Angeles Hospital, a private state-of-the-art hospital in Tijuana, Mexico is conducting a clinical trial on behalf of Irvine, CA biotech sponsor NKMax America (part of Korean Parent) and just announced it treated the first participant in the study of SNK01-MX03, a phase I clinical trial evaluating SNK, an ex vivo expanded autologous natural killer cell therapeutic, in patients with plaque psoriasis.
The study is a non-randomized, dose-escalating and open-labeled clinical trial to evaluate the safety of autologous natural killer cell (NK) infusions (IV) of “SNK01” in adults with moderate-to-severe plaque psoriasis. The study team seeks to understand the safety and tolerability of four infusions of “SNK01” in patients with moderate-to-severe plaque psoriasis. A secondary objective is to determine the preliminary efficacy of “SNK01” in subjects with moderate-to-severe plaque psoriasis. The phase I study will continue till January, 2020.
The Clinical Investigative Site: Hospital Angeles
Hospital Angeles in Tijuana was established in 2006 built on the principles of medical care and patient hospitality. It has been reported as Mexico’s largest private hospital network. Their patient care network includes 28 hospitals, 234 surgical suites, 2,554 beds, and 15,000 specialists. Approximately 5 million patients are treated each year by one of 11,000 Angeles Hospital physicians. The Tijuana institution is involved with medical tourism and seeks to position itself by a service-oriented culture for patients/clientele. Located right next to San Diego and the over 25 million people in Southern California, it has strategic advantage for industry sponsors seeking to conduct studies in Mexico. Tijuana itself has morphed into a metropolis with nearly 2 million inhabitants.
Angeles touts on its website “top tier medical care with the most modern technology and services” from “state-of-the-art” operating rooms and “diagnostic services” across all medical field to their ability to attract “top medical talent from around the world.” The hospital high-end patient (and family) accommodations. They specialize in connecting top medical talent in Mexico to Americana and Canadian as well as European patients (e.g. the medical tourism focus). They conduct a range of treatments.
Clinical Trials at Angeles
They have organized a clinical research unit and it is estimated that they conduct 100 clinical trials annually with major biopharmaceutical and medical device sponsors. They incorporate concierge services potentially enhancing the clinical trial experience for the patient.
Regenerative Specialty at Angeles
The Regenerative Medicine Institute is based out of Hospital Angeles Tijuana. The clinic markets that it can provide high quality chronic disease treatments centered around patient dignity and safety. It offers team members that include board certified specialists offering adipose-derived stem cell therapies to patients. The hospital’s Regenerative Medicine Institute is on record driving and complete clinical trials such as the ANGEL trial sponsored by BIOHEART Inc.
The Investigational Product: SNK01
This investigational product harnesses the power of the body’s immune system through the development of Natural Killer (NK) cell therapies. SNK01 is an autologous therapy that is manufactured by harvesting a small number of a patient’s immune cells. After harvesting, the NK cells are separated from the blood, purified, activated and expanded at the cGMP facility of its maker NKMax America, Inc. The activated NK cells are then injected into the patient to fight against targeted diseases such as cancer or psoriasis.
The Commercial Sponsor: NKMax America, Inc.
NKMax America, Inc. is a privately held concern employing about 25. The company focuses on developing therapies that harness the power of the body’s immune system through the development of unique Natural Killer (NK) cell therapies. It is a subsidiary to Korea-based NKMax Co Ltd. CEO Park Sang-woo declared at an investor relations briefing in Korea that the company had plans for the NKMax America subsidiary to go public on the U.S. stock exchange (NASDAQ) in 2020.
The company has developed what they purport to be a novel and unique technology that has overcome some of the existing limitations with NK cell therapies such as the lack of mass production capability as well as purity concerns. They claim that their ability to cultivate highly active NK cells in patients at almost the same level as in healthy people—at 98% purity—truly differentiates them from much of the competition. CEO Sang-woo declares “We can mass propagate high-purity NK cells and plan to apply them to various diseases.”
As reported in Korea Biomedical Review, the Super NK cell therapy methodology involves the following: 1) Take out 60 mL of peripheral blood from the patient’s body 2) separate NK cells 3) cultivate NK cells using the company’s platform technology 4) generate about 2.5 million effective NK cells (highly capable of killing cancer cells) 5) mass propagate 2 billion to 6 billion NK cells in vitro 6) inject them into the patient’s body 7) NK cells attack and kill cancer cells in oncology scenarios.
Capital infusion is necessary to compete in global biopharmaceutical markets. Hence the company will push for the NASDAQ listing. They have selected U.S. law firm Cooley to manage their IPO. The company is actively seeking investors in the United States. They have hired Helen S. Kim, a business advisor involved with the Gilead Sciences acquisition of Kite Pharma. With Ms. Kim’s leadership the company is now also engaging with select venture capitalists. She believes that Super NK cell therapy may represent a strategy to overcome shortcomings with CAR-T therapy and this aligns with strategic agendas of many large biopharma sponsors.
Active Clinical Trials
The company has two major programs presently including 1) Phase I study focusing on expanded autologous Natural Killer Cells in patients pathologically confirmed cancer refractory to conventional therapy and 2) Phase I study in Mexico covered in this article—patient with moderate to severe psoriasis.
Daniela Gutiérrez, MD Hospital Angeles, Tijuana