August 20, 2018 07:20 AM EDT
R&D
China
Pharma

Har­bour Bio­Med jumps in­to the crowd­ed PD-1/L1 race, look­ing to take a Chi­nese as­set glob­al as check­point pipeline bulges

Amber Tong

Editor

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.

AUTHOR

Amber Tong

Editor

amber@endpointsnews.com @AmberTongPW
Amber Tong on LinkedIn
Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)
July 5, 2020 02:12 PM EDT
Pharma
Coronavirus

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

John Carroll

Editor & Founder

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)
June 30, 2020 09:39 AM EDT
People
R&D
Pharma

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

John Carroll

Editor & Founder

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

Endpoints News

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June 29, 2020 05:59 AM EDTUpdated 10:34 AM
R&D
Cell/Gene Tx

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

John Carroll

Editor & Founder

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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George Yancopoulos (Regeneron)
July 1, 2020 08:28 AM EDTUpdated July 3, 05:50 PM
People

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

John Carroll

Editor & Founder

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)
July 2, 2020 06:30 AM EDTUpdated 2 hours ago
People
Coronavirus

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

John Carroll

Editor & Founder

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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July 1, 2020 06:37 AM EDTUpdated July 2, 02:40 AM
Deals
R&D
Pharma

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

John Carroll

Editor & Founder

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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July 1, 2020 09:37 AM EDTUpdated 09:53 AM
R&D
Coronavirus

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

John Carroll

Editor & Founder

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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July 1, 2020 05:46 AM EDT
Pharma
Regulatory

New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

Amber Tong

Editor

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)
June 30, 2020 09:07 AM EDTUpdated 10:20 AM
Bioregnum
R&D

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Har­bour Bio­Med jumps in­to the crowd­ed PD-1/L1 race, look­ing to take a Chi­nese as­set glob­al as check­point pipeline bulges

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire