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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.