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

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.