WASH­ING­TON, DC — One of Nek­tar Ther­a­peu­tics’ top can­cer drugs gained the spot­light at the So­ci­ety for Im­munother­a­py of Can­cer meet­ing over the week­end with the first cut of some promis­ing re­sponse rates in a range of tu­mor types. And the pub­lic biotech $NK­TR be­lieves the re­sults point them to a short path at the FDA that could lead to the drug’s first, fast ap­proval.

Mary Tagli­a­fer­ri

The drug is NK­TR-214, an IL-2 im­muno-on­col­o­gy ther­a­py — built from the ground up by the biotech — which is de­signed to bind to the CD122 re­cep­tor on the sur­face of CD-8 and CD-4 pos­i­tive im­mune cells to whip up an at­tack on var­i­ous can­cers. Nek­tar struck a 50/50 deal with Bris­tol-My­ers Squibb $BMY to use their drug in com­bi­na­tion with Op­di­vo (nivolum­ab), match­ing a ther­a­py aimed at dri­ving an im­mune re­sponse with a pop­u­lar check­point block­buster that helps take the brakes off the as­sault.

At SITC, the com­pa­ny pro­duced a med­ley of da­ta points, in­clud­ing:

• In treat­ment-naïve first-line pa­tients with stage IV melanoma, re­searchers tracked re­spons­es in 7 of 11 pa­tients (63%), with 2 com­plete re­spons­es — no vis­i­ble signs of the dis­ease — and 5 par­tial re­spons­es. Not all of these num­bers are pre­cise. It’s im­por­tant to note though that one of the CRs and one of the PRs were un­con­firmed — em­pha­siz­ing just how ear­ly these re­sults are.
• Among 13 kid­ney can­cer pa­tients with one or more base­line scans, re­spons­es were ob­served in 6 (46%), with 1 com­plete re­sponse and 5 par­tials.
• For a small group of 4 pa­tients with ad­vanced PD-L1/neg­a­tive non-small cell lung can­cer, the in­ves­ti­ga­tors tracked a re­sponse in 3 (75%), with 1 com­plete and 2 par­tials.

“Sin­gle-agent nivolum­ab is known for all these in­di­ca­tions, with a 34% re­sponse for melanoma,” Mary Tagli­a­fer­ri, se­nior vice pres­i­dent, clin­i­cal at Nek­tar, tells me. “We have a 64% re­duc­tion.”

That’s what in­vestors liked to hear. Nek­tar’s stock quick­ly jumped 23% in pre-mar­ket trad­ing on Mon­day.

Jonathan Za­levsky

“Our re­sponse rate is just over 50% even in PD-L1 neg­a­tive pa­tients,” says Jonathan Za­levsky, Nek­tar’s se­nior vice pres­i­dent of bi­ol­o­gy and pre­clin­i­cal de­vel­op­ment. “And what we like about those met­rics, it gives us a nice con­fir­ma­tion of the in­crease we’re see­ing in our com­bi­na­tion.”

This is an ear­ly snap­shot of this drug, to be sure, but Nek­tar’s team be­lieves that the safe­ty and ef­fi­ca­cy pro­files they’re see­ing in the first snap­shot of da­ta un­der­scores the biotech’s chances of go­ing af­ter an ac­cel­er­at­ed ap­proval for cer­tain pa­tient groups that face par­tic­u­lar­ly poor prospects.

“There is an op­por­tu­ni­ty for Nek­tar to pur­sue an ac­cel­er­at­ed path­way in those pa­tient pop­u­la­tions where the re­sponse rate is very, very low,” says Tagli­a­fer­ri.

They wouldn’t be the first to suc­ceed at that, ei­ther. The FDA has proven ea­ger to get new ther­a­pies to pa­tients with poor prospects, and Nek­tar has filed for “break­through” sta­tus to help en­list reg­u­la­tors’ sup­port for their plans.

The Phase II has now been ex­pand­ed from 250 to 330 pa­tients with 13 co­horts.

So what’s an ap­proval worth here?

Cowen an­a­lyst Chris Shibu­tani is one of the most op­ti­mistic an­a­lysts cov­er­ing the drug, es­ti­mat­ing its 2023 rev­enue at $950 mil­lion — but every­thing has to go right for it to get close to the block­buster mark.

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.

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.

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.

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.