X-Vax Technology Raises $56 Million in Upsized Series A Financing to Advance Lead Herpes Vaccine Program

[Whymewhyus?]

https://mailchi.mp/0e356a563af0/x-vax-raises-56-million-in-series-a-financing?e=c1735e56fb

[RNY18]

X-Vax Technology Raises $56 Million in Upsized Series A Financing to Advance Lead Herpes Vaccine Program

A new approach to beating herpes by inducing antibodies that mediate the killing of infected cells Participants include Johnson & Johnson Innovation – JJDC, Inc. (JJDC); Adjuvant Capital, an impact investment fund supported by the Bill & Melinda Gates Foundation as an anchor investor; Serum Institute of India; Alexandria Venture Investments; Founders Fund.

JUPITER, FL, July 23, 2019. X-Vax Technology, Inc. (X-VAX), a biotechnology company developing vaccines based on a new approach that mediates the killing of infected cells, today announced that it has raised $56 million in an upsized Series A financing with participation from strategic and institutional investors, including Johnson & Johnson Innovation – JJDC, Inc. (JJDC); Adjuvant Capital, an impact investment fund supported by the Bill & Melinda Gates Foundation as an anchor investor; Serum Institute of India; Alexandria Venture Investments; and FF DSF VI, a scout investment vehicle out of Founders Fund. Proceeds from the financing will be used to advance X-VAX’s lead program, a vaccine candidate against herpes, called ∆gD-2 (delta gD-2) for further development and production, including a Phase 1 clinical study.   “We are pleased to have the support of our new and existing investors as we continue to build our leadership position in the development of a herpes vaccine,” said Ulf Wiinberg, President and Chief Executive Officer of X-VAX. “We are encouraged by the preclinical data for our new approach to beating herpes and creating a potentially world-changing vaccine.”    “Herpes infections are a significant global health problem that affect all age groups from infants to the elderly. Infection is associated with a wide range of disease,” said Betsy Herold, MD, co-Inventor and Professor of Pediatrics, Microbiology & Immunology at Albert Einstein College of Medicine in New York. “The ability of the virus to successfully escape clearance by the immune system and to establish a non-replicating state known as latency with periodic reactivation results in lifelong infection and ongoing risk of transmission.”    “We believe that ∆gD-2 may be more promising than other previous vaccine candidates because it elicits a different type of immune response against HSV-1 and HSV-2 that is more effective in preclinical models at clearing virus and preventing the establishment of latency. In nonclinical models, immunization with ∆gD-2 elicits antibodies that facilitate the killing of infected cells, rapidly clearing the virus and thereby inducing sterilizing immunity,” added William Jacobs, PhD, co-Inventor and Professor of Microbiology & Immunology at Albert Einstein College of Medicine.   Maxim Merchant Capital, a division of Maxim Group LLC, acted as sole placement agent for the financing.   About herpes, a global epidemic There is no approved vaccine for herpes simplex. Herpes simplex virus is categorized into 2 types: herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2). More than 3.7 billion people under the age of 50 around the world are infected with HSV-1, while over 400 million have HSV-2. Neonatal infection can be devastating, at 60% fatality without treatment. Other complications include encephalitis or meningitis (inflammation of the brain or the tissue that covers the brain and spinal cord), and infectious blindness. HSV-2 is also known to contribute significantly to the spread of HIV. Antiviral drug therapy shows only moderate efficacy and comes with significant side effects. Attempts to develop an effective vaccine have repeatedly failed.   About X-Vax Technology, Inc. We are a biotech company committed to developing vaccines against pathogens acquired by mucosal infection such as herpes. Our research leads us to believe that the new approach we are taking could succeed in defeating herpes. We have created a herpes vaccine candidate that we call ∆gD-2 (delta gD-2) because it is based on an HSV-2 virus genetically deleted for glycoprotein D (gD-2). With it, we have been able to prevent infections caused by herpes type 1 (HSV-1) and type 2 (HSV-2) in multiple preclinical models—with encouraging results. The vaccine induces Fc receptor activating antibodies that mediate antibody-dependent cell-mediated killing (ADCK) as the primary mechanism of protection. ADCK is induced to flag infected cells for destruction by natural immune cells.   Forward-looking statements This news release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, we are using forward-looking statements when we discuss the proposed use of proceeds from the Series A financing, when we describe our belief that our new approach to beating herpes could succeed in potentially creating a world-changing vaccine, when we discuss the belief that our vaccine candidate is more promising than other previous vaccine candidates and when we state our belief that our new approach could succeed in defeating herpes. These forward-looking statements and their implications are based on the current expectations of the management of X-VAX only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation may adversely impact us inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of X-VAX to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.    Contact Andreas Eggert aeggert@x-vax.com +1-561-517-XVAX (+1-561-517-9829)   x-vax.com

Edited July 23, 2019 by RNY18

[RNY18]

Got this this morning, definitely positive news.

