Prep­ping for AS­CO? In­vestor Brad Lon­car of­fers his own break­down of what to watch for

Brad Lon­car

Every­body has their own spe­cial line­up of the most keen­ly an­tic­i­pat­ed events sched­uled for the up­com­ing ses­sion of AS­CO this week­end. Brad Lon­car, an in­de­pen­dent in­vestor who set up the Lon­car Can­cer Im­munother­a­py ETF $CN­CR, has been prep­ping for this all year long.

Lon­car wrote up a long list of things he’ll be watch­ing for this up­com­ing week­end. I found it in­ter­est­ing and I think you will too. His list:


IDO In­hibitors

– There are es­sen­tial­ly 1,000 com­bi­na­tion tri­als on­go­ing with PD-(L)1s but so far noth­ing oth­er than CT­LA-4 has come close to rear­ing its head as a suc­cess­ful +1.  Will IDO be the one?

– Amaz­ing­ly, In­cyte’s $IN­CY IDO pro­gram is be­ing val­ued some­where in the range of $10-$15B.  Peak sales are be­ing es­ti­mat­ed as high as $4B.  But we have seen min­i­mal da­ta to back this up.  Is it ir­ra­tional ex­u­ber­ance or based in re­al­i­ty?

– The NSCLC ab­stract In­cyte had with Mer­ck $MRK looked en­cour­ag­ing but we need to see more time, how durable the re­spons­es are, and al­so to see PFS bro­ken out.

– In­cyte will have 5 piv­otal stud­ies with Mer­ck and at least 1 with Bris­tol on­go­ing by the end of the year so we need to see more da­ta to hand­i­cap the stock’s cur­rent val­u­a­tion and the po­ten­tial suc­cess of these tri­als and this IDO pro­gram.

– NewLink $NLNK con­verse­ly is es­sen­tial­ly a pure play IDO com­pa­ny and has three IDO as­sets yet, is on­ly worth about $500M

– In­cyte de­serves to be val­ued sig­nif­i­cant­ly high­er for many rea­sons (they are years ahead, more tri­als, bet­ter part­ners, more cred­i­bil­i­ty, etc) but 20-30 times more?

– NewLink and Roche’s IDO/PD-L1 ab­stract didn’t look very hot.  Why?  Wrong pa­tient pop­u­la­tion, da­ta too ear­ly, types of can­cers treat­ed, IDO is not that great?

– I think ei­ther In­cyte is gross­ly over­val­ued or NewLink is gross­ly un­der­val­ued.  And I’m not en­tire­ly sure which it is…maybe a lit­tle of both.  If the IDO path­way tru­ly works, I have a hard time be­liev­ing one is worth $10B+ and the oth­er $500M.

– In­cyte and Mer­ck’s piv­otal melanoma read­out is set­ting up to be a huge bi­na­ry event next year.

– In gen­er­al I lean pos­i­tive on IDO be­cause I don’t think these com­pa­nies are start­ing all of these piv­otal tri­als based on guess­work.  But there is a lot on the line for it to suc­ceed.

CAR-T

– CAR-T had ups and downs last year, but po­ten­tial­ly might be ap­proved in two in­di­ca­tions soon.  No­var­tis $NVS in pe­di­atric ALL and Kite $KITE in ag­gres­sive NHL (DL­B­CL). That is very sig­nif­i­cant!

– We know that CAR-T works in those types of leukemias and lym­phomas be­cause of the low-hang­ing-fruit CD19 tar­get.

– A next ad­vance that peo­ple are look­ing for out of CAR-T is whether there are more tar­gets and types of can­cers it can work for.

– BC­MA in mul­ti­ple myelo­ma is very high on every­body’s list for that next suc­cess.  Is this war­rant­ed?

– Blue­bird $BLUE had very en­cour­ag­ing da­ta with BC­MA CAR-T in No­vem­ber 2016 but it was on­ly a hand­ful of pa­tients and the da­ta was very pre­lim­i­nary.  How will their AS­CO da­ta look with more pa­tients and longer fol­low-up?

– A Chi­nese com­pa­ny, Nan­jing Leg­end Biotech is al­so pre­sent­ing BC­MA CAR-T da­ta.

– In adult ALL, Juno $JUNO had to halt their tri­al last year due to tox­i­c­i­ties and pa­tient deaths.  Kite will be pre­sent­ing an up­date in adult ALL at AS­CO.  Both Juno and Kite use the CD28 co-stim­u­la­to­ry do­main (some peo­ple blame CD28 for Juno’s prob­lem).

– Will Kite’s adult ALL da­ta look safer and/or bet­ter than Juno? For adult ALL, will we learn that it is too dif­fi­cult of a can­cer to treat with CAR-T or was there some­thing specif­i­cal­ly prob­lem­at­ic with Juno?

– I think cel­lu­lar ther­a­pies in gen­er­al are a ris­ing star and a huge­ly in­ter­est­ing sto­ry. But there will be many ups and downs over time as we have seen.

PD-(L)1s

– Mer­ck’s Keytru­da showed a sur­vival ad­van­tage in blad­der can­cer but Roche’s Tecen­triq failed. Up to this point, we have as­sumed that PD-(L)1s are all es­sen­tial­ly the same.

-Even Bris­tol’s $BMY new head of R&D said on their last earn­ings call that he didn’t think there was much dif­fer­ence among these drugs. But that was be­fore Tecen­triq failed.

– Why did Tecen­triq fail where Keytru­da suc­ceed­ed?  Was it due to 1) a bet­ter tri­al de­sign for Mer­ck or 2) be­cause PD-(L)1s are tru­ly dif­fer­ent and Keytru­da is bet­ter (or Tecen­triq is in­fe­ri­or)?

– It would be very sig­nif­i­cant for the field if it’s be­cause Keytru­da is bet­ter than oth­ers (or Tecen­triq is in­fe­ri­or).

– There’s re­al­ly no spe­cif­ic ab­stract to look to for this, but in gen­er­al I’m very in­ter­est­ed to learn more about the the dif­fer­ences in PD-(L)1s if they ex­ist. We will want to look close­ly at da­ta from all PD-(L)1 tri­als for dif­fer­ences and this will be a top­ic of dis­cus­sion for at­ten­dees.

– Al­so, what will FDA do with Tecen­triq in blad­der can­cer now that the tri­al has failed … re­scind their ac­cel­er­at­ed ap­proval?

– Is Roche ner­vous about po­ten­tial­ly hav­ing an in­fe­ri­or as­set in such an im­por­tant cat­e­go­ry?

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Suf­fer­ing No­var­tis part­ner Cona­tus grabs the ax and packs it in on NASH af­ter a se­ries of set­backs

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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