Cell­tri­on's rheuma­toid arthri­tis drug meets both end­points in PhI­II; New com­pa­ny Tri­bune emerges to take on fi­brot­ic dis­eases

Cell­tri­on Health­care an­nounced pos­i­tive re­sults from its year-long Phase III tri­al of its rheuma­toid arthri­tis drug Yu­fly­ma in pa­tients re­ceiv­ing ther­a­py on Tues­day, as the tri­al met both the pri­ma­ry and sec­ondary end­points.

The tri­al in pa­tients with mod­er­ate-to-se­vere RA test­ed 3 groups: 1 in pa­tients who re­ceived 40 mg of CT-P17 or 1 that re­ceived the ref­er­ence drug Hu­mi­ra, and a third that switched from Hu­mi­ra to CP-P17 halfway through the tri­al, for the re­main­der of the year.

The av­er­age Ctrough lev­els were main­tained af­ter week 24 in all 3 treat­ment groups, and the safe­ty pro­file was com­pa­ra­ble across all 3 groups. An­ti-drug an­ti­body and neu­tral­iz­ing an­ti­body re­sults were sim­i­lar across the 3 groups too, with 28.4%/24.8% in CT-P17 main­te­nance, 27.0%/24.3% in ref­er­ence to Hu­mi­ra main­te­nance and 28.3%/26.3% in switched to CT-P17 groups. — Josh Sul­li­van

New com­pa­ny Tri­bune emerges to take on Fi­brot­ic dis­eases

No­vo Hold­ings and Health­Cap an­nounced on Wednes­day that they have joined forces to cre­ate Tri­bune Ther­a­peu­tics, a com­pa­ny fo­cused on tar­get­ing fi­brot­ic dis­eases.

Tri­bune has emerged from stealth mode as a com­pa­ny found­ed in 2020 with a pipeline the com­pa­ny has called promis­ing, and ready to take on a range of fi­brot­ic dis­eases, in­clud­ing those that af­fect the kid­ney, lung and liv­er. The pipeline is based on re­search from Hå­vard At­tra­madal’s lab at Oslo Uni­ver­si­ty Hos­pi­tal.

Georg Vo Beiske,  the in­com­ing CEO of Tri­bune, said in a state­ment:

There is a great need for nov­el treat­ment op­tions for pa­tients suf­fer­ing from fi­brot­ic dis­eases. Tri­bune Ther­a­peu­tics is built on strong sci­ence and has the po­ten­tial to de­vel­op life-chang­ing ther­a­pies for these pa­tients. With the sup­port of No­vo Seeds and Health­Cap we are ea­ger to bring the sci­ence in­to phar­ma­ceu­ti­cal de­vel­op­ment.

— Josh Sul­li­van

Kine­ta scores fi­nanc­ing for sol­id tu­mor an­ti­body

A Seat­tle-based biotech fo­cused on on­col­o­gy closed a $10 mil­lion fi­nanc­ing round Tues­day.

Kine­ta is el­i­gi­ble to re­ceive up to $25 mil­lion in ad­di­tion­al fi­nanc­ing be­fore the end of 2021, the com­pa­ny said in a re­lease. The round was led by Cheong­bo In­dus­tri­al. The pro­ceeds will go to­ward ad­vanc­ing Kine­ta’s an­ti-VISTA an­ti­body KVA12.1 to an in­ves­ti­ga­tion­al new drug ap­pli­ca­tion with the FDA.

CEO Shawn Iado­na­to said in the press re­lease:

We are ex­cit­ed to have the con­fi­dence of this lead­ing in­vestor syn­di­cate in sup­port­ing KVA12.1 and our pipeline of nov­el im­munother­a­pies.  Clos­ing this fi­nanc­ing round fur­ther val­i­dates the in­no­v­a­tive re­search and de­vel­op­ment at Kine­ta. These new funds pro­vide the re­sources to ad­vance the pre­clin­i­cal de­vel­op­ment of our po­ten­tial best-in-class an­ti-VISTA an­ti­body to ben­e­fit pa­tients with a broad range of sol­id tu­mor can­cers.

An in­vestor from CBI, to be named lat­er, will al­so join the Kine­ta board of di­rec­tors.

KVA12.1 is an an­ti-VISA an­ti­body in de­vel­op­ment for the treat­ment of sol­id tu­mors. VISTA block­ades can re­pro­gram sup­pres­sive myeloid cells and re­ac­ti­vate an­ti­tu­mor im­mune func­tion. — Josh Sul­li­van

As­traZeneca and Pro­teros team up in can­cer part­ner­ship

As­traZeneca is ap­point­ing a Ger­man com­pa­ny as a new col­lab­o­ra­tion part­ner, with the duo go­ing af­ter dif­fer­ent types of can­cer.

The Big Phar­ma will team up with Pro­teros Biostruc­tures on an un­spec­i­fied num­ber of new pro­grams, the pair an­nounced Wednes­day. As­traZeneca will pay out up to $75.6 mil­lion in po­ten­tial mile­stones to take Pro­teros re­search and push them for­ward in­to the clin­ic.

“Pro­teros’ pro­pri­etary dis­cov­ery plat­form en­ables us to screen epi­ge­net­ic tar­gets in a phys­i­o­log­i­cal­ly rel­e­vant set­ting, sup­port­ing ac­cel­er­at­ed dis­cov­ery and de­vel­op­ment of the next wave of an­ti-can­cer med­i­cines,” As­traZeneca se­nior VP of on­col­o­gy R&D Su­san Gal­braith said in a state­ment.

Pro­teros works with sev­er­al phar­ma com­pa­nies and biotechs to pro­vide ear­ly-stage ser­vices. The com­pa­ny says it helps “most” of the world’s 20 biggest phar­ma com­pa­nies and more than 250 bio­phar­mas. — Max Gel­man

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.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

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)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

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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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

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).

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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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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Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection: