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Phio Pharmaceuticals Announces Dosing of First Patient in Collaborative Clinical Trial with AgonOx, Inc. and Providence Cancer Institute Trial targeting treatment of metastatic melanoma and other solid tumors MARLBOROUGH

Key Takeaway: Phio Pharmaceuticals has announced the dosing of the first patient in a collaborative clinical trial with AgonOx, Inc. and Providence Cancer Institute. The trial will investigate the safety and potential benefits of using AgonOx's AGX148 ‘double positive’ CD8 tumor-infiltrating lymphocytes combined with Phio's PD-1 silencing PH-762 in treating metastatic melanoma and other solid tumors. This initiative marks a significant step forward in the pursuit of innovative immunotherapy treatments against challenging malignancies.
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Market Sentiment Analysis

POSITIVE FACTORS

  • First patient has been dosed in a collaborative clinical trial.
  • The trial aims to improve treatments for metastatic melanoma and solid tumors.
  • Involvement of reputable partners like AgonOx and Providence Cancer Institute enhances credibility.

CONCERNS & RISKS

  • The outcomes of the trial and product efficacy remain uncertain until results are analyzed.
  • There are inherent risks associated with clinical trials that can impact success.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~9 mo
Medium dilution risk
Lead asset
DP CD8 TIL
Phase 1 · HNSCC

Full Press Release Details

Phio Pharmaceuticals Announces Dosing of First
Patient in Collaborative Clinical Trial with AgonOx, Inc.
and Providence Cancer Institute
treatment of metastatic melanoma and other solid tumors
MARLBOROUGH, MA., August 21, 2023 (Globe Newswire) -Phio Pharmaceuticals
Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to
make immune cells more effective in killing tumor cells, today announced that its clinical development partners, AgonOx, Inc. and Providence
Cancer Institute of Oregon, have dosed their first patient in an Adoptive Cell Therapy clinical trial.
This first-in-human trial is investigating the safety and the potential
for enhanced therapeutic benefit from the administration of AgonOx's AGX148 'double positive' (DP) CD8 tumor-infiltrating lymphocytes
(TIL) alone and in combination with Phio's PD-1 silencing PH-762 in patients with melanoma and other advanced solid tumors. More information
about this clinical trial is available at clinicaltrials.gov. The clinical trial is one of two studies cleared by the FDA which will utilize
Phio's lead product candidate, PH-762.
The trial is being conducted at Providence Cancer Institute in Portland,
Oregon, by Principal Investigator Brendan Curti, M.D., medical oncologist and Robert W. Franz Endowed Chair for Clinical Research at the
Earle A. Chiles Research Institute, a division of Providence. "Our institute has been at the leading edge of immunotherapy clinical
research including checkpoint immunotherapy, novel co-stimulatory agents and cancer vaccines," said Dr. Curti. "Our vision
of the future is to select and engineer immune cells with enhanced abilities to attack tumors. We have a strong record of accomplishment
in translating laboratory ideas into clinical practice. The work with Dr. Weinberg is another example of exciting first-in-human translational
science from our Institute and its many ongoing collaborations."
"TIL therapies hold the promise of clinical benefit in patients
with solid malignancies. This product is different from current TIL therapies as we are selectively expanding the tumor-reactive T cells
and potentially increasing their potency by reducing PD-1 suppression," said Andrew Weinberg, Ph.D., Founder and CSO of AgonOx,
Inc., and Judith Ann Hartmann Endowed Chair for the Laboratory of Basic Immunology at the Earle A. Chiles Research Institute.
"This is an important collaborative milestone between these organizations
in the advancement of treatments for solid tumors," said Robert Bitterman, President and CEO of Phio Pharmaceuticals.
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology
company whose proprietary INTASYL RNAi technology is designed to make immune cells more effective in killing tumor cells. INTASYL
is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins
that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems.
For additional information, visit the Company's
AgonOx, Inc. is a privately held, Portland, OR-based
biotechnology company. The company was the first to identify and expand tumor-reactive T cells using CD39 and CD103 (DP) CD8s. A patented
process that can also be used to identify tumor-reactive TCRs. AgonOx is also developing a pipeline of novel immunotherapy drugs targeting
key regulators of the immune response to cancer. For additional information, visit the company's website, www.agonox.com.
About Providence Cancer Institute of Oregon
Providence Cancer Institute of Oregon, a part of Providence St. Joseph
Health, offers the latest in cancer services, including diagnosis, treatment, prevention, education and support. Providence is home to
the Earle A. Chiles Research Institute, an internationally renowned leader in the field of cancer immunotherapy since 1993, where investigators
lead numerous clinical trials for patients with cancers of the breast, colon, prostate, lung, esophagus, liver, pancreas, head and neck,
ovary, skin, blood and other conditions. Learn more at Providence.org/ORcancer.
Forward Looking Statements
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends,"
"believes," "anticipates," "indicates," "plans," "expects," "suggests," "may,"
"would," "should," "potential," "designed to," "will," "ongoing," "estimate,"
"forecast," "target," "predict," "could" and similar references, although not all forward-looking
statements contain these words. These statements are based only on our current beliefs, expectations and assumptions and are subject to
inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.
Examples of forward-looking statements include statements regarding the timing of the clinical trial with AGX148 DP TIL alone and in combination
with PH-762, as well as the progress of, and data reported from, this clinical trial and the therapeutic potential of AG148 DP TIL alone
or in combination with PH-762. Our actual results may differ materially from those indicated in the forward-looking statements as a result
of a number of important factors, including, but not limited to, the impact to our business and operations by inflationary pressures,
rising interest rates, recession fears, the development of our product candidates, results from our preclinical and clinical activities,
our ability to execute on business strategies, our ability to develop our product candidates with collaboration partners, and the success
of any such collaborations, the timeline and duration for advancing our product candidates into clinical development, the timing or likelihood
of regulatory filings and approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture
and supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to
establish and maintain for intellectual property rights covering our technology platform, our ability to obtain future financing, market
and other conditions and those identified in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption
"Risk Factors" and in other filings the Company periodically makes with the SEC. Readers are urged to review these risk factors
and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking
statements. Phio does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that
occur after the date of this release, except as required by law.
Phio Pharmaceuticals Corp.

Frequently Asked Questions

What clinical trial has Phio Pharmaceuticals initiated?

Phio Pharmaceuticals, in collaboration with AgonOx and Providence Cancer Institute, has started a clinical trial for treating metastatic melanoma and other solid tumors.

What is the focus of the clinical trial?

The trial examines the safety and effectiveness of AgonOx's AGX148 tumor-infiltrating lymphocytes combined with Phio's PD-1 silencing PH-762.

Where is the clinical trial being conducted?

The trial is taking place at the Providence Cancer Institute in Portland, Oregon.

What is INTASYL technology?

INTASYL is Phio's RNAi technology that enhances immune cells' ability to target and kill tumor cells without needing special drug delivery systems.

Who leads the trial at Providence Cancer Institute?

Dr. Brendan Curti, a medical oncologist and clinical research chair, is the principal investigator for the trial.

Last updated: Aug 21, 2023