David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

Sev­er­al months af­ter strik­ing an al­liance with No­var­tis, TCR ther­a­py-fo­cused TScan Ther­a­peu­tics has reeled in a crossover round that should hold it over for the next two years as it eyes a pub­lic de­but.

The Christoph West­phal port­fo­lio com­pa­ny had been ar­rang­ing the crossover for the last few months, CEO David South­well said. Just be­fore Christ­mas, they nailed down what he called a “re­al­ly blue-chip” syn­di­cate of four new in­vestors, in­clud­ing Black­Rock, RA Cap­i­tal Man­age­ment and two undis­closed funds. They closed on the $100 mil­lion Se­ries C just over a week ago, and wait­ed un­til Mon­day morn­ing to an­nounce it.

“I think it’s like­ly that we’re go­ing to go pub­lic at some point,” South­well told End­points News. But for now, the Se­ries C cash gives them flex­i­bil­i­ty through 2022.

The Har­vard Uni­ver­si­ty spin­out is build­ing a repos­i­to­ry of clin­i­cal­ly-ac­tive TCRs us­ing its high-through­put whole genome dis­cov­ery plat­form. The com­pa­ny had com­pared it to a vend­ing ma­chine or a li­brary of sorts, be­fore fi­nal­ly set­tling on the term “bank,” South­well said.

The process be­gins with T cells from pa­tients’ tu­mors. Re­searchers use the dis­cov­ery plat­form to find out ex­act­ly what tar­gets the T cell is hit­ting, then clin­i­cal­ly val­i­date the TCR to see if it has any off-tar­get ef­fects. When the TCR is val­i­dat­ed, it gets added to the bank. Know­ing a pa­tient’s HLA type and tu­mor tar­get, re­searchers can then take TCRs out of the bank, “grow them up, and put them in­to the pa­tient,”  South­well said.

“Those T cell re­cep­tors are of­ten there in the pa­tient, but the prob­lem is that they’re not there in suf­fi­cient abun­dance to re­al­ly at­tack the tu­mor,” he added.

The ap­proach comes from the lab of Har­vard pro­fes­sor Stephen Elledge, who set out years ago to screen anti­gen-TCR match­es in a faster, more sys­tem­at­ic way. He spent 7 years putting to­geth­er the tech for a plat­form that could run mul­ti­ple TCRs against anti­gen epi­topes and pin­point the ex­act pairs that ap­pear to in­ter­act. Now, what be­gan as 96 plates in Elledge’s lab has trans­formed in­to a com­pa­ny that has raised $180 mil­lion to date and at­tract­ed the likes of No­var­tis.

Back in April, the No­var­tis In­sti­tutes for Bio­Med­ical Re­search put down $30 mil­lion to kick off a new TCR im­muno-on­col­o­gy pro­gram with TScan. The part­ners are work­ing on dis­cov­er­ing tar­gets in a “se­lect sol­id tu­mor in­di­ca­tion,” TScan re­vealed. NI­BR pitched in­to TScan’s Se­ries B round, along­side the phar­ma’s ven­ture fund.

“There’s a lot with this dis­cov­ery plat­form that we can do, that we’re not go­ing to de­vel­op on our own,” South­well said, in­clud­ing Covid-19 work.

Com­ing up in 2021, TScan plans on fil­ing INDs for two liq­uid tu­mor TCR T cell ther­a­pies — TSC-100 and TSC-101. It has an­oth­er three sol­id tu­mor can­di­dates ex­pect­ed to hit the clin­ic in 2022.

While the com­pa­ny cur­rent­ly has 60 staffers, South­well pre­dicts they’ll have well over 100 in the next six to nine months as they build out their man­u­fac­tur­ing and cell pro­cess­ing units.

The feel­ing at TScan? “We’re re­al­ly ex­cit­ed,” South­well said.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

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

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.