The first drug from Eli Lil­ly's new-look on­col­o­gy group gets speedy re­view as Bilenker's team hones fo­cus

The first drug from Eli Lil­ly’s Loxo buy­out is near­ing the fin­ish line.

The phar­ma gi­ant has re­ceived pri­or­i­ty re­view for its RET in­hibitor selper­ca­tinib, set­ting it up for an FDA de­ci­sion some­time be­tween Ju­ly and Sep­tem­ber. That will give it a fur­ther leg up on Blue­print Med­i­cines in the race to get the first of this new class of can­cer drugs ap­proved. Blue­print has yet to sub­mit an NDA, al­though it plans to this quar­ter.

Selper­ca­tinib, or LOX-292,  pro­duced a 68% re­sponse rate in 105 non-small cell lung can­cer pa­tients back in Sep­tem­ber, ce­ment­ing its place at the top of Lil­ly’s new-look on­col­o­gy group. The com­pa­ny bought Loxo hop­ing to restart a can­cer di­vi­sion that had fall­en far be­hind the rest of the in­dus­try. Then they hired Loxo’s for­mer heads, in­clud­ing ex-CEO Josh Bilenker, to run the di­vi­sion, hop­ing — in that al­chemist way Big Phar­ma and their biotech ac­qui­si­tions of­ten do – to keep the biotech’s nim­ble in­ge­nu­ity alive, on­ly with bet­ter re­sources.

Josh Bilenker

An ac­cel­er­at­ed ap­proval would be a ma­jor en­dorse­ment of the orig­i­nal $8 bil­lion ac­qui­si­tion, al­though Blue­print will like­ly be not far be­hind. It’s dif­fi­cult to com­pare tri­als, but they al­so demon­strat­ed a re­sponse rate a lit­tle over 60% in a lit­tle more than 100 NSCLC pa­tients. About 2% of NSCLC pa­tients have a RET mu­ta­tion.

Since his tran­si­tion to can­cer R&D chief, Bilenker has pared down old as­sets, in­clud­ing their $40 mil­lion col­lab­o­ra­tion with NextCure from 2018, and in­vest­ed in ones that looked most promis­ing. That in­cludes four main clin­i­cal as­sets, two from Loxo and two from Lil­ly. From Loxo: selper­ca­tinib and Loxo-305, their ver­sion of the sec­ond-gen­er­a­tion, non-co­va­lent BTK in­hibitor sev­er­al biotechs and Big Phar­ma com­pa­nies are try­ing to de­vel­op. From Lil­ly: LY3484356, a se­lec­tive es­tro­gen re­cep­tor de­grad­er, and LY3499446, their con­tri­bu­tion to the KRAS race.

There’s al­so the CDK4/6 drug Verzenio, al­ready ap­proved for breast can­cer, that the group is work­ing to es­tab­lish in com­bos, in­clud­ing with the KRAS drug.

We may get a clos­er read of the re­or­ga­ni­za­tion un­der­way in on­col­o­gy with Lil­ly’s up­com­ing Q4 re­view.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

With lumasir­an on the FDA's doorstep, Al­ny­lam reads out new PhI­II da­ta in PH1

Just over a month away from its December PDUFA date, Alnylam flaunted new data from two Phase III studies to back lumasiran in primary hyperoxaluria type 1 (PH1), a rare liver condition.

The Cambridge, MA-based biotech snagged a priority review for the candidate back in June, and got positive feedback from the EMA’s Committee for Medicinal Products for Human Use just last week. Lumasiran uses RNA interference (RNAi) to silence the gene for glycolate oxidase, an enzyme used in the production of oxalate.

Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.

Pfiz­er scoops up an an­tibi­ot­ic in rare M&A deal, bag­ging a vir­tu­al start­up op­er­at­ing on a shoe­string bud­get

Pfizer is stepping up with a rare antibiotics buyout deal today, grabbing Palo Alto, CA-based Arixa Pharmaceuticals in a bid to add a new oral version of avibactam, a beta lactamase inhibitor — or BLI — approved back in 2015 as part of the IV treatment Avycaz.

The Arixa acquisition follows some encouraging Phase I responses demonstrating that 60% to 80% of the oral drug is absorbed into the bloodstream. Only 7% of the IV version is absorbed orally, far below the 30% threshold Arixa has pointed to as a therapeutic threshold. The buyout gives Pfizer’s hospital group a line on a new oral combo with antibiotics like ceftibuten to go after drug-resistant cases of urinary tract infections and other ailments.

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News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

Another pharma company is intending to use a SPAC to join the Nasdaq.

4D pharma, a UK-based biotech, is reverse-merging with a blank check company in a deal worth up to $37.6 million. The move will give 4D pharma a new Nasdaq ticker, which will be $LBPS, using the American Depositary Share program. 4D will continue to trade on the London stock exchange under its previous ticker.

As a result of the move, 4D pharma will gain $14.6 million in cash held by the blank check company, dubbed Longevity. The merger is expected to be completed in early 2021, after which shares will be immediately tradeable on Nasdaq.

Can B cells break the bound­aries of cell ther­a­py? Long­wood start­up has $52M to prove a new en­gi­neer­ing tech

Back in December 2017, as the cell therapy world was still basking in the virtually back-to-back approvals of two pioneering CAR-Ts, researchers at Seattle Children’s Research Institute reported a scientific first in a different corner of the field: engineer B cells to treat disease.

The team, led by David Rawlings and Richard James, eventually worked with Longwood Fund to start a biotech around those findings. And now Atlas Venture and RA Capital Management are coming on board to lead a $52 million launch round, joined by Alta Partners, for Be Biopharma.

Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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HHS secretary Alex Azar (at the podium) and FDA commissioner Stephen Hahn (Pete Marovich/Getty Images)

Covid-19 roundup: Azar open­ly plan­ning Hahn ouster — re­port; Vul­ner­a­ble pop­u­la­tions like­ly to get vac­cines by Jan­u­ary

The relationship between HHS secretary Alex Azar and FDA commissioner Stephen Hahn has deteriorated to the point where Azar has suggested replacing Hahn, according to a Politico report.

Azar was angered by the FDA’s pushback of the Trump administration’s proposals for authorizing Covid-19 vaccines, so much so that he began openly floating potential replacements for Hahn. The report cited six unnamed sources that said Azar discussed bringing up Hahn’s removal to the White House.

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