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.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges


Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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vTv Ther­a­peu­tics cuts 65% of em­ploy­ees in shake­up; Freenome bags $300M in Se­ries D to ex­pand mul­ti­omics plat­form

vTv Therapeutics has decided to chop down its workforce by almost two-thirds.

The High Point, NC biotech announced Monday that it would pivot and now prioritize its lead program, the oral glucokinase activator TTP399, as it gears up for Phase III pivotal trials.

The drug was granted breakthrough therapy designation after showing a 40% reduction in hypoglycemic episodes compared to placebo, and back in October vTv announced positive results in a study showing no increased risk for ketoacidosis, a severe complication of diabetes.

Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.