In two-way race with No­var­tis, Mer­ck scores first reg­u­la­to­ry ap­proval for tar­get­ed lung can­cer drug

In the two-man race to de­vel­op a new in­hibitor for an ag­gres­sive form of lung can­cer, Mer­ck KGaA has won the first reg­u­la­to­ry ap­proval.

Japan be­came the first coun­try to ap­prove the phar­ma gi­ant’s MET in­hibitor tepo­tinib, the first tar­get­ed pill for the 3 to 4% of non-small lung can­cer pa­tients with a MET mu­ta­tion. In a Phase II study pub­lished last year in Clin­i­cal On­col­o­gy, just over half of the 89 pa­tients re­spond­ed to the treat­ment. The re­sponse last­ed for a me­di­an of 9.8 months.

Mer­ck pre­sent­ed that da­ta at AS­CO a year ago — the same day No­var­tis pre­sent­ed da­ta on their MET in­hibitor cap­ma­tinib, which showed a 68% over­all re­sponse in first-line pa­tients and 41% in sec­ond-line pa­tients. At the time, Mer­ck’s da­ta showed 59% in first-line pa­tients and 45% in sec­ond-line pa­tients. Du­ra­tion of re­sponse was sim­i­lar, al­though Mer­ck’s drug looked to be more tol­er­a­ble.

The Japan­ese de­ci­sion clears tepo­tinib as both a first and lat­er-line ther­a­py and means it will be the first of the two drugs to reach pa­tients. No­var­tis, though, has the lead on US ap­proval. Last month, the Swiss drug­mak­er filed for FDA ap­proval and won pri­or­i­ty re­view. They didn’t an­nounce a PDU­FA date, but bar­ring any pan­dem­ic-re­lat­ed dis­rup­tions or oth­er de­lays, the award should cut four months off the usu­al process and bring a de­ci­sion in Au­gust.

Mer­ck shouldn’t be far be­hind. They, like No­var­tis, won break­through sta­tus for the drug — of­ten a pre­cur­sor to pri­or­i­ty re­view — and are thought to be near­ing an FDA sub­mis­sion.

The spe­cif­ic mu­ta­tion both drugs tar­get is known as a MET ex­on 14 skip­ping mu­ta­tion. That ex­on codes for an E3 lig­ase bind­ing site, the area the body’s pro­tein degra­da­tion sys­tem latch­es on­to to dis­pose of the pro­tein. Its ab­sence has sev­er­al down­stream ef­fects, in­clud­ing an ac­cu­mu­la­tion of MET, that help give rise to can­cer.

No­var­tis CEO Vas Narasimhan in­clud­ed the com­pa­ny’s MET in­hibitor as one of sev­en po­ten­tial block­busters the com­pa­ny was hop­ing to bring on to the mar­ket in 2020. It was orig­i­nal­ly de­vel­oped by In­cyte.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.