Sir­naomics puts off an IPO a lit­tle longer as it pock­ets an­oth­er megaround. Is an S-1 around the cor­ner this time?

Back in Oc­to­ber, when small in­ter­fer­ing RNA play­er Sir­naomics land­ed its Se­ries D round, CEO Patrick Lu said he was open to prepar­ing for an IPO “in (the) near fu­ture.” Those S-1 pa­pers nev­er came, and now Lu’s tak­ing an­oth­er trip down VC lane.

Sir­naomics un­veiled a $105 mil­lion Se­ries E round on Thurs­day, led by the same firm that led the last megaround: Ro­tat­ing Boul­der Fund. The biotech says it will pump the funds in­to its RNAi port­fo­lio aimed at treat­ing can­cers, vi­ral in­fec­tions, fi­bro­sis and meta­bol­ic dis­eases.

siR­NA ther­a­peu­tics were pop­u­lar­ized by Al­ny­lam, which scored the first OK in the field with On­pat­tro back in 2018. Scott Got­tlieb, FDA com­mis­sion­er at the time, said the ap­proval was “part of a broad­er wave of ad­vances that al­low us to treat dis­ease by ac­tu­al­ly tar­get­ing the root cause.”

Patrick Lu

siR­NA kicks off ac­tion in the RNA-in­duced si­lenc­ing com­plex, which then goes on to cleave a spe­cif­ic mR­NA, there­by down­reg­u­lat­ing tar­get genes. But Sir­naomics thinks it has a bet­ter ve­hi­cle to car­ry the siR­NA car­go to cells — a polypep­tide nanopar­ti­cle, or PNP. The pep­tide is biodegrad­able, of­fers pro­tec­tion to the siR­NA while in the blood­stream, and can car­ry mul­ti­ple siR­NA se­quences, al­low­ing the com­pa­ny’s prod­ucts to go af­ter mul­ti­ple genes at once.

Sir­naomics’ lead can­di­dates — STP705 and STP707 — are dual tar­get­ing siR­NAs against TGF-β1 and COX-2, and can be ad­min­is­tered lo­cal­ly or sys­tem­i­cal­ly. In De­cem­ber, the com­pa­ny said Phase IIa re­sults showed that STP705 helped clear tu­mor cells in pa­tients with squa­mous cell skin can­cer.

“Based on suc­cess­ful clin­i­cal and pre­clin­i­cal stud­ies, a fu­ture clin­i­cal fo­cus will be tar­get­ed to­wards im­mune on­co­log­i­cal eval­u­a­tion, with com­bi­na­tion de­sign of the nov­el RNAi drug can­di­date and im­mune check­point in­hibitors, such as PD-1/PD-L1 mon­o­clon­al an­ti­bod­ies,” Sir­naomics said.

The Gaithers­burg, MD-based biotech has a slate of oth­er can­di­dates in the works to treat a range of con­di­tions, from Covid-19 to car­diometa­bol­ic dis­eases. Back in April, Lu struck a co-de­vel­op­ment deal with Wal­vax Biotech­nol­o­gy for its an­tivi­ral siR­NA can­di­date STP702.

“At Sir­naomics specif­i­cal­ly, we are forg­ing a path to bring RNAi ther­a­peu­tics to the main­stream as ther­a­peu­tic modal­i­ties for treat­ment of many dis­eases, such as non-melanoma skin can­cer, liv­er can­cer, liv­er fi­bro­sis and NASH,” Lu said in 2019, short­ly af­ter nab­bing a $47 mil­lion Se­ries C round. He fol­lowed that up with a $105 mil­lion Se­ries D just last year.

Though head­quar­tered in Mary­land, Sir­naomics has sub­sidiaries in Suzhou and Guangzhou, Chi­na.

The com­pa­ny wasn’t avail­able for an in­ter­view be­fore press time, but Lu men­tioned in a state­ment that the com­pa­ny is en­ter­ing its “next phase of growth.” Could that mean an IPO? Looks like we’ll have to wait and see.

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.

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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Samantha Du, Zai Lab CEO (Zai Lab)

Saman­tha Du's Zai Lab inks sur­pris­ing re­search col­lab with Schrödinger for DNA dam­age drug

Headed by Samantha Du, Chinese oncology specialist Zai Lab has made no qualms about its aggressive in-licensing strategy to drive Western drugs into regional markets. That strategy has been profitable so far, but that doesn’t mean Du’s team isn’t willing to try something new.

In a surprising volte-face, Zai Lab has signed its name to a research collaboration with physics-based discovery outfit Schrödinger looking for an oncology candidate targeting the DNA damage repair pathway, the partners said Wednesday.

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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