Can two Chi­nese biotechs vault a home­grown PD-L1 agent to fron­trun­ner sta­tus in the crowd­ed glob­al check­point race?

Har­bour Bio­Med thinks the an­swer is yes, and it’s will­ing to spend a to­tal of $350 mil­lion to make that a re­al­i­ty.

Pay­ing an un­spec­i­fied up­front to Cheng­du-based Kelun Biotech — with whom it al­ready has an ear­ly-stage col­lab­o­ra­tion — Har­bour grabs ex­clu­sive rights to de­vel­op, man­u­fac­tur­ing and com­mer­cial­ize A167 out­side of greater Chi­na. Har­bour is head­quar­tered in Shang­hai with a Boston out­post.

In ad­di­tion to shar­ing da­ta from the Phase I and II tri­als it’s been con­duct­ing in Chi­na among pa­tients with lym­phoma and sol­id tu­mors, Kelun will al­so work with Har­bour to ex­plore any po­ten­tial com­bi­na­tion ther­a­pies — a hot strat­e­gy with check­point in­hibitors. And all that will ide­al­ly form the ba­sis of the de­vel­op­ment, reg­u­la­to­ry and com­mer­cial mile­stones.

Jing­song Wang

“We plan to con­duct A167-based com­bi­na­tion tri­als glob­al­ly by our­selves, in­clud­ing with in­no­v­a­tive com­pounds we are de­vel­op­ing, or in col­lab­o­ra­tion with our part­ners, to find bet­ter ther­a­peu­tic op­tions against a wide range of tu­mor types,” said CEO Jing­song Wang, a Sanofi R&D vet, in a state­ment.

A167 was one of 22 PD-1/L1 check­points da­ta an­a­lyt­ics firm Pharm­Cube count­ed in its re­cent tal­ly of Chi­nese biotech ef­forts in the field. And that fits in­to a glob­al ex­plo­sion of check­point stud­ies, which the Can­cer Re­search In­sti­tute es­ti­mat­ed at 1,502 clin­i­cal tri­als (1,105 of those com­bos) in­volv­ing 164 PD-1/L1 agents last De­cem­ber.

CRI warned that the gold rush on I/O was lead­ing com­pa­nies to jump in­to com­bo stud­ies with­out much sci­en­tif­ic back­ing. And the on­rush of new PD-1/L1s in the clin­ic could have big im­pli­ca­tions for mar­ket lead­ers Mer­ck and Bris­tol-My­ers Squibb, which both en­joy block­buster in­come from their check­points.

This marks the sec­ond li­cens­ing pact for Har­bour this month, hav­ing just ob­tained Chi­na rights to a breast can­cer drug tar­get­ing HER2 and CD3 from In­dia’s Glen­mark Phar­ma­ceu­ti­cals days ago.

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.

Nancy Pelosi unveiled the Democrats’  drug pricing bill back in September and brought the fight straight to the industry with a proposal to empower the US government to negotiate prices for select drugs. Republicans, who decried the bill reeks of heavy-handed government intervention which will stifle innovation, now have a counterproposal they claim will result in cheaper drugs and incentivize R&D — further clouding the prospects of a bipartisan compromise that could land on Donald Trump’s desk.

Perceptive Advisors is one of those prolific biotech investor groups which has traditionally enjoyed zeroing in on clinical-stage investments and crossover rounds, a group that prefers more established drug development players with near-term payoff potential.

But now they’re partnering with Xontogeny chief and longtime biotech entrepreneur Chris Garabedian on a $210 million fund — with money contributed by institutional investors and family funds — to go into the launch space with their first early-stage VC fund. Dubbed the Perceptive Xontogeny Venture Fund, LP, or just PXV Fund, they plan to favor upstarts that Garabedian is fostering in his incubator. But they’ll also plan to reach outside that inner circle for more A rounds to back, with plans to dominate initial funding with $10 million to $20 million per newborn biotech.

The US biosimilar industry has lingered in the shadow of the European market since the US pathway for approvals was initiated in 2009.

Ten years later (or less than five years since the first FDA approval of a biosimilar), and just 42% (11 out of 26) of FDA-approved biosimilars have launched. But in the next three months (see chart below), a clutch of new biosimilars will hit the market, including new ones in oncology, hinting at a wave of uptake.

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.