Antroquinonol

Pancreatic cancer. Golden Biotechnology has shared updated data on its mushroom-derived drug candidate in metastatic pancreatic cancer, linking first-line use of the molecule to median overall survival (OS) of 14.1 months. People with metastatic pancreatic cancer lack good options, to the extent that the National Institutes of Health recommends that all newly diagnosed patients should consider enrolling in clinical trials. Chemotherapy remains the least bad option for many patients, with the FOLFIRINOX cocktail and gemcitabine-nab-paclitaxel combination respectively chalking up median OS figures of 11.1 months and 8.5 months. Another chemotherapy regimen, NALIRIFOX, also achieved a median OS of 11.1 months last year. Golden Biotech is presenting data on its attempt to clear that OS bar at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium this week. The median OS in metastatic pancreatic cancer patients who received its drug antroquinonol, along with gemcitabine and nab-paclitaxel as a first-line treatment was 14.1 months. Median progression-free survival clocked in at 5.3 months. The OS has increased since an earlier look at the data, when it came in at 12.6 months. In 2014, an ASCO committee said a 4-5 month improvement over FOLFIRINOX, or 3-4 month edge over gemcitabine-nab-paclitaxel, would be clinically meaningful. Research suggests more patients are eligible for gemcitabine-nab-paclitaxel than the more effective FOLFIRINOX.  In the absence of a control arm, it is impossible to tell whether adding antroquinonol to the treatment mix improves on the OS achieved by chemotherapy. Investors appeared unmoved, with little change in the Taiwanese biotech’s share price on the Taipei Exchange. Golden Biotech’s statement lacks a close look at the safety and tolerability results. An earlier cut of the data showed the rates of neutropenia, thrombocytopenia and anemia were lower in the antroquinonol group than in an earlier chemotherapy trial, although the rates of vomiting and diarrhea were higher.  Antroquinonol is a ubiquinone derivative found in a mushroom that grows on a tree of Taiwan. Evidence that the molecule blocks RAS signaling has spurred Golden Biotech to advance the molecule in pancreatic cancer. Other biotechs are going after the cancer by targeting KRAS, NTRK fusions, RET and other drivers of pancreatic tumors.

TAIPEI, Jan. 18, 2024 /PRNewswire/ -- Golden Biotechnology Corp.(TPEX 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical drug development company, had unveiled the findings of its Phase II clinical trial investigating Antroquinonol (HOCENA) in combination with the standard of care (SOC): nab-paclitaxel + gemcitabine, as first-line treatment for metastatic pancreatic cancer. The trial showed a positive median overall survival (mOS) of 14.1 months, which is a substantial increase compared to 8.5 months mOS observed in the standard of care Phase III clinical study (nab-paclitaxel + gemcitabine). Notably, when compared to current first-line treatment options for this very difficult to treat cancer, there was a highly significant survival advantage of patients treated with oral Antroquinonol in combination with SOC. Metastatic Pancreatic Cancer remains a devastating disease with very low survival rate and significant unmet medical needs in terms of treatment options. The ASCO Gastrointestinal Cancers Symposium 2024 Committee has selected Golden Biotech's Phase 2 Study, titled "A Phase I/II study of Antroquinonol in combination with Nab-Paclitaxel and Gemcitabine for patients with metastatic pancreatic cancer," for poster presentation. This multinational study, registered under NIH Clinical Trial Registration Number NCT03310632, employed a single-arm, open-label design with participating sites in the United States, South Korea, and Taiwan. The study revealed clinically meaningful responses in subjects treated with Antroquinonol in combination with the standard of care. The treatment demonstrated significantly longer overall survival (median OS) and OS rates at both 6 and 12 months when compared to the standard of care Phase III study. The OS figures were 14.1, 8.5, and 6.7 months for (Antroquinonol + nab-paclitaxel + gemcitabine), (nab-paclitaxel + gemcitabine), and gemcitabine alone, respectively. The corresponding OS rates at 6 months were 85.5%, 67%, and 55%, while the rates at 12 months were 62.2%, 35%, and 22%. In addition, Antroquinonol in combination with the standard of care surpassed the efficacy of another chemotherapy regimen, FOLFIRINOX, in terms of median OS and OS rates (Antroquinonol + standard of care vs FOLFIRINOX: OS= 14.1 vs 11.1 months; OS rate at 6 months=85.5% vs 76%; OS rate at 12 months=62.2% vs 48%). The trial results also showed an mPFS of 5.3 months and a 6-month PFS rate of 41.7% for Antroquinonol in combination with the standard of care drugs. The American Society of Clinical Oncology (ASCO) Committee have defined Clinically Meaningful Goals for clinical trials in Pancreas, Breast, Lung, and Colorectal Cancers. For Pancreatic Cancer patients eligible for treatment with Gemcitabine or Gemcitabine/Nab-paclitaxel, the current baseline median overall survival is estimated to range from 8 to 9 months. It is considered "clinically meaningful" if the minimum improvement over current overall survival is between 3 to 4 months. Golden Biotech's Antroquinonol has gained recognition for its groundbreaking work in the field of cancer treatment. It has been granted Orphan Drug Designation (ODD) by the FDA for the treatment of Pancreatic Cancer, Acute Myeloid Leukemia (AML), and Hepatocellular Carcinoma (liver cancer), as well as ODD by the EMA for Pancreatic Cancer. These acknowledgments underscore the potential of Antroquinonol in addressing the high-unmet medical needs associated with these challenging diseases. When compared to gemcitabine and other existing first-line therapies for metastatic pancreatic cancer, Antroquinonol in combination with the standard of care exhibited a significant survival advantage. Additionally, hematological adverse events (AEs) induced by nab-paclitaxel and gemcitabine, such as neutropenia, thrombocytopenia, anemia, and leukopenia, were substantially improved across all grade levels. No additional safety concerns were observed during the study. By combining nab-paclitaxel and gemcitabine with Antroquinonol, the incidence of hematological side effects also decreased across all grades. The results of this clinical trial may be a potential game changer for metastatic pancreatic cancer. Antroquinonol in combination with the standard of care may provide patients with significantly improved median overall survival and reduced hematological side-effects. Providing new hope for patients everywhere, for this very difficult to treat cancer FORWARD-LOOKING STATEMENTS: The statements contained herein may contain certain forward-looking statements relating to Golden Biotechnology Corporation (the "Company") that are based on the current beliefs and expectations of the Company's management as well as assumptions made by and information currently available to the Company's management. These forward-looking statements include, but are not limited to, statements relating to the Company's business prospects, future developments, trends and conditions in the industry and geographical markets in which the Company operates; the Company's inventions, patents, patent applications, strategies, plans, objectives and goals; the Company's ability to control costs; and statements relating to prices, volumes, operations, margins, overall market trends, risk management and exchange rates. 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All forward-looking statements herein are qualified by these cautionary statements and there can be no assurance that the actual results or anticipated developments will be realized or, even if substantially realized, that they will have the expected consequence to or effects on the Company's business or operations. View original content to download multimedia: SOURCE Golden Biotechnology Corp. Company Codes: Gretai:4132, Taiwan:4132.TWO, Taiwan:4132