Lian­Bio an­nounces terms for IPO next week; NIH and White House of­fi­cials dis­cuss hy­po­thet­i­cal bio-med re­search agency

Lian­Bio, a biotech that has op­er­a­tions in both the US and Chi­na, an­nounced the terms yes­ter­day for its ini­tial pub­lic of­fer­ing.

The biotech plans to raise $325 mil­lion by of­fer­ing 20.3 mil­lion shares priced be­tween $15 and $17.

At the mid­point of the pro­posed range, Lian­Bio could com­mand a ful­ly di­lut­ed mar­ket val­ue of $1.8 bil­lion, based on a num­ber of ex­pect­ed out­stand­ing shares.

The two year old biotech has fo­cused on in-li­cens­ing and com­mer­cial­iza­tion of ther­a­peu­tics in Chi­na, Hong Kong, Tai­wan, Macau and oth­er Asian mar­kets. The com­pa­ny cur­rent­ly has nine pro­grams across five ther­a­peu­tic ar­eas, in­clud­ing on­col­o­gy, car­dio­vas­cu­lar, and in­flam­ma­to­ry dis­eases.

The IPO is ex­pect­ed to price some­time next week.

White House of­fi­cials, NIH Di­rec­tor Collins dis­cuss pro­posed DARPA-es­que agency for bio­med­ical re­search — and some of the agency’s goals

White House and NIH of­fi­cials hopped on­to a 90-minute Zoom call yes­ter­day to dis­cuss the pro­posed NIH en­ti­ty “Ad­vanced Re­search Pro­jects Agency for Health,” or ARPA-H.

As the pro­posed agency may have sim­i­lar au­ton­o­my to oth­er agen­cies such as DARPA, this agency would fo­cus pri­mar­i­ly on bio­med­ical re­search, ac­cord­ing to NIH Di­rec­tor Fran­cis Collins, who will be re­tir­ing from his po­si­tion by the end of the year.

To Collins, ARPA-H is an op­por­tu­ni­ty to stretch bound­aries and see what could be pos­si­ble. By way of ex­am­ple, he named tech­nol­o­gy to de­liv­er drugs to on­ly the ex­act right cell type, or an mR­NA vac­cine that would im­mu­nize a pa­tient against the fifty most com­mon mu­ta­tions that cause sol­id tu­mors, to next-gen wear­able sen­sors to help a pa­tient man­age chron­ic dis­ease.

Tara Schwetz, from the White House Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy (OSTP), con­curred with Collins.

“The goals of ARPA-H are re­al­ly to sup­port trans­for­ma­tive, high risk, high re­ward med­ical re­search, and em­brac­ing a sense of ur­gency to speed, the ap­pli­ca­tion and im­ple­men­ta­tion of break­throughs at a va­ri­ety of dif­fer­ent lev­els,” Schwetz said.

In the rest of the pre­sen­ta­tions and fol­low­ing Q&A, there was an em­pha­sis on fail­ing fast and fail­ing ear­ly.

“Again, I un­der­stand this, you do want to fail ear­ly. So if we don’t fail at any­thing … maybe we’re not tak­ing enough bold, in­no­v­a­tive chances,” said NIH prin­ci­pal deputy di­rec­tor Lawrence Tabek.

Af­ter talk­ing about hav­ing mile­stones in place as a type of safe­guard, he con­tin­ued, “If fail­ure is hap­pen­ing, you will know that ear­ly, and you won’t keep throw­ing re­sources at some­thing that’s not go­ing to suc­ceed. So fail fre­quent­ly, but fail fast.”

So far, there is fund­ing for the agency in Con­gress’s FY22 bills — but the House and Sen­ate still need to rec­on­cile on an amount.

An­ten­gene and LegoChem pair up in ADC deal

Chi­nese biotech An­ten­gene is team­ing up with South Ko­re­an biotech LegoChem Bio­sciences in an ADC-fo­cused re­search and li­cense agree­ment.

Un­der the deal an­nounced this morn­ing, both com­pa­nies will joint­ly dis­cov­er and eval­u­ate po­ten­tial ADC can­di­dates us­ing An­ten­gene’s an­ti­bod­ies and LegoChem’s ADC plat­form.

An­ten­gene will re­tain the op­tion to li­cense glob­al rights for the de­vel­op­ment and com­mer­cial­iza­tion of re­sult­ing ADC can­di­dates. When the op­tion is ex­er­cised, LCB will re­ceive up­front and mile­stone pay­ments, as well as tiered roy­al­ties. In ad­di­tion, LCB is el­i­gi­ble to re­ceive a pre-spec­i­fied per­cent­age of any sub-li­cens­ing in­come re­ceived by An­ten­gene.

“LCB and An­ten­gene will team up to ac­cel­er­ate the de­vel­op­ment of new ther­a­pies that com­bine An­ten­gene’s ex­per­tise in on­col­o­gy with LCB’s clin­i­cal­ly val­i­dat­ed ADC tech­nol­o­gy plat­form,” said LegoChem pres­i­dent and CEO Yong-Zu Kim.

Op­di­vo re­ceives ap­proval in EU in com­bi­na­tion with chemo for HER2-neg­a­tive can­cer types

Bris­tol My­ers Squibb an­nounced the Eu­ro­pean Com­mis­sion’s ap­proval of PD-L1 in­hibitor Op­di­vo to­day.

The ap­proval is for use in com­bi­na­tion with flu­o­ropy­rim­i­dine- and plat­inum-based com­bi­na­tion chemother­a­py — and it will serve as a first-line treat­ment of HER2-neg­a­tive ad­vanced or metasta­t­ic gas­tric, gas­troe­sophageal junc­tion (GEJ), or esophageal ade­no­car­ci­no­ma (EAC) in adults.

