BOLT Bolt Biotherapeutics Inc.

13.02
+0.02  (+0%)
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  1. REDWOOD CITY, Calif., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that it will be presenting three abstracts at the 2021 Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting, which is being held from Nov. 10-14, both virtually and in person in Washington, D.C.

    The three poster presentations highlight assets in Bolt's preclinical pipeline, including two Boltbody immune stimulating antibody conjugate (ISAC) candidates and an agonist antibody. BDC-2034 is a Boltbody ISAC targeting CEA…

    REDWOOD CITY, Calif., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that it will be presenting three abstracts at the 2021 Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting, which is being held from Nov. 10-14, both virtually and in person in Washington, D.C.

    The three poster presentations highlight assets in Bolt's preclinical pipeline, including two Boltbody immune stimulating antibody conjugate (ISAC) candidates and an agonist antibody. BDC-2034 is a Boltbody ISAC targeting CEA, and the other Boltbody ISAC program targets PD-L1. The company's proprietary agonist antibody targets Dectin-2 (also known as TAM1). Information about these presentations can be found below and on the 2021 SITC Annual Meeting website.

    Title: BDC-2034: Discovery of a CEA-targeting Immune-Stimulating Antibody Conjugate (ISAC) for Solid Tumors

    Presenter: William G. Mallet, Ph.D.

    Poster Number: 784

    Details: Saturday, Nov. 13, 2021, 7:00 a.m. - 8:30 p.m. EST, Poster Hall

    Title: Dectin-2, a novel target for tumor macrophage reprogramming in cancer immunotherapy

    Presenter: Justin A. Kenkel, Ph.D.

    Poster Number: 862

    Details: Saturday, Nov. 13, 2021, 7:00 a.m. - 8:30 p.m. EST, Poster Hall

    Title: PD-L1-targeted ISAC combines myeloid cell activation, immune-checkpoint inhibition and ADCP to improve anti-tumor efficacy over anti-PD-L1 antibodies in preclinical models

    Presenter: Marcin Kowanetz, Ph.D.

    Poster Number: 782

    Details: Saturday, Nov. 13, 2021, 7:00 a.m. - 8:30 p.m. EST, Poster Hall

    About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform

    ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient's innate immune system. By initially targeting a single marker on the surface of a patient's tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's lead candidate, BDC-1001, is a BoltbodyTM Immune-stimulating Antibody Conjugate (ISAC) comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of early-stage immuno-oncology products. To learn more about Bolt Biotherapeutics, please visit www.boltbio.com.

    Investor Relations and Media Contacts:

    Karen L. Bergman

    Vice President, Communications and Investor Relations

    Bolt Biotherapeutics, Inc.

    650-665-9295

    kbergman@boltbio.com

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com



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  2. REDWOOD CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that it has entered into a clinical collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMY) to investigate Bolt Biotherapeutics' BDC-1001 in combination with Bristol Myers Squibb's PD-1 checkpoint inhibitor Opdivo® (nivolumab). BDC-1001 is a HER2-targeting Boltbody™ immune-stimulating antibody conjugate (ISAC) in development for the treatment of patients with HER2-expressing solid tumors.

    "We look forward to working…

    REDWOOD CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that it has entered into a clinical collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMY) to investigate Bolt Biotherapeutics' BDC-1001 in combination with Bristol Myers Squibb's PD-1 checkpoint inhibitor Opdivo® (nivolumab). BDC-1001 is a HER2-targeting Boltbody™ immune-stimulating antibody conjugate (ISAC) in development for the treatment of patients with HER2-expressing solid tumors.

    "We look forward to working with BMS in our continued development of BDC-1001, which has shown promising results in preclinical and early clinical studies," said Randall Schatzman, CEO of Bolt Biotherapeutics. "Our unique ISAC approach initiates an innate and an adaptive immune response that may be synergistic with BMS' innovative PD-1 inhibitor Opdivo. The combination of BDC-1001 and Opdivo holds potential as a treatment for cancer patients, and we welcome the opportunity to investigate this in a clinical setting." He added, "We remain grateful to all of the healthcare professionals, scientists, patients, and families involved with Bolt's clinical studies."

    BDC-1001 is a human epidermal growth factor receptor 2 (HER2) ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists with an intervening non-cleavable linker, for the treatment of patients with HER2-expressing solid tumors. It is currently being investigated in a Phase 1/2 clinical trial (NCT04278144) in patients with solid tumors, including breast, gastroesophageal and colorectal, that are HER2+ or HER2-low, for which Bolt recently presented preliminary data detailing safety, tolerability, and signs of activity at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial is being conducted in four parts, with dose-escalation and dose-expansion parts exploring both monotherapy and combination with a PD-1 checkpoint inhibitor. BMS will provide Opdivo for the combination dose escalation and combination dose expansion portions of the trial. Bolt Biotherapeutics is the study sponsor and will be responsible for costs associated with the trial execution. The combination dose escalation is expected to start later in 2021.

    Opdivo® is a trademark of Bristol-Myers Squibb Company.

