Company: BOLT
Filing Date: 2025-03-24
Form Type: 10-K
Source: 0000950170-25-043873
Chunk: 17

Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-03-24
Form: 10-K
Item: Item 1
Chunk 17
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 targeting CD40, CD47, Clever-1, dectin-1, LAIR1, LILRBs/ILTs, and SIRP-alpha.

To our knowledge, BDC-4182 is the only ISAC targeting claudin18.2. There are numerous claudin 18.2 targeting agents in development that utilize different therapeutic approaches, including monoclonal antibodies such as zolbetuximab, ASKB-589, FG-M108, TST001, ADCs such as ATG-022, AZD0901/CMG901, EO-3021, IBI-343, LM-302, bispecific antibodies such as ASP2138, AZD5863, givastomig, IBI-389, QLS31905 and cell therapies or CAR-Ts such as CT041, IBI-345, TAC101-CLDN18.2, Clever-1, dectin-1, LAIR1, LILRBs/ILTs, and SIRP-alpha.

Companies developing ISACs or TLR agonists could also be long-term competitors for our Boltbody ISAC platform technology. To the best of our knowledge, the only other ISAC in active clinical development is Mersana Therapeutics’ XMT-2056, a HER2-targeting antibody conjugated to a STING agonist. Turning to systemically administered TLR agonists, Eikon Therapeutics is developing EIK1001, a TLR 7/8 agonist. EIK1001 is in a Phase 3 study in combination with the PD-1 inhibitor pembrolizumab in melanoma and a Phase 2 study in combination with chemotherapy and pembrolizumab in non-small cell lung cancer. In preclinical studies, Boltbody ISACs have demonstrated greater effectiveness with differentiated biology compared to unconjugated TLR or STING agonists. 

Many of our potential competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical, and clinical development, obtaining regulatory approvals, and marketing approved drugs than we do. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites, and enrolling subjects for our clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.