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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Chica­go-area biotech sends 2nd drug to In­di­a's reg­u­la­tors; Pen­ny stock play­er spins out PhI­II can­cer can­di­date in­to new com­pa­ny

Pharmazz is on its way to India’s drug regulator for the second time as its investigational treatment passed muster in a Phase III study in patients with acute ischemic stroke.

The Chicago suburbs-based biotech said its drug sovateltide led to better improvement than placebo on certain measurements of neurological outcomes.

Sovateltide led an improvement of ≥2 points on mRS and an increase of ≥6 points on NIHSS at day 90 in the trial of 158 adults in India. The modified Rankin scale looks at the degree of dependence in the daily activities of people post-stroke event, and the NIH stroke scale measures the stroke-related neurologic deficit.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.