Though still struggling, Bellicum can resume trial on CAR-T hopeful after FDA lifts clinical hold - Endpoints News

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Af­ter a dis­as­trous 2020 that in­clud­ed ax­ing near­ly 80% of its staff amid strug­gling clin­i­cal re­sults for the few mol­e­cules re­main­ing in its pipeline, Hous­ton biotech Bel­licum fi­nal­ly got a piece of good news Thurs­day.

The FDA, Bel­licum said in a press re­lease, lift­ed a clin­i­cal hold on a Phase I/II tri­al of BPX-601 and rim­iducid — a treat­ment can­di­date for prostate and pan­cre­at­ic can­cer tu­mors — im­ple­ment­ed af­ter a pan­cre­at­ic can­cer pa­tient in the tri­al died in an ear­ly-stage test.

The death was clas­si­fied as un­re­lat­ed to the drug or the tri­al, but Bel­licum has had to work with the FDA since the hold’s is­suance on Dec. 7 to eval­u­ate pa­tient en­roll­ment and dosage stan­dards. The re­view ap­par­ent­ly went pos­i­tive­ly, as the FDA re­quired no pro­to­col changes up­on lift­ing the clin­i­cal hold.

“I am pleased that our team was able to ad­dress the FDA’s clin­i­cal hold ques­tions in a time­ly man­ner, en­abling us to eval­u­ate BPX-601 in a co­hort of pa­tients with pre­vi­ous­ly treat­ed metasta­t­ic prostate can­cer,” Rick Fair, Bel­licum’s CEO, said in a state­ment. “I re­main op­ti­mistic about the safe­ty and po­ten­tial clin­i­cal ben­e­fit of our BPX-601 prod­uct can­di­date in these pa­tients.”

Rick Fair

The po­ten­tial clin­i­cal ben­e­fit of BPX-601, though, re­mains to be seen. The afore­men­tioned staff cuts at Bel­licum came af­ter an Oc­to­ber ear­ly read­out of Phase I/II tri­al da­ta came back less than im­pres­sive. The com­pa­ny was frank in its as­sess­ment of the tri­al at the time: “Clin­i­cal­ly mean­ing­ful ef­fi­ca­cy as mea­sured by RE­CIST cri­te­ria was not ob­served.”

Af­ter that read­out, Fair said Bel­licum would shift the fo­cus of the tri­al to con­tin­ue test­ing the mol­e­cule’s safe­ty while en­rolling a new metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer group in­to the study.

That di­rec­tion seems to still be the fo­cus, and with the tri­al’s re­sump­tion, clin­i­cal da­ta on the ef­fi­ca­cy of BPX-601 in treat­ing metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer are ex­pect­ed ei­ther late this year or in ear­ly 2022. The eq­ui­ty an­a­lyst firm Laden­burg Thal­mann said to watch for that da­ta, as well as po­ten­tial first-in-hu­man da­ta on BPX-603, a Bel­licum mol­e­cule for HER2+ sol­id tu­mors, as pos­si­ble key cat­a­lysts for the biotech.

Bel­licum $BLCM stock shares have stayed most­ly steady since the hold was lift­ed, and cur­rent­ly sit at $3.84.

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Though still struggling, Bellicum can resume trial on CAR-T hopeful after FDA lifts clinical hold - Endpoints News
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