New Data Finds Tumor Treating Fields Initiates Downstream Anti-Tumor Response

Rhea-AI Summary

Novocure (NASDAQ: NVCR) announced a new study in the Journal of Clinical Investigation, revealing that Tumor Treating Fields (TTFields) activate anti-tumor immune responses with limited systemic toxicity. The research indicates TTFields can complement existing immunotherapy treatments for solid tumors by inducing a pro-inflammatory immune response. Preliminary results from the 2-THE-TOP clinical study show promising progression-free survival in patients treated with TTFields and anti-PD-1 therapy. This supports TTFields' potential role in enhancing cancer treatment modalities.

Positive

• New study demonstrates TTFields activate anti-tumor immune responses.
• Promising progression-free survival median of 11.2 months in clinical study.
• Limited systemic toxicity with TTFields reported.

Negative

• None.

Tumor Treating Fields dually activates the STING and AIM2 pro-inflammatory signaling pathways that drive early anti-tumor immune responses

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced that a new study published in the Journal of Clinical Investigation (JCI) finds treatment with Tumor Treating Fields (TTFields) mediated cell disruption activates the immune system and triggers an anti-tumor cell response that may be effectively used together with existing immunotherapy approaches in the treatment of solid tumors, with limited systemic toxicity.

“TTFields’ ability to activate a downstream immune response, effectively turning a cold tumor hot, is a unique element of TTFields therapy,” said Uri Weinberg, Novocure’s Chief Science Officer. “Given the depth of clinical research focused on the use of immunotherapies and the broad applicability of TTFields, this could be critical to the treatment path for solid tumor cancers.”

Preclinical research has shown evidence that TTFields may induce a pro-inflammatory and broader immunological effect on tumor cells. This study outlines translational research by Dr. Dongjiang Chen and colleagues from the David Tran Laboratory of Quantitative Cancer Research at the University of Florida. Preclinical data demonstrated that treatment with TTFields directly disrupted the nuclear envelope of glioblastoma (GBM) tumor cells. This led to leakage of DNA that activates the cGAS/STING and AIM2 signaling pathways, driving early anti-tumor immune responses. Further, a genetic signature was identified in patients treated with TTFields therapy indicating an acquired immune response. Collectively, these novel preclinical and patient data further elucidate the downstream cellular processes resulting from TTFields’ mechanism of action that support the potential for a therapeutic advantage when used together with immunotherapy, with limited systemic toxicity.

Based on these findings, Dr. David Tran, Chief of the Division of Neuro-Oncology, at the McKnight Brain Institute at the University of Florida, designed the phase 2 pilot 2-THE-TOP clinical study, evaluating the use of TTFields therapy together with the anti-PD-1 therapy (pembrolizumab) and chemotherapy (temozolomide) for the treatment of newly diagnosed GBM in 25 patients. In November 2021, updated data from the ongoing 2-THE-TOP study was presented at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting. These preliminary data showed 19 patients with greater than 9 months of follow-up displayed a median progression-free survival (primary endpoint) of at least 11.2 months. Additionally, 193,760 peripheral blood mononuclear cells were sequenced in 12 patients before pembrolizumab was administered and detected robust post-TTFields T cell activation in 11 of 12 patients via the T1IFN trajectory with a strong correlation with the TCRαβ clonal expansion Simpson index (Spearman coefficient r=-0.8, P=0.014). This finding is in line with the JCI publication, and contributes to the building body of evidence suggesting TTFields’ mechanism of action induces a downstream signaling pathway that initiates an active immune response that aids the body’s ability to fight cancer cells.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 22,000 patients have been treated with TTFields therapy.

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Jersey, and with a growing global footprint, Novocure has regional operating centers in Root, Switzerland, Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 24, 2022 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220223006438/en/

Investor Contact:

Ingrid Goldberg

investorinfo@novocure.com

610-723-7427



Media Contact:

Leigh Labrie

media@novocure.com

610-723-7428

Source: Novocure

FAQ

What is the recent study about Novocure's Tumor Treating Fields (TTFields)?

The study published in the Journal of Clinical Investigation shows that TTFields can activate anti-tumor immune responses, potentially complementing existing immunotherapies for solid tumors.

What are the results from the 2-THE-TOP clinical study for NVCR?

Preliminary data indicate that patients treated with TTFields and anti-PD-1 therapy have a median progression-free survival of at least 11.2 months.

Is there any toxicity associated with the use of TTFields?

TTFields therapy has shown limited systemic toxicity, with mild to moderate skin irritation being the most common side effect.

How does TTFields therapy work in cancer treatment?

TTFields disrupt cancer cell division and activate pro-inflammatory immune responses, making tumors more responsive to treatment.

What is the importance of the new findings on TTFields for NVCR's future?

The findings support the potential for TTFields to enhance existing therapies for solid tumors, which could improve treatment outcomes and expand market opportunities.