Oncology Pharma's Co-Development Agreement Pursues Strategic and Direct Objectives
Oncology Pharma, Inc. (OTC PINK:ONPH) has outlined its strategy for a Co-Development deal focused on pediatric cancers, aiming to expedite drug commercialization and reduce costs. The project involves developing a dactinomycin nanoemulsion, which mitigates toxicity while improving delivery to tumor sites. Funding is secured for preclinical studies, with goals to submit an IND application to the FDA for human trials. The company emphasizes the need for improved therapies for rare pediatric cancers and plans to use its intellectual properties to meet this unmet need.
- Focus on developing therapies for rare pediatric cancers, addressing a significant unmet medical need.
- Engagement in a Co-Development project with secured funding for IND-enabling preclinical work.
- Utilization of a nanoemulsion formulation to enhance safety and efficacy of dactinomycin.
- Current negative operating cash flows necessitating additional funding, possibly dilutive.
- Risks related to licensing arrangements and joint ventures, impacting anticipated benefits.
- Potential challenges in obtaining necessary regulatory clearances and market acceptance.
SAN FRANCISCO, CA / ACCESSWIRE / August 23, 2021 / Oncology Pharma, Inc. (OTC PINK:ONPH) defines its objective and strategy for recently signed Co-Development deal. The primary goal of the Co-Development plan is to bring new pharmaceutical drug formulations to market with a focused approach that aims to reduce overall costs and time to commercialization.
Oncology Pharma is focusing on rare pediatric cancers. Pediatric cancers are traditionally underserved and very much in need of improved therapies such as those being developed by Oncology Pharma. The FDA provides an Orphan Drug pathway to companies developing drugs targeted at rare diseases, identified as those with less than 200,000 people in the US. The Orphan Drug pathway enables expedited review by the FDA and the potential for lower number of patients needed in clinical studies. Also, for pediatric oncology products, there is a potential for New Drug Approval after successful completion of Phase II clinical studies, with Phase III data being able to be collected while in the market. This incentive enables drug companies to focus on rarer diseases and dramatically decreases the potential costs and time to market approval. In order to encourage development of improved therapies for these under-served patient populations.
The co-development project is for the development of a dactinomycin nanoemulsion drug product, a targeted lipid nanoparticle formulation. Dactinomycin has been shown to be effective in destroying cancer cells. However, the practical use of the drug is very limited due to its high toxicity. Encapsulating drugs in lipid nanoparticles is known to mitigate toxicity and is therefore an excellent approach to reformulate highlytoxic pharmaceuticalsubstances.
Encapsulating dactinomycin enables the localization of the drug at the tumor site,which improves the safety and efficacy of the final formulation. The nanoparticle that encloses the dactinomycin protects healthy tissues while traveling to the tumor, and then slowly releases the drug over time. Additionally, the nano-sized particles "leak" through the blood vessels near the tumor and localize the drug-filled nanoparticle at the tumor site. Having the nanoemulsion release the medicine slowly over time and at the tumor site enables the destruction of the invading cancer while minimizing negative effects on the rest of the body. Therefore, an otherwise toxic dose may be administered more safely. This approach provides the potential to give suitable drug candidates a superior safety and efficacy profile.
Funding has already been committed to perform all necessary IND-enabling preclinical work for the first lead candidate. The first step will be to formulate an existing FDA-approved active pharmaceutical ingredient (dactinomycin) inside a nanoemulsion formulation. The next step will involve assessing the lead drug formulation in nonclinical pharmacokinetic and toxicokinetic safety studies. This is to determine if the nanoemulsion formulation is safer than the free drug alone. With data accumulated demonstrating a safer drug, the Investigational New Drug application will be submitted to the US FDA, seeking permission to move into human clinical trials.
Oncology Pharma has been working very diligently to launch this initial co-development project and is excited with the potential for utilizing its licensed intellectual properties to help address a virtually unmet medical need. Updates will be made available as news and data become relevant in the coming weeks and months.
ABOUT ONCOLOGY PHARMA, INC.
ONCOLOGY PHARMA, INC. (OTC PINK: ONPH) (the 'Company') is currently engaging in research and development of therapeutics for oncology and prides itself for having a world-class Advisory Board that keeps the Company in the forefront of developing technologies in cancer research, biotechnology, and healthcare.
FORWARD LOOKING STATEMENTS
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include risks related to licensing arrangements and joint ventures, including the need to negotiate the definitive agreements for the relationships; possible failure to realize anticipated benefits of business relationships, and costs of providing funding to these business relationships. Other risks and uncertainties relating to the Company include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company's ability to implement its long range business plan for various applications of its technology; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture partners; the impact of competition; the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company's technology; management of growth; and, other risks and uncertainties. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company's financial position.
CONTACTS:
For additional Information, please contact the Oncology Pharma at:
One Sansome Street, Suite 3500
San Francisco, CA 94104
Phone: 415-869-1038
Fax: 415-946-8801
website: www.oncology-pharma.com
email: info@oncology-pharma.com
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