From left: James Brown, Michael Chambers, John Ballantyne

Alde­vron founders back a biotech start­up that's look­ing to end the moral de­bate over cell lines once and for all

For mil­lions of Catholics around the world, the de­vel­op­ment of new vac­cines to com­bat Covid-19 has sparked a moral dilem­ma. All the ap­proved vac­cines in use re­lied — in some fash­ion — on cell lines that were de­rived from abort­ed fe­tal tis­sue.

While church lead­ers ac­cept­ed the vac­cines and rec­om­mend­ed their use to end the pan­dem­ic, a num­ber al­so high­light­ed their pref­er­ence for the mR­NA vac­cines from Pfiz­er/BioN­Tech and Mod­er­na over the J&J and As­traZeneca shots, which they not­ed were more heav­i­ly de­pen­dent on cell lines that they found moral­ly ob­jec­tion­able.

That in­tense de­bate over cell lines that large num­bers of peo­ple ob­ject to on moral grounds, wide­ly used in ther­a­peu­tic de­vel­op­ment pro­grams, has now spawned a new­ly cre­at­ed up­start biotech which is ab­solute­ly de­ter­mined to re­place cell lines like the com­mon­ly used HEK293 — used to man­u­fac­ture the As­traZeneca Covid-19 vac­cine — and PER.C6, a cell line based on hu­man em­bry­on­ic reti­na tis­sue used to man­u­fac­ture the J&J jab. And they plan to use new gene edit­ing tools to do an even bet­ter job at cre­at­ing cell lines that no one could ob­ject to.

The com­pa­ny — Agath­os — is tiny right now as it steps out on the biotech stage, but it’s be­ing found­ed by a trio of ex­pe­ri­enced ex­ecs who have built up Alde­vron, one of the world’s top man­u­fac­tur­ers of plas­mid DNA, mR­NA, CRISPR/Cas9, vec­tors and more, serv­ing the bur­geon­ing world of gene ther­a­py de­vel­op­ers around the world.

The 3 are James Brown, Michael Cham­bers and John Bal­lan­tyne. Brown re­cent­ly left Alde­vron in Far­go, ND to join a small band of biotech en­tre­pre­neurs that have been qui­et­ly build­ing a thriv­ing lit­tle hub of their own in the en­vi­rons around the CMO, which has spe­cial­ized in cell and gene ther­a­py. And he’s in­vest­ed in the com­pa­ny along­side Cham­bers and Bal­lan­tyne, the two men who found­ed the com­pa­ny in the late ’90s and now find them­selves in the midst of one of the biggest booms in biotech.

Their new com­pa­ny has 3 main fo­cus­es, says Brown:

  • Bio­man­u­fac­tur­ing and cell line de­vel­op­ment.
  • Pay­load de­liv­ery, whether it’s pro­teins or nu­cle­ic acids how they’re de­liv­ered.
  • And then the in-house de­vel­op­ment of cell and gene ther­a­pies.

“We’re just get­ting start­ed,” Brown tells me in a Zoom in­ter­view from new­ly leased space. He’s build­ing the ini­tial team now that will cre­ate a plat­form they plan to use them­selves, and make avail­able to oth­ers.

“This isn’t the case where we have a tech­nol­o­gy that’s look­ing to solve a prob­lem,” Brown says. “We have a prob­lem and we’re look­ing to solve it with tech­nol­o­gy.”

They’re not look­ing for a de­bate and have vowed to re­main po­lit­i­cal­ly ag­nos­tic. But they think they can do a bet­ter job and of­fer new cell lines that would be prefer­able — if on­ly be­cause mass num­bers of peo­ple shun phar­ma prod­ucts that don’t square with their con­science.

“Our goals are to take ad­van­tage of the ad­vances in cell and gene ther­a­py, bio­man­u­fac­tur­ing and ge­net­ic pay­load de­liv­ery. We look at how drugs are man­u­fac­tured, es­pe­cial­ly in cell and gene ther­a­py, and think there are op­por­tu­ni­ties to do bet­ter,” says Brown.

“In par­tic­u­lar one of the chal­lenges that I think the field faces with some of these man­u­fac­tur­ing process­es and the ma­te­ri­als that are used is that they are very good at what they do but they come from eth­i­cal­ly prob­lem­at­ic sources,” he adds. “We can use the tools that are avail­able to de­vel­op these drugs and man­u­fac­ture them with­out us­ing moral­ly com­pro­mised cell lines and avoid that choice that peo­ple have to make in fol­low­ing their con­science.

“If we had some­thing that was just as good and a com­pa­ny looked at it and said: ‘I have some­thing just as good, so why wouldn’t I choose that one be­cause more peo­ple are go­ing to buy my prod­uct?’”

I asked Michael Cham­bers via email why he was co-found­ing the biotech. His re­ply:

There are a few rea­sons we are in­vest­ing in Agath­os. James is a tal­ent­ed sci­en­tist and CEO, and he is putting a world-class team to­geth­er. We are pri­mar­i­ly in­ter­est­ed be­cause Agath­os meets an un­met need for mil­lions of peo­ple from dif­fer­ent faiths and back­grounds — the de­sire for tech­no­log­i­cal­ly su­pe­ri­or bio­man­u­fac­tur­ing cell lines and prod­ucts with­out eth­i­cal con­cerns

Just start­ing out, they’re fo­cused on var­i­ous mam­malian cell lines that could of­fer a bet­ter al­ter­na­tive. Or, they might de­vel­op cell lines from scratch.

“Michael jokes, he’s like, ‘Go out and kill a jackrab­bit and put it in a blender and cre­ate cell lines from scratch and de­vel­op them,” Brown says. “Be­cause we have so many more tools with CRISPR and gene edit­ing and what­not, that we can ma­nip­u­late these things. We want to use these tools to do new and in­no­v­a­tive things and ad­dress some of the short­com­ings.”

By the end of this year, says Brown, he ex­pects the team will grow to 5 to 10 peo­ple. Af­ter that, he says, “the sky’s the lim­it.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

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While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

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While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

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The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

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