Ab­b­Vie grap­ples with an­oth­er set­back as 2 PhI­II tri­als for its PARP veli­parib flop

Up un­til now, PARP in­hibitors have been blaz­ing a broad, long trail of suc­cess in the clin­ic, with Lyn­parza, Rubra­ca and now Ze­ju­la hit­ting a busy and grow­ing mar­ket for can­cer pa­tients.

Ab­b­Vie CEO Richard Gon­za­lez

But Ab­b­Vie $AB­BV won’t be join­ing that crowd any­time soon.

Re­searchers at the com­pa­ny chose to an­nounce late Wednes­day that their PARP, veli­parib, failed in two Phase III stud­ies in pa­tients with squa­mous non-small cell lung can­cer (NSCLC) and triple neg­a­tive breast can­cer.

De­tails will have to wait un­til an up­com­ing can­cer drug con­fer­ence. But Ab­b­Vie prepped a few short words for the late-stage bur­ial de­tail.

“Re­search shows there is a role for PARP in­hibitors in can­cers as­so­ci­at­ed with DNA re­pair deficits, such as those with BR­CA mu­ta­tions. In these clin­i­cal tri­als, we want­ed to ex­plore whether a PARP in­hibitor could aug­ment chemother­a­py in pa­tients with squa­mous non-small cell lung can­cer and triple neg­a­tive breast can­cer by dis­rupt­ing the re­pair of can­cer cells,” said Gary Gor­don, the VP of on­col­o­gy clin­i­cal de­vel­op­ment at Ab­b­Vie. “Un­for­tu­nate­ly, these da­ta do not sup­port the use of veli­parib in com­bi­na­tion with chemother­a­py in these pa­tients.”

There’s plen­ty of work ahead as the rest of the new wave of PARPs looks to broad­en la­bels and ex­pand mar­ket pen­e­tra­tion. Still to be heard from? Pfiz­er, which grabbed ta­la­zoparib in their $14 bil­lion ac­qui­si­tion of Medi­va­tion. The phar­ma gi­ant will need to do much bet­ter than Ab­b­Vie if it wants to jus­ti­fy the price it paid.

Ab­b­Vie has been hus­tling up a big late-stage ef­fort to bring new drugs to the mar­ket, be­fore it los­es patent pro­tec­tion on the all-im­por­tant $16 bil­lion Hu­mi­ra flag­ship fran­chise. But it’s been strug­gling on the can­cer front, fail­ing so far to im­press an­a­lysts with Ro­va-T, which it ac­quired in a $10 bil­lion buy­out.

Ge­of­frey Porges at Leerink likes some of Ab­b­Vie’s late-stage pro­grams, but he’s writ­ing off veli­parib as es­sen­tial­ly worth­less. He not­ed:

While two dis­ap­point­ing tri­als would not nor­mal­ly com­plete­ly doom a pro­gram, the lack of ef­fect in­deed con­firms our view that veli­parib has lim­it­ed ac­tiv­i­ty and is not com­pet­i­tive with oth­er prod­ucts in this class. For this rea­son we are tak­ing the prob­a­bil­i­ty of suc­cess (POS) of the pro­gram to ze­ro, and re­duc­ing our rev­enue and earn­ings ex­pec­ta­tions ac­cord­ing­ly.

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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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.

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.

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.