-- Poster presentation to highlight data from
completed first-in-human, Phase 1 ascending dose clinical trial of
ADX-097 in healthy volunteers; results support Phase 2 dose
selection and continued clinical advancement of ADX-097 --
WALTHAM,
Mass., Oct. 14, 2024 /PRNewswire/ -- Q32 Bio
Inc. (Nasdaq: QTTB) ("Q32 Bio"), a clinical stage biotechnology
company focused on developing biologic therapeutics to restore
immune homeostasis, today announced that it will present clinical
data supporting its program for innate immunity, ADX-097, at the
American Society of Nephrology (ASN) Kidney Week 2024, taking place
October 24-27, 2024, in San Diego, Calif. Abstracts are available
here. ADX-097, Q32 Bio's lead product candidate from its
tissue-targeted complement inhibitor platform, is a humanized
anti-C3d mAb fusion protein being evaluated for the treatment of
patients with renal diseases associated with increased complement
activation.
"We look forward to presenting our promising clinical data at
ASN Kidney Week 2024 that supports the continued advancement of
ADX-097, our novel tissue-targeted inhibitor of complement
activation designed to inhibit complement in the diseased tissue
and minimize systemic complement blockade," said Shelia
Violette, Ph.D., Chief Scientific Officer of Q32 Bio. "In our
Phase 1 clinical trial, ADX-097 was observed to be generally
well-tolerated with desirable pharmacokinetics and pharmacodynamics
(PK/PD) properties. We believe ADX-097 has the potential to achieve
relevant complement inhibition directly in the tissue while sparing
systemic activity, with the goal of addressing limitations of the
currently available systemic approaches, including infection risk
and the need for high drug doses and frequent administration to
achieve therapeutic levels of complement inhibition."
"These first-in-human data for ADX-097 that we will share at
Kidney Week demonstrate the potential of our novel and
differentiated approach to inhibiting the complement system, a
validated biologic target," said Jodie Morrison, Chief
Executive Officer of Q32 Bio. "We remain focused on advancing our
pipeline of programs targeting the immune system for the treatment
of autoimmune and inflammatory diseases, including ADX-097 in two
Phase 2 clinical trials."
Presentation Details:
Abstract Title: ADX-097, a Tissue-Targeted
Complement Inhibitor for the Treatment of Renal Diseases: Phase 1
Results in Healthy Participants and Model-Informed Phase 2 Dose
Selection
Presenter: Dr. Bernd
Jilma, M.D., Professor, Department of Clinical Pharmacology,
Medical University of Vienna,
Austria
Date & Time: Saturday, October 26,
2024, from 10:00 a.m. to 12:00 p.m.
PT
Session Type: Poster
Session Title: C3G, TMA, MGRS, Amyloidosis, and More
Abstract ID: 4123429
Summary:
- ADX-097, a C3d mAb – fH fusion protein, was designed to
inhibit complement in the diseased kidney while avoiding systemic
blockade, providing the potential for an enhanced activity and
safety profile. In a Phase 1 ascending dose clinical study of
ADX-097 in healthy volunteers, ADX-097 demonstrated a favorable
safety profile and desired PK/PD properties, supporting a Phase 2
dose that is predicted to provide tissue inhibition of complement
in glomerular diseases while sparing systemic complement
activity.
About ADX-097
ADX-097, the lead product candidate from Q32 Bio's
tissue-targeted complement inhibitor platform, is a humanized
anti-C3d mAb fusion protein. ADX-097 is designed to restore
complement regulation—an integral part of the innate immune
system—through a novel, tissue-targeted mechanism. Q32 Bio is
currently evaluating ADX-097 in an open-label Phase 2 renal basket
clinical trial and is planning to evaluate ADX-097 in a Phase 2
clinical trial in ANCA-Associated Vasculitis (AAV).
About Q32 Bio
Q32 Bio is a clinical stage biotechnology company developing
biologic therapeutics targeting potent regulators of the innate and
adaptive immune systems to re-balance immunity in autoimmune and
inflammatory diseases. Q32 Bio's lead programs, focused on the IL-7
/ TSLP receptor pathways and complement system, address immune
dysregulation to help patients take back control of their
lives.
