Helixmith

Helixmith Co., Ltd. (VM BioPharma in the US) is a biotechnology company located in Seoul, Korea with US presence in Atlanta and the San Francisco Bay Area. The company works on DNA and protein-based therapeutics for various life-threatening diseases, along with herbal-based medicines, and nutraceuticals. ViroMed has five main products in its pipeline targeting cardiovascular disease, cancer, and immune-related disorder, with clinical trials in the US, Korea, and China. The company has established partnerships with global firms including Johnson & Johnson (Biologics Delivery Systems Group of Cordis Corp., USA), SBI Biotech (Japan), and Green Cross (Korea). The company also conducts preclinical developmental studies in the aspects of toxicology, efficacy and pharmacokinetics. Phase I and II clinical studies are also carried out.

History

Helixmith Co., Ltd. (prev. ViroMed) was established in 1996 as ViroMedica Pacific, Inc., later changed to ViroMed in 1999. ViroMed has been listed on KOSDAQ (084990) since 2006. As of January 6th, 2017, the total number of issued shares is 15,956,260 with market capitalization approximately at US$1.6 billion.

Products

VM202

VM202 is a DNA-based medicine designed to express two isoforms of hepatocyte growth factor (HGF), a protein known to induce the formation of new blood vessels and the growth of damaged nerve cells. Currently, VM202 is being tested for 4 major cardiovascular or neurological diseases. In all cases, VM202 is delivered by simple intramuscular injection around the affected site. A phase III study for painful diabetic peripheral neuropathy (VM202-DPN) has been successfully initiated in the US in 2016. As of May 2017, over 160 have been randomized in the US among whom over 140 patients have completed their first injections at 21 clinical sites. A phase III study for chronic, non-healing foot ulcer associated with diabetes (VM202-PAD) has received approval from the US FDA and will have patient enrollment in 2017 in the US. After successful phase I trial for coronary artery disease (VM202-CAD), a phase II study is planned as IRB review in clinical sites is currently underway in Korea. VM202 has also successfully completed a phase I/II for amyotrophic lateral sclerosis (VM202-ALS), also known as Lou Gehrig's disease, which received orphan drug status and fast track designation from the US FDA. Its phase II IND has been approved by the US FDA in 2016.

In 2004, ViroMed transferred VM202 and associated technologies to Beijing Northland Biotech for commercialization purposes; in 2018, VM202 continued on to phase III clinical trials in China.

VM206

VM206 is a therapeutic cancer vaccine targeting HER2/neu positive breast or ovarian cancer. Her2/neu is over-expressed in about 30% of breast cancers and is strongly associated with poor prognosis. VM206 can elicit an immune response to HER2/neu, which is hoped to reduce the growth and recurrence rate of breast or ovarian cancer.

VM501

VM501 is a re-engineered form of interleukin 11 (IL-11) targeting chemotherapy-induced thrombocytopenia (CIT) that is said to be less toxic than the existing FDA-approved drugs.

Clinical trials

According to its website, the company is involved in the following clinical trials:

1. VM202-PAD - Phase 2 clinical trial, China (completed): Angiogeneic therapeutics for critical limb ischemia.
2. VM202-PAD - Phase 3 clinical trial, USA (underway): Angiogeneic therapeutics for critical limb ischemia.
3. VM202-DPN - Phase 3 clinical trial, USA (underway): Disease modifying drug as neovasculazation & neurogenesis therapeutics for diabetic peripheral neuropathy.
4. VM206 - Phase 1 clinical trial, Korea (completed)