Can a Nek­tar ri­val make it on Nas­daq with a $100M IPO? Syn­thorx is giv­ing it a shot

Af­ter all the hub­bub around Nek­tar’s sec­ond-gen take on a pe­gy­lat­ed IL-2, is Nas­daq ready for a ri­val that be­lieves it can do the whole field one bet­ter?

Syn­thorx, a pre­clin­i­cal biotech with pri­mate da­ta that was set up by Aval­on, has filed for a $100 mil­lion IPO — hop­ing to catch a wave of ex­cite­ment that has pro­pelled scores of S-1s this year for ear­ly-stage com­pa­nies.

Like Nek­tar, Syn­thorx start­ed out with the knowl­edge that Pro­leukin nev­er lived up to its in­cred­i­ble ini­tial promise in can­cer, large­ly be­cause of a bad tox pro­file high­light­ed by vas­cu­lar leak syn­drome. And the lit­tle biotech has been work­ing on its own al­ter­na­tive un­der the guid­ance of CEO Lau­ra Shawver, an ex­pe­ri­enced biotech vet.

Here’s the rel­e­vant sec­tion from the S-1 filed with the SEC:

Us­ing our Ex­pand­ed Ge­net­ic Al­pha­bet plat­form tech­nol­o­gy, we site-specif­i­cal­ly pe­gy­lat­ed IL-2 to in­vent THOR-707 for im­muno-on­col­o­gy, or IO. We have de­signed THOR-707 to kill tu­mor cells by in­creas­ing CD8+ T and NK cells with­out caus­ing VLS (vas­cu­lar leak syn­drome) that has been ob­served with aldesleukin. In our non-hu­man pri­mate…pre­clin­i­cal stud­ies THOR-707 at dos­es ten times high­er than the dos­es ob­served to max­i­mal­ly ex­pand CD8+ T cells in NHP did not re­sult in signs of VLS, as mea­sured by in­creas­es in eosinophil count and lung and liv­er weight. Pub­lished pre­clin­i­cal lit­er­a­ture shows that com­bin­ing IL-2 treat­ment with PD-1 in­hibitors could have syn­er­gis­tic ef­fects in en­hanc­ing CD8+ T cell re­spons­es. As a re­sult, we be­lieve that THOR-707 in com­bi­na­tion with im­mune check­point in­hibitors may have greater an­ti-tu­mor ef­fects than PD-1 in­hibitors alone with­out the VLS ob­served with aldesleukin.

There’s al­so an­oth­er IL-2 pro­gram that works in re­verse, pro­mot­ing reg­u­la­to­ry T cells that sup­press the im­mune sys­tem to the ad­van­tage of pa­tients suf­fer­ing from au­toim­mune dis­ease.

Nek­tar’s NK­TR-214 is spot­light­ed as the biggest ri­val in the clin­ic. But the S-1 al­so cites Roche’s RO6874281, which spurred 3 ob­jec­tive re­spons­es in an ear­ly study. That drug, they say, is sim­i­lar to their own. And there is al­so Alk­er­mes’ ALKS-4230, “where a por­tion of the al­pha re­cep­tor is at­tached to IL-2, which dis­ables al­pha bind­ing. In a Phase I study of ad­vanced sol­id tu­mors, no re­spons­es were ob­served in 24 pa­tients.”

Jay Lichter’s Aval­on still con­trols the largest batch of stock, with 32%, with Pe­ter Kolchin­sky at RA Cap­i­tal in for 28.2% and Or­biMed hold­ing 21.5%. Those are the big 3. Shawver her­self has a slight 1% of the eq­ui­ty. Tighe Rear­don, the CFO at Aval­on, has 6.5% of the shares.

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.”