Lara Sullivan, Pyxis Oncology CEO

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.”

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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Siddhartha Mukherjee, AP Images

Sid Mukher­jee's Vor taps a CAR-T de­vel­op­ment part­ner to strap to its at­tempt at bet­ter stem cell trans­plants

In the buzzy world of oncology, few names shine brighter than Columbia oncologist and bestselling author Siddhartha Mukherjee, whose Vor Biopharma is looking to rewrite the rules of stem cell transplants. If his team’s tech works as planned, it would also rewrite the rules on how CAR-Ts can be deployed in blood cancer — and now it’s partnering up with a little-known biotech to test that hypothesis.