From L to R: Manifold Bio co-founders Gleb Kuznetsov (CEO), Shane Lofgren (head of BD) and Pierce Ogden (CSO)

Pro­tein ther­a­peu­tics biotech us­ing 'pro­tein bar­codes' in drug de­vel­op­ment se­cures new fi­nanc­ing — led by Jeff Hu­ber

Two years af­ter kick­ing things off with $5.4 mil­lion, a George Church spin­out is re­fill­ing its cof­fers to fu­el its ef­forts tack­ling pro­tein ther­a­peu­tics R&D.

Boston biotech Man­i­fold Bio an­nounced the new Se­ries A Thurs­day, led by new VC Tri­atom­ic Cap­i­tal, rais­ing $40 mil­lion to ad­vance its in­ter­nal pipeline and ex­pand its plat­form ca­pa­bil­i­ties. CEO and co-founder Gleb Kuznetsov tells End­points News that the fi­nanc­ing should last the biotech close to 2.5 years, de­pend­ing on how fast the com­pa­ny spends it.

Jeff Hu­ber

The biotech was Tri­atom­ic’s first in­vest­ment, Man­i­fold said in a state­ment. The VC was found­ed by none oth­er than Jeff Hu­ber, the for­mer Google ex­ec and once-CEO of Sil­i­con Val­ley can­cer test­ing start­up Grail be­fore it got bought out by Il­lu­mi­na last year. Hu­ber will be join­ing Man­i­fold’s board of di­rec­tors.

The com­pa­ny got its start when Kuznetsov and an­oth­er co-founder, Man­i­fold’s CSO Pierce Og­den, were grad­u­ate stu­dents in famed ge­neti­cist George Church’s lab. Ac­cord­ing to Kuznetsov, the pair were very in­ter­est­ed in pro­teins and pro­tein de­sign — which led them to talk to dif­fer­ent in­dus­try folks about the over­all price and ther­a­peu­tics process, and see­ing if there was a way to in­cor­po­rate more tech­nol­o­gy in­to it.

Kuznetsov orig­i­nal­ly grad­u­at­ed from MIT with a Bach­e­lor’s and then a Mas­ter’s in Com­put­er Sci­ence and spent a year at Google as a soft­ware en­gi­neer. Sev­er­al years lat­er, he went back to MIT for a PhD in Bio­physics.

“We didn’t want to just kind of bring for­ward, you know, a new drug, and, you know, kind of go the stan­dard route of pick­ing one drug and de­vel­op it,” Kuznetsov said — ref­er­enc­ing a mind­set he had seen about “you just kind of dog­mat­i­cal­ly test one mol­e­cule in an an­i­mal even­tu­al­ly, and that sort of make it or break it for a pro­gram.” That said, that led to Man­i­fold’s whole ob­jec­tive: to use tech­nol­o­gy to re­de­fine the pro­tein ther­a­peu­tic dis­cov­ery process.

The biotech first got off the ground in 2020 with $5.4 mil­lion in seed fund­ing.

As for what ex­act­ly Man­i­fold does, Kuznetsov said that the biotech wants to ad­dress what he called “bot­tle­necks” in drug cre­ation, with a spe­cif­ic pipeline fo­cus on can­cer tu­mors. One ex­am­ple was tar­get­ing — how to get a drug to start killing can­cer cells with­out harm­ing the rest of the pa­tient. Speci­fici­ty and com­plex­i­ty of which tar­gets a drug go af­ter were al­so key ques­tions at Man­i­fold.

To tack­le these bot­tle­necks, the biotech us­es “pro­tein bar­cod­ing” to track its drugs.

“From an en­gi­neer­ing per­spec­tive, you want to make these en­gi­neer mol­e­cules nav­i­gate this com­plex mam­malian en­vi­ron­ment and get just to those can­cer cells,” the CEO said. Af­ter mak­ing the drug com­po­nents in-house, the biotech then adds the pro­tein bar­codes — tiny bits of pro­tein that track how the drugs work and how ef­fec­tive the pro­tein ther­a­peu­tics are. Kuznetsov then gave an ex­am­ple, say a mouse mod­el that has a can­cer tu­mor.

Af­ter re­searchers put the drug can­di­dates in­to the tu­mor and an­a­lyze the re­sults, they count, us­ing pro­tein bar­codes plus some pro­pri­etary tech, which of the com­pa­ny’s drug de­signs end up ac­tu­al­ly be­ing suc­cess­ful.

Be­yond that, Man­i­fold has been in­ves­ti­gat­ing com­bin­ing mul­ti­ple binders to bet­ter tar­get can­cer cells that ex­press dif­fer­ent com­bi­na­tions of tar­gets. How­ev­er, the CEO not­ed that as you add this kind of com­plex­i­ty, the en­gi­neer­ing re­quired goes up too.

Kuznetsov al­so men­tioned that he has worked with Church di­rect­ly for a decade — start­ing in the ge­neti­cist’s lab back in 2012 as a re­search en­gi­neer be­fore start­ing his PhD in 2014. And be­cause of that re­la­tion­ship, Church meets with Man­i­fold once a month where the founders “ba­si­cal­ly pri­or­i­tize what we’re try­ing to do. And then George brings forth his own view of things,” the CEO not­ed.

The biotech, cur­rent­ly 15 strong, is plan­ning on dou­bling in size through­out the Se­ries A.

Kuznetsov added that while the biotech is not cur­rent­ly look­ing at ex­pand­ing its pipeline be­yond on­col­o­gy, it is in dis­cus­sions with a num­ber of oth­er com­pa­nies for pos­si­ble part­ner­ships. The biotech al­so not­ed that it start­ed work­ing on the Se­ries A just ear­li­er this year — and that it on­ly took a few months to se­cure in­vest­ments in light of how the biotech mar­ket has per­formed since Jan­u­ary.

New in­vestors for the Se­ries round in­clude Sec­tion 32, FPV, Hori­zons and Ten­cent. Pre­vi­ous in­vestors that al­so par­tic­i­pat­ed in this round in­clude Fifty Years, Play­ground Glob­al and FAST by GET­TY­LAB.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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David Hallal (L) and George Daley (Hallal photo: Bertrand Guay/AFP via Getty Images)

David Hal­lal's El­e­vate­Bio launch­es new com­pa­ny to 'dis­rup­t' off-the-shelf cell ther­a­py, but pro­vides few oth­er de­tails

David Hallal’s ElevateBio is launching a new company Thursday as it looks to continue making its mark in the cell and gene therapy spaces. But Hallal is also keeping his cards close to the vest, preferring to toe the line between bombast and mystique rather than going all-in in one direction.

The new company comes out of a partnership with Boston Children’s Hospital and research from George Daley, the dean of Harvard Medical School. The triumvirate claims to have found a way to design better off-the-shelf cell therapies using new methods discovered in Daley’s Boston Children’s Hospital lab (Harvard is not involved in the collaboration).

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.