OS Therapies: Targeting osteosarcoma & other solid tumors

See why now could be the best time to start your research on OS Therapies Inc (NYSE: OSTX).

LATEST NEWS

OS Therapies Announces Pricing of its Initial Public Offering on NYSE American - Company to Trade under Symbol “OSTX”

5 Reasons Why OS Therapies Inc (NYSE: OSTX) Could Be Poised For Significant Upside Potential in 2024

Innovative and De-risked Lead Asset: OST-HER2 (OST31-164) Lm Vector Technology has a strong proof of concept demonstrated in animal trials and the company's lead asset for HER2+ Osteosarcoma in in a Phase 2b Human trial to prevent recurrence, both of which reduce risk for human applications and expand the potential for success in treating other cancers.

Cutting-edge Tunable Drug Conjugate (TDC): platform, licensed from BlinkBio, which incorporates innovative ligands, linkers, and payloads that are conditionally active. The initial program targeting Folate Receptor-α expressing ovarian cancer, with potential for expansion into other cancers, positions OS Therapies at the forefront of precision oncology.

Robust manufacturing and development partnerships with leading biotech firms. Their OST-HER2 Canine and Human lyophilized lots are manufactured by Wacker Biotech BV, while their pre-clinical Hexa-Caps for OST-TDC are produced by Sygene, with CMC activities managed by WuXi. These collaborations ensure high-quality production and accelerate development timelines.

Strong financial strategy: having raised $46 million in a crossover round to support the approval of OST-HER2 and advance the Phase I development of OST-TDC in ovarian cancer. This financial backing secures resources for ongoing platform development and future growth.

Experienced Leadership Team: The company is led by a group of seasoned professionals with extensive experience in biotechnology and oncology. Their combined expertise in drug development, clinical trials, and strategic management provides a solid foundation for driving the company's innovative programs forward.

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IDENTIFYING THE OPPORTUNITY

With a low float of 1.6M shares and an active pipeline, the price action received a triple-digit bullish rally soon after IPO

OS Therapeutics Inc

(NYSE: OSTX)

Addressing Unmet Medical Need in Kids and Adults

OS Therapeutics Inc (NYSE: OSTX) is a clinical stage therapeutic company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OS Therapies was launched to meet significant unmet need for new treatments in cancers of the bone in kids and adults.

Osteosarcoma is an extremely challenging and often aggressive cancer that has particular treatment challenges due to location, changing genotypes, and high recurrence rates. This company's mission is to answer the calls for new treatments, considering there have been no new treatments for OS in over 30 years.

OS Therapeutics Inc (NYSE: OSTX) has expanded the pipeline beyond Osteosarcoma with OST-HER2 into other solid tumors with the same recurrence mechanism of action, including Breast, Esophageal, and Lung cancer. With the addition of OST-tADC, considered a next generation Antibody Drug Conjugate (ADC) platform technology, they will be widening their scope to Ovarian, Lung, and Pancreatic cancer.

The goal of the company is to identify lead candidates in the treatment of Osteosarcoma and other solid tumors for clinical development, regulatory approval and commercialization. Starting with the most common genetic mutation found in Osteosarcoma, OS Therapies has identified a lead candidate in HER-2 Osteosarcoma with a goal of rapid clinical and regulatory analysis and review. This will be immediately follows in parallel with the OST-tADC development.

Company Timeline

The Details: OST-HER2 Mechanism of Action (MOA)

The intravenous OST-HER2 vector is rapidly cleared by the immune system’s antigen-presenting cells (APCs). Once inside the body, these APCs are strongly activated and generate potent HER2-specific T cells from within the patient. These T cells then proliferate and travel through the bloodstream, where they are attracted to and hunt down micro-metastases. As they target these cancerous cells, their contents spill out, revealing additional cancer targets to the immune system.

The exposure of new cancer targets leads to the generation of further T cells specifically targeting these newly identified antigens. This ongoing process ensures that the immune response continues to adapt and expand, effectively extending the treatment's reach and duration. Through this cycle, the OST-HER2 vector enhances the immune system's ability to combat cancer by continually revealing and targeting new cancerous cells.

