Totus pulls in $40M Series A with sights on PI3Kα; FDA asks Sesen for another trial after CRL, biotech says

Af­ter spend­ing the last 18 months work­ing on iden­ti­fy­ing a lead can­cer drug, biotech start­up To­tus Med­i­cines has now raised $40 mil­lion in a Se­ries A round to get the ther­a­py head­ed to the clin­ic.

The biotech isn’t hold­ing any­thing back in its re­lease, tout­ing its ‘rev­o­lu­tion­ary’ plat­form ap­proach and prospects in a high­ly com­pet­i­tive field. Their orig­i­nal tar­get is PI3Kα.

CEO Neil Dhawan says:

We are drug­ging un­drug­gable tar­gets at scale, mov­ing us clos­er to a world where every physi­cian and every pa­tient can look for­ward to ef­fec­tive treat­ments for the most dev­as­tat­ing ill­ness­es. The TOS-358 drug pro­gram is a crown­ing achieve­ment in that mis­sion, and we look for­ward to ad­vanc­ing the pro­gram—and many oth­ers—in­to the clin­ic.

DCVC and North­pond Ven­tures led the round, with funds from Cam­ford Cap­i­tal and seed fund­ing out of So­cial Im­pact Cap­i­tal. — John Car­roll

FDA asks Sesen to con­duct an­oth­er tri­al af­ter CRL

Sesen Bio be­lieves it’s found a path for­ward af­ter an Au­gust CRL de­railed its blad­der can­cer drug, but it’s one that could see the need for a new ran­dom­ized study.

The biotech de­tailed agency feed­back in a re­lease put out Thurs­day morn­ing, say­ing reg­u­la­tors rec­om­mend­ed a study com­par­ing the drug Vicineum to in­ves­ti­ga­tors’ choice of chemother­a­py. Though all the de­tails are still be­ing ham­mered out, Sesen said it ex­pects to meet with the FDA again in ear­ly 2022 to fin­ish lay­ing out the tri­al pro­to­col.

Sesen called the Au­gust CRL ‘un­ex­pect­ed’ at the time, say­ing the rea­son for the CRL was a com­bi­na­tion of man­u­fac­tur­ing is­sues and re­quests for more da­ta and sta­tis­ti­cal analy­ses. The com­pa­ny had been ramp­ing up com­mer­cial ac­tiv­i­ty sig­nif­i­cant­ly ahead of the po­ten­tial launch, in­clud­ing hir­ing 60 sales reps, a new as­sis­tant gen­er­al coun­sel and chief com­pli­ance of­fi­cer. — Max Gel­man

Mi­cro­bio­me biotech gets $12M Se­ries A for epilep­sy, ALS pro­grams

On a day when ALS drug R&D re­ceived a bi­par­ti­san en­dorse­ment from the US House of Rep­re­sen­ta­tives, one biotech look­ing to de­vel­op a can­di­date for the dis­ease timed its Se­ries A for­tu­itous­ly.

Bloom Sci­ence closed a $12 mil­lion Se­ries A to push for­ward its plat­form for rare neu­rode­gen­er­a­tive dis­eases, the com­pa­ny an­nounced Thurs­day. The com­pa­ny is re­search­ing how bac­te­ria in the mi­cro­bio­me can be turned in­to ther­a­pies, fo­cus­ing on what it calls the ‘gut-im­mune-brain ax­is, an in­ter­con­nect­ed net­work com­prised of mi­crobes in the gas­troin­testi­nal tract, the host im­mune sys­tem, the cen­tral ner­vous sys­tem and the brain.’

Funds from Thurs­day’s raise will go to­ward the lead pro­gram BL-001, be­ing de­vel­oped for or­phan, drug-re­sis­tant epilep­sies, and help Bloom file and IND and start Phase I stud­ies — though the time­line was not laid out. Oth­er cash will help Bloom push de­vel­op­ment for­ward for an ALS ther­a­py de­rived from bac­te­ria in the gut.

The round was led by Leaps by Bay­er, the im­pact in­vest­ment arm of Bay­er AG, and the ALS In­vest­ment Fund. Ad­di­tion­al in­vestors in­clude Apol­lo Health Ven­tures, as well as ex­ist­ing in­vestor, Joy­ance Part­ners. — Max Gel­man

In­ter­cept Phar­ma­ceu­ti­cals with­draws mar­ket­ing au­tho­riza­tion re­quest for con­flict­ed liv­er drug Ocali­va

In yet an­oth­er blow to Ocali­va, In­ter­cept Phar­ma­ceu­ti­cals is with­draw­ing its mar­ket­ing au­tho­riza­tion ap­pli­ca­tion (MAA) from the Eu­ro­pean Med­ical Agency, the biotech an­nounced this morn­ing.

Ocali­va, a drug can­di­date orig­i­nal­ly ap­proved in 2016 for pri­ma­ry bil­iary cholan­gi­tis, was be­ing in­ves­ti­gat­ed to treat liv­er fi­bro­sis due to non­al­co­holic steato­hep­ati­tis (NASH). That in­di­ca­tion scored a mixed win back in 2019, af­ter a piv­otal Phase III study hit a sta­tis­ti­cal­ly sig­nif­i­cant score on im­prove­ment in liv­er fi­bro­sis with­out any wors­en­ing of NASH — but failed on NASH res­o­lu­tion with­out fi­bro­sis get­ting worse.

This lat­est an­nounce­ment is yet an­oth­er set­back to the biotech pur­su­ing ap­proval for Ocali­va in that in­di­ca­tion. Af­ter be­ing hit with a CRL in June 2020, the com­pa­ny axed 170 jobs three months lat­er in Sep­tem­ber. Fol­low­ing that, now-for­mer CEO Mark Pruzan­s­ki left In­ter­cept last De­cem­ber, and Ocali­va was then re­strict­ed by the FDA ear­li­er this year be­cause of se­vere liv­er dam­age in pa­tients with ad­vanced cir­rho­sis.

Ac­cord­ing to In­ter­cept, the ini­tial MAA was filed two years ago in De­cem­ber 2019 — and the CHMP com­mit­tee would not ex­tend the time­line fur­ther while In­ter­cept is wait­ing on more da­ta, which is ex­pect­ed ear­ly next year.

‘Once we have the re­sults of these new analy­ses, we will as­sess the pos­si­bil­i­ty of sub­mit­ting a new ap­pli­ca­tion to the EMA,’ said In­ter­cept pres­i­dent and CEO Jer­ry Dur­so in a com­pa­ny state­ment. — Paul Schloess­er
https://endpts.com/totus-pulls-in-40m-series-a-with-sights-on-pi3k%CE%B1-fda-asks-sesen-for-another-trial-after-crl-biotech-says