HTBX Heat Biologics Inc.

0.84
-0.03  -3%
Previous Close 0.87
Open 0.89
52 Week Low 0.195
52 Week High 1.25
Market Cap $71,460,896
Shares 84,669,308
Float 79,803,584
Enterprise Value $49,188,135
Volume 3,273,902
Av. Daily Volume 10,337,108
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Upcoming Catalysts

Drug Stage Catalyst Date
HS-130
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
PTX-35
Solid tumors
Phase 1
Phase 1
Phase 1 initiation of dosing announced June 22, 2020.
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 data presented at ASCO May 29, 2020. Median overall survival (mOS) of 28.7 months.
HS-410
Bladder cancer
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - November 30, 2016.
HS-110
Non-small cell lung cancer (NSCLC)
Phase 1b
Phase 1b
Phase 1b data released December 6, 2016.

Latest News

  1. DURHAM, NC / ACCESSWIRE / June 22, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced that the first patient has been treated in the Company's first-in-human Phase 1 clinical trial evaluating PTX-35, the first antibody product candidate developed by Heat Biologics' Pelican Therapeutics subsidiary.

    This first-in-human study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care. Eligible patients will be enrolled to receive PTX-35 every two weeks until disease progression. Escalating dose levels…

    DURHAM, NC / ACCESSWIRE / June 22, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced that the first patient has been treated in the Company's first-in-human Phase 1 clinical trial evaluating PTX-35, the first antibody product candidate developed by Heat Biologics' Pelican Therapeutics subsidiary.

    This first-in-human study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care. Eligible patients will be enrolled to receive PTX-35 every two weeks until disease progression. Escalating dose levels of PTX-35 will be explored until optimal immunological dose or maximum tolerated dose is established. The objectives of the study include safety evaluation, determination of the recommended Phase 2 dose as well as exploratory analyses of clinical benefit and immunological effect of PTX-35. This trial is supported by a $15.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

    Jeff Wolf, CEO of Heat Biologics, commented, "This is an important milestone as we advance our first antibody product candidate into clinical development. I am very pleased with our team's effort in accelerating the development of PTX-35 as well as the speed of execution to initiate our first-in-human study following FDA clearance of our Investigational New Drug (IND) Application. I believe that PTX-35, our potential first-in-class T-cell co-stimulatory antibody, will offer a differentiated approach to benefit cancer patients."

    About PTX-35

    PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction. Preclinical studies have demonstrated that PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function. A favorable safety profile was demonstrated in preclinical studies, with no deleterious cytokine release in mice, non-human primates or in vitro human immune cells.

    A $15.2 million grant has been awarded by Cancer Prevention and Research Institute of Texas (CPRIT) to support the pre-clinical development, manufacturing and Phase 1 clinical development for PTX-35.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company's gp96 platform is designed to activate immune responses against cancer or pathogenic antigens. Multiple product candidates in development leveraging the gp96 platform, including HS-110 which has completed enrollment in its Phase 2 trial, HS-130 in Phase 1, and a COVID-19 vaccine program in preclinical development. In addition, Heat is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35 which is enrolling in a Phase 1 trial. For more information, please visit www.heatbio.com.

    Forward Looking Statement

    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, expectation, and assumptions and include statements such as the expected enrollment in the trial, the potential of PTX-35 as a first-in-class antibody T-cell co-stimulator, and PTX-35 offering a differentiated approach to benefit patients. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability to successfully enroll and complete the first-in-human clinical trial of PTX-35 in solid tumors, the ability of Heat's therapies 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/594675/Heat-Biologics-Announces-First-Patient-Treated-in-First-in-Human-Clinical-Trial-of-PTX-35

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  2. Anthony Tolcher, M.D., FRCPC appointed as the lead investigator

    DURHAM, NC / ACCESSWIRE / June 18, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced initiation of the first clinical trial site for PTX-35. Anthony Tolcher, M.D., FRCPC, a medical oncologist and co-founder of NEXT Oncology, has been appointed the lead investigator for the Phase 1 clinical trial.

    PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced…

    Anthony Tolcher, M.D., FRCPC appointed as the lead investigator

    DURHAM, NC / ACCESSWIRE / June 18, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced initiation of the first clinical trial site for PTX-35. Anthony Tolcher, M.D., FRCPC, a medical oncologist and co-founder of NEXT Oncology, has been appointed the lead investigator for the Phase 1 clinical trial.

    PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction. Preclinical studies have demonstrated that PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function. A favorable safety profile was demonstrated in preclinical studies, with no deleterious cytokine release in mice, non-human primates or in vitro human immune cells.

    Rahul Jasuja, PhD, CEO of Pelican Therapeutics, commented, "We are pleased to welcome Dr. Anthony Tolcher as the lead investigator for our PTX-35 Phase 1 trial. He is a distinguished medical oncologist with over 25 years of early drug development and clinical trial expertise and a principal investigator for 20 Phase 1 clinical studies of new agents that subsequently were FDA approved for the treatment of cancer, including Merck's pembrolizumab (Keytruda®). Dr. Tolcher has over 100 peer-reviewed publications in top scientific journals, and a proven track record of advancing multiple innovative oncology products through Phase 1. We believe NEXT Oncology under the leadership of Dr. Tolcher is an ideal site for our study and look forward to enrolling our first patient shortly."

    Dr. Tolcher said, "PTX-35 is a promising product candidate that exquisitely targets TNFRSF25. This is a first-in-class antibody that targets an important pathway to activate antigen-experienced memory CD8+ T cells. I believe PTX-35 may provide additional treatment options for patients when current therapy does not work in controlling their cancers. Immunotherapy is the most exciting and a rapidly growing area of oncology and we are just beginning to see the potential for expanding new avenues and targets in harnessing the immune system for the treatment of cancer."

    A $15.2 million grant has been awarded by Cancer Prevention and Research Institute of Texas (CPRIT) to support the pre-clinical development, manufacturing and Phase 1 clinical development for PTX-35.

    About NEXT Oncology

    NEXT Oncology is dedicated to the advancement of Phase 1 cancer research through clinical trials of anticancer agents with the goal of providing innovative developments in cancer treatment. Dr. Anthony Tolcher is a medical oncologist and co-founder of NEXT Oncology. He is dedicated to the advancement of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them. Many of the initial Phase 1 studies of new agents that Dr. Tolcher was involved in were subsequently approved by FDA, including pembrolizumab (Keytruda®), copanlisib (Aliqopa®), trastuzumab emtansine (Kadcyla®), regorafenib (Stivarga®), liposomal vincristine (Marqibo®), cabazitaxel (Jevtana®), carfilzomib (Kyprolis®), gefitinib (Iressa®), erlotinib (Tarceva®) and eribulin (Halaven®). He is a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research and Annals of Oncology, and chaired the Developmental Therapeutics Review Committee for the American Society for Clinical Oncology Annual Scientific Program. Dr. Tolcher has over 100 peer-reviewed publications in scientific journals.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company's gp96 platform is designed to activate immune responses against cancer or pathogenic antigens. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in Phase 2, HS-130 in Phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35 in Phase 1. For more information, please visit www.heatbio.com.

    Forward Looking Statement

    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, expectation, and assumptions and include statements such as NEXT Oncology under the leadership of Dr. Tolcher being an ideal site for the study, enrolling the first patient shortly, PTX-35 being a promising product candidate, PTX-35 providing additional treatment options for patients when current therapy does not work in controlling their cancer and PTX-35 being a potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability to successfully initiate and complete the first-in-human clinical trial of PTX-35 in solid tumors, the ability of Heat's therapies 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/594353/Heat-Biologics-Announces-Initiation-of-the-Lead-Clinical-Trial-Site-for-PTX-35

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  3. PTX-35 represents a potential first-in-class agonistic antibody of TNFRSF25

    DURHAM, NC / ACCESSWIRE / June 8, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PTX-35, developed by Heat's Pelican Therapeutics subsidiary. Pelican has near-term plans to initiate its Phase 1 clinical trial in patients with solid tumors.

