ADC Ther­a­peu­tics is­n't go­ing pub­lic in the US af­ter all, while three oth­er biotech IPOs bring in $319M

ADC Ther­a­peu­tics is tak­ing a last-minute U-turn at the NYSE af­ter bump­ing their IPO goal up from $150 mil­lion to a po­ten­tial $200 mil­lion — while three oth­er biotechs went ahead by pric­ing at the mid­point or low end of their re­spec­tive ranges.

De­spite ear­li­er in­di­ca­tions that in­sid­ers would pur­chase $115 mil­lion worth of shares, the Lau­sanne, Switzer­land-based com­pa­ny cit­ed “ad­verse mar­ket con­di­tions” for its de­ci­sion to with­draw.

Chris Mar­tin ADC

“We are for­tu­nate to have a strong bal­ance sheet, high­ly sup­port­ive in­vestors, al­ter­na­tive fi­nanc­ing op­tions and a steady flow of forth­com­ing mile­stones, all of which fac­tored in­to our de­ci­sion to not pro­ceed with an ini­tial pub­lic of­fer­ing in the cur­rent mar­ket con­di­tions,” CEO Chris Mar­tin said in a state­ment.

The biotech is flush with cash to run piv­otal tri­als for two of its name­sake an­ti­body-drug con­ju­gates. Just two months ago ADC stacked an­oth­er $103 mil­lion on a $200 mil­lion Se­ries E.

But fund­ing oth­er, ear­li­er stud­ies may call for more cap­i­tal, as will the scale-up of com­mer­cial and man­u­fac­tur­ing op­er­a­tions to sup­port mar­ket­ing around the world. If all goes ac­cord­ing to plan, ADC plans to launch its first prod­uct, the CD-19 tar­get­ing AD­CT-402 for re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma, in 2021. They would be set­ting up a mar­ket­ing team in New Jer­sey and eye­ing a “sub­stan­tial in­crease in staff, par­tic­u­lar­ly in the North Amer­i­can part of the or­ga­ni­za­tion,” Mar­tin told Fierce­Biotech in June.

Biotech has en­joyed a hot streak of high-val­u­a­tion IPOs in 2019, with sev­er­al more gun­ning for $100 mil­lion this week. But as the elec­tion year looms, how long that win­dow will stay open has be­come a peren­ni­al ques­tion.

Viela Bio had lit­tle is­sue bag­ging $150 mil­lion on its Nas­daq de­but $VIE, thought the price of $19 rep­re­sent­ed the low end of the range. The As­traZeneca spin­out had to sell more shares — 7.9 mil­lion to­tal — to main­tain the deal size.

Bing Yao

CEO Bing Yao has laid out swift clin­i­cal time­lines for the au­toim­mune dis­ease pipeline he’s carved out of the Med­Im­mune bi­o­log­ics unit, which be­came a rel­ic fol­low­ing an over­haul at As­traZeneca. The an­ti-CD19 drug inebi­lizum­ab is now un­der re­view and, if ap­proved, will di­rect­ly chal­lenge Alex­ion’s Soliris in neu­romyelitis op­ti­ca spec­trum dis­or­der — a block­buster in­di­ca­tion that Roche is al­so an­gling for.

Mean­while, Fre­quen­cy Ther­a­peu­tics {FREQ} couldn’t quite reach the orig­i­nal $100 mil­lion CEO David Lucchi­no had pen­ciled in. Not on­ly did it price at the low end of the range at $14 to bag $84 mil­lion, the com­pa­ny al­so sold on­ly 6 mil­lion shares in­stead of 6.7 mil­lion.

The new cash will help fund a Phase IIa tri­al for its lead drug can­di­date — a small mol­e­cule drug that promis­es to stim­u­late re­gen­er­a­tion of hair cells in the in­ner ear, there­by restor­ing hear­ing. FX-322 was de­signed on the PCA, or prog­en­i­tor cell ac­ti­va­tion, plat­form out of a col­lab­o­ra­tion be­tween il­lus­tri­ous MIT re­searcher Robert Langer and Har­vard’s Jeff Karp.

Aprea was the safe and small play­er in the group, and the IPO price of $15 as well as the $85 mil­lion it reaped was more or less with­in ex­pec­ta­tions. For the biotech, which has roots in Swe­den’s Karolin­s­ka De­vel­op­ment, all eggs are in the p53 bas­ket. In the up­com­ing piv­otal tri­al they will test their the­o­ry that re­ac­ti­vat­ing mu­tant p53 can make a dif­fer­ence in myelodys­plas­tic syn­dromes when com­bined with chemother­a­py.

Tri­als for that lead pro­gram, APR-246, and man­u­fac­tur­ing as well as IND work for its oral p53 re­ac­ti­va­tor, APR-458, fea­tured promi­nent­ly in the IPO $APRE.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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