    About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform

    ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient's innate immune system. By initially targeting a single marker on the surface of a patient's tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to collaborate with Bristol-Myers Squibb to investigate combination therapeutics for the treatment of cancer, our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative 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 represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become 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 actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the SEC, including our Quarterly Report on Form 10-Q for the three months ended March 31, 2021. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

    Investor Relations and Media Contacts:

    Karen L. Bergman

    Vice President, Communications and Investor Relations

    Bolt Biotherapeutics, Inc.

    650-665-9295

    kbergman@boltbio.com

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com  



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  3. REDWOOD CITY, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that management will present a corporate update and conduct meetings with the investment community at four upcoming virtual investor conferences in September:

    • Citi's 16th Annual BioPharma Virtual Conference
      Meetings with investors on Wednesday, Sept. 8
    • Wells Fargo Virtual Healthcare Conference
      Presentation on Thursday, Sept. 9, at 12:30 p.m. PT (3:20 p.m. ET)
    • Morgan Stanley 19th Annual Global Healthcare Conference
      Fireside chat on Monday…

    REDWOOD CITY, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that management will present a corporate update and conduct meetings with the investment community at four upcoming virtual investor conferences in September:

    • Citi's 16th Annual BioPharma Virtual Conference

      Meetings with investors on Wednesday, Sept. 8

    • Wells Fargo Virtual Healthcare Conference

      Presentation on Thursday, Sept. 9, at 12:30 p.m. PT (3:20 p.m. ET)

    • Morgan Stanley 19th Annual Global Healthcare Conference

      Fireside chat on Monday, Sept. 13, at 12:30 p.m. PT (3:30 p.m. ET)

    • 2021 Cantor Fitzgerald Virtual Global Healthcare Conference

      Presentation on Thursday, Sept. 30, at 11:00 a.m. PT (2:00 p.m. ET)

    A live webcast of the presentations will be available on the Events and Presentations page of Bolt's website at www.boltbio.com. Archived replays will be available for 30 days following the event.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugate (ISAC) approach uses immunostimulants to engage and activate myeloid cells that directly kill tumor cells. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing additional Boltbody ISAC product candidates targeting CEA and PD-L1. For more information, visit https://www.boltbio.com/.

    Investor Relations and Media Contacts:

    Karen L. Bergman

    Vice President, Communications and Investor Relations

    Bolt Biotherapeutics, Inc.

    650-665-9295

    kbergman@boltbio.com

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com



    Primary Logo

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  4. SAN FRANCISCO and SUZHOU, China, Aug. 26, 2021 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Bolt Biotherapeutics, Inc. ("Bolt") (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates.

    The parties will leverage Innovent's…

    SAN FRANCISCO and SUZHOU, China, Aug. 26, 2021 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Bolt Biotherapeutics, Inc. ("Bolt") (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates.

    The parties will leverage Innovent's proprietary therapeutic antibody portfolio and discovery capability against undisclosed oncology targets in combination with Bolt's advanced ISAC technology and myeloid biology expertise to create three new cancer treatments with the potential to provide significant benefit to patients. The Boltbody ISAC platform combines a tumor-targeting antibody, a stable non-cleavable linker, and a proprietary immune stimulant. Boltbody ISACs unite the precision of antibody targeting with the power of innate and adaptive immune system response.  

    Under the agreement, Innovent has the rights to all three programs in Greater China, and retains an option to license global rights for one program, as well as rights for all territories except North America for another program. Bolt retains the option to license global rights outside of Greater China for one program, and North American rights for another program. Innovent is responsible for all research and development costs through clinical proof-of-concept (POC).  Upon review of the initial clinical proof-of-concept data, the companies can exercise licensing options for continued development and exclusive commercialization rights in specific territories on a program-by-program basis. Bolt will receive an upfront payment of US$5 million in cash from Innovent at signing and a possible future equity investment of up to US$10 million. Furthermore, both Innovent and Bolt are eligible to receive additional milestones payments and royalties associated with the development and commercialization of products in each other's territories.

    Dr. Yong Jun Liu, President of Innovent Biologics, stated, "We are very excited about the potential for the Boltbody ISAC platform to generate best-in-class approaches treating multiple tumor types. Bolt has spent several years building and optimizing this platform, which we can leverage to expedite the development of important new products. We look forward to working together with Bolt to bring innovative therapies to patients as soon as possible."

    "Innovent is a leader in the development of innovative antibody therapeutics for the treatment of cancer, with advanced research and development teams and an expanding commercial infrastructure in China. We look forward to collaborating with Innovent on the development of novel ISAC anti-cancer therapeutic candidates," said Randall Schatzman, Ph.D., CEO of Bolt. "Our preclinical and early clinical studies have demonstrated  the safety and efficacy of the ISAC approach and the benefits of stimulating both the innate and adaptive arms of the immune system in the fight against cancer."

    About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform

    ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient's innate immune system. By initially targeting a single marker on the surface of a patient's tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

    About Innovent

    Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

    Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 25 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical studies.

    Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

    Note:

    Sintilimab is not an approved product in the United States.

    BYVASDA® (bevacizumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), and SULINNO® (adalimumab biosimilar injection) are not approved products in the United States.

