Clin­ton cam­paign staff: "We have start­ed the war with phar­ma!!"

Just one Tweet from Hillary Clin­ton drove biotech stocks down sharply last fall, the open­ing round in what would be a sav­age bear mar­ket for the in­dus­try. And her se­nior staffers in the cam­paign were deliri­ous.

Clin­ton had jabbed Mar­tin Shkre­li hard for his de­ci­sion to jack up the price of Dara­prim by more than 5,000%, and the sharp, swift re­ac­tion on Wall Street to the mes­sage on drug prices was cheered by her se­nior pol­i­cy ad­vis­ers, ac­cord­ing to one of sev­er­al email ex­changes in­clud­ed in Wik­iLeaks hacked John Podes­ta files.

FYI – We have start­ed the war with Phar­ma!!,” ex­claimed Ann O’Leary re­gard­ing the press that fol­lowed. “Great!,” replied out­side ad­vis­er Mandy Grun­wald.

A few weeks lat­er, though, Clin­ton strate­gist Jim Mar­go­lis was be­gin­ning to fret that Shkre­li hadn’t caved on the price.

I’m a lit­tle ner­vous that we ran the spot and this dude is still stick­ing it to pa­tients. Has there been any fur­ther dis­cus­sion about this?

That wouldn’t be the on­ly ex­change re­gard­ing Hillary Clin­ton’s ad­ver­sar­i­al re­la­tion­ship with Big Phar­ma, which was care­ful­ly con­sid­ered in­side her cam­paign.

Last fall, as Hillary Clin­ton’s cam­paign team was sound­ing out var­i­ous po­si­tions that would help high­light her stance on the phar­ma in­dus­try, the nom­i­na­tion of Robert Califf as FDA com­mis­sion­er pre­sent­ed a tempt­ing tar­get to at least one of her top ad­vis­ers.

A New York Times ar­ti­cle had raised the is­sue of Califf’s ties to the in­dus­try, and O’Leary – a se­nior pol­i­cy ad­vis­er – saw it as a po­ten­tial open­ing for a po­lit­i­cal jab that would high­light Hillary Clin­ton’s ea­ger­ness to stand up to Big Phar­ma, ac­cord­ing to one of the hacked emails that emerged in the John Podes­ta files re­leased by Wik­iLeaks.

O’Leary wrote:

Califf the Oba­ma nom­i­nee does have re­al ties to the drug in­dus­try – Chris Jen­nings is call­ing a few peo­ple for me to learn more so we don’t tip our hand di­rect­ly. We are clean on Clin­ton Ad­min FDA Com­mis­sion­er – it was David Kessler, an aca­d­e­m­ic who had run a teach­ing hos­pi­tal – and best known for tak­ing on big to­bac­co.  We could cer­tain­ly sig­nal that we want some­one will­ing to stand up to Phar­ma (in the same way Kessler stood up to To­bac­co).

BUT – I want to do a lit­tle more dig­ging and due dili­gence be­fore we hit this guy.  Hav­ing been through a nom­i­na­tion fight with my hus­band (in which he lost), this is per­son­al and messy and hor­ri­ble on the per­son nom­i­nat­ed and their fam­i­lies – so I don’t take at­tack­ing this guy light­ly.

Clin­ton spokesman Bri­an Fal­lon not­ed that he liked the idea, not­ing that Joe Biden – a po­ten­tial con­tender for the nom­i­na­tion – would be re­quired to be in Califf’s cor­ner.

Any up­date on this? As we con­sid­er fights that fit in­to the larg­er themes we are try­ing to pro­mote, this seems like a good fight to have.

Plus, the VP would be in a box of hav­ing to sup­port this nom­i­nee.

The email ex­change even­tu­al­ly pe­ters out, but it does un­der­score that Clin­ton all along in­tend­ed to help dis­tin­guish her can­di­da­cy by crit­i­ciz­ing the phar­ma in­dus­try, a po­si­tion that fell more nat­u­ral­ly in­to her lap when Mar­tin Shkre­li was be­ing pil­lo­ried for rais­ing the price of an old gener­ic drug more than 5,000%.

(Shehla Shakoor con­tributed to this sto­ry.)

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.

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.

Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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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.

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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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.