StemZyme is developing Transformative Cancer Supportive Care with its Phase 3 registration trial ready Enzyme medicine TZ 101 with several therapeutic indications that address critical unmet needs for late-stage metastatic cancer patients with solid tumors.
Phase 3 REgistration
Cancer Supportive Care for
Blood Cancer Patients
Accelerating Hematopoietic Recovery to Prevent Life-Threatening Side-Effects Associated with Curative Treatments: Infections, GVHD, Internal
Bleeding, Graft Failure.
Awarded by FDA
Supportive Care for Patients with
Accelerating Hematopoietic Recovery to Prevent Life-Threatening Side-Effects Associated with this Curative Treatment: Infections, Internal Bleeding, Graft Failure.
Supportive Care for Cancer Patients with Solid Tumors Receiving
Hematopoietic Rescue and
Relapse Free Survival
StemZYME: TZ 101 Cancer Supportive Care Enzyme Product that is Registration Trial Ready
TZ 101 our registration trial ready, off-the-shelf enzyme product is aimed at accelerating hematopoietic recovery post intense chemotherapy/hematopoietic stem cell transplantation to help prevent/reduce the incidence of various morbidities such as viral, bacterial and fungal infections, GVHD, engraftment failure, internal bleeding thereby potentially improving patient survival. It's unique and differentiated in that it is PREVENTIVE and prevents various morbidities potentially replacing the use of multiple cancer supportive care drugs each of which treat one morbidity versus prevent various morbidities.
Potential Peak Annual for this drug is $4B/year. Orphan Drug Designations Enable 7 Years Market Exclusivity from Approval and a 50% tax writeup of acquisition price. Pediatric Priority Review Voucher Upon Approval Enables a Potential Auction Revenue of $100MM-$300MM.
Human efficacy and safety have been established in phase 2 clinical trials resulting in an FDA phase 3 Special Protocol Assessment award which provides a clear regulatory pathway towards first approval for its later stage clinical asset. The company also has multiple FDA orphan drug awards in place, over 27 worldwide awarded patents and over 50 patent pending applications in place. A BLA designation enables 12 years protection from generic drugs.
TZ 101's mechanism of action is triggered by the interaction between selectins (P and E-selectins) found on the lining of blood vessels and epithelium of a multitude of tissues and certain cell-surface biomolecules to which a sugar (fucose) is enzymatically added by fucosylation. It increases the physiological mechanisms by which infused therapeutic cells circulating in the bloodstream traffic preferentially to the diseased tissues resulting in 400-700 percent more therapeutic cells reaching the micro-environment of the diseased organs from the blood vessel vasculature. Interestingly data points to TZ 102 increasing immune cell and stem cell residence time in sites of disease as well as engrafting more effectively for improved patient outcomes.
Our Adoptive Immune cell therapy products have also been shown in preclinical studies to help turn cold tumors into hot tumors, thereby immune-potentiating products such as checkpoint inhibitors, MABs, growth factors etc. for improved efficacy outcomes for patients as well as enabling market expansion into cold tumor clinical indications.