Entering Phase IB First-In-Human Study, Pipeline Expansion & Potential Acquisition Opportunity
MELBOURNE, Australia–(BUSINESS WIRE)–Propanc Biopharma, Inc. (OTCQB: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, announced today that its Chief Executive Officer, Mr. James Nathanielsz, provided a description of future target milestones and an update as the Company’s lead product candidate, PRP, advances towards a Phase IB, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. Mr. Nathanielsz also highlighted the Company’s strategic objectives to evaluate possible pipeline expansion opportunities, as it looks to transform into a clinical stage, immuno-oncology player targeting metastatic cancer from solid tumors. Any potential acquisition would be considered a novel, first in class therapy, potentially further enhanced by PRP, which has the ability to penetrate and alter the tumor micro-immune environment and therefore make once resistant and impenetrable tumors susceptible to other approaches, like CAR-T therapy, which may be a novel approach to target and treat solid tumors.
“As we progress further into 2021, our management team continues to work on advancing PRP to a FIH study, but also focusing on strategic objectives which can leverage our capabilities, fast track growth and offer potentially exciting new possibilities for the way we treat advanced cancer patients suffering with solid tumors. We feel the challenges of last year as a result of the global pandemic appear to be behind us and optimism in the biotech sector remains robust,” said Mr. Nathanielsz. “Therefore, we intend to capitalize on this current environment and look to fast track the growth of our Company by potentially identifying exciting new therapeutic candidates which are IND (Investigational New Drug) ready.”
- Completion of remaining process development activities, subsequent engineering run and full scale GMP manufacture of PRP in preparation for a FIH study in advanced cancer patients;
- Completion of the validation of the bioanalytical method for the FIH study.
- Preparation of the Investigational Medicinal Product Dossier (IMPD), as part of a clinical trial application (CTA) for a FIH study, to be submitted at the Peter Mac Center, in Melbourne, Australia.
POP1 Joint Research & Drug Discovery Project:
- Expanding the pipeline through production of biological compounds that mimic the action of proenzymes, whilst minimizing variation between different lots and without the use of animals as the primary source of materials. The Company’s researchers are currently optimizing conditions to extract high titers of the active materials before further analysis determining whether they are producing the right quality compounds.
- Mr. Nathanielsz and the Propanc management team are evaluating possible pipeline expansion opportunities that complements its existing technology, which can potentially halt aggressively spreading tumors and prevent tumor niche formation, therefore possibly further enhancing the response rate of a new drug candidate. Potential candidates will have advanced towards IND ready stage, are innovative with a significant advantage over the competition, and where the Propanc management team can fast track development milestones and commercialization to realize value for investors.
About Propanc Biopharma, Inc.
Propanc Biopharma, Inc. (the “Company”) is developing a novel approach to prevent recurrence and metastasis of solid tumors by using pancreatic proenzymes that target and eradicate cancer stem cells in patients suffering from pancreatic, ovarian and colorectal cancers. For more information, please visit www.propanc.com.
The Company’s novel proenzyme therapy is based on the science that enzymes stimulate biological reactions in the body, especially enzymes secreted by the pancreas. These pancreatic enzymes could represent the body’s primary defense against cancer.
To view the Company’s “Mechanism of Action” video on its anti-cancer lead product candidate, PRP, please click on the following link: http://www.propanc.com/news-media/video
All statements other than statements of historical facts contained in this press release are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements. These factors include uncertainties as to the Company’s ability to continue as a going concern absent new debt or equity financings; the Company’s current reliance on substantial debt financing that it is unable to repay in cash; the Company’s ability to successfully remediate material weaknesses in its internal controls; the Company’s ability to reach research and development milestones as planned and within proposed budgets; the Company’s ability to control costs; the Company’s ability to obtain adequate new financing on reasonable terms; the Company’s ability to successfully initiate and complete clinical trials and its ability to successful develop PRP, its lead product candidate; the Company’s ability to obtain and maintain patent protection; the Company’s ability to recruit employees and directors with accounting and finance expertise; the Company’s dependence on third parties for services; the Company’s dependence on key executives; the impact of government regulations, including FDA regulations; the impact of any future litigation; the availability of capital; changes in economic conditions, competition; and other risks, including, but not limited to, those described in the Company’s Registration Statement on Form S-1, Amendment No. 5, filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 3, 2020, and in the Company’s other filings and submissions with the SEC. These forward-looking statements speak only as of the date hereof and the Company disclaims any obligations to update these statements except as may be required by law.
Investor Relations and Media Contacts:
Mr. James Nathanielsz
Propanc Biopharma, Inc.