Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Large­ly known for its non­pep­tide small mol­e­cule re­search, Cri­net­ics has been keep­ing its ra­dio­phar­ma work com­par­a­tive­ly un­der wraps. But that changed Mon­day af­ter­noon as the Cal­i­for­nia biotech spun out a new com­pa­ny fo­cused sole­ly on the bur­geon­ing field.

Cri­net­ics launched Ra­dio­net­ics af­ter the clos­ing bell Mon­day, the com­pa­ny an­nounced, seed­ing the new en­ti­ty with $30 mil­lion raised from 5AM Ven­tures and Fra­zier Health­care Part­ners. Ra­dio­net­ics will start with its own ra­dio­phar­ma-cen­tric plat­form and a pipeline of 10 pro­grams aimed at sol­id tu­mors.

“We’re go­ing to hit the ground run­ning,” Cri­net­ics CEO Scott Struthers told End­points News. Struthers will al­so serve on the Ra­dio­net­ics board, and he added that there’s no time­line on any of the pro­grams yet.

The pipeline comes out of Cri­net­ics’ dis­cov­ery en­gine, and it’s aimed at cre­at­ing a po­ten­tial­ly new busi­ness mod­el for the com­pa­ny. Though it’s not giv­ing Ra­dio­net­ics any more mon­ey, Struthers said Cri­net­ics is es­sen­tial­ly act­ing as a VC by sign­ing on­to a re­search agree­ment with Ra­dio­net­ics. The spin­out will re­ceive an ex­clu­sive li­cense for the plat­form and pro­gram in ex­change for more than $1 bil­lion in mile­stones.

Struthers’ mo­ti­va­tion to launch this new com­pa­ny now large­ly stems from the suc­cess he’s seen with the prostate can­cer drug Lu­tathera, de­vel­oped by Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions and ac­quired by No­var­tis in 2017. He wants to hit “all sol­id tu­mors” with Ra­dio­net­ics, which he freely ad­mits is a bold claim.

But both com­pa­nies’ fo­cus on small mol­e­cules means they can hit more tar­gets than com­pa­nies that re­ly on pep­tides, as many ra­dio­phar­ma com­pa­nies do.

“The clin­i­cal ben­e­fit there has just been re­mark­able such that No­var­tis has made it one of its pil­lars of the plat­forms for their com­pa­ny,” Struthers said. “With that suc­cess, any re­al can­cer cen­ter now is go­ing to need this type of nu­clear med­i­cine ca­pa­bil­i­ty … we want to ex­pand that to a broad range of ad­di­tion­al can­cer types.”

As the ra­dio­phar­ma world con­tin­ues to de­vel­op, No­var­tis has emerged as the leader of the pack. In ad­di­tion to Lu­tathera, the bio­phar­ma re­ceived a break­through ther­a­py des­ig­na­tion for a pro­gram ac­quired in its $2.1 bil­lion En­do­cyte buy­out back in 2018, af­ter the can­di­date scored a Phase III win in March of this year.

No­var­tis’ drug tar­gets prostate-spe­cif­ic mem­brane anti­gen, or PS­MA, which is com­mon­ly found in metasta­t­ic prostate can­cer.

There are oth­er play­ers out there as well. Ger­many’s ITM raised $109 mil­lion in loan fi­nanc­ing back in April and the biotech Ak­tis se­cured a $72 mil­lion round. Rayze­Bio has been the biggest re­cent win­ner, how­ev­er, land­ing a $258 mil­lion Se­ries C in June.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.