As­traZeneca gets in on RNA game with Mi­NA re­search col­lab­o­ra­tion

Two months af­ter No­var­tis spent near­ly $10 bil­lion on The Med­i­cines Com­pa­ny’s RNA-based cho­les­terol drug, As­traZeneca will try to co-de­vel­op its own RNA-based meta­bol­ic ther­a­py.

The Eu­ro­pean drug­mak­er has part­nered with Mi­NA Ther­a­peu­tics to de­vel­op small ac­ti­vat­ing RNA (saR­NA) for meta­bol­ic dis­eases. The agree­ment gives As­traZeneca the right to ne­go­ti­ate a li­cens­ing agree­ment af­ter a se­ries of pre­clin­i­cal stud­ies.

Like As­traZeneca’s re­cent $1 bil­lion ex­pan­sion in­to Chi­na, the deal marks an­oth­er ef­fort by the lega­cy phar­ma to keep up with the lat­est tech­nol­o­gy in its es­tab­lished ther­a­peu­tic ar­eas.

The part­ner­ship is the third ma­jor phar­ma col­lab­o­ra­tion for Mi­NA. The biotech part­nered with Japan-based So­sei in a deal that gave Mi­NA $45 mil­lion and So­sei a 25% stake along with an ex­clu­sive op­tion to buy the com­pa­ny for $140 mil­lion, pend­ing the out­come of a Phase I/II tri­al on Mi­NA’s liv­er can­cer drug can­di­date.

The same year, Mi­NA signed an up-to €307 mil­lion deal with Boehringer In­gel­heim for three liv­er fi­bro­sis tar­gets, in­clud­ing at least one NASH drug. So­sei passed on the buy­out op­tion in 2018 amid Phase I tri­al re­sults that showed lit­tle aside from safe­ty and phar­ma­co­ki­net­ics, but they main­tained their 25% stake in the com­pa­ny.

It’s not clear yet which spe­cif­ic in­di­ca­tions As­traZeneca and Mi­NA will fo­cus on. In an in­ter­view with Fierce­Biotech, Mi­NA CEO Robert Habib cit­ed in­clisir­an, the RNA in­ter­fer­ence (RNAi) cho­les­terol drug No­var­tis ac­quired from The Med­i­cines Com­pa­ny, as an ex­am­ple of RNA’s po­ten­tial in meta­bol­ic dis­eases.

“That shows ex­act­ly the pow­er of an RNA ther­a­py of­fer­ing su­pe­ri­or phar­ma­col­o­gy to pa­tients in meta­bol­ic dis­ease,” he said.

Robert Habib

Mi­NA’s saR­NA tech is dis­tinct, though, from the RNAi ther­a­pies of­fered by No­var­tis and Al­ny­lam.

Mi­NA’s pub­lished pa­pers de­scribe small ac­ti­vat­ing RNA as “sim­i­lar to RNA in­ter­fer­ence” in that they both re­ly on short strands of RNA and a pro­tein called Arg­onaute-2. But they do es­sen­tial­ly op­po­site things in the cell. RNAi si­lences genes; it hi­jacks a nat­ur­al cel­lu­lar process and cuts up RNA that ex­press­es a dis­ease-caus­ing pro­tein. saR­NA am­pli­fies; it in­duces what’s called tran­scrip­tion­al elon­ga­tion, help­ing cells cre­ate more of a pro­tein that’s be­ing un­der-ex­pressed.

For ex­am­ple, Mi­NA’s liv­er can­cer drug is de­signed to re­store the ex­pres­sion of CEB­PA, a gene hy­poth­e­sized to al­ter the im­mune sys­tem in the tu­mor mi­croen­vi­ron­ment and make the tu­mor more sus­cep­ti­ble to can­cer drugs.

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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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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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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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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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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