Javier García Cogorro, Viralgen CEO

A vi­ral vec­tor play­er is ex­pand­ing its foot­print in Basque Coun­try amid height­ened de­mand

As the de­mand for vi­ral vec­tors grows un­abat­ed amid the Covid-19 pan­dem­ic, a CD­MO is drop­ping a se­ri­ous in­vest­ment to build out a new Basque Coun­try fa­cil­i­ty.

The new fa­cil­i­ty is in the same tech­nol­o­gy park as Vi­ral­gen’s ex­ist­ing man­u­fac­tur­ing site. It in­creas­es ca­pac­i­ty five-fold, and clients should ex­pect the first batch­es from its 2,000-liter biore­ac­tor re­leased by the mid­dle of next year. The $83.1 mil­lion in­vest­ment will turn in­to a $142.4 mil­lion tab af­ter the fi­nal two build­ings are com­plet­ed. The ex­pan­sion will bring 130 new jobs to Vi­ral­gen, which should grow the team to 250 peo­ple by 2022.

Vi­ral­gen got its start in 2017 and spe­cial­izes in AAV man­u­fac­tur­ing from pre­clin­i­cal tri­als through Phas­es II.

“Pro­duc­tion is a re­al bot­tle­neck in the mar­ket, and we will of­fer a full ser­vice at a very com­pet­i­tive cost of goods to our part­ners. This will high­ly ben­e­fit pa­tients around the world who are in need of gene ther­a­py prod­ucts,” CEO Javier Gar­cía Co­gor­ro said in a press re­lease.

Sheila Mikhail

A short­age in vi­ral vec­tors, dat­ing back to be­fore the start of the pan­dem­ic, has led to de­lays in man­u­fac­tur­ing gene ther­a­pies and vac­cines. J&J and As­traZeneca’s Covid-19 vac­cines both use vi­ral vec­tors, as does the No­var­tis gene ther­a­py Zol­gens­ma. As cell and gene ther­a­pies have grown in pop­u­lar­i­ty, a vi­ral vec­tor short­age is caus­ing man­u­fac­tur­ers to think out­side the box for ways to even out the sup­ply.

“De­mand for safe, re­li­able gene ther­a­py man­u­fac­tur­ing ca­pa­bil­i­ties is grow­ing as more com­pa­nies en­ter the gene ther­a­py space,” said Sheila Mikhail, co-Founder and CEO of AskBio, said in a press re­lease. “Vi­ral­gen plays a crit­i­cal role to AskBio and the in­dus­try by pro­vid­ing safe, re­li­able AAV vec­tors for clin­i­cal and com­mer­cial use, and this ex­pan­sion al­lows the high­ly skilled Vi­ral­gen team to max­i­mize those ef­forts.”

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Am­gen adds new NC plant to the list as part of $1B man­u­fac­tur­ing ex­pan­sion plans state­side

What can $1 billion buy? If you’re Amgen, it’s good for two manufacturing facilities in the US.

The California-based drug giant will invest close to $550 million in a drug substance plant in Holly Springs, NC, adding itself to an ever-growing list of biotech companies that have decided to call North Carolina home, and marking its second drug manufacturing announcement in a little more than a month.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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Jeffrey Bluestone, Sonoma CEO (Photo credit: Steve Babuljak)

Jeff Blue­stone just raised $265M to de­vel­op cu­ra­tive cell ther­a­pies. We asked him how

Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot more money on hand to pay for the considerable amount of work ahead at Sonoma Biotherapeutics.

This morning Bluestone is taking the wraps off a $265 million B round after boosting the core syndicate of A-list investors he started with. Even by today’s standards, that sum dwarfs the kind of $100 million-plus megarounds that have become standard fare in biotech over the last 2 years.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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