David Southwell. TScan

No­var­tis backs Har­vard spin­out's quest to build TCR repos­i­to­ry in $48M round

As T cell re­cep­tors emerged as a po­tent tool for the im­mune sys­tem to latch on­to tu­mor anti­gens, Stephen Elledge want­ed to screen anti­gen-TCR match­es in a faster, more sys­tem­at­ic way — one that would go be­yond cur­rent­ly known tar­gets but stop short of the new realms of neoanti­gens bioin­for­mat­ic pre­dic­tions.

Stephen Elledge

So the Har­vard pro­fes­sor spent the last 7 years con­sol­i­dat­ing new tech to come up with a plat­form that can run mul­ti­ple TCRs against anti­gen epi­topes and pin­point the ex­act pairs that ap­pear to in­ter­act. There’s al­so a built-in li­brary of the hu­man pep­tidome to flag any off-tar­get ef­fects and pre­vent safe­ty scares down the road.

What start­ed out on 96 plates in Elledge’s lab has now been scaled up and spun out to TScan Ther­a­peu­tics, which is now mak­ing its first pub­lic ap­pear­ance with $48 mil­lion in to­tal Se­ries A and B fund­ing.

The in­ter­est from No­var­tis In­sti­tutes for Bio­Med­ical Re­search was a key im­pe­tus for the round, CEO David South­well told me. The phar­ma gi­ant’s ven­ture arm al­so joined along­side Besse­mer, GV and Long­wood Fund.

“The whole goal is sort of to do it dif­fer­ent­ly than the way every­one else is do­ing it,” he said, which al­so ex­plained why he jumped on board last Oc­to­ber af­ter merg­ing In­otek with Rock­et.

One of Elledge’s big break­throughs here, South­well said, is de­vel­op­ing a unique flu­o­res­cent de­tec­tor sys­tem to find the prover­bial nee­dle in the haystack.

“It’s long been known as what hap­pens when a cy­to­tox­ic T cell meets an anti­gen is that it puts out com­pounds like per­forin, which put holes in the tu­mor cells, and granzyme B, which is a mes­sen­ger that is es­sen­tial­ly a cy­tokine which tells a cell to die. So that’s been known,” he said. “The ques­tion is how do you ac­tu­al­ly mea­sure the ac­tu­al killing ac­tiv­i­ty be­tween the cy­to­tox­ic T cell and a tar­get?”

The abil­i­ty to sort that all out on the fly means TScan can run a high-through­put, whole-genome search for nov­el anti­gens and the T cell re­cep­tors that may tar­get them.

There are many paths to go down with a plat­form as broad as this, and South­well read­i­ly ad­mits he’s yet to make up his mind as to whether TScan will opt for plat­form li­cens­ing or keep more of the de­vel­op­ment pro­grams to it­self. But the mon­ey they have is more than enough for a team of 20 sci­en­tists — many scooped from promi­nent biotechs like Ed­i­tas, CRISPR, KSQ and Juno — do­ing dis­cov­ery work.

The plat­form “is so broad that we could do a num­ber of phar­ma part­ner­ships that are dif­fer­ent in their scope, they don’t com­pete with each oth­er, and they leave us open to de­vel­op what we want, which is a repos­i­to­ry of TCR anti­gen pairs that work in both sol­id and liq­uid tu­mors,” he said.

Be­fore ar­riv­ing at that al­lo­gene­ic fu­ture, though, TScan has a tight time­line to ex­e­cute on au­tol­o­gous projects. The goal is to have two lead can­di­dates with­in 6 to 9 months and go in­to 2021 with a cou­ple of INDs.

Much of that will be con­duct­ed in a new site at Waltham, Mass­a­chu­setts, which will of­fer a key com­po­nent that their cur­rent digs at Har­vard Med­ical School lack: GMP man­u­fac­tur­ing fa­cil­i­ties.

“One of the biggest mis­takes that cell ther­a­py com­pa­nies make is hav­ing a plat­form like this and then you find a lead, and you’re re­al­ly ex­cit­ed about your lead, and you haven’t fig­ured out how to man­u­fac­ture it,” he said.

He’s re­cruit­ed Ken LeClair out of Ed­i­tas to run that op­er­a­tion. Gavin MacBeath, a sci­en­tif­ic founder of Mer­ri­mack, is CSO; Am­gen vet Hen­ry Rath is han­dling all the phar­ma in­ter­est as CBO; and Robert Crane is CFO.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.