Af­ter a bruis­ing turn as Sarep­ta CEO, Chris Garabe­di­an is back in biotech with a new role as god­fa­ther to a bunch of star­tups

Chris Garabe­di­an is back.

Two years af­ter the for­mer Sarep­ta CEO end­ed a tur­bu­lent reign marked by a roller coast­er ride for in­vestors — which is still not over, even af­ter the con­tro­ver­sial FDA OK of eteplirsen — Garabe­di­an has won $15 mil­lion from some loy­al back­ers at Per­cep­tive Ad­vi­sors to es­tab­lish a com­pa­ny that promis­es to guide biotech star­tups through that first crit­i­cal stage of de­vel­op­ment lead­ing to proof-of-con­cept da­ta.

This is brand new and its called Xon­toge­ny. Now that he has the first tranche of a $25 mil­lion com­mit­ment in hand, Garabe­di­an is putting to­geth­er a small team that will be tasked with god­fa­ther­ing new drug de­vel­op­ment for a group of would-be en­tre­pre­neurs who ei­ther can’t or re­al­ly don’t want to go the tra­di­tion­al VC route to fund a biotech start­up.

“I was get­ting a num­ber of calls from en­tre­pre­neurs who had an idea, had their hands on some­thing of val­ue, in­creas­ing­ly look­ing for some­one to part­ner with but with­out a lot of deep in­dus­try ex­pe­ri­ence,” Garabe­di­an tells me. VCs ei­ther weren’t all that in­ter­est­ed or want­ed way too much eq­ui­ty. These were “unique and good op­por­tu­ni­ties that would nev­er see a path­way for­ward un­less they found some­one to help them find a way for­ward.”

For about a half dozen to 10 new star­tups, Garabe­di­an and his team plan to play that role.

At one point, Per­cep­tive’s stake in Sarep­ta amount­ed to one of its largest in­vest­ments. And that gave Garabe­di­an time to get to know CEO Joseph Edel­man and the oth­er ex­ecs at Per­cep­tive, a fund which backs pub­lic biotechs and of­ten plays a crossover role in the lead up to an IPO. But Garabe­di­an stress­es that Xon­toge­ny isn’t a fund. They may be able to put up a few hun­dred thou­sand for seed cash to get things start­ed at a promis­ing new ven­ture, but most of Per­cep­tive’s mon­ey will go to cre­at­ing the team and fund­ing their op­er­a­tion through the start­up pe­ri­od.

The group will shep­herd new drugs through a proof-of-con­cept event, pro­vid­ing the in­fra­struc­ture on in­dus­try spe­cial­ists that each new biotech doesn’t re­al­ly need to start with from scratch. And then af­ter that point, they can con­sid­er what to do next, with all the usu­al choic­es of in­dus­try sale, a ven­ture round or IPO. And they plan to take eq­ui­ty in pay­ment, with Garabe­di­an fill­ing a role as ex­ec­u­tive chair­man or board mem­ber.

“It will be a rel­a­tive­ly small team,” says Garabe­di­an, “like a typ­i­cal se­nior biotech op­er­at­ing team, about 12 with sup­port staff” and ex­per­tise in things like pre­clin­i­cal tox and reg­u­la­to­ry work. And they can play a vir­tu­al role in man­ag­ing a range of star­tups. Garabe­di­an plans to work with aca­d­e­mics as well as some deeply pas­sion­ate dis­ease ad­vo­cates who are look­ing to launch a com­pa­ny around a new drug prospect, per­haps li­censed in. And he ex­cit­ed­ly told me — in gen­er­al terms — about sev­er­al he’s al­ready in talks with.

“What I’ve ob­served,” says Garabe­di­an, who com­plet­ed stints at Gilead and Cel­gene be­fore tak­ing the helm at Sarep­ta, “is that noth­ing has beat­en the val­ue of clin­i­cal proof-of-con­cept da­ta.”

That’s still true to­day, he adds, even with biotech val­u­a­tions run­ning high. He watched Sarep­ta shares shoot up from $45 to $55 a share on Phase II da­ta. To­day, with a drug on the mar­ket, it’s $35.

So what did he learn at Sarep­ta that would help guide him at Xon­toge­ny?

“I think Sarep­ta found it­self and I found my­self at the cen­ter of many things the in­dus­try and the FDA was grap­pling with,” he tells me. Maybe he was too trans­par­ent, he adds, though com­mu­ni­cat­ing with the pa­tient com­mu­ni­ty at every turn al­so pro­vid­ed a foun­da­tion of pas­sion­ate sup­port that was ul­ti­mate­ly crit­i­cal to the FDA ap­proval process. But per­haps the best les­son is that run­ning a pub­lic com­pa­ny is not his best role.

“I can be that pub­lic com­pa­ny CEO,” he says, “but that’s not what dri­ves me. I in­her­it­ed a30-year-old com­pa­ny that need­ed a lot of fix­ing, with min­i­mal fi­nanc­ing, no top tier board or sci­en­tif­ic founders.”

With Xon­toge­ny he can “work with peo­ple who want to work with me.” He can fo­cus on de­vel­op­ment, in­stead of the dis­trac­tions of man­ag­ing a larg­er com­pa­ny in the pub­lic eye.

“A lot of peo­ple love the spot­light,” he says. “I re­al­ly want to fo­cus on de­vel­op­ment. I feel I can beat the in­dus­try av­er­ages.”

Now he has the mon­ey to find out.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

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Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

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Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

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The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

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