One of the best con­nect­ed biotech star­tups in Boston snags a plum dis­cov­ery deal with No­var­tis

No­var­tis’ drug dis­cov­ery crew in­side the NI­BR cam­pus in Cam­bridge, MA is putting $30 mil­lion on the ta­ble to get a new TCR im­muno-on­col­o­gy pro­gram kicked off with one of the re­cent star­tups to de­but in the field — se­ri­ous mon­ey for what they be­lieve can of­fer an ef­fec­tive ap­proach to tack­ling sol­id tu­mors.

Christoph West­phal

Christoph West­phal’s lat­est biotech cre­ation, TScan, lined up the deal, which drew in a No­var­tis crew at­tract­ed by their ap­proach in de­vel­op­ing TCR-en­gi­neered T cell ther­a­pies.

Waltham, MA-based TScan ob­tained the IP — in­clud­ing the high through­put screen­ing plat­form and a num­ber of post-doc staffers — from the lab of Har­vard Med School pro­fes­sor Steve Elledge, which promis­es to iden­ti­fy shared T cell anti­gens in a way that al­so promis­es to nar­row the field to cells with­out any off-tar­get is­sues that can raise safe­ty ques­tions. That’s a key dis­tin­guish­ing fac­tor from the pi­o­neers in TCRs, like Adap­ti­m­mune, which ran in­to ear­ly safe­ty is­sues with MAGEA3.

“Our cen­tral phi­los­o­phy is learn­ing from pa­tients,” says CEO David South­well. “Tak­ing cells and us­ing them to treat pa­tients.” And it’s an ap­proach that they’re us­ing in-house on liq­uid tu­mors while No­var­tis shoots for sol­id tu­mors. South­well’s 40-strong team is al­so ap­ply­ing the tech to Covid-19.

But this sto­ry is as much about peo­ple as it is tech­nol­o­gy.

Lea Hachi­gian

Lea Hachi­gian, a sci­en­tist with a PhD from MIT and a prin­ci­pal at West­phal’s Long­wood Fund, played a key role in bring­ing the com­pa­ny to­geth­er. Her hus­band, Tomasz Ku­la, was work­ing in Elledge’s lab on the TCR ef­fort. Hachi­gian, the found­ing pres­i­dent at TScan, got West­phal in­volved, says South­well, and then West­phal did what he does best in bring­ing to­geth­er an ex­pe­ri­enced man­age­ment team.

There’s South­well, who traces his biotech ca­reer back through a CEO stint at Rock­et, a CFO run at Hu­man Genome Sci­ences and on back to his in­vest­ment bank­ing days at Lehman Broth­ers. With a re­sume like that, it’s no sur­prise to hear him talk about the prospects of a crossover round and even­tu­al IPO, when the tim­ing is right. For now, this com­pa­ny is very much a pre­clin­i­cal play.

Gavin MacBeath, a co-founder at Mer­ri­mack, is CSO at the com­pa­ny. He al­so has some deep roots in the busi­ness that go back to Har­vard and a PhD from Scripps.

David South­well

Their first 2 rounds at TScan brought in $60 mil­lion from an A list group of in­vestors. NI­BR came in on the Se­ries B, along­side Pi­tan­go Ven­ture Cap­i­tal, Astel­las Ven­ture Man­age­ment, 6 Di­men­sions Cap­i­tal, Long­wood Fund, Besse­mer Ven­ture Part­ners, GV (the VC for­mer­ly known as Google Ven­tures), and No­var­tis Ven­ture Fund. The mon­ey from NI­BR in­cludes $20 mil­lion for the up­front and $10 mil­lion to cov­er re­search costs.

West­phal has had his share of mis­takes in re­cent years. Flex Phar­ma be­came a burned out shell that was tossed off in a re­verse merg­er gam­bit fol­low­ing their clin­i­cal fail­ure. And Ve­rastem cratered as the orig­i­nal on­col­o­gy plan failed, forc­ing a switch to a PI3K dis­card from In­fin­i­ty.

West­phal al­so en­gi­neered the still con­tro­ver­sial $720 mil­lion sale of Sir­tris’ longevi­ty ef­fort to GSK, where it ul­ti­mate­ly mi­grat­ed to and then dis­ap­peared un­der the sur­face of the gi­ant’s large R&D ops. But the set­backs have been large­ly for­giv­en and he re­mains one of the best con­nect­ed biotech ex­ecs in Cam­bridge/Boston, still boast­ing of play­ing the role of found­ing CEO at RNAi pi­o­neer Al­ny­lam.

Even­tu­al­ly one of his oth­er star­tups may hit. It’s time for TScan to take the next shot.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Immunocore CEO Bahija Jallal (L) and Gadeta CEO Marcel Zwaal

In search for a 'u­ni­ver­sal T cell en­gager', Im­muno­core inks deal with Gilead-backed Gade­ta

Immunocore, which became the first company to win approval for a TCR therapy earlier this year, has penned a deal with gamma delta T cell specialist Gadeta to develop treatments for solid tumors, starting with colorectal cancer.

Immunocore R&D head David Berman told Endpoints News the deal is part of the company’s efforts to develop a “universal T cell engager.” TCR therapies made from typical T cells, like Immunocore’s TCR therapy Kimmtrak, are restricted to patients with certain HLA types, a kind of marker that helps the body separate friend and foe. Kimmtrak, for instance, is indicated only for patients with unresectable or metastatic uveal melanoma, a rare form of cancer that happens in the eye, who have the tissue type HLA-A*02:01, one of the more common HLA types which by Berman’s estimate includes around 40-50% of the population.