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.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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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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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

CRO start­up Vial scores $67M Se­ries B led by Gen­er­al Cat­a­lyst

Vial, a CRO specializing in offering clinical trial services to biotech companies, raised $67 million in a new round of funding, bringing its total money raised to $100 million.

The San Francisco-based company’s Series B round was led by General Catalyst and supported others such as Byers Capital and BoxGroup.

Vial co-founder and CEO Simon Burns said the company will use the funding to expand its clinical operations and strategy teams in the US and across the European Union and Asia-Pacific in order to support its clients globally.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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