After Big Pharma sparked interest in the US, Ablaze looks to bring radiopharmaceuticals overseas

Ken Song, Ablaze chairman and RayzeBio CEO

Thanks in part to in­ter­est from Big Phar­ma play­ers like Bay­er and No­var­tis over the last decade, there’s been no short­age in cash for new com­pa­nies look­ing to slay tu­mor cells with tar­get­ed ra­dioiso­topes. Now a transpa­cif­ic up­start has hooked $75 mil­lion to bring the in­creas­ing­ly pop­u­lar drugs to Chi­na.

Ablaze Phar­ma­ceu­ti­cals emerged from stealth on Mon­day with a Vi­vo Cap­i­tal and Ad­van­Tech Cap­i­tal-led Se­ries A round and a li­cens­ing pact with Ver­sant-backed Rayze­Bio. The goal? In­tro­duce tar­get­ed ra­dio­phar­ma­ceu­ti­cal ther­a­pies (TRTs) to the Chi­nese mar­ket.

‘Tar­get­ed ra­dio­phar­ma­ceu­ti­cal ther­a­pies rep­re­sent the next foun­da­tion­al modal­i­ty to treat can­cer,’ Ken Song, Rayze­Bio CEO and chair­man of the board at Ablaze, said in a state­ment. ‘In form­ing Ablaze, we re­al­ized to be suc­cess­ful, it was crit­i­cal to have a com­pa­ny fo­cused on the Chi­na mar­ket and fo­cused on ra­dio­phar­ma­ceu­ti­cals.’

Un­like ra­di­a­tion ther­a­py, which is ad­min­is­tered by an ex­ter­nal beam of high-en­er­gy rays, ra­dio­phar­ma­ceu­ti­cals de­liv­er ra­dioiso­topes to tu­mors via the blood­stream. Song told End­points News back in June that the over­all con­cept is sim­i­lar to that of an an­ti­body-drug con­ju­gate. You start with a binder, a link­er and a pay­load — ex­cept in­stead of an an­ti­body, there are small­er pep­tides, and in­stead of a chemother­a­peu­tic pay­load, there’s a ra­dioac­tive par­ti­cle which is ‘many or­ders of mag­ni­tude’ more po­tent. By switch­ing ra­dioiso­topes, sci­en­tists can al­so per­form imag­ing di­ag­no­sis, Ablaze says.

Bay­er was one of the ear­ly en­trants in this space, with an Al­ge­ta-part­nered ra­dionu­clide ther­a­py that was shown to boost the over­all sur­vival of cas­tra­tion-re­sis­tant prostate can­cer pa­tients with symp­to­matic bone metas­tases. Bay­er snapped up Al­ge­ta just be­fore the drug, Xofi­go, was ap­proved by the FDA. Mean­while, No­var­tis se­cured its place in the race through multi­bil­lion-dol­lar buy­outs of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions and En­do­cyte, giv­ing it FDA-ap­proved Lu­tathera among oth­er pro­grams. Then there are the small­er play­ers, like San Diego-based Rayze­Bio, MPM-found­ed Ak­tis On­col­o­gy, and now Ablaze, which has lo­ca­tions in both Shang­hai and San Diego. CEO Alex Qiao says Ablaze is al­ready in the clin­ic, though he of­fered few de­tails on the com­pa­ny’s pro­grams. In ad­di­tion to the Rayze­Bio pro­grams, the com­pa­ny has one part­nered pro­gram with an aca­d­e­m­ic in­sti­tu­tion, he said.

The Se­ries A — which al­so saw par­tic­i­pa­tion from RAYZ In­vest­ments, Nan Fung Life Sci­ences, Piv­otal bioVen­ture Part­ners Chi­na, ven­Bio Part­ners, Sam­sara Bio­Cap­i­tal and Ven­rock Health­care Cap­i­tal Part­ners — will be used to es­tab­lish a pipeline of TRTs for the treat­ment of sol­id tu­mors, ex­pand the team, and build up in­fra­struc­ture, ac­cord­ing to Qiao.

It’s al­so ex­plor­ing oth­er part­ner­ships, the CEO said. But for now, in­vestors are con­fi­dent the com­pa­ny will be able to break in­to the mar­ket over­seas.

‘TRT is an emerg­ing field that has al­ready demon­strat­ed tremen­dous clin­i­cal ef­fi­ca­cy in treat­ing can­cer world­wide,’ Hong­bo Lu, man­ag­ing part­ner of Vi­vo Cap­i­tal, said in a state­ment.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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Stéphane Bancel, Moderna CEO

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Tillman Gerngross (Adagio)

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.

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Bo Ying, Abogen founder (Xi’an Jiaotong-Liverpool University)

With Moderna and BioNTech offering a model — in the US and Europe, respectively — for how mRNA biotechs can enjoy a meteoric rise to profit and fame with just one successful Covid-19 vaccine, a Chinese player is ready to put itself on the map.

Abogen, which set a record just three months ago with a $720 million Series C, has now raised another $300 million as it prepares to file its vaccine candidate for authorization. Partnered with Walvax and China’s military, ABO-028M first entered clinical testing in the summer of 2020 and is now in Phase III trials in Mexico, Indonesia and Nepal.

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.
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