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 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.

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.

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.