Dana-Far­ber’s Lau­rie Glim­ch­er helps launch a NYC biotech up­start with some key in­sights on im­muno-on­col­o­gy tech

Years be­fore Lau­rie Glim­ch­er left her job as dean at Weill Cor­nell Med­ical Col­lege and took the top job at Dana-Far­ber, the sci­en­tist was in the lab prob­ing the way in which cer­tain con­di­tions caused un­fold­ed pro­teins to clut­ter en­do­plas­mic retic­u­lum (ER) path­ways — study­ing the ways that played out in the tu­mor mi­croen­vi­ron­ment.

The ER stress that sparked in turn trig­gered var­i­ous sur­vival mech­a­nisms — in par­tic­u­lar the tu­mor-pro­mot­ing IRE1α path­way — that could help these tu­mors adapt to a num­ber of threats.

“The ER stress path­way is de­signed to help cells sur­vive in a hos­tile en­vi­ron­ment,” Glim­ch­er tells me, the kind of hos­tile en­vi­ron­ment that fre­quent­ly be­sets tu­mors. But there was more to come. One of the for­mer post­docs in her lab, Juan Cu­bil­los-Ruiz, found that an­oth­er way they pro­mot­ed tu­mor sur­vival was by di­rect­ly tamp­ing down on the im­mune cells dis­patched for an at­tack — coun­ter­ing the im­mune re­sponse that has be­come a cen­tral fea­ture in new can­cer fight­ing com­bos.

They’ve been work­ing on a small mol­e­cule IRE1α in­hibitor with some sci­en­tif­ic proof of prin­ci­ple ev­i­dence to back them up.

“What is a lit­tle more sur­pris­ing is that we could not on­ly in­crease the death of tu­mors,” says Glim­ch­er, but al­so block a process that dis­abled im­mune cells, which “in­creased their abil­i­ty to kill off cells.”

That pa­per pub­lished in Cell in 2015, she said, “turned the field on its head.”

Michael Aber­man

Their work pro­vid­ed the sci­en­tif­ic foun­da­tion for a new im­muno-on­col­o­gy start­up fos­tered by Ver­sant Ven­tures in 2016. And now their biotech, Quen­tis Ther­a­peu­tics, is de­but­ing with a $48 mil­lion A round with plans to get in­to the clin­ic next year.

Michael Aber­man, who left his job as se­nior strate­gist for Re­gen­eron last fall to run the com­pa­ny, says Quen­tis now has 4 full time staffers, in­clud­ing him­self, and a few part-timers to help out. But that is about to change, with enough mon­ey in the launch round to staff up to 20 to 30 em­ploy­ees for the pre­clin­i­cal stretch ahead.

In the process, they are kick­ing off yet an­oth­er Big Ap­ple up­start that at­tract­ed sup­port from a large syn­di­cate that in­cludes New York Ven­tures, which is back­ing lo­cal star­tups in an ef­fort to gen­er­ate a crit­i­cal mass of life sci­ence com­pa­nies in New York. Ver­sant and Po­laris co-led the round. The rest of the in­ter­na­tion­al group al­so in­cludes LS Po­laris In­no­va­tion Fund, Ab­b­Vie Ven­tures, Tai­ho Phar­ma­ceu­ti­cal, Yonghua Cap­i­tal and Alexan­dria Ven­ture In­vest­ments.

It’s that com­bi­na­tion of glob­al cash and sci­en­tif­ic tal­ent that New York is re­ly­ing on to spur a host of new biotech star­tups with the hope that one day they can ri­val a ma­jor hub like Cam­bridge/Boston.

Glim­ch­er, mean­while, has al­so been play­ing a qui­et but promi­nent role at Lon­don-based Glax­o­SmithK­line, where she re­cent­ly joined the board to help ad­vise on its sci­en­tif­ic fo­cus at a time GSK is div­ing deep in­to new can­cer ther­a­pies and grow­ing the on­col­o­gy pipeline.

When you can start to re­pro­gram the tu­mor mi­croen­vi­ron­ment, she says, you have the po­ten­tial to sub­stan­tial­ly broad­en the im­pact of new ther­a­pies, reach­ing far big­ger num­bers of pa­tients.

“Won­der­ful as im­muno-on­col­o­gy has been,” says Glim­ch­er, “we’re still treat­ing a mi­nor­i­ty of pa­tients. We’re re­al­ly at the tip of the ice­berg here.”

Star­tups like Quen­tis are go­ing deep­er.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

Seven years after founding Roivant Sciences as an upstart contender in the world of biotech creation, Vivek Ramaswamy and his recently anointed CEO Matt Gline are gliding into Nasdaq on the gilded wings of a cash-heavy SPAC.

In a carefully crafted SPAC pact aimed at wedding new investors at Montes Archimedes Acquisition Corp. with a syndicate of investors coming back to re-up for the next round of company building, they’ve assembled a fresh $611 million in financing for Roivant — $411 million held in trust from the investors in MAAC with a fresh $200 million from the syndicate.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Kelli Luginbuhl and Ashutosh Chilkoti

Start­up sets out to tack­le the gene ther­a­py man­u­fac­tur­ing cri­sis

After Kelli Luginbuhl finished her PhD, her advisor, Duke bioengineer and PhaseBio co-founder Ashutosh Chilkoti, sat her down and asked if she wanted to launch and then run a company. Chilkoti had a once-obscure technology he and the venture capitalist Joe McMahon thought could form the basis of his second company and finally pay huge dividends. Luginbuhl knew the tech from years in his lab and was already looking for biotech jobs. It all added up.

June Lee, Esker CEO

Vik Ba­ja­j's start­up in­cu­ba­tor at Fore­site un­cloaks an im­munol­o­gy play­er with a lead TYK2 in­hibitor in tow

Looking at a healthcare system made more unequal by Covid-19, Foresite Capital managing director Vik Bajaj recently launched an expansive plan to launch five innovative startups to address unmet need. Just weeks after the first of those biotechs emerged from stealth, a second has now uncloaked, and it’s got immunology in its sights.

Esker Therapeutics launched Wednesday with a $70 million Series A to pursue precision immunology targets backed by Foresite Labs’ analytics engine kickstarted by Bajaj’s team, the biotech said. Foresite footed the entire round for Esker as it continues to develop its pipeline and advance its lead compound.

Josh Bilenker, Endpoints JPM 2020

Josh Bilenker and Jeff En­gel­man bun­dle a moth­er lode of cash for their stealthy start­up, at­tract­ing a who's who of biotech in­vestors

Josh Bilenker and Jeff Engelman won’t be worrying about money for their stealthy startup anytime soon.

Late last week the pair filed a Form D for their new biotech Treeline Biosciences outlining a $212 million raise for their new company — which Bilenker founded around the time he ejected from his top position at Eli Lilly’s oncology group.

Their plan is to top out the raise at $220 million, but with Bilenker’s list of marquee investors on board for his latest creation, that won’t be much of a stretch.

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