TrovaGene: Overcoming Challenges in Cancer Immunotherapy

After decades of attempting, but failing, to harness the immune system power to treat cancer (Cancer immunotherapy), novel approaches based on new discoveries have finally demonstrated they can do the hard job. These treatments, however, are facing challenges, which must be dealt with. Will Trovagine (TROV) succeed in dealing with the challenges?

Indeed, using the body’s own immune system to fight cancer is working by either stimulating a patient’s immune system to attack cancer cells or using antibodies that inhibit immune checkpoint proteins on the surface of the immune system cells, which diminish their ability to find and attack cancer cells.

The New immunotherapy treatments such as anti-PD-1 antibodies Opdivo® (nivolumab) and Keytruda® (pembrolizumab), have demonstrated higher rates of response in some cancer resistant to conventional treatments.

These treatments, however, are facing challenges, which must be dealt with. They include:

The concept of pseudo-progression: This is a phenomenon that does not exist with conventional treatments. It consists of tumor swelling, instead of shrinking, as observed when traditional imaging modalities are used to determine whether the immunotherapy is being effective, or ineffective in treating a patient. Pseudo-progression is probably caused by T-cell infiltration and inflammation of the tumor as it responds to immunotherapy. Oncologists are convinced that this phenomenon is good news, rather than bad news and that they must continue the treatments instead of stop them after reviewing the diagnostic imaging results that demonstrate tumors have swelled, instead of shrinking.

The lack of non-invasive diagnostics to monitor biomarkers’ responses

Bottom line, findings and interpretation of results from cancer imaging are not always reliable in determining the response to immunotherapy, and some oncologists are now relying on biopsies to confirm the therapeutic efficacy of these treatment regimens.

Are there diagnostic procedures other than radiology and invasive biopsies that would enable oncologists to learn early on whether the treatments are, or are not effective?

Are there any non-invasive diagnostic procedures that would enable progressive monitoring of cancer response to immunotherapy treatments?

 In The NEWS

TROVAGENE

Tovagene (TROV), a biotech firm that focuses on developing cell-free molecular diagnostics, announced the launch of a study to determine the ability of its Precision Cancer Monitoring℠ (PCM) technology to predict response to treatment in advanced melanoma patients receiving one or a combination of the novel immunotherapy agents.

The targeted novel immunotherapy agents include the immune checkpoint protein inhibitor drugs Yervoy® (ipilumumab), a CTLA-4 inhibitor, and Opdivo® (nivolumab), a PD-1 inhibitor.

Researchers at Memorial Sloan Kettering Cancer Center (MSK) will be conducting the Trovagene study with 50 patients on board.

Biomarkers used: BRAF and NRAS oncogene mutations will be used as biomarkers to monitor tumor dynamics in treated patients.

Study primary objectives: To verify if circulating tumor (ctDNA), can determine response to therapy early and if the results would correlate with the clinical course of disease.

The need to quantitatively monitor early response to cancer immunotherapy is a necessity given the challenges cited above. A successful non-invasive diagnostic procedure would protect   patients from unnecessary ineffective treatments; would save time and money and would enable oncologists to pinpoint the effective treatments for their cancer patients.

Paul Chapman, M.D., a medical oncologist at MSK Cancer Center who will oversee the study of Trovagene approach said, “As more immunotherapies become available for the treatment of cancer, it becomes more important to have non-radiographic tools to assess treatment effects.” Dr. Chapman added, “Responses to immunotherapy vary greatly in timing and extent, and radiographic responses may not reflect accurately the true response.  A rapid, accurate, and quantitative method to determine therapeutic effect as early as possible could help align new treatment strategies to patients’ needs.”

Trovagene has previously shown that its PCM platform can detect response to therapy within days of treatment in lung, colorectal, and pancreatic cancers.

“In this study, we attempt to better inform clinicians of the early benefits of immunotherapy in advanced melanoma,” said Mark Erlander, PhD, chief scientific officer of Trovagene. “We have previously shown in lung, colorectal, and pancreatic cancers that our PCM platform can detect response to therapy within days of treatment. Here, we intend to demonstrate that quantitative monitoring of driver mutations can provide reliable insight into tumor dynamics and response to immunotherapy, which is particularly important given the shortfalls of cancer imaging in this clinical situation.”

While Yervoy® and Opdivo® are registered trademarks of Bristol-Meyers Squibb Company. Keytruda® is a registered trademark of Merck & Co., Inc., we must not ignore the fact that immune checkpoint protein inhibitors work better in combination with other immunotherapy drugs, targeted drugs, or other small molecule drugs. In this respect, we can state that biotech firms have y drugs that are being used in combination with Yervoy and Opdivo. These firms include Incyte (INCY); Exelixis (EXEL); Celdex (CLDX) and others. Some other biotech firms involved in immunotherapy or have small molecule drugs for cancer will be soon joining.

And the revolution in treating cancer is ongoing at a very fast speed.

We appreciate the efforts spent by all the above-mentioned firms and we are long on the biotech firms mentioned in this article based on the Trovagene news. 

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