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

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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vTv Ther­a­peu­tics cuts 65% of em­ploy­ees in shake­up; Freenome bags $300M in Se­ries D to ex­pand mul­ti­omics plat­form

vTv Therapeutics has decided to chop down its workforce by almost two-thirds.

The High Point, NC biotech announced Monday that it would pivot and now prioritize its lead program, the oral glucokinase activator TTP399, as it gears up for Phase III pivotal trials.

The drug was granted breakthrough therapy designation after showing a 40% reduction in hypoglycemic episodes compared to placebo, and back in October vTv announced positive results in a study showing no increased risk for ketoacidosis, a severe complication of diabetes.

Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.