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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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