Axel Hoos, incoming Scorpion CEO

Ax­el Hoos, the keep­er of the on­col­o­gy flame at Glax­o­SmithK­line, steps away for his next chal­lenge at tiny Scor­pi­on

Ax­el Hoos has long kept the flame alive at Glax­o­SmithK­line’s on­col­o­gy di­vi­sion, en­dur­ing lean days af­ter the British phar­ma ditched its late-stage pipeline to No­var­tis and de­cid­ed to re­build anew. Now, watch­ing the pipeline he helped re­mold fi­nal­ly bear fruit, Hoos is ready for a new chal­lenge — and it will come at a tiny biotech at the fron­tier of “pre­ci­sion med­i­cine 2.0.”

Hoos will jump ship af­ter a nine-year stint at GSK to helm Scor­pi­on Ther­a­peu­tics, a stealthy biotech work­ing on iden­ti­fy­ing and tar­get­ing “un­drug­gable” tar­gets in on­col­o­gy. He will pick up the man­tle in Au­gust, mark­ing his long-await­ed re­turn to biotech and first go at the CEO role.

Most re­cent­ly un­der the helm of CSO and R&D chief Hal Bar­ron, Hoos over­saw a long-await­ed turn­around at GSK on­col­o­gy af­ter the com­pa­ny opt­ed to of­fload its en­tire late on­col­o­gy pipeline to Swiss drug­mak­er No­var­tis in March 2015. That move came as part of an ex­pan­sive as­set swap in­clud­ing No­var­tis’ vac­cines busi­ness and a con­sumer health­care joint ven­ture.

Af­ter the deal, Hoos, who led de­vel­op­ment of CT­LA-4 in­hibitor ip­il­i­mum­ab (Yer­voy) dur­ing his time at Bris­tol My­ers Squibb, spent three years work­ing on ear­ly-stage de­vel­op­ment as the British drug­mak­er looked for next-gen home­grown drugs to turn around the flag­ging fran­chise. With Bar­ron’s hir­ing in ear­ly 2018, that ef­fort took off.

In Au­gust, Hoos’ years­long ef­fort came to fruition with the ap­proval of Blenrep for mul­ti­ple myelo­ma, a BC­MA-tar­get­ing an­ti­body de­vel­oped com­plete­ly in-house un­der Hoos’ lead­er­ship. Now, with Blenrep es­tab­lish­ing proof of con­cept, on­col­o­gy will be a ma­jor fo­cus point for the “New GSK” out­lined by CEO Em­ma Walm­s­ley, who is still fac­ing some of the old ac­tivist wor­ries the drug­mak­er hasn’t done enough to move its pipeline for­ward.

That’s no fault of Bar­ron’s, who has spun one deal af­ter an­oth­er to find the next big thing, but for the most part those high-dol­lar ac­qui­si­tions and in-house pro­grams haven’t paid off in the way GSK had hoped.

The ap­proval was the first of what Hoos hopes will prove to be a fruit­ful pipeline for GSK. But hav­ing helped re­build the drug­mak­er’s pipeline and tal­ent pool ef­fec­tive­ly from scratch, Hoos told End­points News he’s ready for his next chal­lenge.

“There’s an op­por­tu­ni­ty here that just has to be seized,” he said.

Just a year in­to ex­is­tence, Scor­pi­on has built a drug dis­cov­ery en­gine around drug­ging the clas­si­cal­ly “un­drug­gable” tar­gets in on­col­o­gy by go­ing af­ter well-known and high­ly val­i­dat­ed onco­gene tar­gets, Hoos said. While the 50-man team is still in very ear­ly de­vel­op­ment, Hoos said the biotech hopes to have its first IND in hand by end of 2022 and is look­ing to build a team around him to match that rapid pace of de­vel­op­ment.

Un­like oth­er biotech CEOs, who keep their am­bi­tions close to the vest, Hoos is straight­for­ward in the fact that Scor­pi­on will aim for an IPO in the fu­ture. The biotech has al­ready earned the back­ing of At­las Ven­ture as part of a $108 mil­lion Se­ries A in Oc­to­ber, quick­ly fol­lowed by a $162 mil­lion Se­ries B this Jan­u­ary, and thinks the mar­ket will be re­cep­tive to the tech­nol­o­gy it’s de­vel­oped in go­ing af­ter hard-to-hit tar­gets. (For more in­fo on biotech’s hot IPO mar­ket, book­mark our track­er here.)

There’s al­so a de­gree of trep­i­da­tion there: While Hoos has amassed a strong or­ga­ni­za­tion­al back­ground at GSK and else­where, mile­stones like pub­lic of­fer­ings are some­thing new for him. How­ev­er, Hoos thinks he has the vi­sion to hire the best peo­ple around him for those big-tick­et mo­ments.

“Crit­i­cal for me as a CEO is that you’re de­ci­sive, you’re a good lis­ten­er so you get all the in­for­ma­tion you need to make de­ci­sions and then you car­ry that for­ward with con­vic­tion,” he said. “Con­vic­tion is a big thing, es­pe­cial­ly in biotech. You can­not be suc­cess­ful if you don’t be­lieve in what you’re do­ing.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.