An ex­plo­sion of PD-1/L1 check­point stud­ies is crowd­ing the in­dus­try pipeline — and that’s a prob­lem

WASH­ING­TON, DC — The Can­cer Re­search In­sti­tute has been do­ing the math on the PD-1/L1 check­point pipeline, and you might not be­lieve what we’re see­ing now in terms of clin­i­cal re­search pro­grams.


Samir Khleif

In a dis­cus­sion here at the So­ci­ety for Im­munother­a­py of Can­cer meet­ing, Samir Khleif, an im­muno-on­col­o­gist and SITC board mem­ber, laid out the num­bers from the CRI.

With 5 check­points on the mar­ket, there are now 164 dif­fer­ent check­point ther­a­pies be­ing stud­ied from the pre­clin­i­cal through late-stage phase. There are three more right now in Phase III — REGN-2810 from Sanofi/Re­gen­eron, PDR001 from No­var­tis and INC­SHR-1210 from In­cyte/Jiang­su Hen­grui — and 9 in Phase II.

CRI counts 1,502 clin­i­cal tri­als un­der­way in­volv­ing a PD-1/L1, with 1,105 com­bo stud­ies in the pipeline. Quite a few of those tri­als might well pay off, Khleif not­ed, but here’s the prob­lem:

“We are not on the right path,” Khleif tells me. “Cur­rent­ly there are a lot of com­bi­na­tion clin­i­cal tri­als and some of those tri­als are not based on sci­ence.”

Log­ic may lead you to be­lieve that PD-1/L1 com­bined with just about any­thing else will work bet­ter, he says. But that isn’t al­ways so. You might think that a check­point and OX40 would work to­geth­er, he used by way of ex­am­ple, by elim­i­nat­ing the sup­pres­sive en­vi­ron­ment in the tu­mor. But the com­bi­na­tion ac­tu­al­ly in­hibits im­mune re­sponse, he says, which has been shown in an­i­mal stud­ies.

The gold rush on I/O, though, is 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.

In the mean­time, he adds, it’s be­come hard­er and hard­er to find can­cer pa­tients for these stud­ies. “We’re go­ing to have prob­lems re­cruit­ing pa­tients any way,” Khleif says, mak­ing it all that more im­por­tant to make sure that pro­grams aren’t rushed in­to the clin­ic.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

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Stéphane Bancel, Getty

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In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

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Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

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The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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