-Merger creates a publicly-traded clinical stage immuno-oncology company developing treatments for advanced cancers including aggressive brain tumors, pancreatic cancer, and melanoma
-Phase 2 clinical data on lead product candidate OT-101 demonstrated robust tumor responses including complete responses and long-term survival in several patients with aggressive brain tumors.
-Company plans to initiate multiple Phase 3 registration trials of OT-101 in high-grade gliomas and pancreatic cancer
In connection with the merger,
Upon the closing of the merger, Dr.
“I would like to welcome Mateon’s Dr.
The company’s lead product candidate, OT-101, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers, including high-grade gliomas and pancreatic cancer. The company plans to initiate phase 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer. During phase 2 clinical trials in pancreatic cancer, melanoma, and colorectal cancers (Study P001) and in high-grade gliomas (Study G004), meaningful clinical benefits were observed and OT-101 exhibited a favorable safety profile. These clinical benefits included long term survival and meaningful tumor reduction. Both partial and complete responses have been observed in the G004 Phase 2 clinical trial of OT-101 as a single agent in patients with aggressive brain tumors.
“The deep and sustained complete responses achieved in G004 with OT-101 alone as a single agent contributes to our optimism that new treatment strategies leveraging this promising anti-sense therapeutic candidate will favorably change the therapeutic landscape in these and other difficult-to-treat malignancies”, said
The company’s self-immunization protocol (SIP©) is based on novel and proprietary sequential treatment of cancers with OT-101 (an antisense against TGF-β2) and chemotherapies. This sequential treatment strategy is aimed at achieving effective self-immunization against a patients’ own cancer, resulting in robust therapeutic immune response and consequently better control of the cancer and improved survival. Prolonged states of being cancer-free have been observed in some patients with the most aggressive forms of cancer, raising a renewed hope for a potential cure. The use of OT-101 lifts the suppression of the patient’s immune cells around the cancer tissue, providing the foundation for an effective initial priming, which is critical for a successful immune response. The subsequent chemotherapy results in the release of neoantigens that result in a robust boost of the immune response. The company believes that a rational combination of the Oncotelic SIP platform with immune-modulatory drugs like interleukin 2 (IL-2) and/or immune checkpoint inhibitors has the potential to help achieve sustained and robust immune responses in patients with the most difficult-to-treat forms of cancer.
Following the merger, the company has approximately 83,120,000 shares of common stock and 193,713 shares of Series A Preferred Stock outstanding. Each share of Series A preferred stock will automatically convert into 1,000 shares of common stock following stockholder approval of additional authorized shares of common stock or a reverse split sufficient to permit conversion of all Series A preferred stock into common stock.
The company aims to translate its unique insights, which span more than three decades of original work using RNA therapeutics, into the deployment of antisense as an RNA therapeutic for diseases which are caused by TGF-beta overexpression, starting with cancer. Mateon’s current management was part of the team that developed Abraxane® as a chemotherapeutic agent for breast, lung, melanoma, and pancreatic cancer. Abraxane® was approved in 2005 and generates annual sales over
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, "estimate," "intend," "believe" and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the company’s annual report on Form 10-K filed with the
Source: Mateon Therapeutics