Idera of­fi­cial­ly puts to rest its Phase III tri­al in ad­vanced melanoma; BeiGene nabs pri­or­i­ty re­view for sN­DA

Idera dropped some dis­ap­point­ing news in late March, when it showed its lead drug failed to hit its pri­ma­ry end­point in a Phase III tri­al. Now, Idera, which worked with Bris­tol My­ers Squibb to test the drug, known as tilso­tolimod, in com­bi­na­tion with ip­il­i­mum­ab ver­sus ip­il­i­mum­ab alone in pa­tients with an­ti-PD-1 re­frac­to­ry ad­vanced melanoma, is say­ing that tri­al will not fin­ish.

“Our con­clu­sion is that the to­tal­i­ty of the da­ta, with all pa­tients hav­ing com­plet­ed the study treat­ment, does not sup­port the like­li­hood that the com­bi­na­tion of tilso­tolimod with ip­il­i­mum­ab would achieve a sta­tis­ti­cal­ly sig­nif­i­cant OS ben­e­fit over ip­il­i­mum­ab alone,” Vin­cent Mi­lano, Idera’s CEO, said in a state­ment on Wednes­day.

What’s more, Idera’s CMO Eliz­a­beth Tar­ka al­so an­nounced she’s leav­ing the com­pa­ny next week. The com­pa­ny said it will con­tin­ue to en­roll pa­tients in a Phase 2 study of tilso­tolimod in com­bi­na­tion with BMS’s nivolum­ab and ip­il­i­mum­ab for pa­tients with mi­crosatel­lite-sta­ble col­orec­tal can­cer and to sup­port Ab­b­Vie in pro­vid­ing study drug in their tri­al for pa­tients with head and neck squa­mous cell car­ci­no­ma. — Zachary Bren­nan

BeiGene nabs pri­or­i­ty re­view for sN­DA

The FDA has agreed to a quick­er re­view of BeiGene’s sN­DA for Brukin­sa (zanubru­ti­nib) for the treat­ment of adult pa­tients with mar­gin­al zone lym­phoma who have re­ceived at least one pri­or an­ti-CD20-based ther­a­py. The agency has un­til Sep­tem­ber 19 to make a de­ci­sion.

“This is our first reg­u­la­to­ry sub­mis­sion in MZL, a se­ri­ous dis­ease di­ag­nosed in more than 2,000 pa­tients every year in the U.S., with no clear stan­dard of care,” the com­pa­ny said in a state­ment.

FDA pre­vi­ous­ly ap­proved Brukin­sa as a sec­ond line treat­ment for man­tle cell lym­phoma. — Zachary Bren­nan

Rare dis­ease coali­tion adds Texas-based Taysha

Taysha Gene Ther­a­pies has joined the new­ly formed Rare Dis­ease Com­pa­ny Coali­tion, the com­pa­ny an­nounced Wednes­day.

The gene ther­a­py com­pa­ny that fo­cus­es on AAV-based cen­tral ner­vous sys­tem dis­eases will join a num­ber of oth­ers in ed­u­cat­ing and ad­vo­cat­ing pol­i­cy­mak­ers of the cir­cum­stances of rare dis­ease com­pa­nies. Its mem­bers in­clude Or­chard Ther­a­peu­tics, Agios Phar­ma­ceu­ti­cals and Ac­celeron Phar­ma.

Over the next month, the coali­tion will dis­cuss mean­ing­ful drug and health­care poli­cies and reg­u­la­tions, such as drug pric­ing.

“As we grow to be­come a leader in the de­vel­op­ment of gene ther­a­pies for the treat­ment of rare dis­eases, we have a re­spon­si­bil­i­ty to our com­mu­ni­ty, es­pe­cial­ly to our pa­tients and their fam­i­lies, to ad­vo­cate for more ef­fec­tive poli­cies and reg­u­la­tions that will en­cour­age in­no­va­tion around po­ten­tial­ly life-sav­ing ther­a­pies,” CEO RA Ses­sion II said in a state­ment. — Josh Sul­li­van

BAR­DA-fund­ed CARB-X gives grant to Basilea to fight drug-re­sis­tant in­fec­tions 

Switzer­land-based Basilea Phar­ma­ceu­ti­cals has been award­ed a grant worth $2.7 mil­lion from CARB-X to de­vel­op treat­ments for drug-re­sis­tant in­fec­tions.

Basilea will use the fund­ing to de­vel­op new class an­tibi­ot­ic to treat Gram-neg­a­tive bac­te­ria, such as Acine­to­bac­ter bau­man­nii and mul­ti-drug re­sis­tant Pseudomonas aerug­i­nosa. Both bac­te­ria are list­ed as se­ri­ous threats by the CDC and WHO, and are in need of new an­tibi­otics.

CARB-X — which stands for Com­bat­ing An­tibi­ot­ic-Re­sis­tant Bac­te­ria Bio­phar­ma­ceu­ti­cal Ac­cel­er­a­tor — is led by Boston Uni­ver­si­ty, and re­ceives fund­ing from BAR­DA. Basilea has suc­cess­ful­ly launched 2 an­tibi­ot­ic treat­ments, Cre­sem­ba for in­va­sive fun­gal in­fec­tions and Zevtera for se­vere bac­te­r­i­al in­fec­tions. — Josh Sul­li­van

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Ei­sai cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.