Two more big phar­ma vets at Roche, As­traZeneca make the leap to top biotech R&D jobs as the great mi­gra­tion con­tin­ues

A pair of promi­nent biotech poach­ers have claimed two more mar­quee names from the ranks of big phar­ma R&D.

Omar Khwa­ja

David Berman, who un­til re­cent­ly was head of I/O re­search at As­traZeneca, has been bumped up to the top job in R&D at Im­muno­core, the TCR biotech which re­cent­ly re­cruit­ed Med­Im­mune chief Bahi­ja Jal­lal as CEO. And Omar Khwa­ja has jumped from his post as glob­al head of Roche’s neu­ro­science trans­la­tion­al med­i­cine group as well as rare dis­eases to Voy­ager $VY­GR, where he’ll be CMO.

Berman is a well known play­er in on­col­o­gy R&D and comes with cre­den­tials that in­cludes a lengthy stint along­side his new CEO at Im­muno­core, which spe­cial­izes in TCR work. Berman ac­tu­al­ly joined Im­muno­core, which is look­ing to reestab­lish its rep as a leader in its field wor­thy of a hefty uni­corn val­u­a­tion, last Sep­tem­ber. He took over the lead role for the com­pa­ny’s top pro­gram for the late-stage ef­fort on IM­Cgp100.

Biotech ob­servers may re­call that Bris­tol-My­ers sued Berman back in 2015, try­ing to force him to the side­lines for a year rather than let him make the leap straight to As­traZeneca.

Im­muno­core has been un­der­go­ing a year-long tran­si­tion pe­ri­od af­ter CEO Eliot Forster left. Forster en­coun­tered some ma­jor head­winds when he tried to raise a new round of $300 mil­lion-plus for the biotech, and pret­ty much the en­tire top team ex­it­ed soon af­ter.

Berman left As­traZeneca ahead of a ma­jor re­vamp that al­so in­clud­ed the de­par­ture of com­pa­ny CMO Sean Bo­hen as ex-MSK star José Basel­ga was brought in to run the can­cer re­search ops at the phar­ma gi­ant un­der CEO Pas­cal So­ri­ot. Mene Pan­ga­los land­ed the oth­er top R&D job at the com­pa­ny, no­tably af­ter his name sur­faced as a con­tender for the throne once So­ri­ot makes an ex­it.

Khwa­ja is a gene ther­a­py ex­pert. His work at Roche in­volved cre­at­ing new gene ther­a­py pro­grams for a list of rare dis­eases, in­clud­ing spinal mus­cu­lar at­ro­phy as well as Hunt­ing­ton’s dis­ease. And he’ll put that ex­per­tise to work now for Voy­ager, which has been strug­gling with a lead pro­gram on Parkin­son’s.

The lat­est word from Voy­ager was that the FDA had cooled to the no­tion of us­ing their Phase II study as a piv­otal tri­al suf­fi­cient for an ap­proval, shift­ing to the view that it’s re­al­ly an ex­plorato­ry ef­fort. In re­sponse, the biotech not­ed a few days ago that it will add pa­tients to the Phase II and run a par­al­lel Phase III in or­der to give reg­u­la­tors da­ta from two well con­trolled stud­ies — the in­dus­try gold stan­dard on da­ta.

The mi­gra­tion from phar­ma gi­ant to lit­tle biotech has been trans­form­ing the field for a few years now. But why can’t phar­ma hold on to its top play­ers? As we’ve seen with the CEOs mak­ing the shift, these small­er com­pa­nies have a lot more lat­i­tude when it comes to com­pen­sa­tion pack­ages. You of­ten hear about these ex­ecs’ pref­er­ence to leave the big bu­reau­cra­cies be­hind. And a po­ten­tial score with a new big drug, along­side the ever present pos­si­bil­i­ty of a buy­out, has al­so con­spired to make biotech a more ex­cit­ing place to be — for now.


Im­age: David Berman at End­points News event, 2018. JEFF RU­MANS, END­POINTS NEWS

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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