Busy IPO week winds down as two more biotechs — and one look­ing to im­prove clin­i­cal tri­als — file for pub­lic de­buts

Ed­i­tor’s note: In­ter­est­ed in fol­low­ing bio­phar­ma’s fast-paced IPO mar­ket? You can book­mark our IPO Track­er here.

Two more biotech com­pa­nies — and one that’s com­mit­ted to sup­port­ing clin­i­cal re­search — filed for IPOs just be­fore the long week­end.

No­bel lau­re­ate Jen­nifer Doud­na’s Cari­bou Bio­sciences is pen­cil­ing in a $100 mil­lion raise to sup­port its off-the-shelf CAR-T ther­a­pies, one of which is mak­ing its way through a Phase I study in B-cell non-Hodgkin lym­phoma. Al­so look­ing for a $100 mil­lion raise is WCG Clin­i­cal Ser­vices, which es­tab­lished it­self as an al­ly to bio­phar­ma com­pa­nies and CROs back in 2012. The com­pa­ny of­fers plan­ning, pa­tient en­gage­ment, and eth­i­cal re­view ser­vices, and says it was be­hind more than 723 Covid-19 tri­als. Mean­while, transpa­cif­ic biotech Brii Bio­sciences is look­ing for its own tick­er on the Hong Kong Stock Ex­change, and says it’ll use the funds across its broad in­fec­tious dis­ease and CNS pipeline.

Here’s what you need to know about the lat­est set of com­pa­nies gear­ing up for a pub­lic de­but:

Jen­nifer Doud­na-launched Cari­bou Bio­sciences says it’s ready for Wall Street

When Cari­bou Bio­sciences nabbed a $115 mil­lion Se­ries C round back in March, CEO Rachel Hau­r­witz told End­points News an IPO was “con­ceiv­able one day.” Now, that day has come.

Rachel Hau­r­witz

Hau­r­witz sub­mit­ted Cari­bou’s S-1 pa­pers on Thurs­day, pen­cil­ing in a $100 mil­lion raise — though, in this mar­ket, it wouldn’t be sur­pris­ing if the com­pa­ny ends up with more. The funds will give a boost to the com­pa­ny’s three off-the-shelf CAR-T ther­a­pies, the most ad­vanced of which is an an­ti-CD19 can­di­date in Phase I for B-cell non-Hodgkin lym­phoma.

“It’s been in par­tic­u­lar over the past few years that we’ve re­al­ly fo­cused on us­ing this next-gen­er­a­tion CRISPR tech­nol­o­gy plat­form to de­vel­op our own pipeline of off-the-shelf cell ther­a­pies for on­col­o­gy,” Hau­r­witz said in March.

The com­pa­ny got its start in Jen­nifer Doud­na’s lab at Cal-Berke­ley, where Hau­r­witz was Doud­na’s first grad­u­ate stu­dent to work on CRISPR. In 2011, they launched the com­pa­ny with James Berg­er (who’s now at the Johns Hop­kins School of Med­i­cine) and Mar­tin Jinek.

What sets Cari­bou apart is its hy­brid DNA/RNA edit­ing plat­form, which Hau­r­witz calls chRD­NA (pro­nounced “chardon­nay,” like the wine). The biotech be­lieves the hy­brid guides can pre­vent off-tar­get edit­ing com­mon to cur­rent CRISPR ap­pli­ca­tions.

Some of the IPO pro­ceeds will go to IND-en­abling ac­tiv­i­ties for Cari­bou’s oth­er two can­di­dates, CB-011 and CB-012. The for­mer tar­gets BC­MA for the treat­ment of re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma and us­es “im­mune cloak­ing” to avoid the im­mune sys­tem. That can­di­date is ex­pect­ed to hit the clin­ic next year. CB-012 goes af­ter CD371, which Cari­bou says is an at­trac­tive tar­get for acute myeloid leukemia.

The com­pa­ny’s al­so look­ing to go be­yond on­col­o­gy, and they’re ex­plor­ing the ar­eas of im­mune cell ther­a­py, iP­SC, and in vi­vo-gene edit­ing. In Feb­ru­ary, Ab­b­Vie shelled out $40 mil­lion up­front with an­oth­er $300 mil­lion in biobucks for two of the biotech’s al­lo­gene­ic CAR-Ts.

