Co­di­ak lands on Wall Street in sec­ond shot at IPO, rais­es $83M

Co­di­ak Bio­sciences fi­nal­ly hit Wall Street on Tues­day in its sec­ond at­tempt to go pub­lic, but didn’t quite reach its $100 mil­lion goal.

The Cam­bridge, MA-based biotech raised $83 mil­lion by pric­ing 5.5 mil­lion shares at $15, the mid­point of a $14 to $16 range. When Co­di­ak $CDAK sub­mit­ted pa­per­work with the SEC in Sep­tem­ber, it ini­tial­ly pro­posed a $100 mil­lion raise — up from the $86.2 mil­lion raise it sought back in April 2019. Un­fa­vor­able mar­ket con­di­tions led Co­di­ak to back out of the first IPO last Ju­ly.

So far, 2020 has been the year for biotech IPOs. Nas­daq head of health­care list­ings Jor­dan Saxe told End­points News that he wouldn’t be sur­prised if there were 65-70 biotech IPOs (on the low end) be­fore New Year’s. That num­ber is well over the 47 tracked last year by Brad Lon­car.

Co­di­ak is en­gi­neer­ing ex­o­somes for use as de­liv­ery ve­hi­cles for a range of ther­a­peu­tic pay­loads. Its fo­cus is on a pro­gram that us­es a STING path­way ag­o­nist, li­censed from the French biotech Kay­la Ther­a­peu­tics. Near­ly 30% of the IPO pro­ceeds — $24.8 mil­lion — will go to­ward clin­i­cal de­vel­op­ment of Co­di­ak’s lead can­di­date, ex­oST­ING, which is in a Phase I/II tri­al in pa­tients with ad­vanced/metasta­t­ic, re­cur­rent, in­jectable sol­id tu­mors.

An­oth­er $34.3 mil­lion is des­ig­nat­ed for the ex­pan­sion of what Co­di­ak calls its en­gEx Plat­form — the en­gi­neer­ing of the so-called de­liv­ery ve­hi­cles. As stat­ed in the S-1/A:

Us­ing our en­gEx Plat­form, we have demon­strat­ed pre­clin­i­cal­ly our abil­i­ty to en­gi­neer ex­o­somes to in­cor­po­rate var­i­ous types of bi­o­log­i­cal­ly ac­tive drug mol­e­cules ei­ther on the ex­o­some sur­face, us­ing PT­GFRN as a scaf­fold, or in­side the lu­men of the ex­o­some, us­ing BASP1 as a scaf­fold, to tar­get mem­brane or cy­to­plas­mic and nu­clear drug tar­gets in spe­cif­ic cells.

Fi­nal­ly, $10 mil­lion will be used to give ex­oIL-12, an­oth­er en­dEx can­di­date, a push. That can­di­date’s in a Phase I tri­al in healthy vol­un­teers and pa­tients with ear­ly stage cu­ta­neous T cell lym­phoma, ac­cord­ing to the S-1/A.

Doug Williams

Since it was found­ed in 2015, Co­di­ak has burned through $234.8 mil­lion. The com­pa­ny is helmed by ex-Bio­gen re­search chief Doug Williams, who now holds a 3.49% stake af­ter the of­fer­ing. ARCH Ven­ture Funds, Flag­ship Ven­ture Funds and Fi­deli­ty hold 19.47%, 13.14% and 10.41% of shares, re­spec­tive­ly.

Last Jan­u­ary, Co­di­ak bagged $56 mil­lion up­front in a deal with Jazz Phar­ma­ceu­ti­cals. And this June, it signed a $72.5 mil­lion deal with Sarep­ta to build out its gene ther­a­py tar­gets.

On Mon­day, SQZ Biotech and Lux Health Tech Ac­qui­si­tion, a SPAC formed by Lux Cap­i­tal, al­so filed to go pub­lic. SQZ pro­posed a $75 mil­lion raise to de­vel­op its cell ther­a­pies, while Lux is look­ing to nab $300 mil­lion.

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.

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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Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

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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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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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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Derek Chalmers, Cara Therapeutics CEO

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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