Xiayang Qiu, Regor Therapeutics CEO

Af­ter in­vest­ing in their Se­ries B, Lil­ly bags a li­cense for a batch of meta­bol­ic can­di­dates

Eli Lil­ly will li­cense in Re­gor Ther­a­peu­tics ther­a­pies for meta­bol­ic dis­or­ders, as a part of an agree­ment an­nounced Fri­day that will give the Chi­nese biotech an up­front pay­ment of up to $50 mil­lion, part of which is an eq­ui­ty in­vest­ment.

In a vague­ly word­ed re­lease, Lil­ly said it has a li­cense for cer­tain Re­gor “in­tel­lec­tu­al prop­er­ty” and will have an op­tion to ex­tend that li­cense. In ex­change, Lil­ly will over­see glob­al clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion for any ther­a­pies, with the ex­cep­tion of Chi­na, Macau, Hong Kong and Tai­wan. Re­gor, a Shang­hai-based com­pa­ny, will re­serve the rights to these re­gions.

The com­pa­ny is el­i­gi­ble for up to $1.5 bil­lion in po­ten­tial pay­ments based on pre­clin­i­cal, clin­i­cal and com­mer­cial mile­stones, as well as tiered roy­al­ties from sales.

Re­gor CEO Xi­ayang Qiu said that the col­lab­o­ra­tion is, in part, a recog­ni­tion of Re­gor’s core tech­nol­o­gy, the Com­put­er Ac­cel­er­at­ed Ra­tio­nal Dis­cov­ery plat­form. CARD, an­oth­er in a long line of fan­ci­ly named biotech com­pu­ta­tion­al plat­forms, is de­signed to cre­ate a more ef­fi­cient process for the dis­cov­ery of new drugs.

Min Zhong

Through CARD, the team has ad­vanced a num­ber of prod­ucts in its pipeline in just two years, in­clud­ing RGT-587 for on­col­o­gy, which is set to en­ter Phase I tri­als, and and RGT-075 to tar­get a glucagon-like pep­tide 1 re­cep­tor hor­mone, which stim­u­lates glu­cose-in­duced in­sulin se­cre­tion. That can­di­date is en­ter­ing Phase II/III tri­als.

Wenge Zhong

The com­pa­ny was found­ed in 2018 by a team that in­cludes two Pfiz­er vet­er­ans and three — Qiu and Min Zhong, and CTO Wenge Zhong — who used to work for Am­gen’s Chi­nese R&D op­er­a­tions. Re­gor’s fo­cus so far has been on on­col­o­gy, meta­bol­ic dis­eases and au­toim­mune dis­eases.

“Re­gor’s tech­nol­o­gy will al­so al­low Lil­ly to fur­ther ac­cel­er­ate in­no­va­tion and de­liv­er break­through ther­a­pies in obe­si­ty and di­a­betes,” Ruth Gi­meno, the VP of di­a­betes re­search at Lil­ly, said in a state­ment.

Ruth Gi­meno

In Feb­ru­ary, Lil­ly Asia Ven­tures led the Se­ries B fundrais­ing round, in which the com­pa­ny raised $90 mil­lion to back their clin­i­cal de­vel­op­ment. It al­so land­ed an in­vest­ment from Loy­al Val­ley Cap­i­tal, a com­pa­ny that played a role in fi­nanc­ing the so­cial me­dia video app Tik­Tok, and was list­ed as a top-10 in­flu­en­tial pri­vate eq­ui­ty firm in Chi­na.

“To­geth­er we are work­ing hard for a bet­ter world by in­no­v­a­tive and trans­for­ma­tive med­i­cines which make mean­ing­ful im­pacts to pa­tients glob­al­ly,” Loy­al Val­ley founder Andy Lin said in a state­ment at the time.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.