Hal Barron, GSK Investor Day

Glax­o­SmithK­line punts a key Ze­ju­la com­bo study in ovar­i­an can­cer with added set­backs on ICOS and RSV

A chink has ap­peared in the ar­mor of da­ta that Glax­o­SmithK­line R&D chief Hal Bar­ron has been build­ing for the PARP in­hibitor Ze­ju­la.

The phar­ma gi­ant’s Q2 up­date on Wednes­day in­cludes the note that re­searchers have end­ed their Phase II MOON­STONE study, one of a slate of tri­als that Bar­ron has cit­ed to “help es­tab­lish Ze­ju­la as the most com­pelling PARP in­hibitor for women with ovar­i­an can­cer.”

The study had been set up to test the drug plus dostar­limab — its new­ly ap­proved PD-1 play­er now sold as Jem­per­li — among women with plat­inum-re­sis­tant ovar­i­an can­cer with­out a known BR­CA mu­ta­tion. Their pre­planned analy­sis sug­gest­ed it wouldn’t “meet the high bar” set out in the sin­gle-arm study track­ing the over­all re­sponse rate.

That wasn’t the on­ly ef­fort to get the heave-ho to­day. Their ICOS ag­o­nist fe­ladil­imab failed the EN­TRÉE-Lung sub study 1 at the in­ter­im analy­sis. This lung can­cer flop is the third straight fail­ure for this drug in re­cent months, which has suf­fered from low ex­pec­ta­tions af­ter a key set­back at Jounce on ICOS. It failed the IN­DUCE-3 and IN­DUCE-4 tri­als for head and neck squa­mous cell car­ci­no­ma.

GSK al­so not­ed that “de­vel­op­ment of phase II RSV pae­di­atric can­di­date vac­cine (vi­ral vec­tor) dis­con­tin­ued fol­low­ing as­sess­ment that tar­get ef­fi­ca­cy pro­file was un­like­ly to be met.”

Bar­ron was an en­thu­si­as­tic sup­port­er of the deal to ac­quire Tesaro and Ze­ju­la for $5.1 bil­lion in late 2018. He was bet­ting that an in­sight in­to the ge­net­ics of can­cer would make the drug a big­ger play­er than many on Wall Street gave it cred­it for. And he got dostar­limab, re­cent­ly ap­proved as the 7th PD-(L)1 to the US mar­ket, in the same deal, with some equal­ly mut­ed ex­pec­ta­tions giv­en its sched­uled late ar­rival.

Ze­ju­la sales were £98 mil­lion in the quar­ter, a ris­ing fig­ure, but one that is still con­sid­er­ably off the block­buster track that would have jazzed an­a­lysts.

Bar­ron’s track record at the helm of the R&D group has come un­der in­creased scruti­ny. Ge­of­frey Porges in par­tic­u­lar has fault­ed the com­pa­ny’s per­for­mance in drug de­vel­op­ment as shares re­main un­der pres­sure. And while he’s struck sev­er­al high-pro­file deals over the last few months, set­backs in on­col­o­gy have con­tin­ued to raise ques­tions about the R&D group’s abil­i­ty to line up new block­busters.

CEO Em­ma Walm­s­ley, mean­while, took an ag­gres­sive stance in to­day’s quar­ter­ly up­date, bull­ish­ly cit­ing a re­turn to more of a busi­ness-as-usu­al stance in key health­care mar­kets that buoyed earn­ings. There was al­so $358 mil­lion in ad­ju­vant sales pinned to Covid-19. But GSK’s large vac­cine group has large­ly sat out the Covid cri­sis, skip­ping any po­ten­tial wind­falls. And doubts about its long-run per­for­mance con­tin­ue to af­flict ex­pec­ta­tions as ac­tivists push for change.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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