No­var­tis lat­er­als two PhII an­ti-ag­ing drugs to a PureTech start­up, grab­bing an eq­ui­ty stake

Jay Brad­ner, No­var­tis

Phar­ma gi­ant No­var­tis is spin­ning out a pair of Phase IIb-ready drugs now bound for ad­vanced tri­als on re­pair­ing the de­te­ri­o­rat­ing im­pact of ag­ing on the hu­man im­mune sys­tem.

Boston-based PureTech Health is on the re­ceiv­ing end of the deal, set­ting up a sub­sidiary called resTOR­bio which it will now fund, in tranch­es, with $15 mil­lion. And it can earn a grow­ing stake in the op­er­a­tion, ris­ing to 58% on the al­lo­ca­tion of the full $15 mil­lion, with an op­tion to in­crease that to 67% if it adds $10 mil­lion more.

No­var­tis re­tains an eq­ui­ty stake as well as un­spec­i­fied mile­stones and roy­al­ties.

There’s noth­ing new about a ma­jor phar­ma op­er­a­tion like No­var­tis spin­ning out as­sets from a large pipeline. Vivek Ra­maswamy’s Roivant has es­tab­lished com­pa­nies based on ne­go­ti­at­ing the re­ceiv­ing end of that arrange­ment. And No­var­tis it­self has a few oth­er re­cent deals to un­der­score the trend.

What’s in­ter­est­ing this year is that the whole field of di­vest­ing as­sets is grow­ing hot­ter as com­pa­nies look to repri­or­i­tize pipelines in the wake of in­creas­ing re­sis­tance by pay­ers, as Ernst & Young point­ed out re­cent­ly.

In this case PureTech is grab­bing two drugs that have com­plet­ed stud­ies for im­munose­nes­cence. The treat­ment in­hibits the mTORC1 path­way, which has been long stud­ied for its abil­i­ty — in an­i­mals — to re­vi­tal­ize T cell func­tion and amp up an ag­ing im­mune sys­tem.

“mTORC1 in­hibitors could lead us to a new par­a­digm for treat­ing sev­er­al ag­ing-re­lat­ed con­di­tions,” said Chen Schor, a PureTech se­nior ex­ec­u­tive and the leader of the resTOR­bio pro­gram.

Ag­ing has been a grow­ing fo­cus among a hand­ful of biotechs, though there are still plen­ty of pesky de­tails about de­vel­op­ment and end­points that still need to be worked out with the FDA. Still, this is an ad­vanced ef­fort, es­pe­cial­ly com­pared to cell senes­cence pro­grams at star­tups like Uni­ty.

Don’t be sur­prised if you see some more of these kinds of out­sourc­ing deals from No­var­tis.

Jay Brad­ner, who runs the No­var­tis In­sti­tutes for Bio­Med­ical Re­search (NI­BR), said:

We re­gard the fur­ther de­vel­op­ment of these com­pounds by PureTech Health for the po­ten­tial treat­ment of con­di­tions such as im­munose­nes­cence, as a prime ex­am­ple of our con­tin­ued com­mit­ment to work more open­ly with in­no­va­tors be­yond our walls to ad­vance projects that have the po­ten­tial to help pa­tients lead health­i­er lives.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

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The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

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It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

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A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).