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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.