Mer­ck clears PFS end­point in con­fir­ma­to­ry tri­al for Keytru­da in clas­si­cal Hodgkin lym­phoma

Clas­si­cal Hodgkin lym­phoma was the first blood can­cer that Mer­ck’s Keytru­da was ap­proved to treat. Three years af­ter that OK ar­rived — kick­ing off a spate of new in­di­ca­tions for the star PD-1 in­hibitor — the com­pa­ny fi­nal­ly has some sol­id ev­i­dence of its ef­fect.

Build­ing on the over­all re­sponse rates that con­vinced FDA reg­u­lars to hand down an ac­cel­er­at­ed ap­proval in March 2017, Mer­ck said Keytru­da hit a co-pri­ma­ry end­point on pro­gres­sion-free sur­vival in the Phase III con­fir­ma­to­ry tri­al.

The up­date comes from an in­ter­im analy­sis com­par­ing Keytru­da to Ad­cetris, an an­ti­body-drug con­ju­gate from Seat­tle Ge­net­ics, among pa­tients with re­lapsed or re­frac­to­ry cHL who have re­ceived three or more lines of ther­a­py.

“Pa­tients with clas­si­cal Hodgkin lym­phoma are gen­er­al­ly young and when they do not achieve re­mis­sion fol­low­ing stan­dard treat­ment, their can­cer is chal­leng­ing to treat,” Jonathan Cheng, VP of on­col­o­gy clin­i­cal re­search at Mer­ck Re­search Lab­o­ra­to­ries, said in a state­ment.

The study, KEYNOTE-204, will con­tin­ue to eval­u­ate the oth­er co-pri­ma­ry end­point of over­all sur­vival. Re­sults will be pre­sent­ed at an up­com­ing med­ical meet­ing.

Mer­ck in­clud­ed the monother­a­py reg­i­men in fourth-line treat­ment of cHL in its ap­pli­ca­tion for a new Keytru­da dos­ing sched­ule of every six weeks — to which the FDA re­spond­ed with a com­plete re­sponse let­ter days ago. But Mizuho an­a­lyst Mara Gold­stein char­ac­ter­ized it as one of the “less mean­ing­ful in­di­ca­tions” com­pared to core com­bo fran­chis­es in non-small cell lung can­cer and re­nal cell car­ci­no­ma in dri­ving sales of $20 bil­lion by 2024 as she has pre­vi­ous­ly es­ti­mat­ed.

The com­pa­ny has two oth­er cHL tri­als for Keytru­da un­der way, in­clud­ing com­bi­na­tion tests with chemo among chil­dren and young adults new­ly di­ag­nosed with the dis­ease (KEYNOTE-667), and with Af­fimed’s AFM13 in the post-Ad­cetris set­ting (KEYNOTE-206).

So­cial im­age: Shut­ter­stock

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

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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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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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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.