Jeffrey Lu, Engine Biosciences CEO

Tim Lu is ready to take his AI-fo­cused biotech to the next lev­el with first big fundrais­ing round

Tim Lu

Fa­mous MIT re­searcher Tim Lu took the wraps off a transpa­cif­ic biotech he’d launched a lit­tle over three years ago with his broth­er Jef­frey with a $10 mil­lion seed round, at­tempt­ing to use ma­chine learn­ing to de­vel­op new small mol­e­cule drugs. Now, the com­pa­ny is ready to take its next step.

En­gine Bio­sciences un­veiled its first ma­jor VC round with a $43 mil­lion Se­ries A, the biotech an­nounced Wednes­day morn­ing. Over the last three years, the com­pa­ny has worked to es­tab­lish its plat­form, Jef­frey Lu — who is En­gine’s CEO — told End­points News, and re­cent­ly nom­i­nat­ed two tar­gets for their in­ter­nal pipeline.

With the new funds, Lu ex­pects En­gine has enough run­way to get its lead pro­gram in­to its first clin­i­cal tri­al by 2023.

Back in 2018, the Lu broth­ers were part of a wave of biotechs that set the field abuzz, with their ef­forts to tie AI and ma­chine learn­ing to hands-on drug de­vel­op­ment work. It’s an idea that’s gained trac­tion over the last sev­er­al years, as more com­pa­nies and bio­phar­mas aim to speed up the dis­cov­ery process and cut down on R&D costs.

James Collins

Their team al­so in­clud­ed a host of big names in the field, in­clud­ing Tim Lu’s MIT col­league Jim Collins, Mayo Clin­ic pro­fes­sor Hu Li and UC-San Diego re­searcher Prashant Mali.

En­gine’s ap­proach com­bines two dif­fer­ent sys­tems in­to one plat­form. The first al­lows the com­pa­ny to test how hun­dreds of thou­sands of pos­si­ble ge­net­ic com­bi­na­tions can be af­fect­ed by ed­its or changes, and the sec­ond feeds those ex­per­i­ments in­to an al­go­rithm that can pre­dict how those changes might be im­pli­cat­ed by new drugs.

Jef­frey Lu said re­searchers can start with ei­ther sys­tem, but En­gine it­self be­gan on the ex­per­i­ment side.

“It’s kind of chick­en and egg for what comes first,” Lu told End­points. “[The sys­tem] al­lows us to use things like CRISPR for mul­ti­ple ed­its in a sin­gle cell, knock­ing down or switch­ing ex­pres­sion two or three at a time, and see­ing what hap­pens to a cell.”

Af­ter three years of buildup, how­ev­er, Lu added that the AI al­go­rithm is ad­vanced enough to func­tion as the start­ing point as well, mak­ing pre­dic­tions about how edit­ed cells might re­act to drugs. That work can then be checked by re­searchers, us­ing the plat­form to con­duct its ex­per­i­ments.

En­gine has tak­en ad­van­tage of CRISPR thus far to con­duct some of its edit­ing ex­per­i­ments, but the plat­form is adapt­able to oth­er meth­ods such as mi­croR­NA and gene ex­pres­sion, Lu said. It’s al­lowed them to prep its first pipeline can­di­date where they’re go­ing af­ter liv­er, ovar­i­an and col­orec­tal can­cer all at once.

The biotech’s plat­form helped dis­cov­er a ge­net­ic mu­ta­tion linked to all three of these can­cer types, though Jef­frey Lu is keep­ing his cards close to the vest here. He de­clined to re­veal both the tar­get and the bio­mark­er for this small mol­e­cule pro­gram, not­ing on­ly that IND stud­ies will like­ly be­gin in 2022 with the goal for a 2023 clin­i­cal tri­al.

En­gine’s sec­ond pro­gram, which is a bit fur­ther be­hind the lead, is aim­ing for triple neg­a­tive breast can­cer at first.

Wednes­day’s round was led by Po­laris Part­ners, joined by a promi­nent undis­closed Sin­ga­pore firm and In­vus. Ex­ist­ing in­vestors al­so par­tic­i­pat­ed, in­clud­ing 6 Di­men­sions Cap­i­tal, WuXi AppTec, DHVC, ED­BI, Baidu Ven­tures, Vec­tr Ven­tures, Good­man Cap­i­tal, WI Harp­er, and Nest.Bio.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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