Bolt Bio CEO Randy Schatzman

Bolt Bio goes bust as in­vestors boo sin­gle re­sponse in ear­ly test against HER2-ex­press­ing tu­mors

Bolt Bio’s BDC-1001, an an­ti­body con­ju­gate drug de­signed to amp up the body’s in­nate im­mune sys­tem re­sponse to tu­mors, post­ed a sin­gle par­tial re­sponse in a Phase I/II study in pa­tients with HER2-ex­press­ing sol­id tu­mors af­ter a year of dos­ing. Just 13 of 40 evalu­able pa­tients showed any signs of “clin­i­cal ac­tiv­i­ty,” the biotech said Mon­day.

BDC-1001 links a HER2-tar­get­ing biosim­i­lar of Her­ceptin with a TLR7/8 ag­o­nist, which is de­signed to ac­ti­vate myeloid cells in the in­nate im­mune sys­tem and dri­ve tu­mor cy­to­tox­i­c­i­ty, Bolt said. But the ear­ly re­sults paint the pic­ture of a drug with lit­tle ef­fect on HER2 tu­mors, one of the most high­ly val­i­dat­ed tu­mor tar­gets in drug de­vel­op­ment.

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