EF-009
EF-009 Wafer
Pancreatic Cancer Treatment
Curing Rare Cancers
- Rare Cancers are a subset of orphan diseases that affect so few people that trying to cure them makes little economic sense without public incentives and special regulatory benefits.
- Our mission is to develop orphan drugs to treat rare cancers chosen for their low probability of survival due to the lack of effective treatments, the presence of few competitors offering objectively inferior products based on key medical metrics, and the possibility of rapidly gaining market share via licensing agreements with global pharma partners.
Pancreatic cancer (PC)
While the mortality rate of pancreatic cancer (PC) is rising rapidly, treating it remains a formidable challenge. Surgery followed by adjuvant chemotherapy is the standard of care but, without additional therapy, over 90% of patients relapse and die. PC remains highly resistant to conventional chemotherapy and only 5% of patients survive more than 5 years.
Our Innovative Approach
Harness the Power of the Human Immune System
We seeks to identify and develop active compounds with the ability to amplify the body’s natural defense across many metrics, both by fortifying the patients’ immune system and weakening the disease to increase its vulnerability to medical treatments.
Use Small Molecules Drugs as Our Key Therapeutics
Given their relatively low molecular weight, simple chemical structures, more predictable pharmacokinetics and pharmacodynamics, small molecule drugs not only have superior safety profiles, but they can pass through cell membranes to reach intracellular targets and be formulated in many forms.
Improving Efficacy with Targeted Drug Delivery
We use targeted drug delivery platforms to improve the efficacy of our products with options like slow-released local delivery system, systemic drug delivery system, dripping pill formulation, dermal application formulation and injectable formulation.
Product Profile
Product Name
EF-009 Wafer
Disease
Pancreatic cancer
Target Market
North America, Europe, China, Japan
Market Size
US market worth around USD 26.31 billion
Competition Size
Animal study revealed much more survival than the chemotherapy drug, Gemcitabine.
Objective Size
First-in-class surgical combination therapy targeting both chemotherapy and targeted therapy markets, aiming to secure a 15% market share through direct competition.
EF-009 Wafer
The mortality rate of pancreatic cancer (PC) is rising rapidly.
However, the treatment of pancreatic cancer remain a formidable challenge and has 5-year survival rate of approximately less than 5%. Surgery followed by adjuvant chemotherapy the standard of care – without additional therapy, over 90% of patients relapse and die. However, PC remains highly resistant to conventional chemotherapy.
The great challenges lies firstly, in delivering chemotherapeutic agents effectively to bypass the protective barriers around pancreatic cancer; and secondly, in reversing the immunosuppressive environment caused by the presence of cancer stem cells.
EF-009 is a slow-releasing drug for the treatment of pancreatic cancer with multiple targeting effects. It can accumulate in targeted areas around the tumor, make it vulnerable and easily killed by chemotherapy or immune cells, with manageable toxicity.
EF-009 Wafer represents an innovative and challenging approach to pancreatic cancer treatment as an implant wafer formulation. Designed for in situ therapy, this sustained-release drug delivery system provides continuous drug release at the tumor site for up to one month. It effectively inhibits cancer cell proliferation, modulates the tumor microenvironment, alleviates immune evasion, and enhances immune response.
Why EF-009 Wafer Does It Better on Curing Pancreatic Diseases?
■ Promising Results and Low Toxicity
Preclinical studies on animal models have shrunk tumors with manageable toxicity.
■ Local Drug Delivery
After implantation, the tablets will slowly decompose and release small-molecule targeted drugs directly into the tumor, so that sufficient drug concentration can be achieved locally in the lesion.
■ Longer Life Expectancy
Preclinical studies on animal models have proven to prolong survival by 3.2 times.
■ Poor Alternatives
No effective target drugs despite survival period of 8-11 months from diagnostic.
■ Pancreatic cancer belongs to rare disease, US FDA Orphan Drug Certification will be applied soon
– the protection and preferential measures are granted under the Orphan Drug Development Act.
