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.”

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

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

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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