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.”

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
Overview
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.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,200+ biopharma pros reading Endpoints daily — and it's free.

Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,200+ biopharma pros reading Endpoints daily — and it's free.

Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,200+ biopharma pros reading Endpoints daily — and it's free.

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.

UP­DAT­ED: Ob­sE­va makes case for hor­mone sup­pres­sive ther­a­py in uter­ine fi­broid study, but safe­ty qualms vex in­vestors

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, but the therapy’s safety profile irked investors.

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).