Is Roche's pRED fi­nal­ly ready to step out from be­hind Genen­tech for its close­up? Prob­a­bly not

John Reed
Bioreg­num
The view from John Car­roll

It’s been close to 5 years since John Reed jumped from San­ford-Burn­ham to be­come the head of Roche’s Basel-based pRED or­ga­ni­za­tion. And on­ly now is the big drug re­search group he leads get­ting a close­up af­ter years spent watch­ing his col­leagues at gRED — Genen­tech — steal the show with a string of block­buster hits.

The old pRED was shred­ded when Roche an­nounced in the sum­mer of 2012 that it would shut­ter its big R&D cam­pus in Nut­ley, NJ and move a group of sur­vivors in­to Man­hat­tan. The re­or­ga­ni­za­tion, like any such R&D or­ga­ni­za­tion, Reed told me in 2013, was pure “poi­son” for the group, vow­ing to stick with a re­search strat­e­gy and avoid any more such trau­mat­ic dis­rup­tions.

There was one key suc­cess, with Gazy­va, but that hasn’t per­formed spec­tac­u­lar­ly well so far on the mar­ket­ing side of things. And some of the drugs that Reed men­tioned to me back in 2013 — like RG7116 and emac­tuzum­ab — ap­pear to have ei­ther been lost along the way or still face a long clin­i­cal path. And even in­side Roche there ap­pears to have been some grow­ing frus­tra­tions.

Sev­erin Schwan

Roche CEO Sev­erin Schwan, though, is now ready to em­brace the long over­shad­owed pRED, tap­ping some mid-stage pro­grams as top prospects. Here’s what he had to tell Reuters:

“In pRED, some ex­cit­ing op­por­tu­ni­ties are now com­ing through af­ter a time when many things did not work. It goes in waves. You can’t pro­gram to have a cer­tain num­ber of mol­e­cules com­ing through the pipeline every year in each unit.”

An­oth­er ex­ec put it this way: “Thank God. It took a while, but pRED is fi­nal­ly start­ing to de­liv­er.”

So what’s in the spot­light?

A bis­pe­cif­ic called CEA-TCB that en­gages T cells for an at­tack on can­cer cells, a fol­low-up drug for Lu­cen­tis, ida­sunut­lin for AML and an autism drug.

It’s un­usu­al for any gi­ant phar­ma com­pa­ny like Roche to tout mid-stage pro­grams, which have a high mor­tal­i­ty rate, es­pe­cial­ly as mar­ket­ing chal­lenges can now just as eas­i­ly kill off a pro­gram just as sure­ly as bad da­ta ever could. But then it’s al­so ex­tra­or­di­nar­i­ly un­usu­al for a com­pa­ny like Roche to suc­cess­ful­ly ac­quire Genen­tech with­out killing the in­no­v­a­tive spir­it that drove a leg­endary string of new can­cer drugs in­to ex­is­tence.

The gen­er­al con­sen­sus at the time was that the but­toned down Basel crew would de­stroy the col­or­ful cul­ture at Genen­tech, elim­i­nat­ing its abil­i­ty to stay on the cut­ting edge of drug re­search. In­stead, even as top ex­ecs moved on to oth­er things, flow­er­ing Bay Area star­tups, the Bay Area com­pa­ny con­tin­ued to thrive.

Reed and pRED, both of which have main­tained a very low pro­file in re­cent years, still have a long way to go be­fore prov­ing whether Roche can cre­ate the same spir­it in the large­ly Eu­ro­pean or­ga­ni­za­tion.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.