“We view this col­lab­o­ra­tion as an ex­ter­nal recog­ni­tion of the po­ten­tial for our chRD­NA genome-edit­ing tech­nol­o­gy to sig­nif­i­cant­ly im­prove genome-edit­ing speci­fici­ty and ef­fi­cien­cy,” Cari­bou’s S-1 states.

Months af­ter a $155M raise, trans-Pa­cif­ic Brii Bio­sciences looks to make its pub­lic de­but

Word spread last Au­gust that Brii Bio­sciences was con­sid­er­ing a Hong Kong IPO. Now, al­most a year lat­er, the com­pa­ny has filed its pa­pers.

Zhi Hong

Zhi Hong launched Brii back in 2018 to bridge the gap in in­no­va­tion be­tween the US and Chi­na. The trans-Pa­cif­ic biotech hooked a $155 mil­lion Se­ries C round in March to fund its broad in­fec­tious dis­ease pipeline and CNS pro­gram. And now, it plans to of­fer about 111.6 mil­lion shares glob­al­ly, ac­cord­ing to the fil­ing. 

“Since our found­ing in 2018, Brii Bio has made tremen­dous progress to­ward our mis­sion to ac­cel­er­ate the de­vel­op­ment and de­liv­ery of break­through med­i­cines through part­ner­ships and our own in­sight in high­ly dif­fer­en­ti­at­ed med­i­cine dis­cov­ery,” Hong said in a March state­ment.

A ma­jor­i­ty of the IPO pro­ceeds would fund Brii’s he­pati­tis B pro­grams, in­clud­ing its core prod­uct BRII-179 which Brii in-li­censed from VBI Vac­cines short­ly af­ter its launch. Last week, Brii said the can­di­date was “well-tol­er­at­ed” in a Phase Ib/IIa study for chron­ic HBV pa­tients, and in­duced B and T cell re­spons­es when ad­min­is­tered alone or in com­bi­na­tion with in­ter­fer­on-al­pha.

Brii kicked off an­oth­er Phase II chron­ic HBV study as­sess­ing BRII-179 along with BRII-835, its can­di­date li­censed from Vir, back in April. The com­pa­ny plans to launch two more Phase II stud­ies this year test­ing BRII-835 in com­bo with oth­er agents.

Brii’s oth­er in­fec­tious dis­ease pro­grams range from HIV to Covid-19. Back in March, the NIH eject­ed Brii’s Covid-19 an­ti­body com­bo from its AC­TIV-3 tri­al, af­ter the cock­tail failed to show a trend to­ward clin­i­cal ben­e­fit. The NIH found no safe­ty is­sues with the treat­ment — which con­tained two Brii an­ti­bod­ies dubbed BRII-196 and BRII-198 — and said the ther­a­py would con­tin­ue in the AC­TIV-2 tri­al in mild-to-mod­er­ate Covid-19 pa­tients who don’t need to be hos­pi­tal­ized.

WCG Clin­i­cal Ser­vices seeks to solve ‘pain points’ in clin­i­cal tri­als

WCG Clin­i­cal Ser­vices launched back in 2012 as an al­ly to bio­phar­ma com­pa­nies and con­tract re­search or­ga­ni­za­tions, seek­ing to ad­dress what it calls “crit­i­cal pain points” in clin­i­cal tri­al per­for­mance. Now, it’s look­ing for its own stock tick­er.

Don­ald Deieso

The Prince­ton, NJ-based com­pa­ny filed an S-1 on Thurs­day, pen­cil­ing in a $100 mil­lion raise. It claims to have sup­port­ed around 90% of glob­al clin­i­cal tri­als that took place over the last two years, pro­vid­ing ser­vices like study plan­ning, pa­tient en­gage­ment, and eth­i­cal re­view. The team par­tic­i­pat­ed in more than 723 Covid-19 tri­als, ac­cord­ing to CEO Don­ald Deieso.

The com­pa­ny aims to tack­le is­sues like slow en­roll­ment, “bur­den­some ad­min­is­tra­tive process­es,” and the un­der-rep­re­sen­ta­tion of mi­nor­i­ty pa­tients.

“We firm­ly be­lieve that we must have the clin­i­cal in­sight to de­vel­op, the courage to ad­vance, and the per­sis­tence to trans­form a change-re­sis­tant in­dus­try, while nev­er com­pro­mis­ing the high­est lev­el of eth­i­cal stan­dards,” Deieso said in the S-1.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.