Bolt Biotherapeutics to Present Interim Clinical Data on BDC-1001 Phase 1/2 Clinical Trial at ESMO Immuno-Oncology Congress 2021
Bolt Biotherapeutics (BOLT) has announced the presentation of interim clinical data for BDC-1001 at the ESMO I-O Congress 2021, scheduled from December 8-11, 2021. This data includes insights from over 50 patients and highlights safety, tolerability, and early signs of clinical activity. The presentation will inform an ongoing Phase 1/2 study and support the initiation of a combination dose-escalation study with Opdivo by year-end. The poster will be accessible online starting December 6, 2021, at 12 p.m. CET, with a company conference call planned for the same date at 8:00 a.m. ET.
- Presentation of interim clinical data for BDC-1001, indicating early signs of clinical activity.
- Data includes insights from over 50 patients, enhancing understanding of safety and tolerability.
- Plans to initiate a combination dose-escalation study with Opdivo by year-end, indicating forward progress.
- None.
REDWOOD CITY, Calif., Dec. 02, 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 the company will be presenting interim clinical data in a virtual poster on BDC-1001, starting on December 6, 2021 in conjunction with the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021 taking place on December 8 - 11, 2021. BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated to a TLR7/8 agonist with a non-cleavable linker.
“The data we will be presenting at ESMO I-O includes more than 50 patients at increasing exposures and builds upon the data presented at ASCO 2021. We will be presenting additional insights into BDC-1001’s safety and tolerability profile, pharmacokinetics, tumor and serum biomarkers, and early signs of clinical activity. These interim results support continued investigation towards an optimal dosing regimen, as well as the initiation of a combination dose-escalation study with Opdivo® by year-end,” said Edith A. Perez, M.D, Chief Medical Officer of Bolt Biotherapeutics.
The poster will be available in the e-Posters section of the conference virtual platform as of December 6 at 12 p.m. CET:
Abstract Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors
Presenter: Manish R. Sharma, M.D., Associate Director of Clinical Research, START Midwest
Presentation Number: 164P
Timing: On-Demand Access
Bolt Biotherapeutics management will host a conference call for the investment community, in conjunction with the now virtual ESMO Immuno-Oncology Congress 2021, to discuss emerging clinical data and insights from the ongoing Phase 1/2 study at 8:00 a.m. ET/5 a.m. PT on Monday, December 6, 2021.
A live webcast, including slides, will be available on the Events & Presentations page of Bolt Biotherapeutic’s website at www.boltbio.com. An archived replay can be accessed for 30 days following the webcast.
Opdivo® is a trademark of Bristol-Myers Squibb Company.
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 the success and results of our pipeline programs and product candidates and the potential initiation of an additional combination dose escalation study by year-end, 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 Annual Report on Form 10-K for the year ended December 31, 2020. 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
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david.schull@russopartnersllc.com
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