Last updated: 17/01/2022
Hi all,
This sticky aims to keep new and existing members updated on progress of HSV research, clinical trials status and our HCR group goals:
Group Goals:
Research progress tracker:
Donations to support work towards a cure:
Fred Hutch & Dr Jerome :
Dr Friedman / Penn Uni:
Detailed research status (more detail for those interested - grab a coffee/drink and enjoy!):
(1)
· Research is developing a gene therapy to fully eradicate HSV-1 and HSV-2. So far, his team has removed over 95% of latent HSV-1 in mice, effectively curing the disease since the remaining 5% of the latent virus appears to remain inactivated.
· Using our fundraisers, Dr Jerome has begun similar work to cure guinea pigs with a goal to start human clinical trials in late 2023.
· FHC provided the following milestones which have now been achieved - thanks to all contributions up to $200k and especially to the one incredibly generous donation of $255k!
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With first $100k raised, FHC hired a research technician (in Dec-20) to dedicate resource towards guinea pig testing.
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Reaching $250K helped cover the complete amount of testing needed on the guinea pigs.
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Reaching $450K helped cover the FULL cost of this project, including spending that is necessary to keep the project running but is not always covered in NIH grants. At a high level this includes (1) material costs for the project such as guinea pig purchases, laboratory supplies, reagents; (2) service costs such as animal housing/care, viral vector production/sequencing, tissue processing/analyses (3) personnel effort for lead scientist & research technician.
· Video on Fred Hutch's motivation and history:
· Latest detailed video update on curing mice from Dr Jerome is here:
· Jan-21 Q&A update specifically for us is here:
· Guinea pigs are currently being tested on and we're expecting to hear first results on therapy efficacy in Q1-22.
· Below is also a list of FAQs that cover key questions around their research / progress to trials:
(2)
· Excision Bio has illustrated the possibility in developing a curative gene therapy using CRISPR in treating both active and latent HSV infection in the body.
· Currently waiting to hear when they are planning to enter clinical trials for their HSV treatment.
· This is due to the company's primary focus being curing HIV first with CRISPR.
· In Feb-21, Excision announced $60 million raised in funding to focus on their research streams including HSV:
· Updates on IND filing status can be found here:
(3) Shanghai BDgene Co., Ltd
· Shanghai BDgene Co., Ltd. is running a Phase I/II clinical trial in Shanghai, China to cure HSV-1 keratitis - latest update appears to be that the first patient has been cured for over a year with no adverse affects - post discussing this is located here:
· The trial is set to end in May 2022. The company is closely linked to Shanghai Jiao Tong University, one of the "Ivy Leagues" of China.
· More information here:
(4) Redbiotec
· Redbiotec has developed a that has shown an over 90% efficacy in reducing HSV-2 symptoms and shedding in preclinical trials in guinea pigs.
· The company raised in funding and we're waiting to hear when they will enter clinicial human trials.
· More info here: and
(5)
· This company has developed delta gD-2 vaccine candidate for prophylactic applications.
· Whilst referred to as a preventative, X-VAX website suggests potential for a therapeutic benefit too:
"Why may ∆gD-2 work as both a preventative and a therapeutic vaccine?
Pending results from clinical trials, the same antibodies that activate cellular killing to prevent infection with herpes virus may also treat someone with recurrent disease. Following vaccination with ∆gD-2, the antibodies would rapidly clear the reactivated virus, thus preventing or ameliorating recurrent disease or transmission to others."
· Latest response to from X-Vax (on 07/02/21):
We have completed extensive pre-clinical studies in both mice and guinea pigs. Links to the study publications are provided on our website . We expect to start clinical trials in 2022.
· Company website & more info:
(6) Dr Harvey Friedman (Prophylactic + sponsored therapeutic research)
· Latest mice studies by Dr Friedman have shown vaccine candidate is effective at preventing genital infection caused by HSV-1. Previous publishing showed the same for HSV-2 in mice/guinea pigs.
· He is expecting to begin Phase I trials that test prevention of genital herpes in humans around Jun-22.
· Latest video updates for us from Dr Friedman can be found here:
Feb-21:
Nov-21:
· has set up a dedicated fundraiser which has already hit the following milestones:
- $50k - being used to hire one new research person to specifically help assess therapeutic benefits that this vaccine could bring.
