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.
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 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.