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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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