GSK poised to leap back in­to the on­col­o­gy mar­ket with more pos­i­tive be­lan­tam­ab mafodotin re­sults — but BC­MA ri­vals are swarm­ing in be­hind

Glax­o­SmithK­line took an im­por­tant step to­ward a key new ap­proval Mon­day night, post­ing their sec­ond pos­i­tive round of piv­otal da­ta for the BC­MA-tar­get­ing mul­ti­ple myelo­ma con­ju­gate be­lan­tam­ab mafodotin (GSK2857916). And with up­beat DREAMM-2 da­ta, they’ve filed for an ap­proval with hopes of get­ting a pri­or­i­ty re­view for their “break­through” drug can­di­date.

But af­ter the stel­lar rounds of new da­ta in the BC­MA field at ASH a few days ago, don’t ex­pect a tremen­dous lev­el of ex­cite­ment to greet them over the out­come.

To be sure, a 31% over­all re­sponse rate among 97 very sick pa­tients with 3 com­plete re­spons­es in the bunch is like­ly enough to war­rant an FDA OK — giv­en reg­u­la­tors’ track record when it comes to pa­tients and op­tions. But the re­sults leave open the ques­tion of what the long-term com­mer­cial prospects can be as GSK makes its way back in­to the on­col­o­gy mar­ket af­ter a long and painful ab­sence.

Me­di­an du­ra­tion has not been es­tab­lished yet.

For ‘7916, the new da­ta batch marks a sig­nif­i­cant drop from the 60% ORR in DREAMM-1, though in­ves­ti­ga­tors note that this new tri­al in­clud­ed a much sick­er set of pa­tients with dwin­dling op­tions. At ASH we al­so saw a CAR-T from J&J that de­liv­ered a 100% re­sponse rate in the BC­MA field for mul­ti­ple myelo­ma. That came with a jaw drop­ping 69% com­plete re­sponse rate. Re­gen­eron im­pressed with its bis­pe­cif­ic REGN5458, while blue­bird and Bris­tol-My­ers Squibb lead the boom­ing BC­MA field, and now add their bis­pe­cif­ic CC-92369 to the list of am­bi­tious can­di­dates. The list goes on.

And out in front, Darza­lex con­tin­ues to make new progress in com­bi­na­tion with oth­er drugs for mul­ti­ple myelo­ma. At ASH Am­gen post­ed a 37% re­duc­tion in the risk of pro­gres­sion of mul­ti­ple myelo­ma for pa­tients treat­ed with a com­bi­na­tion of Kypro­lis and the block­buster Darza­lex from J&J and Gen­mab, com­pared to ei­ther alone.

Game over for GSK?

Not quite.

Ax­el Hoos

Ax­el Hoos, the GSK on­col­o­gy R&D chief who kept the flame of ear­ly-stage can­cer R&D burn­ing af­ter a big pipeline/com­mer­cial swap with No­var­tis, read­i­ly agrees that both the CAR-Ts as well as the bis­pecifics have a lot of ex­cit­ing da­ta be­hind them. They al­so have fur­ther to go in the clin­ic, he adds, and in CAR-T’s case, se­ri­ous cy­tokine re­lease syn­drome safe­ty is­sues as well as a con­tin­u­ing set of man­u­fac­tur­ing ob­sta­cles that con­tin­ues to drag back the pi­o­neers.

Move back to a con­ju­gate like theirs, Hoos says, and there are re­al ad­van­tages in scal­a­bil­i­ty and ac­cess that gives GSK a re­al shot at mak­ing a mark in the field — soon.

“We think we have a more po­tent agent and that should play out as you start com­bin­ing,” he adds, im­por­tant in a field where com­bi­na­tions are king. In the mean­time, every­thing from DREAMM-3 to DREAMM-10 are in the works, un­der­scor­ing a com­mit­ment to amp up their com­mit­ment to drugs that have po­ten­tial.

Armed with a break­through ther­a­peu­tic des­ig­na­tion at the FDA, and PRIME from the EMA, it’s like­ly that GSK won’t have to wait much longer be­fore it starts to put its toe back in the can­cer drug mar­ket. And with Luke Miels lead­ing the com­mer­cial charge fol­low­ing the Tesaro PARP buy­out, every­one at GSK knows they have a lot to prove as R&D chief Hal Bar­ron and CEO Em­ma Walm­s­ley take new steps to prove they’ve re­vived a stag­nant phar­ma R&D group.

Here we go.

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.