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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Pascal Soriot, AstraZeneca CEO (via Getty images)

UP­DAT­ED: FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

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