Pro­tein degra­da­tion pi­o­neer C4 Ther­a­peu­tics nabs $170M; Barcelona start­up has €30M to go af­ter can­cer metas­tases

→ Pro­tein degra­da­tion has been good to C4 Ther­a­peu­tics. The Wa­ter­town, MA-based biotech just raised $170 mil­lion. That in­cludes a $150 mil­lion B round as well as $20 mil­lion in ven­ture debt from Per­cep­tive. “This fund­ing comes at a sig­nif­i­cant junc­ture, as our com­pa­ny is mov­ing to a clin­i­cal stage,” says CEO Marc Co­hen. “We plan on fil­ing our first IND by the end of this year and ex­pect to have four drug can­di­dates in the clin­ic by the end of 2022.” The syn­di­cate is big. The round was co-led by ex­ist­ing in­vestor Co­bro Ven­tures and new in­vestor Per­cep­tive Ad­vi­sors. New eq­ui­ty in­vestors in the round in­clud­ed Adage Cap­i­tal Man­age­ment, Ax­il Cap­i­tal, Bain Cap­i­tal Life Sci­ences, Com­modore Cap­i­tal, 3E Bioven­tures Cap­i­tal, HBM Health­care In­vest­ments, Lightchain Cap­i­tal, Lo­gos Cap­i­tal, Mizuho Se­cu­ri­ties Prin­ci­pal In­vest­ment, Nex­tech, RA Cap­i­tal Man­age­ment, RTW In­vest­ments, Sphera Funds Man­age­ment, Tai­wa­nia Cap­i­tal Man­age­ment, Yon­jin Ven­ture, and funds and ac­counts man­aged by T. Rowe Price As­so­ci­ates and Janus Hen­der­son In­vestors. Ex­ist­ing in­vestors al­so par­tic­i­pat­ed.

→ A Barcelona-based start­up with its own ap­proach to metas­ta­sis has just raised a €30 mil­lion launch round. Ona Ther­a­peu­tics has round­ed up the mon­ey from Asabys Part­ners and new in­vestors Al­ta Life Sci­ences, Bpifrance – In­no­Bio 2, Fund+ and Ys­ios Cap­i­tal. The biotech is found­ing on key find­ings by co-founder Sal­vador Az­nar-Ben­i­tah, who showed that metasta­t­ic cells are ad­dict­ed to fat — un­like pri­ma­ry tu­mors, which feasts most­ly on sug­ar. While many can­cer drug de­vel­op­ers have tend­ed to lump pri­ma­ry tu­mors and metas­tases to­geth­er, “we see it as a dif­fer­ent type of beast,” CEO Va­lerie Van­hooren told End­points News. The Abl­ynx vet ex­pects the cash to take them through a large proof-of-con­cept bas­ket tri­al in­volv­ing up to 150 pa­tients, from which Ona will se­lect the most promis­ing in­di­ca­tions to pur­sue for its an­ti­bod­ies.

→ Hop­ping on the SPAC band­wag­on, RA Cap­i­tal has filed for a $100 mil­lion IPO for its blank check com­pa­ny. Pe­ter Kolchin­sky is Ther­a­peu­tics Ac­qui­si­tion’s CEO and chair­man — which in ef­fect means he will lead the search for a promis­ing biotech to buy and flip to the Nas­daq. Spe­cial pur­pose ac­qui­si­tion com­pa­nies have be­come a trendy ve­hi­cle among mar­quee health­care in­vestors, with Chardan and RTW al­ready ex­e­cut­ed the merg­ers that their SPACs were set up for.

→ Shen­zhen, Chi­na-based Im­mvi­ra has raised $58 mil­lion to fund de­vel­op­ment of its on­colyt­ic virus­es, which promis­es to repli­cate bet­ter, kill can­cer cells more ef­fec­tive­ly, and in­duce more im­mune re­sponse than the pre­vi­ous gen­er­a­tion. Its lead can­di­date has launched clin­i­cal stud­ies in Aus­tralia, Chi­na and the US. Hua­gai Cap­i­tal led the round, with par­tic­i­pa­tion from Apri­cot Cap­i­tal and Cowin Cap­i­tal.

→ Can CAR-T be part of the an­swer to an HIV cure? A group of UCLA re­searchers have re­ceived a $13.65 mil­lion grant from the NIH to find out. By mod­i­fy­ing a pa­tient’s own stem cells to re­sist HIV in­fec­tion and hunt down in­fect­ed cells, the treat­ment would ide­al­ly repli­cate the ef­fect of a stem cell trans­plan­ta­tion.

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.

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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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

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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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

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.

Raul Rodriguez, Rigel Pharma CEO

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.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

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

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

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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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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