TG Ther­a­peu­tics scores pri­or­i­ty re­view for PI3Kδ in­hibitor; Gala­pa­gos search­es for IBD tar­gets in new pact

TG Ther­a­peu­tics’ pitch for um­bral­is­ib as a safer PI3Kδ in­hibitor has con­vinced the FDA to put it on the fast lane.

Reg­u­la­tors have ac­cept­ed the NDA for the once-dai­ly drug, a dual in­hibitor of PI3K-delta and CK1-ep­silon first aimed at two in­di­ca­tions: mar­gin­al zone lym­phoma pa­tients who have re­ceived at least one an­ti-CD20-based reg­i­men, and fol­lic­u­lar lym­phoma pa­tients who have gone through at least two lines of sys­temic ther­a­pies.

As the MZL use was des­ig­nat­ed “break­through” ther­a­py, the FDA is al­so grant­i­ng pri­or­i­ty re­view and set­ting a PDU­FA date of Feb­ru­ary 15, 2021. The FL de­ci­sion has a dead­line in June.

“The FDA al­so no­ti­fied the Com­pa­ny that it is not cur­rent­ly plan­ning to hold an ad­vi­so­ry com­mit­tee meet­ing to dis­cuss this ap­pli­ca­tion,” TG Ther­a­peu­tics wrote, usu­al­ly a pos­i­tive sign.

The da­ta pack­age came most­ly from the UNI­TY-NHL Phase IIb tri­al, the com­pa­ny added, where both the MZL and FL co­horts met the 40%-50% tar­get on over­all re­sponse rate, the pri­ma­ry end­point. The sin­gle-agent study was specif­i­cal­ly de­signed to mod­el the stud­ies that brought ac­cel­er­at­ed FDA ap­proval for oth­er PI3Kδ drugs, CEO Michael Weiss pre­vi­ous­ly not­ed.

Gala­pa­gos inks tar­get dis­cov­ery deal fo­cused on in­flam­ma­to­ry bow­el dis­ease

Tak­ing the pre­ci­sion med­i­cine ap­proach on au­toim­mune dis­eases, Gala­pa­gos has en­list­ed Boston-based Sci­pher Med­i­cine to iden­ti­fy new tar­gets and path­ways that can lead to new treat­ments for in­flam­ma­to­ry bow­el dis­ease.

Gala­pa­gos — whose own drugs for in­flam­ma­tion and fi­bro­sis have in­spired multi­bil­lion-dol­lar deals from Gilead — has the op­tion to move up the tar­gets in­to drug dis­cov­ery and de­vel­op­ment. Sci­pher re­tains the rights to opt in, on top of re­ceiv­ing up­front and mile­stone pay­ments.

“Our break­through ap­proach com­bines ex­ten­sive pa­tient-lev­el mol­e­c­u­lar da­ta with AI meth­ods to dis­cov­er nov­el tar­gets with the po­ten­tial to treat spe­cif­ic groups of pa­tients, in­clud­ing those not re­spond­ing to ther­a­pies cur­rent­ly avail­able,” said Alif Saleh, CEO of Sci­pher.

Red­Hill finds a man­u­fac­tur­er for As­traZeneca drug — which is al­so fund­ing R&D work

Red­Hill Bio­phar­ma has tied a few more knots with its Dublin-based part­ners at Cos­mo, lin­ing up a man­u­fac­tur­ing deal as well as some cash for two ex­per­i­men­tal drugs.

Three drugs are cov­ered in the deal: Movan­tik, the treat­ment for opi­oid-in­duced con­sti­pa­tion Red­Hill re­cent­ly li­censed from As­traZeneca; RHB-204, an oral com­bi­na­tion of clar­ithromycin, ri­fabutin, and clo­faz­imine de­signed to tack­le pul­monary non­tu­ber­cu­lous my­cobac­te­ria (NTM) in­fec­tions; and a yet un­named drug for H. py­lori in­fec­tions.

Cos­mo has agreed to fund the piv­otal Phase III study for RHB-204, with $5 mil­lion due up­on sign­ing and $7 mil­lion di­vid­ed be­tween two mile­stone pay­ments, in ex­change for 15% roy­al­ty pay­ments. It’s al­so pay­ing $7 mil­lion up­front to li­cense Eu­ro­pean rights to the un­named ex­per­i­men­tal com­pound and com­mit­ting $2 mil­lion up­on ap­proval, while foot­ing 30% of the clin­i­cal tri­al costs in both the US and Eu­rope. Red­Hill will be en­ti­tled to 30% roy­al­ties.

As part of the agree­ment, Red­Hill is al­so hir­ing Cos­mo to be the sole man­u­fac­tur­er of both these drugs as well as Movan­tik. The Is­raeli biotech is pay­ing €5.5 mil­lion for the tech trans­fer, for­mu­la­tion and de­vel­op­ment work.

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.

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.

#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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#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.