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.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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UCB buys its way to epilep­sy show­down with Jazz with $1.9B Zo­genix ac­qui­si­tion

Zogenix’s epilepsy drug Fintepla may only have brought in around $100 million of sales in its first year, but UCB clearly believes it can go much, much higher.

The Belgian pharma has inked a $1.9 billion deal to buy out Zogenix, paying $26 per share in cash and offering a contingent value right worth $2 more per share if Fintepla lands an extra EU approval by the end of 2023.

But even the upfront marks a 72% premium to California-based Zogenix’s shares, which were trading just north of $15 on Tuesday.

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