    PTX-35 is a novel, first-in-class agonist antibody targeting TNFRSF25, also known as death receptor 3 (DR3…

    PTX-35 represents a potential first-in-class agonistic antibody of TNFRSF25

    DURHAM, NC / ACCESSWIRE / June 8, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PTX-35, developed by Heat's Pelican Therapeutics subsidiary. Pelican has near-term plans to initiate its Phase 1 clinical trial in patients with solid tumors.

    PTX-35 is a novel, first-in-class agonist antibody targeting TNFRSF25, also known as death receptor 3 (DR3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction. Preclinical studies have demonstrated PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function.

    Rahul Jasuja, PhD, CEO of Pelican Therapeutics, commented, "The mechanism of action for PTX-35 is highly differentiated compared to other co-stimulators. Activation of TNFRSF25 by PTX-35 in preclinical models leads to a more pronounced expansion of tumor antigen-specific cytotoxic, or "killer" T cells, resulting in enhanced tumor growth inhibition and prolonged survival. The team has delivered a robust IND package, demonstrating pre-clinical efficacy along with a favorable safety profile in mice and non-human primates."

    Jeff Wolf, CEO of Heat, said, "PTX-35 is a potential first-in-class therapy that may provide additional treatment options for cancer patients. We are close to initiating our first-in-human clinical trial of PTX-35 in multiple solid tumors and look forward to providing further updates as we achieve anticipated milestones. We would like to thank Cancer Prevention Research Institute of Texas (CPRIT) for the $15.2 million grant to support the preclinical work, cGMP manufacturing and Phase 1 development of PTX-35."

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company's gp96 platform is designed to activate immune responses against cancer or pathogenic antigens. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in phase 2, HS-130 in phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35. For more information, please visit www.heatbio.com.

    Forward Looking Statement

    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, expectation, and assumptions and include statements such as the potential of PTX-35 as a potential first-in-class therapy that may provide additional treatment options for cancer patients and near-term plans to initiate a Phase 1 clinical trial in patients with solid tumors. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability to successfully initiate and complete the first-in-human clinical trial of PTX-35 in solid tumors, the ability of Heat's therapies 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/593048/Heat-Biologics-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-PTX-35

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  4. On track to complete vaccine development and initiate manufacturing in August

    DURHAM, NC / ACCESSWIRE / June 4, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including a novel COVID-19 vaccine and multiple oncology product candidates, today announced further progress on its COVID-19 vaccine program.

    Jeff Hutchins, Chief Scientific and Operating Officer of Heat, stated, "I am pleased to report important advancements related to our COVID-19 vaccine program. Specifically, we have achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in our clinically validated human cell…

    On track to complete vaccine development and initiate manufacturing in August

    DURHAM, NC / ACCESSWIRE / June 4, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including a novel COVID-19 vaccine and multiple oncology product candidates, today announced further progress on its COVID-19 vaccine program.

    Jeff Hutchins, Chief Scientific and Operating Officer of Heat, stated, "I am pleased to report important advancements related to our COVID-19 vaccine program. Specifically, we have achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in our clinically validated human cell line, enabling selection of our COVID-19 vaccine. These steps are important milestones and necessary precursors to completion of our vaccine in preparation for its manufacture and use in clinical trials."

    Jeff Wolf, CEO of Heat, commented, "We remain on track to complete design and development of our COVID-19 vaccine in July, and expect that our gp96/nCoV-2 expressing cell line will be available for clinical-grade manufacturing with our partner, Waisman Biomanufacturing, in early August. Given our progress to date, we remain encouraged by the potential of our unique vaccine to provide broad cellular T-cell and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses."

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company's gp96 platform is designed to activate immune responses against cancer or pathogenic antigens. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in phase 2, HS-130 in phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35. For more information, please visit www.heatbio.com.

