In­cyte nabs pri­or­i­ty re­view for bile duct can­cer drug; Temasek shows in­ter­est in an­oth­er Wood­ford dar­ling — re­port

In­cyte’s de­ci­sion to stop co-fund­ing baric­i­tinib in fa­vor of oth­er pipeline op­por­tu­ni­ties is pay­ing off, as the FDA grants pri­or­i­ty re­view to pemi­ga­tinib in a type of pre­vi­ous­ly treat­ed, lo­cal­ly ad­vanced or metasta­t­ic cholan­gio­car­ci­no­ma. Pa­tients cur­rent­ly have “lim­it­ed treat­ment op­tions be­yond first-line chemother­a­py and of­ten face a poor prog­no­sis,” said Pe­ter Lang­muir, group vice pres­i­dent for tar­get­ed ther­a­peu­tics. The drug in­hibits fi­brob­last growth fac­tor re­cep­tor, or FGFR, and has been shown to in­duce an over­all re­sponse rate of 36% with a me­di­an du­ra­tion of re­sponse of 7.5 months among pa­tients with FGFR2 fu­sions or re­arrange­ments. The PDU­FA date is set for May 30, 2020.

→ Af­ter ex­tend­ing a $90 mil­lion life­line to Benev­o­len­tAI, Sin­ga­pore’s Temasek is re­port­ed­ly eye­ing an­oth­er biotech uni­corn in the port­fo­lio of the strug­gling fund for­mer­ly man­aged by Neil Wood­ford. The firm is in talks to in­vest in DNA se­quenc­ing play­er Ox­ford Nanopore, the Sun­day Times re­port­ed. The high fly­ing Ox­ford spin­out has been look­ing to raise £125m ($161 mil­lion) af­ter aban­don­ing plans to go pub­lic, ac­cord­ing to the pa­per, but it’s un­clear whether Temasek wants to par­tic­i­pate in that fi­nanc­ing or a sep­a­rate arrange­ment.

→ Four months af­ter Am­gen and Al­ler­gan launched the first Her­ceptin biosim­i­lar in the US, My­lan and Bio­con are catch­ing up with their own copy­cat, Ogivri. De­spite scor­ing an FDA ap­proval ear­li­er than ri­vals, their set­tle­ment with Roche pre­vent­ed them from rolling out the drug un­til to­day. It marks the sec­ond biosim­i­lar that My­lan is mar­ket­ing in the US through its part­ner­ship with Bio­con, fol­low­ing the ar­rival of Neu­las­ta knock­off Ful­phi­la. Ogivri is al­so ap­proved in more than 80 coun­tries world­wide, the com­pa­nies said.

→ As In­ter­cept turns the fi­nal reg­u­la­to­ry cor­ner on its ex­per­i­men­tal NASH drug, the biotech is pro­mot­ing Ja­son Cam­pagna to the CMO role. Hav­ing joined as the NASH pro­gram leader in 2016 from The Med­i­cines Com­pa­ny, Com­pagna will now over­see strate­gic med­ical and sci­en­tif­ic moves while the R&D, reg­u­la­to­ry, med­ical af­fairs and safe­ty & phar­ma­covig­i­lance units all work to­geth­er to push obeti­cholic acid as the first ap­proved ther­a­py for the big liv­er dis­ease.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

Image: Shutterstock

Covid-19 roundup: Sanofi and GSK pledge 200M vac­cine dos­es for a glob­al dis­tri­b­u­tion cam­paign

Sanofi and GSK have agreed to give 200 million doses of their vaccine candidate to the COVAX Facility, which is part of a program set up by CEPI, the WHO and Gavi to equitably distribute vaccines around the world.

The idea behind COVAX is to give all participating countries equal access to vaccines, regardless of income level. As of Oct 14, more than 180 countries had signed agreements to the COVAX Facility, including France and the UK. China joined earlier this month, pledging to make its vaccines a “global public good.” One country notably off the list is the United States.

News brief­ing: No­var­tis' Zol­gens­ma hits block­buster sta­tus, trig­ger­ing $80M mile­stone; Caris rais­es $310M for ge­nom­ic pro­fil­ing ex­pan­sion

Novartis reported that Zolgensma earned $291 million in Q3, which puts the SMA gene therapy squarely in the blockbuster category. That, in turn, is paying benefits to Regenxbio, which provided the NAV AAV9 vector used by Zolgensma.

The biotech $RGNX reported Tuesday morning that it is getting an $80 million milestone payment from Novartis, which now has earned more than $1 billion cumulatively from the new gene therapy franchise. And with large percentages of newborns now being screened for the rare, lethal ailment, the franchise can continue to grow.

Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.

Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,700+ biopharma pros reading Endpoints daily — and it's free.