PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing a growing pipeline of targeted
immunotherapies for cancer and infectious disease, today announced
that updated clinical data from the ongoing IMMUNOCERV Phase 2
clinical trial was presented during a poster session on November 11
at the 37th Annual Meeting for the Society for Immunotherapy of
Cancer (SITC 2022). These data expand upon results detailed in the
abstract submitted to SITC 2022 that was released to the public on
November 7.
The enhanced data was presented in the poster titled,
“IMMUNOCERV, an Ongoing Phase II Trial Combining PDS0101, an
HPV-Specific T Cell Immunotherapy, with Chemotherapy and Radiation
for Treatment of Locally Advanced Cervical Cancers,” which
highlights key findings from The University of Texas MD Anderson
Cancer Center-led IMMUNOCERV Phase 2 clinical trial (NCT04580771).
The study is investigating PDS0101 in combination with
standard-of-care chemoradiotherapy (CRT) for the potential
treatment of cervical cancer in patients with large tumors over 5
cm in size and/or cancer that has spread to the lymph nodes (lymph
node metastasis). New data from the study presented at SITC 2022
include:
- 9 of the 17 patients have now completed a day 170
post-treatment Positron Emission Tomography, Computed Tomography
(PET CT) scan to assess the status of their cancer. This includes
78% (7/9) of treated patients with advanced cervical cancer (FIGO
stage III or IV).
- 100% (9/9) of patients treated with the combination of PDS0101
and CRT had a clinical response with tumor shrinkage >60% at
mid-point evaluation by MRI.
- 89% (8/9) of patients treated with the combination of PDS0101
and CRT demonstrated a complete response (CR) on day 170 by PET CT.
One patient who received 3 of the 5 scheduled doses of PDS0101
showed signs of residual disease. One patient who had a CR died
from an event unrelated to either their underlying disease or
treatment.
- 1-year disease-free survival and 1-year overall survival of 89%
(8/9) in patients treated with the combination of PDS0101 and
CRT.
- As previously reported, data confirm PDS0101 treatment
activates HPV16-specific CD8+ T cells. This increase was not seen
in patients who did not receive PDS0101. The increase in
HPV16-specific T cells generated by the treatment is positively
correlated with tumor cell death, suggesting cytotoxic CD8+ T cells
are important mediators of antigen-specific immunity.
- The data affirm that PDS0101 activates Type 1 interferon
pathway in humans, mimicking the mechanism previously demonstrated
in preclinical studies in animal models.
- Toxicity of PDS0101 remains limited to low-grade local
injection site reactions.
“The updated data from the ongoing IMMUNOCERV Phase 2 clinical
trial presented during SITC 2022 add to the encouraging results
observed thus far and suggest that the combination of PDS0101 and
CRT may hold promise as a potential first-line treatment for
advanced, localized cervical cancer,” said Dr. Frank Bedu-Addo, CEO
of PDS Biotech. “Importantly, 100% of patients responded to
treatment with the combination of PDS0101 and CRT. We believe this
study also provides further confirmation that PDS0101 induces the
right type, quality, and potency of killer T cells in humans that
may translate to effective treatment of cervical cancer. We look
forward to the continued advancement of the IMMUNOCERV Phase 2
clinical trial and the opportunity to report updated data during
2023.”
In addition, a second poster titled “Immune Correlates
Associated with Clinical Benefit in Patients with Checkpoint
Refractory HPV-Associated Malignancies Treated with Triple
Combination Immunotherapy,” was presented at SITC 2022 and reported
data from the Phase 2 triple combination trial being led by the
Center for Cancer Research at the National Cancer Institute (NCI),
part of the National Institutes of Health. The study is
investigating PDS0101 in combination with two investigational
immune-modulating agents: M9241, a tumor-targeting IL-12
(immunocytokine), and bintrafusp alfa, a bifunctional checkpoint
inhibitor (PD-L1/ TGF-β). The triple combination is being studied
in checkpoint inhibitor (CPI)-naïve and -refractory patients with
advanced HPV-positive anal, cervical, head and neck, vaginal, and
vulvar cancers who have failed prior therapy. For most patients who
are CPI refractory, there is no effective therapy. The immune
correlates before and after treatment in the CPI refractory patient
population were studied. Highlights from the study presented at
SITC 2022 included:
- A more than two-fold increase in HPV16-specific T cells in the
blood of 79% (11/14 tested) of the evaluated patients.
- Increases on day 15 in several monitored immune correlates,
such as granzyme B and interferon-gamma (IFN-γ), were associated
with a clinical response.
- Immune responses were associated with increases in natural
killer cells, soluble granzyme B (associated with active killer T
cells), IFN-γ, tumor necrosis factor-alpha (TNF-α), etc., two weeks
after the first treatment cycle thus signaling a pro-inflammatory
response.
- These immunogenicity findings highlight the potential role of
the combination in altering immune suppressive forces, and support
previously announced results documenting promising clinical
outcomes in the CPI-refractory population receiving the triple
combination.
