Bolt Biotherapeutics presented new preclinical data from three pipeline projects at the annual meeting of the Society for Cancer Immunotherapy (SITC)

2021-12-08 12:40:00 By : Ms. Jenny Moo

Demonstrated preclinical data supporting the selection of BDC-2034 (an ISAC targeting CEA) as Bolt Biotherapeutics’ second Boltbody™ ISAC drug candidate

Demonstrate a novel multifunctional mechanism of ISAC that combines PD-1/PD-L1 axis inhibition with TLR activation

Identification of a novel agonist antibody targeting Dectin-2, now shown as Bolt Biotherapeutics’ TAM1 target, designed to reprogram tumor-supporting macrophages into tumor-destroying macrophages

Redwood City, California, November 12, 2021 (GLOBE NEWSWIRE) - Bolt Biotherapeutics, Inc. (NASDAQ: BOLT), a clinical-stage biotechnology company, pioneered a class of conjugated antibody targeting precision With the power of the innate immune system and the adaptive immune system, the company announced today that the company will demonstrate its three pipelines at the 2021 Association for Cancer Immunotherapy (SITC) annual meeting on Saturday, November 13th. The new data poster for the project will be held in Washington, D.C. from November 10th to 14th in a virtual way and in person. Each presentation emphasized the progress made in preclinical research to demonstrate the potential of each candidate pipeline as a new method for the treatment of cancer.

Dr. David Dornan of Bolt Biotherapeutics said: “We are providing new data for our three pipeline projects, which demonstrate the depth of our technology platform and our team’s ability to regulate bone marrow cell biology to develop promising therapeutic candidates. Professional knowledge." Chief Science Officer. "The repolarization of tumor-associated macrophages or TAMs through the new target Dectin-2 is a tumor-destructive work. This is a pioneering work that may have a synergistic effect with our entire Boltbody ISAC product portfolio. We are targeting The work of CEA and PD-L1 reinforces our commitment to developing therapies that may have good activity against solid tumors with limited treatment options."

The highlights of the three posters are as follows. A copy of the poster can be found on the Bolt Biotherapeutics website. Poster #784: "BDC-2034: Discovery of CEA Targeted Immunostimulatory Antibody Conjugate (ISAC) for Solid Tumors" Speaker: Dr. William G. Mallet Details: Saturday, November 13, 2021, 7: United States 00 am to 8:30 pm Eastern Standard Time, Poster Hall

The main findings of the study: CEA is a fully validated tumor antigen that can be used to develop targeted therapies for many types of solid tumors (such as colon cancer), which urgently need new treatment options. In view of the large number of innate immune cells in CEA-expressing cancers, innate immune stimulation is a promising treatment strategy. Using Boltbody platform technology, Bolt Biotherapeutics scientists have developed a new type of CEA targeting ISAC, BDC-2034, to take advantage of the overexpression of CEA in cancer. BDC-2034 is designed to trigger the innate immune system, leading to adaptive anti-tumor immunity and tumor destruction.

BDC-2034 contains a new CEA targeting antiphagocytic antibody coupled to a proprietary TLR7/8 agonist payload. Both elements of the molecule have been fine-tuned to enable selective immune activation in tumors.

The new data reported on SITC 2021 indicates that tumor cell clearance and innate immune activation in cells and in vivo models of cancer expressing CEA. In addition, systemic administration in tumor-bearing animals can lead to selective tumor immunity.

Based on these data, Bolt Biotherapeutics has designated BDC-2034 as a clinical candidate drug, and is currently conducting IND-supported research, and expects to initiate clinical development of BDC-2034 in 2022.

Poster #782: "PD-L1 targeting ISAC combines bone marrow cell activation, immune checkpoint suppression, and ADCP to improve the anti-tumor efficacy of anti-PD-L1 antibodies in preclinical models." Speaker: Dr. Marcin Kowanetz. Details: Saturday, November 13, 2021, 7:00 am-8:30 pm Eastern Standard Time, Poster Hall

The main findings of the study: Bolt Biotherapeutics scientists demonstrated for the first time the preclinical data of a new type of multifunctional PD-L1 targeting Boltbody ISAC. The data has proven to be possible to improve the efficacy of PD-L1/PD-1 inhibition, especially in the Immune checkpoints suppress tumor types that do not respond well.

Bolt Biotherapeutics' PD-L1 ISAC uniquely combines three mechanisms of action: ADCP and bone marrow cell activation of ISAC, coupled with immune checkpoint suppression, can act through PD-L1 expressed on tumors and immune cells.

