At­las-in­cu­bat­ed Kymera leaps out of stealth mode, joins the hunt for game-chang­ing pro­tein degra­da­tion drugs

Pro­tein degra­da­tion R&D isn’t new. Jay Brad­ner launched C4 Ther­a­peu­tics to blaze the pro­tein degra­da­tion ap­proach just be­fore he took the helm at the No­var­tis In­sti­tute of Bio­med­ical Re­search, then re­cent­ly formed a dis­cov­ery al­liance with UC Berke­ley with the same ba­sic ap­proach in mind. Arv­inas al­so has cen­tered on pro­tein degra­da­tion, build­ing on the lab work of Yale’s Craig Crews.

But to­day there’s an­oth­er start­up join­ing the pi­o­neers called Kymera, and the Cam­bridge, MA-based play­er is com­ing out of stealth mode to­day with a $30 mil­lion launch round and a de­vel­op­ment strat­e­gy cre­at­ed on the no­tion that there’s plen­ty of vir­gin ter­ri­to­ry for every­one to ex­plore.

Nel­lo Main­olfi

Nel­lo Main­olfi, a No­var­tis vet, Kymera co-founder and chief tech­nol­o­gy of­fi­cer, says it start­ed back when he was sit­ting in Bruce Booth’s At­las Ven­ture of­fice in late 2015 dis­cussing the best way to jump in­to the pro­tein degra­da­tion field — look­ing for ways to de­risk tar­get se­lec­tion and go af­ter some break­through ther­a­pies with game-chang­ing po­ten­tial.

That con­ver­sa­tion would lead to some in­ter­changes with some of the aca­d­e­mics at work in the field — we’ll hear more about who that is at a lat­er point — while they built a tool­box that could be used to ef­fi­cient­ly de­grade spe­cif­ic pro­teins of in­ter­est.

The con­cept be­hind these pro­grams sounds sim­ple enough. Where pro­tein in­hi­bi­tion has cre­at­ed some ad­vanced meds — specif­i­cal­ly for dis­eases like prostate and breast can­cer — de­grad­ing them could prove to be a much more durable so­lu­tion. Hi­jack­ing the body’s ubiq­ui­tin-pro­tea­some sys­tem that’s used to dis­pose of pro­teins, bind­ing to pro­teins and mark­ing them for de­struc­tion, they’re build­ing a plat­form that can be used to stymie any dis­ease-caus­ing pro­tein. But Booth notes that jump­ing from in­hi­bi­tion to degra­da­tion re­quires adding a third part to the equa­tion, a math prob­lem re­lat­ed to an en­dur­ing cat­alyt­ic de­struc­tion of the tar­get.

And that’s re­al­ly not sim­ple at all. Booth wrote a blog about this, which ex­plains the whole process in clear terms.

Over the past 18 months, the team at Kymera has grown to 12, and they’ve been us­ing the seed cash to start the pre­clin­i­cal work need­ed to iden­ti­fy the first pro­gram to take in­to the clin­ic.

Lau­rent Au­doly

Lau­rent Au­doly, an­oth­er Big Phar­ma vet­er­an who jumped from his job as R&D chief at Pierre Fab­ry to take the CEO’s post, says it’s still too ear­ly to say ex­act­ly what dis­ease tar­gets they’re go­ing af­ter, but all three of the prin­ci­pals are hap­py to iden­ti­fy the toll-like re­cep­tor and in­ter­leukin-1 path­way as their ini­tial fo­cus. And the new CEO plans to dou­ble the size of the staff over the course of the next year.

The goal, says Au­doly, is to “mine a path­way in a very sys­tem­at­ic man­ner.”

Kymera has all the clas­sic ear­marks of a Bruce Booth spe­cial. He brought in two cor­po­rate ven­ture funds — Am­gen and Lil­ly Ven­tures — to fund the A round af­ter some ef­fi­cient in­cu­ba­tion work. Lab space was pro­vid­ed by Lab­Cen­tral, which came with a “Gold­en Tick­et” from J&J/JLABS. And like many At­las star­tups, Booth and his col­leagues will have al­ready be­gun the work of lin­ing up some mar­quee part­ners to do the work with — stan­dard op­er­at­ing pro­ce­dure for plat­form com­pa­nies with a lot of po­ten­tial drug tar­gets to work with.

