We are developing cytokine-based intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer. We have built a deep and diverse clinical pipeline utilizing our primary technology, TAVO™ (tavokinogene telseplasmid) as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors. TAVO™ has the potential to become the first marketed therapeutic to address a great unmet medical need: anti-PD-1 non-responders.
TAVO is DNA-based interleukin-12 (IL-12), a naturally occurring protein in the body with immune-stimulating functions. TAVO™ is administered directly into the tumor using our proprietary electroporation (EP) gene delivery system, which employs a series of momentary energy pulses. Those pulses increase the permeability of the cell membrane and facilitate uptake of IL-12 coded DNA into cells. This non-invasive method is easy to perform and avoids systemic toxicity issues historically associated with IL-12 usage.
Clinical studies have demonstrated that TAVO induces local expression of IL-12, converting immunologically suppressed “cold tumors” into T-cell inflamed “hot tumors” which is fundamental to generating objective responses in both treated and untreated distant tumors.
TAVO is being studied in multiple clinical trials, including a registration-directed pivotal Phase 2 trial in metastatic melanoma and two Phase 2 trials in triple negative breast cancer (TNBC) and head and neck cancer. Results from recently completed clinical studies of TAVO have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach.
Roll over images to reveal how TAVO + EP gene delivery is designed to work.
We have developed proprietary novel applicators and generators that allow for electroporation of a wide array of immunologically relevant genes into cells located in visceral lesions, which are tumors located inside the body, including liver, pancreatic, lung and gastrointestinal-based cancers.
Our VLA technology is designed to work with our advanced generator to leverage plasmid-optimized electroporation, enhancing the depth and frequency of transfection and yielding a significant therapeutic benefit in preclinical models.
This next step in gene delivery has been further augmented with our next-generation plasmid therapeutic, which enhances IL-12 expression along with complementary immunomodulatory genes easily coded into this customizable vector backbone.
With product development expediency and preclinical efficacy in mind, we are leveraging miniaturization concepts, engineering, and distal geometry it developed and currently uses with respect to its preclinical applicator for the development of its VLA. We believe this is advantageous because the large body of preclinical data will directly support the transition of the VLA development for clinical approval.