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.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Athena Countouriotis, Avenzo Therapeutics CEO (website via Nasdaq)

Ex-Turn­ing Point ex­ecs plan to have their next bet, Aven­zo, on the Nas­daq next sum­mer

The crew at Turning Point Therapeutics is back together for a new biotech that wants to acquire early-stage oncology small molecules, including antibody drug conjugates, and potentially form partnerships with China-based drug developers for ex-China rights as it eyes a speedy leap onto the Nasdaq around this time next year, CEO Athena Countouriotis told Endpoints News.

After selling Turning Point to Bristol Myers Squibb, announced at the onset of last year’s ASCO confab, she and colleague Mohammad Hirmand founded Avenzo Therapeutics. The CEO and CMO already have approximately $200 million in seed and Series A financing from five big-name investors to evaluate which drugs to bring into its pipeline. That includes SR One, OrbiMed, Foresite Capital, Citadel’s Surveyor Capital and Lilly Asia Ventures. Bidding wars for assets have led Avenzo to miss out on some deals in recent months, but the biotech has three active term sheets and hopes to bring in its first asset in the third quarter, Countouriotis said in a Friday morning interview.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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