Bob Langer-found­ed cell ther­a­py play­er loads up $65M to fund Roche-part­nered can­cer work while ex­pand­ing in­to vac­cines for in­fec­tious dis­eases

SQZ Biotech isn’t plan­ning to test any­thing against Covid-19 for now. But when the next pan­dem­ic strikes, CEO Ar­mon Sharei wants its cell ther­a­py plat­form — which is es­sen­tial­ly al­so a vac­cine plat­form — to be ready for plug-and-play.

The ex­pan­sion in­to in­fec­tious dis­eases is one of many things the Wa­ter­town, MA-based com­pa­ny plans to ac­com­plish with its lat­est $65 mil­lion Se­ries D.

Bob Langer

Vi­ral and bac­te­r­i­al in­fec­tions, both the chron­ic kind and the ones that can pose a sud­den, glob­al threat, had been on his radar since his PhD days at Bob Langer’s MIT lab, Sharei told End­points News. Now that they have pushed the first im­ple­men­ta­tion of their cell en­gi­neer­ing tech­nique in­to the clin­ic and fig­ured out the man­u­fac­tur­ing set­up — in the form of an on­col­o­gy pro­gram part­nered with Roche — with an­oth­er lined up for lat­er this year, the time is ripe for some prepa­ra­tion for an IND fil­ing in 2021.

As with the ap­pli­ca­tions in can­cer, two of SQZ’s three tech plat­forms, name­ly the anti­gen pre­sent­ing cells (APC) and ac­ti­vat­ing anti­gen car­ri­ers (AAC), can come in­to play here. Un­der both ap­proach­es, cells get squeezed and, as their mem­branes get tem­porar­i­ly dis­rupt­ed, have ma­te­r­i­al slipped in­side. That car­go of in­ter­est can be a vi­ral pro­tein for well-char­ac­ter­ized virus­es, such as the spike pro­tein in SARS-CoV-2, or even a whole chunk of the virus in sit­u­a­tions where sci­en­tists have yet to de­ci­pher a nov­el pathogen. The for­mer in­volves white blood cells while the lat­ter us­es red blood cells as a kind of Tro­jan horse at var­i­ous lym­phoid or­gans to kick off an im­mune re­sponse.

Ei­ther way, it di­verges from the tra­di­tion­al goal of in­duc­ing an an­ti­body re­sponse.

“Ul­ti­mate­ly the core prob­lem we ad­dress with the APC pro­gram and the AAC pro­gram re­lates to gen­er­at­ing CD8 T cells re­spons­es which all these pri­or at­tempts at can­cer vac­cines had failed,” Sharei said. “A lot of times vac­cines can on­ly ever work pro­phy­lac­ti­cal­ly. But this mech­a­nism of vac­ci­na­tion, be­cause it lever­ages killer T cells, it could be used for both con­texts.”

On top of that dual func­tion, this plat­form promis­es to soothe the man­u­fac­tur­ing headache that’s be­set even de­vel­op­ers of the most ad­vanced vac­cine can­di­dates in the Covid-19 race.

Be­gin­ning with the very first pa­tient they dosed this Jan­u­ary, SQZ has been able to com­plete pro­cess­ing the cells with­in 24 hours and re­turn them to pa­tients for in­fu­sion — ship­ping and re­lease test­ing in­clud­ed — in a week. The rel­a­tive­ly sim­ple pro­ce­dure and ab­sence of pre­con­di­tion­ing re­quire­ments have al­so al­lowed their tri­al, in­volv­ing pa­tients with HPV+ tu­mors, to con­tin­ue.

To go even faster, Sharei said his team will be look­ing to con­sol­i­date that whole process — from the ac­tu­al squeez­ing to cell wash­ing and oth­ers — in­to a sin­gle box that can be de­ployed at a point-of-care fa­cil­i­ty, shav­ing even more time off.

“There’s ob­vi­ous­ly some en­gi­neer­ing work to do, I don’t want to triv­i­al­ize it, but there is no big leap nec­es­sary to in­te­grate it,” Sharei said.

Dis­cus­sions with reg­u­la­tors will al­so need to es­tab­lish the kinds of qual­i­ty con­trol and test­ing that would be need­ed if the ma­te­r­i­al no longer needs to be shipped across the coun­try.

With 100 full timers on staff, SQZ is al­so con­tin­u­ing to plough on the au­toim­mune field with its third and ear­li­est-stage plat­form, the to­ler­iz­ing anti­gen car­ri­ers (TACs), which al­so lever­ages red blood cells.

The Ju­ve­nile Di­a­betes Re­search Foun­da­tion is a col­lab­o­ra­tor here, and their T1D Fund has chipped in on the lat­est round af­ter back­ing SQZ’s Se­ries C.

Oth­er ex­ist­ing in­vestors such as GV, Il­lu­mi­na Ven­tures, In­vus, Nan­oDi­men­sion and Po­laris Part­ners al­so par­tic­i­pat­ed in the round, which was led by Temasek.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.