Il­lu­mi­na co-founder Mark Chee moves from the genome to the pro­teome with up­start En­co­dia

When Mark Chee co-found­ed Il­lu­mi­na in 1998, the ge­nomics field was just heat­ing up. It had been three years since the first bac­teri­um genome was se­quenced, but the Hu­man Genome Pro­ject was still years away from com­ple­tion. That space has since erupt­ed, and now Chee is on to what re­searchers think is the next big thing: pro­teomics.

Mark Chee

Chee and fel­low Il­lu­mi­na vet­er­an Kevin Gun­der­son co-found­ed pro­tein se­quenc­ing-fo­cused En­co­dia back in 2015. Af­ter keep­ing qui­et for the last few years, the up­start broke the si­lence on Wednes­day to spread the word of its $75 mil­lion Se­ries C round, led by North­pond Ven­tures and Deer­field Man­age­ment. The funds will be used to com­mer­cial­ize En­co­dia’s patent­ed pro­tein analy­sis plat­form, dubbed Pro­teoCode.

“Our aim is to de­liv­er a sys­tem that en­ables re­searchers to probe the im­mense com­plex­i­ty of the pro­teome rou­tine­ly and at a scale that was pre­vi­ous­ly un­at­tain­able,” said Chee, who serves as pres­i­dent.

The plat­form com­pa­ny joins a hand­ful of oth­er biotechs — in­clud­ing So­ma­Log­ic and Seer, which reeled in a $55 mil­lion round back in Ju­ly — work­ing on the pro­teome. For decades, sci­en­tists tossed around the idea that in­stead of look­ing at DNA or RNA to un­der­stand the body and its dis­or­ders, you could look at the pro­teins made by ge­net­ic code, which in most cas­es, ul­ti­mate­ly do the dam­age.

Kevin Gun­der­son

As promis­ing as it sounds, it’s no sim­ple feat: While DNA has four let­ters and bonds in very spe­cif­ic ways and struc­tures, pro­teins are formed from up to 20 amino acids and can bond in a count­less num­ber of ways, and then change af­ter their cre­ation in­to a va­ri­ety of states de­pend­ing on what bonds to them. There’s al­so the chal­lenge that DNA and RNA can be repli­cat­ed and am­pli­fied in a lab while pro­teins can’t.

“The com­plex chem­istry, im­mense va­ri­ety, and broad range of con­cen­tra­tions that make pro­teins com­pelling tar­gets for study have al­so made their ex­plo­ration at depth and scale ex­treme­ly dif­fi­cult,” En­co­dia said in a state­ment.

En­co­dia’s pro­tein se­quenc­ing ap­proach us­es re­verse-trans­la­tion tech­nol­o­gy that turns pep­tide se­quences in­to DNA, which can then be read by a DNA se­quencer, ac­cord­ing to their web­site.

Aside from Chee and Gun­der­son, who serves as VP and CTO, the team al­so in­cludes an­oth­er Il­lu­mi­na vet­er­an: VP of sys­tems in­te­gra­tion Ken­neth Kuhn, who start­ed as a sci­en­tist at Il­lu­mi­na and worked his way up to se­nior di­rec­tor over 16 years. Se­r­i­al en­tre­pre­neur and Ax­ioMx founder Michael Wein­er has joined the board.

GV, Alexan­dria Ven­ture In­vest­ments, ARCH Ven­ture Part­ners, Bio­mat­ics Cap­i­tal, Decheng Cap­i­tal, Tao Cap­i­tal Part­ners, and Nan Fung Life Sci­ences al­so chipped in to the Se­ries C round.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

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The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

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Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

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With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

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