Still seems so far off....

[RNY18]

More X-Vax Info :

https://markets.businessinsider.com/news/stocks/x-vax-technology-raises-56-million-in-upsized-series-a-financing-to-advance-lead-herpes-vaccine-program-1028376554

"We believe that ∆gD-2 may be more promising than other previous vaccine candidates because it elicits a different type of immune response against HSV-1 and HSV-2 that is more effective in preclinical models at clearing virus and preventing the establishment of latency. In nonclinical models, immunization with ∆gD-2 elicits antibodies that facilitate the killing of infected cells, rapidly clearing the virus and thereby inducing sterilizing immunity," added William Jacobs, PhD, co-Inventor and Professor of Microbiology & Immunology at Albert Einstein College of Medicine..."

[Cas9]

1 hour ago, RNY18 said:

Got this this morning, definitely positive news.

Still seems so far off....

Their pipeline indicates that pre-clinical work is essentially complete. The next steps are Toxicology study and IND. I emailed them to see if I could get some details on the length of those processes and about when they might be going into clinical trials.

Edited July 23, 2019 by Cas9

[LightafterDarkness]

This is pretty impressive for a number of reasons:

• Average funding for a series A in biotech is around ~$50M but the median is around ~$30M as of 2018
  • The takeaway then is the XVax is at the higher end of the spectrum suggesting (1) High investor interest, (2) XVax is thinking big
• A robust set of investors- good to see that there are multiple names here rather than 1-2. Again, suggests robust interest from investors
  • Note that the anchor investor (i.e., the biggest) is Adjuvent who are backed by Bill and Melinda Gates Foundation, good to see that HSV continues to be of interest to them (my theory: due to the link with HIV and Alzheimer now)

 

Overall everyone should be cheering this news given the impressive results seen with animal models. Still remember this is going to be a multi year process- I would hope to see a phase I in 2020

[JHenry]

This is wonderful news!  Impressive dollars raised and the team is absolutely outstanding.  For those who have been dreaming of the Bill and Melinda Gates Foundation on our side, consider your prayers answered.  William Jacobs and Betsy Herold from Einstein have “sounded” extremely confident all along.  While maybe not just “around the corner” this is amazingly exciting!   If there was ever a person that possibly could be a force in “fast tracking” could it be Mr. Bill Gates? 

While it may seem “so far off”, for those of us having been infected for 20+ years or more, it is still music to our ears, and the  glass is always half full-without hope you have nothing.  

Never forget this line from Shawshank Redemption:                                           “Hope is a good thing, maybe the best of things, and no good thing ever dies”. 

[JHenry]

1 hour ago, Cas9 said:

Their pipeline indicates that pre-clinical work is essentially complete. The next steps are Toxicology study and IND. I emailed them to see if I could get some details on the length of those processes and about when they might be going into clinical trials.

 

Cas, This is sooooooo exciting I may need a diaper!  How bout you?  😊

[The]

Great update. Money makes everything easier. Hopefully some advanced drugs will come out in the meantime while we wait around for this though as this vaccine is prophylactic (still awesome nonetheless).

I wish all HSV projects got this type of support. They must really have faith in this one.

[Cas9]

20 minutes ago, JHenry said:

 

Cas, This is sooooooo exciting I may need a diaper!  How bout you?  😊

By the time the vaccine becomes commercially available (if it does), we probably WILL, need diapers

It is good news but remember that clinical trials could take 2 - 3 years per phase, so we're talking 6 - 9 years for those trials.

Nevertheless, it's good to see this prophylactic vaccine making progress through the process. I've always been excited about their novel approach and the results they achieved, albeit in mice only. The vaccine may also elicit a therapeutic effect. Not sure what test results they've obtained on that front.

