J&J does Alzheimer's gene ther­a­py deal, along with 14 oth­er new col­lab­o­ra­tions

John­son & John­son has inked a re­search deal with Uni­ver­si­ty of Penn­syl­va­nia to work on gene ther­a­py for Alzheimer’s. The part­ner­ship lever­ages the uni­ver­si­ty’s ade­no-as­so­ci­at­ed virus­es and J&J’s an­ti-Alzheimer’s an­ti­bod­ies in hopes to pen­e­trate the blood brain bar­ri­er.

The part­ner­ship in­volves the phar­ma gi­ant’s in­no­va­tion-fo­cused arm John­son & John­son In­no­va­tion and Janssen Phar­ma­ceu­ti­cals. J&J hopes to use the uni­ver­si­ty’s AAV vi­ral de­liv­ery to trig­ger the ex­pres­sion of ther­a­peu­tic an­ti­bod­ies to the brain – an ef­fort that would change the sta­tus quo. Cur­rent­ly, the blood brain bar­ri­er lim­its the use of an­ti­bod­ies to treat brain dis­eases.

Janssen will have ex­clu­sive glob­al rights to com­mer­cial­ize prod­ucts un­der this new agree­ment.

Paul Stof­fels, J&J

The new re­search deal was one of 15 new col­lab­o­ra­tions J&J an­nounced as part of their reg­u­lar op­er­a­tional up­dates. John­son & John­son In­no­va­tion is no stranger to deals like this, as it’s penned more than 350 such part­ner­ships since its in­cep­tion in 2012.

“By ad­vanc­ing trans­for­ma­tive health­care in­no­va­tions to­geth­er with en­tre­pre­neurs, aca­d­e­m­ic cen­ters and in­sti­tu­tions, we are one step clos­er to ad­dress­ing many press­ing glob­al health­care chal­lenges,” said Paul Stof­fels, ex­ec­u­tive vice pres­i­dent and CSO of John­son & John­son, in a state­ment.

Here’s a sum­ma­ry of oth­er no­table ther­a­peu­tic re­search deals an­nounced in­volv­ing var­i­ous J&J arms:

→ A mul­ti-year re­search col­lab­o­ra­tion with Bea­con Dis­cov­ery, a G-Pro­tein Cou­pled Re­cep­tor (GCPR) drug dis­cov­ery in­cu­ba­tor launched by Belviq-mak­er Are­na Phar­ma­ceu­ti­cals in 2016. The col­lab­o­ra­tion will be to dis­cov­er and de­vel­op next-gen­er­a­tion ther­a­peu­tics to treat obe­si­ty and oth­er meta­bol­ic dis­eases.

→ A col­lab­o­ra­tion with a Boston mi­cro­bio­me ther­a­peu­tics com­pa­ny Holo­bio­me Cor­po­ra­tion to treat dis­eases of the cen­tral and en­teric ner­vous sys­tems. The col­lab­o­ra­tion will ex­am­ine a con­sor­tium of bac­te­ria that could be used to cre­ate a dif­fer­en­ti­at­ed pro­bi­ot­ic or over-the-counter of­fer­ing that ad­dress­es sleep­less­ness.

→ A col­lab­o­ra­tion with San Diego’s Der­mala to de­vel­op mi­cro­bio­me-de­rived treat­ments for skin con­di­tions. Der­mala’s tech­nol­o­gy har­ness­es the ben­e­fi­cial func­tion of good skin bac­te­ria to elim­i­nate the bad bac­te­ria and bal­ance the mi­cro­bio­me.

→ A col­lab­o­ra­tion with Monash Uni­ver­si­ty aimed at fur­ther ex­plor­ing the un­der­ly­ing trig­gers of pso­ri­a­sis to dis­cov­er and de­vel­op po­ten­tial new treat­ments that pre­vent fu­ture oc­cur­rences of the dis­ease.

→ A col­lab­o­ra­tion with the Tai­wan In­dus­tri­al Tech­nol­o­gy Re­search In­sti­tute to set up co-fund­ing agree­ments for projects in lung can­cer, chron­ic ob­struc­tive pul­monary dis­ease, di­a­betes, eye health and dig­i­tal health ini­tia­tives.

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.

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.

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.

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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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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