Ab­b­Vie scoops up op­tion to li­cense Har­poon's BC­MA drug for $50M up­front as biotech part­ner preps PhI/II tri­al

Ab­b­Vie is arm­ing it­self with an­oth­er set of bow and ar­rows to shoot at BC­MA in mul­ti­ple myelo­ma — and this time it has turned to col­lab­o­ra­tors at Har­poon Ther­a­peu­tics.

In pay­ing $50 mil­lion for an op­tion to li­cense HPN217, Ab­b­Vie gains ex­clu­sive ac­cess to a Tri-spe­cif­ic T cell Ac­ti­vat­ing Con­struct, or Tri­TAC, that is be­ing steered to a Phase I/II tri­al. The dos­ing of the first pa­tient will call for an­oth­er $50 mil­lion in con­tin­gent mile­stone pay­ment. Once Har­poon comes up with the da­ta, its phar­ma gi­ant part­ner will de­cide whether to of­fi­cial­ly add it to the ar­se­nal.

It is an ar­se­nal that al­ready fea­tures a CD3/BC­MA bis­pe­cif­ic from Teneo­bio, a lit­tle known play­er un­til Ab­b­Vie swooped in with $90 mil­lion in cash this Feb­ru­ary. The Sil­i­con Val­ley biotech’s pitch cen­ters on a T cell en­gager plat­form that “in­volves a com­bi­na­tion of a heavy chain on­ly an­ti-BC­MA binder and a nov­el an­ti-CD3 binder, which de­cou­ples tar­get can­cer cell killing from cy­tokine re­lease.”

The re­la­tion­ship with MPM-backed Har­poon dates back to 2017, when Ab­b­Vie dished out $17 mil­lion up­front to kick off some dis­cov­ery ef­forts on the Tri­TAC plat­form. The trans­ac­tion an­nounced to­day can be worth up to $510 mil­lion, the com­pa­nies said.

Na­tal­ie Sacks

“As our pipeline of ini­tial Tri­TAC clin­i­cal can­di­dates ad­vance in prostate and ovar­i­an can­cers, we are thrilled to part­ner with Ab­b­Vie in pur­suit of ther­a­pies geared to­wards hema­to­log­ic can­cers,” Har­poon CMO Na­tal­ie Sacks said in a state­ment.

BC­MA is a par­tic­u­lar­ly hot tar­get for mul­ti­ple myelo­ma, en­tic­ing a swarm of CAR-T de­vel­op­ers like blue­bird and Juno as well as in­spir­ing no­table ef­forts to de­vel­op bis­pecifics by Am­gen and Re­gen­eron. At last count, there were 38 BC­MA-tar­get­ed agents in clin­i­cal de­vel­op­ment.

On top of HPN217, Ab­b­Vie is al­so dou­bling down on the dis­cov­ery front, ex­pand­ing the agree­ment to in­clude two more Tri­TAC mol­e­cules and the op­tion to se­lect up to four ad­di­tion­al tar­gets. Each se­lect­ed tar­get could earn Har­poon up to $310 mil­lion in to­tal.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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UCB buys its way to epilep­sy show­down with Jazz with $1.9B Zo­genix ac­qui­si­tion

Zogenix’s epilepsy drug Fintepla may only have brought in around $100 million of sales in its first year, but UCB clearly believes it can go much, much higher.

The Belgian pharma has inked a $1.9 billion deal to buy out Zogenix, paying $26 per share in cash and offering a contingent value right worth $2 more per share if Fintepla lands an extra EU approval by the end of 2023.

But even the upfront marks a 72% premium to California-based Zogenix’s shares, which were trading just north of $15 on Tuesday.

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