Clinical Relevance
Innovation with Impact
SINNAIS™ Thrives in CNS Research Alliances: Harvard, MGH, and USC Collaborations
Treating central nervous system (CNS) diseases, including multiple neurological and other diseases such as cancer, is difficult [page 175 to 176; 181 of S-4] because the blood-brain barrier, which helps protect the brain from viral and bacterial infections, also prevents the penetration of most drugs at effective therapeutic levels.
In the United States, there are at least 180,000 cases per year in our target CNS disease and neurological cancer patient population, comprised of estimated annual diagnoses (i) of 110,000 for Leptomeningeal carcinomatosis (LC) cancer, (ii) 60,000 for pancreatic cancer, and (iii) 12,000 for glioblastoma multiforme (GBM). Within the LC diagnoses, breast cancer, melanoma, and lung cancer make up more than 50% of the potential target population.
No implantable pumps are currently marketed for intraventricular treatment of CNS diseases. Instead, the current standard of care for administering drugs to the brain is a gravity-fed reservoir implanted below the scalp, with the therapeutic is delivered in a single bolus repeated at long intervals of days or weeks, often multiple times per week, resulting in significant swings in the concentration of the delivered therapeutic. In contrast, Cognos SINNAIS™ is designed for metronomic delivery, which is the delivery of sub-microliter-level amounts of drugs at consistently repeating rates. SINNAIS’s proprietary, state-of-the-art piezoelectric pump is capable of delivering precise microliter doses according to a preprogrammed and scheduled regimen.
Addressable patient populations
LC is a complication [from SEC filed corporate presentation; slide 7] in which the primary tumor metastasizes to leptomeninges (tissue covering the brain and spinal cord). Approximately 5% to 10% of solid tumors progress into LC, although many are underdiagnosed. Majority of LC cases arise in patients with breast cancer, lung cancer, or melanoma. The average survival rate from diagnosis is 3-4 months.
Pancreatic cancer accounts for approximately 3% of all diagnosed cancers and 7% of all cancer deaths, with its global incidence doubling between 1990 and 2017. The majority of pancreatic cancer cases are detected once resection is no longer feasible, resulting in a 5-year relative survival rate of 10.8%.
Glioblastoma multiforme is the most common malignant brain/CNS tumor, representing 16% of all such neoplasms. There has been increased incidence of GBM in recent years, possibly due to more sophisticated neuroimaging. GBM prognosis is poor with a median five-year survival rate of less than 5%.
The Fourth Modality:
Continuous Surveillance
The current treatment of solid and malignant tumors entails three modalities: surgery, chemotherapy, and radiation. The Sinnais implantable pump technology provides the fourth modality in the oncologists’ arsenal, allowing them to directly attack tumor-based cancers by targeting the malignancy at the source. The main idea behind Sinnais is the concept of “continuous surveillance”, which is employed and embedded in the design and architecture of Sinnais’ electronics, sensory output, and performance.
SINNAIS is designed for metronomic delivery, which is the delivery of sub-microliter-level amounts of drugs at consistently repeating rates. SINNAIS’s proprietary, state-of-the-art piezoelectric pump is capable of delivering precise microliter doses according to a preprogrammed and scheduled regimen. Sinnais is also designed to be implanted in a patient’s body for twelve to up to thirty-six months, with a reservoir that is refilled approximately once a month and can last up to six months depending on drug stability, making it suitable for long-term surveillance, and dynamic interventions.
Strategic Collaborators
Cognos has entered into a strategic and clinical collaboration with Massachusetts General Hospital and Harvard University to do a joint study for the use of Sinnais to deliver drug to the brain.
Conducted a small study to demonstrate local delivery of a combination of Avastin® and Campto® improves survival rate in mice.