Leen Kawas, Athira CEO

An­oth­er biotech — Seat­tle-based Athi­ra — files for an IPO, hop­ing to fi­nal­ly break through in Alzheimer's

Yet an­oth­er biotech is aim­ing to go pub­lic, as this year’s IPO boom con­tin­ues to show no sign of abat­ing any time soon.

The newest en­trant to the mar­ket is Athi­ra Phar­ma, a small, Seat­tle-based com­pa­ny that pegs a $100 mil­lion tar­get as its raise es­ti­mate. So far in 2020, there have al­ready been 48 biotech IPOs, a num­ber that sur­pass­es the to­tal from all of 2019.

Per­cep­tive is the most promi­nent backer of the com­pa­ny, per the SEC fil­ing, with the Joe Edel­man-run hedge fund own­ing 11.6% of shares. RTW In­vest­ments put in a 10.9% stake, and Athi­ra CEO Leen Kawas checks in at third with 9.4% own­er­ship.

Athi­ra fo­cus­es its ef­forts on neu­rode­gen­er­a­tive dis­eases, main­ly Alzheimer’s, and just a cou­ple months ago closed an $85 mil­lion Se­ries B fi­nanc­ing. Found­ed in 2011, the com­pa­ny has spent the ma­jor­i­ty of its time push­ing the NDX-1017 pro­gram, a small mol­e­cule that tar­gets he­pa­to­cyte growth fac­tor (HGF) and its re­cep­tor, MET.

Hon­ing in on the dam­aged synap­tic net­work in the brain is a fa­mil­iar strat­e­gy in Alzheimer’s re­search, but the HGF tar­get is rel­a­tive­ly un­ex­plored.

The goal of the Se­ries B raise was to fund Phase II/III tri­als for the pro­gram af­ter Athi­ra pre­sent­ed what they said was a pos­i­tive ef­fi­ca­cy pro­file in Phase Ib.

In that study, re­searchers mea­sured pa­tients’ abil­i­ty to count dis­tinct tones in­sert­ed through­out a string of re­peat­ed sounds. For those with de­men­tia, the nor­mal recog­ni­tion falls with­in a 400 to 450 mil­lisec­ond range, Kawas said in June, and the study’s base­line was 390 mil­lisec­onds. In the drug arm of the tri­al, which en­rolled just sev­en pa­tients, that dropped to an av­er­age of 311 mil­lisec­onds. There was no change among four place­bo pa­tients, Kawas not­ed.

The Phase II/III study, ran­dom­ized and dou­ble-blind­ed, is mea­sur­ing two dif­fer­ent dos­es in pa­tients with mild-to-mod­er­ate Alzheimer’s. Athi­ra is plan­ning a sep­a­rate late-stage study that will run in par­al­lel to the cur­rent­ly on­go­ing tri­al.

Alzheimer’s re­search has gen­er­al­ly end­ed poor­ly for those that have come be­fore Athi­ra, with the most promi­nent fail­ures com­ing from mul­ti­ple high-pro­file stud­ies at Bio­gen sur­round­ing the amy­loid be­ta the­o­ry. Back in 2018, con­tro­ver­sy arose about the de­sign of a Phase II tri­al af­ter an­a­lysts not­ed pos­i­tive da­ta were over­shad­owed by the fact that APOe4 car­ri­ers, who are at a high­er risk of the dis­ease, were placed in the low­er-dose arm of the tri­al with­out tak­ing them out of the place­bo. Ul­ti­mate­ly, that dis­crep­an­cy may have al­lowed the da­ta to hit its sta­tis­ti­cal­ly sig­nif­i­cant end­point.

Ac­cord­ing to SVB Leerink’s Ge­of­frey Porges, in­de­pen­dent re­searchers “in­di­cat­ed that they be­lieve most or all of the ap­par­ent dif­fer­ence in the [Phase II] tri­al was at­trib­ut­able to APOe4 dif­fer­ences,” and were “al­so very sus­pi­cious about the ba­sis for Bio­gen’s en­roll­ment ex­pan­sion for their piv­otal tri­als, and thought this was best ex­plained as an at­tempt to achieve sta­tis­ti­cal sig­nif­i­cance from a mar­gin­al sig­nal.”

But as Athi­ra plans for their IPO, they ap­pear un­daunt­ed by the tri­als that have come be­fore.

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 have vowed not to let politics get in the way of 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 health agencies under his purview — including the FDA — of their rulemaking 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.

Eli Lilly CSO Dan Skovronsky (file photo)

#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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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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