Lan Huang, BeyondSpring CEO

Reel­ing from FDA re­jec­tion, Be­yond­Spring ax­es 35% of US staffers in hopes of I/O come­back

It’s been a roller coast­er few months for Be­yond­Spring Phar­ma­ceu­ti­cals — and the New York-based biotech is now ask­ing a third of its staffers to alight the train ear­ly.

Be­yond­Spring is chop­ping its US work­force by 35%, with some of those em­ploy­ees be­ing as­signed to sub­sidiaries, in a move de­scribed as “or­ga­ni­za­tion­al stream­lin­ing” im­ple­ment­ed to “pre­serve long-term sus­tain­abil­i­ty.”

The low-pro­file biotech found it­self in a sud­den spot­light back in Au­gust af­ter re­leas­ing sur­pris­ing­ly pos­i­tive Phase III re­sults sug­gest­ing its off­beat ap­proach to im­munother­a­py could ex­tend the over­all sur­vival of non-small cell lung can­cer pa­tients. But the sky­rock­et­ing shares came crash­ing down a few months lat­er when the FDA re­ject­ed the same drug for a dif­fer­ent in­di­ca­tion, dash­ing its im­me­di­ate hopes for a mar­ket en­try.

Not much is ex­act­ly chang­ing at Be­yond­Spring, where the plinab­u­lin fran­chise will re­main the core fo­cus.

A se­lec­tive im­munomod­u­lat­ing mi­cro­tubule-bind­ing agent de­rived from sea­weed, the drug was ini­tial­ly test­ed, in com­bi­na­tion with a G-CSF ana­log, for the pre­ven­tion of chemother­a­py-in­duced neu­trope­nia (a con­di­tion marked by dan­ger­ous­ly low lev­els of cer­tain white blood cells lead­ing to height­ened risk of in­fec­tion).

With da­ta from on­ly one tri­al, though, the FDA deemed Be­yond­Spring’s pack­age “not suf­fi­cient­ly ro­bust to demon­strate ben­e­fit” and asked for a sec­ond well-con­trolled tri­al in its com­plete re­sponse let­ter.

The com­pa­ny sug­gest­ed it will con­tin­ue to push for a CIN ap­proval in Chi­na and the US, while gear­ing up for an NDA fil­ing of the NSCLC in­di­ca­tion af­ter stun­ning in­vestors with what one an­a­lyst called “VERY un­ex­pect­ed” da­ta.

In a Phase III tri­al in­volv­ing 559 pa­tients, the com­pa­ny re­port­ed that near­ly twice as many pa­tients were alive af­ter two years on the drug arm than on the stan­dard-of-care arm. And by year four, 10.6% of pa­tients who re­ceived plinab­u­lin plus chemo were alive, com­pared to none of the pa­tients who re­ceived place­bo plus chemo.

Those re­sults drew Chi­nese on­col­o­gy gi­ant Jiang­su Hen­grui to ink a $170 mil­lion de­vel­op­ment and com­mer­cial­iza­tion pact. But as Be­yond­Spring re­leased more de­tailed da­ta, out­side on­col­o­gists al­so raised ques­tions about the mag­ni­tude of the ben­e­fit and whether it may have been dri­ven in part by some pa­tients in the tri­al re­ceiv­ing “sub­stan­dard” care.

It’s now time to hun­ker down and de­liv­er on those promis­es, in­clud­ing test­ing plinab­u­lin in oth­er I/O com­bos — while the oth­er pre­clin­i­cal pro­grams go on the back­burn­er.

“This re­or­ga­ni­za­tion will en­able Be­yond­Spring to re­duce op­er­at­ing ex­pens­es and ex­tend its cash run­way,” CEO Lan Huang said in a state­ment.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Winselow Tucker, Eli Lilly's new Loxo unit chief commercial officer

Eli Lil­ly plucks a new com­mer­cial chief from Bris­tol My­ers in man­age­ment shuf­fle as HR chief re­tires

Eli Lilly has found a new chief commercial officer from among the ranks at Bristol Myers Squibb, as it says farewell to its longtime head of human resources Stephen Fry.

Fry announced on Thursday his plans to retire after more than 35 years with Lilly. He’ll vacate his seat as SVP of human resources and diversity at the end of the year, and current Loxo CCO Eric Dozier is slated to take his place. As a result, BMS’ Winselow Tucker is joining the team as Loxo CCO at the end of the month.