Uni­ty's ear­ly longevi­ty da­ta look 'en­cour­ag­ing'; Adap­tive Biotech­nolo­gies looks to raise $200M in IPO

Bob Nelsen-backed longevi­ty start­up Uni­ty $UBX on Tues­day un­veiled the first ever in-hu­man da­ta on its drug, UBX0101, which is de­signed to de­lay the ag­ing process by snuff­ing senes­cent (old) cells. The first part (A) of the small Phase I study test­ed mul­ti­ple dos­es of the os­teoarthri­tis drug against a place­bo — while the sec­ond por­tion (B) eval­u­at­ed the high­est 4 mg dose of UBX0101 ver­sus a place­bo. The main goal of the study was safe­ty and tol­er­a­bil­i­ty, which was met. In terms of sec­ondary goals such as pain, da­ta from part A were pos­i­tive, with signs of im­prove­ments in pain and func­tion­al scores. Part B re­sults were nu­mer­i­cal­ly su­pe­ri­or in terms of pain and func­tion­al­i­ty, but not deemed sta­tis­ti­cal­ly sig­nif­i­cant. “Our con­clu­sion from the Part A da­ta mea­sure­ments are en­cour­ag­ing… For Part B, we be­lieve more fre­quent dos­ing and longer-term ob­ser­va­tion could lead to im­prove­ments across the pain and func­tion scales,” Can­tor Fitzger­ald an­a­lysts wrote in a note en­ti­tled “Proof Of Con­cept: Check, but More Work is Still to Be Done.”

→ Seat­tle-based ge­net­ic test mak­er Adap­tive Biotech­nolo­gies on Mon­day broke out the terms of its IPO. The com­pa­ny — which mon­i­tors and en­ables the treat­ment of dis­eases such as can­cer, au­toim­mune con­di­tions and in­fec­tious dis­eases — has two com­mer­cial prod­ucts and oth­ers in the pipeline to di­ag­nose. It said in a fil­ing that it plans to raise $200 mil­lion by of­fer­ing 12.5 mil­lion shares at a price range of $15 to $17. The com­pa­ny plans to list on the Nas­daq un­der the sym­bol “$ADPT.”

→ While the few drug de­vel­op­ers in the an­tibi­ot­ic space strug­gle to keep afloat and ag­o­nize over the scarce in­cen­tives in place de­signed to en­cour­age drug de­vel­op­ment, UK’s Sum­mit Ther­a­peu­tics $SMMT is hop­ing its des­tiny is dif­fer­ent. The drug de­vel­op­er — which is in the lat­ter stages of de­vel­op­ing its an­tibi­ot­ic, ri­dini­la­zole, to tack­le the stub­born C. dif­fi­cile in­fec­tion (a prime tar­get of the fe­cal mi­cro­bio­ta trans­plant and “crap­sule” field) — on Tues­day said that BAR­DA has en­hanced its award for the clin­i­cal and reg­u­la­to­ry de­vel­op­ment of  ri­dini­la­zole to up to $63.7 mil­lion.

→ While In­trex­on $XON (and UK unit Ox­itec) works on erad­i­cat­ing Zi­ka us­ing its bio­engi­neered self-lim­it­ing Aedes ae­gyp­ti mos­qui­to, it has al­so mus­cled its way in­to the om­nipresent cannabis busi­ness. On Tues­day, the com­pa­ny said it had inked a deal with Surter­ra Well­ness worth up to $100 mil­lion. Un­der the part­ner­ship, In­trex­on’s yeast fer­men­ta­tion tech­nol­o­gy will be em­ployed to make Surter­ra’s cannabi­noids pro­duc­tion cost-ef­fec­tive — In­trex­on is on track to re­al­ize the pro­duc­tion of pure cannabi­noids at a tar­get cost of goods of <$1,000/kg, it said. “With In­trex­on, Surter­ra will be a leader in bring­ing to mar­ket prod­ucts fea­tur­ing rare cannabi­noids that are tra­di­tion­al­ly too chal­leng­ing to com­mer­cial­ize via agri­cul­tur­al meth­ods, de­liv­er­ing to pa­tients and con­sumers high­ly cred­i­ble nat­ur­al reme­dies as we chal­lenge in­cum­bents in the nu­traceu­ti­cal and phar­ma­ceu­ti­cal space,” said Jay Holmes, ex­ec­u­tive di­rec­tor of strat­e­gy at Surter­ra Well­ness, in a state­ment. This the sec­ond deal be­tween the two com­pa­nies this year.

→ Gene ther­a­py de­vel­op­er Abeona Ther­a­peu­tics has notched a fast track des­ig­na­tion for its or­phan drug ABO-202, which is de­signed to treat CLN1 dis­ease, al­so known as in­fan­tile Bat­ten dis­ease. It does so by de­liv­er­ing a func­tion­al copy of the PPT1 gene to pa­tients who are un­able to pro­duce a cru­cial lyso­so­mal en­zyme.

→ The FDA has ex­pand­ed the use of No­vo Nordisk’s Vic­toza to a much younger pop­u­la­tion. The old GLP-1 ana­log is now ap­proved to treat pa­tients with type 2 di­a­betes as young as 10 at a time more than 5,000 new cas­es of the dis­ease are di­ag­nosed in youth un­der age 20 every year, the agency said.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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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.

What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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De­sert­ed by Astel­las and Mer­ck, lit­tle Cor­re­vio still can't win over FDA pan­el con­cerned with its AFib drug's safe­ty

When the FDA spurned Astellas’ pitch for atrial fibrillation drug vernakalant in 2008, regulators made it abundantly clear that it wasn’t the efficacy they had a problem with — two Phase III trials had shown the drug successfully restored 52% of patients’ heartbeat from irregular to normal — but the cardio safety issues for a drug that was to compete with well established, low-risk options. One licensing deal, one clinical hold and several studies later, the chances of approval aren’t looking any better.

New trade deal knocks out long-sought bi­o­log­ics pro­tec­tions for drug­mak­ers

House Democrats negotiating with the Trump Administration on a new North American trade deal settled early on four issues: enforcement, labor and environmental standards and drug pricing.

On drug pricing, Politico reports, Trump crumbled within weeks of heightened negotiations.

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