PTX-35 Featured in Nature Publication
DURHAM, NC / ACCESSWIRE / October 4, 2018 / Heat Biologics, Inc.
(NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient's immune system against cancer, and its
Pelican Therapeutics subsidiary ("Pelican") today provided a progress update on its novel PTX-35 co-stimulatory antibody. PTX-35 is
designed to harness the body's natural antigen-specific immune activation mechanisms. When combined with immunotherapies, including
checkpoint inhibitors as well as Heat's ImPACT® and ComPACT™ technologies, PTX-35 has been shown to enhance
antigen-specific T-cell activation to eliminate tumor cells in pre-clinical models.
Recent PTX-35 highlights:
- Completed cell line development and creation of validated master cell bank for cGMP manufacturing
- Established CMC path for the production of GMP clinical material and non-clinical preliminary pharmacology / non-GLP
toxicology studies
- Preliminary non-GLP pharmacology demonstrates positive results, including efficient binding and activation on cells
expressing the TNFRSF25 receptor, as well as increased expansion of T-cells in-vivo
- 2-week IND enabling dose range finding toxicology studies in primates receiving two doses show no signs or signals of
clinical toxicity across wide dose range
- Ongoing pre-IND discussions with FDA; expect to submit IND in Q1 2019
Rahul Jasuja, Ph.D., CEO of Pelican, commented, "We are progressing rapidly with our pre-clinical activities and expect to
submit an IND for PTX-35 in the first quarter of 2019. We are strongly encouraged by the preliminary pre-clinical efficacy and
safety data which shows no signs of toxicity across a wide range of doses."
Dr. Jasuja continued, "We have been efficient in our use of funds, which has allowed us to come in under budget, further
extending our runway for this program. Given our operating efficiency thus far, we expect to receive the next tranche of grant
funding once we fully utilize the funds that the Cancer Prevention Research Institute of Texas ("CPRIT") has previously provided.
As we progress, our plan is to advance a broad clinical development program that could include combination therapy with Heat's
ImPACT® and ComPACT™ therapies, as well as other costimulatory agonists, checkpoint inhibitors and immune
modifiers to address the unmet need for patients who do not respond well to current cancer therapies."
The Company further reported that PTX-35 was featured in Nature's Biopharma Dealmakers September 2018 edition, which is
available at: https://heatbio.com/wp-content/uploads/2018/09/Activating_Antitumor_Activity-Nature_Biopharma_Sept-2018.pdf
To-date, Pelican has received $8.3 million in grants from CPRIT. The CPRIT award supports pre-clinical development,
manufacturing and clinical development through a comprehensive 70-patient Phase 1 clinical trial for PTX-35. The Company expects to
meet the qualifications to receive the third tranche of its $15.2 million CPRIT grant award, totaling $6.9 million, later this
year.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against
cancer using of CD8+ "Killer" T-cells. Our T-Cell Activation Platform (TCAP) produces therapies designed to turn "cold" tumors
"hot" and be administered in combination with checkpoint therapies and other immuno-modulators to increase their effectiveness.
HS-110 is our first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own
T-cells to attack cancer. Our ComPACT™ technology is the first potential, dual-acting immunotherapy designed to
deliver T-cell activation and co-stimulation in a single product. We are currently enrolling patients in our Phase 2 clinical trial
for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®). We also have numerous
pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.
About Pelican Therapeutics
Pelican Therapeutics, Inc., a subsidiary of Heat, is focused on the development of therapies designed to activate the immune
system. PTX-35 targets the T-cell co-stimulator, TNFRSF25, and is designed to harness natural immune mechanisms that may reprogram
tumor immunity. When combined with immunotherapies, including Heat's T-cell Activation Platform (TCAP), PTX-35 may have the ability
to boost antigen-specific T-cells and eliminate tumor cells in patients.
In June 2016, Pelican was awarded a $15.2 million Cancer Prevention Institute of Texas (CPRIT) grant to support further
development of PTX-35 and fund a Phase 1 clinical trial to examine potential benefits to patients with several types of
cancers.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified
by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and include
statements regarding the expected filing of an IND for PTX-35 in the first quarter of 2019, the expected receipt of funding form
CPRIT, the ability of PTX-35 to harness the body's natural antigen-specific immune activation mechanisms, to boost antigen-specific
T-cells and eliminate tumor cells in patients, and the plan to advance a broad clinical development program that could include
combination therapy with ImPACT® and ComPACT™, as well as other costimulatory agonists, checkpoint inhibitors and immune modifiers
to address the unmet need for patients who don’t respond well to current cancer therapies. These statements are based on
management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and
uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current
expectations and assumptions from those set forth or implied by any forward-looking statements, including the ability of Heat’s
ImPACT® therapy, ComPACT™ therapy and PTX-35 to perform as designed, to demonstrate safety and efficacy, as well
as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and
achieve desired results and benefits, the ability to obtain regulatory approvals for commercialization of product candidates or to
comply with ongoing regulatory requirements, regulatory limitations relating to Heat’s and Pelican’s ability to promote or
commercialize product candidates for specific indications, acceptance of product candidates in the marketplace and the successful
development, marketing or sale of products, the ability to maintain license agreements, the continued maintenance and growth of the
patent estates, the ability to establish and maintain collaborations, the ability to obtain or maintain the capital or grants
necessary to fund its research and development activities, and the ability to retain key scientists or management personnel, and
the other factors described in Heat’s most recent annual report on Form 10-K and other filings with the SEC. The information in
this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking
statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1-919-289-4017
investorrelations@heatbio.com
SOURCE: Heat Biologics, Inc.