Co­di­ak Bio­sciences out­lines a new fo­cus for its ex­o­some plat­form in $86M IPO fil­ing

Ven­ture rais­es from mar­quee in­vestors? Check. Col­lab­o­ra­tion deal? Check. Clin­i­cal tri­al time­line? Check. For its next step, Co­di­ak Bio­sciences is head­ed for an IPO.

Doug Williams

The S-1 re­veals lit­tle that we didn’t al­ready know about the Cam­bridge, MA-based biotech, which has a plat­form to re­pur­pose ex­o­somes as drug de­liv­ery ve­hi­cles to car­ry a range of ther­a­peu­tic pay­loads, from small mol­e­cules to pro­teins to nu­cle­ic acids. CEO Doug Williams has raised $168.2 mil­lion so far in his first gig since leav­ing the top re­search job at Bio­gen, and re­cent­ly brought in a fur­ther $56 mil­lion in up­front pay­ment from an al­liance with Jazz.

It did dis­close a li­cens­ing pact with a mys­te­ri­ous French com­pa­ny called Kay­la Ther­a­peu­tics, in which Co­di­ak ob­tained a STING ag­o­nist pre­sum­ably used in its lead prod­uct can­di­date, ex­oST­ING. The up­front pay­ment reg­is­tered at $6.5 mil­lion.

Raghu Kalluri

By chauf­feur­ing the com­pound di­rect­ly to anti­gen pre­sent­ing cells, Co­di­ak hopes to ful­ly un­leash the can­cer killing po­ten­tial of the STING path­way with­out hav­ing to wor­ry about sys­temic tox­i­c­i­ty that stems from “leak­age” out of the tu­mor. The clin­i­cal tri­al to be kicked off in the first half of 2020 will fo­cus on “cold” tu­mors, i.e. those re­sis­tant or non-re­spon­sive to check­point ther­a­pies.

They have a sim­i­lar log­ic for the run­ner up in the pipeline, exo-IL-12, for which clin­i­cal tests are planned for H2 2020.

Mean­while, the pro­gram where they load ex­o­somes with siR­NA tar­get­ing KRAS for pan­cre­at­ic can­cer — an ear­ly can­di­date the start­up has tout­ed — is put on the back­burn­er. Co­di­ak li­censed the rel­e­vant IP from MD An­der­son Can­cer Cen­ter in an agree­ment that could re­sult in a one-time pay­ment any­where from $20 mil­lion to $150 mil­lion (in cash or stock) when the com­pa­ny de­buts on the Nas­daq as $CDAK.

Richard Brud­nick

Hav­ing ini­ti­at­ed the part­ner­ship with MD An­der­son, seed­ed the com­pa­ny and led sub­se­quent fi­nanc­ings, Arch Ven­ture Part­ners’ stake now sits at over 28%. Flag­ship Pi­o­neer­ing, whose new com­pa­ny cre­ation arm pro­vid­ed the oth­er half of the foun­da­tion­al ex­o­some re­search, con­trols 18%. Fi­deli­ty is in for 14%. No­tably, Raghu Kalluri, the MD An­der­son re­searcher be­hind much of Co­di­ak’s sci­ence, is a 7.65% stock­hold­er, in ad­di­tion to the 6.72% that the in­sti­tute owns. Er­ic Lan­der of the Broad, a Co­di­ak board di­rec­tor, has 6.08%.

Lin­da Bain

Williams, who holds 5% of the com­pa­ny him­self, bagged a com­pen­sa­tion pack­age of $2.1 mil­lion last year — with over a mil­lion in op­tion awards. Chief busi­ness of­fi­cer and Biover­a­tiv vet Richard Brud­nick got $1.5 mil­lion, while CFO Lin­da Bain’s pack­age was worth around $700,000.

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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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.

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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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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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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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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