Up to 45 Patients aged 12 to 39 with osteosarcoma (bone cancer) that had recurred in the lungs and has recently been surgically removed will be enrolled. Patients will receive OST31-164 infusions every 3 weeks over 48 weeks and be followed after that for 3 years.

Start Date21 Oct 2021

Sponsor / Collaborator

George Clinical Pty Ltd.

NCT02386501 / CompletedPhase 1/2

A Phase 1b Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors

This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.

Start Date01 Sep 2015

Sponsor / Collaborator

Advaxis, Inc.

100 Clinical Results associated with ADXS-31164

100 Translational Medicine associated with ADXS-31164

100 Patents (Medical) associated with ADXS-31164

Literatures (Medical) associated with ADXS-31164

01 Sep 2016·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Immunotherapy with a HER2-Targeting Listeria Induces HER2-Specific Immunity and Demonstrates Potential Therapeutic Effects in a Phase I Trial in Canine Osteosarcoma

Q1 · MEDICINE

Article

Author: Gaurnier-Hausser, Anita ; Gnanandarajah, Josephine S. ; Mason, Nicola J. ; Paterson, Yvonne ; Wallecha, Anu ; Laughlin, Danielle ; Engiles, Julie B. ; Gray, Falon ; Huebner, Margie

Abstract:

Purpose: Recombinant Listeria vaccines induce tumor-specific T-cell responses that eliminate established tumors and prevent metastatic disease in murine cancer models. We used dogs with HER2/neu+ appendicular osteosarcoma, a well-recognized spontaneous model for pediatric osteosarcoma, to determine whether a highly attenuated, recombinant Listeria monocytogenes expressing a chimeric human HER2/neu fusion protein (ADXS31-164) could safely induce HER2/neu-specific immunity and prevent metastatic disease.Experimental Design: Eighteen dogs that underwent limb amputation or salvage surgery and adjuvant chemotherapy were enrolled in a phase I dose escalation clinical trial and received either 2 × 108, 5 × 108, 1 × 109, or 3.3 × 109 CFU of ADXS31-164 intravenously every 3 weeks for 3 administrations.Results: Only low-grade, transient toxicities were observed. ADXS31-164 broke peripheral tolerance and induced antigen-specific IFNγ responses against the intracellular domain of HER2/neu in 15 of 18 dogs within 6 months of treatment. Furthermore, ADXS31-164 reduced the incidence of metastatic disease and significantly increased duration of survival time and 1-, 2-, and 3-year survival rates when compared with a historical control group with HER2/neu+ appendicular osteosarcoma treated with amputation and chemotherapy alone.Conclusions: These findings demonstrate that ADXS31-164 administered in the setting of minimal residual disease can induce HER2/neu-specific immunity and may reduce the incidence of metastatic disease and prolong overall survival in a clinically relevant, spontaneous, large animal model of cancer. These findings, therefore, have important translational relevance for children with osteosarcoma and adults with other HER2/neu+ cancers. Clin Cancer Res; 22(17); 4380–90. ©2016 AACR.

01 Aug 2016·Clinical and translational medicineQ2 · MEDICINE

A One Health overview, facilitating advances in comparative medicine and translational research

Q2 · MEDICINE

ArticleOA

Author: Katz, Martin L ; Lyons, Leslie A ; Gray, Falon ; Bryan, Jeffrey N ; Curiel, David T ; Guloy, Amado S ; Gandolfi, Barbara ; Coates, Joan R ; O'Brien, Dennis P ; Henry, Carolyn J ; Johnson, Gayle C ; Jacobs, Marc ; LeBlanc, Amy K ; Sabbagh, Ubadah ; Wallecha, Anu ; Treml, Laura S ; O'Connor, Daniel ; Dmitriev, Igor ; Mason, Nicola J ; Paterson, Yvonne ; Weiss, Mark L ; Huebner, Margie ; Johnson, Gary S ; Wyckoff, Gerald J ; Stannard, James P ; Karanu, Francis N ; Bergman, Philip J ; Hays, Harlen D ; Duan, Dongsheng ; Rindt, Hans ; Robb, Edward J ; Webster, Debra A ; Likins, Lee ; Skaff, Andrew ; Baron, David A ; Laughlin, Danielle ; Gnanandarajah, Josephine S ; Harman, Robert J ; Stroud, Cheryl ; Engiles, Julie B ; Reinero, Carol ; Gaurnier-Hausser, Anita ; Cook, James L ; Kashentseva, Elena ; Calvet, James P

