Trodelvy notch­es a win in most com­mon form of breast can­cer

Fol­low­ing a promise last year to go “big and fast in breast can­cer,” Gilead has se­cured a win for Trodelvy in the most com­mon form.

The drug was ap­proved to treat HR-pos­i­tive, HER2-neg­a­tive breast can­cer pa­tients who’ve al­ready re­ceived en­docrine-based ther­a­py and at least two oth­er sys­temic ther­a­pies for metasta­t­ic can­cer, Gilead an­nounced on Fri­day.

Bill Gross­man

Trodelvy won its first in­di­ca­tion in metasta­t­ic triple-neg­a­tive breast can­cer back in 2020, and has since added urothe­lial can­cer to the list. HR-pos­i­tive HER2-neg­a­tive breast can­cer ac­counts for rough­ly 70% of new breast can­cer cas­es world­wide per year, ac­cord­ing to se­nior VP of on­col­o­gy clin­i­cal de­vel­op­ment Bill Gross­man, and many pa­tients de­vel­op re­sis­tance to en­docrine-based ther­a­pies or wors­en on chemother­a­py.

“As pa­tients progress on en­docrine ther­a­pies and they get in­to oth­er com­bi­na­tions like CDK4/6, [they are] re­al­ly left on­ly with chemother­a­py at this stage,” Gross­man said. “For the pa­tients from TROP­iCS-02, me­di­an sur­vival is on­ly ap­prox­i­mate­ly one year.”

Gilead tout­ed a bet­ter-than-ex­pect­ed read­out from the TROP­iCS-02 study at last year’s ES­MO con­fer­ence, in which pa­tients with HR+/HER2- metasta­t­ic breast can­cer who re­ceived Trodelvy af­ter pri­or en­docrine ther­a­py, CDK4/6 in­hibitors and two to four lines of chemother­a­py sur­vived a me­di­an of 14.4 months, com­pared to just 11.2 months for those who re­ceived chemo. Trodelvy al­so post­ed a 34% re­duc­tion in the risk of dis­ease pro­gres­sion or death (p=0.0003), Gilead said Fri­day.

Trodelvy sales were up 79% last year, to­tal­ing $680 mil­lion and “re­flect­ing con­tin­ued adop­tion in metasta­t­ic TNBC in the Unit­ed States and Eu­rope,” Gilead an­nounced yes­ter­day in its Q4 earn­ings re­port. On the Q3 call, ex­ecs said they had al­ready be­gun prepar­ing for a po­ten­tial launch in HR-pos­i­tive HER2-neg­a­tive breast can­cer. The drug earned just $380 mil­lion in 2021.

While Trodelvy was slapped with a boxed warn­ing back in 2020 for se­vere neu­trope­nia and se­vere di­ar­rhea, Gross­man said last week that “those are side ef­fects that I think most physi­cians are very, very ac­cus­tomed to.” Neu­trope­nia oc­curs when pa­tients have too few of a type of white blood cell called neu­trophils.

“Physi­cians are pret­ty well-versed in try­ing to rec­og­nize those side ef­fects ear­ly and quick in­ter­ven­tions,” he said.

Last year, As­traZeneca and Dai­ichi Sankyo’s ADC ther­a­py En­her­tu be­came the first ther­a­py ap­proved for a new­ly de­fined sub­set of breast can­cer pa­tients called HER2-low. About 60% of HER2-neg­a­tive pa­tients fall in­to the HER2-low buck­et, mean­ing they have some HER2 pro­teins, but not enough to be clas­si­fied as HER2-pos­i­tive.

Gilead al­so post­ed HER2-low and IHC0 da­ta from the TROP­iCS-02 tri­al at ES­MO, with pro­gres­sion-free sur­vival com­ing in at 6.4 months in the treat­ment arm for HER2-low pa­tients, and five months for IHC0 pa­tients, the com­pa­ny an­nounced at the time.

“In a post-hoc analy­sis, da­ta demon­strat­ed Trodelvy’s ef­fi­ca­cy across HER2-low and IHC0 sta­tus in pre-treat­ed metasta­t­ic breast can­cer pa­tients in the TROP­iCS-02 tri­al,” Gilead said in a news re­lease on Fri­day.

Gross­man called the drug a “cor­ner­stone, bedrock to our pipeline” at ES­MO, while promis­ing to move in­to ear­li­er lines of ther­a­py and across “a wide num­ber of dif­fer­ent tu­mor types.” He re­it­er­at­ed those plans in an in­ter­view ahead of the re­cent de­ci­sion.

“We’re go­ing fast and fu­ri­ous” in adding new prod­ucts to the port­fo­lio, he said. “And Trodelvy is one of those.”

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.

Mass­a­chu­setts judge dis­miss­es law­suit against Bio­gen over failed launch of Alzheimer's drug Aduhelm

A Massachusetts federal judge on Wednesday dismissed a class action lawsuit filed by investors against Biogen and several of its current and former executives over the company’s failed Alzheimer’s drug, Aduhelm (aducanumab).

The investors argued that Biogen’s contact with the FDA was unlawful and that the company made 25 false and misleading statements, including statements about the rollout and price of the drug.

Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

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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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.

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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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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