    Forward Looking Statement

    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, expectation, and assumptions and include statements such as remaining on track to complete development of the vaccine in July, Heat's gp96/nCoV-2 expressing cell line being available for clinical-grade manufacturing with its partner, Weisman Biomanufacturing, in early August and the potential of Heat's unique vaccine to provide broad cellular T-cell and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability of Heat's therapies 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine and to complete development of the vaccine within the anticipated timeline, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/592698/Heat-Biologics-Provides-Update-on-COVID-19-Vaccine-Efforts

    View Full Article Hide Full Article
    • Median overall survival of 28.7 months in previously treated checkpoint inhibitor naïve non-small cell lung cancer patients
    • Significantly greater median overall survival of 42.1 months observed in patients with injection site reaction
    • Planning to engage FDA for end-of-phase 2 meeting

    DURHAM, NC / ACCESSWIRE / May 29, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today presented its latest data at the ASCO Annual Meeting. The poster presentation can be viewed on the ASCO meeting website at: https://meetinglibrary.asco.org/record/184864/poster

    • Median overall survival of 28.7 months in previously treated checkpoint inhibitor naïve non-small cell lung cancer patients
    • Significantly greater median overall survival of 42.1 months observed in patients with injection site reaction
    • Planning to engage FDA for end-of-phase 2 meeting

    DURHAM, NC / ACCESSWIRE / May 29, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today presented its latest data at the ASCO Annual Meeting. The poster presentation can be viewed on the ASCO meeting website at: https://meetinglibrary.asco.org/record/184864/poster and on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications

    HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients' immune system against multiple cancer testis antigens (CTAs) to elicit a diverse and robust T-cell attack against tumor cells. A Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb's (BMS) Opdivo® (nivolumab) for multiple treatment settings in advanced non-small cell lung cancer (NSCLC) is ongoing, with enrollment of this trial completed in July 2019.

    This data demonstrated that significant survival benefit was observed in a cohort of previously treated, checkpoint inhibitor (CPI) naïve patients with advanced NSCLC; with a median overall survival (mOS) of 28.7 months for the intent-to-treat (ITT) patients (N = 47). This data compares favorably with published data of Checkmate 057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting. Notably, a statistically significant survival benefit with mOS of 42.1 months was observed in patients with injection site reaction (p = 0.0001). Exploratory biomarker analyses showed that overlapping CTA expression in patients' tumors at baseline with HS-110, as well as the expression of a specific CTA were both associated with statistically significant improved overall survival (p = 0.028 and 0.008, respectively).

    "Our exploratory biomarker analysis solidly establishes additional clinical evidence for the HS-110 mechanism of action," said Jeff Hutchins, Chief Scientific and Operating Officer of Heat. "This extended mOS also suggests that HS-110 treatment in combination with a CPI should be considered for any solid tumor type with sufficient CTA overlap with HS-110."

    This study has completed enrollment, and 21 of the 47 patients enrolled (45%) are still alive as of this data cut. HS-110 now has a positive safety profile in over 200 patients, and combination of HS-110 and nivolumab appears to be safe and well-tolerated.

    "This updated data demonstrates the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC", said Jeff Wolf, Chief Executive Officer of Heat. "Heat is planning an end-of-phase 2 meeting with the FDA to discuss registration trial design."

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company's gp96 platform is designed to activate immune responses against cancer or pathogenic antigens. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in phase 2, HS-130 in phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35. For more information, please visit www.heatbio.com.

    Forward Looking Statement

    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, expectation, and assumptions and include statements such as the extended mOS suggesting that HS-110 treatment in combination with a CPI should be considered for any solid tumor type with sufficient CTA overlap with HS-110, the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC, the planned end-of-phase 2 meeting with the FDA to discuss registration trial design and Heat's gp96 platform activating immune responses against cancer or pathogenic antigens. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including , the ability of Heat's therapies 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/591882/Heat-Biologics-Presents-Positive-Survival-Benefit-for-HS-110-in-Combination-with-Nivolumab-in-Phase-2-Lung-Cancer-Trial-at-2020-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting

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