J&J's fa­vorite CAR-T de­vel­op­er, cur­rent­ly owned by a Chi­nese CRO, is lay­ing the ground­work for US IPO

Gen­Script, the low-pro­file own­er of CAR-T dark horse Nan­jing Leg­end Biotech, is hatch­ing a plan to spin out its fa­mous sub­sidiary and shoot for a US IPO.

Yuan Xu

The con­tract re­search or­ga­ni­za­tion dis­closed its pro­pos­al in a fil­ing to the Hong Kong Stock Ex­change, where it’s been list­ed since late 2015. With the HKEX’s bless­ing, Leg­end Biotech has sub­mit­ted a draft reg­is­tra­tion state­ment to the SEC, it wrote.

Leg­end was a vir­tu­al un­known un­til it turned up at AS­CO in 2017 with ear­ly da­ta on its BC­MA CAR-T con­tender show­ing a 100% ob­jec­tive re­sponse rate and a 94% clin­i­cal re­mis­sion rate among a small group of mul­ti­ple myelo­ma pa­tients. J&J was so im­pressed that it dropped $350 mil­lion in cash to part­ner on that pro­gram, now JNJ-68284528.

An anti­gen found on the sur­face of B cells, BC­MA has since be­come one of the hottest tar­gets in im­muno-on­col­o­gy, with more than two dozen oth­er de­vel­op­ers vy­ing for a place in CAR-T, along­side a hand­ful in the CD3 bis­pe­cif­ic and the an­ti­body-drug con­ju­gate fields.

Bris­tol My­ers Squibb, through part­ner­ship Cel­gene had with blue­bird, has a fron­trun­ner in ide-cel, per­haps bet­ter known as bb2121.

Frank Fan

Ex­pect con­tin­ued de­bate on how J&J and Leg­end’s can­di­date mea­sures up. While the mid-stage num­bers from the LEG­END-2 study pre­sent­ed at ASH 2018 (88% ORR, 74% com­plete re­sponse rate re­port­ed at ASH in 2018) fell from the ear­ly, awe-in­spir­ing lev­els, ex­ecs man­aged to con­vince the EMA to hand down its prized PRIME des­ig­na­tion based on a more en­cour­ag­ing pic­ture paint­ed by CAR­TI­TUDE-1. Those lat­est re­sults, pre­sent­ed at ASH last year, sug­gest­ed once again a 100% re­sponse rate among pa­tients who’ve had a me­di­an of five (and at least three) pri­or treat­ments.

One thing we know for sure is that Leg­end had grown to be a ma­jor fac­tor in Gen­Script’s val­u­a­tion. Fol­low­ing Leg­end’s big break three years ago, Gen­Script’s stock price jumped five-fold to HKD30 at its peak. And when an ob­scure in­vest­ment firm pub­lished a scathing short re­port ac­cus­ing Leg­end of ma­nip­u­lat­ing its ear­ly da­ta, its shares nose­dived, re­bound­ing on­ly af­ter a staunch de­fense was is­sued.

That all sets the op­er­a­tions, led by CEO Yuan Xu and CSO/founder Frank Fan, up for an in­de­pen­dent path. But the terms of the spin­off has yet to be de­ter­mined, Gen­Script cau­tioned:

Share­hold­ers and po­ten­tial in­vestors of the Com­pa­ny should be aware that there is no as­sur­ance that the Pro­posed Spin-off will take place or as to when it may take place.

In­vestors ap­peared to have tak­en that ad­vice. The stock trad­ed down on Tues­day, cur­rent­ly sit­ting at HKD16.6.

A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Force 5 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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Aaron Royston, venBio

In­vest­ing in the time of coro­n­avirus: the good, the bad and the hope­ful, as biotech VC firms close funds worth $3B

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

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GSK vac­cine chief heads for AIDS vac­cine ini­tia­tive; Pfiz­er en­lists Sue Desmond-Hell­mann to its board of di­rec­tors

→ Rip Ballou, who until very recently led vaccine research and development at GlaxoSmithKline, is joining the International AIDS Vaccine Initiative (IAVI) to lead its USAID-funded ADVANCE program. The program uses a network of researchers and institutions in Africa to help develop a vaccine for HIV. Ballou had worked at GSK since 2010 and has led global vaccine R&D since 2015. Prior to that he held posts at the Bill & Melinda Gates Foundation, a different post at GSK, Medimmune, and Walter Reed Army Institute of Research.  IAVI is led by Mark Feinberg, the former CSO of Merck Vaccines. 

Ahead of US IPO, Leg­end Biotech adds $150M, top-tier in­vestors to back CAR-T pipeline

Last month Nanjing Legend Biotech revealed that it sees, and was quietly planning for, a future as a public company in the US, separate but still tied to its former parent, Chinese CRO GenScript. It’s evidently a vision that enticed investors, drawing marquee names for a pre-IPO round.

The Series A fetched a whopping $150.5 million from Hudson Bay Capital Management, Lilly Asia Ventures, Vivo Capital, RA Capital Management and JJDC, the venture arm of J&J. The pharma giant has helped fund Legend’s CAR-T work with the $350 million upfront payment it handed over to partner on the lead BCMA program.

Covid-19 roundup: Mod­er­na CEO Stéphane Ban­cel be­comes a bil­lion­aire; No­var­tis, In­cyte pitch Jakafi PhI­II to tack­le se­vere cas­es

You can now add Moderna CEO Stéphane Bancel to the list of biotech billionaires.

Since investors began to understand the full scope of the coronavirus outbreak in late February, cash has flushed out of much of the stock market and into the handful of companies leading the fight for drugs and vaccines. That’s meant hundreds of millions for Moderna, the Flagship-backed company that emerged early as the world’s first best hope for a Covid-19 vaccine.

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J&J gives pi­o­neer­ing stem cell biotech its first Big Phar­ma deal, part­ner­ing on iP­SC CAR-T and CAR-NK

Late last summer, one of the earliest stem cell therapy companies got two government decisions in the span of three weeks: The USPTO granted them a patent for iPSC-derived CAR-T cells, and then the FDA cleared them for their first-in-human CAR-NK trial.

Yesterday, the two technologies landed them an up-to $3.1 billion deal.

Fate Therapeutics and J&J announced a global collaboration that will pay Fate $100 million upfront and a trove of potential milestones to develop multiple CAR-T and CAR-NK therapies. It’s the first Big Pharma partnership Fate has announced in their 13-year existence and the largest, although at least one longtime follower thought they could have landed more.

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FDA re­ports short­age of se­da­tion drug used for putting Covid-19 pa­tients on ven­ti­la­tors

The FDA on Thursday updated its list of drugs in shortage to include the sedation drug midazolam, which along with other sedatives is being used to treat COVID-19 patients requiring mechanical ventilation.

The updated listings for five manufacturers note an increased demand for midazolam and may just be the beginning of what’s to come for other sedation drugs too.

Michael Ganio, senior director of pharmacy practice and quality at the American Society for Health-System Pharmacists, told Focus via email: “We have multiple reports of increases in purchases and utilization of sedatives like midazolam, fentanyl, and propofol to treat COVID-19 patients who require mechanical ventilation.”

Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.