As­traZeneca scores again: Calquence ap­proved for CLL as BTK race heats up

Six months af­ter first boast­ing about Phase III da­ta, As­traZeneca has earned ex­pand­ed FDA ap­proval for its BTK in­hibitor Calquence. The drug will now be used to treat one of the most com­mon adult blood can­cers, chron­ic lym­pho­cyt­ic leukemia (CLL).

In the spring, the Eu­ro­pean gi­ant called its shot ear­ly, point­ing to­ward reg­u­la­to­ry sub­mis­sions as in­ter­im tri­al da­ta came out. They said in May the drug had aced a Phase III tri­al as a sec­ond-line CLL treat­ment. Then in June, they an­nounced high pro­gres­sion-free sur­vival from pa­tients in a tri­al of pa­tients who re­ceived Calquence as a front­line ther­a­py.

The drug is now ap­proved as a sin­gle agent and as a com­bi­na­tion ther­a­py for front­line and sec­ond-line treat­ment. The drug is al­so ap­proved to treat SLL or small lym­pho­cyt­ic leukemia, which is the same dis­ease as CLL but ap­pears in the lymph nodes as op­posed to blood or bone mar­row. Pre­vi­ous­ly, it was on­ly ap­proved for man­tle cell lym­phoma.

The EL­E­VATE-TN study on Calquence as a front­line treat­ment showed the drug low­ered the risk of dis­ease pro­gres­sion or death by 90% in com­bi­na­tion with an­oth­er ther­a­py and by 80% as a monother­a­py.

José Basel­ga As­traZeneca

De­spite Imfinzi’s con­tin­ued stum­bles, As­traZeneca’s on­col­o­gy group has large­ly thrived un­der new chief José Basel­ga, who ar­rived at the phar­ma gi­ant af­ter a con­tro­ver­sial ex­it at Memo­r­i­al Sloan Ket­ter­ing. In Au­gust, the com­pa­ny an­nounced two more rounds of strong Phase III da­ta from their PARP in­hibitor Lyn­parza, first in prostate can­cer and then in ovar­i­an can­cer.

Calquence is part of the next gen­er­a­tion of BTK in­hibitors that have promised to be safer and more tol­er­a­ble to pa­tients. These in­hibitors block Bru­ton’s ty­ro­sine ki­nase, an en­zyme that plays a role in onco­genic sig­nal­ing and the rise of some leukemic cells. J&J and Ab­b­Vie un­veiled the first such drug, Im­bru­vi­ca, in 2013, but de­spite bil­lions in rev­enue, the drug can have steep side ef­fects.

Ear­li­er this month, the FDA ap­proved BeiGene’s sec­ond-gen­er­a­tion BTK in­hibitor, Brukin­sa, for man­tle cell lym­phoma. It was the first-ever Chi­nese can­cer drug ap­proved in the US.

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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Rep. Buddy Carter (R-GA) (Bill Clark/CQ Roll Call via AP Images).

US House as­sem­bles bi­par­ti­san cau­cus on do­mes­tic phar­ma man­u­fac­tur­ing

The US House of Representatives is taking a further interest in domestic pharma manufacturing by creating the Domestic Pharmaceutical Manufacturing Caucus, led by Reps. Buddy Carter (R-GA), Elissa Slotkin (D-MI), Gus Bilirakis (R-FL) and Chrissy Houlahan (D-PA).

As the supply chain increasingly is outsourced to China and India, particularly on the active pharmaceutical ingredient side, the caucus will aim to focus on moving forward legislation that incentivizes greater domestic manufacturing of medicines. Carter said the caucus will try to reduce US reliance on “foreign adversaries,” try to ensure an adeqate supply of pharmaceuticals and try to halt supply chain disruptions.

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.