Frank Zhang (AP Images)

Plot thick­ens around Leg­end Biotech, Gen­Script with founder Frank Zhang's ar­rest

Two months af­ter Leg­end Biotech made the star­tling dis­clo­sure that founder and then-CEO Frank Zhang was placed un­der “res­i­den­tial sur­veil­lance,” its par­ent com­pa­ny re­vealed that he’s been for­mal­ly ar­rest­ed.

Zhang — who, since found­ing Gen­Script 18 years ago, has tak­en the CRO pub­lic and groomed Leg­end Biotech in-house un­til the J&J-part­nered CAR-T play­er was ma­ture enough for its own Nas­daq list­ing — is sev­er­ing his fi­nal ties with both. He is re­sign­ing as board chair/non-ex­ec­u­tive di­rec­tor of Gen­Script and di­rec­tor of Leg­end.

The cir­cum­stances around the cus­toms in­ves­ti­ga­tions and the ar­rest re­main opaque.

But the com­pa­nies are ready to move on. Gen­Script has in­stalled Meng Jiange, its VP of in­vestor re­la­tions, as the chair, while adding for­mer chief strat­e­gy of­fi­cer Zhu Li and Wang Xue­hai, VP of the Chi­na Phar­ma­ceu­ti­cal En­ter­pris­es As­so­ci­a­tion, to the board. Zhu is al­so join­ing Leg­end’s board.

“While no charges have been filed against him, Dr. Zhang de­cid­ed that to avoid un­nec­es­sary dis­trac­tion to Leg­end Biotech, his res­ig­na­tion would be in the in­ter­ests of Leg­end Biotech and its share­hold­ers,” a state­ment from Leg­end read.

In an HKEX fil­ing, Gen­Script re­port­ed it had learned about his ar­rest on Fri­day from a fam­i­ly mem­ber who sent over “a copy of a no­tice of ar­rest is­sued by (the) Cus­toms An­ti-Smug­gling De­part­ment of Zhen­jiang” dat­ed Nov. 20. The sus­pect­ed of­fense had to do with “smug­gling goods pro­hib­it­ed by the im­port and ex­port reg­u­la­tions un­der the laws of the PRC.”

Two oth­er em­ploy­ees who had han­dled im­port and ex­port ac­tiv­i­ties have al­so been ar­rest­ed, it wrote. There was no word on what the goods might be.

Jef­feries an­a­lyst Biren Amin has pre­vi­ous­ly sug­gest­ed, based on a chat with Leg­end, that the po­ten­tial vi­o­la­tion sur­round­ed Gen­Script’s ex­port of blood and ge­net­ic sam­ples out of Chi­na.

With a crit­i­cal fil­ing for its BC­MA CAR-T cell ther­a­py loom­ing, Leg­end shares $LEGN fell 4.84% pre-mar­ket.

Ying Huang, the for­mer CFO, is now over­see­ing all that as CEO while Gen­Script co-founder Sal­ly Wang serves as board chair­woman.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

Dutch VC Forbion is hopping on the ever-lengthening SPAC train.

To be led by Jasper Bos, who joined Forbion Growth as a general partner back in May just after the fund closed at $428 million, Forbion European Acquisition will target late-stage opportunities in the life sciences industry in Europe to merge with and bring onto Nasdaq.

Cyril Lesser, senior controller at Forbion, will be the CFO while Bos serves as CEO.

Jeff Albers, Blueprint Medicines CEO

Look­ing past Big Phar­ma ri­vals, Blue­print buys a pre­clin­i­cal biotech for $250M+

J&J’s Rybrevant scored the first approval back in May for a small group of lung cancer patients with a rare EGFR mutation. Despite a swarm of other biopharma companies angling for a piece of that market, Blueprint Medicines is betting nearly $500 million on a candidate it thinks will stand out.

Blueprint is putting down $250 million in cash and another $215 million in biobucks for Lengo Therapeutics and its preclinical non-small cell lung cancer program LNG-451. Though it hasn’t been tested in humans, Blueprint says the candidate was “highly brain-penetrant” in preclinical trials, and has the potential to inhibit all common EGFR exon 20 insertion variants — which are found in just 2% to 3% of NSCLC patients.

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