Im­age: Colleen Cut­cliffe WHOLE BIO­ME

The boom in mi­cro­bio­me ther­a­peu­tics has el­e­vat­ed the “good” gut bac­te­ria from pro­bi­otics to drug sta­tus, spurring some up­starts backed by promi­nent ven­ture in­vestors to take their ther­a­pies on the high­ly reg­u­lat­ed jour­ney to­ward an FDA ap­proval. But Whole Bio­me wants to go a sep­a­rate di­rec­tion by oc­cu­py­ing the mid­dle ground with what it’s call­ing “med­ical pro­bi­otics.”

“This is ba­si­cal­ly a prod­uct that has phar­ma­ceu­ti­cal grade ef­fi­ca­cy, clin­i­cal ef­fi­ca­cy, but it has es­sen­tial­ly got the safe­ty of a pro­bi­ot­ic,” CEO Colleen Cut­cliffe tells me as the com­pa­ny emerges from stealth mode with $35 mil­lion in Se­ries B cash.

Jim Bullard Whole Bio­me

Cut­cliffe, a vet­er­an of Elan Phar­ma­ceu­ti­cals, was work­ing at the DNA se­quenc­ing com­pa­ny Pa­cif­ic Bio­sciences when she met her co-founders, Jim Bullard and John Eid. Com­bin­ing their bio­chem­istry, bio­sta­tis­tics and physics back­ground, the trio built a plat­form that com­pares deep se­quenc­ing da­ta from dif­fer­ent pop­u­la­tions, ar­riv­ing at meta­bol­ic maps that sug­gest ex­act­ly which mi­crobes are miss­ing in pa­tients with cer­tain dis­eases.

Se­quoia Cap­i­tal was an ear­ly sup­port­er of the 6-year-old ven­ture, chip­ping in­to the cur­rent round with True Ven­tures, Khosla Ven­tures, Mayo Foun­da­tion, AME Cloud Ven­tures and oth­ers. Roelof Botha is join­ing the board.

John Eid Whole Bio­me

Whole Bio­me plans to com­mer­cial­ize its first off-the-shelf prod­uct, for type 2 di­a­betes, ear­ly next year. Da­ta from sev­er­al re­cent — though un­pub­lished — place­bo-con­trolled clin­i­cal tri­als show that their treat­ment achieved re­duc­tion in A1C and glu­cose spikes on top of the stan­dard met­formin reg­i­men, Cut­cliffe says.

The the­o­ry is that peo­ple with type 2 di­a­betes lack the mi­crobes that are en­tire­ly re­spon­si­ble for me­tab­o­liz­ing fiber, which then trig­gers GLP1 re­sponse for reg­u­lat­ing glu­cose and in­sulin. WBF-011, which Whole Bio­me in­tends to mar­ket as a med­ical food, is de­signed to put ex­act­ly those mi­crobes back.

With 40 staffers and its own man­u­fac­tur­ing op­er­a­tions at its San Fran­cis­co base, the com­pa­ny is al­so ex­plor­ing oth­er prod­ucts for ir­ri­ta­ble bow­el syn­drome and a third, undis­closed in­di­ca­tion.

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.