In­vestors fret as VBI's hep B vac­cine fails key sec­ondary PhI­II study goal

Sobered by mount­ing costs, Dy­navax $DVAX last month made the de­ci­sion to fo­cus all its re­sources on its 2017-ap­proved he­pati­tis B vac­cine Hep­lisav-B, which ri­vals and su­per­sedes the ef­fi­ca­cy and con­ve­nience pro­file of GSK’s $GSK es­tab­lished En­ger­ix-B. The Cal­i­for­nia-based com­pa­ny will be on the look­out for an­oth­er com­peti­tor — VBI Vac­cines, which on Mon­day un­veiled late-stage da­ta on its hep B vac­cine: Sci-B-Vac.

Sci-B-Vac, which has al­ready se­cured ap­proval in Is­rael and 10 oth­er coun­tries, is in Phase III de­vel­op­ment in North Amer­i­ca and Eu­rope. It is en­gi­neered to mim­ic all three sur­face anti­gens of the hep B virus to in­duce a po­tent im­mune re­sponse and is be­ing de­vel­oped to work at low­er dos­es than ex­ist­ing hep B vac­cines.

VBI on Mon­day broke out da­ta from the PRO­TECT study, in which 1,607 sub­jects aged 18 years and old­er were ei­ther giv­en a three-dose course of Sci-B-Vac (10 µg) or a three-dose course of En­ger­ix-B (20 µg).

Sci-B-Vac failed to show that two dos­es of the drug were equal­ly ef­fec­tive as three dos­es of En­ger­ix-B in the study — a key sec­ondary end­point. In­vestors were not im­pressed, and the Cam­bridge, Mass­a­chu­setts-based com­pa­ny’s shares $VBIV cratered 58% tak­ing VBI in­to pen­ny stock ter­ri­to­ry at 81 cents be­fore the open­ing bell on Mon­day.

Mean­while, the VBI vac­cine was found to be as pro­tec­tive as En­ger­ix-B at the end of the third vac­ci­na­tion — meet­ing the main goal of the study. In fact, da­ta showed that the rate of sero­pro­tec­tion (an an­ti­body re­sponse ca­pa­ble of pre­vent­ing in­fec­tion) — was 91.4% for Sci-B-Vac-treat­ed sub­jects, ver­sus 76.5% for En­ger­ix-B — a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence.

In ad­di­tion, the sero­pro­tec­tion rate (SPR) in sub­jects aged 45 and over was 89.4% for Sci-B-Vac, ver­sus 73.1% for En­ger­ix-B af­ter the third vac­ci­na­tion — meet­ing the co-pri­ma­ry end­point. It al­so cleared oth­er sec­ondary goals in sub-analy­ses strat­i­fied by age, gen­der, body mass in­dex, di­a­bet­ic sta­tus and smok­ing sta­tus.

Jeff Bax­ter VBI

Da­ta from an­oth­er late-stage tri­al, CON­STANT, com­par­ing Sci-B-Vac and En­ger­ix-B is ex­pect­ed by the end of 2019. Pend­ing the suc­cess­ful com­ple­tion of CON­STANT, VBI is on to sub­mit mar­ket­ing ap­pli­ca­tions in the U.S., Eu­rope, and Cana­da next year, com­pa­ny chief Jeff Bax­ter said on Mon­day.

Hep B is trans­mit­ted through con­tact with blood and bod­i­ly flu­ids of an in­fect­ed per­son and is a high­ly in­fec­tious virus, 50 to 100 times more in­fec­tious than HIV — even slight laps­es in in­fec­tion con­trol can re­sult in pa­tient-to-pa­tient trans­mis­sion. Since the ear­ly 1990’s the Unit­ed States has im­ple­ment­ed vac­ci­na­tion pro­grams in new­born chil­dren, but those born be­fore re­main sus­cep­ti­ble. CDC da­ta now sug­gests 95% per­cent of new hep B in­fec­tions in the Unit­ed States oc­cur in adults, as there is no stan­dard­ized sys­tem for vac­ci­nat­ing peo­ple af­ter school age, and par­tic­u­lar­ly since spikes in in­jec­tion drug use may be lead­ing to acute out­breaks.

Af­ter be­ing linked to a string of in­ex­plic­a­ble safe­ty is­sues, Hep­lisav-B was fi­nal­ly ap­proved in No­vem­ber 2017. De­spite its check­ered path to the fin­ish line, the vac­cine’s ef­fi­ca­cy and con­ve­nience pro­file su­per­sedes En­ger­ix-B.

So­cial im­age: Shut­ter­stock

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.