Am­gen vet Patrick Baeuer­le in­spires a $45M round from A-list VCs for a next-gen I/O drug plat­form

MPM found­ed Har­poon Ther­a­peu­tics and seed­ed its ear­ly work look­ing to make the leap in­to next-gen im­muno-on­col­o­gy drugs with some in­sights from one of the pi­o­neers in the field. Now it has put to­geth­er a glob­al syn­di­cate of some A-list ven­ture in­vestors to back a $45 mil­lion B round to move their lead drug in­to the clin­ic next year.

Har­poon was in­spired by Patrick Baeuer­le, who led the de­vel­op­ment work on Mi­cromet BiTE plat­form, which used an an­ti­body to redi­rect killer T cells to de­stroy tu­mor cells. Am­gen went on to ac­quire Mi­cromet in 2012, back when Roger Perl­mut­ter was run­ning R&D and fell in love with the work. Perl­mut­ter, now run­ning R&D at Mer­ck, brought Baeuer­le on board at Am­gen to con­tin­ue work on Blin­cy­to, which was ap­proved in late 2014 as the first bis­pe­cif­ic CD19-di­rect­ed CD3 T-cell en­gager.

The sci­en­tist then left for MPM, bring­ing along some ideas on how next-wave drugs could go much, much fur­ther.

The big idea now, to be test­ed with HPN424 for prostate can­cer, is built around a new plat­form dubbed Tri­TAC, for tri-spe­cif­ic T-cell ac­ti­vat­ing drugs. Done prop­er­ly, the biotech be­lieves it has a bet­ter way “to un­leash the tar­get­ed cell-killing prop­er­ties of a pa­tient’s own im­mune sys­tem through T-cell ac­ti­va­tion.” That’s a big goal, and done prop­er­ly the biotech be­lieves it will pen­e­trate tis­sue bet­ter and ex­tend serum ex­po­sure, with ap­pli­ca­tions in can­cer as well as im­munol­o­gy.

“We’re giv­ing an an­ti­body-type mol­e­cule, not an an­ti­body per se, and we give that to pa­tients,” says Har­poon CEO Jer­ry McMa­hon, had been CEO at Koll­tan un­til Celldex bought it out last year. “The mol­e­cule will cre­ate a bridge be­tween the tu­mor cells and the T cells, and that bridge – or synapse – al­lows the T cell to kill the tu­mor cell.”

McMa­hon sees this as a third class of I/O drug, fol­low­ing check­point in­hibitors and CAR-T, ad­van­taged by their abil­i­ty to be able to ad­just dosage and reg­i­men.

The lat­est round brings the to­tal amount raised so far to $60 mil­lion, with enough cash to get at least through the next two years, with plans to dou­ble the cur­rent 15-mem­ber staff by the end of next year. In ad­di­tion to its prostate can­cer drug, McMa­hon adds that the biotech al­so has an­oth­er ther­a­py be­ing prepped for hu­man stud­ies that tar­gets lung, ovar­i­an and pan­cre­at­ic can­cer.

Har­poon, found­ed in 2015, spun one of its oth­er plat­forms us­ing the tu­mor mi­croen­vi­ron­ment to ac­ti­vate T cells in­to a sep­a­rate biotech called Mav­er­ick, which at­tract­ed a $125 mil­lion in­vest­ment last Jan­u­ary tied to an op­tion to ac­quire it.

Baeuer­le has been busy of late, boot­ing up new com­pa­nies. He and MPM al­so found­ed TCR2 Ther­a­peu­tics, an­oth­er im­muno-on­col­o­gy com­pa­ny that hopes to pi­o­neer a new class of T cell ther­a­pies that re­pro­grams the nat­ur­al T cell re­cep­tor com­plex to rec­og­nize spe­cif­ic anti­gens found on tu­mors, rapid­ly killing can­cer cells.

Lon­don-based Ar­ix Bio­science and New Leaf Ven­ture Part­ners co-led the lat­est round, with help from MPM Cap­i­tal and Tai­ho Ven­tures, an­oth­er new in­vestor.

“Har­poon Ther­a­peu­tics has a nov­el, T-cell en­gager plat­form which we be­lieve will be in­stru­men­tal to the dis­cov­ery and de­vel­op­ment of im­por­tant new ther­a­peu­tics in on­col­o­gy,” said Mark Chin, in­vest­ment man­ag­er at Ar­ix Bio­science. “Cou­pled with its sci­en­tif­ic ex­per­tise and strong man­age­ment team, Har­poon is well-po­si­tioned to play a lead­ing role in the im­muno-on­col­o­gy field.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.