TABLE OF CONTENTS:

A1 One health advances and successes in comparative medicine and translational researchCheryl StroudA2 Dendritic cell-targeted gorilla adenoviral vector for cancer vaccination for canine melanomaIgor Dmitriev, Elena Kashentseva, Jeffrey N. Bryan, David T. CurielA3 Viroimmunotherapy for malignant melanoma in the companion dog modelJeffrey N. Bryan, David Curiel, Igor Dmitriev, Elena Kashentseva, Hans Rindt, Carol Reinero, Carolyn J. HenryA4 Of mice and men (and dogs!): development of a commercially licensed xenogeneic DNA vaccine for companion animals with malignant melanomaPhilip J. BergmanA5 Successful immunotherapy with a recombinant HER2-expressing Listeria monocytogenes in dogs with spontaneous osteosarcoma paves the way for advances in pediatric osteosarcomaNicola J. Mason, Josephine S. Gnanandarajah, Julie B. Engiles, Falon Gray, Danielle Laughlin, Anita Gaurnier-Hausser, Anu Wallecha, Margie Huebner, Yvonne PatersonA6 Human clinical development of ADXS-HER2Daniel O'ConnorA7 Leveraging use of data for both human and veterinary benefitLaura S. TremlA8 Biologic replacement of the knee: innovations and early clinical resultsJames P. StannardA9 Mizzou BioJoint Center: a translational success storyJames L. CookA10 University and industry translational partnership: from the lab to commercializationMarc JacobsA11 Beyond docking: an evolutionarily guided OneHealth approach to drug discoveryGerald J. Wyckoff, Lee Likins, Ubadah Sabbagh, Andrew SkaffA12 Challenges and opportunities for data applications in animal health: from precision medicine to precision husbandryAmado S. GuloyA13 A cloud-based programmable platform for healthHarlen D. HaysA14 Comparative oncology: One Health in actionAmy K. LeBlancA15 Companion animal diseases bridge the translational gap for human neurodegenerative diseaseJoan R. Coates, Martin L. Katz, Leslie A. Lyons, Gayle C. Johnson, Gary S. Johnson, Dennis P. O'BrienA16 Duchenne muscular dystrophy gene therapyDongsheng DuanA17 Polycystic kidney disease: cellular mechanisms to emerging therapiesJames P. CalvetA18 The domestic cat as a large animal model for polycystic kidney diseaseLeslie A. Lyons, Barbara GandolfiA19 The support of basic and clinical research by the Polycystic Kidney Disease FoundationDavid A. BaronA20 Using naturally occurring large animal models of human disease to enable clinical translation: treatment of arthritis using autologous stromal vascular fraction in dogsMark L. WeissA21 Regulatory requirements regarding clinical use of human cells, tissues, and tissue-based productsDebra A. WebsterA22 Regenerative medicine approaches to Type 1 diabetes treatmentFrancis N. KaranuA23 The zoobiquity of canine diabetes mellitus, man's best friend is a friend indeed-islet transplantationEdward J. RobbA24 One Medicine: a development model for cellular therapy of diabetesRobert J. Harman.

01 Jan 2011·CANCER GENE THERAPY

Development of a live and highly attenuated Listeria monocytogenes-based vaccine for the treatment of Her2/neu-overexpressing cancers in human.

Article

Author: Maciag, P. C. ; Shahabi, V. ; Wallecha, A. ; Rivera, S. ; Seavey, M. M.

A chimeric human Her2/neu gene (ChHer2) harboring most of the known major histocompatibility complex class I epitopes of the HER2/neu oncogene was expressed as a fusion protein to a non-hemolytic fragment of listeriolysin O (LLO), by the highly attenuated Listeria vector LmddA, which lacks antibiotic selection markers and the ability to spread from cell-to-cell. This construct (ADXS31-164) was tested for immunogenicity and anti-tumor effects in mice. Despite being highly attenuated, ADXS31-164 proved to be efficacious in breaking immune tolerance toward the HER2/neu self-antigen. ADXS31-164 elicited strong T-cell immune responses in experimental animals. In tumors, ADXS31-164 caused a reduction in regulatory T cells (Treg) accompanied by an increase in the CD8(+)/Treg ratio. Comparison of this vaccine with the conventional antibiotic resistant Listeria vector (Lm-LLO-ChHer2) shows that ADXS31-164 is more efficacious in delaying tumor growth in Her2/neu transgenic animals. Because of its well-defined attenuation mechanism and independence from antibiotic selection markers, ADXS31-164 is potentially more suitable for human use. These results support the future clinical development of this vaccine for the treatment of HER2/neu-overexpressing malignancies, such as breast, colorectal and pancreatic cancers.

