On June 7, 2021 Morphogenesis, Inc., a clinical-stage biotechnology company, reported that it has obtained funding to develop a new therapeutic drug to treat cervical cancer (Press release, Morphogenesis, JUN 7, 2021, View Source [SID1234583692]). Globally, more than half a million women are diagnosed and over 300,000 die from cervical cancer each year due to lack of access to lifesaving care. Cancer treatment regimens in low-resource settings require a fundamental transformation to overcome this horrific toll.
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A multi-discipline team that includes scientists from Morphogenesis, Medisca, a pharmaceutical compounding company specializing in customized medication, and Moffitt Cancer Center is developing an innovative therapy that would expand care to patients with limited access to lifesaving treatments. A Small Business Innovation Research (SBIR) proposal entitled, "A low-cost topical immunotherapy formulation suitable for treating cervical cancer in low- and middle-income countries and low-resource settings in the U.S.", received excellent scores following a competitive review process, and was awarded $400,000 from the National Cancer Institute (NCI) at the National Institutes of Health (NIH). The proposed work will reformulate Morphogenesis’s immunomodulatory cancer drug, IFx-Hu2.0, to a preparation that is applicable to treat women in locations with limited healthcare infrastructure.
IFx-Hu2.0 functions by recruiting the enormous power of the immune system towards the destruction of tumor cells. IFx-Hu2.0 treatment delivers a bacterial gene to a patient’s tumor that leads to the expression of an antigenic bacterial protein on the surface of those tumor cells. The bacterial antigen primes and educates the immune system to destroy tumor cells without harming healthy tissues.
IFx-Hu2.0 is a liquid drug preparation that is delivered by intratumoral injection. To facilitate cancer treatment in limited-resource settings, the team will formulate IFx-Hu2.0 to a non-toxic, affordable, commercially viable immunotherapy that can be stored and shipped at room temperature and self-administered. The goal is for this product to enable treatment in a variety of settings without the need for surgery, specialized training, or facilities.
"We are extremely excited about the global implications of our technology," said Pat Lawman, PhD, CEO of Morphogenesis, Inc. "While some of the other immune-oncology products being tested have tremendous promise, they will be prohibitively expensive and logistically unfeasible for treating patients in low resource settings. This project is near and dear to my heart since it embodies the culture of Morphogenesis, which is to create products that are accessible to those who would otherwise be without hope."
Shari Pilon-Thomas, Ph.D., Associate Member of Moffitt’s Department of Immunology, will direct studies designed to measure the efficacy of the reformulated drug in pre-clinical models. "This grant strengthens the ongoing collaboration between Moffitt and Morphogenesis. Results from this study will raise the potential for this incredible product to reach cervical cancer patients that are most in need of novel therapies," said Dr. Pilon-Thomas.
"The immuno-oncology products that we are developing will be instrumental in our company’s mission to end needless suffering. The lack of side-effects from our treatment means that there will be no added expense for supportive care needed with other therapies to treat chemotoxic or immunotoxic reactions," added Morphogenesis’ President, Michael Lawman, FRSB, Ph.D.
About Morphogenesis, Inc.: Morphogenesis is a clinical-stage pharmaceutical company based in Tampa, Florida developing novel "off-the-shelf" personalized immunotherapies for the treatment of cancer. Their IFx-based treatments induce personalized, tumor agnostic, multivalent, systemic, and sustained immune responses and have the potential to treat a broad range of cancers through enhanced tumor recognition, immune activation, and epitope spreading. IFx-based drugs have an established safety profile in multiple animal models. The IFx-Hu2.0 drug has just completed a Phase 1 clinical trial (safety) for Stage III/IV unresectable cutaneous melanomas and is currently in an expanded Phase 1 trial that includes cutaneous squamous cell carcinoma (cSCC) and Merkel cell carcinoma.
The Company’s patented immunotherapy is based on a single bacterial gene that when expressed on the surface of a patient’s tumor cells, educates the immune system to target the patient’s unique set of tumor antigens (neoantigens) without the toxic side effects that are common to most other cancer treatment regimens. Morphogenesis continues to innovate and reach major milestones towards its goal of bringing their gene therapy to treat a wide range of human cancer patients. Last year, Morphogenesis augmented its portfolio with three US patent awards and made multiple applications for worldwide patent protection. These patents are an important component of Morphogenesis’s exclusive intellectual property portfolio that includes some 55 issued patents and patent applications.