Jeff Baxter, VBI Vaccines CEO (ChromaDex)
VBI Vaccines celebrated a new approval Wednesday morning, announcing the FDA has greenlighted its hepatitis B vaccine for adults. But questions remain on how well the new shot will sell.
The biotech intends to hit the market in the first quarter of next year, joining three other adult hepatitis B vaccines from Merck, Dynavax and GlaxoSmithKline. CEO Jeff Baxter said in an analyst call Wednesday the price of VBI’s shot, branded as PreHevbrio, won’t be revealed until commercialization, but claimed it would be ‘highly competitive.’
In response to the news, VBI shares $VBIV traded about 15% higher in Wednesday’s pre-market session. The price remains well within penny stock territory, hitting about $3.45 per share.
Merck and Dynavax are the big names in this market, and Baxter faced questions from investors on Wednesday’s call about how VBI intends to differentiate itself from those two shots. Baxter touted VBI’s vaccine as the first to contain three different antigens against the hepatitis B virus and said that the ’90 percent-plus’ protection after two doses gives VBI a potential advantage.
One key remaining piece is a full sign-off from the CDC’s ACIP, which voted last month to broadly recommend universal hepatitis B vaccines to all adults aged 19-59. Baxter noted the endorsement for VBI’s shot would need to happen before launch, but demurred when asked if he wanted to see additional updates to the vaccine recommendations.
‘At this stage I don’t think it goes beyond that but just given that recommendation obviously … it is a very important first step, and creates a level playing field for PreHevbrio,’ Baxter said on the call.
He added that the full go-ahead will help VBI get its shot covered by both public and private and insurers, giving it another avenue to cut into the Merck and Dynavax pie. But the biotech will also need to engage in awareness campaigns with physicians as well, for which Baxter said VBI is prepared.
Approval of the new vaccine came due to two Phase III studies, published in scientific journals in May and October of this year. VBI compared its vaccine to GSK’s shot, which only includes one of the hepatitis B antigens. The first study showed higher seroprotection in all adults, at 91.4% to 76.5%, as well as adults over 45 — 89.4% to 73.1%.
The second study, meanwhile, aimed to show that VBI’s seroprotection remained consistent across three different vaccine lots. After two doses, PreHevbrio managed a 90.4% seroprotection rate compared to 51.6% for the control. The rates increased for both vaccines after third doses, hitting 99.3% and 94.8%, respectively.
Outside the US, the EMA is continuing its review of the shot, while VBI is planning to file regulatory submissions to the UK and Canada early next year.
While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.
Stéphane Bancel, Moderna CEO
Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.
Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?
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Michael Handley, Statera Biopharma CEO
Last summer, when Cytocom merged with Cleveland BioLabs to grab a spot on Nasdaq, it also inherited an intriguing rare disease program that was under clinical hold. With a new name and brand, the company says it’s ready to bring that program back to the forefront.
The FDA has lifted its clinical hold on entolimod, a toll-like receptor 5 (TLR5) agonist being developed for patients exposed to lethal amounts of radiation, the company — now called Statera Biopharma — announced on Wednesday.
Lan Huang, BeyondSpring CEO
BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?
The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.
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Reshma Kewalramani, Vertex CEO (Vertex via YouTube)
Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.
The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.
The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.
For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.
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Philip Dormitzer, new GSK global head of vaccines R&D
GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.
Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.
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With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.
Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.
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