Bob Langer-backed spin­out shoots for $75M-plus IPO while biotech SPACs con­tin­ue to rule on Wall Street

SQZ Biotech is look­ing to go pub­lic, squeez­ing its way on­to a long list of biotechs to hit Wall Street this year.

The Wa­ter­town, MA-based biotech filed on Fri­day for a $75 mil­lion IPO to de­vel­op its cell ther­a­pies, now the main fo­cus fol­low­ing a shift in pri­or­i­ties to pipeline build­ing. Num­ber 1 on its list of pri­or­i­ties is its Roche-part­nered anti­gen pre­sent­ing cell (APC) tech, which is cur­rent­ly in Phase I for HPV and sol­id tu­mors.

SPACs are al­so far­ing well in the 2020 boom. Lux Health Tech Ac­qui­si­tion, a blank check com­pa­ny formed by Lux Cap­i­tal, an­nounced its pub­lic de­but on Fri­day, too. The com­pa­ny is look­ing to raise $300 mil­lion by of­fer­ing 30 mil­lion shares at $10 apiece. While the S-1 states Lux doesn’t have any spe­cif­ic tar­gets in mind, the com­pa­ny says it will go af­ter busi­ness­es at the “in­ter­sec­tion of the health­care and tech­nol­o­gy in­dus­tries.”

Lux will trade un­der {$LUXA.U}.

A num­ber of fac­tors, in­clud­ing the pan­dem­ic, cre­at­ed the “per­fect storm” for an IPO boom, Nas­daq head of health­care list­ings Jor­dan Saxe told End­points News at the end of Sep­tem­ber. He pre­dict­ed there will be 65-70 biotech IPOs (on the low end)  by the end of the year  — well over the 47 tracked by Brad Lon­car last year.

SQZ (pro­nounced “squeeze”) was formed from the lab of MIT’s Bob Langer in 2013. Cur­rent CEO Ar­mon Sharei helped dis­cov­er the tech­nol­o­gy as a PhD stu­dent, which squeezes cells through a mi­croflu­idic chip, cre­at­ing an open­ing for drug­mak­ers to slip ma­te­ri­als in­to the cell more ef­fec­tive­ly. As of June, the com­pa­ny had blown through $96.8 mil­lion.

Ar­mon Sharei

Back in 2018, Roche en­tered a $1.37 bil­lion-plus deal to fo­cus the tech­nol­o­gy on im­muno-on­col­o­gy. The biotechs are us­ing the plat­form to de­liv­er anti­gens in­tend­ed to in­duce a storm of CD8 killer cells to fight can­cer. The first pa­tient was dosed this Jan­u­ary, and since then, SQZ says it’s been able to process the cells in 24 hours and re­turn them to pa­tients for in­fu­sion in a week.

Its ac­ti­vat­ing anti­gen car­ri­ers (AAC) plat­form works in a sim­i­lar man­ner, and is cur­rent­ly in pre­clin­i­cal de­vel­op­ment. SQZ plans on sub­mit­ting an IND for HPV+ tu­mors in 2020, which would lead to ini­tial da­ta in the sec­ond half of 2021. Its third and ear­li­est plat­form, to­ler­iz­ing anti­gen car­ri­ers (TACs), is al­so in pre­clin­i­cal de­vel­op­ment.

SQZ is us­ing its lat­est $65 mil­lion Se­ries D to ex­pand its pipeline to in­fec­tious dis­eases. Us­ing its APC and AAC plat­forms, SQZ be­lieves there’s an op­por­tu­ni­ty to de­liv­er a vi­ral pro­tein, like the spike pro­tein in SARS-CoV-2, or even a whole piece of a virus to trig­ger an an­ti­body re­sponse. SQZ isn’t test­ing its plat­form against Covid-19 for now, but could be ready for fu­ture out­breaks of in­fec­tious dis­ease.

Sharei, whose 2019 base salary was $460,000, holds just over 6% of the com­pa­ny’s shares, ac­cord­ing to the S-1. SQZ will ap­pear un­der the tick­er $SQZ.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

More man­u­fac­tur­ing is­sues: Fen­nec preps for sec­ond CRL for po­ten­tial hear­ing loss drug

Shares of Fennec Pharmaceuticals stock were cut almost in half early Monday as the company said manufacturing issues caused another FDA rejection of its reformulated version of sodium thiosulfate, which is intended to help kids who lose hearing due to chemo treatment.

The biotech had resubmitted an NDA for the drug to treat platinum-based, chemo-related ototoxicity in young children earlier this year. The first NDA was denied by the FDA last year, with the agency citing manufacturing issues with the biotech’s supplier.

Róbert Wessman, Alvogen CEO

Biotech bil­lion­aire Róbert Wess­man en­gi­neers $450M deal for Alvo­gen sub­sidiaries

Alvogen is handing off two of its subsidiaries to CEO Róbert Wessman and his healthcare investment firm Aztiq — who has now tied the two together in a massive biobucks deal.

In an alliance with Thailand’s PTT Group subsidiary Innobic, the two companies signed an agreement last week to buy a 100% stake in Alvogen Emerging Market Holdings Limited (AEMH) for $475 million from Alvogen, buying out shareholders such as CVC Capital Partners and Singapore’s Temasek. And now, the group is the majority shareholder of Alvogen’s former Asian subsidiary Lotus Pharmaceuticals and the only shareholder of Alvogen Malta, the owner of B2B pharma Adalvo.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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