The I-Mab team from L-R: CFO Jielun Zhu; President Zheru Zhang; Founder and chairman Jingwu Zang; CEO Joan Shen; and chief commercial officer Ivan Yifei Zhu

I-Mab in talks about deals, stake sale to build on $3B Ab­b­Vie al­liance — Bloomberg

A year af­ter I-Mab made head­lines with its $2.9 bil­lion deal li­cens­ing a CD47 drug to Ab­b­Vie, the Chi­nese biotech is re­port­ed­ly hold­ing ear­ly talks with glob­al phar­ma play­ers about part­ner­ships and po­ten­tial in­vest­ment.

The Shang­hai-based, Nas­daq-list­ed com­pa­ny is mulling “clin­i­cal and com­mer­cial co­op­er­a­tion in Chi­na and a po­ten­tial eq­ui­ty stake sale,” Bloomberg re­port­ed, quot­ing peo­ple fa­mil­iar with the mat­ter. Both US and Eu­ro­pean drug­mak­ers are among the suit­ors in­volved in pre­lim­i­nary dis­cus­sions.

I-Mab did not re­spond to a re­quest for com­ment. For any­one who’s been fol­low­ing the com­pa­ny, though, it wouldn’t come as a sur­prise.

Un­der founder and chair­man Jing­wu Zang — who had helmed Glax­o­SmithK­line’s Chi­na R&D ops un­til he was dis­missed amid a scan­dal — I-Mab has been clear about want­i­ng to lead among a grow­ing pack of Chi­nese com­pa­nies that be­lieve they have a role to play on the glob­al stage. Not on­ly does I-Mab have an of­fice in Mary­land to over­see clin­i­cal tri­al work, it al­so di­vides its pipeline in­to two port­fo­lios: Chi­na and glob­al.

As Big Phar­ma in­creas­ing­ly looks to Chi­na as a source of new drugs, do­mes­tic drug­mak­ers from In­novent and BeiGene to Leg­end and CStone have al­so scored high-pro­file part­ner­ships (with Eli Lil­ly, Am­gen, J&J and Pfiz­er, re­spec­tive­ly) that come in a va­ri­ety of forms.

When it emerged that Ab­b­Vie was pay­ing $180 mil­lion to grab lem­zopar­limab and first dibs to oth­er re­lat­ed an­ti­bod­ies, Zang point­ed to the phar­ma gi­ant’s in­ter­est in im­muno-on­col­o­gy, clin­i­cal de­vel­op­ment ex­per­tise and an­ti­body man­u­fac­tur­ing savvi­ness as the main draws to the al­liance.

“For us this is not just a one-time deal,” he told End­points News at the time. “This is the be­gin­ning of a se­ries of val­i­da­tion, glob­al deals we are ex­pect­ing in the next few years.”

For Ab­b­Vie, it was a tick­et in­to the steam­ing-hot CD47 space, which has on­ly got­ten more at­ten­tion since fol­low­ing Pfiz­er’s $2.3 bil­lion buy­out of Tril­li­um.

Ac­cord­ing to the Bloomberg re­port, I-Mab is seek­ing a part­ner to joint­ly de­vel­op the CD73 an­ti­body uliledlimab, in hopes of repli­cat­ing the suc­cess of the Ab­b­Vie pact.

It’s clear­ly not just mon­ey Zang is af­ter. Al­ready boast­ing near­ly $5 bil­lion in mar­ket cap on Nas­daq, the com­pa­ny is in the process of pur­su­ing a dual list­ing on Shang­hai’s STAR board.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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James Dentzer, Curis CEO

FDA lifts par­tial hold on Curis' lym­phoma study — shares spike

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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