The Can­cer Re­search In­sti­tute is shin­ing a light on the ex­plo­sive growth of cell ther­a­pies in the clin­ic, spot­light­ing Chi­na’s vir­tu­al overnight suc­cess in grab­bing a lead role in the field. And they’re ask­ing the world’s can­cer drug de­vel­op­ment com­pa­nies to adopt a new ap­proach that will help the in­dus­try man­age a fi­nite num­ber of po­ten­tial tri­al pa­tients while point­ing re­searchers to the most like­ly av­enue for do­ing some­thing im­por­tant — rather than just frit­ter­ing away bad­ly need­ed re­sources.

The non­prof­it CRI re­cent­ly quan­ti­fied the pro­lif­er­a­tion of I/O agents in the clin­ic, cap­tur­ing our at­ten­tion with the news that 164 PD-1/L1 ther­a­pies were in the pipeline, look­ing to whit­tle away at the block­buster lead­ers from Mer­ck and Bris­tol-My­ers Squibb. Now we learn from an up­date in Na­ture Re­views Drug Dis­cov­ery — penned by a team that in­cludes Jill O’Don­nell‐Tormey and Aiman Sha­l­abi — that they tracked down 753 cell ther­a­pies, with 375 in the clin­ic.

That fig­ure is up 87% in just 6 months, with 350 added to the pipeline around the world.

The tal­ly re­veals that “378 are in pre­clin­i­cal phase, 160 in phase I, 205 in phase II, 6 in phase II and 4 ap­proved (2 in the US, 1 in South Ko­rea and 1 in Italy),” re­ports the CRI. “In­ter­est­ing­ly, 404 of the 753 agents are chimeric anti­gen re­cep­tor (CAR) T cell ther­a­pies.”

Not sur­pris­ing­ly, the US is in the clear lead here, with 344 pro­grams. But Chi­na is num­ber two, and catch­ing up fast, with 203. In a field where aca­d­e­m­ic cen­ters fre­quent­ly play a lead role in demon­strat­ing their po­ten­tial, 125 of Chi­na’s pro­grams — 62% — are in the hands of aca­d­e­mics.

Here’s a look at the glob­al play­ing field:

In the mean­time, it’s get­ting rapid­ly eas­i­er to get these ther­a­pies pro­duced for clin­i­cal tri­als vir­tu­al­ly any­where. “(W)ith the rapid ad­vance­ment of lo­cal cell pro­duc­tion tech­nolo­gies, such as Clin­i­MACS Prodi­gy (Mil­tenyi Biotec), Co­coon (Lon­za) and Bea­con (Berke­ley Lights), we an­tic­i­pate a low en­try hur­dle for lo­cal man­u­fac­ture of cells for in­ves­ti­ga­tion­al clin­i­cal use.”

There are 113 tar­gets on the radar in this field, with 73 in the clin­ic. CD19 rules the roost, for now, with BC­MA a grow­ing but still rel­a­tive­ly small seg­ment. Here’s a look at the top 30:

The boom­ing on­col­o­gy re­search field has de­liv­ered some im­por­tant gains in the last two years. But at this rate, the gold rush for ad­vanc­ing new drugs is spurring the CRI to out­line some bad­ly need­ed re­forms. Here are three:

• They’re ask­ing the R&D ex­ecs here to shift more of their fo­cus to in­tro­duc­ing ge­net­ic con­structs in­to cells, rather than con­cen­trate on vi­ral vec­tors, where a pro­duc­tion bot­tle­neck has de­vel­oped.
• Rather than squan­der the lim­it­ed ac­cess to pa­tient vol­un­teers on a mas­sive num­ber of new stud­ies, they want de­vel­op­ers to move to adap­tive tri­al de­signs that ac­com­mo­date mul­ti­ple drugs and tar­gets at once.
• And with the big push on to ex­pand in­to sol­id tu­mors, CRI wants de­vel­op­ers to fo­cus on the most im­por­tant tar­gets not cur­rent­ly be­ing treat­ed well with ex­ist­ing drugs.

There’s no R&D czar in the world, though, that can de­mand dis­ci­pline in this field. Large play­ers have been re­sis­tant to be­ing told what to do as much as the small­er play­ers. And every­one wants to con­trol their own eco­nom­ics. The mar­ket is dri­ving the growth of the field, but it can’t triage how it grows — un­less in­vestors start hold­ing back funds in search of more com­mon sense.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.