One of the Holy Grails in the boom­ing im­muno-on­col­o­gy re­search field right now in­volves find­ing an IL-2 drug that can be used safe­ly and ef­fec­tive­ly to com­bat can­cer, with­out the im­mense tox­i­c­i­ty that has large­ly side­lined the orig­i­nal IL-2 Pro­leukin. Bris­tol-My­ers Squibb paid Nek­tar $1.85 bil­lion in up­front cash to part­ner on NK­TR-214 — which has since come un­der a cloud of un­cer­tain­ty over flail­ing re­sponse rates in their key demon­stra­tion study com­bin­ing it with Op­di­vo.

Now a group of sci­en­tists at the Uni­ver­si­ty of Wash­ing­ton says they built an IL-2 pro­tein ther­a­py all their own, and they’ve launched a new biotech — Ne­oleukin — to take it for­ward from mouse stud­ies to­ward the clin­ic.

Umut Ulge

De­scrib­ing their work to a writer at UW Med­i­cine, the group says they de­signed their pro­tein to bind specif­i­cal­ly to IL-2  be­ta and gam­ma re­cep­tors to whip up a more po­tent T cell re­sponse to can­cer while steer­ing clear of CD25 to cir­cum­vent the tox­ic re­ac­tion. By do­ing that they cre­at­ed a lab mod­el of the drug that the sci­en­tists were able to ratch­et up the dose on with­out the lethal re­ac­tion.

They al­so added a com­ple­men­tary com­po­nent for IL-15 to in­crease the ef­fi­ca­cy and dubbed the drug Neo-2/15, de­scrib­ing it as par­tic­u­lar­ly small and sta­ble. And the game plan is to con­tin­ue to use their com­pu­ta­tion­al skills to im­prove the drug.

“Neo-2/15 has ther­a­peu­tic prop­er­ties that are at least as good as or bet­ter than nat­u­ral­ly oc­cur­ring IL-2, but it was com­pu­ta­tion­al­ly de­signed to be much less tox­ic,” said Umut Ulge, one of the lead au­thors of a pa­per pub­lished in Na­ture.

Ne­oleukin, though, is hard­ly the on­ly ri­val to the throne that Nek­tar and Bris­tol-My­ers Squibb have been striv­ing for. Lau­ra Shawver’s Syn­thorx has al­so been an­gling for the clin­ic — in H1 of this year — with their drug can­di­date Syn­thorin IL-2, backed by Or­bimed and Medicxi. The biotech $THOR went pub­lic just a few weeks ago, rais­ing $150 mil­lion.

Last No­vem­ber Nek­tar Ther­a­peu­tics $NK­TR man­aged to add 1 more pa­tient out of its 38 evalu­able stage 4 melanoma pa­tients to the win col­umn with its close­ly-watched 3-month up­date on Op­di­vo/NK­TR-214’s ob­jec­tive re­sponse rate. That man­aged to nudge up the ORR from 50% — a fig­ure that rout­ed Nek­tar’s stock at AS­CO — to 53%. But the sci­en­tists al­so pushed up the com­plete re­sponse rate to 24%, main­tain­ing they were sat­is­fied with the im­proved re­sponse they were see­ing.

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.

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Scripps Research Institute has settled a case with the Justice Department alleging claims of misappropriated funds, the US attorney for the district of Maryland announced late last week.

Prosecutors said the institute improperly used NIH-funded research grants for non-grant related activities, including working on new grant applications, teaching activities and other administrative tasks. As part of the settlement, Scripps has agreed to pay $10 million.

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

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.

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.