PhRMA's new re­port counts each can­cer drug in the US pipeline, which has now swelled to over 1,000 in the clin­ic

Can­cer drugs are crowd­ing in to an al­ready cramped pipeline this year, with hun­dreds of im­muno-on­col­o­gy hope­fuls now tak­ing a shot at clin­i­cal test­ing. That’s ac­cord­ing to a new can­cer re­port from PhRMA, which count­ed 1,120 on­col­o­gy drugs in the clin­ic so far this year — a mas­sive in­crease from pre­vi­ous years — and that’s just in the US.

For per­spec­tive, there were on­ly 836 can­cer ther­a­pies count­ed by PhRMA in 2015, which means the pipeline has swelled 34% in less than three years. The or­ga­ni­za­tion on­ly count­ed drugs al­ready in the clin­ic or await­ing re­view from the FDA. That means there’s a sig­nif­i­cant back­log of ther­a­pies in pre­clin­i­cal de­vel­op­ment, wait­ing to el­bow their way in­to the fray.

Of the 1,120 ther­a­pies in the clin­ic, near­ly 300 are im­muno-on­col­o­gy drugs or vac­cines. And just what counts as im­muno-on­col­o­gy? The or­ga­ni­za­tion said it count­ed “rec­og­nized class­es” such as CAR-T ther­a­pies, bi-spe­cif­ic an­ti­bod­ies, cy­tokine ther­a­pies, im­mune check­point mod­u­la­tors, on­colyt­ic virus ther­a­pies, and vac­cines.

SOURCE: PhRMA

The re­port takes a re­gion­al look at a trend we’ve been track­ing for a while now. Back in Jan­u­ary, an End­points News pan­el dis­cussed the rapid ex­pan­sion of the on­col­o­gy pipeline (in par­tic­u­lar, im­muno-on­col­o­gy) at the JP Mor­gan Health­care Con­fer­ence in San Fran­cis­co. That re­port iden­ti­fied a mind-bog­gling 2,004 im­muno-on­col­o­gy agents, with 940 in the clin­ic and the rest in pre­clin­i­cal de­vel­op­ment.

There’s been an on­go­ing dis­cus­sion about whether the mar­ket can sup­port the crowd­ing in fields such as PD-1/L1 — not just in the US, but in Chi­na and oth­er re­gions.

For its part, PhRMA re­mains up­beat about the pipeline, tout­ing the in­dus­try’s in­no­va­tions and call­ing at­ten­tion to the 85% of can­cer drugs in de­vel­op­ment it says are first-in-class treat­ments. And the or­ga­ni­za­tion is quick to point out that the need for new can­cer treat­ments is still cru­cial. Al­though can­cer death rate has de­clined 26% since its peak in the 1990s, more than 1.7 mil­lion new cas­es of can­cer are ex­pect­ed to de­vel­op in the US in 2018.

For a com­plete list of the 1,120 can­cer drugs in de­vel­op­ment, check out PhRMA’s new list.


Im­age: Steve Ubl, CEO of PhRMA, speaks at an End­points News event in San Fran­cis­co, Jan­u­ary 2017 End­points News

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Karen Aiach, Lysogene CEO (RE(ACT) Discovery Institute)

Gene ther­a­py flunks PhII/III study, but for­mer Sarep­ta part­ner sees a path for­ward — if it can find the cash

The development path for Lysogene’s gene therapy for MPS IIIA has been a rocky one. After the FDA slapped a partial clinical hold on a Phase II/III study, a patient already dosed in the trial died, although it was deemed unrelated to treatment. Then earlier this year, Sarepta pulled out of their three-year partnership due to disagreements on who will handle commercial supply.

And now, Lysogene reported the trial has failed its primary endpoint.

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