The ap­proval al­lows for the use of Op­di­vo in the 27 mem­ber states of the Eu­ro­pean Union, as well as Ice­land, Liecht­en­stein, and Nor­way.

The EC’s de­ci­sion is based on re­sults from the Phase III Check­Mate -649 tri­al, in which first-line treat­ment with Op­di­vo plus ei­ther chemother­a­py pro­to­col FOL­FOX or CapeOX was com­pared to sole­ly chemo.

“We are es­pe­cial­ly pleased to move the field for­ward and in­tro­duce this Op­di­vo-based com­bi­na­tion for pa­tients in the Eu­ro­pean Union,” said Bris­tol My­er’s de­vel­op­ment lead for gas­troin­testi­nal can­cers, Ian Wax­man.

blue­bird bio files with SEC to with­draw mar­ket­ing au­tho­riza­tion for mul­ti­ple drugs

blue­bird bio had an­nounced that as part of the wind­ing down of its op­er­a­tions in Eu­rope, it would with­draw its mar­ket­ing au­tho­riza­tion for neu­ro­log­i­cal gene ther­a­py treat­ment Skysona from the EU, along with its mar­ket­ing ap­pli­ca­tion for the treat­ment from the UK. In a form 8-K filed with the SEC ear­li­er to­day, that with­draw­al is of­fi­cial.

Ad­di­tion­al­ly, blue­bird bio an­tic­i­pates with­draw­ing mar­ket­ing au­tho­riza­tions for blood dis­or­der med­ica­tion Zyn­te­glo from both the EU and the UK by ear­ly next year.

While blue­bird ex­pects to con­tin­ue ac­tiv­i­ties for the long-term fol­low-up of pa­tients pre­vi­ous­ly en­rolled in EU clin­i­cal tri­als as planned, the biotech does not in­tend to ini­ti­ate any new clin­i­cal tri­als in Eu­rope for be­ta-tha­lassemia, CALD or sick­le cell dis­ease, ac­cord­ing to the form 8-K.

Charles Riv­er Lab­o­ra­to­ries ex­pands Cam­bridge re­al es­tate for ear­ly-stage drug re­search

Just as Charles Riv­er Lab­o­ra­to­ries of­floaded two as­sets last week, the com­pa­ny is ex­pand­ing — again.

The firm an­nounced yes­ter­day the ex­pan­sion of its Charles Riv­er Ac­cel­er­a­tor and De­vel­op­ment Lab, or CRADL, on Bin­ney Street in Cam­bridge, along with adding a sec­ond Cam­bridge lo­ca­tion on Bent Street.

Af­ter CRADL’s flag­ship lo­ca­tion opened on Bin­ney Street in 2018, the lab had 15,000 square feet of space. The lat­est ad­di­tion has tripled the space to 45,000 square feet.

Ad­di­tion­al­ly, Charles Riv­er has be­gun the process of open­ing a sec­ond CRADL lo­ca­tion on Bent Street in Cam­bridge, adding an ad­di­tion­al 18,000 square feet of ca­pac­i­ty for clients, with the first phase planned to open by the end of the year.

Both lo­ca­tions of­fer rental space for biotechs and re­search in­sti­tu­tions, al­low­ing sci­en­tists to fo­cus on re­search while leav­ing an­i­mal hus­bandry and vi­var­i­um man­age­ment to “a trust­ed part­ner,” ac­cord­ing to a com­pa­ny state­ment.

“In the bio­phar­ma­ceu­ti­cal in­dus­try, both in­fra­struc­ture and staffing can be pro­hib­i­tive­ly ex­pen­sive and take sig­nif­i­cant time to de­vel­op,” said CRADL op­er­a­tion di­rec­tor at Charles Riv­er Julie Free­ber­syser. “By out­sourc­ing their vi­var­i­um space, re­searchers can fo­cus on re­search, in­stead of lo­gis­tics.”

Sabin Vac­cine In­sti­tute re­ceives mil­lions from BAR­DA from con­tract op­tion

Sabin an­nounced to­day that BAR­DA has ex­er­cised a $34.5 mil­lion con­tract op­tion from their 2019 con­tract — to ad­vance vac­cine de­vel­op­ment against ebo­la su­dan and mar­burg virus­es through Phase II clin­i­cal tri­als.

BAR­DA had award­ed Sabin a de­vel­op­ment con­tract in Sep­tem­ber 2019, val­ued up to $128 mil­lion. So far, more than $40 mil­lion has been pro­vid­ed.

The con­tract op­tion will en­able Sabin to con­tin­ue ef­fi­ca­cy and safe­ty stud­ies, Phase II clin­i­cal tri­als in Africa, and vac­cine man­u­fac­tur­ing process­es to en­sure qual­i­ty and safe­ty, ac­cord­ing to a Sabin state­ment.

“We are grate­ful for BAR­DA’s con­tin­ued sup­port of Sabin’s ef­forts to ad­vance vac­cines against these dead­ly virus­es,” said Sabin CEO Amy Fi­nan. “We al­so thank our part­ners at the Vac­cine Re­search Cen­ter of the NIH Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases for their con­tin­ued col­lab­o­ra­tion, and GSK for their ear­li­er work on the can­di­dates.”

The two can­di­date vac­cines, based on a GSK pro­pri­etary plat­form, were ex­clu­sive­ly li­censed to the Sabin Vac­cine In­sti­tute in 2019.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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