Rich Hey­man's Metacrine tacks on an­oth­er $65M to tack­le a su­pe­ri­or NASH drug

Just six months af­ter un­wrap­ping its B round to push a NASH drug through the clin­ic, San Diego’s Metacrine is ramp­ing up ef­forts to­wards that cause with a $65 mil­lion in­fu­sion of cash.

Rich Hey­man

The mon­ey comes from a long list of new in­vestors led by Ven­rock, and it brings the start­up’s to­tal VC haul to $125 mil­lion since its 2015 found­ing. The com­pa­ny was co-found­ed by se­r­i­al en­tre­pre­neur Rich Hey­man — the man be­hind Aragon and Ser­agon, which both sold for over $1 bil­lion in the span of one year — and Ronald Evans, the Salk sci­en­tist be­hind a slew of biotech com­pa­nies, in­clud­ing Lig­and Phar­ma­ceu­ti­cals and the re­cent­ly ac­quired Mi­to­bridge. Both Evans and Hey­man are still in­volved with Metacrine: Hey­man is chair­man, while Evans sits on the board.

Metacrine is tack­ling ther­a­pies in liv­er, gas­troin­testi­nal and meta­bol­ic dis­eases, with a lead NASH pro­gram called MET409.

Ken Song

The com­pa­ny’s CEO, Ken Song, who’s led Metacrine for just un­der two years now, told me late last year he’s acute­ly aware of the need to dif­fer­en­ti­ate from oth­er play­ers pur­su­ing NASH.

“This is prob­a­bly one of the most com­pet­i­tive ar­eas in biotech right now,” Song said. “It’s an enor­mous dis­ease in­di­ca­tion, and there’s no ap­proved ther­a­pies in the space. Those two fac­tors are dri­ving a lot of in­ter­est. Every week there’s an­oth­er new an­gle or new tar­get.”

The start­up’s shtick is not to find a brand new tar­get to take down NASH. In­stead, Song said the com­pa­ny is fo­cus­ing on the on­ly clin­i­cal­ly-val­i­dat­ed tar­get in the space: the Far­ne­soid X Re­cep­tor. FXR is a nu­clear hor­mone re­cep­tor, which is a class of pro­teins Evans hap­pens to be an ex­pert in.

The tar­get has been val­i­dat­ed by In­ter­cept, a com­pa­ny that’s in its own Phase III tri­al in­volv­ing a bile acid FXR ag­o­nist in NASH. But Song said this ap­proach ap­pears to come with some un­want­ed side ef­fects for pa­tients: itch­i­ness and a boost to their LDL cho­les­terol.

Metacrine has ideas on what’s caus­ing both side ef­fects: the bile acid. So the com­pa­ny plans to try out a non-bile acid FXR ag­o­nist in hopes to re­solve the is­sues.

The com­pa­ny plans to use cash from this re­cent round to fi­nance MET409’s progress in the clin­ic, with a Phase I study set for ear­ly 2019. Metacrine al­so has plans for ap­pli­ca­tions in IBS-D, and in­flam­ma­to­ry bow­el dis­ease, and to ex­pand its pipeline through some in­ter­nal dis­cov­ery work.

“The strong in­ter­est from high-qual­i­ty in­vestors fur­ther val­i­dates the po­ten­tial of MET409 for treat­ing liv­er and gas­troin­testi­nal dis­eases,” Song said in a state­ment. “We have pur­pose­ful­ly de­signed an in­dus­try lead­ing FXR ag­o­nist port­fo­lio with the po­ten­tial for best-in-class ther­a­py in NASH and first-in-class ther­a­pies for IBS-D and IBD.”

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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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.”

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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Lanny Sun, co-founder, CEO and chairman of Full-Life Technologies

Se­quoia Chi­na leads $37M in­fu­sion in­to ra­dio­phar­ma­ceu­ti­cals play­er set­ting up shop in Chi­na and Bel­gium

It’s not just American startups that are tuning into the rising interest in radiopharmaceuticals.

Sequoia China is leading a $37 million Series A into Full-Life Technologies, a biotech headquartered in Shanghai with offices in Brussels, Belgium, to develop a pipeline of radioactive cancer therapies.

The idea isn’t new: As clinicians started routinely deploying radiation to kill cancer cells, scientists and drugmakers have long been exploring ways to limit that powerful effect only to cancer cells while sparing healthy cells. But recent progress in the production of radioisotopes — coupled with big investments from Big Pharma, most notably Novartis and Bayer — has inspired a new wave of startups.

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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