Take­da takes a swing at RNA small mol­e­cules with dis­cov­ery pact for mul­ti­ple po­ten­tial Evotec pro­grams

Heart­ened by an FDA ap­proval for Roche’s Evrys­di last year as the first small mol­e­cule mod­u­la­tor for RNA, the rest of bio­phar­ma is look­ing to place their bets in the promis­ing field. No stranger to ear­ly-stage dis­cov­ery deals, Take­da has now iced a pact with a Ger­man play­er to chase the first small mol­e­cule lig­and for RNA.

Ger­many-based Evotec will team up with Take­da to dis­cov­er and de­vel­op RNA tar­gets ripe for small mol­e­cule ther­a­peu­tics, the com­pa­ny an­nounced Mon­day.

In ad­di­tion to re­ceiv­ing re­search fund­ing, Evotec will be el­i­gi­ble to re­ceive dis­cov­ery, pre-clin­i­cal, clin­i­cal, com­mer­cial and sales mile­stone pay­ments of up to $160 mil­lion per pro­gram, as well as tiered roy­al­ties on net sales of any prod­ucts that come from the col­lab­o­ra­tion.

Cord Dohrmann

Tar­get in­di­ca­tions weren’t dis­closed as part of the an­nounce­ment. An Evotec spokesper­son couldn’t be reached for com­ment by press time.

The col­lab­o­ra­tion will use Evotec’s RNA tar­get­ing plat­form to iden­ti­fy promis­ing RNA se­quences to tar­get small-mol­e­cule lig­ands that can be de­vel­oped in­to ther­a­peu­tics, a state­ment said. It’s an­oth­er shot on goal at RNA tar­gets, which al­low drug de­vel­op­ers to by­pass hard-to-hit pro­teins, ac­cord­ing to Cord Dohrmann, CSO of Evotec.

“Many high­ly val­i­dat­ed tar­gets have proven to be in­tractable via con­ven­tion­al pro­tein tar­get­ing ap­proach­es,” Dohrmann said in a state­ment. “For this rea­son, Evotec has been pi­o­neer­ing RNA tar­get­ing strate­gies and ap­proach­es for quite some time.”

This type of part­ner­ship is noth­ing new for Evotec and marks the sec­ond time in the past year that it’s fos­tered an al­liance with Take­da.

In April 2020, Take­da tapped Evotec to de­vel­op gene ther­a­py tar­gets across four broad ther­a­peu­tic ar­eas — on­col­o­gy, rare dis­eases, neu­ro­science and gas­troen­terol­o­gy. In Oc­to­ber, the com­pa­ny an­nounced plans to in­vest more in cell and gene ther­a­py re­search af­ter re­ceiv­ing a $236 mil­lion in­vest­ment from Mubadala In­vest­ment Com­pa­ny, the UAE’s sov­er­eign wealth fund.

Two months ear­li­er, in Au­gust 2020, the drug dis­cov­ery com­pa­ny was en­list­ed by Dan­ish gi­ant No­vo Nordisk to tar­get chron­ic kid­ney dis­ease. The com­pa­ny al­so has long-term dis­cov­ery al­liances with com­pa­nies like Bay­er, Boehringer In­gel­heim, No­var­tis, Pfiz­er and Sanofi.

Lar­ry Hamann

Evotec’s plat­form is de­signed to iden­ti­fy RNA ter­tiary struc­tur­al el­e­ments where rSM are able to bind with “suf­fi­cient se­lec­tiv­i­ty and affin­i­ty,” dis­cov­er and de­vel­op rSM binders that could po­ten­tial­ly de­liv­er oral­ly avail­able drugs and iden­ti­fy and de­liv­er proof-of-tar­get en­gage­ment for dis­ease-rel­e­vant RNA struc­tures, al­low­ing bi­o­log­i­cal­ly ac­tive rSM binders.

“Take­da rec­og­nizes tar­get­ing RNA with small mol­e­cules as a promis­ing new modal­i­ty that has tremen­dous po­ten­tial for much need­ed med­i­cines for pa­tients through mod­u­lat­ing his­tor­i­cal­ly un­drug­gable tar­gets,” said Lar­ry Hamann, Head, Drug Dis­cov­ery Sci­ences at Take­da. “We are ex­cit­ed to be work­ing with Evotec and their im­pres­sive ca­pa­bil­i­ties.”

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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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.

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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No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

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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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.