Jo Lager, Sanofi

CHICA­GO — The two top im­muno-on­col­o­gy in­ves­ti­ga­tors for Re­gen­eron $REGN and Sanofi, Is­rael ‘Izzy’ Lowy and Jo Lager, came to Chica­go to of­fer a very promis­ing snap­shot of the ear­ly da­ta they’ve reaped from a study of their PD-1 drug REGN2810 for cu­ta­neous squa­mous cell car­ci­no­ma — the sec­ond dead­liest form of skin can­cer be­hind melanoma.

Like No­var­tis or In­cyte or some of the oth­er com­pa­nies work­ing on PD-(L)1 ther­a­pies in the large sec­ond wave form­ing in the pipeline fol­low­ing the first 5 that have been ap­proved, these two ma­jor league play­ers see this as a key build­ing block for the com­bos they want to de­vel­op. But it would be a mis­take, they say, to sim­ply write this one off as the lat­est check­point of this stripe look­ing to line up for the mar­ket.

Is­rael Lowy, Re­gen­eron

“I don’t think we’re the sixth,” Lowy told me in a con­ver­sa­tion over the week­end. “We’re the third.”

Re­gen­eron has some of the best an­ti­body spe­cial­ists in the busi­ness, which they’ve proved with a string of new drug ap­provals. Lowy says he’s learned a lot about PD-(L)1 while they’ve been work­ing on REGN2810. And some of their in­sights have ma­jor im­pli­ca­tions for every­one work­ing in the field.

One of the biggest lessons is that PD-1 is a sig­nif­i­cant­ly bet­ter path­way to fol­low than PD-L1, says Lowy.

The team cre­at­ed a PD-L1 as a com­ple­men­tary pro­gram in case their work on PD-1, but they feel now that PD-1 ther­a­pies of­fer a much more ef­fec­tive way to  un­leash an im­mune at­tack, some­thing that’s been un­der­scored by the dom­i­nance of Keytru­da and Op­di­vo  as well as Roche’s re­cent stun­ning set­back with the PD-L1 drug Tecen­triq.

And that’s why Re­gen­eron and Sanofi feel they can leapfrog ahead of some of the ear­ly en­tries.

Re­gen­eron and Sanofi al­so didn’t set out to cre­ate a bet­ter PD-1 than Keytru­da or Op­di­vo.

“One of the things was a ma­jor re­quire­ment for it to be at least as good as any­one else’s,” says Lowy, “not as­sum­ing that we could make an an­ti­body that was bet­ter. That be­ing said, we’re very hap­py with it. We screened many an­ti­bod­ies to pick the one that was our bet­ter can­di­date.”

Not on­ly is the first cut of the da­ta very good, this check­point is al­ready in a po­ten­tial­ly piv­otal Phase II tri­al.

Here’s what they found:

REGN2810 de­liv­ered an im­pres­sive over­all re­sponse rate of 46.2% — 12 of 26 pa­tients — which in­cludes 2 com­plete re­spons­es, 9 par­tial re­spons­es and 1 un­con­firmed par­tial re­sponse. The dis­ease con­trol rate hit 69.2%, cov­er­ing 18 of 26 pa­tients with 12 ORR and 6 with sta­ble dis­ease. The me­di­an pro­gres­sion-free sur­vival and over­all sur­vival rate were not reached at the da­ta cut­off date with a me­di­an fol­low-up of 6.9 months. Ten pa­tients re­main in re­sponse as of the da­ta cut­off date, with a range of 8 to 40 weeks du­ra­tion of re­sponse.

Ge­of­frey Porges, Leerink

Leerink’s Ge­of­frey Porges called the re­sults “com­pelling,” not­ing that the Re­gen­eron/Sanofi team could have a $300 mil­lion peak sales op­por­tu­ni­ty in the US alone. “(T)he com­pa­ny will al­most cer­tain­ly file an ap­pli­ca­tion with the two tri­als, and then take the risk of a pos­si­ble ad­vi­so­ry com­mit­tee re­view (new drug/new in­di­ca­tion for PD-1) about the clin­i­cal sig­nif­i­cance of the re­sult and the im­por­tance of the in­di­ca­tion.”

“We rec­og­nized long ago that block­ade of the PD-1 path­way is an es­sen­tial com­po­nent of any im­muno-on­col­o­gy pro­gram,” Lowy tells me. “Al­though a fab­u­lous ad­vance, it’s re­al­ly just the first chap­ter, or a pref­ace.”

“We want to have our own to fa­cil­i­tate the abil­i­ty to de­vel­op nov­el com­bi­na­tions with­out hav­ing to re­ly on any­one else’s agent,” he adds.

Re­gen­eron and Sanofi are well on their way. The rest of the in­dus­try might want to pay more at­ten­tion.

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.

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.

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.

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.