Out to pi­o­neer gene edit­ing in Chi­na, Edi­Gene bags $67M to be­gin clin­i­cal test­ing for β-tha­lassemia ther­a­py, uni­ver­sal CAR-T

A gene edit­ing play­er hail­ing from Bei­jing has clinched $67 mil­lion to steer two of its lead can­di­dates in­to the clin­ic — and to prove it­self as a CRISPR pi­o­neer in Chi­na.

Dong Wei

Edi­Gene gath­ered the Se­ries B from a slate of top-tier Chi­nese in­vestors, in­clud­ing 3H Health In­vest­ment (who led the round), Se­quoia Cap­i­tal Chi­na, Al­win Cap­i­tal and Kun­lun Cap­i­tal. Pre­vi­ous back­ers, in­clud­ing IDG Cap­i­tal, Lil­ly Asia Ven­ture, Hua­gai Cap­i­tal and Green Pine Cap­i­tal Part­ners, al­so par­tic­i­pat­ed.

With the new cash, the biotech has of­fi­cial­ly crossed the $100 mil­lion mark in fundrais­ing over the past two years, ac­cord­ing to CEO Dong Wei.

“The round en­ables us to fur­ther scale up and trans­form our pipeline in­to clin­i­cal-stage, which is al­so a big step for­ward in build­ing a glob­al­ly com­pet­i­tive gene edit­ing com­pa­ny,” Wei said in a state­ment.

CRISPR may have had a bad rep in Chi­na in the af­ter­math of a scan­dalous hu­man ex­per­i­ment in which Jiankui He — who’s since been cast as a rogue sci­en­tist and sen­tenced to three years in jail — cre­at­ed the world’s first known gene edit­ing ba­bies by tin­ker­ing with a gene of an em­bryo in an at­tempt to con­fer pro­tec­tion against HIV. But Edi­Gene, which was launched in 2015 and has set up a BD of­fice in Cam­bridge, MA in ad­di­tion to head­quar­ters in Bei­jing and a GMP & ap­pli­ca­tion cen­ter in Guangzhou, clear­ly en­joys a dif­fer­ent po­si­tion.

“Edi­Gene is lead­ing the wave in Chi­na, as they have es­tab­lished out­stand­ing re­search and de­vel­op­ment ca­pa­bil­i­ties, and more im­por­tant­ly, they have de­vel­oped an im­pres­sive port­fo­lio of pro­pri­etary gene edit­ing tools and prod­uct can­di­dates,” said Minchuan Wang, a part­ner of 3H Health In­vest­ment.

Wen­sheng Wei

An ear­ly San Fran­cis­co trans­plant, Wei be­gan his biotech ca­reer at Ch­i­ron, took a de­tour in trad­ing and con­sult­ing, then worked his way through a slew of posts at Bio­Marin, Elan and J&J. His last role in the US — be­fore de­cid­ing in 2018 to move back and spend more time with fam­i­ly in Chi­na — was Shire’s glob­al de­vel­op­ment team leader for im­munol­o­gy.

It was nat­ur­al to then join Wen­sheng Wei, a co-founder of Edi­Gene and Dong Wei’s close friend from Peking Uni­ver­si­ty who end­ed up be­ing a PhD bud­dy at Michi­gan State Uni­ver­si­ty. By that time, Wen­sheng Wei was a pro­fes­sor at Peking Uni­ver­si­ty’s School of Life Sci­ences and had tasked Dong Wei with find­ing a CEO for Edi­Gene af­ter try­ing, in vain, to re­cruit him to the job.

The com­pa­ny boasts of four dif­fer­ent plat­forms re­volv­ing around CRISPR gene edit­ing tech: ex vi­vo edit­ing for hematopoi­et­ic stem cells, ex vi­vo edit­ing to cre­ate CAR-T cells, in vi­vo RNA-based edit­ing, as well as high-through­out genome edit­ing screen­ing for drug dis­cov­ery. Right now, the key pri­or­i­ties are ET-01 for se­vere β-tha­lassemia and U CAR-T ET-02 for can­cer.

Both are in­di­ca­tions where US biotechs have done ground­break­ing work, Dong Wei ac­knowl­edged in an in­ter­view with Pharm­Cube this March. Zyn­te­glo, blue­bird bio’s ex vi­vo ther­a­py for β-tha­lassemia, has al­ready been ap­proved in the EU.

But when he asked a friend — a blue­bird ex­ec — about whether that leaves any room for Edi­Gene on the mar­ket, the an­swer he got was blunt: Even though the Chi­nese pa­tient pop­u­la­tion is large, the coun­try’s pric­ing sys­tem and the re­quired in­vest­ment for man­u­fac­tur­ing doesn’t jus­ti­fy putting mon­ey be­hind it.

“When the com­pa­ny with the best tech­nol­o­gy in the world be­lieves there is no in­vest­ment val­ue in do­ing this in Chi­na, what should we do?” Wei said. “Are we just not go­ing to do it ei­ther?”

Ul­ti­mate­ly, he added, it all comes down to the ecosys­tem. In terms of the ac­tu­al gene edit­ing tech­nol­o­gy, he reck­ons that Chi­na is on par with in­ter­na­tion­al stan­dards — thanks to a serendip­i­tous over­lap in the tim­ing for de­vel­op­ment of gene edit­ing and the Chi­nese gov­ern­ment’s em­pha­sis on the biotech in­dus­try.

But the US is still way out front in terms of trans­la­tion, he not­ed:

For ex­am­ple, when a pro­fes­sor pub­lish­es a pa­per, you’d soon see re­searchers across Boston and San Fran­cis­co Bay Area fol­low­ing up on the tech­nol­o­gy. This is the aug­men­ta­tion ef­fect; or for ex­am­ple, 90% of VC in­vest­ment re­lat­ed to gene edit­ing is in Boston and 10% is in San Fran­cis­co — this is the clus­ter­ing ef­fect; and then if you look at the whole biotech field, San Fran­cis­co and Boston are es­sen­tial­ly equal, and to­geth­er they take up 80% of all Amer­i­can ven­ture in­vest­ing. All these are ecosys­tem ef­fects.

Mean­while in the US, say Wen­sheng pub­lished a new pa­per on gene edit­ing. Six months lat­er you’d sel­dom see oth­er labs ap­ply­ing this new tech to cre­ate new­er in­no­va­tion. This is like we con­quered a city, but didn’t have time to build the city in­to a bet­ter place.

At 5 years old and 100-plus em­ploy­ees, though, the con­struc­tion crew at Edi­Gene is ready to roll up their sleeves.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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