GeoVax Expands Immuno-Oncology Pipeline with Acquisition of Clinical-Stage Cancer Program


of Gedeptin® Adds Orphan Drug Clinical Program for

of Advanced Head and Neck Cancers

Atlanta, GA – (NewMediaWire) – September 28, 2021 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company

specializing in developing human vaccines and cancer immunotherapies, today

announced that it has entered into an Assignment and License Agreement (the

“License”) with PNP Therapeutics, Inc. (“PNP”), that grants GeoVax exclusive

rights to develop and commercialize Gedeptin®, a novel patented product

for the treatment of solid tumors.  

The License provides exclusive

worldwide rights to key intellectual property,

including Gedeptin patents, know-how, regulatory filings, clinical

materials, and trademarks.  The patent portfolio covering Gedeptin was

originally licensed from the University of Alabama at Birmingham (UAB) and

Southern Research Institute (SRI) by PNP.  Under the License, GeoVax will

become the successor to PNP under its license agreement with UAB/SRI. Detailed

financial terms of the transaction were not disclosed, but include a

combination of upfront payments, milestone fees, and royalties on net sales.

A cycle of Gedeptin therapy

consists of three intra-tumoral injections of Gedeptin over a two-day

period followed by infusion of a prodrug, fludarabine phosphate, once a day for

three days.  A Phase 1 dose ranging study, evaluating the safety of a

single cycle of Gedeptin therapy, found the therapy to be well tolerated, with

evidence of a reduction in tumor size in patients with solid tumors.

A Phase 1/2 trial, evaluating the

safety and efficacy of repeat cycles of Gedeptin therapy in patients with

recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s)

accessible for injection and no curable treatment options, is currently

enrolling.  The initial stage of the study is being funded by the FDA

pursuant to its Orphan Products Clinical Trials Grants Program. 

The FDA has also granted Gedeptin orphan drug status for the

intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers,

including cancers of the lip, tongue, gum, floor of mouth, salivary gland and

other oral cavities.

The Gedeptin technology was

developed with funding support from the National Cancer Institute of the

National Institutes of Health.  The License also grants GeoVax the rights

to expand the use of Gedeptin to all human diseases and/or conditions

including, but not limited to, other cancers. 

David Dodd, GeoVax President and

CEO, commented, “The signing of this license agreement is an important and

exciting event for GeoVax and our stockholders, as it adds a clinical program

in immuno-oncology to our pipeline, which is one of the primary focus areas for

our company. The initial stage (10 patients) of the ongoing clinical trial for

Gedeptin is being funded by the FDA pursuant to its Orphan Products Grants

Program, with five patients having been enrolled to date.  Our immediate

objective will be to accelerate patient enrollment to complete this stage, then

expand the trial to additional study sites and at least 25 patients in

total.  Based on PNP’s End-of-Phase-1 meeting with the FDA, we believe

that a successful outcome from the expanded trial may lead to labeling

discussions with the FDA at the end of the study.”

Dodd added, “In addition to the

immediate opportunity resulting from the existing clinical program, the license

to the Gedeptin technology opens additional opportunities to potentially

develop novel therapies for other indications.  We also feel that

potential synergies exist between the Gedeptin technology and our GV-MVA-VLP

platform related to immuno-oncology, providing further expanded opportunities

for developing novel cancer immunotherapies that may benefit cancer patients

across multiple cancers.  As we continue to advance our programs such as

MVA-VLP-MUC1, we will also evaluate synergistic opportunities between the two

technology platforms.” 

In conclusion, Dodd commented,

“Approximately one year ago, we achieved a critical strategic watershed with

the successful recapitalization, financing and listing of GeoVax on the Nasdaq

stock market.  Since then, we have further strengthened the Company

resources and status, including our ability to finance the Gedeptin

transaction, including expansion and acceleration of the clinical trial using

our current cash reserves.  We have progressed our two core product

development areas related to SARS-CoV-2 vaccines and immuno-oncology. 

Today’s announcement accelerates our progress within immuno-oncology, providing

a pivotal clinical-stage status via the Gedeptin program.  We similarly remain

focused on accelerating progress related to our SARS-CoV-2 vaccine and look

forward to providing further updates soon.” 

