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.

Achiev­ing Dig­i­tal Trans­for­ma­tion: Un­lock­ing Cost Re­duc­tion, Clin­i­cal Ex­cel­lence & Pre­ci­sion Ther­a­peu­tics Man­u­fac­tur­ing

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Athena Countouriotis, Avenzo Therapeutics CEO (website via Nasdaq)

Ex-Turn­ing Point ex­ecs plan to have their next bet, Aven­zo, on the Nas­daq next sum­mer

The crew at Turning Point Therapeutics is back together for a new biotech that wants to acquire early-stage oncology small molecules, including antibody drug conjugates, and potentially form partnerships with China-based drug developers for ex-China rights as it eyes a speedy leap onto the Nasdaq around this time next year, CEO Athena Countouriotis told Endpoints News.

After selling Turning Point to Bristol Myers Squibb, announced at the onset of last year’s ASCO confab, she and colleague Mohammad Hirmand founded Avenzo Therapeutics. The CEO and CMO already have approximately $200 million in seed and Series A financing from five big-name investors to evaluate which drugs to bring into its pipeline. That includes SR One, OrbiMed, Foresite Capital, Citadel’s Surveyor Capital and Lilly Asia Ventures. Bidding wars for assets have led Avenzo to miss out on some deals in recent months, but the biotech has three active term sheets and hopes to bring in its first asset in the third quarter, Countouriotis said in a Friday morning interview.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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