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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.