Toca­gen shoots for $86 mil­lion IPO, spot­light­ing a high-risk shot at a quick OK for brain can­cer ther­a­py

A cou­ple of weeks af­ter Toca­gen nabbed the FDA’s break­through ther­a­py des­ig­na­tion for a new treat­ment for re­cur­ring brain can­cer, the San Diego-based biotech is try­ing its hand at an $86 mil­lion IPO.

The biotech has gath­ered some Phase I re­sults for a ther­a­py dubbed To­ca 511 & To­ca FC. To­ca 511 us­es a vec­tor to de­liv­er a gene ther­a­py to can­cer cells in the brain which con­verts To­ca FC in­to the can­cer agent 5-FU. When it kills can­cer cells, they re­lease anti­gens that then spark an im­mune re­sponse to help amp up the ef­fect of the ther­a­py, ac­cord­ing to the com­pa­ny’s S-1.

The Phase I open la­bel study re­cruit­ed 126 pa­tients, and Toca­gen used a snap­shot of one group in that study – 43 pa­tients – who demon­strat­ed an av­er­age 12.4 month over­all sur­vival rate that was 4 months bet­ter than the his­tor­i­cal con­trol in­ves­ti­ga­tors of­fered for com­par­i­son. Sub­sets and his­tor­i­cal con­trols aren’t ide­al, but Phase I dose-es­ca­la­tion stud­ies are rarely ide­al.

The biotech re­cent­ly fin­ished en­rolling the Phase II por­tion of a Phase II/III study to see if it can repli­cate that re­sult from Phase I. And they plan to try for an ac­cel­er­at­ed ap­proval with the FDA on mid-stage re­sults.

Cue pages of risk fac­tors re­lat­ed to de­vel­op­ing new drugs in gen­er­al and brain can­cer reme­dies in spe­cif­ic.

Toca­gen has been a low-pro­file play­er in the biotech busi­ness. And it burned through $128 mil­lion to get to where it is to­day, at one point tak­ing an $18 mil­lion loan to cov­er costs. If it can suc­ceed with the IPO in an­oth­er mut­ed year for new of­fer­ings, the biotech plans to trade as $TO­CA.

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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