Unum Ther­a­peu­tics stum­bles on its Nas­daq de­but, rais­ing $69M and some trans­paren­cy is­sues

Unum Ther­a­peu­tics is limp­ing out on­to Nas­daq this morn­ing af­ter rais­ing close to $70 mil­lion from the sale of its stock.

Unum priced 5.8 mil­lion shares $UM­RX at $12 each, the bot­tom end of the range. That’s not a de­feat, but it’s no big win, ei­ther.

The Cam­bridge, MA-based biotech at­tract­ed a flur­ry of at­ten­tion when it filed for its IPO, but not for the rea­sons it would have liked. The com­pa­ny re­vealed in its S-1 fil­ing a few weeks ago that two pa­tients in the high-dose arm of a clin­i­cal tri­al for their lead can­cer drug died, forc­ing the FDA to slap a clin­i­cal hold on the tri­al which was dropped just be­fore they made their bid to go pub­lic.

Chuck Wil­son, Unum CEO

The then pri­vate com­pa­ny may not have vi­o­lat­ed any rules in the process, but they didn’t im­press any­one with a com­mit­ment to trans­paren­cy, ei­ther. It al­so like­ly didn’t help that this all played out just af­ter Sol­id Bio­sciences kept a par­tial hold for their lead drug on the down low right up un­til they sold shares — and then got ham­mered af­ter an ad­verse re­ac­tion trig­gered a full hold soon af­ter.

That sud­den about-face trig­gered a rout of Sol­id’s share price and a flur­ry of law­suits — un­der­scor­ing the dan­gers of go­ing pub­lic with one strike against you.

Unum — one of many that has built a rep around a top team and re­li­able ven­ture back­ers — has been build­ing a new cell ther­a­py that en­gi­neers pa­tient’s T cells in­to a dou­ble wham­my on can­cer cells. The cells are first de­signed to ex­press AC­TR, a chimeric pro­tein en­com­pass­ing pro­teins from T cells and nat­ur­al killer cells, then com­bined with an­oth­er tu­mor-spe­cif­ic drug, whip­ping up a cy­to­tox­ic as­sault on can­cer cells. The lead drug is AC­TR087, and Unum com­pares it to Gilead’s Yescar­ta and No­var­tis’ Kym­ri­ah, the two pi­o­neer­ing CAR-Ts on the mar­ket.

See­ing sim­i­lar tox­i­c­i­ty is­sues as the ear­ly CAR-Ts, though, wasn’t on the agen­da.

Re­searchers con­clud­ed that there were two cas­es of AC­TR087-re­lat­ed se­vere CRS — one fa­tal — and one pa­tient died from AC­TR087-re­lat­ed neu­ro­tox­i­c­i­ty. There was one fa­tal case of en­te­ro­coc­cal sep­sis con­sid­ered re­lat­ed to AC­TR087 and “one pa­tient sub­se­quent­ly ex­pe­ri­enced a fa­tal case of sep­sis con­sid­ered not re­lat­ed to AC­TR087,” ac­cord­ing to the S-1.

Mor­gan Stan­ley and Cowen are act­ing as joint book-run­ning man­agers for the of­fer­ing. Sun­Trust Robin­son Humphrey and Wed­bush Pac­Grow are act­ing as lead man­agers.

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.

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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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.

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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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.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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