Days af­ter seal­ing Sanofi pact, Kymera beats a path to the Nas­daq with $100M IPO pitch

Back in March, when Kymera Ther­a­peu­tics closed $102 mil­lion in Se­ries C fund­ing led by Biotech­nol­o­gy Val­ue Fund and Red­mile Group, CEO Nel­lo Main­olfi not­ed the pro­tein degra­da­tion play­er was “at the cusp of tran­si­tion­ing” in­to a ful­ly in­te­grat­ed R&D com­pa­ny. Five months and a ma­jor Sanofi pact lat­er, he’s back ask­ing for an­oth­er lit­tle push to get there.

Nel­lo Main­olfi

Kymera has pen­ciled in $100 mil­lion in its first IPO pitch — al­though giv­en the pub­lic mar­ket’s seem­ing­ly in­sa­tiable ap­petite for biotechs these days the fi­nal fig­ure is any­one’s guess.

The ris­ing tide is ap­par­ent­ly float­ing all boats, too. GoodRx, which has thrived on help­ing more than 10 mil­lion US pa­tients nav­i­gate the labyrinthine drug pric­ing sys­tem, is re­port­ed­ly look­ing to file an IPO. Reuters not­ed that the com­pa­ny was val­ued at $2.8 bil­lion in 2018 by a pri­vate eq­ui­ty backer. The list­ing could come this year or ear­ly 2021, ac­cord­ing to sources.

Stick­ing to “high im­pact tar­gets that have been elu­sive to con­ven­tion­al modal­i­ties,” Kymera’s trio of ini­tial pro­grams are de­signed to de­grade IRAK4, IRAKIMiD and STAT3, re­spec­tive­ly. These are crit­i­cal sig­nalling nodes in the in­ter­leukin-1 re­cep­tor/toll-like re­cep­tor (IL-1R/TLR) and janus ki­nase/sig­nal trans­duc­ers and ac­ti­va­tors of tran­scrip­tion, or JAK/STAT, path­ways.

Lever­ag­ing E3 lig­as­es to tag the tar­get pro­tein for dis­pos­al, Kymera’s drugs promise to stem dis­eases by com­plete­ly re­mov­ing the pro­teins caus­ing them.

Pro­ceeds from the IPO are ex­pect­ed to fund the de­vel­op­ment of all three through the end of Phase I. The first fil­ing, for an IRAK4 de­grad­er dubbed KT-474, is slat­ed to be dis­patched in the first half of 2021, with the oth­ers to fol­low lat­er in the year.

As a pi­o­neer in a field where mon­ey has been free flow­ing, Kymera will join two oth­er pro­tein degra­da­tion spe­cial­ists on the Nas­daq. But while it shares a fo­cus on can­cer with Arv­inas and Nurix, the biotech has al­so ven­tured out to in­flam­ma­to­ry and au­toim­mune dis­eases as well as fi­bro­sis.

“Ob­vi­ous­ly when you’re work­ing out­side of tar­get­ed on­col­o­gy, you ac­tu­al­ly bring a lot more com­plex­i­ty giv­en that you’re go­ing af­ter a va­ri­ety of cell pop­u­la­tion and not just the one can­cer cell pop­u­la­tion,” Main­olfi pre­vi­ous­ly told End­points News.

But over the years Kymera has man­aged to go deep. Burn­ing through $108.1 mil­lion, they pro­filed around 600 E3 lig­as­es to learn about the ex­pres­sion and dis­tri­b­u­tion while gen­er­at­ing a tool­box of lig­ands to bind to them. Both Ver­tex and Sanofi have been at­tract­ed to the plat­form, pro­vid­ing $220 mil­lion in col­lec­tive up­front.

Sanofi, in par­tic­u­lar, is keen to ap­ply the tools to the chron­ic in­flam­ma­to­ry dis­ease space, start­ing with IRAK4 — where the phar­ma gi­ant sees an op­por­tu­ni­ty to repli­cate the block­buster suc­cess of Dupix­ent in der­ma­tol­ogy. Once Cam­bridge, MA-based Kymera wraps up first-in-hu­man test­ing, Sanofi would led the Phase II but the biotech re­tains the op­tion to share US de­vel­op­ment costs and rev­enue.

In ad­di­tion to the named lead can­di­date, it dis­closed in a fil­ing, they have three back­up de­graders di­rect­ed against IRAK4.

At­las Ven­ture, rep­re­sent­ed by co-founder and chair­man Bruce Booth on the board, still holds the largest chunk of stock at 26.76%. Ver­tex is next on the ros­ter with 7.31%, fol­lowed by Lil­ly Ven­tures Fund (6.47%) and Pfiz­er (5.18%). The oth­er top VC in­vestors are 6 Di­men­sions and Besse­mer Ven­ture Part­ners.

The com­pa­ny al­so re­vealed that Lau­rent Au­doly was paid $1.1 mil­lion for his fi­nal year as pres­i­dent and CEO be­fore hand­ing over to Main­olfi in No­vem­ber 2019.

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.

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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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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