In a release issued under the same headline earlier today
by PDS Biotechnology Corporation (Nasdaq: PDSB), we've
been informed by the company, the beginning of the conference call
paragraph should read "The company is hosting a conference
call today at 8:00 am ET to discuss the data presented at
ASCO." instead of "The company is hosting a conference call
tomorrow morning at 8:00 am ET to discuss the data presented
at ASCO." The completed corrected text follows.
PDS Biotechnology Corporation (Nasdaq: PDSB), a
clinical-stage immunotherapy company developing novel cancer
therapies based on the Company’s proprietary Versamune® T-cell
activating technology, today announced the presentation of interim
data from the Phase 2 trial led by the National Cancer Institute
(NCI), of the National Institutes of Health (NIH), at the American
Society of Clinical Oncology (ASCO) 2021 Annual Meeting.
The Phase 2 trial (NCT04287868) studies PDS0101
(Versamune®-HPV16) in combination with two investigational
immune-modulating agents: bintrafusp alfa (M7824), a bifunctional
“trap” fusion protein targeting TGF-β and PD-L1, and NHS-IL12
(M9241), a tumor-targeting immunocytokine. PDS0101 is an
immunotherapy candidate designed to treat cancers caused by
infection with HPV16 (HPV16-positive cancers) by activating the
immune system to produce in vivo CD8+ (killer) T-cells to target
and kill tumors that are HPV16-positive. Analyses of immune
responses and other immune correlates are ongoing.
Highlights from the presentation include the
following:
- Data from a total of 25 patients
with data available as of the time of presentation submission:
- Update on the data previously
reported for the original fourteen (14) HPV16-positive patients who
were in the subject of the abstract published on May 19th.
- An additional seven (7)
HPV16-negative patients (patients whose cancer was NOT caused by
HPV16 infection) who were not discussed in the abstract.
- An additional four (4)
HPV16-positive patients who are checkpoint inhibitor refractory
whose data became available after the abstract submission.
- 100% (25/25) of patients enrolled
had failed chemotherapy treatment.
- 96% (24/25) of patients enrolled
had failed both chemotherapy and radiation treatment.
- 56% (14/25) of patients enrolled
had failed checkpoint inhibitor therapy (checkpoint inhibitor
refractory).
- Most types of HPV-related cancers
(anal, cervical, head and neck, vaginal and vulvar cancers) were
represented among the study subjects.
- The following update was provided
on the initial six (6) HPV16-positive patients who had NOT been
treated with checkpoint inhibitors (checkpoint inhibitor naïve):
- 83% (5/6) of the patients
demonstrated an objective response (tumor reduction
>30%). The reported objective response rate with
current standard of care checkpoint inhibitor treatment is
12-24%.
- 100% (6/6) are still alive at 8
months – the historic average (median) survival or life span for
this patient population is 7-11 months.
- 80% (4/5) of patients who had an
objective response still have an ongoing response at 8 months.
- One (1) patient had a complete
response (no evidence of disease).
- No new patients had been added to
this group by the time of submission.
- The following information was
provided on the twelve (12) HPV16-positive patients who have also
failed treatment with checkpoint inhibitors after failing
chemotherapy and radiation treatment (checkpoint inhibitor
refractory):
- Four patients had recently been
added since the abstract. Tumor reduction was observed in 58%
(7/12), with an overall objective response rate of 42% (5/12)
already achieved; the objective response rate of the current
standard of care is 5-12%
- One patient in this group had
achieved a complete response by the time of reporting
- 80% (4/5) of patients who had an
objective response have an ongoing response at 8 months
- 83% (10/12) of patients are still
alive at 8 months; historic average (median) survival or life span
for this patient population is only 3-4 months
- PDS0101 is designed to treat
patients whose cancer is caused by infection with HPV16. Seven (7)
patients had cancer that was not caused by HPV16 (HPV16-negative
patients). In this group
- 0% (0/7) experienced tumor
reduction.
- 80% (4/5) checkpoint inhibitor
naïve patients are still alive at 8 months.
- 0% (0/2) checkpoint inhibitor
refractory patients are still alive at 8 months.
The NCI Center for Cancer Research’s Laboratory
of Tumor Immunology and Biology (LTIB) and Genitourinary
Malignancies Branch (GMB) are jointly leading this Phase 2 trial.
Bintrafusp alfa is being jointly developed by Merck KGaA,
Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being
developed by Merck KGaA, Darmstadt, Germany.
