JW Ther­a­peu­tics hauls in $300M IPO just as liso-cel-in­spired CAR-T nears the fin­ish line in Chi­na

Close to two years af­ter Juno Ther­a­peu­tics dis­ap­peared from Nas­daq, a CAR-T biotech it spawned is set­tling on a stock ex­change on the oth­er side of the globe.

James Li

JW Ther­a­peu­tics, a joint ven­ture be­tween Juno and WuXi AppTec, raised $300 mil­lion in its IPO on the Hong Kong Stock Ex­change — build­ing on $190 in ven­ture mon­ey since launch­ing in 2018.

The pitch is all about bring­ing cell ther­a­py break­throughs to Chi­na, tap­ping in­to Amer­i­can con­nec­tions that ex­tend in­to Lyell, a new start­up led by Juno co-founder Rick Klaus­ner, and Eu­re­ka, a long­time part­ner of Juno. WuXi, a glob­al CRO, brings ex­per­tise in process de­vel­op­ment and man­u­fac­tur­ing to the mix.

Full grasp on the com­plex­i­ties of tin­ker­ing with cells is cru­cial to the suc­cess of any CAR-T play­ers, CEO James Li pre­vi­ous­ly told End­points News, and that’s why he doesn’t see the mar­ket crowd­ing out any time soon.

Fo­s­un Kite (al­so a joint ven­ture) and J&J-part­nered Leg­end (now list­ed on Nas­daq) are among the pi­o­neers. Then there’s Gra­cell and CARs­gen lead­ing a slew of new­er en­trants.

“What peo­ple don’t re­al­ize is it takes a much longer time ac­tu­al­ly if you want to have a com­mer­cial­ly vi­able process, to have some­thing mean­ing­ful you can com­mer­cial­ize,” he said.

With its first po­ten­tial ap­provals JW is repli­cat­ing the trail blazed by its US coun­ter­parts. The lead pro­gram, CD19-tar­get­ed rel­ma-cel, is cur­rent­ly un­der re­view at the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion; it’s a spin on Juno’s liso-cel (now be­ing shep­herd­ed to the FDA by Bris­tol My­ers via Cel­gene) with the same CAR back­bone, and the ini­tial in­di­ca­tion is third-line dif­fuse large B cell lym­phoma.

Be­hind that there’s a BC­MA pro­gram for which JW plans to file an IND in the first half of 2021, the com­pa­ny wrote in its IPO ap­pli­ca­tion,

Even though the first gen­er­a­tion of CAR-T ther­a­pies — led by No­var­tis Kym­ri­ah and Gilead’s Yescar­ta — tar­get­ing hema­to­log­i­cal can­cers has yet to be avail­able in the coun­try, JW is al­ready look­ing in­to sol­id tu­mors through its pacts with Lyell and Eu­re­ka. The new pro­ceeds will al­so help fu­el new deals.

“To me, it’s the fu­ture of cell ther­a­py,” Li said.

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.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”