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.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

Bing Li, Debra Yu and Konstantin Poukalov, LianBio

Per­cep­tive births its first in-house start­up — and it's a Chi­na play

Perceptive Advisors is going to China.

The decision dates back two years, chief investment officer Adam Stone tells Endpoints News, when the firm began to figure out how it can, in hedge fund-speak, strategically increase its exposure to a growing biopharma market poised to be a key geographic area in the next several decades. It was a bit of a blindspot for Perceptive, he admits.

As “globalized scientist-investors, we just couldn’t afford to have that blindspot in place,” he says.

Lig­and scoops up Pfenex for up to $516M, adding pro­teins to their an­ti­body chick­ens and de­liv­ery tech

The technology hunting folks over at Ligand Pharmaceuticals have picked up a new one from across town, for a significant price.

Ligand has acquired fellow San Diego-based biotech Pfenex and their protein expression platform for $438 million cash, plus $78 million in contingent value agreements should an undisclosed milestone be hit before the end of next year.  The deal pays $12 per share, or $4.34 more than what Pfenex had been trading at before the announcement.

Ugur Sahin, BioNTech CEO

Covid-19 roundup: Pfiz­er-backed BioN­Tech plans to seek FDA OK for a new vac­cine 'as ear­ly as' Oc­to­ber — ahead of the elec­tion

BioNTech execs say they’re on track to get their late-stage data on a Covid-19 vaccine — partnered with Pfizer — into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they won’t be wasting any time in hustling that over to the FDA.

“I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and co-founder.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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