As­traZeneca's En­her­tu gets BTD for breast can­cer; Centes­sa nabs $300M loan

The FDA has grant­ed break­through des­ig­na­tion to As­traZeneca’s and Dai­ichi Sankyo’s HER2 ADC En­her­tu, the com­pa­nies joint­ly an­nounced to­day.

The BTD is for the treat­ment of adult pa­tients with un­re­sectable or metasta­t­ic HER2 pos­i­tive breast can­cer who have re­ceived one or more pri­or an­ti-HER2-based reg­i­mens.

Break­through ther­a­py des­ig­na­tion was based on da­ta from the DES­TINY-Breast03 piv­otal tri­al at #ES­MO21 just last month, which showed a 72% re­duc­tion com­pared to Roche’s ADC Kad­cy­la in the risk of dis­ease pro­gres­sion or death in pa­tients with HER2 pos­i­tive un­re­sectable and/or metasta­t­ic breast can­cer pre­vi­ous­ly treat­ed with trastuzum­ab and a tax­ane.

“This is an im­por­tant step in bring­ing En­her­tu as a po­ten­tial new op­tion in ear­li­er lines of treat­ment for HER2 pos­i­tive metasta­t­ic breast can­cer, giv­en the ur­gent need to im­prove out­comes,” said As­traZeneca EVP of on­col­o­gy R&D Su­san Gal­braith in a state­ment.

Pre­vi­ous BTDs for the drug were in late-line HER2 pos­i­tive metasta­t­ic breast can­cer in 2017 and HER2 mu­tant metasta­t­ic non-small cell lung can­cer (NSCLC) and HER2 pos­i­tive metasta­t­ic gas­tric can­cer in 2020. — Paul Schloess­er

Centes­sa en­ters $300m fi­nanc­ing deal

Centes­sa en­tered a $300 mil­lion fi­nanc­ing agree­ment to­day with New York in­vest­ment firm Ober­land Cap­i­tal Man­age­ment.

Ober­land will pur­chase up to $300 mil­lion of 6-year, in­ter­est-on­ly, se­nior se­cured notes, in­clud­ing $75 mil­lion pur­chased to­day and the next $125 mil­lion avail­able in tranch­es of $75 mil­lion and $50 mil­lion with­in two years.

This $300 mil­lion fa­cil­i­ty, com­bined with Centes­sa’s ex­ist­ing cash bal­ance as of June 30, gives Centes­sa ac­cess to over $900 mil­lion to ad­vance their pipeline of clin­i­cal and pre-clin­i­cal pro­grams — which rolled out their first da­ta for he­mo­phil­ia can­di­date Ser­pin­PC ear­ly last month.

“This fi­nanc­ing will al­low us to fur­ther scale up our de­vel­op­ment ac­tiv­i­ties and pro­vide en­hanced bal­ance sheet flex­i­bil­i­ty for pipeline ex­pan­sion,” said Centes­sa CFO Gre­go­ry Wein­hoff. — Paul Schloess­er

Law­mak­ers in­tro­duce FDA-re­lat­ed leg­is­la­tion as Dem plans re­main in flux

‘Tis the sea­son for law­mak­ers to un­veil their FDA-re­lat­ed pri­or­i­ties as De­moc­rats con­tin­ue to fight over what to put in­to and how to pay for their two ma­jor leg­isla­tive pack­ages.

Just last week, 5 new FDA-re­lat­ed bills were in­tro­duced in Con­gress. Al­though some or all of these bills may nev­er cross the fin­ish line, some of the ideas con­tained with­in them may make it in­to law.

The bills and their in­tro­duc­ers are:

  • A bill au­thored by Rep. David Schweik­ert (R-AZ) to amend the Fed­er­al Food, Drug, and Cos­met­ic Act to clar­i­fy that ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing tech­nolo­gies can qual­i­fy as a prac­ti­tion­er el­i­gi­ble to pre­scribe drugs if au­tho­rized by the State in­volved and ap­proved, cleared, or au­tho­rized by the FDA, and for oth­er pur­pos­es.
  • A bill from Sen. Tina Smith (D-MN) to amend the 180-day ex­clu­siv­i­ty pe­ri­od for gener­ic drugs.
  • A bill from Rep. Earl Blu­me­nauer (D-OR) to amend the FD­CA to es­tab­lish a Neu­ro­science Cen­ter of Ex­cel­lence and a Neu­ro­science Trans­la­tion Work­ing Group. The goal of adding a neu­ro­science cen­ter for ex­cel­lence at FDA is al­so in­clud­ed in the Cures 2.0 draft leg­is­la­tion.
  • A bill from Rep. G.K. But­ter­field (D-NC) to amend the FD­CA to es­tab­lish ad­di­tion­al au­thor­i­ties at FDA re­gard­ing the con­duct of pe­di­atric in­ves­ti­ga­tions of mol­e­c­u­lar­ly tar­get­ed drugs to treat can­cer, and for oth­er pur­pos­es.
  • A bill au­thored by Rep. Matthew Rosendale (R-MT) To in­crease re­port­ing re­quire­ments and trans­paren­cy re­quire­ments in the 340B Drug Pric­ing Pro­gram. — Zachary Bren­nan

Atara and Pierre Fab­re join forces for tab-cel com­mer­cial­iza­tion worth up to $365M up­front

Atara Bio­ther­a­peu­tics and Pierre Fab­re agreed to an ex­clu­sive com­mer­cial­iza­tion agree­ment for tab­ele­cleu­cel, or tab-cel in Eu­rope, Mid­dle East, Africa, and oth­er se­lect mar­kets for Ep­stein-Barr virus (EBV)-pos­i­tive can­cers, ac­cord­ing to a state­ment re­leased to­day.

