With a po­ten­tial FDA ap­proval loom­ing, G1 Ther­a­peu­tics taps ex-GSK US pres­i­dent Jack Bai­ley as new CEO

There’s nev­er a per­fect time to step down from a lead­er­ship po­si­tion, G1 Ther­a­peu­tics CEO Mark Vel­le­ca said. But to him, this felt like the right one.

On Jan­u­ary 1 — a month be­fore the FDA rules on what could be the biotech’s first ap­proved drug  — Vel­le­ca will pass the torch to GSK vet John “Jack” Bai­ley, who joined G1’s board in March. Bai­ley stepped down at GSK’s US pres­i­dent last year, where he gained con­sid­er­able ex­pe­ri­ence on the sales side.

“I very much feel like I’ve ac­com­plished what I was orig­i­nal­ly cast to do,” Vel­le­ca said.

Mark Vel­le­ca

In Au­gust, the North Car­oli­na-based com­pa­ny an­nounced pri­or­i­ty re­view for its drug tri­laci­clib, which is de­signed to proac­tive­ly re­duce the side ef­fects of chemother­a­py. The drug’s PDU­FA date is Feb­ru­ary 15, and if ap­proved, G1 hopes to roll it out ear­ly next year.

“It’s very clear what we need to do,” Bai­ley said. The biotech is al­ready work­ing on oth­er in­di­ca­tions, in­clud­ing col­orec­tal can­cer. The com­pa­ny an­tic­i­pates a glob­al Phase III tri­al in about 300 pa­tients with col­orec­tal can­cer will be­gin “very soon,” which would pro­duce da­ta in 2023, Vel­le­ca said.

In June, G1 en­tered a mar­ket­ing agree­ment with Boehringer In­gel­heim. Vel­le­ca said G1 of­fered Boehringer a “mod­est” up­front pay­ment, and will put down more in rev­enue-based pay­ments over the course of the three-year deal, which is on­ly for small cell lung can­cer. BI stood out to the team at G1 be­cause they’ve been in on­col­o­gy for years, and have “well-es­tab­lished re­la­tion­ships spe­cif­ic for lung can­cer,” Bai­ley said.

The new CEO said he’s been “ad­mir­ing (G1) from afar” since it was launched by NCI chief Ned Sharp­less in 2008. He comes by way of Glax­o­SmithK­line, where he worked as pres­i­dent of their phar­ma­ceu­ti­cals and vac­cines busi­ness in the US. He al­so spent 18 years at Eli Lil­ly, serv­ing a num­ber of roles in­clud­ing se­nior vice pres­i­dent of ac­count-based mar­kets, gen­er­al man­ag­er of Eli Lil­ly South Africa, and area di­rec­tor for the sub-Sa­ha­ran re­gion.

Tri­laci­clib — which Vel­le­ca de­scribed as Sharp­less’ “brain­child” in an Au­gust in­ter­view with End­points News — en­tered the clin­ic in 2014. It snagged a break­through des­ig­na­tion in 2019, and G1 sub­mit­ted an NDA this June. The drug is meant to pre­serve bone mar­row and im­mune func­tions in pa­tients on chemother­a­py. It works by tem­porar­i­ly ar­rest­ing bone mar­row cells and pre­vent­ing them from di­vid­ing while the chemo fights tu­mor cells.

It’s a proac­tive treat­ment, as op­posed to “res­cue in­ter­ven­tions” per­formed af­ter the dam­age is al­ready done, Vel­le­ca said.

The cur­rent CEO said back in Au­gust that he be­lieves the drug could prove ef­fec­tive in “any pa­tient with a sol­id tu­mor” re­ceiv­ing myelo­sup­pres­sant chemother­a­py. “This is a fun­da­men­tal­ly new way to spare pa­tients from myelo­sup­pre­sion,” he added on Thurs­day. Af­ter sur­ren­der­ing his top spot, Vel­le­ca will stick around as se­nior ad­vi­sor.

G1 spokesman Jeff Mac­don­ald did not dis­close the an­tic­i­pat­ed price of tri­laci­clib, but said it will like­ly come in above Neu­las­ta, which has a list price of $6,231 per dose.

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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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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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.

Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.

Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Lit­tle Zosano takes an­oth­er beat­ing as the FDA slaps down their ap­pli­ca­tion for a mi­graine patch

Zosano $ZSAN has officially come up short in its bid to develop a migraine patch.

The FDA rejected the company’s application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta, Zosano said Wednesday morning, issuing a CRL for the microneedle patch. Regulators cited inconsistent exposure levels across multiple clinical trials as the main reason for the thumbs down.

Investors did not take too kindly to the news, with Zosano shares plunking down around 25%. The company is requesting a Type A meeting to “provide clarity on the next steps for the program,” CEO Steven Lo said in a statement.