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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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