One year in, Joanne Kotz as­sumes CEO role at Jnana; Pres­i­dent/Ex­ec­u­tive chair duo will now run Black­Thorn

Joanne Kotz

Jnana Ther­a­peu­tics is mark­ing its an­niver­sary with the in­stal­la­tion of a per­ma­nent chief, and it’s go­ing for some­one who’s been there since the be­gin­ning: co-founder and pres­i­dent Joanne Kotz. Amir Nashat, the in­ter­im CEO who will now fo­cus on his oth­er job as man­ag­ing part­ner of Po­laris, cred­its Kotz for build­ing “a tal­ent­ed team and a col­lab­o­ra­tive, em­pow­er­ing cul­ture, while al­so lead­ing im­por­tant work to val­i­date Jnana’s pro­pri­etary drug dis­cov­ery plat­form.” Be­fore launch­ing the SLC trans­porter-fo­cused biotech, Kotz had held lead­er­ship roles at the F-Prime Bio­med­ical Re­search Ini­tia­tive and the Broad In­sti­tute.

Greg Vontz has stepped down as pres­i­dent and CEO of Black­Thorn Ther­a­peu­tics, prompt­ing the pro­mo­tion of CSO Bill Mar­tin to the pres­i­dent and COO role. Mar­tin will now run the com­pa­ny along­side new ex­ec­u­tive chair­man Paul Berns, a vet­er­an biotech ex­ec­u­tive of ARCH, match­ing his fa­mil­iar­i­ty with Black­Thorn’s neu­robe­hav­ioral ther­a­pies with Berns’ prod­uct de­vel­op­ment, strate­gic and com­mer­cial ex­per­tise.

→ Sea­soned di­ag­nos­tics and phar­ma ex­ec Bern­hard Sixt is the new CEO at Ed­in­burgh Mol­e­c­u­lar Imag­ing, tasked with steer­ing its op­ti­cal imag­ing prod­uct on a path to ap­proval and even­tu­al com­mer­cial­iza­tion. EMI-137 has com­pared fa­vor­ably to colonoscopy in a can­cer de­tec­tion tri­al, the com­pa­ny says, and is be­ing test­ed in sev­er­al oth­er can­cer in­di­ca­tions.

Michael Lin­den

Michael Lin­den has cho­sen Touch­light Ge­net­ics as the next stop of his gene ther­a­py jour­ney. As CSO, he is re­spon­si­ble for ap­ply­ing Touch­light’s dog­gy­bone DNA tech on its dis­cov­ery pipeline and trans­la­tion­al re­search ef­forts. A for­mer aca­d­e­m­ic ac­tive­ly ad­vo­cat­ing for gene ther­a­py re­search, Lin­den re­cent­ly served as Pfiz­er’s VP of gene ther­a­py and head of its Ge­net­ics Med­i­cines In­sti­tute.

→ Af­ter months of search­ing for a per­ma­nent CFO, Five Prime Ther­a­peu­tics has de­cid­ed to lock in David Smith, a for­mer Genen­tech staffer and re­cent COO of foren­sics DNA com­pa­ny In­te­genx be­fore Ther­mo Fish­er snapped it up. The South San Fran­cis­co-based im­muno-on­col­o­gy biotech likes his breadth of ex­pe­ri­ence, hav­ing worked at a mix of com­pa­nies span­ning dif­fer­ent scales and stages. Lin­da Ru­bin­stein, who’s been fill­ing in from a CFO ser­vices firm, is sign­ing off.

→ As Steve Frucht­man piv­ots to the pres­i­dent’s job at On­cono­va $ON­TX, he’s tapped Richard Wood­man to suc­ceed him as CMO. Wood­man, a for­mer head of No­var­tis’ hema­tol­ogy fran­chise, in­her­its a late-stage pipeline fo­cused on myelodys­plas­tic syn­dromes. Two oth­er new hires will help him hus­tle the lead drug, rigosert­ib, to­ward an ap­proval: clin­i­cal op­er­a­tions di­rec­tor Matthew Par­ris, who joins from In­ovio; and Cel­gene vet David Evans, who will be as­so­ciate di­rec­tor, reg­u­la­to­ry af­fairs.

