Dutch biotech company, Mucosis, announced on Wednesday that it secured a $4 million fund awarded from the Wellcome Trust foundation. This will go toward clinical trials – a phase I dose-finding and safety study, followed by a novel phase II challenge study to assess the efficacy for its respiratory syncytial virus (RSV) intranasal vaccine called SynGEM.
Currently there is no available vaccine for RSV, but according to the World Health Organization, there are 64 million cases of RSV globally each year and 160,000 deaths.
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Mucosis isn’t the only one looking to develop a RSV vaccine, but they do have an innovative approach. CEO Tom Johnston shared in an interview about the company’s current progress and how their vaccine differs from other potential options.
How does SynGEM work and what makes it different from what others are doing?
We have a platform technology that we have already successfully applied to influenza, and we are now applying it to RSV. RSV is a large unmet need around the world, and a lot of companies are looking to develop vaccines.
What makes ours unique is two things:
First, the antigen design we’ve created is believed to be a more potent form, thereby creating more potent antibodies in the system to prevent reinfection. You can be infected every year even if strains change, and they believe it’s because the virus has a way of hiding. Our antigen selection is different from others, it’s been patented.
Secondly, we are providing the vaccine through different routes of administration. We are pursuing the intranasal route. It sounds simple, but that’s the how the virus comes into your body. Your body has two lines defense – it has the mucosal line and the systemic line, which is through your blood. Most vaccines approach the systemic line with injections. We believe approaching the mucosal line of defense adds an additional layer of protection to reduce infection and severity.
We are working on the intranasal first and then will look to develop an injectable as well, which is targeted more toward pregnant women.
Will SynGem essentially be like a normal nasal spray, but with a physician or clinician administering it?
Yes, it will be exactly like that. It’s a simple spray into the nostril. A physician, a physician’s assistant or a pharmacist would administer it, much like many of the vaccines that require someone who is authorized to administer it.
It would be very simple to administer for someone on their own, but availability for that kind of product would really depend on the comfort of regulators.
Would the intranasal vaccine be sufficient on its on, or would it be supplementary to an injectable vaccine?
We believe that the intranasal will be sufficient for most of the population. An intramuscular injection is better for pregnant mothers. In that case, she’s passing over the antibodies into the placenta to the child in gestation. You want the child to be born with some form of protection while its airways are developing. That will be our next product. But the first product, and the one that the Wellcome Trust foundation has provided the funds for, are to proceed with the clinical trial for the intranasal product that will start in July of this year.
When do you see this being available for use commercially?
It will take some time to develop, so the earliest that it would be available on the market would be sometime in 2019 or 2020 – that all depends on regulations.
The company plans to continue raising additional funds or potentially partnering with a pharmaceutical company, although as Johnston shared, they have had a relatively smooth ride with investments thus far that should allow them to continue moving forward and then they will get more involved with the injectable product.
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