The trial is evaluating the treatment
combination in both checkpoint inhibitor naïve and refractory
patients with advanced HPV-associated cancers that have progressed
or returned after treatment. The vast majority of these cancers are
caused by HPV16 infection. Objective response is measured by
radiographic tumor responses according to RECIST 1.1. These
reported data provide additional insights following the preclinical
studies published by the NCI examining the potentially
complementary mechanisms of action of the three immunotherapies,
understood to involve potent in-vivo HPV16-specific killer and
helper T-cell induction with effective T-cell tumor infiltration
(PDS0101), blocking of immune checkpoints as well as targeting of
TGF-β (Bintrafusp alfa). The preclinical results suggested superior
tumor regression.
“The achievement of a 67% tumor reduction among
all HPV16-positive cancer patients including both CPI naïve and CPI
refractory patients continues to strengthen the evidence supporting
continuing clinical investigation of novel Versamune® platform’s
potential ability to induce high levels of tumor-specific CD8+
killer T-cells that attack the cancer in which we believe results
in a strong synergy with bintrafusp alfa and NHS-IL12. The data
provide early evidence of notable clinical activity, and we saw
effective tumor regression in these patients,” commented Dr. Lauren
Wood, Chief Medical Officer of PDS Biotech. “The interim data
demonstrating that this response was limited only to patients with
HVP16-positive cancer, and also the fact that all responding
patients who have stayed on treatment continue to show ongoing
responses after a median duration of 8 months solidifies our belief
that PDS0101’s ability to generate a robust, targeted T-cell
response may have the potential to significantly improve clinical
outcomes for patients with advanced, refractory HPV16-associated
cancers who have limited treatment options.”
There are more than 630,000 cases of
HPV-associated malignancies including cervical, oropharyngeal and
anal cancer worldwide annually. HPV-16 is responsible for most of
these cases. About 15-20% of HPV-associated malignancies respond to
PD-(L)1 inhibitors. However, for the overwhelming majority of
patients who progress on these immunotherapies there is no
effective standard of care therapy.
The company is hosting a conference call today
at 8:00 am ET to discuss the data presented at ASCO. Registration
for the conference call is now open and a live webcast of the event
will be available online in the investor relations section of the
company's website at
https://pdsbiotech.com/investors/news-center/events. A replay will
be available on the company website for 90 days following the
webcast.
For patients interested in enrolling in this
clinical study, please call NCI’s toll-free number 1-800-4-Cancer
(1-800-422-6237) (TTY: 1-800-332-8615), email
NCIMO_Referrals@mail.nih.gov, and/or visit the
website: https://trials.cancer.gov.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy
company developing a growing pipeline of cancer immunotherapies and
infectious disease vaccines based on the Company’s proprietary
Versamune® T-cell activating technology platform. Our
Versamune®-based products may overcome the limitations of current
immunotherapy by inducing in vivo, large quantities of
high-quality, highly potent polyfunctional tumor specific CD4+
helper and CD8+ killer T-cells. PDS Biotech has developed multiple
investigational therapies, based on combinations of Versamune® and
disease-specific antigens, designed to train the immune system to
better recognize diseased cells and effectively attack and destroy
them. Our immuno-oncology product candidates are initially being
studied in combination therapy to potentially enhance efficacy
without compounding toxicity across a range of cancer types. The
company’s lead investigational cancer immunotherapy product PDS0101
is currently in Phase 2 clinical studies in HPV-associated cancers.
To learn more, please visit www.pdsbiotech.com or follow us on
Twitter at @PDSBiotech.
About PDS0101
PDS 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. PDS Biotech is also conducting two additional
Phase 2 studies in advanced HPV-associated cancers and advanced
localized cervical cancer with the NCI and The University of Texas
MD Anderson Cancer Center, respectively. The current product
targets HPV16-positive cancers, and upon successful proof of
concept will be broadened to address cancers caused by other
oncogenic HPV-types.
Forward Looking Statements
This 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® based
products; 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® based products 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 our ability to fully fund our 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 results, 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; the
acceptance by the market of the Company’s product candidates, if
approved; the timing of and the Company’s ability to obtain and
maintain U.S. Food and Drug Administration or other regulatory
authority approval of, or other action with respect to, the
Company’s product candidates; 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.
Media & Investor Relations
Contact:
Deanne RandolphPDS BiotechPhone: +1 (908)
517-3613Email: drandolph@pdsbiotech.com
Rich CockrellCG CapitalPhone: +1 (404) 736-3838
Email: rich@cg.capital
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