Mark Kotter, CEO

Cell ther­a­py start­up adds $100M+ to its cof­fers and some im­pres­sive names to its board of di­rec­tors CEO Mark Kot­ter says the last ma­jor rev­o­lu­tion in bio­phar­ma oc­curred around the 1980s, when an­ti­bod­ies — or, as some called them, an­ti­cancer “mag­ic bul­lets” — opened up the door for new ther­a­pies.

Now cell ther­a­py is hav­ing a very sim­i­lar mo­ment, he told End­points News, and some blue-chip in­vestors are giv­ing his cell cod­ing com­pa­ny $103 mil­lion to get be­hind it.

Kot­ter un­veiled the high-dol­lar Se­ries B round on Fri­day, with par­tic­i­pa­tion from Arch Ven­tures, Charles Riv­er Lab­o­ra­to­ries, Fore­site Cap­i­tal, Na­tion­al Re­silience, Meta­plan­et, Puhua Cap­i­tal and Ten­cent. The new cash builds on a $41.5 mil­lion Se­ries A round that at­tract­ed some in­ter­est­ing in­vestors last June, in­clud­ing Na­tion­al Can­cer In­sti­tute ex-chief Rick Klaus­ner, Arch’s Bob Nelsen and Fore­site Cap­i­tal CEO Jim Tanan­baum.

Greg Win­ter

The lat­est round brings a few more no­table names on­to’s board of di­rec­tors, in­clud­ing mon­o­clon­al an­ti­body pi­o­neer and No­bel lau­re­ate Greg Win­ter, Amadeus Cap­i­tal Part­ners co-founder Her­mann Hauser, and Alan Roe­mer, the en­tre­pre­neur be­hind both Phar­mas­set and Roivant.’s roots trace back to the Uni­ver­si­ty of Cam­bridge’s Stem Cell In­sti­tute, where Kot­ter worked on a plat­form ap­proach to cod­ing for cells at an in­dus­tri­al scale, mak­ing it pos­si­ble to rel­a­tive­ly quick­ly gen­er­ate batch­es of spe­cif­ic cells that come out with en­hanced fea­tures.

First-gen­er­a­tion cell ther­a­pies are made with a mix of cells that are of­ten “not in very good shape,” Kot­ter said, adding that sci­en­tists will start with cells tak­en from pa­tients who are al­ready bat­tling can­cer.

“There’s a lot of vari­abil­i­ty with the cells, and you have very lit­tle con­trol,” he added.

Her­mann Hauser is one of the many com­pa­nies pur­su­ing an off-the-shelf ap­proach, start­ing with en­gi­neered pluripo­tent stem cells. It’s a group that in­cludes oth­er new en­trants like Garu­da Ther­a­peu­tics which launched last year, and Clade Ther­a­peu­tics, which emerged from stealth ear­li­er this week.

What will set the Cam­bridge, Eng­land com­pa­ny apart from the pack? Scal­a­bil­i­ty, Kot­ter says.

“Oth­er com­pa­nies in that space have made in­cred­i­ble progress,” he said. “We now have a few stem cell prod­ucts be­ing test­ed in the mar­ket, but they’re still hav­ing is­sues with scale and with re­pro­ducibil­i­ty.”

Kot­ter says’s bi­ol­o­gy is more per­mis­sive, adding that the com­pa­ny is al­ready at in­dus­tri­al scale in terms of cell pro­duc­tion. He com­pared the com­pa­ny’s “op­ti-ox” plat­form to a hack in­to the soft­ware of the cell. By ac­ti­vat­ing spe­cif­ic tran­scrip­tion fac­tors, sci­en­tists can es­sen­tial­ly change the pro­gram or iden­ti­ty of the cell. Now all the team needs is to get in­to the clin­ic — though Kot­ter didn’t pro­vide a time­line for that.

“I’m not go­ing to say this is go­ing to be easy,” he said. “It’s go­ing to be su­per hard, but our ad­van­tage is that we’re not fight­ing a bi­ol­o­gy that is re­sist­ing, you know, scale up and con­sis­ten­cy.”

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

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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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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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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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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)

Up­dat­ed: 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.