Co­di­ak files for an IPO, again, this time shoot­ing for a nine-dig­it raise

Sec­ond time’s the charm?

Co­di­ak Bio­sciences is fil­ing for an IPO once again, sub­mit­ting pa­per­work Wednes­day, af­ter back­ing out of its pre­vi­ous at­tempt in Ju­ly 2019 due to un­fa­vor­able mar­ket con­di­tions. The com­pa­ny is pric­ing in a new raise of $100 mil­lion, up from $86 mil­lion in its ini­tial pur­suit.

There have al­ready been four dozen biotech IPOs so far this year, net­ting the sec­tor more than $11 bil­lion.

Doug Williams

The Cam­bridge, MA-based out­fit is head­ed by the ex-Bio­gen re­search chief Doug Williams, who has about a 5% stake in the com­pa­ny, ac­cord­ing to the S-1. Ma­jor in­vestors hold the li­on’s share of the stock, with ARCH Ven­ture Funds own­ing 28.3%, Flag­ship Ven­ture Funds hold­ing 18.9% and Fi­deli­ty tak­ing 14.1% of the pie.

Co­di­ak has fo­cused its re­search on a plat­form that re­pur­pos­es ex­o­somes as de­liv­ery ve­hi­cles for a range of ther­a­peu­tic pay­loads, from small mol­e­cules to pro­teins to nu­cle­ic acids. Specif­i­cal­ly, the biotech has honed in on a pro­gram that us­es a STING path­way ag­o­nist, li­censed from a French com­pa­ny called Kay­la Ther­a­peu­tics. Its lead can­di­date, dubbed ex­oST­ING, over­ex­press­es Co­di­ak’s pro­pri­etary scaf­fold pro­tein PT­GFRN and is loaded with a syn­thet­ic CDN to tar­get this path­way.

By trans­port­ing the com­pound di­rect­ly to anti­gen pre­sent­ing cells, Co­di­ak hopes to har­ness the po­ten­tial of the STING path­way while avoid­ing tox­i­c­i­ty that stems from “leak­age” out of the tu­mor. Co­di­ak aims to use some of this new fund­ing to con­duct a Phase I/II tri­al, study­ing ex­oST­ING in pa­tients with ad­vanced/metasta­t­ic, re­cur­rent, in­jectable sol­id tu­mors.

Some of the mon­ey will al­so go to­ward an­oth­er of Co­di­ak’s pro­grams, ex­oIL-12. The run­ner-up in the pipeline is en­gi­neered to fa­cil­i­tate tu­mor re­ten­tion and sus­tained ac­tiv­i­ty us­ing the same scaf­fold pro­tein as ex­oST­ING. Mon­ey from the raise will sup­port a Phase I tri­al in healthy vol­un­teers and ear­ly stage cu­ta­neous T cell lym­phoma.

The re­main­der of the funds will help ex­pand Co­di­ak’s en­gEx plat­form, in­clud­ing the ad­vance­ment of R&D for oth­er pre­clin­i­cal and dis­cov­ery pro­grams, as well as mis­cel­la­neous cor­po­rate pur­pos­es.

Williams has led the com­pa­ny through sev­er­al im­pres­sive fundrais­ing rounds, col­lect­ing $162.8 mil­lion in the com­pa­ny’s first two years af­ter be­ing found­ed in 2017. Co­di­ak al­so inked a $56 mil­lion deal with Jazz and a $72.5 mil­lion pact with Sarep­ta to de­vel­op the first mul­ti­ple-dose gene ther­a­py.

The ex­o­some field is grow­ing, how­ev­er, as Co­di­ak gained a no­table com­peti­tor at the end of Ju­ly, when Mantra Bio came out of stealth with a $25 mil­lion Se­ries A. Found­ed by Alex Mok, Katie Planey, and Ter­ry Gaige, the biotech is seek­ing to solve some of the tra­di­tion­al ex­o­some prob­lems us­ing a com­pu­ta­tion­al plat­form to find tar­gets, de­sign ex­o­somes and then build a set of them in their lab.

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.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”