Ning Li (Junshi)

Af­ter chim­ing in an­ti­body to Covid-19 fight, Jun­shi drops $30M to kick off mR­NA joint ven­ture in Chi­na

A pi­o­neer­ing biotech in Chi­na has its eyes on mR­NA.

Jun­shi Bio­sciences — which made its name as the first do­mes­tic drug­mak­er to steer a PD-(L)1 across the fin­ish line at the NM­PA — is team­ing up with fel­low Shang­hai biotech Im­mor­na on a joint ven­ture that will be ded­i­cat­ed to both con­ven­tion­al non-repli­cat­ing mR­NA drugs and self-repli­cat­ing ver­sions.

The ini­tial in­vest­ment from Jun­shi comes in at around $30 mil­lion (RMB$200 mil­lion), a quar­ter of which will be used to buy up 50% of the JV, with the po­ten­tial to in­ject up to $123 mil­lion to­tal (RMB$799 mil­lion). What Im­mor­na brings to the ta­ble is its plat­form, the val­ue of which is es­ti­mat­ed at RMB$50 mil­lion.

While the over­whelm­ing suc­cess­es of mR­NA vac­cines against Covid-19, both clin­i­cal­ly and fi­nan­cial­ly, have in­spired a fer­vent search in the US and Eu­rope for the next Mod­er­na and BioN­Tech, Chi­nese in­vestors and com­pa­nies ap­pear much less en­thu­si­as­tic so far. The vac­cines that have so far been ap­proved and de­ployed in Chi­na are based on the much old­er ap­proach of in­ac­ti­vat­ed virus­es.

But au­thor­i­ties have al­so sig­naled that mR­NA could have a role to play, hav­ing ini­tial­ly sup­port­ed home­grown ef­forts at Wal­vax. More re­cent­ly, reg­u­la­tors com­plet­ed a re­view of BioN­Tech’s vac­cine — to be dis­trib­uted by part­ners at Fo­s­un — with the ex­pec­ta­tion that the coun­try would need mR­NA jabs as boost­ers, Caix­in re­port­ed.

Through a part­ner­ship with Eli Lil­ly, Jun­shi has been in­volved in the pan­dem­ic fight by con­tribut­ing an an­ti­body, dubbed ete­se­vimab, that was paired with Ab­Cellera-dis­cov­ered bam­lanivimab.

The vi­sion for the mR­NA joint ven­ture, though, goes much broad­er than Covid-19. What Jun­shi saw, in CEO Ning Li’s words, is the po­ten­tial for mR­NA in­dus­tri­al­iza­tion — and solv­ing prob­lems on the glob­al scale with Chi­nese IP. It’s a mis­sion that Li has em­braced since start­ing Jun­shi in 2012 fol­low­ing stints at the FDA and Sanofi’s reg­u­la­to­ry de­part­ment.

“As the mR­NA Tech­nol­o­gy Plat­form grad­u­al­ly ma­tures, its po­ten­tial in a va­ri­ety of fields — in­clud­ing in­fec­tious dis­eases, can­cer, rare dis­eases, and oth­er dis­eases — has be­come in­creas­ing­ly ev­i­dent,” he said in a state­ment, adding that those ther­a­peu­tic ar­eas align with Jun­shi’s own R&D fo­cus.

Found­ed in 2019, Im­mor­na closed a mod­est Se­ries A ear­ly this year and has since re­vealed a big-name deal with I-Mab, which was sim­i­lar­ly in­ter­est­ed in can­cer. As BioN­Tech re­mind­ed the world in its re­cent ac­qui­si­tion of Kite’s TCR tech and man­u­fac­tur­ing site, that can be a siz­able op­por­tu­ni­ty for mR­NA vac­cines, too.

Im­mor­na CEO Zi­hao Wang high­light­ed im­munother­a­py and in­fec­tious dis­ease pre­ven­tion as the main ap­pli­ca­tions to ex­plore ini­tial­ly.

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

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.

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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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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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.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

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.

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.