Pfiz­er, Astel­las tout pos­i­tive PhI­II da­ta to po­ten­tial­ly ex­pand Xtan­di la­bel

Pfiz­er and Astel­las are gun­ning to add a fourth in­di­ca­tion to their can­cer drug Xtan­di with Phase III tri­al re­sults re­leased to­day.

The study, look­ing at Xtan­di plus le­upro­lide and Xtan­di as a monother­a­py in men with non-metasta­t­ic hor­mone-sen­si­tive prostate can­cer, met its pri­ma­ry end­point with a “sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful im­prove­ment” in metas­ta­sis-free sur­vival in the pa­tients treat­ed with Xtan­di plus le­upro­lide, ac­cord­ing to the com­pa­nies, though no de­tailed da­ta was giv­en.

Xtan­di is al­ready ap­proved in the US in men as a dai­ly ther­a­py with metasta­t­ic hor­mone-sen­si­tive prostate can­cer, metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer and non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer.

Le­upro­lide is an al­ready-ap­proved drug com­mon­ly used to treat symp­toms of ad­vanced prostate can­cer, of­ten un­der the brand names Eli­gard and Lupron. It works by low­er­ing the amount of testos­terone, which can help slow the growth of can­cer cells. Lupron was first ap­proved for use in prostate can­cer in 1985.

“While cur­rent treat­ment op­tions for lo­cal­ized prostate can­cer are in­tend­ed to be cu­ra­tive, some men re­main at high­er risk for bio­chem­i­cal re­cur­rence fol­low­ing pri­ma­ry treat­ment, which may re­sult in metas­tases,” Ah­san Arozul­lah, se­nior VP and head of de­vel­op­ment in ther­a­peu­tics at Astel­las, said in a state­ment.

“The EM­BARK tri­al is the first study to demon­strate a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in MFS us­ing the com­bi­na­tion of XTAN­DI plus le­upro­lide in men with this stage of dis­ease.”

The sec­ondary end­point, over­all sur­vival, showed a “pos­i­tive trend” but the da­ta aren’t ma­ture, ac­cord­ing to the com­pa­nies. There will be a fi­nal analy­sis of the da­ta af­ter fol­low­ing up with the pa­tients.

An­oth­er sec­ondary end­point look­ing at Xtan­di as a monother­a­py al­so showed “sta­tis­ti­cal­ly sig­nif­i­cant” im­prove­ment in metas­ta­sis-free sur­vival.

Ac­cord­ing to the press re­lease, the com­pa­nies will dis­cuss the da­ta with the FDA about a po­ten­tial new sub­mis­sion for Xtan­di in this can­cer.

Xtan­di was first ap­proved back in 2012 for late-stage cas­tra­tion-re­sis­tant prostate can­cer, and since then, more than 720,000 pa­tients have been treat­ed with XTAN­DI glob­al­ly, ac­cord­ing to da­ta from Astel­las.

But the price has been a grow­ing con­cernin Jan­u­ary, de­mo­c­ra­t­ic law­mak­ers added their voic­es to the mix and pressed for the fed­er­al gov­ern­ment to use its march-in rights to low­er the price of Xtan­di.

The law­mak­ers re­quest­ed a pub­lic hear­ing on a pe­ti­tion to low­er Xtan­di’s price filed by pa­tients by al­low­ing gener­ic drug­mak­ers to pro­duce cheap­er ver­sions of the drug, over­rid­ing the patent mo­nop­oly. The av­er­age whole­sale price is more than $189,000 per year, the pe­ti­tion­ers wrote to HHS Sec­re­tary Xavier Be­cer­ra.

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

Editor’s note: This is a live story and will be updated.

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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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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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.

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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