- Donations made (link at top of sticky) will go towards supporting work towards a therapeutic vaccine.
- Latest fundraiser progress can be found here:
· Link to latest research papers/results:
(7) (RVx-201 HSV-2)
· Have kept RV on here as they are focused solely on diseases resulting from herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) infections.
· However we should consider it with caution - this company has seen a lot of controversy in recent years, due to running a Phase I trial in St. Kitts outside the FDA's jurisdiction and facing heavy scrutiny.
· Latest update from Diane Abbitt on 15/02/21 (thanks for providing):
- RV are working with MHRA in the UK and preparing to file an IND with the FDA. Phase I clinical trials will be 2022 in the US (potentially sooner in the UK but we will have to wait and see).
- Members from HCR will be invited to register for trials once they begin recruiting on the registry.
The company continues to work very hard to complete the development of what we all believe will be an effective treatment for herpes, working with the MHRA in the UK and preparing to file an IND (Investigative New Drug) application with the FDA. We believe we will be approved in the UK for a clinical trial, but have not yet been given the green light to do so. We are continuing to work on our IND application and believes it will be ready for submittal the later part of this year. I do not think the company will be approved for a Phase I clinical trial in the US till 2022.
However, in preparation for the day when the company is approved to conduct a clinical trial, I am in the process of establishing a registry for persons who wish to participate in such a clinical trial. It should be established in the next couple of months at which time I will contact you to let you know the registry is open and inviting you and the other members of HerpesCure Research to register. Being on the registry will not guarantee an individual’s selection as a participant included in a trial. The third-party company that will conduct the trial will have your information, along with the contact info for all the other registrants, and it will make the decision as to who will be chosen as a participant. Please know our company is mission driven. Our goal is the same as yours – obtaining approval to bring to market a safe and effective treatment for herpes.
Link to pipeline:
(8) GEN-003 - Genocea/ Shionogi
(9) Excell BioTech - EXD-12
As you know 2020 was a very challenging year for everyone. Due to the unforeseen circumstances of 2020 we experienced delays in our preclinical and clinical testing outlook. We have now been able to pivot in another direction and get things back on track. We have worked tirelessly in 2020 to upgrade our laboratory infrastructure. HSV is our top priority moving forward and we are very excited about the internal data that we have compiled over this last year. We believe through our trials and tribulations of 2020 we have come out the other side a much better and stronger organization in the fight against HSV. 2021 is going to be an exciting year for Excell Biotech! We currently have three different versions of our EXD-12 that we are going to move forward in preclinical testing. We will be putting the best candidate forward in the end to ensure we have the safest and most efficacious therapeutic vaccine ever created. We are going put our best foot forward and make sure we can help the millions of people suffering in silence from this terrible disease. Please hang in there with us as exciting things are on the way!
(10) SADBE (SQX770) - Squarex
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has conducted FDA-approved clinical trials over the past few years that illustrated the efficacy of SADBE as an immunotherapy for HSV. So far, the company has conducted a , , and clinical trial with FDA oversight.
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In their Phase I clinical trial, 54 patients with 6 or more annual outbreaks were enrolled in the study. After just one dose of 2% SADBE, the median time to the next outbreak in the dosed group was 122 days compared to 40 days in the placebo group. Moreover, 16 of the 28 participants dosed with 2% SADBE were still outbreak free on Day 300. Lastly, 60% of 2% SADBE-dosed participants were outbreak-free on Day 122 compared to 20% in the placebo group.
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In their Phase II clinical trial, 140 patients with 4 or more annual outbreaks (with an average of ~8 annual outbreaks) were enrolled in the study. The results showed that the median time to the next outbreak was 121 days, and was statistically significant to a large degree compared to the placebo group. Moreover, approximately 80% of 2% SADBE-dosed participants were outbreak-free on Day 122 compared to less than 60% in the placebo group.
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If SquareX completes Phase III trials and gets FDA sign-off, then the company can create the product themselves and market it as an immunotherapy for HSV. This would mean that any customer who would like to try SADBE as an immunotherapy for HSV would have to purchase the product from SquareX. The company does have plans to conduct Phase III clinical trials, and through email exchange, have indicated they hope to begin them in the next 12-18 months. Phase III trials will enroll a much larger cohort of patients and evaluate the immunotherapy's efficacy and safety on a much larger population.
