Oncology Pharma Expands on Feasibility Studies and Data

SAN FRANCISCO, CA / ACCESSWIRE / February 17, 2022 / Oncology Pharma Inc. (OTC PINK:ONPH) - Oncology Pharma, Inc. ("The Company") wants to expand on a previously announced press release that included results of formulations and data on licensed technology with NanoSmart Pharmaceuticals demonstrating the time release characteristic that is expected to improve the safety and localization profile of the eventual lead candidate formulations.

The active pharmaceutical ingredient, dactinomycin is an actinomycin antibiotic belonging to a class of polypeptide antitumor antibody. It inhibits transcription by binding to DNA at the transcription initiation complex and preventing elongation of RNA chain by RNA polymerase. Dactinomycin has been used both alone and in combination with other drug products to treat a wide range of cancers. Specifically, it has demonstrated clinical benefit for the treatment of pediatric and adult sarcomas and is used routinely as part of standard treatment regimens in clinical practice for the treatment of Ewing's Sarcoma.

The benefits of lipid nanoparticle drug delivery are well understood. In addition to sequestering toxic drugs from healthy tissues, the small particle size (100 nm - 400 nm diameter range) enables passive accumulation of the drug at the tumor sites. Passive accumulation occurs because blood capillaries associated with tumors have enlarged "pores" between the lining endothelial cells and nanoparticles are able to pass through these "leaky" capillaries and enter the interstitial fluid space within the tumor mass. Additionally, conjugation to polyethylene glycol (PEG) protects the nanoparticle from being recognized and detoxified by the liver.

Oncology Pharma, Inc. has licensed and has financed the early feasibility studies to date for this technology from NanoSmart and intends on commercially developing, distributing and utilizing this product and continuing the studies so that it can jointly bring this product to market with the target of initially focusing on the pediatric market. The Company believes the pediatric market is under-served and it gives an edge to Oncology Pharma as a pioneer in this critical market and allows Oncology Pharma to be a significant participant in this well deserved market.

Described below are the results of the early studies we addressed before:

• Initial Formulations
  • Tested for drug incorporation (visual): > 95% drug incorporation.
• 50% remaining after 3 hours (better than free-drug formulation).
• However, formulation had aggregation after several days in 4^oC storage. This is not optimal for formal development, but more favorable solutions were found with further testing.
• Series A-1 Formulation
  • Tested for drug incorporation (spectrophotometer - quantitative measurement) - 100% drug incorporated.
• However, formulation had aggregation after several days in 4^oC storage.
• Series A-2 Formulation
  • Preparation showed aggregation overnight at 4^oC, could not be filtered through 0.22 um membrane filter.
• Decided to switch to natural vs. hydrogenated oil to increase amount of drug incorporation and to reduce aggregation (natural oil appears to aggregate less than hydrogenated in storage).
• Series B-1 Formulation (natural oil)
• Attempted to filter through 0.22 um filter. Filter clogged quickly, indicating significant aggregation after formulation (prior to storage).
• Series B-2 Formulation
  • Dilution and minor change to B-1 formulation change and extrude 10X.
• Showed 100% incorporation of drug (visual).
• Still visible aggregation upon storage at 4^oC (approx. 50%) - still possible to filter through a 0.22 um filter.
• Upon additional research, appears that repeated extrusion may impart additional energy to nanoemulsion causing nanodroplets to aggregate. In addition, an ice bath was not used during this prep which may be a factor.
• Series B-3 Formulation
• B-2 formulation was extruded 3x through 400/200/100 nm membranes at room temperature.
• B-3 formulation was possible to filter trough 0.22 um filter without clogging (see picture next slide).
• Increasing amount of glycerol added to B-3 formulation did not improve formulation.
• Drug release study conducted at 37^oC:
  • 70% remaining after 1 hour, 35% remaining after 3 hours, 5% remaining after 6 hours. Improving upon this is desirable, but this is workable as a time-release formulation.
  • Submitting split samples for physical characterization and initial analytical method validation.

The proprietary nanoemulsion being developed also has the novel potential to be stable during storage for an extended period of time. This is in contrast to most lipid nanoparticle formulations that typically have a very short shelf-life once formulated. The nanoemulsion formulation can likely be utilized for a broad range of cancer drugs that are lipophilic (i.e. not water soluble), thus expanding the potential to license additional drug formulations utilizing this same platform technology, with each novel drug being safer and more effective than the predicate drug formulation currently on the market.

Advancement continues to be made on the feasibility testing and initial gathering of data of nanoemulsion formulations for dactinomycin. Early work continues to be promising with formulations demonstrating a satisfactory level of nanoemulsion loading and retention of dactinomycin. Studies to assess the physical characterization of the formulations, as well as quantitative performance measures (e.g., storage stability, time-to-release, etc.) are underway.

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.

ABOUT NANOSMART PHARMACEUTICALS, INC.

NanoSmart® Pharmaceuticals is a privately-held California corporation that is developing nanoparticle drug delivery platforms, including utilization of anti-nuclear antibody (ANA) to enable targeted drug delivery of existing drug therapies to areas of necrosis present in virtually all solid cancer tumors.

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

SOURCE: Oncology Pharma Inc.