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.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

From left: Rajul Jain, Stefan Vitorovic, Arjun Goyal, Arie Belldegrun, Jean-Philippe (JP) Kouakou-Zebouah, Helen Kim

Arie Bellde­grun's Vi­da Ven­tures goes back to the well with $825M mega­fund and its eyes set on more in­no­v­a­tive meds

Among the list of bright names in biopharma, few shine brighter than Kite founder and serial entrepreneur Arie Belldegrun, who has rattled off a remarkable run of success in recent years. Now, a Belldegrun investment team is locking up a massive third fund to keep chasing the cutting edge in therapeutics.

Vida Ventures closed its third investment fund at a whopping $825 million — its largest yet — as the ever-expanding VC firm hits 30 companies in its portfolio developing new routes to hard-to-treat diseases, the company said Thursday.

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New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.