Armed with CRISPR and a $38M round, eGe­n­e­sis tack­les the Holy Grail of xeno­trans­plan­ta­tion

Luhan Yang, eGe­n­e­sis

The first crude re­search in­volv­ing xeno­trans­plan­ta­tion goes back to the 1960s, when in­ves­ti­ga­tors first ac­tive­ly con­sid­ered the pos­si­bil­i­ties of har­vest­ing or­gans from pri­mates for use in hu­mans. That failed, and sub­se­quent at­tempts run­ning through the mid-90s al­so flopped, with in­com­pat­i­bil­i­ty prov­ing im­pos­si­ble to over­come, while al­so rais­ing some big fears about trans­fer­ring pig virus­es to hu­mans with po­ten­tial­ly cat­a­stroph­ic re­sults.

But George Church and his cel­e­brat­ed team at Har­vard have been us­ing a hot new lab tool to give xeno­trans­plan­ta­tion an­oth­er shot at the re­al world. And now the team has raised $38 mil­lion from some for­ward-think­ing in­vestors to see if yes­ter­day’s sci­ence fic­tion can be­come to­mor­row’s land­mark re­al­i­ty.

Xeno­trans­plan­ta­tion “has been aban­doned for the past 15 years,” says Luhan Yang, an award-win­ning young sci­en­tist who’s the CSO and co-founder at eGe­n­e­sis. But Yang and her 10-mem­ber crew are us­ing CRISPR gene edit­ing tech­nol­o­gy to knock out prob­lem anti­gens to ad­dress the re­jec­tion is­sue while prov­ing in a pre­clin­i­cal set­ting that you can erad­i­cate the prob­lem virus from the pig genome, hope­ful­ly clos­ing the door on any pos­si­ble plague that could be trig­gered.

George Church

Yang says she’s al­ready pub­lished her work show­ing the pos­si­bil­i­ties there, but she’s al­so quick to ac­knowl­edge just how ear­ly-stage the pre­clin­i­cal an­i­mal re­search is, and the long road ahead be­fore this can be test­ed in hu­mans.

“We have to see whether the or­gan is safe, com­pat­i­ble with the hu­man host, be­fore we move in­to the pa­tient,” says the CSO. “2017 is a very im­por­tant year for us” as eGe­n­e­sis con­tin­ues its work on Pigs 2.0 to ad­dress both is­sues.

It took some vi­sion­ary VCs will­ing to fund some rad­i­cal ideas to make this pos­si­ble, says Yang. Bio­mat­ics Cap­i­tal and Arch Ven­ture Part­ners co-led the round with par­tic­i­pa­tion from Khosla Ven­tures, Al­ta Part­ners, Alexan­dria Eq­ui­ties, Her­itage Provider Net­work, Berggru­en Hold­ings North Amer­i­ca Ltd., Up­ris­ing, and Fan Ven­tures. In ad­di­tion, Daniel S. Lynch — the for­mer CEO of Im­Clone — has joined eGe­n­e­sis as ex­ec­u­tive chair­man. They’ve be­gun the process of look­ing for a CEO while the team is set to grow to about 15 to 20 now that the new fi­nanc­ing has ar­rived.

I wrote about Bio­mat­ics and its two man­ag­ing part­ners yes­ter­day. They’ve put to­geth­er a $200 mil­lion fund look­ing for some break­through sci­ence to sup­port. And it doesn’t get much more am­bi­tious than this. Arch, mean­while, has prid­ed it­self in bankrolling break­through ideas in biotech. This was tai­lor made for them.

Xeno­trans­plan­ta­tion may sound a lit­tle far-fetched to some, con­cedes Yang. But if they can get this to work, the con­se­quences of farm­ing tis­sue and or­gans like hearts and kid­neys are enor­mous. In her na­tive Chi­na, she says, the cul­ture and re­li­gion make or­gan do­na­tions rare. Xeno­trans­plan­ta­tion would save a large num­ber of lives.

For now, though, the team is keep­ing its time­lines to it­self. How much time will it take to try this in hu­mans? It’s still to ear­ly to say, says Yang, who al­so didn’t want to spec­u­late. But they’ve just tak­en some big steps for­ward with the fi­nanc­ing.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

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If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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