Ken Song (RayzeBio)

No­var­tis bet $6B on the idea — now Ver­sant, ven­Bio have $45M to birth a plat­form play for ra­dio­phar­ma­ceu­ti­cals

Back in 2017, in the wake of back-to-back set­backs and a re­or­ga­ni­za­tion, a strug­gling lit­tle biotech named En­do­cyte com­plet­ed a $12 mil­lion li­cens­ing deal that would ul­ti­mate­ly put it on a path to­ward a $2.1 bil­lion buy­out.

As it turned out, Ver­sant Ven­tures was al­so eye­ing that very same drug out of Ger­many: PS­MA-617, a ra­di­oli­gand ther­a­peu­tic for cas­tra­tion-re­sis­tant prostate can­cer.

Jer­el Davis

“We ac­tu­al­ly put a term sheet out on that as­set be­cause we just thought the ef­fi­ca­cy da­ta were so pro­found there,” man­ag­ing di­rec­tor Jer­el Davis told End­points News, re­fer­ring to a drug that reg­is­tered a pro­gres­sion-free sur­vival rate of 7.6 months among PS­MA-pos­i­tive pa­tients, with one co­hort hit­ting an over­all sur­vival rate of 13.5 months.

Af­ter three years of scout­ing the (small) space for op­por­tu­ni­ties Ver­sant reck­ons a fresh start is the way to go. The biotech fledg­ling, Rayze­Bio, is de­but­ing to­day with $45 mil­lion in Se­ries A mon­ey, with ven­Bio as a co-leader and Sam­sara Bio­Cap­i­tal al­so chim­ing in.

With No­var­tis now claim­ing two of the most ad­vanced pro­grams in the field — both PS­MA-617 and FDA-ap­proved Lu­tathera, from a $3.9 bil­lion ac­qui­si­tion of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions — ra­dio­phar­ma­ceu­ti­cals has in­trigued quite a few biotech ob­servers, not­ed CEO Ken Song. But se­cur­ing a steady sup­ply of ther­a­peu­tic ra­dioiso­topes, es­pe­cial­ly the more po­tent al­pha iso­topes, has been a chal­lenge for any­one look­ing to mount an ear­ly-stage ef­fort.

While the tar­get­ed de­liv­ery ap­proach be­hind ra­dio­phar­ma­ceu­ti­cals is sim­i­lar to an­ti­body-drug con­ju­gates, ra­dioiso­topes such as Ac­tini­um-225, which Rayze­Bio is de­ploy­ing, are “many fold more po­tent, prob­a­bly 100 or 500 times more po­tent” than cy­to­tox­ic pay­loads in AD­Cs, Davis added.

“What has hap­pened over the last sev­er­al years is that a mul­ti­tude of groups in both acad­e­mia and in­dus­try have de­vised al­ter­nate ways to gen­er­ate Ac­tini­um-225 where they’ve ac­tu­al­ly pro­vid­ed da­ta to show that this can be pro­duced and scaled up to suf­fi­cient quan­ti­ties,” he said. “That’s on­ly come to light over the last year, year and a half.”

Deb­o­rah Charych

That opened up a white space that Song, who was look­ing to “take a con­sid­er­able amount of time off” and turned down dozens of oth­er of­fers as he stepped down from the helm at Metacrine, couldn’t pass up.

The founders, led by Nek­tar vet and for­mer Third Rock en­tre­pre­neur Deb­o­rah Charych, were in­tent on cre­at­ing a pur­pose-built op­er­a­tion that would go broad­er and deep­er than cur­rent play­ers, said Aaron Roys­ton, man­ag­ing part­ner of ven­Bio.

In­stead of re­pur­pos­ing ex­ist­ing mol­e­cules to tar­get can­cer anti­gens, for in­stance, Rayze­Bio has part­nered up with Japan’s Pep­tiDream to dis­cov­er new pep­tides against a range of val­i­dat­ed sol­id tu­mor tar­gets. The pep­tides will then be ra­di­o­la­beled with Ac­tini­um-225 — in-house for pre­clin­i­cal work and by con­tract man­u­fac­tur­ers in clin­i­cal stud­ies through com­mer­cial­iza­tion.

“We’re re­al­ly ask­ing the pep­tides to do ex­act­ly what pep­tides do well,” Roys­ton said. They can pen­e­trate tu­mors with their small sizes, are spe­cif­ic to tar­gets, and have rel­a­tive­ly short half life — prop­er­ties that peo­ple usu­al­ly don’t want in a drug. Yet “with ra­dio­phar­ma I think it’s a per­fect ap­pli­ca­tion.”

Aaron Roys­ton

In line with a vi­sion to be the first ra­dio­phar­ma plat­form play, the biotech has put to­geth­er 7 ac­tive pro­grams, with the goal to have at least one de­vel­op­ment can­di­date by the sec­ond half of 2021. The first clin­i­cal tri­als should hap­pen no more than one year there­after.

No­tably, Rayze­Bio will be able to use part of its drugs to iden­ti­fy the pa­tients it wants to re­cruit in­to tri­als by tak­ing the same binders but swap­ping out the ther­a­peu­tic iso­tope for an imag­ing agent. It spells a tar­get­ed yet broad­ly ap­plic­a­ble ap­proach that Song be­lieves would at­tract and ac­com­mo­date a large num­ber of play­ers.

“Some­one needs to be part of the ear­ly pack,” Song said about Rayze­Bio’s team, which con­sists of 10 full timers and about a dozen con­sul­tants and ad­vi­sors. “Our goal ob­vi­ous­ly is to al­ways be ahead of every­one be­cause we’re get­ting a head start by fo­cus­ing on it now. But that is up to us to en­sure that we main­tain that ad­van­tage.”

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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