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It can be accessed via compounding pharmacies and shows promise in symptom reduction against HSV-2 - however please be aware it is not yet officially FDA approved for HSV and to be used at own risk until approved.
(11) UB-621 /
· United Biopharma have developed a anti HSV antibody where treatment is likely to see a middle ground between antivirals and vaccine.
· As an injection with a life of 25 days could be used for both type 1 and type 2.
· Phase II trial is expected to start Jun 2022 and finish June 2023.
· Clinical trial information here:
(12) HDIT101 / Heidelberg ImmunoTherapeutics
· HDIT101 is currently being compared in a phase II trial against Valaciclovir – the idea is that a single dose of HDIT101 could be more effective in symptom reduction for HSV-2.
· Phase II trial was expected to complete September 2021 but remains active and progressing currently.
· Trial information here:
(13) Pritelivir - AiCuris / Innovative Molecules - IM-250
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Whilst not a cure, Pritelivir could be a fantastic improvement on daily anti-virals such as Valtrex/Acyclovir.
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With Phase 2 having shown good results, AiCuris have now progressed into a Phase 3 trial ending in Mar-24.
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Based on abstract modelling, it has shown to potentially reduce viral shedding by 96%:
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Whilst currently being tested on acyclovir resistant participants, it has been granted breakthrough therapy and fast track designation which FDA grants to expedite the drug review process. This could likely result in a new drug approval earlier than scheduled Phase 3 completion.
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It would need to be taken regularly but has potential to serve as an excellent interim in significantly reducing risk of transmission until wider research offers a functional/sterilizing cure.
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Latest Phase 3 trial info here:
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As a separate initiative, a team of researchers at Innovative Molecules GmbH, working with several other institutions in Germany, has developed a small-molecule therapy for the treatment of latent herpes simplex virus infections. The tweaking by the team involved changing out a sulfonamide for a sulfoximine to remove undesired off-target effects. They also changed one of the aromatic groups to make the molecule even smaller, allowing it to enter the central nervous system. The team has named the new therapy IM-250.
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IM has raised $20 million euros for Series A funding and will be using this to push forward from pre-clinical stage to Phase II trials.
(14) NE HSV-2 - BlueWillow
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BlueWillow are working on a intranasal vaccine for HSV-2 which has shown to have success in prevention within guinea pigs.
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In a therapeutic guinea pig model, the same intranasal NE vaccine formulation reduced genital herpes lesion recurrence and viral shedding by more than 50% also.
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This suggests their approach offers an intranasal vaccine that is prophylactic (this will be the goal of clinical trials) but potentially yield therapeutic benefit too.
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Latest response from BW's MD on 24/02/21 (thanks for this) confirms they are planning to enter clinical trials in 2022/23:
We received funding from the NIH last year to advance our program through the remaining preclinical work. We are hopeful we will launch our first prophylactic clinical trial in 2022-23. Please continue to visit our website (which will be improved and updated soon) for updates.
Thanks and best, Chad Costley, MD
(15) GSK4108771A (HSV-2) - GlaxoSmithKline
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GSK have recently cancelled a Phase I trial however this has been in order to enable development of an enhanced version of the vaccine.
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However it's possible that they will return to clinical trials once happy with the efficacy but we'll need to wait and see for further information.
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Latest clinical trial information posted from GSK can be found here:
(16) SL Vaxigen - DNA Plasmid vaccine HSV-2 Therapeutic
Thanks to one of our Korean members forwarded info about an interesting DNA Plasmid vaccine being developed by Korean company SL Vaxigen (a vaccine development subsidiary of the company Genexine). It is understood to be a therapeutic HSV-2 vaccine.
Korean FDA as confirmed that recruiting for phase 1 of this trial has been completed at a specific location in Korea.
You can see in the "Pipeline" section of the company website this vaccine for "genital herpes" appears.
One Korean HCR member is going to try to follow this up and we will post any updates.
This is encouraging because Korea has very advanced biotech capabilities. If you followed the news, Korea was able to first mass produce coronavirus tests, which were mass distributed internationally, among other accomplishments. We'll keep this updated as progress is seen.
As we can see, a HUGE amount of great research activities and results to come through shortly - please do keep raising awareness of both this group and progress above!
We WILL win together.
