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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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