Jay Mei at BIIS 2018 (Endpoints/PharmCube)

Ex-Cel­gene ex­ec steers his biotech start­up to Hong Kong IPO as po­ten­tial can­cer drug launch looms

Jay Mei re­mem­bers the ex­act date he first met BeiGene CEO John Oyler.

It was May 14, 2016, and Mei — then an ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment at Cel­gene — ac­com­pa­nied CEO Mark Alles on a trip from New Jer­sey to Bei­jing. The meet­ing ce­ment­ed more than just Cel­gene’s ground­break­ing part­ner­ship with BeiGene, in which the Chi­na-based biotech of­fered its PD-1 in­hibitor in ex­change for Cel­gene’s com­mer­cial op­er­a­tion in the coun­try.

For Mei, it al­so so­lid­i­fied his con­vic­tion that in ad­di­tion to over­seas and lo­cal drug­mak­ers, the time was ripe for a third kind of com­pa­ny: a hy­brid biotech that blends multi­na­tion­al cor­po­rate cul­ture with a deep un­der­stand­ing of Chi­na.

With­in a year he’d launch his own start­up in Shang­hai, with a foun­da­tion­al li­cens­ing deal and fi­nanc­ing from Cel­gene. Two more rounds to­tal­ing $141 mil­lion lat­er, with Cel­gene now part of Bris­tol My­ers Squibb and Alles now sit­ting on the board, An­ten­gene is shoot­ing for an IPO in Hong Kong (rather than Nas­daq, an op­tion that Mei said was equal­ly like­ly back in 2018).

As is cus­tom­ary, An­ten­gene did not in­di­cate how much it’s plan­ning to raise in its HKEX fil­ing. But ac­cord­ing to an IFR re­port, its goal is around $200 mil­lion.

The ap­pli­ca­tion comes just three days af­ter the biotech an­nounced that Chi­nese reg­u­la­tors have cleared the IND for a Phase II tri­al of ATG-008, or onatasert­ib, oral dual mTORC1/2 in­hibitor from Cel­gene. Aside from monother­a­py tri­als, An­ten­gene is al­so do­ing com­bi­na­tion stud­ies with PD-1 in ad­vanced he­pa­to­cel­lu­lar car­ci­no­ma and ad­vanced non-small cell lung can­cer.

But the biggest loom­ing de­ci­sion has to do with se­linex­or, which Karyopharm has steered to ap­provals in the US for re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma and R/R dif­fuse large B cell lym­phoma.

Known as ATG-010 in the An­ten­gene pipeline, the drug is in reg­is­tra­tional Phase II stud­ies for those ex­act two in­di­ca­tions. It’s al­so be­ing test­ed in pa­tients with R/R T cell lym­phoma, NK/T cell lym­phoma and KRAS-mu­tant NSCLC. An NDA sub­mis­sion is slat­ed by 2021.

An­ten­gene li­censed two oth­er SINE com­pounds — se­lec­tive in­hibitor of nu­clear ex­port — plus a PAK4/NAMPT in­hibitor from Karyopharm. Both eltane­x­or and verdinex­or are in Phase I/II tri­als now, while ATG-019 is in Phase I.

Then there’s ATG-017, the most ad­vanced mol­e­cule from a deal inked with As­traZeneca last No­vem­ber around ERK 1/2 in­hibitors. If the Phase I and sub­se­quent clin­i­cal pro­gram pan out, An­ten­gene is on the hook for $294 mil­lion in to­tal.

The rest of the pipeline (which con­sists of 12 can­cer drugs to­tal) is all dis­cov­ered in-house, hit­ting some up-and-com­ing tar­gets such as Claudin 18.2 and KRAS G12C be­fit­ting Mei’s mot­to to nev­er do me-too or me-bet­ter drugs.

For all that work, though, An­ten­gene is keep­ing a lean team of 90, half of which are in­volved in R&D. The ma­jor­i­ty is based in Shang­hai, Bei­jing and Shaox­ing.

“In an­tic­i­pa­tion of the launch of ATG-010 (se­linex­or), we plan to fur­ther ex­pand our com­mer­cial­iza­tion team to have 100 full time em­ploy­ees by the end of 2021,” the com­pa­ny wrote.

It’s al­so build­ing a 16,300 square-me­ter man­u­fac­tur­ing site in Shaox­ing, to be on­line around 2022.

Pri­or to the pub­lic float, CEO Mei holds the largest chunk of the stock at 35%. Qim­ing and Boyu, the re­spec­tive lead­ers of the Se­ries A and B, con­trols 7.82% and 12.89%. Oth­er in­vestors in­clude Foun­tain­Vest, Cel­gene and WuXi.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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