Mark Kotter, bit.bio CEO

Cell ther­a­py start­up bit.bio adds $100M+ to its cof­fers and some im­pres­sive names to its board of di­rec­tors

Bit.bio 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 bit.bio’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.

Bit.bio’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

Bit.bio 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 bit.bio’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.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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