GemVax Considers Licensing GV1001 Alzheimer's Treatment Technology... Samsung Pharm in the Spotlight

[Asia Economy Reporter Hyunseok Yoo] Investor interest is increasing in the technology transfer of ‘GV1001,’ an Alzheimer’s treatment drug under development by GemVax & Kael (GemVax).

According to industry sources on the 25th, GemVax is reportedly discussing the technology transfer of domestic distribution rights for the Alzheimer’s treatment drug ‘GV1001’ with Samsung Pharm and others. Currently, Samsung Pharm is considered the most likely candidate. It is estimated that Samsung Pharm will utilize the cash secured from selling some production facilities and idle land on the 16th.

GV1001 is a peptide composition consisting of amino acids derived from telomerase. Telomerase is an enzyme that functions to maintain the length of telomeres located at the ends of chromosomes and has various functions such as anti-inflammatory antioxidant effects, cell protection, anti-aging, and stem cell activation. Telomeres, known as the ‘biological clock,’ play a role in preventing genetic damage but shorten with human aging.

GV1001 applied for domestic Phase 3 clinical trials with the Ministry of Food and Drug Safety in January. Once approved, the clinical trial plans to evaluate the efficacy and safety of GV1001 compared to a placebo in 306 patients with moderate to severe Alzheimer’s disease. The clinical trials will be conducted at about 30 hospitals nationwide, including Seoul Asan Medical Center and Hanyang University Guri Hospital.

The Alzheimer’s treatment drug GV1001 has already confirmed safety and efficacy in Phase 2 clinical trials conducted from 2017 to 2019 at 12 medical institutions in Korea. The company stated, “In the clinical trial for moderate or higher Alzheimer’s disease, the primary endpoint, the Severe Impairment Battery (SIB), which is most commonly used, showed a 7.11-point difference in the test group administered 1.12 mg of GV1001 compared to the control group administered donepezil alone, confirming excellent improvement effects.” They also added, “All three groups in the clinical trial confirmed safety with no serious adverse drug reactions, and statistical significance was confirmed in the secondary endpoint, the Neuropsychiatric Inventory (NPI).”

Meanwhile, on the 16th, Samsung Pharm announced plans to improve profitability by increasing liquidity for funds to be invested in new drug development and reducing fixed costs, utilizing 42 billion KRW secured through the transfer of tangible assets.

Previously, Samsung Pharm licensed domestic rights for a pancreatic cancer treatment drug from GemVax in 2015 and conducted Phase 3 clinical trials, receiving a successful Clinical Study Report (CSR) at the end of last year. The company announced it plans to file a New Drug Application (NDA) within the year based on this.