Post-con­spir­a­cy claims, Arc­turus los­es an­oth­er ex­ec­u­tive amid board putsch; Gates Foun­da­tion hands $6.5M to No­var­tis for in­fec­tious di­ar­rhea treat­ment

Pad Chivuku­la

→ Lit­tle Arc­turus $ARCT is go­ing through a dra­mat­ic shake­up this month. Short­ly af­ter news that its founder and CEO Joseph Payne was boot­ed from the com­pa­ny (with board mem­bers al­leged­ly con­spir­ing on his ouster), Arc­turus is now los­ing an­oth­er top ex­ec­u­tive. The com­pa­ny’s chief sci­en­tif­ic of­fi­cer and chief op­er­at­ing of­fi­cer Pad Chivuku­la is step­ping down, the com­pa­ny said in a state­ment. That’s in­ter­est­ing, con­sid­er­ing Payne re­cent­ly not­ed that both he and Chivuku­la had been left out of par­tic­i­pa­tion in board dis­cus­sions and votes. Chivuku­la will stay on as sci­en­tif­ic ad­vi­sor to Arc­turus, the com­pa­ny said. The news comes in con­junc­tion with a new state­ment filed with the SEC not­ing that Payne, the ex-CEO, is de­mand­ing an “ex­tra­or­di­nary meet­ing” of the board to vote on an ouster of his own de­sign. In the let­ter, he calls for the boot to four com­pa­ny di­rec­tors — Stu­art Collinson, Craig Wil­lett, Daniel Gef­fken, and David Shapiro — who he says en­gaged in an in­trigue that vi­o­lat­ed the rules es­tab­lished by the Is­raeli laws that gov­ern its op­er­a­tions. Payne is sug­gest­ing four new di­rec­tors take their place, in­clud­ing some of the biggest names in San Diego biotech: Mag­da Mar­quet, Pe­ter Far­rell, An­drew Sas­sine, and James Bar­low. Mar­quet, founder and co-chair of Althea Tech­nolo­gies, is a well-known in­dus­try ex­ec­u­tive who’s a bit of a leg­end in San Diego. And Far­rell, is the founder and for­mer long-term CEO and cur­rent chair­man of ResMed, one of the largest med­ical de­vice com­pa­nies in San Diego.

No­var­tis $NVS is team­ing up with the Bill and Melin­da Gates Foun­da­tion to tack­le cryp­tosporidio­sis, a lead­ing cause of (of­ten fa­tal) in­fec­tious di­ar­rhea in chil­dren world­wide. The Gates Foun­da­tion will pro­vide $6.5 mil­lion in fund­ing to fur­ther de­vel­op KDU731, a pre­clin­i­cal drug can­di­date cur­rent­ly be­ing test­ed for safe­ty in prepa­ra­tion for clin­i­cal tri­als. The drug, a PI(4)K (phos­phatidyli­nos­i­tol-4-OH ki­nase) in­hibitor, has shown promise in treat­ing Cryp­tosporid­i­um in­fec­tion. “To­day’s glob­al health is­sues can­not be solved by one or­ga­ni­za­tion alone,” said Thier­ry Di­a­gana, head of the No­var­tis In­sti­tute for Trop­i­cal Dis­eases. “Pri­vate com­pa­nies, gov­ern­ments, non-gov­ern­men­tal or­ga­ni­za­tions, acad­e­mia, and oth­er stake­hold­ers need to work to­geth­er to cre­ate sus­tain­able so­lu­tions.”

→ Japan’s Astel­las has ac­quired Seat­tle-based Uni­ver­sal Cells in a $102.5 mil­lion deal. The mon­ey, spread out over an up­front and mile­stones, gives Astel­las new stem cell tech that should help them cre­ate cell ther­a­py prod­ucts that do not re­quire Hu­man Leuko­cyte Anti­gen match­ing, re­duc­ing the risk of re­jec­tion.

→ Can­cer Re­search UK and Bi­cy­cle Ther­a­peu­tics have dosed the first pa­tient in their Phase I/IIa tri­al eval­u­at­ing BT1718 in pa­tients with ad­vanced sol­id tu­mors.

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.

News brief­ing: Bausch Health clos­ing in on deal to ac­quire Al­le­gro as­sets; PharmAbcine strikes deal with Sam­sung Bi­o­log­ics to de­vel­op an­ti­body pro­gram

Bausch Health is closing in on a deal that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million.

The payment would be made in two tranches: $10 million at signing, and $40 million in 2021.

Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD). It’s expected to enter two concurrent Phase III trials for that indication in the next year. The drug is also being tested in patients with diabetic macular edema (DME), and last year met the primary endpoint in a Phase II study, with 48% of patients gaining 8 or more letters in visual acuity from baseline at week 28, compared to 7% in the control group at week 12.

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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#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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