News (Medical) associated with ADXS-31164

24 Dec 2024

·www.businesswire.com

OS Therapies Announces Pricing of $6 Million Private Placement

NEW YORK--( BUSINESS WIRE )-- OS Therapies, Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it has entered into securities purchase agreements with investors to sell 1.5 million units at a price of $4.00 per unit, with each unit consisting of one share of Series A Senior Convertible Preferred Stock (“the Preferred Stock”) initially convertible into one share of common stock and one warrant to purchase one share of common stock, expected to yield gross proceeds to the Company of $6 million, before deducting offering-related expenses. The conversion price of the Preferred Stock into shares of common stock is $4.00 and the exercise price of the warrants is $4.40 per share. The private placement is expected to close on or about December 27, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the proceeds from the private placement for working capital, primarily focused on the clinical and regulatory milestones to support commercialization of the Company’s lead therapeutic candidate OST-HER2 in the treatment of recurrent, resected metastatic osteosarcoma in the United States in 2025, and for general corporate purposes. The FDA has granted OST-HER2 rare pediatric disease, fast track and orphan drug designations. Brookline Capital Markets, a division of Arcadia Securities, LLC, served as placement agent and Ceros Financial Services, Inc. was engaged as a selected dealer to the placement agent. The securities being issued and sold in the private placement, as well as the common shares the securities are convertible or exercisable into, have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws and may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. The Company has agreed to file a registration statement with the Securities and Exchange Commission (the SEC”) registering the resale of the shares of common stock issued in this private placement (the “Resale Shares”). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the Resale Shares under the resale registration statement will only be by means of a prospectus. For more information, please see the Company's website at www.ostherapies.com . About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company’s lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma, with results expected in the fourth quarter of 2024. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing strong preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company’s proprietary silicone linker technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com . Forward-Looking Statements This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts included in this press release, including, but not limited to, OS Therapies’ expectations regarding the completion of the private placement, the satisfaction of customary closing conditions related to the private placement and the expected receipt and intended uses of the proceeds from the private placement, are forward-looking statements. OS Therapies cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, uncertainties related to market conditions and the completion of the private placement on the anticipated terms or at all; the expected future balances of the Company’s cash, cash equivalents and short-term investments; the expected duration over which the Company’s cash, cash equivalents and short-term investments balances will fund its operations; and other risks and uncertainties described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s registration statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Forward-looking statements reflect our analysis only on their stated date, and OS Therapies takes no obligation to update or revise these statements except as may be required by law.

Fast TrackImmunotherapyPhase 1Phase 2Orphan Drug

15 Nov 2024

·www.businesswire.com

OS Therapies Reports Third Quarter 2024 Financial Results and Provides Business Update