Conference Call

Management will host a conference

call at 4:30 p.m. ET on Wednesday, September 29, 2021 to review the transaction

and discuss the Gedeptin technology. Following management’s formal remarks,

there will be a question-and-answer session.  

Participants are asked to

pre-register for the call via the following link:

The conference call will be

available through a live webcast found here:

A webcast replay of the call will

be available via the same link as the live webcast approximately one hour after

the end of the call through December 28, 2021.  A telephonic replay of the

call can be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088

(international) and using access code 10160579.  The telephonic replay

will be available until October 13, 2021.

About the Gedeptin® Technology


Many common cancers (including

prostate, breast, colon, lung, brain, melanoma, pancreas, ovarian, kidney)

become untreatable despite the best medical intervention and the highest

standard of care and are eventually fatal. Chemotherapeutic agents may be able

to destroy these tumors, but many are much too toxic to administer systemically

to already debilitated cancer patients. Most conventional anti-cancer drugs in

use today derive their anti-tumor specificity from the ability to kill rapidly

dividing cells. These drugs are suitable for systemic administration

specifically because they are most toxic to cells that are dividing. However,

many tumors such as head and neck squamous cell carcinoma (HNSCC) are resistant

to treatment because they have a very low growth fraction (i.e., a relatively

small percentage of tumor cells dividing at any particular point in time).

Compounds toxic to non-proliferating cells generally are not used in the

treatment of cancer, because most of the cells in a patient are not

proliferating and such compounds have no selectivity when administered


Among the various gene therapy

strategies for cancer treatment, GDEPT (Gene-Directed Enzyme Prodrug Therapy)

has shown promise. In GDEPT a vector is used to selectively transduce tumor

cells with a nonhuman gene, which expresses an enzyme that can convert a

nontoxic prodrug into a very toxic antitumor compound.  A prodrug is a

pharmaceutical compound that remains inactive in its biochemical form until it

reaches its target site, such as an organ or tissue, and then undergoes an

immediate metabolic breakdown; it then releases the molecular compounds of the

parent drug, or active ingredients, at the point of delivery. Because the

nonhuman gene is only expressed in tumor tissue, the nontoxic prodrug is only activated

in tumor tissue. Therefore, unlike conventional chemotherapy, GDEPT should

result in selective killing of tumor cells with little or no systemic toxicity.

GDEPT strategies that produce

potent cytotoxic agents (active against nonproliferating and proliferating

tumor cells) and that have high bystander activity could have dramatic effects

on the treatment of solid tumors. A bystander effect typically refers to the

death, altered growth or damage of cells that have not directly received

chemotherapy or irradiation. Earlier GDEPT approaches have had limited efficacy

specifically because of poor bystander activity and inability to destroy

non-proliferating tumor cells. 

Gedeptin potentially overcomes

previous GDEPT limitations and may serve as a robust platform for development

in multiple indications. Gedeptin consists of a non-replicating adenoviral

vector expressing an optimized E. coli purine nucleoside phosphorylase (E. coli

PNP) that is injected intra-tumorally, and then followed by intravenous or intra-tumoral

administration of a prodrug.  

Among the prodrugs that have been

evaluated for use with Gedeptin, fludarabine phosphate (Fludara®) is of

particular interest because (i) it is currently approved by the FDA for use in

humans and (ii) it has demonstrated excellent in vivo antitumor activity in

murine models when only 2-3% of tumor cells express E. coli PNP. Fludarabine is

currently approved by the FDA to treat chronic lymphocytic leukemia, but has

not been shown to be effective against other solid tumors.  But when

fludarabine is administered following Gedeptin, the combination exploits

the selective expression of the E. coli PNP gene in tumor cells to utilize

fludarabine phosphate as a prodrug, resulting in the localized production of fluoroadenine

(F-Ade), a potent cytotoxic compound with pronounced antitumor activity.

