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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Norbert Bischofberger, Kronos CEO

Three more biotechs look to jump on­to Nas­daq amid IPO boom, in­clud­ing Nor­bert Bischof­berg­er's Kro­nos

Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is wide open.

First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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