TAVO

TAVO™ + Electroporation (EP) Gene Delivery

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.

Key Highlights Include

  • Safety Profile

    In clinical studies, TAVO + EP gene delivery has shown a favorable safety profile to date and has been generally well-tolerated across multiple treatment cycles with no treatment-related serious adverse events reported.

  • Anti-Tumor Activity with Abscopal Effect

    Data from our Phase II melanoma program provide preliminary evidence of anti-tumor activity with a whole body (abscopal) effect, paving the way for expansion of our immuno-oncology pipeline.

  • Cold to Hot

    Data indicates that local delivery and expression of TAVO™ promotes tumor immunogenicity and increases tumor-infiltrating lymphocytes (TILs). As a pro-inflammatory cytokine, IL-12 can promote the recruitment of T-cells to the tumor. By driving T-cells or TILs into the tumor microenvironment, TAVO™ may enhance response to anti-PD-1 and convert anti-PD-1 non-responders to responders.

How It’s Designed to Work

Roll over images to reveal how TAVO + EP gene delivery is designed to work.

Step 1

Cancer is identified in the body.

Step 5

DNA-based IL-12 is expressed in the local tumor microenvironment.
 
 

Step 2

DNA-based interleukin-12 (IL-12), a naturally occurring protein, is injected directly into the tumor.

Step 7

Immune cells are educated to recognize the patient’s cancer.
 
 

Step 3

The applicator supplies a sequence of short-duration electrical pulses through a series of needles.
 

Step 7

Immune cells are educated to recognize the patient’s cancer.
 
 

Step 4

Electrical pulses result in increased permeability of the cell membrane, allowing DNA-based IL-12 to enter.
 

Step 8

Educated immune cells identify and attack tumors throughout the body.
 
 

Visceral Lesion Applicator (VLA) Expands Potential

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.

Technology

Our plasmid DNA delivery platform is designed to boost the body’s immune system to target and attack cancer

Partnerships

We have a track record of establishing, operating and evolving high-performance partnerships globally

Leadership Team

Our senior leaders bring a powerful combination of proven clinical, strategic and scientific capabilities