Some of the best con­nect­ed play­ers in the San Diego hub or­ga­nize launch round for an­oth­er biotech with an eye on tri­al da­ta

Mike Grey and his net­work of San Diego-based biotech ex­ecs are for­mal­ly notch­ing a new start­up de­but to­day.

Mike Grey

The com­pa­ny is Re­neo Phar­ma­ceu­ti­cals, which drew a syn­di­cate to­geth­er around CEO Niall O’Don­nell with $50 mil­lion to sup­port their on­go­ing work on new treat­ments for ge­net­ic mi­to­chon­dr­i­al dis­eases.

To­day marks their com­ing out par­ty for the com­pa­ny, but the 12-mem­ber team at Re­neo — 7 in the UK and 5 in San Diego — have been hard at it for more than 2 years. They’ve al­ready steered their way to 2 clin­i­cal tri­als, fo­cus­ing on REN001, a PPAR-delta ag­o­nist be­ing used to treat ge­net­i­cal­ly de­fined rare mi­to­chon­dr­i­al dis­eases such as fat­ty acid ox­i­da­tion dis­or­ders — FAOD — and pri­ma­ry mi­to­chon­dr­i­al my­opathies.

Niall O’Don­nell

O’Don­nell is a for­mer Lu­me­na ex­ec who’s worked with ex-Lu­me­na CEO Mike Grey for years. Shire stepped in to buy the com­pa­ny — where O’Don­nell was in­ter­im CMO — and their lead drug back in 2014. But af­ter the first round of tri­als at Shire failed, Grey formed a new com­pa­ny called Mirum Phar­ma­ceu­ti­cals to get back the rights and re­vive work on the drug.

And that’s not all Grey, the ex­ec­u­tive chair­man at Re­neo, has done. He al­so helped launch Am­plyx, where he was the found­ing CEO be­fore hand­ing the reins to long­time col­league Cia­ra Kennedy, an­oth­er Lu­me­na alum. Now he’s ex­ec­u­tive chair­man at Am­plyx as well.

Cia­ra Kennedy

To­geth­er, the group in­volves some of the best-con­nect­ed sci­en­tists and en­tre­pre­neurs in the San Diego hub, with fin­gers in many start­up pies. O’Don­nell is on the board at Am­plyx and is man­ag­ing di­rec­tor at River­Vest Ven­ture Part­ners. And the well-knit bunch of ex-Lu­me­na ex­ecs con­tin­ue to work on a va­ri­ety of projects to­geth­er with fund­ing from some ven­ture al­lies.

New En­ter­prise As­so­ci­ates is back as the lead in­vestor for Re­neo, along­side Lund­beck­fonden Ven­tures, Pap­pas Cap­i­tal — where Grey is a ven­ture part­ner — and not sur­pris­ing­ly River­Vest Ven­ture Part­ners.

They’re giv­ing O’Don­nell enough mon­ey to see through his proof-of-con­cept work in the clin­ic and the end of next year, set­ting up a fol­low-up shot at piv­otal rare dis­ease work if every­thing pans out. 

That will de­pend large­ly on whether they chose the right PPAR ag­o­nist, which the CEO notes came from vTv Ther­a­peu­tics. Mi­to­chon­dria are of­ten re­ferred to as the body’s pow­er­hous­es, which store and re­lease the en­er­gy need­ed to func­tion. When it goes awry, the con­se­quences can be dev­as­tat­ing.

Their drug is de­signed to in­crease “fat­ty acid me­tab­o­lism,” says the CEO, “which has di­rect im­pli­ca­tions for fat­ty acid ox­i­da­tion dis­or­ders. In ad­di­tion, an in­crease in fat­ty acid me­tab­o­lism has the po­ten­tial to in­crease the amount of ATP with­in cells, which could, in turn, im­prove symp­toms for pa­tients af­flict­ed with mi­to­chon­dr­i­al my­opathies.” 

O’Don­nell tells me he’s hap­py to re­tain all the op­tion­al­i­ty you’d ex­pect in a ven­ture-backed com­pa­ny. There are re­sources to go it alone, rais­ing more mon­ey, maybe go pub­lic or work a deal with the as­set. And with his con­nec­tions, these are all re­al pos­si­bil­i­ties.

Im­age: Shut­ter­stock

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

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.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

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.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

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.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

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.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

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.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

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.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.