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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Philip Astley-Sparke, Replimune CEO

Replimune looks to rope in $225M on the back of melanoma da­ta

The Massachusetts-based, oncolytic virus biotech Replimune is feeling bullish now that it has lifted the cover on data for its lead product.

Replimune said Thursday it looks to nab about $225 million from a public offering after giving a snapshot of some initial data from its IGNYTE clinical study earlier this week. The trial is investigating RP1 in combination with Opdivo, for patients with melanoma and who did not have a response when being treated with a PD-1.