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.”

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.

EQRx chairman Alexis Borisy and CEO Melanie Nallichieri

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

As a self-stylized drug pricing disruptor, EQRx has high hopes for its lead PD-(L)1 to offer proof of concept for the entire business model. After touting a win back in May, the biotech is back with full data in lung cancer that could back up an approval.

Patients dosed with EQRx and CStone Pharmaceuticals’ sugemalimab posted median progression-free survival of 9 months compared with 5.8 months for patients given placebo (p=0.0026), according to full data from the Phase III GEMSTONE-301 study in Stage III non-small cell lung cancer set to be presented at this weekend’s #ESMO21.

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