Ken Song, RayzeBio CEO

Just shy of its 1-year an­niver­sary, ra­dio­phar­ma­ceu­ti­cals plat­form play Rayze­Bio bags an­oth­er megaround

Per­haps they should have called it Raise­Bio.

Not even a full year post-launch, Rayze­Bio’s ra­dio­phar­ma­ceu­ti­cals plat­form has hooked yet an­oth­er $100 mil­lion-plus raise, and it ap­pears the com­pa­ny’s next big catch will be a Nas­daq tick­er.

CEO Ken Song un­veiled the Se­ries C round Tues­day morn­ing, bring­ing the fledg­ling biotech’s to­tal raise to $258 mil­lion. While he was hes­i­tant to call it a crossover round, he said it very well could be Rayze­Bio’s last pri­vate round of fi­nanc­ing.

“We’re open to look­ing at all things, but there’s no im­me­di­ate plans to take the com­pa­ny pub­lic, par­tic­u­lar­ly since we’re so well cap­i­tal­ized at this time,” he told End­points News. 

Rayze­Bio was es­tab­lished back in Au­gust 2020, and launched a cou­ple months lat­er with sev­en ra­dio­phar­ma­ceu­ti­cals pro­grams. Un­like ra­di­a­tion ther­a­py, which is ad­min­is­tered by an ex­ter­nal beam of high-en­er­gy rays, ra­dio­phar­ma­ceu­ti­cals de­liv­er ra­dioiso­topes to tu­mors via the blood­stream.

The over­all con­cept is sim­i­lar to that of an an­ti­body-drug con­ju­gate, Song said — it all starts with a binder, a link­er and a pay­load. Ex­cept in­stead of an an­ti­body, Rayze­Bio is de­ploy­ing small­er pep­tides, and in­stead of a chemother­a­peu­tic pay­load, there’s a ra­dioac­tive par­ti­cle which is “many or­ders of mag­ni­tude” more po­tent.

From the be­gin­ning, Rayze­Bio es­tab­lished a part­ner­ship with Japan’s Pep­tiDream to dis­cov­er new pep­tides against a range of val­i­dat­ed sol­id tu­mor tar­gets. The pep­tides are then ra­di­o­la­beled with the com­pa­ny’s pre­ferred ra­dioiso­tope, Ac­tini­um-225. But Rayze­Bio is al­so ex­plor­ing the use of oth­er ra­dioiso­topes, and ad­di­tion­al ap­proach­es to iden­ti­fy binders — and as a re­sult, the team has ex­pand­ed be­yond its ini­tial sev­en pro­grams.

Song plans on us­ing the Se­ries C funds to bring more than one can­di­date in­to the clin­ic, though he de­clined to com­ment on a time­line.

“We’re still very much fo­cused on ad­vanc­ing a pret­ty broad pipeline of pro­grams, and we’ll be able to pro­vide an up­date hope­ful­ly in the near fu­ture, as to­wards tim­ing in­to the clin­ic,” he said.

Since De­cem­ber, the team has grown from 13 to more than 30, not count­ing con­tract work­ers. That in­cludes Er­ic Bischoff, a col­league from Song’s Metacrine days, who’s now SVP of de­vel­op­ment and op­er­a­tions. Gary Li, head of bi­ol­o­gy and trans­la­tion­al med­i­cine, was for­mer­ly SVP of trans­la­tion­al med­i­cine at QED Ther­a­peu­tics. Head of dis­cov­ery Derek Cole hails from Take­da, where he led med­i­c­i­nal chem­istry for the GI-drug dis­cov­ery unit. They all joined Deb­o­rah Charych, who co-found­ed Rayze­Bio and is now CTO.

The com­pa­ny came to­geth­er around a “con­ver­gence of in­ter­ests,” Song said. There’s been in­creas­ing in­ter­est in ra­dio­phar­ma­ceu­ti­cals over the last decade, with no­table en­trants like No­var­tis, which snagged FDA-ap­proved Lu­tathera and PS­MA-617 from a $3.9 bil­lion ac­qui­si­tion of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions.

“There’s ac­tu­al­ly a fair num­ber of small­er ra­dio­phar­ma­ceu­ti­cal com­pa­nies that are out there,” Song said. “But I would say that Rayze­Bio is unique in the breadth of our pipeline, as well as our se­lec­tion of tar­gets that we’re pur­su­ing would large­ly be viewed as first-in-class with­in the ra­dio­phar­ma­ceu­ti­cal sec­tor.”

Back in De­cem­ber, the com­pa­ny said it would use part of a $105 mil­lion Se­ries B round to fund stud­ies in­to man­u­fac­tur­ing op­tions. Mak­ing ra­dioiso­tope-drug con­ju­gates re­quires a bit more spe­cial­iza­tion than typ­i­cal ther­a­pies. While the com­pa­ny is cur­rent­ly do­ing some ra­di­o­la­bel­ing in-house, it’s most­ly for re­search pur­pos­es, Song said.

“When it comes to ac­tu­al man­u­fac­tur­ing and dis­tri­b­u­tion, we’re like­ly to work with con­tract man­u­fac­tur­ers to be­gin with and then eval­u­ate whether or not there’s any need to in­vest in any of our own in­fra­struc­ture,” Song said.

The Se­ries C was led by Ven­rock Health­care Cap­i­tal Part­ners, with some help from a slate of new and old in­vestors, in­clud­ing Per­cep­tive Ad­vi­sors, Vi­vo Cap­i­tal, Acu­ta Cap­i­tal Part­ners, Deer­field Man­age­ment, TCG X, ven­Bio Part­ners, Ver­sant Ven­tures, Sam­sara  Bio­Cap­i­tal, Red­mile Group, Viking Glob­al In­vestors, Cor­morant As­set Man­age­ment, Or­biMed, LifeSci Ven­ture Part­ners, Lo­gos Cap­i­tal, Alexan­dria Ven­ture In­vest­ments, and oth­ers.

“Our goal is to build the lead­ing ra­dio­phar­ma­ceu­ti­cal biotech­nol­o­gy com­pa­ny that is able to take prod­ucts from ini­tial con­cept all the way through to de­liv­ery to pa­tients, and be a free stand­ing en­ter­prise,” he added.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Nader Pourhassan, CytoDyn CEO (Photo by Jeff Kravitz/FilmMagic for CytoDyn’s Pro)

Cy­to­Dyn faces DOJ, SEC sub­poe­nas af­ter pro­mot­ing failed Covid-19 drug

The little, PR-happy drug company publicly called out by the FDA is now getting attention from both the SEC and the Department of Justice.

CytoDyn, a one-time penny stock that has gained both money and notoriety for aggressively pushing an old HIV drug as a treatment for Covid-19, disclosed in a regulatory filing Friday the SEC and DOJ have separately subpoenaed the company and “certain of its executives” as part of investigations into the company’s promotion and marketing practices.

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Rare dis­ease drug­mak­ers to Con­gress: Don't gut the ac­cel­er­at­ed ap­proval path­way

The controversy over the FDA’s accelerated approval pathway is heating up.

Last week, the FDA’s top oncology official Rick Pazdur said the pathway is “under attack,” largely due to the agency’s recent accelerated approval of Biogen’s controversial Alzheimer’s drug and the surrogate endpoint used in that decision. In the meantime, three accelerated approval indications have been pulled since July 1 (two from Bristol Myers Squibb and one from Merck in recent weeks), even as Pazdur called on critics of the pathway to not miss the more positive, big picture, with some cancer drugs proving to be enormously helpful and approved years before their confirmatory trials were completed.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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