DECOY BIOSYSTEMS

WHAT

Decoy Biosystems is a private, JLABS San Diego-based, biotechnology company dedicated to enhancing and expanding curative cancer immunotherapy for patients with unresectable or metastatic solid tumors and lymphomas, which are responsible for >90% of all cancer deaths. We are developing a novel, multi-targeted product that safely activates both innate and adaptive anti-tumor and anti-viral immune responses.

WHY

Current approved cancer immunotherapy products are only capable of curing a small percentage of metastatic or advanced cancer patients. Efficient or high percentage cures will require solutions to two challenges.

First--Tumors evade normal immune surveillance by producing direct immune suppressors, as well as by attracting and stimulating proliferation of negative regulatory immune cells. Fortunately, a number of agents are available which have the potential to reverse tumor-mediated suppression.

The second, unsolved challenge relates to the need for activation of both innate and adaptive immune pathways. When activated, the cellular components of both our innate and adaptive immune systems can kill tumor cells. In addition, activation of the innate system acts as a bridge to promote the most effective activation of the adaptive system. Thus, activation of both systems provides the best chance to produce durable anti-tumor responses. Unfortunately, activation of both systems can lead to excessive toxicity. An effective and safe method to simultaneously activate both systems has not been identified...until now.

HOW

Decoy has taken advantage of the world’s first immunotherapy, developed in 1894, to produce a systemically administered, killed and intact, non-pathogenic bacterial product that is able to synergistically and safely activate both innate and adaptive anti-tumor immune responses. Decoy’s broadly patented technology, including our first clinical candidate, Decoy20, produces significant pre-clinical single agent activity against orthotopic colorectal and metastatic pancreatic carcinoma, and synergizes with existing immunotherapies, including anti-PD-1 checkpoint therapy, targeted therapy and low-dose chemotherapy, to eradicate established colorectal and hepatocellular carcinoma and non-Hodgkin’s lymphoma tumors, with induction of innate and adaptive immunological memory. These initial target indications make up 20% of yearly world-wide cancer cases and 24% of cancer deaths, representing a $25 billion market. Decoy technology is also active against chronic hepatitis B virus (HBV) and HIV infection in standard pre-clinical models. Decoy20 will enter clinical development for cancer and hepatocellular carcinoma-associated HBV in Q1 of 2021.

DECOY BIOSYSTEMS

WHAT

Decoy Biosystems is a private, JLABS* San Diego-based, biotechnology company dedicated to enhancing and expanding curative cancer immunotherapy for patients with unresectable or metastatic solid tumors and lymphomas, which are responsible for >90% of all cancer deaths. We are developing a novel, multi-targeted product that safely primes both innate and adaptive anti-tumor and anti-viral immune responses.

WHY

Approved immunotherapies, such as Interluekin-2, Interferon-alpha and the more recently approved “checkpoint” and CAR-T therapies produce durable responses in a few percent to about fifty percent of patients across about a dozen out of over one hundred different types of cancer. Although checkpoint therapies are able to cure many previously incurable patients, only about 15% of patients receiving this type of therapy respond. The main limitation of existing therapies is that they each only activate one or a small number of key steps in either the innate or adaptive immune system, but there is general agreement that highly efficient cancer immunotherapy will require activation of both innate and adaptive immunity. Our innate and adaptive immune systems are each capable of cell-mediated destruction of tumors if the tumor cells are recognized as foreign or damaged. Activation of innate and adaptive responses is also dependent on immune cells sensing the presence of “danger.” The most potent immune cell activating danger signals are released by bacteria and viruses in the setting of infection, and include agonists of immune cell receptors, such as Toll-Like (TLRs), NOD and STING. Bacterial danger signals, including TLR agonists, can activate both innate and adaptive immune cells, including antigen-presenting cells, promoting innate (NK,  macrophage) and adaptive (T cell-mediated) destruction of tumors. An effective and safe method to simultaneously activate both systems has not been identified...until now.

HOW

Decoy has taken advantage of the world’s first immunotherapy, developed in 1894, to produce a systemically administered, killed and intact, non-pathogenic bacterial product that is able to synergistically and safely activate both innate and adaptive anti-tumor immune responses. Decoy’s broadly patented technology, including our first clinical candidate, Decoy20, produces significant pre-clinical single agent activity against orthotopic colorectal and metastatic pancreatic carcinoma, and synergizes with existing immunotherapies, including anti-PD-1 checkpoint therapy, targeted therapy and low-dose chemotherapy, to regress and induce durable responses against colorectal, hepatocellular, pancreatic carcinoma and non-Hodgkin’s lymphoma tumors, with induction of innate and adaptive immunological memory. Decoy technology is also active against chronic hepatitis B virus (HBV) and HIV infection in standard pre-clinical models. Decoy's target indications include colorectal, hepatocellular (+ HBV), bladder, cervical, pancreatic carcinoma, and non-Hodgkin's lymphoma, which account for 26% of yearly world-wide cancer cases and 29% of cancer deaths, representing a >$20 billion market.

Decoy has carried out successful GMP manufacturing of its lead product, and IND-enabling toxicology studies are nearing completion.  Decoy plans to file an IND in the second half of 2021 and then initiate a Phase I clinical trial with solid tumor and lymphoma patients. 

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*Decoy Biosystem operations are located at Johnson & Johnson Innovation, JLABS at San Diego (JLABS @ San Diego). JLABS is a 30,000 square-foot life science innovation center, located in San Diego. The labs provide a flexible environment for start-up companies pursuing new technologies and research platforms to advance medical care. Through a "no strings attached" model, Johnson & Johnson Innovation does not take an equity stake in the companies occupying JLABS and the companies are free to develop products - either on their own, or by initiating a separate external partnership with Johnson & Johnson Innovation or any other company.

Back to the Future Cancer Immunotherapy

 CONTACT US

Decoy Biosystems, Inc.

JLABS

3210 Merryfield Row

San Diego, CA 92121

(858) 492-0485