Ongoing Phase 1/2 Clinical

 – Currently, Gedeptin is in a Phase 1/2 clinical

trial, being conducted at Stanford University in collaboration with Emory

University. The trial design involves repeat administration using Gedeptin

followed by systemic fludarabine, as a way to gain additional information prior

to expansion towards a larger patient trial. The initial stage of the study (10

patients) is being funded by the FDA pursuant to its Orphan Products

Grants Program.  Five patients have been enrolled to date.

Orphan Drug Status – The

FDA has granted orphan drug status to Gedeptin, for the intra-tumoral treatment

of anatomically accessible oral and pharyngeal cancers, including cancers of

the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.

The orphan drug designation is awarded to drugs designed to treat a rare

disease or condition that affects fewer than 200,000 people in the U.S., and it

is applied specifically to novel therapeutics that could represent a major

improvement in treatment. Orphan drug status provides regulatory incentives,

reduced fees, and a more rapid review by the FDA, and stipulates that competing

therapies can be blocked from the market for up to seven years. Additionally,

this status qualifies the drug sponsor for various development incentives,

including tax credits for qualified clinical testing.

About GeoVax

GeoVax Labs, Inc. is a

clinical-stage biotechnology company developing human vaccines against

infectious diseases and cancer using a novel patented Modified Vaccinia

Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. On this platform,

MVA, a large virus capable of carrying several vaccine antigens, expresses

proteins that assemble into VLP immunogens in the person receiving the vaccine.

The production of VLPs in the person being vaccinated can mimic virus

production in a natural infection, stimulating both the humoral and cellular

arms of the immune system to recognize, prevent, and control the target

infection. The MVA-VLP derived vaccines can elicit durable immune responses in

the host similar to a live-attenuated virus, while providing the safety

characteristics of a replication-defective vector. 

GeoVax’s current development

programs are focused on preventive vaccines against COVID-19, HIV, Zika Virus,

hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as

well as therapeutic vaccines against multiple cancers. The Company has designed

a preventive HIV vaccine candidate to fight against the subtype of HIV

prevalent in the commercial markets of the Americas, Western Europe, Japan, and

Australia; human clinical trials for this program are managed by the HIV

Vaccine Trials Network (HVTN) with the support of the National Institutes of

Health (NIH). GeoVax’s HIV vaccine is also part of a collaborative effort

toward a functional cure for HIV.

Forward-Looking Statements

This release contains

forward-looking statements regarding GeoVax’s business plans. The words

“believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,”

“intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,”

“will,” “expect” and similar expressions, as they relate to us, are intended to

identify forward-looking statements. We have based these forward-looking

statements largely on our current expectations and projections about future

events and financial trends that we believe may affect our financial condition,

results of operations, business strategy and financial needs. Actual results

may differ materially from those included in these statements due to a variety

of factors, including whether: GeoVax is able to

acceptable results from the current phase 1/2 clinical trial

involving Gedeptin or additional tests of  its preventive

vaccine, GeoVax’s immuno-oncology products and preventative vaccines can

provoke the desired responses, and those products or vaccines can be used

effectively, GeoVax’s viral vector technology adequately amplifies immune responses

to cancer antigens, GeoVax can develop and manufacture its immuno-oncology

products and preventative vaccines with the desired characteristics in a timely

manner, GeoVax’s immuno-oncology products and preventative vaccines will be

safe for human use, GeoVax’s vaccines will effectively prevent targeted

infections in humans, GeoVax’s immuno-oncology products and preventative

vaccines will receive regulatory approvals necessary to be licensed and

marketed, GeoVax raises required capital to complete development, there is

development of competitive products that may be more effective or easier to use

than GeoVax’s products, GeoVax will be able to enter into favorable

manufacturing and distribution agreements, and other factors, over which GeoVax

has no control. 

Further information on our risk

factors is contained in our registration statement on Form S-1 and the periodic

reports on Form 10-Q and Form 10-K that we have filed and will file with the

SEC. Any forward-looking statement made by us herein speaks only as of the date

on which it is made. Factors or events that could cause our actual results to

differ may emerge from time to time, and it is not possible for us to predict

all of them. We undertake no obligation to publicly update any forward-looking

statement, whether as a result of new information, future developments or

otherwise, except as may be required by U.S. federal securities law. 

GeoVax Labs, Inc.


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