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VBI's Preventative CMV Shows Encouraging Response



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In July, VBI Vaccines (NASDAQ: VBIV) announced very encouraging interim data from a Phase 1 study of its preventative cytomegalovirus (CMV) vaccine. CMV is a member of the herpes virus family that infects up to 80% of the population according to the NIH. For healthy individuals, CMV infection often goes unnoticed; however, for pregnant women and those with a weakened immune system, CMV infection is a cause for concern.

The Silent Burden

CMV is a leading cause of congenital infections and can cause serious disease in newborns when a woman is infected during pregnancy. Complications include deafness, blindness, birthmarks, and developmental delays. Each year, approximately 30,000 infants are born with CMV infection. More than 5,000 will develop permanent problems resulting in a direct economic cost exceeding $3.0 billion annually. Yet, the disease is still relatively unknown. It's been called the "Silent Burden" despite the fact that the incidence rate exceeds that of fetal alcohol syndrome, Down syndrome, and spina bifida.

VBI Vaccines aims to tackle this problem with VBI-1501A, a preventative congenital CMV vaccine designed to provide protection from CMV infection to newborns babies through vaccinating adolescent girls and expecting mothers. The strategy is analogous to what Merck pioneered with Gardasil®, a vaccine to prevent human papillomavirus (HPV) infection in women that has been implicated in the development of cervical cancer.

VBI-1501A is the first vaccine candidate to progress into clinical studies from the company's proprietary enveloped virus-like particle (eVLP) technology platform. VBI's eVLP technology is a platform to develop a class of synthetic vaccines designed to closely mimic the structure of viruses but without the viral genome, thus offering the potential for more efficacious and safer vaccines. Vaccine candidates developed through the eVLP program offer high immunogenicity, controllable antigen expression, and no risk of reversion to an infectious state. This is in contrast to live-attenuated viruses.

Encouraging Phase 1 Results

A total of 128 CMV-negative healthy adults enrolled in the Phase 1 study last year. Data from July show VBI-1501A is safe and well tolerated at all doses tested, which include 0.5μg, 1.0μg, and 2.0ug levels of antigen. The vaccine induced antibody responses against the CMV glycoprotein B (gB) antigen with clear evidence of dose-dependent boosting after two vaccinations.

Immunization with the highest dose of the vaccine induced seroconversion (i.e. protection) in 100% of subjects after just two doses. Neutralizing antibodies against epithelial cell infection were demonstrated in 17% of subjects who received the highest dose (2.0μg of gB-G content with alum) of VBI-1501A. Importantly, the highest dose still contains 10-fold less antigen content than that used in several competing CMV vaccines. The Phase 1 study continues on plan. Final data read-out is expected during the first half of 2018. Nevertheless, results after the first two doses are highly encouraging, demonstrating a dose-dependent, vaccine-induced, response (see below).

CMV Market Opportunity

For immunocompromised patients, an illness resembling mononucleosis is the most common presentation of CMV, which can include fever, pneumonia, diarrhea, and hepatitis. Pregnant women who become infected with CMV are at low risk of passing the virus to their babies; however, if it is a primary infection, the risk is much higher. Babies that are infected in the womb (congenital CMV) typically appear healthy at birth with some developing serious complications as they get older. The most common complication is hearing loss; however, a few may develop vision impairment or mental retardation.

Babies born with congenital CMV who show signs at birth tend to be very sick and can have jaundice, low birth weight, an enlarged spleen, and seizures. As the following chart shows, the number of children born in the U.S. with congenital CMV that develop long-term medical conditions is greater than the number born with fetal alcohol syndrome or Down syndrome.

There are currently no approved CMV vaccines. Companies including Merck and Pfizer are working on competing agents; Glaxo was working on a competing agent but seems to have stalled. The market opportunity is tremendous given the target market of adolescent girls and pregnant women. There are 20+ million teenage girls currently living in the U.S. and some 6+ million pregnancies each year. HPV vaccination programs have been able to successfully capture 60% of this target market. Even if CMV vaccination penetration rates are half this level, peak sales for VBI-1501A assuming similar pricing to Gardasil® (~$150) is $900 million for preventative and $270 million for the "at risk" population.

Oncology Upside

VBI is also working to expand the target market into oncology. Specifically, CMV infection is known to promote genomic instability (Fortunato et al., 2000), cell migration (Vomaske et al., 2010), and immune evasion (Powers et al., 2008), all factors that could contribute to a pro-oncogenic environment. In 2002, a published a report showing that 27 Glioblastoma multiforme (GBM) samples out of 27 examined had evidence for CMV expression, both in terms of viral proteins and DNA (Cobbs et al., 2002). Evidence of CMV was not found in healthy brain tissue or samples from patients with other brain diseases. These results were confirmed through additional studies from around the world that reported CMV protein and gene expression in GBM samples (Ranganathan et al., 2012).

GBM is an aggressive and lethal brain cancer with reported median overall survival of only 12-15 months. Standard of care treatment currently includes surgery, radiation, and temozolomide (TMZ) chemotherapy. There have been few successes seen in the development of new treatments; thus, a potential preventative or therapeutic vaccine might spark significant interest from the oncologist community.

What This Means

VBI-1501A is an important value-driver for VBI Vaccines. The lead candidate is Sci-B-Vax®, a third generation Hepatitis B vaccine nearing the start of a Phase 3 trial that pits the drug head-to-head versus Glaxo's Energix-B®. There is a strong rationale for when Sci-B-Vax will prove superior to Glaxo's drug, a major catalyst that will likely drive VBI's stock significantly higher in 2018.

In the meantime, these interim results from VBI-1501A prove that VBI is no one-trick pony. VBI-1501A targets a significant unmet medical need and has blockbuster potential should the data continue to look as solid as the recent interim Phase 1 results. Additional data from this program is expected during the first half of 2018.

This article was written by Luke Douglas for on .

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