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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

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Pearl Huang, former Cygnal Therapeutics president and CEO

UP­DAT­ED: Flag­ship builds a new start­up out of pieces from 2 of its biotechs. And a Roche vet leaves to do some­thing new

Flagship has crafted a new startup out of pieces from a pair of fledglings in the VC’s nest. And a prominent Roche veteran who ran one of the biotechs won’t be making the next leg of the journey.

The new company is called Sonata Therapeutics, which is picking up the work that Inzen was doing related to the cellular microenvironment and combining with Flagship’s Cygnal Therapeutics, which came out of stealth more than 3 years ago and put Pearl Huang — the BeiGene founder and former Roche SVP — at the helm.

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Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.