How EF-009 Wafer Compares to Conventional Treatments
Market Share (Forecast)
Key Active Ingredients
Active Pharmaceutical Ingredient (API): EF-API-001
- Small molecule
- Low toxicity: Rat LD50 = 1,850 mg/kg
- PIC/S GMP product
EF-API-001 is a small molecule, discovered from natural product researches and synthesized and manufactured through strict GMP processes and controls. EF-API-001 revealed excellent safety profiles and is an exciting discovery of multiple disease treatment capabilities.
KEY anti-cancer effects of EF-API-001: inhibiting tumor growth, inhibiting stemness, inhibiting chemo drug resistance, and immune response stimulation.
Excipient
- FDA approved, bio-degradable material
- Excellent bio-compatibility
- PIC/S GMP product
The Mechanism of Action for EF-009 Wafer
Aberrant DNA methylation has been shown to play an important role in the carcinogenesis of pancreatic ductal adenocarcinoma (PDAC), with approximately 80% of tumors overexpressing DNMT1 protein. Currently, existing anti-cancer drugs are not effective against PDAC, extending patient survival by only 3 months. Using DNMTs as a screening platform, we identified a new DNMT inhibitor — EF-API-001, which, combined with biodegradable materials, is formulated into the WF-009 Wafer for treatment by implanting into the pancreatic cancer site.
EF-009 Wafer combats pancreatic cancer through the following mechanisms:
Trigger Cancer Cell Apoptosis: It inhibits the proliferation of pancreatic cancer cells and induces cell cycle arrest at the G0/G1 phase, leading to apoptosis. Overexpression of DNMT1 in pancreatic cancer cells can restore this growth inhibition, therefore EF-009 Wafer inhibits DNMT1 expression in a dose-dependent and time-dependent manner.
Inhibiting Cancer Stem Cell Growth: Microarray studies have shown that PTCHD4 is a potential downstream gene of DNMT1. By silencing PTCHD4 expression through siRNA, it inhibits the activation of the Hedgehog signaling pathway, thereby suppressing the proliferation of pancreatic cancer stem cells, reducing cancer cell growth, metastasis, chemotherapy resistance, and post-treatment recurrence.
Inhibiting Cancer Cell Growth: Suppression of CD44 leads to growth inhibition of pancreatic cancer cells.
Synergizing Chemotherapy/Radiotherapy/Immunotherapy: By inhibiting the signaling of CD44ICD (CD44 intracellular domain), it has the potential to reverse the immunosuppressive microenvironment through regulation of the CD44ICD-PD-L1 axis, thereby enhancing the efficacy of chemotherapy, radiotherapy, and immunotherapy.
The Animal Study Results of EF-009 Wafer
The EF-009 Wafer eliminates tumors through long-term local high-concentration release, achieving intra-tumoral concentrations that cannot be attained through oral systemic administration. We established a human pancreatic ductal adenocarcinoma orthotopic xenograft model, where human pancreatic cancer cells were injected into the pancreas of immunodeficient mice. Thirty days after tumor cell injection, the EF-009 Wafer was surgically implanted at the tumor site, and tumor volume was detected using a non-invasive live-imaging system (IVIS).
In the control group (Ctl), the tumor continued to grow, while the chemotherapy drug gemcitabine (GEM) had a limited effect on pancreatic cancer growth. Treatment with the EF-009 Wafer resulted in a greater reduction in tumor volume in a dose-dependent manner. Additionally, similar to the observed tumor reduction, the mean overall survival of the control group (Ctl) and the gemcitabine group (GEM) was comparable (43.8 vs. 45.5 days), whereas the EF-009 Wafer treatment groups (LD, MD, HD) showed a 1.5- to 2.2-fold extension in mean overall survival compared to the control group.
Clinical Study Status
- IND application approved by USFDA and TFDA
Awards & Achievements
2019 IND application approved by USFDA
2020 IND application approved by TFDA
2021 National Innovation Award*
*Taiwan Government Awarded
Patents
Publications
Partnering And Collaboration
EFB is looking for the opportunity to cooperate with international pharmaceutical companies or venture capitals.
Please mail us on efbiotech@efbiotech.com
