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.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the execs at Nasdaq would like nothing better than to see that momentum continue into the first half of next year.

Since January, 72 biotech and biopharma companies have hit Wall Street, according to Nasdaq head of healthcare listings Jordan Saxe, together raising $13.2 billion.

The latest is Flagship’s Foghorn Therapeutics, which priced its shares last night at $16 apiece, the midpoint of a $15 to $17 range. The Cambridge, MA-based biotech — which initially filed for a $100 million raise on Oct. 2 — is netting $120 million from a 7.5 million-share offering. The proceeds will go right into its gene traffic control platform, including two lead preclinical oncology candidates.