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.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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