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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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UCB buys its way to epilep­sy show­down with Jazz with $1.9B Zo­genix ac­qui­si­tion

Zogenix’s epilepsy drug Fintepla may only have brought in around $100 million of sales in its first year, but UCB clearly believes it can go much, much higher.

The Belgian pharma has inked a $1.9 billion deal to buy out Zogenix, paying $26 per share in cash and offering a contingent value right worth $2 more per share if Fintepla lands an extra EU approval by the end of 2023.

But even the upfront marks a 72% premium to California-based Zogenix’s shares, which were trading just north of $15 on Tuesday.

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