Bolt throws a wrench in the pipeline, looking to conserve cash

2022-08-12

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A meltdown in the biotech market is making most execs cautious, including Bolt Biotherapeutics’ CEO, as the company hits the brakes on one preclinical asset and pauses other early-stage work to extend cash reserves by two years. The pipeline re-org will keep Bolt’s lights on through 2025 so the biotech can focus on its clinical-stage HER2 solid tumor drug candidate, which the company should have early-stage data on and a recommended Phase II dose by year’s end. The biotech also wants to focus on its preclinical asset BDC-3042, an immune-stimulating antibody conjugate (ISAC), for KRAS and TP53 mutated tumors. That means Bolt has flashed the red light on BDC-2034, which targets carcinoembryonic antigen cell adhesion molecule 5 (CEA). Bolt’s decision to discontinue BDC-2034 was based on off-target toxicity related to the targeting antibody. The company had previously planned for BDC-2034 to enter the clinic in 2023. SVB Securities analyst Daina Graybosch noted on Aug. 11 that “the discontinuation is another illustration that immunostimulatory antibody-drug conjugation (ISAC) is a difficult drug platform, and we expect extensive product iteration and back-translation will be required in this nascent stage of ISAC development.” The company will bring in a heavy focus on BDC-1001 and BDC-3042 going forward. BDC-1001, an antibody conjugate drug, is designed to ramp up the body’s innate immune system response to tumors. Last year, the company had posted a single partial response in a Phase I/II study in patients with HER2-expressing solid tumors HER2-expressing solid tumors after a year of dosing. Just 13 of 40 evaluable patients showed any signs of “clinical activity,” the biotech had said. The drug is being tested as a monotherapy and in combination Opdivo, Bristol Myers Squibb’s checkpoint inhibitor, Bolt said. BDC-3042, on the other hand, is a myeloid modulating agonist antibody that “reawakens” myeloid cells to attack cancer cells. The drug binds to Dectin-2, a novel cell surface protein on macrophages, which causes the production of pro-inflammatory cytokines. The company hopes to enter human trials with the drug next year. “We have a lot to look forward to with strong investigator and collaborator interest in our programs, data readouts from the BDC-1001 monotherapy and combination dose-escalation studies on the horizon as well as the advancement of BDC-3042 through IND-enabling activities,” Bolt CEO Randall Schatzman added. The company reported $1.4 million in revenue for this quarter — a result of collaborations with Genmab and Innovent Biologics — compared to $0 from the same period in 2021. Bolt had $223.6 million as of June 30.

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