FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Mer­ck’s block­buster can­cer treat­ment Keytru­da has been hand­ed an­oth­er in­di­ca­tion by the FDA.

The US reg­u­la­tor an­nounced on Thurs­day that it has ap­proved Keytru­da to serve as an ad­ju­vant treat­ment for non-small cell lung can­cer (NSCLC), which is its fifth in­di­ca­tion in NSCLC and 34th in­di­ca­tion over­all.

Ac­cord­ing to a Mer­ck re­lease, the ap­proval is based on da­ta from a Phase III tri­al, dubbed Keynote-091, which mea­sured dis­ease-free sur­vival in pa­tients who re­ceived chemother­a­py fol­low­ing surgery. The da­ta from Mer­ck dis­played that Keytru­da cut down on the risk of dis­ease re­cur­rence or death by 27% ver­sus place­bo.

The FDA stat­ed that ad­verse re­ac­tions were about the same be­tween the drug and con­trol arms, with cas­es of hy­pothy­roidism and pneu­moni­tis be­ing re­port­ed. There were two fa­tal re­ac­tions of my­ocardi­tis re­port­ed in the tri­al as well.

“With this ap­proval, KEYTRU­DA of­fers a new, im­por­tant im­munother­a­py treat­ment op­tion for stage IB (T2a ≥4 cm), II, or II­IA pa­tients with non-small cell lung can­cer fol­low­ing surgery and ad­ju­vant chemother­a­py. This pro­vides, for the first time, an ad­ju­vant im­munother­a­py treat­ment op­tion for non-small cell lung can­cer pa­tients with stage IB dis­ease and re­gard­less of PD-L1 ex­pres­sion,” Mer­ck said in an email to End­points News.

Keytru­da is not stop­ping there as, ac­cord­ing to Mer­ck’s email to End­points, the drug has been ac­cept­ed for pri­or­i­ty re­view in com­bi­na­tion with Pad­cev for treat­ing pa­tients with ad­vanced or metasta­t­ic urothe­lial can­cer who are not el­i­gi­ble for re­ceiv­ing chemo. The PDU­FA date for that is set for April 21.

The good news has kept rolling in for Mer­ck’s top sell­er. To­ward the end of 2022, the an­ti-PD-1 an­ti­body had a less-fre­quent dos­ing reg­i­men, pre­vi­ous­ly cleared by the FDA un­der ac­cel­er­at­ed ap­proval, con­vert­ed in­to full ap­proval. That ac­cel­er­at­ed ap­proval al­lowed for the dos­ing of pa­tients once every six weeks with 400 mg of the drug as op­posed to 200 mg every three weeks.

On the sales front, Keytru­da sales grew to $5.4 bil­lion on Mer­ck’s Q3 re­port, but a pre­view re­port from Eval­u­ate showed that Keytru­da sales are ex­pect­ed to add al­most $3 bil­lion. This is on top of the $20.89 bil­lion in 2022 sales.

Ed­i­tor’s Note: An ear­li­er ver­sion of this sto­ry stat­ed that Keytru­da has 33 in­di­ca­tions. The ar­ti­cle has been cor­rect­ed to note that the lat­est in­di­ca­tion brings the to­tal to 34.

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.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

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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Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Sulagna Bhattacharya, Nanoscope Therapeutics CEO

Nanoscope’s eye dis­ease gene ther­a­py shows mixed re­sults in PhII

Dallas-based biotech Nanoscope Therapeutics unveiled Phase II results on its gene therapy for a rare eye disease Thursday morning.

In the RESTORE trial, 18 patients with retinitis pigmentosa got a gene therapy called MCO-010 while nine got placebo. On a vision test called the MLYMT, the treatment group had a one-point greater change over one year in their score compared to the placebo group, the primary endpoint of the study. However, the 95% confidence interval was 0.0 to 3.0, meaning the result was not statistically significant. The p-value was not provided.

Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

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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Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.