OS Therapies Inc

(NYSE: OSTX)

A Robust Pipeline of Innovative Therapies

OS Therapies stands out in the biotechnology sector with its robust pipeline of innovative therapies targeting cancer and other high-impact diseases. The company's lead drug candidate, OSTE-001, is currently in advanced clinical trials, demonstrating promising efficacy and safety profiles. This candidate represents a significant leap forward in cancer treatment, offering a potential breakthrough for patients with limited options. The diverse range of therapies in development also underscores the company's commitment to addressing unmet medical needs and expanding its market potential.

The pipeline includes several preclinical and early-stage candidates, each designed to tackle different aspects of cancer biology. These candidates leverage cutting-edge technologies, including gene editing and novel drug delivery systems, positioning OS Therapies at the forefront of biotechnology innovation. The breadth and depth of the pipeline not only highlight the company's scientific prowess but also its strategic approach to diversifying risk and maximizing opportunities for success.

Furthermore, OS Therapies' dedication to advancing its pipeline is evident through its strategic partnerships and collaborations with leading research institutions and industry players. These alliances enhance the company's research capabilities and accelerate the development of its therapies. The collaborative approach helps in validating the therapeutic potential of their candidates and provides access to additional resources and expertise.

The Link Between Human & Canine Osteosarcoma

The company’s canine trials are a significant step forward in ensuring the safety and efficacy of their treatments before advancing to human trials. By conducting these trials in dogs, researchers can closely monitor the effects of the OST-HER2 vector in a model that shares similar physiological and immunological characteristics with humans. Canines, particularly those with naturally occurring cancers, provide a valuable opportunity to assess how the treatment performs in a real-world, biological setting. This can help identify potential side effects, determine appropriate dosage levels, and refine the treatment protocol based on empirical data from these trials.

The independent NIH Phase III canine trial (COTC 026) evaluating the OST-HER2 treatment arm has yielded promising preliminary results, with a p-value of 0.007 indicating statistically significant benefits. This trial, designed as a multi-arm study, includes several treatment arms compared against the standard of care (SoC) for canine osteosarcoma. The SoC consists of surgery followed by four doses of carboplatin, while the OST-HER2 arm involves SoC followed by three doses of the OST32-64 vector. Other arms in the study test various treatments, such as rapamycin, oncolytic VSV, and inhaled rHu IL-15. The primary endpoint is the disease-free interval (DFI), with secondary endpoints assessing overall survival compared to SoC.

Preliminary data from the Kaplan-Meier survival curves show that the OST-HER2 treatment arm demonstrates a threefold improvement in both overall survival and DFI compared to the SoC. Notably, the OST-HER2 curve is less mature than the SoC curve, which has more data accumulated over time. The OST-HER2 arm exhibits significant curve separation and the preliminary Gehan-Breslow-Wilcoxon test p-value of 0.007 supports early separation in survival curves. This early indication of efficacy suggests that as the study progresses and more events occur, the benefits of the OST-HER2 treatment may become even more pronounced. Experts anticipate that the final topline data, expected within the first half of 2022, will likely reveal even more substantial improvements in the OST-HER2 arm as the data matures.

Human Trials

The company's human trials for the OST-HER2 treatment have generated significant interest due to their promising preliminary outcomes. These trials are designed to evaluate the safety and efficacy of the OST-HER2 vector in patients with HER2-positive cancers. The initial phases have shown encouraging results, with the therapy demonstrating a good safety profile and early indications of effectiveness. The OST-HER2 treatment has been well-tolerated by participants, with manageable side effects and no severe adverse events reported. These findings are crucial for building confidence in the therapy's potential for broader application in treating HER2-positive cancers.

Furthermore, the human trials have provided valuable insights into the therapy's mechanism of action and its impact on cancer progression. Preliminary data suggest that the OST-HER2 treatment can generate a robust immune response against HER2-positive cancer cells, leading to improved disease control and potentially enhanced survival rates. The ongoing trials continue to monitor the long-term effects and overall survival benefits, with hopes that the positive trends observed so far will translate into substantial clinical benefits. As the trials advance, they will play a critical role in determining the therapy's future in oncology and its potential for regulatory approval and widespread use.

OS Therapeutics Inc

(NYSE: OSTX)

Strong Financial Position and Funding History

OS Therapies' strong financial position and impressive funding history make it an attractive investment opportunity. The company has successfully raised substantial capital through multiple funding rounds, including a recent Series C financing round that significantly bolstered its financial reserves. This robust funding history reflects investor confidence in the company's vision and its ability to deliver on its strategic objectives.

