Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapy company focused
on driving innovation to transform outcomes for cancer patients,
today presented initial safety, tolerability and immune activation
and clinical response data from its ongoing Phase 1 open-label,
multi-center, dose escalation and expansion clinical trial of
ONCR-177 at the Society for Immunotherapy of Cancer's (SITC) 36th
Annual Meeting, taking place November 12-14th in Washington, D.C.
and virtually. In the fully enrolled and completed surface lesion
dose escalation part of the Phase 1 study, ONCR-177 was well
tolerated with no dose-limiting toxicities. In addition, three of
eight evaluable patients at RP2D (as of a November 8, 2021 data
cut-off) with cutaneous melanoma, squamous cell carcinoma of the
head and neck (SCCHN), and mucosal melanoma, experienced clinical
benefit after two doses of ONCR-177. ONCR-177, Oncorus’ lead
oncolytic HSV product candidate, is an intratumorally (iTu)
administered viral immunotherapy being developed for multiple solid
tumor indications.
“I’m encouraged by the findings from the ONCR-177 Phase 1 trial
we presented at SITC today,” said Jong Chul Park, M.D., Instructor,
Harvard Medical School and Assistant in Medicine, Massachusetts
General Hospital, and first author on the SITC abstract. “We are
evaluating ONCR-177 in heavily pretreated cancer patients with
advanced disease and no available standard of care. I’m impressed
by the overall favorable safety and tolerability profile of
ONCR-177 observed to date and the clinical responses demonstrated
in some patients after only four weeks of monotherapy treatment. I
look forward to enrolling patients in the combination cohort with
pembrolizumab with the potential for amplification of clinical
benefit.”
Oncorus has engineered its proprietary HSV platform to develop
improved iTu-administered viral immunotherapies that have the
potential to enhance potency without sacrificing safety, a
challenge that has been encountered by earlier-generation programs
in this class. ONCR-177 incorporates two innovative, orthogonal
safety strategies -- the use of microRNA target sequences and a
proprietary mutation engineered in an HSV-1 protein known as UL37
-- to allow for replication only in tumors (Kennedy, Mol Thera
Onco, 2020). These innovations allow for ONCR-177 to keep its
ability to resist interferon challenge, via the retention of γ34.5,
which is deleted in other HSV-based viral immunotherapies either on
the market or in development today, and to be armed with five
immunomodulatory transgenes: IL-12, FLT3L, CCL4, and antagonists of
clinically proven immune checkpoints PD-1 and CTLA-4.
Theodore (Ted) Ashburn, M.D., Ph.D., President and CEO of
Oncorus, commented, “We are excited by these data as they provide
strong proof of concept for our HSV platform. To see clinical
benefit in heavily pretreated patients across multiple histologies
is a testament to the promise of our platform, of ONCR-177, and of
our ability to deliver a potent, multidimensional attack on cancer
without sacrificing safety, thanks to our novel engineering.
Furthermore, these data also support the development of ONCR-GBM,
our HSV preclinical candidate being developed to specifically treat
brain tumors, including glioblastoma multiforme, as well as
potential future HSV programs. With several important milestones
slated for 2022, we look forward to continuing to provide updates
on ONCR-177 and the rest of our pipeline.”
ONCR-177 Phase 1 Trial Design
The Phase 1 clinical trial is designed to evaluate the safety,
tolerability and initial efficacy of ONCR-177 administered alone
and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in
patients with advanced and/or refractory cutaneous, subcutaneous or
metastatic nodal solid tumors or with liver metastases of solid
tumors. The trial is composed of four primary parts:
- Part 1: surface lesion dose escalation (to determine RP2D) and
tissue-specific dose expansion monotherapy, including breast
cancer, melanoma, non-melanoma skin cancer, and head and neck
cancer expansion cohorts;
- Part 2: surface lesion dose expansion combination with
KEYTRUDA;
- Part 3: visceral injection into liver metastases dose
escalation (to determine RP2D) and dose expansion monotherapy;
and
- Part 4: visceral injection dose expansion combination therapy
with pembrolizumab.
