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.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

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Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.