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.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.