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.

Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A P val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a P value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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Sanofi teams up with Mer­ck to pair Keytru­da with a next-gen IL-2 can­di­date from the Syn­thorx buy­out

Nearly a year after snapping up a next-gen immuno-oncology candidate in its $2.5 billion Synthorx buyout, Sanofi is joining forces with Merck to pair the drug with blockbuster Keytruda.

The pharmas are planning a Phase II trial of Sanofi’s non-alpha IL-2 candidate THOR-707 in combination or sequenced administration with Keytruda for various cancers. While the companies are keeping mum about the financial terms and targets, they said the trials will be Sanofi-sponsored.

CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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