Q32 Bio's program for adaptive immunity, bempikibart (ADX-914),
is a fully human anti-IL-7Rα antibody that re-regulates adaptive
immune function for the treatment of autoimmune diseases. It is
being evaluated in two Phase 2 trials for the treatment of atopic
dermatitis and alopecia areata. The IL-7 and TSLP pathways have
been genetically and biologically implicated in driving several T
cell-mediated pathological processes in numerous autoimmune
diseases. Q32 Bio's program for innate immunity, ADX-097, is based
on a novel platform enabling tissue-targeted regulation of the
complement system without long-term systemic blockade – a key
differentiator versus current complement therapeutics. Q32 Bio has
completed a first-in-human, Phase 1 ascending dose clinical study
of ADX-097 in healthy volunteers.
For more information, visit www.Q32Bio.com.
Availability of Other Information About Q32 Bio
Investors and others should note that we communicate with our
investors and the public using our company
website www.Q32Bio.com, including, but not limited to, company
disclosures, investor presentations and FAQs, Securities and
Exchange Commission filings, press releases, public conference
call transcripts and webcast transcripts, as well as on X (formerly
Twitter) and LinkedIn. The information that we post on our website
or on X or LinkedIn could be deemed to be material information. As
a result, we encourage investors, the media and others interested
to review the information that we post there on a regular basis.
The contents of our website or social media shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933, as amended.
Forward-Looking Statements
This communication contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995, as amended, relating to our business, operations and
financial condition, including but not limited to current beliefs,
expectations and assumptions regarding the future of our business,
future plans and strategies, our clinical results and related
timing, including statements regarding expectations surrounding the
potential, safety, efficacy, and regulatory and clinical progress
of Q32 Bio's product candidates, including ADX-097, and anticipated
milestones and timing, among others.
Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or
conditions, and include words such as "may," "will," "should,"
"would," "expect," "anticipate," "plan," "likely," "believe,"
"estimate," "project," "intend," and other similar expressions
among others. Statements that are not historical facts are
forward-looking statements. Forward-looking statements are based on
current beliefs and assumptions that are subject to risks and
uncertainties and are not guarantees of future performance. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors,
including, without limitation: interim, topline and preliminary
data may change as more patient data become available, and are
subject to audit and verification procedures that could result in
material changes in the final data; data generated from our
preclinical and clinical studies such as our Phase 2 clinical
trials of ADX-097, may not meet our expectations; our product
candidates may not provide the intended therapeutic benefits; our
product candidates may cause serious adverse side effects; the
ability to integrate our business with our merger partner
successfully and to achieve anticipated synergies; the possibility
that other anticipated benefits of the merger will not be realized,
including without limitation, anticipated revenues, expenses,
earnings and other financial results, and growth and expansion of
our operations, and the anticipated tax treatment of the merger;
our ability to retain, attract and hire key personnel; potential
adverse reactions or changes to relationships with employees,
suppliers or other parties resulting from the completion of the
merger; potential business uncertainty, including changes to
existing business relationships that could affect our financial
performance; the need for additional funding, which may not be
available; failure to identify additional product candidates and
develop or commercialize marketable products; the early stage of
our development efforts; potential unforeseen events during
clinical trials could cause delays or other adverse consequences;
risks relating to the regulatory approval process; the inability to
maintain our collaborations, or the failure of these
collaborations; our reliance on third parties, including for the
manufacture of materials for our research programs, preclinical and
clinical studies; failure to obtain U.S. or international marketing
approval; ongoing regulatory obligations; effects of
significant competition; unfavorable pricing regulations,
third-party reimbursement practices or healthcare reform
initiatives; product liability lawsuits; securities class action
litigation; the impact of global pandemics and general
economic conditions on our business and operations, including the
our preclinical studies and clinical trials; the possibility of
system failures or security breaches; risks relating to
intellectual property; significant costs incurred as a result of
operating as a public company; and such other factors as are set
forth in Q32 Bio's periodic public filings with the SEC, including
but not limited to those described under the heading "Risk Factors"
in our Form 10-Q filed with the Securities and Exchange Commission
on August 8, 2024 and any subsequent filings made with
the Securities and Exchange Commission. Except as required by
applicable law, we undertake no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contacts:
Investors: Brendan Burns
Media: Sarah Sutton
Argot Partners
212.600.1902
Q32Bio@argotpartners.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/q32-bio-to-present-tissue-targeted-complement-inhibitor-adx-097-positive-phase-1-clinical-trial-results-at-the-american-society-of-nephrology-kidney-week-2024-302274267.html
SOURCE Q32 Bio