    TYVYT® (sintilimab injection, Innovent)

    BYVASDA® (bevacizumab biosimilar injection, Innovent)

    SULINNO® (adalimumab biosimilar injection, Innovent)

    Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    Innovent Biologics, Inc. Forward-Looking Statements

    This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

    These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

    Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

    Cision View original content:https://www.prnewswire.com/news-releases/innovent-and-bolt-biotherapeutics-announce-collaboration-to-develop-three-new-oncology-boltbody-isac-programs-301363537.html

    SOURCE Innovent Biologics, Inc.

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    • Innovent will provide proprietary antibodies for selected tumor targets and Bolt will provide its proprietary Boltbody™ technology to create new immune-stimulating antibody conjugates (ISACs)

    • Innovent will pay Bolt an upfront payment and fund development through clinical proof of concept

    • Innovent has rights to all programs in Greater China, and both parties have options to participate in full development and commercialization for various regions

    REDWOOD CITY, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems…

    • Innovent will provide proprietary antibodies for selected tumor targets and Bolt will provide its proprietary Boltbody™ technology to create new immune-stimulating antibody conjugates (ISACs)



    • Innovent will pay Bolt an upfront payment and fund development through clinical proof of concept



    • Innovent has rights to all programs in Greater China, and both parties have options to participate in full development and commercialization for various regions

    REDWOOD CITY, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, and Innovent Biologics, Inc. (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates.

    The parties will leverage Innovent's proprietary therapeutic antibody portfolio and discovery capability against undisclosed oncology targets in combination with Bolt's advanced ISAC technology and myeloid biology expertise to create three new cancer treatments with the potential to provide significant benefit to patients. The Boltbody ISAC platform combines a tumor-targeting antibody, a stable, non-cleavable linker, and a proprietary immune stimulant. Boltbody ISACs unite the precision of antibody targeting with the power of innate and adaptive immune system response.

    "Innovent is a leader in the development of innovative antibody therapeutics for the treatment of cancer, with advanced research and development teams and an expanding commercial infrastructure in China. We look forward to collaborating with Innovent on the development of novel ISAC anti-cancer therapeutic candidates," said Randall Schatzman, Ph.D., CEO of Bolt Bio. "Our preclinical and early clinical studies have demonstrated the safety and efficacy of the ISAC approach and the benefits of stimulating both the innate and adaptive arms of the immune system in the fight against cancer."

    "We are very excited about the potential for the Boltbody ISAC platform to generate best-in-class approaches treating multiple tumor types," said Dr. Yong Jun Liu, President of Innovent Biologics. "Bolt has spent several years building and optimizing this platform, which we can leverage to expedite the development of important new products. We look forward to working together with Bolt to bring innovative therapies to patients as soon as possible."

    Under the agreement, Innovent has the rights to all three programs in Greater China, and retains an option to license global rights for one program, as well as rights for all territories except North America for another program. Bolt retains the option to license global rights outside of Greater China for one program, and North American rights for another program. Innovent is responsible for all research and development costs through clinical proof-of-concept. Upon review of the initial clinical proof-of-concept data, the companies can exercise licensing options for continued development and exclusive commercialization rights in specific territories on a program-by-program basis. Bolt will receive an upfront payment of $5 million in cash from Innovent at signing and a possible future equity investment of up to $10 million. Furthermore, both Bolt and Innovent are eligible to receive additional milestone payments and royalties associated with the development and commercialization of products in each other's territories.

    About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform

    ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient's innate immune system. By initially targeting a single marker on the surface of a patient's tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

    About Bolt Biotherapeutics, Inc.

    Bolt Biotherapeutics, Inc. is a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems. Bolt's proprietary Boltbody™ Immune-stimulating Antibody Conjugates (ISACs) are designed to target tumor cells for elimination by myeloid cells, which then activates the myeloid cells to recruit the adaptive immune system in the anti-tumor response. This leads to the conversion of immunologically "cold" tumors to "hot" tumors. Bolt's lead candidate, BDC-1001, is a Boltbody ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to one of Bolt's proprietary TLR7/8 agonists for the treatment of patients with HER2-expressing solid tumors. Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and a pipeline of other immuno-oncology products.

    About Innovent Biologics, Inc.

    Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

    Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 25 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical studies.

    Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

    Forward-Looking Statements

    This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to collaborate with Innovent to discover and develop therapeutics for the treatment of multiple types of cancer, our ability to leverage Innovent's antibody portfolio in connection with our technology and expertise, our ability to develop multiple ISAC therapeutics with Innovent, the achievement of milestone payments or royalties, and our future results of operations, financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative 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 represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become 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 actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the SEC, including our Quarterly Report on Form 10-Q for the three months ended June 30, 2021. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov.

    Investor Relations and Media Contacts:    

    Karen L. Bergman

    Vice President, Communications and Investor Relations

    Bolt Biotherapeutics, Inc.

    650-665-9295

    kbergman@boltbio.com

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

    sarah.mccabe@sternir.com

    Maggie Beller or David Schull

    Russo Partners, LLC

    646-942-5631

    maggie.beller@russopartnersllc.com

    david.schull@russopartnersllc.com  



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