Key safety and exploratory biomarkers include ONCR-177 detection
in skin swabs, anti-HSV-1 antibodies, ONCR-177 payloads in blood,
peripheral inflammatory cytokines, immune infiltration of the tumor
and PD-L1 immunohistochemistry, or IHC, expression.
Phase 1 Initial Safety and Efficacy Results
Today, Oncorus presented preliminary findings at SITC from Part
1 of the trial, including the fully enrolled and completed dose
escalation cohorts (n=14) and patients enrolled in the dose
expansion monotherapy as of a November 1, 2021 data cut-off
(n=5).
ONCR-177 administered to heavily pretreated patients with
advanced, injectable solid tumors was well-tolerated with no
dose-limiting toxicities, and the recommended RP2D was determined
to be 4x108 PFU in 4 mL. No treatment-related adverse events
exceeded Grade 3, and the most common Grade 1 and 2 adverse events
were fatigue, chills, nausea, and mild, dose-dependent cytokine
release syndrome, or CRS. No infectious virions were detected in
skin swabs, in line with ONCR-177 safety expectations.
Seven heavily pretreated patients have been enrolled to date in
the ongoing surface lesion, histology-specific monotherapy
expansion cohorts. As of November 1, four of these expansion
patients were evaluable at the time of the SITC poster
presentation; one patient went off study after a single dose and is
not evaluable; two are too early in their treatment course to be
evaluable. The four evaluable monotherapy expansion patients are in
addition to four evaluable monotherapy escalation patients treated
at the RP2D. After four weeks of ONCR-177 monotherapy treatment
(two doses) at RP2D, three of these eight evaluable patients (all
in the surface lesion monotherapy expansion cohorts) demonstrated
clinical benefit as follows:
- Partial response in a patient with cutaneous melanoma as
measured by calipers per Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 (surface tumor not measurable by CT scan)
- Investigator-reported clinical response in a squamous cell
carcinoma of the head and neck (SCCHN) patient in injected lymph
node after four weeks
- Stable disease in a patient with mucosal melanoma as measured
by RECIST 1.1 with improvement in cancer-related symptoms
Several findings from the study thus far suggest immune
stimulation of the tumor microenvironment, including mild,
dose-dependent CRS in association with increased interferon-γ
(IFN-γ) and T cell proliferation in blood, as well evidence of
tumor PD-L1 expression and immune cell infiltration.
Oncorus plans to initiate enrollment in the surface lesion dose
combination expansion (Part 2) and the visceral lesion dose
monotherapy escalation (Part 3) by the end of 2021. The company
plans to report additional surface lesion monotherapy expansion
data in mid-2022, and initial surface lesion combination expansion
data (ONCR-177 + KEYTRUDA®) and visceral lesion monotherapy dose
escalation data in late 2022.
For more information on the ongoing Phase 1 study, please
visit: https://clinicaltrials.gov/ct2/show/NCT04348916.
Conference Call and Webcast Information Oncorus
will host a conference call and live webcast with slides and
Q&A today at 8:30 a.m. ET. Igor Puzanov, M.D., MSCI, FACP, who
serves as Director of Center for Early Phase Clinical Trials,
Senior Vice President of Clinical Investigation, and Chief of the
Melanoma Section, at the Roswell Park Comprehensive Cancer Center
in Buffalo, New York, will join Oncorus management for the call.
Dr. Puzanov is also participating as an investigator in the
ONCR-177 Phase 1 clinical trial.
To participate in the conference call, please dial (833)
614-1530 (domestic) or (520) 809-9930 (international) and refer to
conference ID 8556488. A live webcast of the presentation will be
available at https://investors.oncorus.com/. A replay of the
webcast will be available shortly after the conclusion of the call
and archived on the company's website for 30 days following the
call.
