IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO pa­rade con­tin­ues march­ing for­ward as 2020 turns to­ward the fourth quar­ter.

IN8bio, a New York-based com­pa­ny fo­cused on ge­net­i­cal­ly mod­i­fied gam­ma delta T cell ther­a­pies, filed to go pub­lic Fri­day seek­ing an $86 mil­lion raise. The com­pa­ny has two clin­i­cal-stage can­di­dates be­ing stud­ied in glioblas­toma and leukemia, re­spec­tive­ly.

By any stretch of the imag­i­na­tion, 2020 has al­ready been a huge year for biotech, and nowhere does it ap­pear more ob­vi­ous than the vast amounts of com­pa­nies hit­ting the pub­lic mar­ket.

The most up­dat­ed of­fi­cial tal­ly comes from Nas­daq’s head of health­care list­ings Jor­dan Saxe, who told End­points News in late Sep­tem­ber that the tal­ly sat at 56 IPOs with a com­bined $11.3 bil­lion raise. At least an­oth­er sev­en com­pa­nies have priced since then, bring­ing the un­of­fi­cial count above 60.

In the last four years, on­ly 2018 comes close in terms of biotechs go­ing pub­lic. That to­tal match­es that year’s tab from in­de­pen­dent an­a­lyst Brad Lon­car. Sev­er­al fac­tors have con­tributed to the boom, Saxe said at the time, no­tably with the Covid-19 pan­dem­ic high­light­ing an al­ready-im­pres­sive amount of in­no­va­tion in the field.

There’s al­so been a steady in­crease of crossover in­vestors from the last few years, Saxe said, and with the pan­dem­ic econ­o­my, the fact that biotechs can pro­vide longer-term in­vest­ments than com­pa­nies re­liant on quar­ter-to-quar­ter sales num­bers makes the in­dus­try more ap­peal­ing. He added that a “con­ser­v­a­tive” es­ti­mate of the fi­nal 2020 IPO num­ber will end up be­tween 65 and 70.

IN8bio’s first can­di­date deals with new­ly-di­ag­nosed glioblas­toma and re­cent­ly en­tered Phase I, as the first pa­tient was dosed in June. Dubbed INB-200, the pro­gram is ex­pect­ed to see its first da­ta read­out in 2021.

The work­ing the­o­ry be­hind this pro­gram cen­ters around com­bin­ing con­ven­tion­al chemother­a­pies with gam­ma delta T cells to al­ter the tu­mor mi­croen­vi­ron­ment. IN8bio us­es its tech to make the cells re­sis­tant to chemother­a­py as a way of avoid­ing the white blood cell death that nor­mal­ly ac­com­pa­nies such treat­ment.

Their sec­ond can­di­date is called INB-100 and fo­cus­es on leukemia. Al­so hav­ing re­cent­ly be­gun dos­ing pa­tients in May, INB-100 da­ta is first an­tic­i­pat­ed to­ward the end of 2022.

It’s here where IN8bio plans to al­lo­cate a good por­tion of its IPO raise. Though the biotech did not get in­to too many specifics, IN8bio said in its S-1 it plans to com­plete these two Phase I stud­ies and ini­ti­ate Phase II in both pro­grams with the ex­pect­ed funds. The rest will go to­ward an IND and a Phase I for a third pro­gram in new­ly di­ag­nosed glioblas­toma, as well as oth­er var­i­ous R&D and ad­min­is­tra­tive mat­ters.

For­mer­ly known as In­cy­sus, IN8bio changed its name in Au­gust and was found­ed in 2016.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.