Tuyen Ong, Flagship CEO-partner and Ring Therapeutics CEO (Flagship)

Keep­ing an 'im­mi­grant mind­set,' Flag­ship taps a self-pro­fessed no­mad as CEO for their next-gen vi­ral vec­tor up­start

Tuyen Ong con­sid­ers him­self a bit of a no­mad.

Ear­ly in his life, he came to the UK as a refugee from Viet­nam, and ob­tained his MD at Uni­ver­si­ty Col­lege Lon­don. Then he went to NYU for an MBA and be­gan his ca­reer in bio­phar­ma at Pfiz­er, mak­ing fur­ther stops across the coun­try at Bausch + Lomb, PTC Ther­a­peu­tics and most re­cent­ly Bio­gen.

Now, he’s ready for his next gig: CEO-part­ner at Flag­ship Pi­o­neer­ing and CEO of Ring Ther­a­peu­tics, a gene ther­a­py out­fit where he’ll be run­ning the show. When Ong looks back at his ca­reer, he says he can see how all the dots con­nect­ed to lead him to this point.

“Noubar [Afeyan] is our founder and he’s an im­mi­grant, and that im­mi­grant mind­set is some­what in our DNA at Flag­ship,” Ong told End­points News. “The abil­i­ty to be able to solve prob­lems, be able to be cre­ative, be able to have that pi­o­neer­ing spir­it to over­come is­sues and find op­por­tu­ni­ty, I think that is a com­mon thread that’s tied through my life, and that’s the phi­los­o­phy I’ve been able to in­ject in­to dif­fer­ent ar­eas of my ca­reer.”

Ring it­self was of­fi­cial­ly launched by Flag­ship in 2017 and fo­cus­es its re­search around a new class of vi­ral shells called anellovirus­es. The com­pa­ny hopes it can be an al­ter­na­tive to ade­n­ovirus-as­so­ci­at­ed virus­es, or AAV, and pro­vide safer gene ther­a­py treat­ments.

Ong said he was drawn to the po­si­tion not on­ly be­cause of his in­ter­est in the gene ther­a­py space — he pre­vi­ous­ly worked at Night­star, which, af­ter be­ing ac­quired by Bio­gen, was how he end­ed up there in the first place — but the abil­i­ty to cre­ate such a plat­form in a more “nat­ur­al” way. That’s be­cause the anellovirus fam­i­ly re­sides in var­i­ous tis­sues in the hu­man body with­out caus­ing any harm.

“These virus­es have ba­si­cal­ly co­hab­it­ed, co-evolved with­in the hu­man sys­tem,” Ong said. “They are be­nign and they’ve some­what evad­ed the im­mune sys­tem. The gene ther­a­py field is thriv­ing but it has hit a few road­blocks, and a lot of what’s dri­ving that is the im­muno­genic­i­ty piece.”

Avak Kahve­jian

Where­as AAV-re­lat­ed gene ther­a­pies can cause a range of ill­ness­es and some pa­tients may al­ready have de­vel­oped an­ti­bod­ies to the treat­ments, anellovirus­es don’t come with as many side ef­fects and can still be used to treat a wide range of dis­eases, found­ing Ring CEO Avak Kahve­jian said. The com­pa­ny orig­i­nal­ly start­ed out with just a hand­ful of anellovirus­es but over the last few years has un­cov­ered “thou­sands” that could po­ten­tial­ly prove use­ful.

Kahve­jian and Ong aren’t quite ready to say in which fields they’re first look­ing to ap­ply the plat­form, but not­ed that the spot­light will be across mul­ti­ple modal­i­ties as well as a swath of dis­eases. And be­cause the sci­ence is still so new, Ring is still work­ing on the best plan of at­tack go­ing for­ward.

“Ring is ex­plor­ing all as­pects of this vi­ral fam­i­ly. Dis­cov­er­ing them, en­gi­neer­ing them, mak­ing them and ap­ply­ing them,” Kahve­jian said. “The fo­cus has been on get­ting do­min­ion over this new, ex­cit­ing area from all as­pects.”

As Ring con­tin­ues ad­vanc­ing this re­search, Kahve­jian says Flag­ship has found some­one who can get pas­sion­ate about their vi­sion in Ong. In their search for the CEO-part­ner, Kahve­jian didn’t just look for some­one with a great track record, but al­so some­one with such “in­tan­gi­bles.”

The com­pa­ny al­ready banked $50 mil­lion back in late 2019, in­di­cat­ing Flag­ship has al­ready liked what they’ve seen. But Ong is con­fi­dent that the best is yet to come.

“I tru­ly see this as a trans­for­ma­tive ther­a­py that can hit up­on so many dif­fer­ent dis­eases,” Ong said. “It’s al­most an ode to Moth­er Na­ture: We owe it to re­al­ly take up the gift that we’ve been giv­en here, the pow­er of anellovirus­es to be able to be de­ployed to treat so many dif­fer­ent ge­net­ic dis­eases.”

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Lit­tle Zosano takes an­oth­er beat­ing as the FDA slaps down their ap­pli­ca­tion for a mi­graine patch

Zosano $ZSAN has officially come up short in its bid to develop a migraine patch.

The FDA rejected the company’s application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta, Zosano said Wednesday morning, issuing a CRL for the microneedle patch. Regulators cited inconsistent exposure levels across multiple clinical trials as the main reason for the thumbs down.

Investors did not take too kindly to the news, with Zosano shares plunking down around 25%. The company is requesting a Type A meeting to “provide clarity on the next steps for the program,” CEO Steven Lo said in a statement.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.

Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.