecting them.

Herpes lives in the nervous system where it is able to avoid the defenses of immune system. Only when reactivated, and traveling from the ganglia nerves to the skin surface, is the virus vulnerable to attack from immune system. In theory, if you could generate antibodies from a MAB, the presence of antibodies may be able to catch the virus when it leaves the nerve cells, before it reaches the epithelial cells on in the mouth or genital region where it causes an outbreak. This would require the right antibodies being properly designed to attack and kill a virus.

One advantage of MAB is that it is possible to inject significantly more of them than the immune system is capable of making. The disadvantages of monoclonal antibodies are they don’t last forever so (while dosing is less frequent than the currently available daily AVTs) MABs would require regular, ongoing dosing. The lifespan for effectiveness is short, so patients will need regular monthly or quarterly injections to maintain efficacy. Also, cost may be a factor, as MABs are expensive to make and regularly dosing could be costly.

What is in the pipeline for Herpes treatment with monoclonal antibodies?

There are two companies with clinical research projects in the Herpes Cure Pipeline are testing MABS: United BioPharma has 3 studies underway (Phase 1 completed, Phase 2 are expected to start in 2022) and Heidelberg Immunotherapeutics who just finished a Phase 2 trial in January 2022. Patient advocates are currently waiting for the Phase 2 results from Heidelberg’s formula HDIT-101.

United BioPharma

There are three Phase 2 clinical trials expected to started in 2022 from United BioPharma, looking at three separate and unique data sets for their mAB formulation, UB-621. They will be measuring the rate of viral shedding, but first will be collecting the rate of occurrences, pre and post dosage, in earlier trial participants.

The studies are focused on genital HSV-2, although it is indicated that UB-621 could also be effective against HSV-1.

What does UB-621 do? It is a fully humanized viral entry inhibitor antibody that recognizes glycoprotein D (gD) of HSV type I and type II.

  • Neutralizes both HSV-1 and HSV-2
  • Long half-life up to 25 days
  • The leading antibody drug for treatment of HSV infection
  • High binding affinity to the gD protein : 3.6 x 10-11 M

Study 1: Safety & Efficacy Against recurrent genital infection (Estimated start of October 2021, Delayed)

Study 2: Repeat Dose for Tolerance and Effectiveness (Estimated start of December 2022)

Study 3: Efficacy to reduce viral shedding (Estimated start of June 2022)

Other parts of the immune system like cd4 and 8 cells have typically been thought to be much more important than antibodies for fighting HSV so these results are highly anticipated.

Heidelberg Immunotherapeutics

Heidelberg Immunotherapeutics just finished Phase 2 clinical trials in Europe for a monoclonal antibody in 2022. This research team is based in The National Center for Tumor Diseases (NCT) Heidelberg, a joint venture of the German Cancer Research Center and the Heidelberg University Hospital. Their formula HDIT101 is administered via an intravenous transfusion, read more about their preclinical work here.

Heidelberg focuses on the discovery, design, engineering and production of novel antibody-based therapeutics for immunotherapy of malignant tumors and viral diseases. 


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Herpes Advocates: Nicole’s Story

Hi, my name is Nicole and I have always thought of myself as a good person. However, sometimes, life can throw you into a dark corner that you never even dreamed imaginable. My experience with HSV2 has been devastating. I am ashamed that I allowed this to happen to me and I turned around and infected someone who absolutely adores me, who is innocent and didn’t deserve this curse. Living with HSV2 is extremely taxing, mentally, physically, emotionally and spiritually – it unfortunately impacts every part of my life. I know what it feels like to feel good, confident and clean, no pain, no itching, because prior to being infected with HSV2, I felt this way. I believe a cure must be an option because I cannot imagine living like this for the rest of my life-I just cannot. I struggle at times with severe depression and anxiety. Antivirals only help in a small way, for me to manage outbreaks 50% of the time, if that. I have to take the antivirals daily, without fail, and especially around my menstrual cycle, which triggers outbreaks.

Years ago, when I first started having symptoms, I sought out clinics – two different medical clinics as I knew something was wrong with my body – down there. Both times, I was either given a prescription for a UTI or for a yeast infection. Even the medical professional didn’t think it was herpes or maybe they didn’t know that when there is viral shedding it can mimic the appearance of a yeast infection…I didn’t know that then, but now I sure do after 13 years of living with HSV-2.

Living with herpes is like having the joy & happiness taken away from the most precious & sacred moments; My husband and I are tentatively planning a wedding vow renewal and I am afraid to plan it as I don’t know ( I cannot say with confidence that I won’t have an outbreak at that time, how horrible would that be!) I have the beautiful dress, but I long for the security of knowing that I will be able to wear it confidently…also, it is extremely hard to see myself with pride as a woman, when I feel as though I wear a scarlet letter on my chest. It’s hard, very hard. I long for the days when I felt clean. 

HSV-2 is more than a virus, it steals your joy. It feels like a dark cloud of impending doom lurking, always lurking. How can anyone live a good life with this looming anxiety? The outbreaks are so painful – ulcers, pain, shame, guilt – the cycle does not end. I pray for a cure, for with a cure, there is hope.



