Juno, WuXi JV in Chi­na score $100M in fresh fund­ing as it sets stage for first CAR-T ap­proval

Chi­na’s on­col­o­gy-fo­cused biotech hub has raised al­ready mil­lions in ven­ture fund­ing and lured pow­er­ful glob­al bio­phar­ma part­ners to ad­dress the high rates of can­cer in the coun­try. In yet an­oth­er ex­am­ple, the joint ven­ture be­tween Juno and to WuXi’s AppTec has raised a siz­able $100 mil­lion in a fresh round of fund­ing.

The Shang­hai-based com­pa­ny, chris­tened JW Ther­a­peu­tics (an ini­tial each from its root com­pa­nies), was cre­at­ed to mar­ry Juno’s CAR-T de­vel­op­ment ex­pe­ri­ence and WuXi’s AppTec’s mus­cu­lar man­u­fac­tur­ing ca­pac­i­ty. In 2018, it scored $90 mil­lion to take its lead ex­per­i­men­tal B cell ma­lig­nan­cy-fo­cused drug, JW­CAR029, in­to the clin­ic and build a new man­u­fac­tur­ing plant.

Now, as the drug is be­ing ush­ered in­to mid-stage de­vel­op­ment, JW has raised an­oth­er $100 mil­lion in a round led by CPE and Mi­rae As­set, joint­ed by CR-CP Life Sci­ence Fund and Oriza Hold­ings, as well as ex­ist­ing in­vestors in­clud­ing Loy­al Val­ley Cap­i­tal, Temasek, Se­quoia Cap­i­tal Chi­na, ARCH Ven­ture Part­ners. Juno (bought out by Cel­gene, which was swal­lowed by Bris­tol My­ers Squibb) along with WuXi al­so con­tributed.

Apart from Temasek, Se­quoia Cap­i­tal Chi­na, and ARCH Ven­ture Part­ners, the funds will be used to bol­ster the com­pa­ny’s CAR-T pipeline and gear up com­mer­cial­iza­tion ca­pac­i­ty to sup­port po­ten­tial launch­es.

In re­cent years, big US and glob­al drug­mak­ers have al­lied with can­cer biotech com­pa­nies as an en­try point or as a way to ex­pand their foot­print in the pop­u­lous coun­try marred by high rates of can­cer and a bur­geon­ing life sci­ences in­dus­try.

Days ago, Sanofi tied up with Al­pham­ab On­col­o­gy — which made a splashy $230 mil­lion in its pub­lic de­but on the Hong Kong Stock Ex­change (HKEX) late last year — to col­lab­o­rate on a bis­pe­cif­ic an­ti­body fo­cused on treat­ing breast can­cer.

In­novent Bi­o­log­ics, which raised a con­sid­er­able $421 mil­lion in its HKEX de­but in 2018, snagged Roche as a part­ner on Tues­day in a deal that grants it ac­cess to the Swiss drug­mak­er’s bis­pe­cif­ic an­ti­body and CAR-T tech­nol­o­gy. In­novent, in col­lab­o­ra­tion with Eli Lil­ly, was the first drug­mak­er to get a home­grown Chi­nese check­point in­hibitor across the fin­ish line in the coun­try — in late 2018, the PD-1 agent Tyvyt (sin­til­imab) scored ap­proval for pa­tients with re­lapsed/re­frac­to­ry clas­si­cal Hodgkin’s lym­phoma. There are a hand­ful of check­point in­hibitors on the Chi­nese mar­ket now, in­clud­ing Jun­shi’s Tuoyi, Mer­ck’s flag­ship Keytru­da and BeiGene’s tislelizum­ab.

BeiGene too has close ties with the Unit­ed States, the world’s largest phar­ma­ceu­ti­cals mar­ket. In ad­di­tion to a cadre of part­ner­ships with small and mid-sized US drug de­vel­op­ers, the com­pa­ny sells a raft of Cel­gene (now Bris­tol My­ers) drugs in Chi­na, while Am­gen has tak­en a hefty 20.5% stake in the drug­mak­er.

Dri­ven part­ly by high rates of pol­lu­tion and smok­ing, can­cer is the lead­ing cause of death in Chi­na. An es­ti­mat­ed 4.3 mil­lion new can­cer cas­es and 2.9 mil­lion new can­cer deaths oc­curred in Chi­na in 2018, ac­cord­ing to a 2019 analy­sis. Com­pared to the USA and UK, Chi­na has low­er can­cer in­ci­dence but a 30% and 40% high­er can­cer mor­tal­i­ty than the two na­tions re­spec­tive­ly, the au­thors found.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.

Alexander Vos, VarmX CEO

'Fun­da­men­tal­ly dif­fer­en­t' from Por­to­la, Dutch biotech lands €32M to steer an­ti-an­ti­co­ag­u­lant through the clin­ic

Portola may not have had much success proving the commercial value of an anti-anticoagulant, but that’s not stopping European investors from pouring $36.2 million (€32 million) into what they see as a superior approach put forth by a Dutch biotech.

VarmX’s blood thinner reversal agent stems from research done by founder and CSO Pieter Reitsma at Leiden University Medical Center. A modified recombinant form of factor X, VMX-C001 “has an insertion of 16 amino acids that replaces a stretch of 7 amino acids in the so-called serine protease domain” compared to the native coagulation factor, CEO Alexander Vos told Endpoints News.

FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Adrian Gottschalk, Foghorn CEO

Mer­ck dan­gles up to $425 mil­lion to team with Flag­ship’s Foghorn Ther­a­peu­tics on drug­ging the shape of DNA

Two years after it first emerged from stealth mode, Flagship’s Foghorn Therapeutics has nabbed its first Big Pharma partner as Merck signs on to the biotech’s vision of drugging the very shape of DNA.

The deal, worth up to $425 million but with the upfront cash undisclosed, comes as Foghorn nears a pivot to a clinical stage biotech. The Cambridge-based company has added nearly 60 staffers from the 25 it had when it first emerged out of Flagship and, CEO Adrian Gottschalk said, they have finally refined the screening technology at the heart of the company, with plans to file their first IND towards the end of the year.

John Reed, Sanofi R&D chief (Endpoints News)

John Reed brings NK cells in­to Sanofi's CD38 ri­val­ry with J&J — and of­fers thumbs up for Kiadis' new fo­cus

Sanofi doesn’t just want to be a challenger to J&J’s dominant Darzalex multiple myeloma franchise. It’s looking to pioneer a new approach by pairing its own — newly approved — anti-CD38 drug with an NK cell therapy it’s just picked up.

The French pharma giant has teed up $19.7 million (€17.5 million) upfront and close to a billion dollars (€857.5 million) in milestones for a license to Kiadis Pharma’s preclinical K-NK004 program, which consists of NK cells that have been genetically engineered not to express CD38.

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