Oncobax®-AK: A New Treatment for Advanced Non-Small Cell Lung Cancer and Renal Cell Carcinoma

What is Oncobax®-AK?

Oncobax®-AK is a new medication being studied for the treatment of advanced cancers. It contains a live strain of bacteria called Akkermansia muciniphila, strain P2261.1 This medication is considered a living bacterial product, which means it contains beneficial bacteria that are alive when administered to patients. Oncobax®-AK comes in the form of a capsule that is taken by mouth.1

Medical Conditions Treated

Oncobax®-AK is being studied for the treatment of two types of advanced cancers:

• Non-Small Cell Lung Cancer (NSCLC): This is the most common type of lung cancer, accounting for about 80-85% of all lung cancers. It occurs when cells in the lungs grow and divide uncontrollably.
• Renal Cell Carcinoma (RCC): This is the most common type of kidney cancer in adults. It starts in the lining of small tubes in the kidney.

Both of these cancers are being studied in their advanced or metastatic stages, which means the cancer has spread to other parts of the body.1

How Oncobax®-AK Works

Oncobax®-AK is designed to work together with immunotherapy, a type of cancer treatment that helps your immune system fight cancer. Specifically, it's being studied in combination with PD-L1-based immunotherapy or chemo-immunotherapy.1

The bacteria in Oncobax®-AK, Akkermansia muciniphila, is thought to play a role in enhancing the effectiveness of immunotherapy. Patients who are deficient in Akkermansia may be eligible for this treatment, suggesting that the bacteria might help improve the body's response to cancer therapy.1

Clinical Trial Details

Oncobax®-AK is currently being studied in a Phase 1/2 clinical trial. This means the study is in its early stages and is designed to test both the safety and effectiveness of the treatment. The trial is divided into two phases:1

1. Phase 1: This phase aims to understand how safe Oncobax®-AK is when given with immunotherapy and how well patients tolerate it.
2. Phase 2: This phase will look at how effective Oncobax®-AK is in treating the cancers when combined with immunotherapy.

The study is "open-label," which means both the patients and the doctors know which treatment is being given. It's also "non-controlled," meaning all participants receive the study treatment (there's no placebo group).1

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key requirements include:1

• Having confirmed Stage IV NSCLC or clear cell RCC
• Being eligible for standard-of-care PD-L1 based immunotherapy or chemo-immunotherapy
• Having a negative stool test for Akkermansia bacteria
• Having at least one measurable tumor
• Being in relatively good overall health (ECOG performance status of 0-1)

There are also several conditions that would prevent a person from participating, such as having certain autoimmune diseases, active infections, or recent live vaccinations.1

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to participating in this clinical trial:

Potential Benefits:

• Access to a new treatment that might be more effective than current options
• Close monitoring by healthcare professionals
• Contributing to medical research that could help future patients

Potential Risks:

• Unknown side effects or complications
• The treatment may not be effective
• Time commitment for study visits and procedures

The study will carefully monitor patients for any side effects or adverse events related to the treatment.1