Research & Development
With our lead drug candidate, CRX-100, we have used an intellectual property portfolio, developed by the company’s founders and exclusively licensed from Stanford University, to create a first-in-class immunotherapy that pairs the power of an oncolytic virus with the tumor-locating ability of cytokine-induced killer (CIK) cells.
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Research & Development

The Challenge

 

Cancer is the leading cause of death across the globe. For years now, researchers have performed studies focused on how to stop this deadly disease in its tracks. Progress in understanding cancer biology and the immune system have fueled major advances. Still, three major problems represent a large unmet need in current cancer therapies, including immunotherapies:

  • Drug Resistance
  • Immune System Evasion
  • Disease Recurrence

 

BioEclipse Therapeutics™ is committed to overcoming these challenges. Using our proprietary technology, we have developed a multi-modal therapeutic approach the combines supercharged immune cells known as cytokine-induced killer (CIK) cells with an adapted oncolytic virus that infects and kills malignant cells. The result of this combination is a multi-mechanistic, targeted treatment that we believe will not only defeat the cancer, but also protect patients from relapse and recurrence, through a durable immune response that prevents the development of new cancers.

Chemotherapy

Problem: Resistant Tumors

 

Tumors grow resistant to most treatments. For instance, more than 80% of ovarian cancer patients become resistant to standard-of-care therapies.

 

Solution: Combination therapy with multiple mechanisms of action

  • CIK cells deliver oncolytic virus specifically to tumor bed
  • The virus and the immune cells work separately, but systematically, to attack cancer cells
  • A high ratio of target to effector (1:1 million)

Problem: Tumor Evasion

 

Tumors use a variety of tricks to evade the immune system. Tumor cells can hide by changing their cell surface to become invisible to immunotherapies.

 

Solution: Tumor-selective virus infects and weaken tumors

  • Virus infection causes an increase in stress ligands on the surface of tumor cells that attacked the innate immune system and our CIK cells
  • Virus proteins placed on the  tumor cell surface makes tumor highly visible to immune system
  • CIK cells target, bind to and kill tumor cells

Problem: Cancer Recurrence

 

Drug resistance and immune evasion can leave behind metastatic or residual disease after treatment with standard therapies, leading to recurrence

 

Solution: Durable immune response against multiple tumor antigens:

  • CIK cells attract the adaptive immune system for a cytotoxic T-cell response
  • This response is against tumor antigens from lysed tumor cells
  • This is a memory T-cell response
BioEclipse R&D

The BioEclipse Approach

 

The pioneering work underway at BioEclipse Therapeutics™ approaches cancer immunotherapy from not just one, but several directions. We believe that to defeat cancer requires a drug with multiple mechanisms of action that work synergistically and systemically to target and kill cancer cells all over the body, and at the same time, create a durable immune response that prepares the patient’s body to prevent relapse and recurrence.

 

With our lead drug candidate, CRX-100, we have used an intellectual property portfolio, developed by the company’s founders and exclusively licensed from Stanford University, to create a first-in-class immunotherapy that pairs the power of an oncolytic virus with the tumor-locating ability of cytokine-induced killer (CIK) cells. What is truly novel, is how this multi-modal therapy overcomes limitations that, until now, have hobbled the efficacy of cellular and oncolytic viral therapies.

Problem: The Immune System’s Anti-Viral Response

 

Oncolytic viral platforms are difficult to deliver systemically. Also, the immune-system’s neutralizing anti-viral responses limits the efficacy of oncolytic viruses and prevents repeat treatment.

 

Solution: Our platform delivers the oncolytic virus inside the CIK cells

  • Protects the virus from the immune system
  • The CIK cells have the ability to deliver the virus directly to the sites of metastatic disease, where the cells serve as viral production factories in situ
  • Large amounts of virus do not need to be generated ex-vivo for systemic delivery.

Problem: Cell Therapies Don’t Work on Solid Tumors

 

CAR-T and other engineered T-cell therapies face unique challenges finding, entering and surviving solid tumors. So, while these therapies have shown encouraging results in hematologic cancers, efficacy against solid tumors has proved elusive.

 

Solution: Our technology does not rely on the identification of specific tumor antigens

  • A durable adaptive immune response recognizes whatever tumor antigens are present in that site of metastatic disease.
  • The multi-faceted MOAs induce an anti-tumor inflammatory response that overcomes the immunosuppressive tumor microenvironment of solid tumors.
  • Specifically, the virus increases stress ligands on the tumor cell surface to make the tumor visible to the immune system. The CIK cells target, bind to and kill the tumor cells.

Scientific Research

 

BioEclipse Therapeutics™ is advancing its lead drug candidate CRX-100 into clinical trials in 2020. The drug has been studied extensively in animal models using mice across several cancer indications, including ovarian, breast, prostate, Non-Hodgkin’s Lymphoma, hepatocellular carcinoma, colon, glioblastoma, neuroblastoma and lung.

 

This data shows that CRX appears to work in both solid and liquid tumors, and that a long-term immune response was generated against even hard to kill metastatic cancers.

CRX-100

 

As the lead investigational candidate in the BioEclipse Therapeutics™ pipeline, CRX-100 represents the first in a new class of combination, synergistic therapies within immuno-oncology, developed using an intellectual property portfolio developed by our founders and exclusively licensed from Stanford University.

 

CRX-100 is a truly differentiated therapeutic that addresses the current limitations of existing cancer therapies and the unmet needs of patients with hard-to-treat cancers or recurrent disease, offering the potential for a curative therapy.

 

How is CRX-100 Unique?

  • The CIK immune cells protect the oncolytic virus and ferry it to the tumor
  • Because this therapy doesn’t depend on a specific biomarker or tumor-specific antigens, it has the potential to treat a broad range of cancers, including many considered untreatable.
  • A multi-mechanistic therapy that targets only cancer cells, limiting toxicity, but still can touch tumors all over the body, holding promise for metastatic disease
  • A high effector-to-target ratio (1:1million) allows for de-bulking tumors
  • A durable immune response is generated, even against hard-to-kill and metastatic cancers
  • The therapy can be made using the patient’s own cells or donor cells
  • Attacks both solid and liquid tumors and multiple doses can be delivered, allowing for repeat treatments

If You Give a Mouse CRX-100

 

CRX -100 has been studied extensively in animal models using mice across several cancer indications with compelling results.

  • Mice with ovarian cancer treated with CRX-100 were all alive and appeared tumor-free 30 days after treatment with CRX-100; The control group (left untreated) were all dead at the 10-day mark
  • Mice with MYC-activated lymphoma showed impressive tumor regression 10 days after treatment with CRX-100 and no recurrence of the disease 180 days after treatment
  • Mice with lymphoma that were treated with CRX-100 at day zero and whose tumors regressed were still resistant to tumor re-challenge after 180 days, as evidenced by the presence of both CD4 and CD8 tumor specific cytotoxicity responses in the animal.  This suggests a long-term memory immune response demonstrated by both re-challenge and clearance attributed to a memory immune response specifically against tumor cells