Lalo Flores (Century)

As al­lo­gene­ic cell ther­a­py ap­proach­es flour­ish, Cen­tu­ry loads up $160M to scale iP­SC plat­form for CAR-T, CAR-NK

La­lo Flo­res is con­fi­dent he’s found the way for­ward in cell ther­a­py.

The feel­ing, to be sure, is not ex­clu­sive. Thanks to splashy com­pa­nies like Al­lo­gene and Arti­va, bio­phar­ma is well aware of the promis­es of al­lo­gene­ic ther­a­pies as next-gen­er­a­tion al­ter­na­tives to the au­tol­o­gous CAR-Ts that have al­ready made it to the mar­ket. But few­er are talk­ing about a fin­er dis­tinc­tion with­in that al­lo­gene­ic group: Where do you find the cells to en­gi­neer and turn in­to a fi­nal off-the-shelf prod­uct?

While most have opt­ed for donor cells, Cen­tu­ry Ther­a­peu­tics — where Flo­res is CEO — is bank­ing on in­duced pluripo­tent stem cells.

Al­most two years af­ter launch­ing with $250 mil­lion in cash and three em­ploy­ees, it’s col­lect­ed $160 mil­lion to fu­el the now 100-per­son team’s dash to the clin­ic.

In par­al­lel with all the ad­vances in cell en­gi­neer­ing over the years, there’s been a sim­i­lar evo­lu­tion in the sci­ence of re­pro­gram­ming skin or blood cells in­to an em­bry­on­ic-like state and coax­ing them in­to T or NK cells. Fate Ther­a­peu­tics, a J&J-part­nered pi­o­neer now in the clin­ic, has done much to ed­u­cate the field about it, and more re­cent­ly we’ve seen star­tups like Notch emerge; Cen­tu­ry wants to join them in the lead­ing spot, Flo­res said.

The room for im­prove­ment, af­ter all, is sig­nif­i­cant. Even in the few lym­phoma in­di­ca­tions where Kym­ri­ah and Yescar­ta have been ap­proved, not all pa­tients achieve a com­plete re­sponse and many who do would re­lapse.

“So clear­ly what that means is that there was not enough pres­sure on the tu­mor, there were enough cells that sur­vived that treat­ment […] and that’s the rea­son pa­tients re­lapse,” Flo­res said. “Our goal at Cen­tu­ry is to in­crease the dura­bil­i­ty of the re­spons­es.”

Cen­tu­ry is “plat­form ag­nos­tic” and there­fore de­vel­op­ing both CAR-T and CAR-NKs cre­at­ed with its iP­SCs. The lead pro­gram is a CD19 CAR-T that they hope to steer in­to a hu­man tri­al by 2022.

In ad­di­tion to the anti­gen tar­gets, the biotech has de­vised a com­bi­na­tion of three ge­net­ic ed­its to pre­vent im­mune re­jec­tion of the ther­a­peu­tic cells — open­ing up the pos­si­bil­i­ty to dose sev­er­al times un­til the pa­tient re­sponds.

With each new pro­gram, once they fi­nal­ize all the mod­i­fi­ca­tions Cen­tu­ry would iso­late a sin­gle clone to start what they call a mas­ter cell bank.

“It may take you a cou­ple of years to get to that point,” Flo­res said. “But once you have a mas­ter cell bank, that is the be­gin­ning of your man­u­fac­tur­ing process. And from there it on­ly takes you 30 days to make a man­u­fac­tur­ing run that will sup­ply thou­sands of dos­es.”

Ul­ti­mate­ly, he en­vi­sions Cen­tu­ry’s ther­a­pies to be stored as a frozen prod­uct in hos­pi­tals. The pre­clin­i­cal pipeline goes af­ter a slate of hema­to­log­i­cal ma­lig­nan­cies as well as sol­id tu­mors like glioblas­toma, where they would de­ploy a bis­pe­cif­ic CAR. The sub­stan­tial back­ing from Ver­sant and Bay­er in its Se­ries B has helped Flo­res re­cruit a ex­perts in pro­tein en­gi­neer­ing, gene edit­ing and man­u­fac­tur­ing, with him man­ag­ing the head­quar­ters in Philadel­phia, R&D chief Hyam Lev­it­sky lead­ing a team in Seat­tle and the group that was for­mer­ly Em­pir­i­ca Ther­a­peu­tics set­ting up a third of­fice in Cana­da af­ter Cen­tu­ry ac­quired the com­pa­ny.

More re­cent­ly, it’s leased the space for an man­u­fac­tur­ing fa­cil­i­ty in New Jer­sey, just 45 min­utes from the HQ, adding in-house ca­pac­i­ty to com­ple­ment the ex­ist­ing pro­duc­tion un­der a part­ner­ship with Fu­ji­film Cel­lu­lar Dy­nam­ics.

“Each time you de­vel­op a prod­uct, you be­gin the whole process of learn­ing how to scale up man­u­fac­tur­ing,” he said. “Go­ing to this jour­ney, there’s many learn­ings and it’s re­al­ly im­por­tant to cap­ture all those learn­ings with­in your own em­ploy­ees, your own sci­en­tists, or with­in your close part­ner as we have in FC­DI.”

They could be tak­ing those learn­ings to Nas­daq soon. Though Flo­res notes Cen­tu­ry now has two to three years of run­way, the Se­ries C syn­di­cate — Fi­deli­ty, the Fed­er­at­ed Her­mes Kauff­man Funds, RA Cap­i­tal, Lo­gos Cap­i­tal, Or­biMed, Mar­shall Wace, Qatar In­vest­ment Au­thor­i­ty, Avid­i­ty Part­ners, and Oc­ta­gon Cap­i­tal — fea­tures well-known crossover play­ers with whom he will be ex­plor­ing an IPO.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.