Pfiz­er scoops up an an­tibi­ot­ic in rare M&A deal, bag­ging a vir­tu­al start­up op­er­at­ing on a shoe­string bud­get

Pfizer is stepping up with a rare antibiotics buyout deal today, grabbing Palo Alto, CA-based Arixa Pharmaceuticals in a bid to add a new oral version of avibactam, a beta lactamase inhibitor — or BLI — approved back in 2015 as part of the IV treatment Avycaz.

The Arixa acquisition follows some encouraging Phase I responses demonstrating that 60% to 80% of the oral drug is absorbed into the bloodstream. Only 7% of the IV version is absorbed orally, far below the 30% threshold Arixa has pointed to as a therapeutic threshold. The buyout gives Pfizer’s hospital group a line on a new oral combo with antibiotics like ceftibuten to go after drug-resistant cases of urinary tract infections and other ailments.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Can B cells break the bound­aries of cell ther­a­py? Long­wood start­up has $52M to prove a new en­gi­neer­ing tech

Back in December 2017, as the cell therapy world was still basking in the virtually back-to-back approvals of two pioneering CAR-Ts, researchers at Seattle Children’s Research Institute reported a scientific first in a different corner of the field: engineer B cells to treat disease.

The team, led by David Rawlings and Richard James, eventually worked with Longwood Fund to start a biotech around those findings. And now Atlas Venture and RA Capital Management are coming on board to lead a $52 million launch round, joined by Alta Partners, for Be Biopharma.

Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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CEO Marc Gleeson (Azura)

Azu­ra Oph­thalmics gets a $20M boost for its R&D work on eye dis­eases

Three years after closing a $16 million Series B, the same group of investors are back to give Azura Ophthalmics a $20 million boost.

That brings the Tel Aviv-Yafo, Israel-based biotech’s total fundraise to $38 million, and should pave the way for a registration study of its lead candidate in Meibomian gland dysfunction (MGD) and related eye diseases, CEO Marc Gleeson told Endpoints News.

The topical candidate, dubbed AZR-MD-001, is designed to address abnormal hyperkeratinization, or the build-up and shedding of proteins at the opening of or within the Meibomian gland. When Meibomian glands become dysfunctional, rapid evaporation of the tear film can occur, leading to dry eye disease.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Jason Kelly, Gingko Bioworks CEO (Mike Blake/Reuters via Adobe)

Ex­clu­sive: Eye­ing big Covid-19 test­ing ex­pan­sion, Gink­go rolls out 50M rapid anti­gen di­ag­nos­tics

In what they hope will be a key part of an extensive effort to boost Covid-19 testing in the US, Ginkgo Bioworks is acquiring and distributing 50 million rapid antigen tests that can potentially be used for virus surveillance in schools and communities and for quick, on the ground diagnoses.

The tests, developed by SD Biosensor, are in line with proposals from the Rockefeller Foundation and Harvard epidemiologists, among others, to blanket the country with fast, low-cost tests. Although not yet authorized in the US, they are a key part of testing efforts from the Bill and Melinda Gates Foundation, who announced plans last month to distribute 120 million of them in low and middle income countries. Roche has commercialized the diagnostic in Europe.

HHS secretary Alex Azar (at the podium) and FDA commissioner Stephen Hahn (Pete Marovich/Getty Images)

Covid-19 roundup: Azar open­ly plan­ning Hahn ouster — re­port; Vul­ner­a­ble pop­u­la­tions like­ly to get vac­cines by Jan­u­ary

The relationship between HHS secretary Alex Azar and FDA commissioner Stephen Hahn has deteriorated to the point where Azar has suggested replacing Hahn, according to a Politico report.

Azar was angered by the FDA’s pushback of the Trump administration’s proposals for authorizing Covid-19 vaccines, so much so that he began openly floating potential replacements for Hahn. The report cited six unnamed sources that said Azar discussed bringing up Hahn’s removal to the White House.

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