Nello Mainolfi, Kymera CEO (via YouTube)

Kymera, rais­ing $173M+, be­comes the 48th biotech IPO of the year as 2020 sur­pass­es 2019

Yet an­oth­er biotech will hit Nas­daq on Fri­day, and this one marks a mile­stone for 2020.

Cam­bridge, MA-based Kymera has priced its IPO, an­nounc­ing a pub­lic price of $20 per share and $173.7 mil­lion raise. That’s up­sized from an ini­tial range of $16 to $18 per share, and would give the com­pa­ny a mar­ket val­ue north of $900 mil­lion.

The an­nounce­ment marks the 48th biotech IPO to go pub­lic this year, sur­pass­ing the to­tal from all of 2019, ac­cord­ing to in­vest­ment an­a­lyst Brad Lon­car. Kymera’s tick­er will be $KYMR.

Launch­ing from stealth mode out of an At­las-backed in­cu­ba­tor in 2017, Kymera has been at or near the fore­front of pro­tein degra­da­tion R&D, join­ing oth­er pi­o­neers C4 Ther­a­peu­tics, Arv­inas and Nurix. Kymera has marched for­ward steadi­ly since then, nab­bing $102 mil­lion in a Se­ries C back in March and agree­ing to a col­lab­o­ra­tion with Sanofi in Ju­ly po­ten­tial­ly worth more than $2 bil­lion.

The biotech is fo­cus­ing re­search on a trio of lead pro­grams de­signed to de­grade IRAK4, IRAKIMiD and STAT3, re­spec­tive­ly. IRAK4 was the star of the Sanofi pact, a tar­get that sits down­stream of “one of the most val­i­dat­ed path­ways in in­nate im­mu­ni­ty,” Kymera CEO Nel­lo Main­olfi pre­vi­ous­ly told End­points News, re­fer­ring to where the IL-1 cy­tokine fam­i­ly and toll-like re­cep­tor sig­nal­ing con­verges.

Pro­ceeds from Fri­day’s IPO are ex­pect­ed to fund the de­vel­op­ment of not on­ly the IRAK4 pro­gram, dubbed KT-474, but the oth­er lead stud­ies through the end of Phase I. Kymera is ex­pect­ed to file its first IND for KT-474 some­time in the first half of 2021, with fil­ings for the oth­er two com­ing lat­er in the year.

Kymera is like­ly look­ing to be­come the sec­ond biotech to bring a pro­tein degra­da­tion pro­gram in­to the clin­ic, af­ter Arv­inas’ pro­tein de­grad­er, an an­dro­gen re­cep­tor-tar­get­ing drug for prostate can­cer, reached hu­man test­ing in 2019. Nurix and C4 Ther­a­peu­tics have not be­gun any clin­i­cal stud­ies yet ei­ther, though the duo have inked col­lab­o­ra­tions with Gilead and Roche, re­spec­tive­ly.

While its pro­tein degra­da­tion com­peti­tors have fo­cused main­ly on can­cers, Kymera has branched out in­to in­flam­ma­to­ry and au­toim­mune dis­eases, as well as fi­bro­sis. The com­pa­ny pro­filed about 600 E3 lig­as­es with its plat­form, at­tract­ing both Sanofi and Ver­tex to sign col­lab­o­ra­tion deals.

Sanofi is like­ly aim­ing to find a suc­ces­sor to its block­buster drug Dupix­ent, and hopes they have found an­oth­er di­a­mond in the rough in KT-474. As part of the agree­ment, the French phar­ma would take the lead on Phase II test­ing once Kymera fin­ish­es first-in-hu­man test­ing.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.