Shailesh Maingi, Inceptor founder and CEO

Not one, not two, but three — biotech claims it will pur­sue CARs T, M and NK all at once

An on­col­o­gy start­up is tout­ing some re­al­ly, re­al­ly bold claims.

In­cep­tor Bio an­nounced its lat­est round of fund­ing Thurs­day at $37 mil­lion, which it plans on us­ing to back pre­clin­i­cal pro­grams in CARs T, M and NK. Not on­ly will it be flesh­ing out its on­col­o­gy pro­grams, the com­pa­ny says it will al­so be putting some of that fi­nanc­ing to build­ing out its man­u­fac­tur­ing fa­cil­i­ty in Gainesville, FL, which it bought from Mass­a­chu­setts CD­MO Ar­ran­ta Bio late last year.

While most biotechs will fo­cus on one kind of CAR, usu­al­ly CAR-T or CAR-NK, or in a few cas­es, both CAR-T and -NK — such as Cen­tu­ry Ther­a­peu­tics, which al­so bought its own man­u­fac­tur­ing fa­cil­i­ty last year — In­cep­tor is the rare biotech at­tempt­ing all three, throw­ing in the new­er CAR-macrophage, or CAR-M, ther­a­py as well.

How­ev­er, un­like Cen­tu­ry, which emerged from stealth with $250 mil­lion in its pock­ets, In­cep­tor on­ly has $26 mil­lion in seed mon­ey from its found­ing in Au­gust 2020 in ad­di­tion to the $37 mil­lion from this re­cent round.

Why all three CARs? “We and oth­ers in the field rec­og­nize that CAR-T is not go­ing to be the so­lu­tion for every tu­mor,” In­cep­tor’s Pres­i­dent and COO Mike Nichol­son told End­points News, not­ing that CAR-T has been more ef­fec­tive against liq­uid tu­mors than sol­id ones. “We want to make sure we are pur­su­ing all of these frankly to in­crease the num­ber of shots we have at mak­ing the im­pact we want to make in the fight against can­cer.”

“As we build these pro­grams, we al­so do see an op­por­tu­ni­ty down the road to po­ten­tial­ly com­bine these [ther­a­pies],” Nichol­son added, cit­ing the po­ten­tial of start­ing a pa­tient on CAR-M and tran­si­tion­ing them to CAR-T or CAR-NK.

In­cep­tor’s pro­gram is an­chored around two key tech­nolo­gies, Nichol­son said. The first is a mol­e­cule the com­pa­ny li­censed from the Uni­ver­si­ty of North Car­oli­na that can be paired with CAR-T to en­hance the ther­a­py, while the sec­ond is a man­u­fac­tur­ing plat­form that sets up CAR-T cells to bet­ter face im­muno­sup­pres­sion from the tu­mor.

Not on­ly is the biotech plan­ning to de­vel­op a di­verse pipeline of CAR ther­a­pies, it al­so plans on ex­pand­ing its staff, Shailesh Main­gi, In­cep­tor founder and CEO, said.

When asked about the dif­fi­cul­ty of pur­su­ing such a di­verse pipeline, Nichol­son said that “we rec­og­nize that it is a chal­lenge. We cer­tain­ly are walk­ing in­to that with our eyes wide open.” How­ev­er, he not­ed that while some parts of the man­u­fac­tur­ing process­es don’t over­lap, a lot of them do, and they are mak­ing sure they take ad­van­tage of those ar­eas.

Main­gi said that he hopes In­ter­cept will get its first IND in the sec­ond half of 2023, but won’t say what in­di­ca­tions they plan on go­ing af­ter.

Ki­neti­cos Ven­tures led this round of fund­ing.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

David Liu (courtesy Broad Institute)

They’re go­ing for it: David Liu’s pre­clin­i­cal biotech shoots for a (maybe $200M) IPO

Can a preclinical biotech with grand ambitions, a star scientific founder and enthusiastic backers with deep pockets fly a big IPO against the gale force headwinds we’ve seen this year?

In this economy?

