Join­ing hunt for hep B cure, Brii Bio inks maid­en deals fea­tur­ing VBI, Vir, WuXi with a big ap­petite for more

This May, Zhi Hong de­buted the ul­tra-con­nect­ed trans-Pa­cif­ic up­start Brii Bio to bridge a gap in in­no­va­tion be­tween the US and Chi­na. Sev­en months in, he’s us­ing some of those con­nec­tions to in-li­cense two po­ten­tial cures for he­pati­tis B, en­ter an­oth­er dis­cov­ery col­lab­o­ra­tion and build a new glob­al head­quar­ters, kick­start­ing a quest to “cre­ate a new ground for in­fec­tious dis­eases.”

And with plen­ty of his $260 mil­lion launch fund still in the bank, the CEO al­ready has his eyes set on more part­ner­ships — all co­or­di­nat­ed from a new R&D hub be­ing built in Bei­jing, which will even­tu­al­ly be able to house up to 200 em­ploy­ees, as well as small­er out­posts across Shang­hai, San Fran­cis­co and Hong’s home base of Durham, North Car­oli­na.

“We are spread out in­to US and Chi­na and we have to call one place home, in a sense,” he tells me. “I’m hop­ing by the end of next year we will have about 50 peo­ple in Chi­na,” up from the cur­rent 20 split be­tween both sides of the Pa­cif­ic.

Lever­ag­ing in­sti­tu­tion­al sup­port for the Bei­jing fa­cil­i­ty and be­ing “very fru­gal” has al­lowed Brii to con­cen­trate its cash on deals, which will like­ly re­main mod­est in size: For Chi­na rights to VBI Vac­cines’ re­com­bi­nant pro­tein-based im­munother­a­peu­tic, Brii is pay­ing an up­front of $11 mil­lion, $7 mil­lion of which is an eq­ui­ty in­vest­ment. Ad­di­tion­al mile­stones add up to $117.5 mil­lion.

The RNAi ther­a­py from Vir, on the oth­er hand, is part of an ex­ist­ing li­cens­ing pact Hong struck with George Scan­gos when he left Glax­o­SmithK­line to start Brii. Orig­i­nat­ing from Al­ny­lam, VIR-2218 is de­signed to re­store pa­tients’ own im­mune re­sponse to HBV by knock­ing down sur­face anti­gens.

“But we can­not as­sume all the pa­tients will have suf­fi­cient amount of in­trin­sic im­mu­ni­ty,” he says. “This is where the VBI 2601 come in where we’re ac­tu­al­ly go­ing to for­mu­late this in such that will stim­u­late, in­duce a broad­er T cell as well as B cell re­sponse.”

There’s more than a hint of a com­bi­na­tion ap­proach here, though it will have to wait un­til the as­sets go past ear­ly-stage test­ing as monother­a­pies.

At the same time, Brii re­searchers will be work­ing on some in-house an­ti­body dis­cov­ery with WuXi Bi­o­log­ics via an ex­clu­sive col­lab­o­ra­tion, uti­liz­ing the CRO pow­er­house’s bis­pe­cif­ic plat­form to tack­le a cou­ple of nov­el im­munomod­u­la­to­ry tar­gets that Hong is stay­ing mum about. The pres­ti­gious Ts­inghua Uni­ver­si­ty, right next door to Brii’s Bei­jing site, will lend a hand on the bi­o­log­ics test­ing.

While ef­forts to tam­per with B cells, T cells and NK cells have in­spired con­sid­er­able in­ter­est in on­col­o­gy, it will rep­re­sent a new par­a­digm for in­fec­tious dis­ease, Hong says.

Hav­ing met with about 80 po­ten­tial part­ners, Hong is ready to ex­e­cute on a rapid suc­ces­sion of deals through 2020 — un­less a big deal comes along that ne­ces­si­tates an­oth­er round of fundrais­ing, he adds. “You nev­er know.”


Im­age: Zhi Hong. BRII BIO

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mallon steps aside at Ironwood on March 12 after close to two years at the helm, and he already has a new change of scenery squared away. Beginning April 19, Mallon takes charge as CEO of cancer-focused genetic test maker NeoGenomics out of Fort Myers, FL while his predecessor, Douglas VanOort, is retiring after 12 years as NeoGenomics’ chairman and CEO.

It’s a fresh start for Mallon after what will amount to a tumultuous 23 months as Ironwood’s chief executive. Last year was marked by trial failures that spelled double trouble, leaving the Ironwood cupboard bare: first, a Linzess reformulation for irritable bowel syndrome with diarrhea (IBS-D) in May, and then the drug IW-3718 for persistent acid reflux in September. After IW-3718’s discontinuation, Ironwood chopped its staff by 35%. On Feb. 8, Mallon announced his departure at Ironwood, with president Tom McCourt getting bumped up to interim CEO.

Covid-19 roundup: Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta; FDA ap­proves Pfiz­er/BioN­Tech vac­cine stor­age at stan­dard freez­er temps

Merck is pushing back plans to supply the US government with a Covid-19 drug after the FDA asked for more data to support an emergency use authorization.

The antibody, MK-7110, had looked promising in a Phase III study conducted by OncoImmune before Merck came along and bought the biotech for $425 million. At the interim analysis, investigators looked at data from 203 patients and concluded that a single dose of the drug cut the risk of death or respiratory failure by more than 50% among severe patients. And those taking the drug had a 60% higher chance of improvement in clinical status compared to placebo.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.