Atara will re­ceive $45 mil­lion up­front as part of the agree­ment and up to ap­prox­i­mate­ly $320 mil­lion in ad­di­tion­al mile­stones, plus roy­al­ties. They will al­so re­tain full rights to tab-cel in oth­er mar­kets, in­clud­ing North Amer­i­ca, the Asia Pa­cif­ic re­gion, and Latin Amer­i­ca. Atara will con­tin­ue to be re­spon­si­ble for the piv­otal AL­LELE study in pos­i­tive post-trans­plant lym­pho­pro­lif­er­a­tive dis­ease, a type of lym­phoma.

Alera is on track to sub­mit an ap­pli­ca­tion for ap­proval to the EU next month for the drug in EBV-pos­tive PTLD as it con­tin­ues a Phase II mul­ti-co­hort study, eval­u­at­ing tab-cel in six ad­di­tion­al pa­tient pop­u­la­tions with the goal of ex­pand­ing in EBV-dri­ven can­cers.

Pierre Fab­re will lead all com­mer­cial­iza­tion and dis­tri­b­u­tion ac­tiv­i­ties in the ter­ri­to­ries, as well as med­ical and reg­u­la­to­ry ac­tiv­i­ties af­ter the an­tic­i­pat­ed MAA ap­proval in Eu­rope. As part of the trans­ac­tion, Atara will al­so pro­vide man­u­fac­tur­ing ser­vices for tab-cel to be paid by Pierre Fab­re. — Paul Schloess­er

Sage and Bio­gen un­veil new da­ta from de­pres­sion treat­ment

Sage Ther­a­peu­tics and Bio­gen showed new da­ta to­day at a Eu­ro­pean con­fer­ence on their de­pres­sion drug zu­ra­nolone, show­ing re­duc­tions in de­pres­sive symp­toms with zu­ra­nolone-treat­ed pa­tients. That in­clud­ed con­sis­tent im­prove­ments in de­pres­sive mood, as well as rapid on­set of sig­nif­i­cant ef­fect by Day 3 of treat­ment, ac­cord­ing to their pre­sen­ta­tions.

“We be­lieve these da­ta rep­re­sent the po­ten­tial for a ben­e­fit-risk pro­file for zu­ra­nolone that may be dif­fer­en­ti­at­ed from the most pre­scribed de­pres­sion drugs on the mar­ket, and may be wel­comed by pa­tients, if ap­proved,” said Sage CMO Steve Kanes in a state­ment. — Paul Schloess­er

Dy­navax part­ners with DoD on re­com­bi­nant plague vac­cine

Cal­i­for­nia-based Dy­navax and the US De­part­ment of De­fense signed an agree­ment for $22 mil­lion over the next 2.5 years to de­vel­op a re­com­bi­nant vac­cine against the plague, ac­cord­ing to a Dy­navax an­nounce­ment to­day.

The DoD will de­vel­op the vac­cine us­ing the agency’s rF1V vac­cine and its own ad­ju­vant so­lu­tion. Dy­navax al­so will kick off a Phase II clin­i­cal tri­al next year for the vac­cine can­di­date.

“We are hon­ored to re­ceive this award and to sup­port the U.S. gov­ern­ment in de­vel­op­ing a plague vac­cine to pro­tect the U.S. mil­i­tary mem­bers who put their lives at risk every day in ser­vice to the coun­try,” said Dy­navax CEO Ryan Spencer. — Paul Schloess­er

Se­qirus to de­vel­op In­fluen­za A vac­cine can­di­dates for BAR­DA

Se­qirus an­nounced to­day that BAR­DA se­lect­ed the com­pa­ny to de­vel­op two In­fluen­za A vac­cine can­di­dates for a Phase I clin­i­cal study as part of pan­dem­ic pre­pared­ness.

The first can­di­date will use a com­bi­na­tion of cell-based and ad­ju­vant­ed tech­nolo­gies, while the sec­ond can­di­date will use self-am­pli­fy­ing mR­NA.

“We are proud to be a trust­ed part­ner in sup­port of BAR­DA’s pan­dem­ic pre­pared­ness ob­jec­tives,” said Se­qirus ex­ec­u­tive di­rec­tor of pan­dem­ic re­sponse so­lu­tions Marc Lacey. — Paul Schloess­er

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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