Sean Park­er’s can­cer in­sti­tute keeps grow­ing with some “mind blow­ing” new re­search projects

Sean Park­er Im­age: Shut­ter­stock

Eigh­teen months af­ter so­cial me­dia mogul Sean Park­er an­ted up $250 mil­lion to launch a new can­cer in­sti­tute de­vot­ed to ground­break­ing re­search work, the group is still ab­sorb­ing labs and top in­ves­ti­ga­tors in­to its swelling net­work. This week, the Park­er In­sti­tute for Can­cer Im­munother­a­py wel­comed a string of labs at the Dana-Far­ber Can­cer In­sti­tute led by some of the best-known sci­en­tists in on­col­o­gy.

These sci­en­tists in­clude Stephen Ho­di, who led the first hu­man study of Yer­voy (ip­il­i­mum­ab), a pi­o­neer­ing CT­LA-4 check­point drug that has been play­ing a pri­ma­ry role in im­muno-on­col­o­gy com­bo stud­ies. Ho­di has been fo­cus­ing on break­ing down re­sis­tance to the new check­points sweep­ing the field. The list al­so in­volves Cather­ine Wu, an anti­gen ex­pert whose been work­ing on iden­ti­fy­ing new tar­gets that can whip up a more ef­fec­tive im­mune re­sponse to can­cer. Philip Kranzusch — study­ing the cGAS-STING path­way to con­trol im­mune sig­nal­ing and an­ti­tu­mor im­mu­ni­ty — and Nick Hain­ing, con­cen­trat­ing on T cells, are al­so sign­ing up.

Jeff Blue­stone

PI­CI CEO (and UC San Fran­cis­co pro­fes­sor) Jeff Blue­stone tells me that they have more than 60 labs in the net­work now, in­clud­ing more than 300 sci­en­tists in the front ranks of a glob­al army of in­ves­ti­ga­tors who are push­ing on­col­o­gy R&D on to the next lev­el.

“It’s more than just a num­bers game,” he says. These new ad­di­tions to the group in­clude ex­per­tise on neoanti­gens and check­point re­sis­tance, which fig­ures promi­nent­ly in the 4 key ar­eas they’re con­cen­trat­ing on. And there are dozens of bio­phar­ma al­liances in the mix, mul­ti­ply­ing now to the point where it can be dif­fi­cult to stay on top of it all.

“I think the phi­los­o­phy in the in­sti­tute is do­ing things step­wise,” he adds, “not just big splashy stuff.”

That all fits in­to what Blue­stone calls his sand­box anal­o­gy. There has to be a con­tained, or­ga­nized ap­proach to their work; a prac­ti­cal strat­e­gy dri­ven by a set of clear goals. It isn’t an un­lim­it­ed, beach-like per­spec­tive.

And the in­ves­ti­ga­tors have to play to­geth­er in the sand­box.

That means shar­ing ideas in twice an­nu­al re­treats or the month­ly calls with the di­rec­tors of the or­ga­ni­za­tion. Sci­en­tists get a chance to pitch new ideas and talk about what they’re work­ing on, look­ing for ways to col­lab­o­rate with oth­ers on projects or just get some fresh per­spec­tive.

PI­CI al­so wants to stay in the “white space,” says Blue­stone, the ar­eas of un­met med­ical need where progress is most need­ed — tough ar­eas like pan­cre­at­ic can­cer.

At this point, the in­dus­try has pumped bil­lions of dol­lars in­to can­cer re­search in a short pe­ri­od of time, cre­at­ing a field that in many re­spects dom­i­nates the glob­al bio­phar­ma busi­ness. And Blue­stone is acute­ly aware that stay­ing on the cut­ting edge is no easy task.

“It’s crowd­ed,” he notes, “in some re­spects it’s a bub­ble.”

But PI­CI plans to keep grow­ing, adding sci­en­tists who are in this for the long haul un­til it gets to the point that the sand­box is full. Where that line is drawn, Blue­stone adds, hasn’t been de­ter­mined. But he thinks he’ll know it when he gets there.

Says Blue­stone: “It’s just mind blow­ing what’s out there.”

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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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.

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.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

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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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

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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