Blue­bird bio $BLUE is jump­ing on the AI tar­get-iden­ti­fi­ca­tion plat­form de­vel­oped at the neo-anti­gen biotech Grit­stone to iden­ti­fy some new TCR pro­grams for the pipeline.

TCRs have been all the rage re­cent­ly as biotech fol­lows a tech trail that they be­lieve will lead to a wider range of can­cer drug tar­gets to go af­ter — par­tic­u­lar­ly in sol­id tu­mors, where cell ther­a­pies face some of their biggest chal­lenges. Just days ago blue­bird aligned on a T cell re­cep­tor de­vel­op­ment deal with biotech pow­er­house Re­gen­eron, bag­ging $100 mil­lion for a 50/50 pact on ac­cel­er­at­ing new pro­grams.

An­drew Allen

In this new al­liance, Grit­stone will bird dog the tu­mor-spe­cif­ic drug tar­gets and nat­ur­al TCRs as blue­bird re­searchers look to ex­pand a cell ther­a­py pipeline now led by its BC­MA-tar­get­ing star bb2121. Grit­stone will be key in pa­tient iden­ti­fi­ca­tion and will re­ceive a $20 mil­lion up­front plus an up­com­ing $10 mil­lion eq­ui­ty in­vest­ment from blue­bird.

The state­ment doesn’t spec­i­fy the mile­stones in­volved, be­yond say­ing they are “sig­nif­i­cant.” With $30 mil­lion in near-term cash for a dis­cov­ery deal like this, the biobucks must be sub­stan­tial.

In­vest­ment in TCRs has no­tice­ably heat­ed up this sum­mer. The ques­tion is whether this is sheer ne­ces­si­ty due to the re­al­i­ty of cell ther­a­pies and sol­id tu­mors or if there is more to it than that.

— Brad Lon­car (@brad­lon­car) Au­gust 23, 2018

“As the field of im­muno-on­col­o­gy has evolved, it has be­come clear that tar­get­ing T-cell ther­a­peu­tics to sol­id tu­mors in a high­ly spe­cif­ic man­ner is vi­tal to en­able po­tent tu­mor cell killing with spar­ing of nor­mal tis­sues,” said An­drew Allen, the CEO of Grit­stone. “We be­lieve that our ar­ti­fi­cial in­tel­li­gence-based ap­proach to iden­ti­fy­ing tu­mor-spe­cif­ic tar­gets and cor­re­spond­ing, nat­u­ral­ly oc­cur­ring TCRs, com­bined with blue­bird bio’s ex­per­tise in gene and cell ther­a­py, will al­low us to de­vel­op cel­lu­lar im­munother­a­pies against dif­fer­en­ti­at­ed on­col­o­gy tar­gets.”

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.