About PDS BiotechnologyPDS
Biotech is a clinical-stage immunotherapy company developing a
growing pipeline of targeted cancer and infectious disease
immunotherapies based on our proprietary Versamune® and
Infectimune™ T cell-activating technology platforms. We believe our
targeted Versamune® based candidates have the potential to overcome
the limitations of current immunotherapy by inducing large
quantities of high-quality, potent polyfunctional tumor-specific
CD4+ helper and CD8+ killer T cells. To date, our lead Versamune®
clinical candidate, PDS0101, has demonstrated the potential to
reduce tumors and stabilize disease in combination with approved
and investigational therapeutics in patients with a broad range of
HPV-expressing cancers in multiple Phase 2 clinical trials. Our
Infectimune™ based vaccines have also demonstrated the potential to
induce not only robust and durable neutralizing antibody responses,
but also powerful T cell responses, including long-lasting memory T
cell responses in pre-clinical studies to date. To learn more,
please visit www.pdsbiotech.com or follow us on Twitter at
@PDSBiotech.
About PDS0101PDS Biotech’s lead
candidate, PDS0101, combines the utility of the Versamune® platform
with targeted antigens in HPV-expressing cancers. In partnership
with Merck & Co., PDS Biotech is evaluating a combination of
PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of
recurrent or metastatic head and neck cancer, and also in
second-line treatment of recurrent or metastatic head and neck
cancer in patients who have failed prior checkpoint inhibitor
therapy. A National Cancer Institute-supported Phase 2 clinical
study of PDS0101 in a triple combination therapy is also being
conducted in checkpoint inhibitor refractory patients with multiple
advanced HPV-associated cancers. A third Phase 2 clinical trial in
first-line treatment of locally advanced cervical cancer is being
led by The University of Texas MD Anderson Cancer Center. A final
Phase 2 clinical trial of PDS0101 monotherapy in first-line
treatment of newly diagnosed patients HPV16+ head and neck cancer
patients is being conducted at the Mayo Clinic.
KEYTRUDA® is a registered trademark of Merck
Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway,
NJ, USA.
Forward Looking StatementsThis
communication contains forward-looking statements (including within
the meaning of Section 21E of the United States Securities Exchange
Act of 1934, as amended, and Section 27A of the United States
Securities Act of 1933, as amended) concerning PDS Biotechnology
Corporation (the “Company”) and other matters. These statements may
discuss goals, intentions and expectations as to future plans,
trends, events, results of operations or financial condition, or
otherwise, based on current beliefs of the Company’s management, as
well as assumptions made by, and information currently available
to, management. 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,” “forecast,”
“guidance”, “outlook” and other similar expressions among others.
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: the
Company’s ability to protect its intellectual property rights; the
Company’s anticipated capital requirements, including the Company’s
anticipated cash runway and the Company’s current expectations
regarding its plans for future equity financings; the Company’s
dependence on additional financing to fund its operations and
complete the development and commercialization of its product
candidates, and the risks that raising such additional capital may
restrict the Company’s operations or require the Company to
relinquish rights to the Company’s technologies or product
candidates; the Company’s limited operating history in the
Company’s current line of business, which makes it difficult to
evaluate the Company’s prospects, the Company’s business plan or
the likelihood of the Company’s successful implementation of such
business plan; the timing for the Company or its partners to
initiate the planned clinical trials for PDS0101, PDS0203 and other
Versamune® and Infectimune™ based product candidates; the future
success of such trials; the successful implementation of the
Company’s research and development programs and collaborations,
including any collaboration studies concerning PDS0101, PDS0203 and
other Versamune® and Infectimune™ based product candidates and the
Company’s interpretation of the results and findings of such
programs and collaborations and whether such results are sufficient
to support the future success of the Company’s product candidates;
the success, timing and cost of the Company’s ongoing clinical
trials and anticipated clinical trials for the Company’s current
product candidates, including statements regarding the timing of
initiation, pace of enrollment and completion of the trials
(including the Company’s ability to fully fund its disclosed
clinical trials, which assumes no material changes to our currently
projected expenses), futility analyses, presentations at
conferences and data reported in an abstract, and receipt of
interim or preliminary results (including, without limitation, any
preclinical results or data), which are not necessarily indicative
of the final results of the Company’s ongoing clinical trials; any
Company statements about its understanding of product candidates
mechanisms of action and interpretation of preclinical and early
clinical results from its clinical development programs and any
collaboration studies; and other factors, including legislative,
regulatory, political and economic developments not within the
Company’s control, including unforeseen circumstances or other
disruptions to normal business operations arising from or related
to COVID-19. The foregoing review of important factors that could
cause actual events to differ from expectations should not be
construed as exhaustive and should be read in conjunction with
statements that are included herein and elsewhere, including the
risk factors included in the Company’s annual and periodic reports
filed with the SEC. The forward-looking statements are made only as
of the date of this press release and, except as required by
applicable law, the Company undertakes 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.
Versamune® is a registered trademark and
Infectimune™ is a trademark of PDS Biotechnology.
Investor Contacts:Deanne
RandolphPDS BiotechPhone: +1 (908) 517-3613Email:
drandolph@pdsbiotech.com
Rich CockrellCG CapitalPhone: +1 (404)
736-3838Email: pdsb@cg.capital
Media Contact:Bill Borden/Dave
SchemeliaTiberend Strategic Advisors, Inc.Phone: +1 (732)
910-1620/+1 (609) 468-9325Email: bborden@tiberend.com
/dschemelia@tiberend.com
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