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.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.

Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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