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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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