→ As Im­pel Neu­roPhar­ma gears up for a cou­ple of mid-stage read­outs of its cen­tral ner­vous sys­tem dis­or­der treat­ments, it has ap­point­ed Ellen Lub­man to scout deals for the drugs and its nasal drug de­liv­ery tech. As chief busi­ness of­fi­cer, Lub­man’s man­date will cov­er “part­ner­ing and ac­qui­si­tion strat­e­gy and ex­e­cu­tion,” not un­like what she did when she was VP of ex­ter­nal sci­ence and in­no­va­tion at Al­ler­gan.

→ With sev­er­al of its pro­grams lined up at the Phase II start­ing line, Alka­h­est has poached vet­er­an sales ex­ec Eliz­a­beth Jef­fords from Roche/Genen­tech to be its chief sales and strat­e­gy of­fi­cer. Jef­fords, who played a big role in mar­ket­ing the big age-re­lat­ed mac­u­lar de­gen­er­a­tion ther­a­py Lu­cen­tis, will now piv­ot to oth­er age-re­lat­ed dis­eases in­clud­ing Alzheimer’s and Parkin­son’s.

→ Cal­gary, Al­ber­ta-based Xortx Ther­a­peu­tics has ap­point­ed James Fair­barin to re­place out­go­ing CFO Dave Matthews. The com­pa­ny is de­vel­op­ing three treat­ments for dif­fer­ent types of pro­gres­sive kid­ney dis­ease.

Farah Ah­mad has jumped from Sy­neos Health to a COO po­si­tion at Strate­gikon Phar­ma, which mar­kets a tool for clin­i­cal tri­al plan­ning and ven­dor man­age­ment.

→ Fol­low­ing a mam­moth $200 mil­lion de­but on the Nas­daq, gene ther­a­py de­vel­op­er Or­chard Ther­a­peu­tics has re­cruit­ed two bio­phar­ma vets to man­age its com­mer­cial op­er­a­tions in the US and the mas­sive bloc re­gion Eu­rope, Mid­dle East and Africa (EMEA), re­spec­tive­ly. Both of them bring sig­nif­i­cant ex­pe­ri­ence with rare dis­eases, Or­chard’s spe­cial­ty. Robin Kense­laar, who spent the past 15 years at Sanofi Gen­zyme, comes on board as SVP of gen­er­al man­ag­er, EMEA com­mer­cial ops. His US coun­ter­part, Brad Math­is, re­cent­ly had a stint at Su­cam­po af­ter 10 years at Alex­ion.   

My­ovant, a mem­ber of Vivek Ra­maswamy’s biotech fam­i­ly fo­cused on women’s health and en­docrine dis­eases, has wooed GSK ex­ec Kim Sablick to be its chief com­mer­cial of­fi­cer. The R&D team is al­so gain­ing a new mem­ber in Jeff Norn­hold, who’s switch­ing a tech­ni­cal op­er­a­tions po­si­tion at Im­pax for a new role as SVP of phar­ma­ceu­ti­cal op­er­a­tions and de­vel­op­ment. Myr­tle Pot­ter and Frank Tor­ti — in­dus­try vets who have re­cent­ly tak­en se­nior roles at Roivant — are join­ing the board along­side Mark Guinan, with Pot­ter ap­point­ed chair­man.   

No­vavax $NVAX has ap­point­ed Rachel King, a sea­soned VC and founder of Gly­coMimet­ics, to its board of di­rec­tors.  

Grail CEO Jen­nifer Cook has tak­en a board seat at De­nali, the high-fly­ing neu­rode­gen­er­a­tion start­up run by some of her for­mer col­leagues from Genen­tech.

→ Hav­ing guid­ed Epizyme through a rough year at the FDA, CEO Robert Baze­more is tak­ing on a side gig as board di­rec­tor at neoanti­gen pi­o­neer Neon Ther­a­peu­tics.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.