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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

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Steve Paul, Karuna Therapeutics CEO

Karuna looks to build on pos­i­tive schiz­o­phre­nia da­ta with one of the biggest pub­lic rais­es this year

Riding high on positive schizophrenia data it believes has the potential to reshape the entire field, Karuna Therapeutics put out word late Monday that it’s shooting for some new cash. And execs are swinging for the fences.

The biotech announced plans Monday afternoon to raise $600 million in a public offering, with a possibility of the total rising to $690 million if all options are exercised. The move aims to capitalize on Phase III data revealed Monday morning showing Karuna’s schizophrenia program significantly reduced symptoms compared to placebo.