Lag­ging fur­ther be­hind, As­traZeneca adds fresh de­tails to its check­point come­back strat­e­gy

As­traZeneca has sketched out some fresh de­tails on its mis­sion crit­i­cal piv­otal study on its check­point drug ap­proach to non-small cell lung can­cer, map­ping an­oth­er like­ly de­lay as the phar­ma gi­ant looks for its first big open­ing in the megablock­buster can­cer mar­ket.

The MYS­TIC study has been en­rolling lung can­cer pa­tients re­gard­less of PD-L1 ex­pres­sion sta­tus. In its state­ment to­day the phar­ma gi­ant says it will eval­u­ate pro­gres­sion-free sur­vival as well as over­all sur­vival for dur­val­um­ab com­bined with treme­li­mum­ab — its all-im­por­tant I/O + I/O matchup that will look to out­per­form the ther­a­pies al­ready ap­proved for front­line and sec­ond line pa­tients — for all com­ers as well as PD-L1 ex­pressers. And it will al­so now ex­plore the da­ta for dur­val­um­ab as a monother­a­py.

Sea­mus Fer­nan­dez, Leerink

Da­ta are ex­pect­ed now mid-year for PFS and no lat­er than some­time in 2018 for OS, which Sea­mus Fer­nan­dez at Leerink counts as a three-month de­lay:

“In the wake of MRK’s (MP) sur­prise fil­ing an­nounce­ment for its Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemother­a­py com­bi­na­tion, AZN’s de­ci­sion to fo­cus on MYS­TIC’s best chance of suc­cess with ei­ther mono- or com­bo ther­a­py is ra­tio­nal, in our view,” Fer­nan­dez not­ed. “In ad­di­tion, the com­pa­ny’s strate­gic up­date on im­muno-on­col­o­gy (IO) monother­a­py (PEARL study) and com­bo ther­a­py (ex­pand­ed NEP­TUNE re­cruit­ment) pro­vides an­oth­er sub­stan­tial shot on goal for the com­pa­ny’s glob­al IO ef­forts.”

The NEP­TUNE study will be used to seek an OK in Chi­na for first-line use based on ear­li­er PFS da­ta while the new­ly launched PEARL will go af­ter PD-L1 ex­pressers in Asian mar­kets, where the rate of NSCLC runs high.

Mer­ck stunned the mar­ket re­cent­ly when it sped through a fil­ing for a com­bi­na­tion of Keytru­da with chemother­a­py in front­line NSCLC, putting some fresh dis­tance be­tween its big check­point and Bris­tol-My­ers Squibb’s ri­val Op­di­vo. Roche was the third play­er on the mar­ket with Tecen­triq, which is al­so in­volved in mul­ti­ple stud­ies.

As­traZeneca, which stum­bled through a se­ries of mishaps last year, des­per­ate­ly needs to do some­thing right with dur­val­um­ab to at least par­tial­ly sat­is­fy some big promis­es CEO Pas­cal So­ri­ot has made to in­vestors. A late ar­rival to the check­point mar­ket, ei­ther along­side or right be­hind Pfiz­er, leaves As­traZeneca with shrink­ing op­por­tu­ni­ties for mak­ing a splash.

It’s still pos­si­ble, though, and an­a­lysts aren’t count­ing the com­pa­ny out.

“While Keytru­da is now ap­proved in 1L pa­tients with PD-L1 ex­pres­sion of 50% or high­er, there re­mains “white space” for dur­va in PD-L1+ pa­tients with low­er (but still pos­i­tive) ex­pres­sion,” re­ports Fer­nan­dez.

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.

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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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.