In­hi­brx takes a sec­ond shot at an IPO — this time bump­ing the goal to $100M-plus

La Jol­la, CA-based In­hi­brx couldn’t get their $75 mil­lion IPO over the goal line last year. But with the fer­vor for new biotech fil­ings seem­ing­ly grow­ing on Wall Street, they plan to see how a $100 mil­lion play will work out now.

This time around, In­hi­brx touts four Phase I drugs in the pipeline de­vel­oped on its sin­gle do­main an­ti­body (sdAb) plat­form, three of which are geared to­ward var­i­ous can­cers. The fourth drug, IN­BRX-101, tar­gets Al­pha-1 An­tit­rypsin De­fi­cien­cy (AATD).

“Our sdAb plat­form al­lows us to pur­sue val­i­dat­ed tar­gets with clin­i­cal promise, but where oth­er an­ti­body and bi­o­log­ic based ap­proach­es have failed. High­ly mod­u­lar, our sd­Abs can be com­bined with pre­cise va­len­cies and mul­ti­ple speci­fici­ties, cre­at­ing ther­a­peu­tic can­di­dates de­signed to be ca­pa­ble of en­hanced cell sig­nal­ing, con­di­tion­al ac­ti­va­tion or com­bined syn­er­gis­tic func­tions,” the lat­est SEC fil­ing states.

Jef­feries Group, Ever­core ISI and Cred­it Su­isse are the joint bookrun­ners on this year’s deal. In 2019, the biotech sold a con­vert­ible promis­so­ry note to­tal­ing $40 mil­lion to Viking Glob­al In­vestors. This April, it raked in an­oth­er $15 mil­lion in notes to Viking and oth­er undis­closed in­vestors. The notes will even­tu­al­ly set­tle in­to shares of the com­pa­ny’s com­mon stock.

Most of the com­pa­ny’s rev­enue trick­les in from grants, eq­ui­ty and debt fi­nanc­ings, and li­cense and mile­stone rev­enue, ac­cord­ing to the fil­ing. By June 30, the com­pa­ny had run through $107.2 mil­lion. As the re­sult of a li­cense deal the com­pa­ny struck with Cel­gene years be­fore the Bris­tol My­ers Squibb buy­out, In­hi­brx could stand to re­ceive up to $934 mil­lion, plus roy­al­ties that range from the “high sin­gle-dig­its” to the “low teens.”

Cur­rent­ly, In­hi­brx’s most ad­vanced drug in the pipeline is IN­BRX-109, a tetrava­lent can­di­date. The drug ag­o­nizes DR5, which In­hi­brx says led to can­cer cell death in pre­clin­i­cal stud­ies. The com­pa­ny be­lieves IN­BRX-109 could trig­ger cell death in a va­ri­ety of can­cers, in­clud­ing col­orec­tal ade­no­car­ci­no­ma, gas­tric ade­no­car­ci­no­ma, pan­cre­at­ic ade­no­car­ci­no­ma, mesothe­lioma and cer­tain sar­co­mas.

The first part of a Phase I tri­al and dose es­ca­la­tion con­duct­ed in 2018 and 2019 re­spec­tive­ly showed that the drug was “well-tol­er­at­ed, with no sig­nif­i­cant tox­i­c­i­ties ob­served at dos­es up to and in­clud­ing the max­i­mum ad­min­is­tered dose of 30 mg/kg,” ac­cord­ing to the com­pa­ny’s web­site.

The com­pa­ny is in the mid­dle of Phase I Part 2, and cur­rent­ly has 75 pa­tients en­rolled with col­orec­tal and gas­tric ade­no­car­ci­no­mas, ma­lig­nant pleur­al mesothe­lioma, and chon­drosar­co­ma. Ini­tial da­ta from the chon­drosar­co­ma and ma­lig­nant pleur­al mesothe­lioma pa­tients should be ready by the end of the year.

In­hi­brx’s sec­ond drug in the pipeline, IN­BRX-106, is an OX40 hexa­va­lent ag­o­nist. The first part of a Phase I tri­al was con­duct­ed in De­cem­ber, with da­ta to come this year.

“We be­lieve IN­BRX-106, a hexa­va­lent ther­a­peu­tic can­di­date with the abil­i­ty to bind six OX40 mol­e­cules per mol­e­cule of drug, has the po­ten­tial to achieve im­proved re­cep­tor clus­ter­ing and down­stream sig­nal­ing. In pre­clin­i­cal stud­ies, we have ob­served that IN­BRX-106 me­di­at­ed T-cell co-stim­u­la­tion and al­so re­duced the sup­pres­sive ac­tiv­i­ty of reg­u­la­to­ry T-cells, with su­pe­ri­or ac­tiv­i­ty to bi­va­lent com­para­tors,” the SEC fil­ing states.

The third of In­hi­brx’s on­col­o­gy drugs, IN­BRX-105, could be used to treat those with PD-L1 ex­press­ing tu­mors. The drug ag­o­nizes 4-1BB, but on­ly in the pres­ence of PD-L1.  Ini­tial dose es­ca­la­tion da­ta is com­ing in 2021, the com­pa­ny says.

IN­BRX-101 is a re­com­bi­nant hu­man AAT-Fc fu­sion pro­tein can­di­date for the treat­ment of AATD. The Phase I dose es­ca­la­tion tri­al was put on hold due to the Covid-19 pan­dem­ic, but should test­ing re­sume, In­hi­brx could an­nounce ini­tial da­ta in the sec­ond half of 2021.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.