In crowd­ed prostate can­cer mar­ket, Pfiz­er's Xtan­di notch­es third ap­proval for use in ear­li­er stage of dis­ease

Pfiz­er’s en­trenched an­dro­gen re­cep­tor in­hibitor Xtan­di has se­cured its third prostate can­cer ap­proval in a mar­ket flush with ri­vals.

On Mon­day, Pfiz­er and part­ner Astel­las an­nounced Xtan­di had scored FDA ap­proval in pa­tients with metasta­t­ic cas­tra­tion (or hor­mone)-sen­si­tive prostate can­cer (mC­SPC). It’s a form of prostate can­cer that has spread to oth­er parts of the body but still re­sponds to a med­ical or sur­gi­cal treat­ment that low­ers testos­terone — af­fect­ing rough­ly 40,000 men in the Unit­ed States cur­rent­ly. Xtan­di is now the on­ly oral FDA-ap­proved ther­a­py in three dis­tinct types of ad­vanced prostate can­cer, the com­pa­nies said.

Xtan­di in com­bi­na­tion with stan­dard an­dro­gen de­pri­va­tion ther­a­py (ADT) was test­ed against ADT plus place­bo in the ARCH­ES tri­al in 1,150 pa­tients with metasta­t­ic hor­mone (or cas­tra­tion) sen­si­tive prostate can­cer.

Da­ta showed the Xtan­di com­bi­na­tion re­duced the risk of ra­di­ograph­ic pro­gres­sion or death by 61% ver­sus place­bo plus ADT (con­fi­dence in­ter­val: 0.30-0.50; p<0.0001) — over­all sur­vival da­ta were not ma­ture at the time of analy­sis.

In the first nine months of 2019, the drug gen­er­at­ed $594 mil­lion in glob­al sales. An­ti-an­dro­gens drugs such as J&J’s Zyti­ga and Pfiz­er’s Xtan­di were first ap­proved in metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC) in 2011 and 2012 re­spec­tive­ly. Since then, this class of drugs has al­so shown to be ef­fec­tive in ear­li­er-dis­ease set­tings such as non-metasta­t­ic CR­PC and metasta­t­ic hor­mone-sen­si­tive prostate can­cer (mH­SPC).

In a note re­flect­ing dis­cus­sions by a pan­el of prostate can­cer ex­perts in Sep­tem­ber, Cowen an­a­lysts cit­ed a pan­elist that in­di­cat­ed that the sev­er­al an­ti-an­dro­gens on the mar­ket are on some­what “equal foot­ing” in the mH­SPC set­ting with sim­i­lar clin­i­cal da­ta. “Pa­tients in the U.S. pre­fer oral hor­mon­al agents over al­ter­na­tive chemother­a­py, so our ex­pert be­lieves Zyti­ga and Xtan­di could both hold sub­stan­tial mar­ket share in mH­SPC,” they wrote.

Prostate can­cer is the sec­ond most com­mon­ly di­ag­nosed ma­lig­nan­cy in men glob­al­ly, and treat­ment op­tions in­clude surgery, ra­di­a­tion treat­ment and ther­a­py us­ing hor­mone-re­cep­tor an­tag­o­nists. How­ev­er, in near­ly every case, the can­cer grows re­sis­tant to con­ven­tion­al hor­mone ther­a­py. Cas­tra­tion-re­sis­tant prostate can­cer (CR­PC) is an ad­vanced form of the dis­ease and is char­ac­ter­ized by per­sis­tent, high-lev­el an­dro­gen re­cep­tor (AR) func­tion and re­sis­tance to con­ven­tion­al an­ti-an­dro­gens.

Ear­li­er this year, Bay­er and Finnish part­ner Ori­on’s AR in­hibitor Nube­qa was ap­proved for pa­tients with cas­tra­tion-re­sis­tant prostate can­cer that has not spread to oth­er parts of the body (nm­CR­PC). Mean­while, PARP and PD-(L)1 agents are al­so be­ing test­ed for use in prostate can­cer.

So­cial im­age: Pfiz­er, Jeff Ru­mens

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.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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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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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Aptinyx eval­u­ates fu­ture of the com­pa­ny fol­low­ing two failed tri­als, 60% lay­offs

This year has been tough for Aptinyx — two failed trials, a 60% cut in its workforce, and now the company has brought on a firm to help evaluate the future of the company.

The press release noted it’s working with the firm Ladenburg Thalmann as its financial advisor to assist in exploring and evaluating “strategic alternatives” — a process that a growing group of struggling biotechs has embarked on, sometimes ending in a merger, asset sale or wind-down.

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