Zhi Hong, Brii Bio CEO (file photo)

Bap­tized by Covid-19 fire, Brii Bio reaps $320M Hong Kong IPO to car­ry on with pipeline for in­fec­tious dis­eases and be­yond

Zhi Hong start­ed Brii Bio three years ago with the clear vi­sion that his trans-Pa­cif­ic start­up should have the best of both worlds — top-notch in­no­va­tion from the US, vast pa­tient pool and mar­ket in Chi­na — teth­ered by his years of ex­pe­ri­ence work­ing at Glax­o­SmithK­line’s in­fec­tious dis­ease team.

Ankang Li

In a sense, the strat­e­gy was ex­em­pli­fied (even if slight­ly re­versed) as the biotech de­cid­ed to join the hunt for a Covid-19 an­ti­body ear­ly last year: Its drug, which was de­vel­oped to­geth­er with Chi­nese sci­en­tists based on mon­o­clon­al an­ti­bod­ies iso­lat­ed from re­cov­ered pa­tients in Chi­na, was se­lect­ed by the NIH for large-scale plat­form tri­als in the US.

But when it came to launch­ing an IPO, Brii Bio had to choose: US or Chi­na first?

The biotech ul­ti­mate­ly went with the Hong Kong ex­change, where it’s now raised $320 mil­lion to steer a di­verse slate of pro­grams through the clin­ic with a fo­cus on pub­lic health. A to­tal of 11 cor­ner­stone in­vestors backed the list­ing, which saw the com­pa­ny price at the top of its range.

“I think Hong Kong stock mar­ket has be­come one of the most ac­tive fundrais­ing mar­kets for biotech com­pa­nies in the past two years,” CFO Ankang Li told End­points News.

Be­sides, out­side of Covid-19, Brii’s most ad­vanced can­di­dates are the two he­pati­tis B pro­grams in-li­censed from Vir and VBI, which are be­ing test­ed as a com­bo in a Phase IIb tri­al. Asian in­vestors, the com­pa­ny be­lieves, are more fa­mil­iar with the Chi­nese mar­ket that it’s try­ing to tap.

“So for HBV mar­ket in gen­er­al, I think Chi­na is def­i­nite­ly the largest mar­ket glob­al­ly,” Li said. “We have more than 78 mil­lion pa­tients in­fect­ed by HBV. So this is a huge mar­ket, and the cur­rent stan­dard of care, which in­cludes an­tivi­ral and in­ter­fer­on, they are not re­al­ly sat­is­fy­ing treat­ments be­cause they de­liv­er very low cure rate, be­low 7%.”

Even with big­ger play­ers like Roche pur­su­ing the same goal, Brii is con­fi­dent about its chances of lead­ing the field on its home turf, with the aim of get­ting a mar­ket­ed drug around 2024.

Be­hind that is a once-week­ly, long-act­ing oral HIV drug that Brii hopes will give GSK’s Vi­iV and Gilead a run for their mon­ey. Li not­ed that Hong, the CEO, ac­tu­al­ly start­ed the re­search on the first long-act­ing HIV reg­i­mens while at GSK, and there’s po­ten­tial to go even longer once they prove their tech­nol­o­gy works.

That spe­cif­ic knowl­edge on long-act­ing for­mu­la­tions al­so ex­plains why Brii has de­cid­ed to tag two CNS pro­grams — one for post­par­tum de­pres­sion and the oth­er for ma­jor de­pres­sive dis­or­der — to the oth­er­wise strict­ly in­fec­tious dis­ease-fo­cused pipeline.

On top of these in-house pro­grams, Brii li­censed Chi­na rights to mul­tidrug re­sis­tant an­tibi­otics from Qpex and an ex­per­i­men­tal treat­ment for mul­ti-drug re­sis­tant TB from AN2. It al­so has a part­ner­ship in place with mi­cro­bio­me spe­cial­ist Ar­ti­zan.

As the HBV pro­gram ad­vances and the an­tibi­otics tri­als start, Li ex­pects the clin­i­cal team to grow in Chi­na — where the strat­e­gy is to fo­cus on “very large in­di­ca­tions” with enough vol­ume to over­come pric­ing bar­ri­ers. The de­vel­op­ment of Brii’s HIV and CNS drugs, on the oth­er hand, will be cen­tered around the US. They cur­rent­ly have about 60 staffers in Chi­na while the US head­count is around 40.

Thanks to Covid-19, Brii has had an crash course on clin­i­cal de­vel­op­ment, speed­ing from pre­clin­i­cal work in­to Phase III with­in a year or so and lever­ag­ing NIH re­sources so that they can keep enough mon­ey for their oth­er pro­grams. Al­though the an­ti­body, like oth­ers from Eli Lil­ly and Glax­o­SmithK­line/Vir, failed to help hos­pi­tal­ized pa­tients, Brii said it seems to re­tain neu­tral­iz­ing ac­tiv­i­ty against mul­ti­ple vari­ants. Re­sults from the Phase III AC­TIV-2 study, tar­get­ed at the out­pa­tient set­ting, are due to read out soon.

Brii al­so has Phase II tri­als un­der­way in Chi­na to ad­dress a re­cent surge and plans to make the drug avail­able to pa­tients if it works, Li said — al­though he im­plies that it won’t be the biggest pri­or­i­ty mov­ing for­ward.

“We are still com­mit­ted to fur­ther de­vel­op our dis­cov­ery and ear­ly R&D team in the US, so in that area I think the US team will al­so grow,” Li said. “So I think we will take a very bal­anced ap­proach and both sides will prob­a­bly see a sig­nif­i­cant growth in the next one or two years.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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