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

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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.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Wen Wang, IASO CEO

Chi­nese CAR-T play­er books a megaround to dri­ve bustling cell ther­a­py port­fo­lio through the clin­ic

China has quickly emerged as a major driver of oncology R&D in recent years, particularly in cell therapies where the potential for cheaper development has investors drooling. Now, one player, with a handful of early data, is swimming in a new round of investor cash.

IASO Bio has closed a $108 million Series C that the Chinese and California-based biotech said it will use to advance its slate of cell therapy lead programs, while also propping up a roster of next-gen allogeneic cell therapies for the future, according to a release.

Multiple antibiotic resistant Pseudomonas aeruginosa bacterium

A new way to in­fil­trate (and de­stroy) some of the dead­liest drug-re­sis­tant bugs

About four years ago, Ruben Tommasi, the gregarious scientific chief of antibiotics startup Entasis, walked into a meeting with his top chemist and top biologist to chew over another batch of unchanging results.

“It felt like we were running the same experiment over and over,” Tommasi told Endpoints News. “We had all sort of come to that point in time where we felt like we were banging our heads against the wall.”

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