Com­put­er sci­ence and en­gi­neer­ing, meet drug R&D. MIT star Tim­o­thy Lu in­ter­twines tech­nolo­gies for an off­beat biotech launch

At 37, Tim­o­thy Lu’s life and work has al­ready spanned sev­er­al sci­en­tif­ic dis­ci­plines and cul­tures. He’s lived in Asia and the US, and af­ter gath­er­ing de­grees in elec­tri­cal en­gi­neer­ing and com­put­er sci­ence at MIT, he struck out to pick up his med­ical de­gree at Har­vard Med and then a PhD at the Har­vard-MIT Health Sci­ences and Tech­nol­o­gy Med­ical En­gi­neer­ing and Med­ical Physics Pro­gram.

Knit­ting that all to­geth­er at the Syn­thet­ic Bi­ol­o­gy Group at MIT, Lu has be­come one of the pi­o­neers in the field, tack­ling dis­ease by cre­at­ing a ge­net­ic cir­cuit pro­gram­ming plat­form that could one day start fix­ing the er­rant code in our ge­net­ics that trig­gers dis­ease.

Af­ter help­ing found a va­ri­ety of dif­fer­ent star­tups, Lu’s fas­ci­na­tion with adap­tive ther­a­pies is push­ing him to launch a new biotech which is com­ing out for its first pub­lic bow af­ter rais­ing $53 mil­lion to cre­ate next-gen cell and gene ther­a­pies at a start­up dubbed Sen­ti Bio­sciences.

Lu is once again on the move, re­lo­cat­ing on sab­bat­i­cal to take the helm of the start­up in the Bay Area as its found­ing CEO. He’s work­ing along­side co-founder Philip Lee, a bio­engi­neer­ing ex­pert with a Berke­ley PhD and an en­tre­pre­neur­ial record at Cel­lA­SIC, a mi­croflu­idics ven­ture which was snapped up by Mer­ck KGaA. Long­time men­tor and MIT pro­fes­sor Jim Collins — who helped found Syn­log­ic with Lu — is along for the ride. And cell en­gi­neer­ing ex­pert Wil­son Wong out of Boston Uni­ver­si­ty is al­so of­fer­ing in­put on the sci­ence.

“I’ve been work­ing in this area for quite a while,” says Lu. “The field re­al­ly has evolved over the past 18 years. We are at the point where we can build fair­ly so­phis­ti­cat­ed ge­net­ic con­structs.”

Fur­ther out on the time hori­zon, it may be pos­si­ble to one day cre­ate a net­work of dis­ease sen­sors that could trig­ger a re­sponse that would stop dis­ease be­fore it ever be­gins. But Lu and his team are acute­ly aware that they’re in the prac­ti­cal prod­uct con­struc­tion phase, build­ing on ear­li­er work that, for in­stance, in­volved de­vel­op­ing an im­munomod­u­la­to­ry gene cir­cuit plat­form that “en­ables tu­mor-spe­cif­ic ex­pres­sion of im­munos­tim­u­la­tors” which could over­come the lim­i­ta­tions of anti­gen dri­ven ther­a­pies.

Lu stress­es that he has his eye on fil­ing an IND in the not too dis­tant fu­ture. Along the way he’d like to at­tract phar­ma part­ners. And the core team of 20 will now ex­pand to close to 40 staffers.

“Our goal is to pur­sue clin­i­cal ap­pli­ca­tions, move to­ward an IND,” he says. And they have the fund­ing to get a lead can­di­date and get close to en­ter­ing the clin­ic in the next 2.5 to 3 years.

The team brings to­geth­er sci­en­tists and ad­vi­sors that al­so span nu­mer­ous fields, com­ing from MIT, the Wyss In­sti­tute at Har­vard, MD An­der­son, Boston Uni­ver­sityand ETH Zurich. His syn­di­cate al­so re­flects an un­usu­al blend of bio­phar­ma and some tech in­vestors you usu­al­ly don’t find mix­ing in the drug de­vel­op­ment world. New En­ter­prise As­so­ci­ates led the round, with par­tic­i­pa­tion from 8VC, Am­gen Ven­tures, Pear Ven­tures, Lux Cap­i­tal, Men­lo Ven­tures, Allen & Com­pa­ny, Nest.Bio, Omega Funds, Good­man Cap­i­tal, and Life­Force Cap­i­tal.

“De­sign­ing ge­net­ic cir­cuits is not easy,” Lu tells me. “It re­quires a lot of en­gi­neer­ing and plat­form build­ing to build, test and learn.” The au­toma­tion and com­pu­ta­tion­al tools need­ed to make it work was the kind of sto­ry that res­onat­ed with tech in­vestors, he adds.

In the mean­time, his broth­er Jef­frey is al­so at work in the Bay Area build­ing En­gine Bio­sciences, which will fo­cus more on nat­ur­al ge­net­ic cir­cuits while Tim­o­thy Lu stays fo­cused more on syn­thet­ic tech.


Im­age: Tim­o­thy Lu. MIT CAM­PAIGN FOR A BET­TER WORLD

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

Covid-19 roundup: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

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President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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