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.

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.

Is there a recipe for M&A suc­cess? The best and worst buy­out deals in the past decade of­fer some keys to suc­cess — and fail­ure

It’s not easy achieving a solid win in M&A in this industry. But if you follow a few simple guidelines, you may be able to increase your odds of success.
Geoffrey Porges and the team at SVB Leerink went about the “notoriously difficult” task of scoring the biopharma buyout of 2009 to 2019. Sizing up current and expected revenue from the products that were gained, they came up with the 5 winners:
Merck/Schering Plough
Bristol/Medarex
Gilead/Pharmasset
Sanofi/Genzyme
AstraZeneca/Acerta
It says a lot about the field that it’s much easier sorting out the 5 worst deals, though there’s also a lot more competition for that title, notes Porges. As picked by the analysts:
J&J/Actelion
Merck/Cubist
Alexion/Synageva
AbbVie/Stemcentrx
Gilead/Kite

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