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 FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

A common approach to treating heart failure with induced pluripotent stem cells involves grafting sheets of cells onto the surface of the heart to improve vascularization and blood flow. It’s the easiest method of transplantation — but you run the risk of not making an electrical connection with the heart and the cells not synchronizing with the patient’s heart muscle.

So what if you could inject spherical clusters of heart cells directly into the heart muscle wall? For Heartseed, that’s now the $37 million question.

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.