I wish we were 20 years younger

[JHenry]

38 minutes ago, Cas9 said:

By the time the vaccine becomes commercially available (if it does), we probably WILL, need diapers

It is good news but remember that clinical trials could take 2 - 3 years per phase, so we're talking 6 - 9 years for those trials.

Nevertheless, it's good to see this prophylactic vaccine making progress through the process. I've always been excited about their novel approach and the results they achieved, albeit in mice only. The vaccine may also elicit a therapeutic effect. Not sure what test results they've obtained on that front.

I wish we were 20 years younger

Yep-I wish so as well,  either way—-diaper or no diaper, the progress is exciting!

[JHenry]

51 minutes ago, The said:

Great update. Money makes everything easier. Hopefully some advanced drugs will come out in the meantime while we wait around for this though as this vaccine is prophylactic (still awesome nonetheless).

I wish all HSV projects got this type of support. They must really have faith in this one.

You read my mind!  Something to hold us through from now until then!  

[LightafterDarkness]

A couple of notes showing up from the VC investors on Twitter:

 

 

[LightafterDarkness]

"It took months of painstaking research and diligence, but the Adjuvant team ultimately concluded that Dr. Herold might be on to something with the ∆gD-2 vaccine candidate that she and Dr. William Jacobs invented at Albert Einstein College of Medicine in the Bronx, just a few miles away from our NYC headquarters."

https://adjuvantcapital.com/news/x-vax-technology/

 

^ good read describing why Adjuvant made the decision to invest. Pretty exciting stuff!

[Cas9]

21 hours ago, Cas9 said:

Their pipeline indicates that pre-clinical work is essentially complete. The next steps are Toxicology study and IND. I emailed them to see if I could get some details on the length of those processes and about when they might be going into clinical trials.

Here's the response to my email:

Thank you for your email and your questions.

In our preclinical studies we have used various mouse strains and guinea pigs. These are considered to be the best approaches to preclinical testing; monkeys are generally not used as they do not have symptomatic infection with human strains of HSV. 

We are still at an early stage and have just begun to transfer the vaccine ∆gD-2 from the research lab to manufacturing facilities for further development and production, and to prepare for a Phase 1 clinical study. The Phase 1 trial for ∆gD-2 is to establish safety, dose, and immunologic proof of concept; the primary endpoint will be safety. Total development timelines depend on several factors, including the target indication and population for the vaccine as well as factors that are outside of the company’s control. Therefore, we cannot predict the time until approval yet.

The GLP toxicology study will be conducted in guinea pigs, which is a standard model accepted by regulatory agencies for herpes simplex. Safety and the lack of vaccine shedding/replication/latency will also be studied in immunodeficient mice.  These studies will be completed before IND filing.

Hope this helps.

Best regards,
Andreas

[Kurdt01]

So is this therapeutic and prophylactic? I read this entire thread and didn’t see anything about that I’m sure I just missed it

[The]

4 hours ago, Kurdt01 said:

So is this therapeutic and prophylactic? I read this entire thread and didn’t see anything about that I’m sure I just missed it

Its primarily a prophylactic by design.

Possibly could end up having some theraputic effect to some degree but they dunno yet.

[JHenry]

6 hours ago, The said:

Its primarily a prophylactic by design.

Possibly could end up having some theraputic effect to some degree but they dunno yet.

“X-Vax Technology is developing a novel vaccine for BOTH the prophylaxis and treatment of herpes simplex virus Type 1 and Type 2 in adults and children. The vaccine candidate was developed in a research laboratory at the Albert Einstein College of Medicine and has been used to characterize the immune response in animals which differs from that of former herpes simplex vaccine candidates. The vaccine confers “sterilizing immunity” with rapid viral clearance and protection from latency in a range of animal models following challenge with a wide range of virulent clinical isolates.”

[Cas9]

30 minutes ago, JHenry said:

“X-Vax Technology is developing a novel vaccine for BOTH the prophylaxis and treatment of herpes simplex virus Type 1 and Type 2 in adults and children. The vaccine candidate was developed in a research laboratory at the Albert Einstein College of Medicine and has been used to characterize the immune response in animals which differs from that of former herpes simplex vaccine candidates. The vaccine confers “sterilizing immunity” with rapid viral clearance and protection from latency in a range of animal models following challenge with a wide range of virulent clinical isolates.”

