Irvine-based Cryoport Inc. will provide transportation services to Gradalis Inc.’s second and third phase clinical trials in advanced stage ovarian cancer and to a second phase trial for Ewing’s sarcoma, a rare tumor associated with children and young adults.
Cryoport specializes in cryogenic—temperatures below the freezing point of water—storage and transportation for biotech companies focusing on biologic and immunotherapeutic therapies. The therapies are sensitive to their environment and require a specific temperature during storage and transit.
“Companies like ours need to transport our [cellular immunotherapy technology] for use in cancer treatments in frozen form, from manufacturing to doctor’s office,” said Sunil Joshi, chief executive officer of Dallas-based Gradalis. “The [U.S. Food and Drug Administration’s] expectation is very clear, [our technology] cannot come somedays frozen and somedays not. We need to guarantee the safe supply of our services.”
Gradalis is focused on developing personalized cancer immunotherapy technology by modifying patients’ own tumor cells into “Engineered Autologous Tumor Cells,” or EATCs. The Vigil EATC technology prevents tumor cells from producing TGF-β, a substance that prevents the body’s immune cells from recognizing and attacking tumor cells.
The transformed cells are reintroduced into the patient’s body, and the goal of the Vigil clinical trials is to enable the immune system to recognize the cancer cells and fight them.
“This whole immunotherapy technology is pretty brand-new, and in terms of Cryoport’s [cryogenic transportation] business, there are not a lot of people doing that,” Joshi said.
Cryoport uses its new SmartPak II condition monitoring system to serve Gradalis. The system, which it launched in June, includes real-time tracking using GPS and advanced integrated monitoring. Some variables it measures include internal and external temperatures, pressure, and humidity.
Cryoport will serve over 50 sites, including 44 sites for ovarian cancer and nine sites for Ewing’s sarcoma, according to Joshi.
Cryoport has a market cap of approximately $54.6 million.
Heart
Lake Forest-based NaviGate Cardiac Structures Inc. announced that one of its tricuspid valve stents has been implanted in a patient.
NaviGate develops heart valve replacement technology for both mitral and tricuspid regurgitation.
The company licensed its valve technology—which includes mitral valve replacement technology and tissue-preservation techniques—from Cleveland Clinic in 2012.
It more recently added a focus on tricuspid replacements.
A 64-year-old woman with severe functional tricuspid regurgitation—a deformation of the tricuspid valve that typically results in heart failure—received NaviGate’s transcatheter tricuspid atrioventricular valve stent at Cleveland Clinic.
The device replaces the diseased, inordinately enlarged tricuspid valve annulus—at the base of a heart valve—with the hope of allowing blood from the right side of the heart to flow to the lungs.
“The patient’s annulus measured 49.7 millimeters in diameter, and there are currently no valved stents that can secure such a dimension without extending into any of the chambers and still provide valvular function,” said Samir Kapadia, an interventional cardiologist at Cleveland Clinic and a scientific advisory board member to NaviGate.
“There are very few players doing what we do—[mitral and tricuspic valve] replacement – most are in repair,” said NaviGate Chief Executive Rodolfo Quijano.
The device company is not alone in its pursuit of the mitral and tricuspid repair and replacement market. Irvine-based Edwards Lifesciences Corp. is in a deal to buy Valtech Cardio Ltd. in Or Yehuda, Israel, for $340 million in cash and stock. The deal is expected to close early this year. Valtech develops a system for transcatheter repair of mitral and tricuspid heart valves.
Implants
Allergan plc received Food and Drug Administration approval to market Natrelle Inspira SoftTouch breast implants. The product adds a different gel firmness and level of shape stability to the drug company’s breast implant line, expanding it to three levels of cohesive gel, according to the company.
The addition “gives Allergan the most extensive variety of implants in the industry and provides doctors with a wide range of options,” said Chief R&D Officer David Nicholson in a statement.
The Natrelle line also received FDA approval in 2015 to market 28 additional styles of 410 silicone-filled breast implants, including extra-full projection, low projection and low height styles.
Dublin-based Allergan has its U.S. headquarters in Parsippany, N.J., and maintains an eye care and aesthetic medicine campus in Irvine. Breast implants are part of its aesthetic medicine business. Their revenue in the third quarter of last year totaled $35.6 million, up about 3% year-over-year.
Breast implants are used in breast reconstruction, augmentation and revision surgery.
Allergan has a market cap of approximately $78.8 billion.
