Servi­er says its next IDH in­hibitor has passed PhI­II, but no reg­u­la­to­ry time­line yet

Servi­er’s IDH in­hibitor vo­rasi­denib has passed its Phase III tri­al in low-grade glioma, the com­pa­ny an­nounced Tues­day morn­ing. How­ev­er, it left its reg­u­la­to­ry time­line up in the air.

Su­san Pandya

The drug met the pri­ma­ry end­point of pro­gres­sion-free sur­vival as well as a sec­ondary end­point of time to next in­ter­ven­tion, Servi­er said. But when asked for more de­tails in an in­ter­view with End­points News, Servi­er’s VP of clin­i­cal de­vel­op­ment Su­san Pandya de­clined to com­ment.

Vo­rasi­denib tar­gets tu­mors with ei­ther the IDH 1 or 2 mu­ta­tions. The for­mer is found in more than 70% of grade 2 and 3 gliomas, ac­cord­ing to a 2009 NE­JM pa­per. The lat­ter is less com­mon, and Pandya es­ti­mat­ed that around 6-8% of peo­ple who have low-grade gliomas have an IDH2 mu­ta­tion.

Servi­er ac­quired the drug along­side Tib­so­vo, an ap­proved IDH1 in­hibitor for AML and bile duct can­cer, when it bought Agios’ can­cer port­fo­lio in 2020. The FDA re­cent­ly ap­proved a Tib­so­vo com­peti­tor in Rigel Phar­ma­ceu­ti­cals’ Re­zlid­hia.

The IN­DI­GO tri­al en­rolled over 300 pa­tients who have un­der­gone surgery as their on­ly oth­er treat­ment and ran­dom­ized them to re­ceive ei­ther vo­rasi­denib or place­bo.

Servi­er said the safe­ty pro­file was sim­i­lar to what it had pre­vi­ous­ly pub­lished on vo­rasi­denib, but didn’t give ad­di­tion­al de­tails. In a Phase I tri­al, the drug caused el­e­vat­ed liv­er en­zyme lev­els, which can lead to liv­er tox­i­c­i­ty. Pa­tients al­so had nau­sea and headaches in that tri­al.

No­tably, Servi­er didn’t set a reg­u­la­to­ry time­line for when it would file for FDA ap­proval. In the press re­lease, Servi­er said, “Due to the ac­cel­er­at­ed en­roll­ment and in­ter­im ef­fi­ca­cy analy­sis out­come, the IN­DI­GO clin­i­cal tri­al is well ahead of sched­ule. Servi­er is work­ing to de­ter­mine fil­ing time­lines and adapt the vo­rasi­denib sup­ply ca­pac­i­ty.”

When asked about the press re­lease, Pandya said that it in part had to do with en­rolling the study over the Covid-19 pan­dem­ic, adding that the study hit the pre-spec­i­fied num­ber of events for pro­gres­sion-free sur­vival ahead of what Servi­er es­ti­mat­ed. “I can’t re­al­ly speak to ex­act­ly what our reg­u­la­to­ry time­line will look like,” she said.

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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