Video: How many PD-1/L1 drugs do we need? Where is im­munother­a­py head­ed? Watch Jay Brad­ner, Hervé Hop­penot, Ellen Si­gal, David Berman, Gideon Blu­men­thal, and Aiman Sha­l­abi dis­cuss with End­points at #JPM18

SAN FRAN­CIS­CO —  In front of a packed house on Tues­day at the End­points News break­fast pan­el dur­ing #JPM18, Aiman Sha­l­abi, CMO at the Can­cer Re­search In­sti­tute kicked pro­ceed­ings off with his re­search on the ex­plod­ing PD-1/L1 pipeline, con­tin­u­ing on through the num­ber of can­cer im­munother­a­py prod­ucts his group is track­ing.

That’s a lot of pos­si­ble re­dun­dan­cy and in­ef­fi­cien­cies, Sha­l­abi said. And just how can we har­ness all this ef­fort in the most ef­fi­cient man­ner?

It’s al­so a sen­ti­ment shared by in­vestors, en­tre­pre­neurs and non­prof­its ad­vo­cat­ing for pa­tient care, each with a dif­fer­ent rea­son for their con­cern. Is the gold rush on I/O caus­ing bio­phar­mas and re­searchers to rush in­to tri­als where they haven’t done the sci­ence to check and see if they have a rea­son­able chance of suc­cess?

What about be­ing able to re­cruit for stud­ies? Is there a scarci­ty of pa­tients?

Jay Brad­ner, the Pres­i­dent of the No­var­tis In­sti­tute for Bio­Med­ical Re­search, said: “It is an is­sue that we give some con­sid­er­a­tion to, but I must say in hear­ing this pre­sen­ta­tion and see­ing these num­bers, I’m in­ter­est­ed to (know from) this com­mu­ni­ty. Does this make you gasp or clap? I think it’s won­der­ful.”

Watch the en­tire video to see how each pan­elist took these ques­tions head on. We’ve in­clud­ed Sha­l­abi’s pre­sen­ta­tion, pic­tures from the event, along with the full video. En­joy!


Full video:


All pho­tographs and video copy­right Jeff Ru­mans, End­points News



Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

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

On the Trump administration response:

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

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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.”

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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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On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

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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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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi preps an­oth­er round of lay­offs as new ex­ecs look to slim down the glob­al phar­ma in an on­go­ing re­or­ga­ni­za­tion — re­port

Sanofi is reportedly once again sharpening up the budget axe as the pharma giant prepares to chop more jobs.

Reuters reports this morning that Sanofi has its sights set on cutting 1,680 jobs in Europe, where the unions have been combating rounds of cutbacks at the Paris-based player. Sanofi itself hasn’t said anything about these cuts, as the company looks to discuss a 3-year plan with staff representatives.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

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Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.