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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.