In an ef­fort to safe­ly de­liv­er mR­NA, Stan­ford Uni­ver­si­ty teams up with Ger­man biotech Evonik

Robert Way­mouth

De­liv­er­ing mR­NA ef­fec­tive­ly and safe­ly in­to the cell is one of the tough­est chal­lenges for ex­pand­ing the use of the ther­a­peu­tics that have tak­en off in pop­u­lar­i­ty as of late. A deal be­tween Ger­many-based spe­cial­ty chem­i­cals com­pa­ny Evonik and Stan­ford Uni­ver­si­ty will help de­vel­op a poly­mer-based de­liv­ery sys­tem for Evonik to li­cense and com­mer­cial­ize.

The com­pa­ny will work with uni­ver­si­ty sci­en­tists to scale up the syn­the­sis and for­mu­la­tion to de­vel­op or­gan se­lec­tive de­liv­ery based on a syn­thet­ic poly­mer through a sys­tem dubbed as CART that was de­vel­oped by Stan­ford pro­fes­sors Robert Way­mouth, Paul Wen­der and Ronald Levy.

Paul Wen­der

Once com­plet­ed, the tech­nol­o­gy will be made avail­able for GMP use in clin­i­cal-stage de­vel­op­ment, and even­tu­al­ly com­mer­cial­ly, if all goes ac­cord­ing to plan. mR­NA de­liv­ery is a lead­ing ob­sta­cle in can­cer im­munother­a­py, pro­tein re­place­ment and gene edit­ing. High­er ups at Evonik think that the com­pa­ny is well-po­si­tion to take on many of the in­dus­try’s un­met needs.

The deal is good for three years, and Evonik an­nounced that it hopes the move will help the com­pa­ny in­crease its nu­tri­tion and care di­vi­sion’s share of sys­tem so­lu­tions from 20% to more than 50% by 2030.

Ronald Levy

Evonik’s port­fo­lio con­sists of lipid nanopar­ti­cles and cus­tom lipids, for­mu­la­tion de­vel­op­ment and the man­u­fac­tur­ing of clin­i­cal sam­ples and com­mer­cial prod­ucts. Evonik’s LNP-based de­liv­ery sys­tems are pro­ject­ed to bring in about $5 bil­lion to the com­pa­ny by 2026, the com­pa­ny says. It ac­quired Tran­f­ser­ra Nanosciences in 2016, and then man­u­fac­tur­er Wilshire Tech­nolo­gies in 2020.

 

Chris­t­ian Kull­mann“If we are to har­ness the full po­ten­tial of mR­NA ther­a­peu­tics, we will need a tool­box of drug de­liv­ery tech­nolo­gies to tar­get an ex­pand­ed range of tis­sues and or­gans,” VP of re­search, de­vel­op­ment and in­no­va­tion Ste­fan Ran­dl said in the press re­lease.

Ste­fan Ran­dl

The com­pa­ny has a broad CD­MO port­fo­lio of par­enter­al drug de­liv­ery tech­nolo­gies, and fo­cus­es on the de­vel­op­ment of drug prod­ucts with high­ly po­tent APIs and con­trolled sub­stances. The port­fo­lio in­cludes more than 6 par­enter­al drug de­liv­ery tech­nolo­gies. Its CD­MO work will take place at the com­pa­ny’s fa­cil­i­ties in Van­cou­ver, BC and Birm­ing­ham, AL, an Evonik spokesman said in an email to End­points News.

 

Mon­day, Evonik al­so an­nounced the launch of a 3D-print­ing bio­ma­te­r­i­al used for Poly­ether ether ke­tone. With the re­lease, the com­pa­ny can pro­vide in­di­vid­u­al­ized pa­tient care in hear­ing aids, den­tal use, pros­thet­ics and sur­gi­cal in­stru­ments. Called Ves­ta­keep Care, it is sup­plied on 500-gram spools that can be used with fused fil­a­ment fab­ri­ca­tion or fused de­po­si­tion mod­el­ing print­ers.

Chris­t­ian Kull­mann, Evonik CEO

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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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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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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Masayoshi Son, SoftBank CEO (glen photo/Shutterstock)

Soft­Bank claims $5B stake in Roche amid grand plans to in­vest in biotech — re­ports

SoftBank has made a somewhat surprising choice in its bid to pour billions into biotech and healthcare.

The Japanese behemoth has quietly acquired a $5 billion stake in Roche, making it one of the Swiss pharma giant’s largest investors, Bloomberg reported. The Financial Times later confirmed the news.

The move marks a significant departure from SoftBank’s previous strategy of channeling biotech investments through its Vision Fund into early-stage startups such as Vir, Sana, XtalPi, Umoja and Exscientia. It also placed a sizable bet on Roivant back in 2017, leading a $1.1 billion round, long before Vivek Ramaswamy and his successor, Matt Gline, landed a SPAC merger at a valuation of $7 billion.