UK-based biotech Scan­cell is lift­ing the veil off a Phase I tri­al for its Covid-19 vac­cine, but it’ll al­so be mak­ing a piv­ot on the vac­cine’s strat­e­gy.

Scan­cell said in a re­lease on Mon­day that it is pre­sent­ing the pre­lim­i­nary da­ta from its Phase I clin­i­cal tri­al, which was con­duct­ed at the Uni­ver­si­ty of Cape Town Lung In­stitue in South Africa. The tri­al was in­tend­ed to look at two of vac­cine Scan­cell’s can­di­dates, SCOV1 and SCOV2, in pa­tients be­fore test­ing them as a boost­er. Ac­cord­ing to the biotech, both can­di­dates are plas­mid DNA-based vac­cines.

The re­sults showed an­ti­body and T cell re­spons­es, with the lev­el of the de­tectable an­ti­bod­ies in the blood at 67% fol­low­ing vac­ci­na­tion by the two can­di­dates. Scan­cell al­so stat­ed that the vac­cines had an im­pact against sev­er­al vari­ants, in­clud­ing Omi­cron. No se­vere ef­fects or ma­jor safe­ty is­sues were re­port­ed dur­ing the tri­al.

But Scan­cell said in the re­lease that it will not be go­ing to take the vac­cine for­ward on its own. Be­cause of the larg­er size of lat­er-stage trails and the com­pet­i­tive­ness of the cur­rent Covid-19 field, the biotech will be look­ing for a part­ner.

Scan­cell CEO Lindy Dur­rant said in the re­lease:

Fur­ther large stud­ies would be re­quired to con­firm the po­ten­tial of the CO­VID­I­TY vac­cine can­di­dates to stim­u­late broad, cross-vari­ant re­ac­tiv­i­ty and com­pete with the cur­rent­ly ap­proved COVID-19 vac­cines. There­fore, and as pre­vi­ous­ly dis­closed, the Board has de­cid­ed to seek a part­ner to fur­ther progress this pro­gramme. Go­ing for­wards, Scan­cell will fo­cus its re­sources on pro­gress­ing the port­fo­lio of in­no­v­a­tive im­muno-on­col­o­gy drug can­di­dates that we have gen­er­at­ed from our plat­forms

How­ev­er, no de­tails on po­ten­tial part­ners or when Scan­cell will be trans­fer­ring the can­di­date were dis­closed. End­points News reached out to the biotech for more in­for­ma­tion.

The Covid-19 mar­ket has changed quite dras­ti­cal­ly since the big vac­cine push­es a few years ago. Phar­ma gi­ant Pfiz­er said on its Q4 earn­ings call that it is ex­pect­ing much low­er sales of Covid-19 prod­ucts due to a low­er fol­low­ing of com­pli­ance with vac­cine reg­u­la­tions and few­er vac­cines be­ing ad­min­is­tered, among oth­er fac­tors. This is lead­ing to an an­tic­i­pat­ed drop of around 60% in vac­cine sales rev­enue.

Last week, Japan can­celed an or­der for more than 140 mil­lion dos­es of No­vavax’s Covid-19 vac­cine, af­ter agree­ing to pur­chase around 150 mil­lion dos­es from Take­da in 2021. Take­da CFO Cos­ta Saroukos said on a pre­vi­ous call that it is see­ing “low mar­ket de­mand” for the vac­cine due to vac­ci­na­tion in Japan and the Omi­cron vari­ant’s pres­ence.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.