Al­loy and Pyx­is spin out new 'com­pa­ny' around high-risk I/O, im­munol­o­gy tar­gets

When CEO Lara Sul­li­van and the team at Pyx­is sat down in 2019 to see which of the many tar­gets from Thomas Gajew­s­ki’s im­muno-on­col­o­gy lab they would try to drug, there were too many for any start­up to pur­sue at once. They pri­or­i­tized the tar­gets they thought had the best chance of suc­cess, leav­ing the rest for some fu­ture date.

That date came soon­er than ex­pect­ed. Last year, the team at Al­loy Ther­a­peu­tics —the con­glom­er­ate of biotech ser­vices, tech­nolo­gies and spin­outs backed by bil­lion­aire in­vestor Pe­ter Thiel — got wind of all that Pyx­is was leav­ing on the ta­ble. Now, the two are spin­ning out a new com­pa­ny, Ky­ma Ther­a­peu­tics, ded­i­cat­ed to find­ing an­ti­bod­ies that can hit two of the high-risk tar­gets, po­ten­tial­ly open­ing up paths to treat­ments in can­cer and im­munol­o­gy.

Errik An­der­son

“We would de­scribe Pyx­is as a very tar­get-rich com­pa­ny. They have a great pipeline of their own mol­e­cules and they had a whole bunch of re­al­ly good, oth­er in­ter­est­ing tar­get ideas and they weren’t go­ing to be able to pros­e­cute all of them in 2020,” Al­loy CEO Errik An­der­son told End­points News. So An­der­son’s team said, “Hey, we’ve got in­fra­struc­ture, where we could pros­e­cute those tar­gets quick­ly — make hu­man mon­o­clon­al an­ti­bod­ies and test them in a re­al­ly ef­fi­cient way.”

The sec­ond spin­out Al­loy has launched in the past year, Ky­ma is for now ef­fec­tive­ly a well-brand­ed part­ner­ship mas­querad­ing as a biotech com­pa­ny. It has no full-time em­ploy­ees and is gov­erned by a “joint-steer­ing com­mit­tee.” Its op­er­a­tion con­sists main­ly of Al­loy us­ing its hu­man­ized mice to de­vel­op an­ti­bod­ies against Pyx­is tar­gets and then send­ing the an­ti­bod­ies back to Pyx­is for test­ing — rough­ly the same out­line that now gov­erns hun­dreds of col­lab­o­ra­tions across the in­dus­try.

An­der­son, though, said the le­gal frame­work gives them greater flex­i­bil­i­ty than they would un­der a nor­mal part­ner­ship, al­low­ing both sides to avoid tire­some ne­go­ti­a­tions. They can add new tar­gets as they go, and they can de­cide down the road as new da­ta ar­rive whether Pyx­is should re­ab­sorb Ky­ma and de­vel­op the an­ti­bod­ies in-house, or whether they should even­tu­al­ly raise cap­i­tal, hire a few em­ploy­ees, and launch Ky­ma as a full-fledged com­pa­ny.

Chris Pacheco

Chris Pacheco, a ven­ture part­ner at Al­loy’s ven­ture stu­dio 82VS, said the for­mat al­lows them to de­vel­op the sci­ence fur­ther be­fore putting re­al mon­ey be­hind it.

“It’s to test out these hy­pothe­ses,” he told End­points. “Get to a place where you ac­tu­al­ly have as­sets in hand and ac­tu­al bi­o­log­i­cal da­ta to sup­port it, as op­posed to just build­ing a team around con­cepts on pa­per.”

Pyx­is was launched to go af­ter new im­muno-on­col­o­gy tar­gets dis­cov­ered in Gajew­s­ki’s lab, tak­ing the field out of PD-1, CT­LA4, LAG-3 and TIG­IT and in­to new, un­chart­ed, acronymic ter­rain. But the com­pa­ny has yet to dis­close any of those tar­gets.

Sim­i­lar­ly, Al­loy is stay­ing tight-lipped on Ky­ma. An­der­son said on­ly that one tar­get was in im­muno-on­col­o­gy and one tar­get was for im­munol­o­gy, that nei­ther had been tar­get­ed in the clin­ic yet and that both were de­signed to help “non-re­spon­ders.” Would that mean can­cer pa­tients non-re­spon­sive to PD-1?

Thomas Gajew­s­ki

“Po­ten­tial­ly yes,” he said. “Or per­haps even oth­er mech­a­nis­tic non-re­spon­ders, when you un­der­stand the mech­a­nism of non-re­sponse.”

A minute lat­er, he added: “Imag­ine your im­mune cells don’t work the way they should.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Jonathan Lim, Erasca CEO (ARCH Venture Partners)

Eras­ca delves fur­ther in­to RAS/MAPK with No­var­tis drug, prices $100M of­fer­ing

After receiving feedback on pivotal studies from European regulators, but not yet the FDA, Novartis is out-licensing a pan-RAF inhibitor going after tumors excited by the RAS/MAPK pathway.

To get the exclusive worldwide license to the asset, Erasca is paying the Swiss Big Pharma $20 million upfront in cash and $80 million worth of shares. Erasca CEO Jonathan Lim told analysts Friday morning that the process was “competitive,” implying his biotech was far from the only one attempting to snag the drug from Novartis, which is going through a reorganization and a fine-tuning to its pipeline.

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