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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most popular targets in drug development, representing about a third of existing drugs, are G-protein coupled receptors — the tiny but integral membrane proteins responsible for recognizing things like light, taste, smell, hormones and pain.

But due to challenges in mapping their structure, the protein family remains largely unexplored.

A slate of companies has emerged over the last few years to change that. If one can figure out the structure of these elusive membrane receptors, it might be possible to create small molecule drugs that overcome the limitations of, say, biologic and peptide therapies. That promise is what gets serial entrepreneur Raymond Stevens out of bed in the morning.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Break­ing: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales.

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With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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Carl June (Brian Ach/Getty Images for TIME 100 Health Summit)

Carl June lends 'wings' to Chi­nese CAR-T start­up led by for­mer post­doc, pur­su­ing off-the-shelf ap­proach with CRISPR fla­vor

Carl June still has plenty of energy to bring forth new iterations of CAR-T technology — wherever they’re coming from.

Adding another role to his already lengthy list of titles, June is joining the scientific advisory board at Nanjing Bioheng Biotech, where he will serve as chairman.

The appointment, if slightly out of the ordinary, is both a testament to the fruitfulness of June’s lab at the University of Pennsylvania and China’s increasing appeal to biotech entrepreneurs educated overseas.