The data provided on SITC 2021 demonstrates how PD-L1 ISAC induces a powerful, goal-dependent activation of the immune system, including the induction of immune memory.

In preclinical models, treatment with PD-L1 ISAC can produce an effective anti-tumor response, which is significantly improved compared to PD-L1 antibody blockade.

Poster #862: "Dectin-2, a new target for tumor macrophage reprogramming in cancer immunotherapy" Speaker: Justin A. Kenkel, Ph.D. Details: Saturday, November 13, 2021, 7 am Eastern Standard Time :00-8:30 pm, poster hall

The main findings of the study: Bolt Biotherapeutics provided data for the first time to provide preclinical verification for Dectin-2 (previously known as TAM1) as a new target for cancer immunotherapy. Expressed by tumor-associated macrophages (TAM), Dectin-2 is a pattern recognition receptor that stimulates the production of pro-inflammatory cytokines and antigen presentation to drive innate and adaptive immune responses.

The research results reported on SITC 2021 indicate that the agonistic effect of Dectin-2 on TAM can cause the secretion of pro-inflammatory cytokines and chemokines, which can trigger productive anti-tumor immunity.

In murine tumor models, Dectin-2 agonists mediate anti-tumor efficacy in a CD8 T cell-dependent manner and induce immune memory against tumors.

Bolt Biotherapeutics scientists have produced Dectin-2 agonist antibodies that show the potential to reprogram tumor-supporting macrophages into tumor-destroying macrophages.

About Boltbody™ Immunostimulatory Antibody Conjugate (ISAC) platform ISAC is a new type of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune system. Boltbody ISAC contains three main components: tumor-targeting antibodies, non-cleavable linkers, and proprietary immunostimulants used to activate the patient's innate immune system. By initially targeting a single marker on the surface of a patient's tumor cells, ISAC can generate a new immune response by activating and recruiting bone marrow cells. Activated bone marrow cells release cytokines and chemokines. These chemical signals attract other immune cells and lower the activation threshold of immune response, starting a feedforward cycle. This will reprogram the tumor microenvironment and trigger an adaptive immune response against the tumor, with the goal of providing a durable response for cancer patients.

About Bolt Biotherapeutics, Inc. Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company that has created a new class of immuno-oncology drugs that combines the targeting accuracy of antibodies with the power of the innate and adaptive immune system. Bolt Biotherapeutics’ main drug candidate, BDC-1001, is a Boltbody™ immunostimulatory antibody conjugate (ISAC) that contains a trastuzumab biosimilar targeting HER2 that is compatible with the company’s proprietary One of the TLR7/8 agonists is coupled to treat patients with solid tumors expressing HER2. Bolt Biotherapeutics is also advancing BDC-2034, a Boltbody ISAC for CEA, and a series of early immuno-oncology products. To learn more about Bolt Biotherapeutics, please visit www.boltbio.com.

Forward-looking statements This press release contains forward-looking statements about us and our industry. These statements involve significant risks and uncertainties and are based on our beliefs and assumptions and the information currently available to us. All statements other than the statements of historical facts contained in this press release, including about the success and results of our pipeline plan, our ability to synergize the pipeline plan with the Boltbody platform, our future operational results, financial status, business strategy and The management plans and goals for future operations are forward-looking statements. In some cases, you can identify forward-looking statements because they contain such things as "expects", "believes", "may", "estimates", "anticipates", "intends", "may", "plans", " Potential, "forecast," "plan," "should," "will," or "will," or the negative forms of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements only represent our current beliefs, estimates and assumptions as of the date of this press release and should not be relied on the information contained in this press release to represent our estimates of any subsequent dates. These statements and related risks, uncertainties, factors and assumptions include but are not limited to the potential product candidates developed by us may not be able to pass clinical development or obtain the required regulatory approval within the expected time or at all; clinical trials may not be able to confirm Any safety, potency, or other product characteristics described or assumed in this press release; such candidate products may not be beneficial to patients or commercialized. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons why actual results may differ materially from the expected results in the forward-looking statements, even if new information is available in the future. More information about factors that may cause actual results to differ materially from those expected in our forward-looking statements is contained in our reports that we have filed or will file with the U.S. Securities and Exchange Commission, including our three-month 10-Q The quarterly report of the form is due on September 30, 2021. These documents (if available) can be found on the Investor Relations section of our website (investor.boltbio.com) and the US Securities and Exchange Commission's website www.sec.gov.

Investor Relations and Media Contact: Karen L. Bergman Vice President of Communications and Investor Relations Bolt Biotherapeutics, Inc. 650-665-9295 kbergman@boltbio.com

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