NEW YORK--( BUSINESS WIRE )-- OS Therapies, Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported financial results for the third quarter of 2024 ended September 30, 2024 and provided a business update. “The third quarter was pivotal for OS Therapies as we completed our initial public offering and finished dosing the final patient enrolled in our Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma,” said Paul Romness, MHP, Chairman & CEO of OS Therapies. “We are now looking forward to releasing topline data in December and then engaging with the FDA regarding getting this potentially life-saving cancer immunotherapy to patients that have no other potential treatment options as quickly as possible.” OS Therapies’ lead product candidate, OST-HER2, is a cancer immunotherapy biologic drug candidate comprised of HER2 bioengineered form of the bacteria Listeria monocytogenes (Lm) that infects HER2 presenting cancer cells and triggers a strong immune response against cancer cells expressing HER2. This off-the-shelf treatment is designed to prevent metastasis, delay recurrence, kill primary tumors expressing HER2 and increase overall survival. The Company has fully enrolled and finished treating all patients in a potentially pivotal Phase IIb clinical trial in recurred, resected osteosarcoma, dosing 41 patients with OST-HER2 at 21 clinical trial sites across the United States. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the Food and Drug Administration (FDA), and Fast Track and Orphan Drug Designations by the FDA and European Medicines Agency (EMA). OS Therapies is in active discussions with FDA regarding Breakthrough Therapy Designation for OST-HER2. Upon any Biologics Licensing Authorization (BLA) from the FDA for OST-HER2 in osteosarcoma, the Company will be granted a Priority Review Voucher based upon the RPDD. OST HER2 has also completed a Phase 1 clinical trial primarily in breast cancer patients, in addition to strong preclinical data demonstrating efficacy on a standalone basis and in combination with HER2-targeting therapeutic antibodies such as Herceptin®. Third Quarter Corporate Highlights: Completed treatment phase for Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma Accepted into Johnson & Johnson – JLABS IPO: NYSE-A: OSTX Financial Highlights for the Third Quarter: The Company is a pre-revenue biotechnology company. The Company anticipates beginning to generate revenue through the sale of a priority review voucher it expects to be issued by FDA upon approval of its rare pediatric disease designated drug candidate OST-HER2 and licensing rights to its products and product candidates as they achieve upcoming de-risking clinical and regulatory milestones. Loss from Operations: The Company recorded a net operating loss of $2.875 million in the third quarter of 2024 compared to an operating loss of $2.006 million in the third quarter of 2023. The increase in net loss was largely due to the expenses associated with the initial public offering. Net loss per share in the third quarter of 2024 was $0.18 on 15.897 million weighted average shares outstanding compared to the third quarter of 2023 where the Company delivered a loss of $0.38 per share on 5.340 million weighted average shares outstanding. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities. For more information, please see the Company's website at www.ostherapies.com About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company’s lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma, with results expected in the fourth quarter of 2024. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing strong preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company’s proprietary silicone linker technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com . Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. OS Therapies' drug development efforts, clinical trial results, patient enrollments, FDA regulatory approvals, designations, and intellectual property protections. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those described under the caption "Risk Factors" and elsewhere in the prospectus filed with the SEC relating to the offering and that actual results may differ materially from those indicated by such forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Phase 2Phase 1ImmunotherapyFast TrackBreakthrough Therapy

17 Oct 2024

·www.biospace.com

OS Therapies to Participate in a Fireside Chat at the 2024 Maxim Healthcare Virtual Summit

NEW YORK--(BUSINESS WIRE)-- OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”) , a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that Paul Romness, Chief Executive Officer, will be presenting at the 2024 Maxim Healthcare Virtual Summit. The summit is being held virtually on October 15 – 17, 2024. Event: Fireside Chat at 2024 Maxim Healthcare Virtual Summit Date: Thursday, October 17, 2024 Time: 3:00 PM ET Webcast: About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company’s lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma, with results expected in the fourth quarter of 2024. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing strong preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company’s proprietary silicone linker technology, enabling the delivery of multiple payloads per linker. For more information, please visit . Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as “anticipate,” “expect,” “intend,” “may,” “will,” “should” or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those described under the section entitled “Risk Factors” of our Registration Statement on Form S-1 declared effective by the Securities and Exchange Commission (the “SEC”) on July 31, 2024, as well as any of our periodic reports filed with the SEC, and that actual results may differ materially from those indicated by such forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Contacts Corporate and Media Contact: Jack Doll 410-297-7793 Irpr@ostherapies.com

ImmunotherapyPhase 2ADCPhase 1

100 Deals associated with ADXS-31164

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bone Cancer	Phase 2	US	George Clinical Pty Ltd.	21 Oct 2021
Osteosarcoma, Recurrent	Phase 2	US	George Clinical Pty Ltd.	21 Oct 2021
Osteosarcoma	Phase 2	US	OS Therapies, Inc.Startup	19 Sep 2021
HER2 Positive Solid Tumors	Phase 2	US	Advaxis, Inc.	01 Sep 2015
Breast Cancer	Phase 1	US	OS Therapies, Inc.Startup	-
Esophageal Carcinoma	Phase 1	US	OS Therapies, Inc.Startup	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PipelineReview Manual	Phase 1	HER2 Positive Breast Cancer HER2-Expressing	12	OST-HER2	dczwmobhnz(rkzpnqazkp) = OST-HER2 was determined to be safe and well tolerated in patients with HER2-expressing solid tumors. jiahnswxnu (ojdbkuyxbr )	Positive	24 Jul 2024

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