REDWOOD CITY, Calif.,
Nov. 10, 2020 /PRNewswire/ -- Bolt
Biotherapeutics, a clinical-stage immuno-oncology company
developing tumor-targeted therapies that leverage the power of the
innate and adaptive immune systems, today presented the trial
design of its ongoing Phase 1/2 clinical trial and preclinical data
demonstrating proof-of-concept of its lead clinical drug candidate,
BDC-1001. The clinical observations and preclinical data are now
available in three posters at the Society for Immunotherapy of
Cancer (SITC) Annual Meeting, being held virtually November 9-14.
"We are proud to present our recent scientific advances at the
SITC Annual Meeting highlighting that systemically-delivered
trastuzumab ISACs induce a robust, target-dependent activation of
the immune system in preclinical models as well as further
mechanistic insight for the observed robust anti-tumor activity,"
said David Dornan, senior vice
president of research and manufacturing at Bolt. "We hope to
confirm the promising results from our preclinical work in our
clinical trial that is currently ongoing."
The in-progress clinical trial poster titled, "Phase 1/2 study
of novel HER2-targeting, TLR7/8 immune-stimulating antibody
conjugate (ISAC) BDC-1001 with or without immune checkpoint
inhibitor in patients with advanced HER2-expressing solid tumors,"
highlighted the framework of Bolt's Phase 1/2 clinical trial, an
actively enrolling global study in patients with refractory
HER2-expressing solid tumors. The primary objectives of the study
are to evaluate safety and tolerability and determine the
recommended Phase 2 dose for both monotherapy and combination with
a checkpoint inhibitor. BDC-1001 is a novel treatment which
combines the targeting and antitumor effect of trastuzumab with
localized stimulation of the immune system via dual TLR7 and TLR8
agonism.
The preclinical results were shown in two posters. The first
titled, "Covalent attachment of a TLR7/8 agonist to tumor-targeting
antibodies drives potent anti-tumor efficacy by synergistically
activating FcgR- and TLR- signaling and enables safe systemic
administration," demonstrated that Bolt's immune stimulating
antibody conjugates (ISACs) are safe and well-tolerated in mice and
non-human primates. The ISACs enable potent toll-like receptor
(TLR) agonists to be safely administered systemically in
preclinical models. ISACs provided distinct and unexpected
biological advantage over unconjugated TLR agonists leading to more
robust and effective anti-tumor efficacy.
The final poster titled, "Systemically administered
HER2-targeted ISACs provoke a rapid, local response that engages
the innate and adaptive arms of the immune system to eradicate
tumors in preclinical models," demonstrated that within 24 hours of
administration, HER2-directed ISACs induced robust,
target-dependent activation of the immune system. There was robust
activation of immune cells following anti-HER2 ISAC treatment. In
contrast to other immune therapies, such as anti-PD1/PD-L1 and
anti-CD40, systemically administered ISACs locally engage both the
innate and adaptive immune system to eradicate tumors.
"These preclinical data further validate our tumor-targeting
BDC-1001 Boltbody ISAC as a promising candidate to treat
HER2-expressing solid tumors in our ongoing Phase 1/2 trial.
Recruitment is going well thanks to our dedicated investigators and
patients," said Edith Perez, M.D.,
Chief Medical Officer at Bolt. "We look forward to reporting the
initial data readout of our clinical trial soon."
About Bolt Biotherapeutics' Immune Stimulating Antibody
Conjugate (ISAC) Platform Technology
The
BoltbodyTM ISAC platform technology harnesses the
ability of innate immune agonists to convert cold tumors into
immunologically hot tumors, thereby illuminating tumors to the
immune system and allowing them to be invaded by tumor killing
cells. Boltbody ISACs have demonstrated the ability to eliminate
tumors following systemic administration as monotherapy in
preclinical models and have also led to the development of
immunological memory, which is predicted to translate into more
durable clinical responses for patients.
About the Ongoing BDC-1001 Phase 1/2 Study in Patients with
HER2-Expressing Solid Tumors
The Phase 1/2, multi-center,
open-label study is evaluating the safety, pharmacokinetics,
pharmacodynamics and proof of mechanism of BDC-1001 in patients
with HER2-expressing solid tumors. The first portion of the study
includes a monotherapy dose-escalation phase in which cohorts of
patients will receive ascending intravenous doses of BDC-1001 to
determine the maximum tolerated dose and/or the recommended dose to
advance into expansion cohorts and Phase 2 based on safety and
tolerability. The second portion of the study is a dose expansion
phase in which patients will receive BDC-1001 monotherapy to
further evaluate the safety, tolerability and clinical antitumor
activity of the recommended Phase 2 dose. Please refer to
www.clinicaltrials.gov NCT04278144 for additional clinical trial
information.
About Bolt Biotherapeutics, Inc.
Bolt
Biotherapeutics, based in the San
Francisco Bay Area, is a clinical-stage immuno-oncology
company developing tumor-targeted therapies that leverage the power
of the innate and adaptive immune systems. Bolt's proprietary
Boltbody ISAC approach utilizes immunostimulants to engage and
activate myeloid cells, including macrophages and dendritic cells,
in an anti-tumor response that illuminates tumors for the immune
system and triggers recruitment of tumor-killing cells. This
approach constitutes a new class of immuno-oncology therapeutics
that have eliminated tumors following systemic administration in
preclinical studies and results in the development of immunological
memory, which may lead to more durable clinical responses for
patients. Bolt's platform technology is applicable to a broad
spectrum of antibodies targeting tumor antigens expressed on all
types of cancer, including patients who are refractory to the
current generation of checkpoint inhibitors. The company was
founded by Dr. Ed Engleman, and its
platform is based on technology exclusively licensed from
Stanford University. The company is
financed by world-class investors, including Novo Holdings, Vivo
Capital, Pivotal bioVenture Partners, Sofinnova Investments, Nan
Fung Life Sciences, RA Capital Management, Surveyor Capital (a
Citadel Company), Rock Springs Capital, Pfizer Ventures, and
Samsara BioCapital. For more information about Bolt
Biotherapeutics, please visit www.boltbio.com
Media Contacts:
Maggie Beller or David
Schull
Russo Partners, LLC
646-942-5631
maggie.beller@russopartnersllc.com
david.schull@russopartnersllc.com
Investor Relations Contact:
Sarah McCabe
Stern Investor Relations, Inc.
212-362-1200
sarah.mccabe@sternir.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/bolt-biotherapeutics-presents-bdc-1001-ongoing-clinical-trial-design-and-supportive-preclinical-data-at-society-for-immunotherapy-of-cancer-annual-meeting-301170149.html
SOURCE Bolt Biotherapeutics, Inc.