GSK’s long-qui­et can­cer R&D group is ready to make some noise as it mounts a break­out late-stage ef­fort

SAN FRAN­CIS­CO — Four years af­ter GSK swapped out its com­mer­cial port­fo­lio of can­cer drugs to No­var­tis, new CEO Em­ma Walm­s­ley is now ready to fos­ter a glob­al role for the can­cer re­search group that was left in the pa­tient hands of Ax­el Hoos.

Ax­el Hoos

The star pro­gram be­longs to a BC­MA an­ti­body-drug con­ju­gate ti­tled GSK2857916, new­ly equipped with the FDA’s break­through des­ig­na­tion for the hard­est cas­es of mul­ti­ple myelo­ma. Hoos, who now works for can­cer drug leg­end Hal Bar­ron, be­lieves that his team is on pace to steer this to an ap­proval and launch in 2020. And the on­col­o­gy chief is now busi­ly look­ing to beef up the can­cer drug pipeline with new deals.

By all ac­counts, BC­MA can make a huge dif­fer­ence in myelo­ma, as we’ve been see­ing from some jaw-drop­ping re­sults record­ed in a pair of lead­ing CAR-T pro­grams. GSK’s ADC strat­e­gy is fo­cused on ad­vanc­ing a drug that has some im­pres­sive, though frankly not as stun­ning, da­ta. Not all pa­tients are go­ing to be able to be el­i­gi­ble for CAR-Ts — es­pe­cial­ly in the com­mu­ni­ty cen­ters where the bulk of ther­a­py is pro­vid­ed.

Hoos has been la­bor­ing qui­et­ly but per­sis­tent­ly look­ing to the day when GSK would make a bid for the mar­ket with a late-stage pipeline in on­col­o­gy. Once Walm­s­ley took the CEO’s job, it be­came quick­ly ev­i­dent that on­col­o­gy would get the spot­light.

Luke Miels

Luke Miels came in from As­traZeneca, where he had worked close­ly with Pas­cal So­ri­ot on can­cer. Lau­rie Glim­ch­er joined the board from Dana-Far­ber, ready to ad­vise on the sci­ence. Walm­s­ley re­struc­tured the R&D group, scal­ing down on dis­eases and of­fer­ing added sup­port for on­col­o­gy as one of 4 key fields they would go af­ter. Then GSK fol­lowed through and in-li­censed a high pro­file cell ther­a­py pro­gram from Adap­ti­m­mune. Bar­ron’s re­cent ar­rival as R&D chief — tak­ing all the reins for a multi­bil­lion-dol­lar re­search ef­fort — sealed the deal.

This week Hoos has been spend­ing time in meet­ings at JP­Mor­gan in San Fran­cis­co, talk­ing over plans for bring­ing in new drugs and tech­nol­o­gy to help shape their re­turn to the can­cer ther­a­py mar­ket.

“JP­Mor­gan is a great stim­u­la­tor,” says Hoos with a smile. He sat down on Tues­day af­ter­noon to dis­cuss his work and shared some of his thoughts on the deal­mak­ing now in the works.

“We will do an­oth­er deal in cell ther­a­py,” he says, “I’m pret­ty con­fi­dent of that.”

And the hunt is on for syn­er­gis­tic tech that can be used to help ad­vance these new plat­form drugs, with an eye to mak­ing the can­cer op­er­a­tion prof­itable af­ter gain­ing the first new ap­provals.

There are some things GSK won’t do in on­col­o­gy R&D, in­clud­ing their own PD-1 pro­gram.

“We will not be a leader in PD-1,” he says. “We have no il­lu­sions and it makes no sense.” And there’s no IDO, no CD-19 pro­gram, al­so ar­eas where lead­ers are well ad­vanced in the field.

Hal Bar­ron

But they have al­lied them­selves close­ly with Mer­ck to use Keytru­da in com­bi­na­tion with their own in-house pro­grams on ICOS and OX40 ag­o­nists and so on. In the mean­time, the con­tract with No­var­tis al­lows the Swiss multi­na­tion­al to of­fer a bid on the drugs they like, and re­quires GSK to en­ter in­to good faith ne­go­ti­a­tions with them if they de­cide to part­ner. But GSK’s hands aren’t tied.

Af­ter years on the side­lines, Hoos be­lieves GSK’s can­cer group is ready for some break­out suc­cess­es.

“We are mov­ing this thing as fast as we can move it,” he says, with the vi­sion that GSK can be­come a leader in the field.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Top Har­vard chemist caught up in FBI’s 'T­hou­sand Tal­ents' drag­net, ac­cused of ly­ing about Chi­nese con­nec­tions, pay

The FBI’s probe into the alleged theft of R&D secrets by Chinese authorities has drawn Harvard’s top chemist into its net.

The agency accused Charles M. Lieber, who chairs the university’s chemistry and chemical biology department, with lying about his involvement in China’s Thousand Talents campaign, which was established as a way of drawing in innovators from around the world. And the scientist, 60, was charged with making false statements about his ties to China.

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Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”