Innovation Pharmaceuticals Reports p53 Drug Candidate Therapeutic Potential Further Supported by Academic Research in Leukemias and in Combination with Cancer Immunotherapies

Independent Research Article on Kevetrin Submitted for Publication in a Leading Oncology Journal

BEVERLY, MA – April 16, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report recent academic and pre-clinical research further supports the therapeutic potential of Kevetrin, the Company’s p53 drug candidate, in leukemias and in combination with cancer immunotherapies. Kevetrin has been successfully evaluated in a Phase 1 clinical trial in advanced solid tumors and a Phase 2a clinical trial in late-stage ovarian cancer.

Kevetrin and Acute Myeloid Leukemia

Building on data presented at the 2017 European Hematological Association (EHA) Annual Meeting by independent cancer researchers and their conclusion“Our results suggest Kevetrin is a promising new drug in AML patients treatment, both in wild type and, even more, in TP53 mutated tumors, through different molecular mechanisms, giving more therapeutic alternatives in the treatment of this disease.”—the Company has been notified that a related scientific article is under review for publication by a leading oncology journal. The paper details Kevetrin’s treatment potential in Acute Myeloid Leukemia (AML) by targeting p53 and several key leukemia-related genes. AML accounts for approximately one-third of all leukemias worldwide and has a 5-year survival rate of only 25 percent.

Kevetrin and Cancer Immunotherapies

After decades of efforts to fight cancer, both pharmaceutical industry and academic researchers have realized that single target approaches to tumor suppression are largely insufficient to stop the adaptive and progressive nature of tumorigenesis. Newer immunotherapies that leverage the body’s innate immune system have been demonstrated to be effective, increasingly part of the standard-of-care in many cancer treatments, but are associated with significant limitations.

Notably, current PD-1 and PD-L1 inhibitors have been shown to be effective only in a smaller subset of cancer patients treated (10 to 30 percent) and in a limited number of tumor types. Responders can also relapse months to years after therapy. Immune checkpoint inhibitors (ICIs) can exhibit significant toxicity, including triggering immune-based attacks on the gastrointestinal tract and in the lungs in a large percentage of patients. Further, ICIs appear only to be effective in “hot” tumors that are rapidly growing and not in slower-developing developing “cold” tumors, in which there is lower frequency of mutation. The tumor microenvironment also poses a treatment challenge in immunotherapy.

Research conducted by Innovation Pharmaceuticals, building on molecular pathway analyses presented at the 2017 American Association for Cancer (AACR) Annual Meeting, has generated further insights and hypotheses regarding Kevetrin. The drug candidate has been shown to regulate multiple key cancer-related genetic pathways, including the downregulation of c-Myc and inhibition of m-TOR. Kevetrin has also been shown to positively affect the tumor microenvironment to promote anti-cancer activity via: downregulation of the chemokine CCL2(MCP-1); inhibition of angiogenesis, which leads to increased T cell infiltration; and enhanced expression of mIR-34a. These multi-pronged anti-cancer attributes are thought to make Kevetrin potentially well-suited to be used in combination with immuno-oncology therapies, aimed at enhancing overall treatment efficacy and safety.

Cancer immunotherapies comprise the majority of oncology-focused current drug development efforts—as of December 2017, over 2000 agents were in the clinical pipeline. And by 2022, it is estimated that the top 15 cancer drugs, collectively, will bring in almost $90 billion in sales.

Management Comments

“The sophisticated genetic pathway mapping that has been conducted to elucidate Kevetrin’s unique and potent anti-cancer properties is important work,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “This research, including the independent Kevetrin paper on AML that is in submission for publication, expands what we’ve observed in the clinic among treated patients—Kevetrin’s potential benefit in treating solid tumors—and is helping further inform interactions that we’re having with interested pharmaceutical companies with oncology immunotherapy programs, and blood-based cancer programs. As the most studied gene of all time, p53 remains a Hot Topic, eliciting significant public and private investment given an approved p53 drug would likely have a large impact in fighting many types of cancer.”

Linked below is a summary, published on the Company’s website, further elaborating on Kevetrin’s treatment potential as a novel, p53-modulating anti-cancer drug candidate.

·       “Kevetrin’s Effect on the p53 Signaling Pathway in a Broader Scientific Context”

As we continue to advance the clinical development of our Brilacidin programs in Oral Mucositis and Inflammatory Bowel Disease, the Company concurrently plans to devote resources to Kevetrin, including completing remaining bridging toxicology work toward developing Kevetrin in oral form. An orally-delivered Kevetrin would likely enhance the therapeutic benefits based on its pharmacokinetics, and broaden its market potential by meeting cancer patient’s strong preference for oral meds.

About Kevetrin and p53

Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by modulating p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial (see NCT01664000) of Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response (see ASCO 2015, ASCO 2013). Additional pre-clinical work supporting Kevetrin’s anti-cancer activity has recently been presented at scientific conferences (see EHA 2017, AACR 2017). The Company has successfully completed a Phase 2a trial of Kevetrin (see NCT03042702) in late stage, platinum-resistant/refractory ovarian cancer, in which intra-tumor modulation of p53 was directly observed. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially multiple times per day. The FDA has awarded Orphan Drug status for Kevetrin in ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.

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