Mark Litton, Athira Pharma CEO

'S­tuck in the past': Athi­ra hits back at bil­lion­aire backer and his bid to put oust­ed CEO Leen Kawas back in the pic­ture

Richard Kayne

The fight over con­trol over the fu­ture of Alzheimer’s biotech Athi­ra Phar­ma is on.

Days af­ter bil­lion­aire backer Richard Kayne launched an at­tack on the cur­rent lead­er­ship team at Athi­ra and pro­posed in­sert­ing him­self on the board of di­rec­tors along­side ex-No­var­tis CFO George Bick­er­staff, Athi­ra’s board re­spond­ed with a let­ter to share­hold­ers plead­ing for their sup­port in vot­ing for three di­rec­tors of its choice in­stead: Joe Edel­man, John Fluke and Grant Pick­er­ing.

Leen Kawas

This is all hap­pen­ing months af­ter Leen Kawas, founder and for­mer CEO, re­signed from Athi­ra amid a da­ta ma­nip­u­la­tion scan­dal. Kayne and Kawas re­cent­ly start­ed a new life sci­ences in­vest­ment firm to­geth­er and Kayne of­fered an im­pas­sioned de­fense of her in his own let­ter, re­leased last week.

“Athi­ra has at­tempt­ed to en­gage con­struc­tive­ly with Mr. Kayne to reach an am­i­ca­ble res­o­lu­tion that would en­able the board and lead­er­ship to di­rect their re­sources and fo­cus on the ex­e­cu­tion of our clin­i­cal tri­als, in­stead of a cost­ly, dis­tract­ing proxy con­test,” the com­pa­ny wrote. “Mr. Kayne has re­ject­ed our at­tempts to find com­mon ground.”

Ac­cord­ing to Athi­ra, it al­ready has the “right strat­e­gy and lead­er­ship team,” cit­ing as ev­i­dence pos­i­tive stock per­for­mance and clin­i­cal progress on the com­pa­ny’s pipeline of neu­ro­log­i­cal drugs — both for the lead can­di­date, fos­go­nime­ton, in Alzheimer’s and two oral drugs for oth­er dis­or­ders.

Kayne and Bick­er­staff will not add any ex­per­tise that the board doesn’t al­ready have, it added, es­pe­cial­ly with the ad­di­tion of Edel­man (founder and CEO of Per­cep­tive Ad­vi­sors), Fluke (sea­soned busi­ness­man) and Pick­er­ing (Vax­cyte CEO who was, as Athi­ra notes, ac­tu­al­ly first added to the board ear­li­er this year at Kayne’s sug­ges­tion).

“Athi­ra is look­ing to the fu­ture and fo­cused on de­liv­er­ing for share­hold­ers,” the biotech de­clared in all-caps. “Mr. Kayne is stuck in the past.”

By that they are re­fer­ring to how Kayne wants Athi­ra to “re­sume a for­mal re­la­tion­ship” with Kawas. But the com­pa­ny not­ed that an in­ter­nal in­ves­ti­ga­tion found she al­tered im­ages in her PhD dis­ser­ta­tion and four oth­er pa­pers while a grad­u­ate stu­dent at Wash­ing­ton State Uni­ver­si­ty, which has al­so start­ed its own probe. Those pa­pers dis­cussed a pro­tein called HGF that could in the­o­ry help neu­rons re­grow and re­store con­nec­tions through­out the brain, as well as the po­ten­tial for a small mol­e­cule to mod­i­fy HGF; they were foun­da­tion­al to es­tab­lish­ing the com­pa­ny.

Cur­rent CEO Mark Lit­ton has pre­vi­ous­ly said that Athi­ra now us­es a dif­fer­ent mol­e­cule than the one Kawas stud­ied, and that oth­er labs have pro­vid­ed ex­ter­nal val­i­da­tion for the HGF tar­get.

“We can­not pre­dict when WSU’s in­ves­ti­ga­tion will be com­plet­ed or what con­clu­sions WSU will reach,” the let­ter went on. “The board be­lieves that end­ing Dr. Kawas’s re­la­tion­ship with Athi­ra was and re­mains in the best in­ter­ests of Athi­ra and our share­hold­ers.”

Athi­ra end­ed its let­ter with a fi­nal ap­peal to vote its se­lec­tion of board mem­bers. As for the vot­ing ma­te­r­i­al they may re­ceive from Kayne? “Please sim­ply dis­re­gard,” it wrote.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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David Hallal (L) and George Daley (Hallal photo: Bertrand Guay/AFP via Getty Images)

David Hal­lal's El­e­vate­Bio launch­es new com­pa­ny to 'dis­rup­t' off-the-shelf cell ther­a­py, but pro­vides few oth­er de­tails

David Hallal’s ElevateBio is launching a new company Thursday as it looks to continue making its mark in the cell and gene therapy spaces. But Hallal is also keeping his cards close to the vest, preferring to toe the line between bombast and mystique rather than going all-in in one direction.

The new company comes out of a partnership with Boston Children’s Hospital and research from George Daley, the dean of Harvard Medical School. The triumvirate claims to have found a way to design better off-the-shelf cell therapies using new methods discovered in Daley’s Boston Children’s Hospital lab (Harvard is not involved in the collaboration).

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.