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Request a Patient Listening Session at the FDA

Hi there Herpes Advocates, we’re happy you’re here.

Advocacy Alert: Request a Patient Listening Session at the FDA

The landscape for prevention of HSV in America is inadequate. There is a critical loophole without an accurate test to diagnose asymptomatic infection. Currently available FDA-approved tests for HSV are inaccurate 50% of the time with confirmatory testing. As a result clinical care, and public health outcomes are suffering.

With only these sub-optimal diagnostic tools in our diagnostic toolkit, Americans are lead to believe they are HSV+ when they are not, or that they are HSV- when they have the infection.

We need your help to tell the FDA: We want a patient listening session to discuss the sub-optimal diagnostic serology tests that they have approved.

Step 1: Fill out this form to request a patient listening session.

Answers to Form fields:

  • Patient Group: Herpes Cure Advocacy
  • Question or Meeting: Meeting
  • What is your request about? A Medical Device
  • Is your request about a specific FDA Program: Yes, Patient Listening Session
  • Name or condition: Herpes Simplex Virus
  • Question: Diagnostic Tests have sub-optimal results, and are wrong 50% of the time. This is leading to many false +/- results and is impacting public health outcomes dramatically. Please schedule a patient listening session so that the impacts of the sub-optimal tests, both on patients health and wellbeing, and impacts to prevention of HSV from a public health perspective can be discussed.

Step 2: Email the FDA HSV Diagnostics Team

Please email all of the following people, and copy info@herpescureadvocacy.com:

CDRH_PatientEngagement@fda.hhs.gov, patientaffairs@fda.hhs.gov, Maria.Garcia@fda.hhs.gov, Kathleen.Whitaker@fda.hhs.gov, Eva.Rorer@fda.hhs.gov, Laura.Ulitzky@fda.hhs.gov, Ryan.Karsner@fda.hhs.gov, Himani.Bisht@fda.hhs.gov
Kathryn.Capanna@fda.hhs.gov , tracy.gray@fda.hhs.gov, Michelle.Tarver@fda.hhs.gov

SUBJECT LINE: Please Schedule a Patient Listening Session to Discuss Health Outcomes w/Sub-Optimal FDA-Approved HSV Diagnostic Tests

SUGGESTED EMAIL CONTENT:

Dear Dr. Maria Garcia Ines and team, I have today submitted this form to request a patient listening session to discuss patients experiences with the sub-optimal results from FDA-approved tests for Herpes Simplex Virus. Currently available tests are proven wrong 50% of the time with confirmatory testing. This is a critical problem in our public health interventions for HSV that needs to be addressed urgently – we should have better standards for our public health interventions and diagnostic tools!

Many reports of inaccurate tests have been filed with the FDA already and studies have been shared documenting the sub-optimal results. Also, please review this study. and please review this study.

Please prioritize the health of American people, by taking the time to schedule a listening session so that you can hear and understand the severe impacts to patients lives first hand.

Feel free to add any of your own personal story with HSV testing that is relevant.



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Koda’s Patient Story

My diagnosis with HSV-1 was traumatic. It was a result of a date where the other party did not disclose their positive status. They had the virus for 10+ years and knew about it, yet did not tell me. When she revealed this to me, after I had already been exposed several times, it was too late. I tested as soon as I could, and it came back positive. When I heard the news, I was at work and shaking. I could barely function and was disassociated for weeks. I had suicidal ideation and almost made an attempt on my life. 

Since having been diagnosed, dating has been near impossible. This virus has impacted my life immensely. In public social engagements, I am paranoid of inadvertently giving it to someone else through a shared glass or utensil. On my health (mental and emotional), I struggle to function when an outbreak occurs. I want to break down, cry, and still I often think about self harm. It doesn’t matter how common the virus is, there’s trauma, health risks, and for many, considering taking their own life from the suffering and pain.

There needs to be action. There needs to be funding for a vaccine and a cure. To save lives and begin repairing the damage to millions of people on their health and their future, and to end the suffering for so many.

I don’t want to be by myself forever and I have teetered on the edge of taking my own life several times because of this virus. There is new technology out there for treating illnesses and new research showing this virus has more detrimental health ramifications than just a few bumps. A vaccine to COVID was developed in record time. No more excuses. There needs to be action. There needs to be funding for a vaccine and a cure. To save lives and begin repairing the damage to millions of people on their health and their future, and to end the suffering for so many. No. More. Excuses. Just like how the polio vaccine was sold for $1, because the inventors knew that the public health was more important profit. It’s time to make a new vaccine and treatment for HSV in the same spirit of Polio and be rid of this virus.



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After Covid-19 success, patients with the world’s ‘most stigmatized’ infection push for their own Operation Warp Speed

“There has not been any kind of herpes advocacy in the 30 years that I’ve been involved in STI prevention and research. It was something that was just never addressed,” said Jeff Klausner, an infectious disease physician at UCLA and the former director of STD prevention and control at San Francisco’s public health department. “There’s just been no one who’s tried. Except now…”

This full feature article is available on Endpoints news. If needed, read more for free here.