Founding and Early Years
Pacific Marine Biotech, LLC (PMB) was formed in 2022, born out of a vision to explore the vast potential of marine biology in advancing human health. Our journey began over 40 years ago in Australia, a region known for its rich marine biodiversity. Below is a chronology of events leading up to the formation of PMB.
- 1962: Sam Grant, Sr. was introduced to the marine ingredients that cured his stomach cancer and eventually became the basis for the product we know today.
- 1981: Sam Grant, Sr. and his son Sam Grant, Jr. formed Aldgate Grove in Australia where they began manufacturing their marine ingredient-based products.
- 1992: Queensland University in Brisbane conducted a double-blind study on a powdered form of the product as an Arthritis Treatment. It was granted Aust R 18678 by the Therapeutic Goods Administration.
2000 - 2022: Early Research and Organic Growth
- 2000: The company relocated from Australia to Vanuatu after batch tests detected pollutants from farming runoff in the waters of the Coral Sea. Vanuatu’s waters were found to be cleaner and therefore more suitable location for production. Aldgate Grove was renamed Unicorn Pacific Corporation.
- 2007: Clinical trials began in the United States on their product TBL-12 for Multiple
Myeloma (plasma cell cancer) at St. Vincent’s Hospital in New York City. - December 2008: FDA granted permission to Unicorn Pacific to conduct Phase II
clinical trials on TBL-12. - 2010: Phase II clinical trials moved to Mt. Sinai and NYU Langone, both in New York
- March 12, 2012: Unicorn Pacific submitted their application to the FDA for Orphan Drug status.
- May 14, 2012: Based on clinical trial results, the FDA granted TBL-12 Orphan Drug designation, a major step towards product marketing. However, given the number of competitors with products available to treat Multiple Myeloma, it was decided that Unicorn Pacific would not pursue marketing approval and instead dedicate its resources to other indications. Currently, TBL-12 is a natural product with Orphan Drug designation approved by the FDA for multiple myeloma.
- 2019: Unicorn Pacific sponsored a study conducted at Nova University in Florida that showed TBL-12 has no toxicity, even at high levels.
- 2021: Unicorn Pacific sponsored a preliminary study at City University that showed TBL-12 penetrates the blood-brain barrier. ( Draft report on the effects of TBL-12 on glioblastoma,” Wah, Lam Yun; Yin, Tong Wing; Ng, Park, City University of Hong Kong, 2021.)
- December 2021: Unicorn Pacific Marketing submitted its pre-IND application to begin human trials on GBM.
- January 11, 2022: Unicorn Pacific Marketing received notice that the FDA granted it a pre-IND to begin human trials on GBM, pending the submission of additional required application materials.
2022 - : Broader and Deeper Cancer Research
- January 11, 2022: Unicorn Pacific Marketing received notice that the FDA granted it a pre-IND to begin human trials on GBM, pending the submission of additional required application materials.
- January 2022: Sam Grant and co-founder Alan Temkin created PMB to organize FDA approved clinical trials on TBL-12 for GBM and DIPG.
- Late 2023: An application was filed with the FDA for approval of clinical trials with Immune12. The FDA approved conducting an Interact Meeting to review the application in early 2024.
- February 2024: Interact Meeting with the FDA completed.
- May 2024: Sponsored Research Agreement signed with University of North Carolina to engage UNC Eshelman School of Pharmacy, Division of Pharmacoengineering and Molecular Pharmaceutics to conduct pre-clinical studies using in vitro, ex vivo and in vivo models to develop pharmacokinetic and pharmacodynamic data.
- August 2024: Multi-site Phase 2 clinical trials using IMMUNE12 for GBM set to commence 1st quarter of 2025 in Australia
- November 2024: Hired Regulatory Consultants, LLC as advisors to manage FDA filings.
- December 2024: Pre-Request for Designation submission for Immune12 filed with FDA
proposing Immune12 be regulated by CBER. - December 2024: Phase 2 Trial examining Immune12 for patients with Glioblastoma Multiforme (GBM) prospectively registered with Australian New Zealand Clinical Trials Registry (ANZCTR). Anticipated target date of patient enrollment is January 20, 2025
- February 2025: Presentation at the 6th Annual Glioblastoma Drug Development Summit
Titled, “Changing the Way Cancer is Treated”.