Tim Lu via TED Talks (TED Conferences)

Tim Lu takes Sen­ti and its gene cir­cuit tech pub­lic in $296M deal rid­ing on Omid Farokhzad's SPAC

Omid Farokhzad

Omid Farokhzad didn’t have to trav­el far to find a pri­vate biotech he want­ed to take pub­lic with his $200 mil­lion blank-check com­pa­ny.

Sen­ti Bio — the syn­thet­ic bi­ol­o­gy play launched and now helmed by MIT whiz Tim Lu — will be merg­ing with Farokhzad’s Dy­nam­ics Spe­cial Pur­pose Corp., the com­pa­nies an­nounced Mon­day morn­ing, in a deal set to de­liv­er $296 mil­lion in gross pro­ceeds.

Us­ing a gene cir­cuit tech­nol­o­gy plat­form out of Lu’s lab, Sen­ti promis­es to pro­gram “sense-com­pute-re­spond” ca­pa­bil­i­ties in­to cell and gene ther­a­pies.

The en­gi­neer­ing method promis­es to en­hance ef­fi­ca­cy, speci­fici­ty and dura­bil­i­ty — all key qual­i­ties any cell and gene ther­a­py de­vel­op­er is look­ing for.

Blue­Rock Ther­a­peu­tics, the Bay­er sub­sidiary, was one of them. Ear­li­er this year (in fact the day af­ter Farokhzad com­plet­ed the IPO for his SPAC) Blue­Rock signed on to de­ploy the tech­nol­o­gy in de­vel­op­ing new cell ther­a­pies for re­gen­er­a­tive use.

The merg­er marks a hefty en­dorse­ment from a group deeply con­nect­ed in the biotech field. The crew at Dy­nam­ics Spe­cial Pur­pose Corp in­cludes CEO Mostafa Ron­aghi, for­mer chief tech­nol­o­gy of­fi­cer at Il­lu­mi­na; CFO Mark Afrasi­abi, who had co-head­ed the in­vest­ment com­mit­tee at Sil­ver Rock Fi­nan­cial; CBO Rowan Chap­man out of J&J In­no­va­tion and three in­de­pen­dent board mem­bers: David Ep­stein, the for­mer No­var­tis phar­ma chief now at Flag­ship, for­mer Il­lu­mi­na CEO Jay Flat­ley and se­nior man­ag­ing part­ner of the Soft­Bank Vi­sion Fund, Deep Nishar.

Farokhzad, the CEO of Seer, long­time Har­vard aca­d­e­m­ic and se­r­i­al en­tre­pre­neur, praised Sen­ti’s foun­da­tion­al tech­nol­o­gy for hav­ing “game-chang­ing im­pli­ca­tions for treat­ing a va­ri­ety of can­cers, as well as po­ten­tial ap­pli­ca­tions be­yond on­col­o­gy.”

On top of the cash re­serves in­side Dy­nam­ics, ex­ist­ing SPAC in­vestors are chim­ing in to pro­vide $86 mil­lion — in­clud­ing ARK In­vest­ment Man­age­ment, funds and ac­counts man­aged by Coun­ter­point Glob­al (Mor­gan Stan­ley In­vest­ment Man­age­ment), In­vus and T. Rowe Price funds. Oth­ers, in­clud­ing 8VC, Am­gen Ven­tures, Life­Force Cap­i­tal, NEA, Park­er In­sti­tute for Can­cer Im­munother­a­py, are swelling the PIPE fi­nanc­ing by an­oth­er $66 mil­lion to a to­tal $153 mil­lion.

“With re­cent ad­vances in syn­thet­ic bi­ol­o­gy, com­pu­ta­tion, and mas­sive bi­o­log­i­cal da­ta gen­er­a­tion, I be­lieve that we have a unique op­por­tu­ni­ty to en­gi­neer in­tel­li­gent cell and gene ther­a­pies that di­rect­ly tack­le the het­ero­gene­ity and dy­nam­ic na­ture of dis­ease, which have the po­ten­tial to fun­da­men­tal­ly trans­form our ther­a­peu­tic ar­se­nal,” Lu said in a state­ment.

The new funds, he added, will fu­el the in­ter­nal pipeline as Sen­ti plans to file its first INDs in 2023 for a log­ic-gat­ed al­lo­gene­ic CAR-NK cell ther­a­py dubbed SEN­TI-202 (for acute myeloid leukemia) and an­oth­er mul­ti-armed al­lo­gene­ic CAR-NK cell ther­a­py dubbed SEN­TI-301 (for he­pa­to­cel­lu­lar car­ci­no­ma). The crew will al­so work on ad­di­tion­al can­di­dates while build­ing out clin­i­cal-scale man­u­fac­tur­ing for the off-the-shelf CAR-NK cell ther­a­pies.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.