The people at Prime Medicine, which bills itself as a CRISPR 3.0 play, aim to find out if they can buck the trend — which has relented enough to allow for one upsized biotech IPO to get through — and possibly help pry open a window that was slammed shut at the beginning of the year.

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David Loew, Ipsen CEO (via Twitter)

Ipsen be­comes the lat­est phar­ma to ex­pand in Ire­land, with a $50M in­vest­ment in its fa­cil­i­ty in Dublin sub­urbs

It is no secret that Ireland has become a hot spot for pharma manufacturing projects over the past year, and it seems that Ipsen will be the latest player to get in on the action.

On Monday Ipsen unveiled the €52 million ($49.9 million) expansion it made into its active pharmaceutical ingredient manufacturing facility in Blanchardstown, a small suburb of Dublin. The investment is aimed at boosting medicine and ingredient production in cancer and rare disease space.

Three with­drawals in ad­vanced ovar­i­an can­cer spell trou­ble for PARP class

When AstraZeneca and Merck’s PARP inhibitor Lynparza was approved for advanced ovarian cancer back in 2014, FDA’s current Oncology Center of Excellence director Richard Pazdur touted it as the first in a “targeted, more personalized” new class of medicines for patients who often relapse after chemotherapy.

Almost a decade later, that option is once again off the table for some patients as three pharma giants yank late-stage indications from their labels over a potential increased risk of death.

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Sally Choe, outgoing director of the FDA's Office of Generic Drugs

FDA's top gener­ic drug leader puts in her two weeks as GDU­FA III looms

The FDA is about to lose another top leader with the departure of Sally Choe, director of the FDA’s Office of Generic Drugs, on Oct. 8. The departure coincides with the transition from the second reauthorization of the Generic Drug User Fee Amendments to the third reauthorization, which Congress has until Friday to finish up.

Choe, who didn’t immediately say where she’s heading post-FDA, but did a stint at Parexel, has served as the OGD director since February 2019, and “has been the principal medical and technical authority on all matters related to generic drug review and advised me and other agency officials,” CDER director Patrizia Cavazzoni said in an email to staff announcing Choe’s departure.

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Denise Scots-Knight, Mereo BioPharma CEO

Ru­bik's Cube still not solved at Mereo as ac­tivist in­vestor re­jects biotech's of­fer for board seats

Last month, Mereo BioPharma said its shareholders “deserve better” and in the latest setback at the UK biotech, the disgruntled 14% owner Rubric Capital Management has rejected an offer that the rare disease drugmaker thought would’ve solved the proxy fight.

The London biotech put out word Monday that it had offered up a principal and new director board seat to Rubric by having two existing Mereo directors retire. The offer didn’t entice Rubric amid a weekslong back-and-forth between the two parties, with Mereo sending multiple letters to the investor to defend itself and mitigate public concerns.

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Julie Brown, incoming GSK CFO (Roche)

With con­sumer health be­hind it, GSK taps As­traZeneca vet Julie Brown as CFO for R&D-fo­cused fu­ture

Four years ago, Emma Walmsley recruited Iain Mackay from the banking world to become GSK’s CFO, spotlighting his “track record of driving cost, cash and capital allocation discipline to deliver strategy.” Now that he’s helped oversee the spinoff of GSK’s consumer health unit, Walmsley is turning to an industry veteran for his successor.

Julie Brown, a veteran of AstraZeneca who recently switched lanes to become Burberry’s chief operating and financial officer, will join GSK as CFO in April as Mackay retires.

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Ron Cooper, Albireo CEO

Liv­er-fo­cused start­up nabs $115M in ex­change for rare dis­ease drug roy­al­ties

A Boston biotech focused on liver disease raised some quick cash last week, selling royalty rights to its sole FDA-approved drug.

Albireo Pharma sold the royalties to Canada-based investment firm Sagard Holdings for $115 million, nabbing the funds in exchange for future sales of Bylvay, approved last year to treat pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). The money will help the biotech extend its runway ahead of a 2024 Phase III readout in biliary atresia, CEO Ron Cooper said in a statement.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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