The company’s sound financial management is evident from its strategic allocation of funds towards critical areas such as research and development, clinical trials, and operational expansion. OS Therapies has demonstrated prudent financial stewardship, ensuring that its resources are efficiently used to advance its therapeutic pipeline and achieve key milestones. This effective financial strategy enhances the company's ability to sustain long-term growth and achieve its objectives.

Moreover, the company's strong investor base includes notable venture capital firms and strategic partners, which provides a solid foundation for future fundraising and collaboration opportunities. This network not only supports the company's financial stability but also opens doors to potential strategic alliances and market expansion. The continued support from a diverse group of investors further validates the company's potential and strategic direction.

Interview Highlights from Key Opinion Leader Experts

Introducing the Management Team of OS Therapies Inc.

(NYSE: OSTX)

Paul Romness, MHPChair, CEO - OS Therapies

Mr. Paul Romness leads OS Therapeutics with over 25 years of experience in the biopharmaceutical industry having served every function within major companies like Johnson & Johnson, Amgen and Boehringer Ingelheim. He has been directly involved in the launch of 9 major products in the industry covering indications for oncology, surgery, HIV, FSD, COPD, IPF, cardiovascular and diabetes. Throughout his professional career and within his community he has focused on and advocated for unmet medical need and getting treatments to patients. Mr. Romness has a B.S. in Finance from American University and a Masters of Health Policy from George Washington University Medical Center.

Robert Petit, PhD | Chief Medical & Scientific Officer Founding Scientist: OST-HER2

Dr. Robert Petit is an accomplished biopharma executive, innovator/inventor, company builder, and medical scientist. His personal mission is to develop new products and treatments that improve and extend the lives of patients. Robert has C-Suite experience leading several public and private therapeutic companies in the biotechnology, oncology, immunology, and infectious disease spaces. He has a consistent track record of excellence in corporate strategy, clinical development, scientific development, pipeline determination, medical and regulatory affairs.

Gerald Commissiong | Chief Business Officer

Mr. Commissiong is healthcare executive with over 15 years of experience serving in C-suite roles in emerging growth companies developing and commercializing novel therapeutics, diagnostics and natural products to address acute and chronic diseases. He previously served as President & CEO of Amarantus Bioscience Holdings, Inc. and Todos Medical, Ltd. helping raise over $70 million in equity and debt capital. His experience spans neurology, regenerative medicine, oncology and infectious disease. Mr. Commissiong received a BS in Management Science & Engineering with a focus on financial decisions from Stanford University and played professional football in the Canadian Football League for the Calgary Stampeders.

Jutta Wanner, PhD | Advisor Founding Scientist: OST-tADC

Dr. Jutta Wanner joins her Tunable Drug Conjugate (Advanced ADC) technology from BlinkBio, where she was Chief Scientific Officer. Before that she was at Roche where she was a co-lead in discovery chemistry. Dr. Wanner brings expertise across multiple therapeutic areas including oncology, inflammation and virology. Dr. Wanner received her PhD from the University of Kansas and conducted her postdoctoral training at The Scripps Research Institute in San Diego.

Jack Doll | Chief of Staff

Mr. Jack Doll is a Research Rock Star and scanning/transmission electron microscope guru. His final research dissertation was on Drug/Antibody-loaded Nanoparticles for Cancer Treatment. A recent Biomaterials and Engineering graduate from the University of Georgia, Jack assists Dr. Petit on the Osteosarcoma Phase IIb Clinical Trial, as well as the final toxicology trial in Tunable Drug Conjugates.

Sources

Source 1: https://ostherapies.com/leadership/
Source 2: https://ostherapies.com/
Source 3: https://ostherapies.com/technology/
Source 4: https://finance.yahoo.com/quote/OSTX/
Source 5: https://ostherapies.com/trials/
Source 6: https://ir.ostherapies.com/
Source 7: https://ir.ostherapies.com/news-events/press-releases/detail/20/os-therapies-forms-osteosarcoma-patient-advocacy-advisory
Source 8: https://ir.ostherapies.com/company-information
Source 9: https://ir.ostherapies.com/stock-data/quote
Source 10: https://d1io3yog0oux5.cloudfront.net/_b76ceebcbe0396766471db74436f8c69/ostherapies/db/2484/23266/pdf/OST_Summer_2022.pdf

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