J&J’s stel­lar prostate can­cer da­ta sig­nals the like­li­hood of a broad­er mar­ket ap­proval, as Pfiz­er ri­val strug­gles

CHICA­GO — J&J will be look­ing to ex­pand its block­buster mar­ket for Zyti­ga (abi­raterone) af­ter post­ing stel­lar da­ta at AS­CO show­ing that the drug com­bined with stan­dard hor­mone ther­a­py reg­is­tered a ma­jor im­prove­ment in pro­gres­sion-free sur­vival among new­ly di­ag­nosed pa­tients with metasta­t­ic prostate can­cer.

The LAT­I­TUDE study da­ta demon­strat­ed that the com­bi­na­tion ther­a­py de­liv­ered an av­er­age stretch of 33 months with­out the dis­ease wors­en­ing, com­pared to 14.8 months for stan­dard hor­mone ther­a­py. Zyti­ga plus pred­nisone in com­bi­na­tion with ADT de­creased the risk of pro­gres­sion or death by 53% com­pared to place­bo plus ADT in pa­tients with mH­N­PC. And while over­all sur­vival was not reached yet for the Zyti­ga com­bo, the com­par­i­son arm came in at 34.7 months.

J&J $JNJ has been duk­ing it out with Pfiz­er’s Xtan­di — re­cent­ly ac­quired in the $14 bil­lion Medi­va­tion deal — in the area of prostate can­cer, where both drugs are cred­it­ed with a ma­jor im­prove­ment in the stan­dard of care for prostate can­cer.

The progress for J&J will like­ly be viewed as Pfiz­er’s loss. The phar­ma gi­ant has post­ed shrink­ing sales for Xtan­di since it com­plet­ed the buy­out. And its fol­low-on da­ta hasn’t been good.

Karim Fizazi, Uni­ver­si­ty Paris-Sud

Late last year Pfiz­er and its part­ners at Astel­las con­ced­ed that Xtan­di com­bined with Zyti­ga and pred­nisone failed to bend the curve on pro­gres­sion-free sur­vival for chemo-naïve pa­tients whose dis­ease had pro­gressed fol­low­ing treat­ment with Xtan­di, com­pared with a group of pa­tients treat­ed with Zyti­ga and pred­nisone alone. The in­ves­ti­ga­tors had been look­ing for a ra­tio­nale to con­tin­ue treat­ment with Xtan­di, which would have ex­pand­ed its block­buster mar­ket even fur­ther.

Said J&J’s prin­ci­pal in­ves­ti­ga­tor Dr. Karim Fizazi:

This is im­por­tant new in­for­ma­tion, as not all pa­tients re­spond well to the cur­rent stan­dard of care. LAT­I­TUDE sug­gests that abi­raterone ac­etate plus pred­nisone, in com­bi­na­tion with an­dro­gen de­pri­va­tion ther­a­py, can of­fer a new and much-need­ed op­tion for pa­tients with high-risk new­ly di­ag­nosed mH­N­PC.

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.

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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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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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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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

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.