About OncorusAt Oncorus, we are focused on
driving innovation to deliver next-generation viral immunotherapies
to transform outcomes for cancer patients. We are advancing a
portfolio of intratumorally (iTu) and intravenously (IV)
administered viral immunotherapies for multiple indications with
significant unmet need based on our Herpes Simplex Virus (HSV)
Platform and Synthetic viral RNA (vRNA) Immunotherapy Platform.
Designed to deliver next-generation viral immunotherapy impact,
our HSV Platform improves upon key characteristics of this
therapeutic class to enhance systemic activity. Our lead HSV
program, ONCR-177, is designed to be directly administered into a
tumor, resulting in high local concentrations of the therapeutic
agent and its five encoded transgenes, as well as low systemic
exposure to the therapy, which could limit systemic toxicities. Our
pioneering Synthetic vRNA Immunotherapy Platform involves a highly
innovative, novel combination of RNA- and oncolytic virus-based
modalities designed to realize the potential of RNA medicines for
cancer. Our lead IV-administered Synthetic vRNA Immunotherapy
clinical candidates, ONCR-021 and ONCR-788, are both currently in
IND-enabling studies.
Please visit www.oncorus.com to learn more.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, implied and
express statements regarding the clinical development of ONCR-177,
including expectations regarding timing for reporting additional
data from the ongoing Phase 1 clinical trial, as well as the
product candidate’s therapeutic potential and clinical benefits and
the utility and potential of Oncorus’ HSV Platform; expectations
regarding data from the ONCR-177 trial providing proof of concept
for the HSV Platform generally and other programs therein,
including ONCR-GBM; the possibility that additional patients will
experience clinical benefits when dosed with ONCR-177 and whether
such treatment effects will be amplified when ONCR-177 is dosed in
combination with Keytruda; and other early findings with respect to
the ONCR-177 clinical trial suggesting broader immune stimulation
or being predictive of trial results to come. The words "may,"
“might,” "will," "could," "would," "should," "expect," "plan,"
"anticipate," "intend," "believe," “expect,” "estimate," “seek,”
"predict," “future,” "project," "potential," "continue," "target"
and similar words or expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Any forward-looking
statements in this press release are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and important factors that may cause actual events or
results to differ materially from those expressed or implied by any
forward-looking statements contained in this press release,
including, without limitation, risks associated with: the risk that
the results of preclinical studies and early results from clinical
trials may not be predictive of future clinical trial results; the
impact of COVID-19 on Oncorus’ operations and the timing and
anticipated results of its ongoing and planned clinical trials;
Oncorus’ ability to successfully demonstrate the safety,
tolerability and efficacy of ONCR-177, ONCR-021 and ONCR-788, or
any future product candidates, and obtain regulatory approval
thereof; Oncorus’ ability to obtain the requisite components for
its product candidates manufactured in accordance with regulatory
requirements; the expansion of Oncorus’ in-house manufacturing
capabilities; the adequacy of Oncorus’ cash resources and
availability of financing on commercially reasonable terms; and
Oncorus’ ability to obtain, maintain and protect its intellectual
property. These and other risks and uncertainties are described in
greater detail in the section entitled "Risk Factors" in Oncorus’
Annual Report on Form 10-K for the year ended December 31,
2020, filed with the Securities and Exchange
Commission on March 10, 2021, as well as discussions of
potential risks, uncertainties, and other important factors in the
other filings that Oncorus makes with the Securities
and Exchange Commission from time to time. These documents are
available under the “SEC filings” page of the Investors section of
Oncorus’ website at http://investors.oncorus.com. Any
forward-looking statements represent Oncorus’ views only as of the
date of this press release and should not be relied upon as
representing its views as of any subsequent
date. Oncorus explicitly disclaims any obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise. No representations or
warranties (expressed or implied) are made about the accuracy of
any such forward-looking statements.
Media Contact:Liz Meloneliz@scientpr.com
Investor Contact: Stern Investor Relations
Julie Seideljulie.seidel@sternir.com
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