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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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