It's initial focus was prophylactic; i.e. Healthy mice were injected with the vaccine and then challenged with several times the lethal dose of hsv. The ADCC immune response generated by the vaccine, completely cleared the virus. No virus was found anywhere, including the neurons.

Obviously, this immune response also has the possibility of being therapeutic. Testing it as a therapeutic will determine it's effectiveness in that regard.

So looking at the vaccine today, we can say that it is being evaluated as both a prophylactic and a therapeutic.

Edited July 25, 2019 by Cas9

[JHenry]

9 hours ago, Cas9 said:

It's initial focus was prophylactic; i.e. Healthy mice were injected with the vaccine and then challenged with several times the lethal dose of hsv. The ADCC immune response generated by the vaccine, completely cleared the virus. No virus was found anywhere, including the neurons.

Obviously, this immune response also has the possibility of being therapeutic. Testing it as a therapeutic will determine it's effectiveness in that regard.

So looking at the vaccine today, we can say that it is being evaluated as both a prophylactic and a therapeutic.

Cas, I am “non-scientific”, but  having said that, does the efficacy as a prophylactic in mice bode well for the possibility of being therapeutic as well?  Don’t break my heart this early in the day, please say YES!  Henry 😉

 

[Cas9]

16 minutes ago, JHenry said:

Cas, I am “non-scientific”, but  having said that, does the efficacy as a prophylactic in mice bode well for the possibility of being therapeutic as well?  Don’t break my heart this early in the day, please say YES!  Henry 😉

 

None of us are scientists. We just read articles and we also learn from each other. For example, I used to think Cas9 itself was packaged in an AAV and transported to the neuron. A more scientific individual on this forum corrected me on that; it's the genes for Cas9 that are packaged in the AAV. Cas9 then gets created in the neuron.

In my opinion, I would think it bodes well  because of the type of immune response. But again, just my opinion. That said it wouldn't be curative. It's effectiveness would be once the replicated virus emerges from the neuron.

[JHenry]

1 hour ago, Cas9 said:

None of us are scientists. We just read articles and we also learn from each other. For example, I used to think Cas9 itself was packaged in an AAV and transported to the neuron. A more scientific individual on this forum corrected me on that; it's the genes for Cas9 that are packaged in the AAV. Cas9 then gets created in the neuron.

In my opinion, I would think it bodes well  because of the type of immune response. But again, just my opinion. That said it wouldn't be curative. It's effectiveness would be once the replicated virus emerges from the neuron.

Possibly a “functional cure”?

[LightafterDarkness]

Per my understanding this could help as a functional cure in that (1) the virus is contained and (2) shedding rates are down to zero (perhaps though you would need to combine this with another treatment option- we just dont know yet). In that case then HSV1/2 become something like Chickenpox-> latent, still in your body, but contained

A full "not in my body anymore" cure can only come from either (A) sending something in to cut out HSV in the ganglia (so Dr. Jerome's work) or (B) some treatment that flushes all the virus out so none of it is latent allowing your body to attack and destroy the viruses.

[Cas9]

7 minutes ago, LightafterDarkness said:

Per my understanding this could help as a functional cure in that (1) the virus is contained and (2) shedding rates are down to zero (perhaps though you would need to combine this with another treatment option- we just dont know yet). In that case then HSV1/2 become something like Chickenpox-> latent, still in your body, but contained

A full "not in my body anymore" cure can only come from either (A) sending something in to cut out HSV in the ganglia (so Dr. Jerome's work) or (B) some treatment that flushes all the virus out so none of it is latent allowing your body to attack and destroy the viruses.

If the immune response generated by the vaccine can stop the virus before it infects the skin cells then yes, I would think that would be considered a functional cure. What I meant in my earlier comment was that the antibodies cannot enter a neuron, therefore they cannot clear the latent virus (i.e. a sterilization cure).

Remember, if it works as a preventative only, that's huge; a potential partner would be protected.

[Voyager2]

I'm excited about this, too.

One little concern. While a phase 1 trial is for safety, the phase 2 and 3 trials will prove efficacy.  Testing a prophylactic vaccine would require vaccinating many people, then waiting to see how many are protected. That could take awhile. Let's hope it can somehow be speeded up.