Jeff Baxter, VBI Vaccines CEO (ChromaDex)

VBI Vac­cines ex­ecs tout ap­proval of new triple-anti­gen he­pati­tis B shot. Can they sell it?

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.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Saurabh Saha, Centessa CEO (BIO19)

One of 2021's star biotech play­ers flags an­oth­er big set­back for the pipeline

Two months after scuttling their lead drug, Centessa’s executive team is back with the latest in a series of setbacks that have tanked its stock and blown holes in its strategic lineup of biotech subs.

The company reported in its Q2 post today that it has decided to scrap ZF874 after a patient demonstrated elevated liver enzymes — a classic red safety flag — in a Phase I study for alpha-1-antitrypsin (A1AT).

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.