Gen­zyme vet David Meek­er takes helm at stealthy KSQ with $76M and a new map for drug dis­cov­ery

David Meek­er left Gen­zyme last April af­ter a 23-year run, in­clud­ing six years as pres­i­dent af­ter Sanofi stepped in to buy the land­mark biotech six years ago. And as it turns out, in­stead of re­tir­ing and end­ing the sto­ry, his ca­reer was shift­ing in­to a brand new chap­ter.

To­day, five months lat­er, af­ter adding a string of biotech board po­si­tions to his sched­ule, Meek­er has land­ed his next big gig in biotech. And like many of his col­leagues ahead of him, he’s tran­si­tion­ing from his for­mal ex­it from the Big Phar­ma world to the thriv­ing cos­mos of biotech star­tups.

Meek­er is now run­ning KSQ Ther­a­peu­tics in Cam­bridge, MA, which hasn’t been com­plete­ly se­cret but has large­ly kept the shades down — un­til now.

Af­ter get­ting seed­ed by Flag­ship Pi­o­neer­ing and Po­laris — a pair of keen start­up shops — 18 months ago with No­var­tis vet­er­an Frank Stegmeier or­ches­trat­ing the use of CRISPR tech­nol­o­gy in drug dis­cov­ery, the team has been as­sem­bling a pipeline of pre­clin­i­cal pro­grams. And with the help of an ex­pand­ed syn­di­cate, there’s a $76 mil­lion A round to fu­el the ini­tial dri­ve to the clin­ic.

From play­ing a key role in a glob­al or­ga­ni­za­tion with 110,000 em­ploy­ees, Meek­er will now be team leader to a com­pa­ny with 40 staffers. And he couldn’t be hap­pi­er. This is, he says, a place where he can make a dif­fer­ence.

“I think our mod­el is strug­gling,” Meek­er says about phar­ma R&D. “We all know that. The cost of de­vel­op­ment is too high.”

At KSQ, he says, you can start an ex­per­i­ment us­ing cut­ting edge tech­nol­o­gy and no bias about out­comes.

With CRISPR, he says, “we can study all 20,000 genes in the genome across a mul­ti­tude of dis­ease mod­els and find out which of those tar­gets has the biggest im­pact in mod­u­lat­ing the dis­ease. We can do it one shot, 20,000 genes at a time.”

Frank Stegmeier joined the ex­o­dus of re­search ex­ecs out of No­var­tis ear­ly, re­cruit­ed in late 2015 from his job as the glob­al head of on­col­o­gy tar­get dis­cov­ery to the CSO’s spot at KSQ. And now he’s had a chance to ex­am­ine that whole galaxy of genes against 600 can­cer and im­mune-based dis­ease mod­els in search of a few big drugs.

Where in­dus­try is chal­lenged is work­ing with drugs that are ac­tive with­out know­ing if it’s the best. “We have a long list of po­ten­tial tar­gets,” says Meek­er. “We can’t pur­sue them all, but we can com­pare them.”

If they are right and “CRISPRomics” works the way they be­lieve it will, the com­pa­ny can move with greater con­fi­dence against a few se­lect pro­grams, look­ing for a more ef­fi­cient mod­el for de­vel­op­ment.

Stegmeier tells me it was a dream job, with a chance to work with some world-renowned sci­en­tif­ic founders: David Saba­ti­ni of the White­head In­sti­tute and MIT, William Hahn of the Broad In­sti­tute and Dana-Far­ber Can­cer In­sti­tute, Jonathan Weiss­man from UCSF, and Tim Wang of MIT.

George Golumbes­ki

It’s the kind of plat­form mod­el that lends it­self to ear­ly part­ner­ing, fit­ting com­fort­able in­to Flag­ship’s mod­el for spawn­ing com­plete com­pa­nies run by im­pres­sive, high-pro­file teams in al­liance with mar­quee sci­en­tists and abun­dant fi­nanc­ing.

ARCH Ven­ture Part­ners, an­oth­er VC that loves to help kick­start am­bi­tious ef­forts like this, and Alexan­dria Eq­ui­ties al­so jumped in­to the A round.

That team of 40 should dou­ble in the next year, says Meek­er. And they’ll have some ex­pert guid­ance on the deal front.

George Golumbes­ki, deal-mak­er ex­tra­or­di­naire who’s made quite a name for him­self at Cel­gene, is lend­ing a hand as a spe­cial ad­vis­er and board mem­ber.

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

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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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.

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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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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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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