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Weird science: Cancer center announces first patient has received potentially cancer-stopping pill

City of Hope, one of the largest cancer research and treatment organizations in the United States, announced Oct. 19 that the first patient to receive its novel, promising cancer medicine AOH1996 is doing well.

A City of Hope-developed investigational cancer medicine developed by Linda Malkas, Ph.D., professor in City of Hope's Department of Molecular Diagnostics & Experimental Therapeutics, is in Phase 1 clinical trials. [Credit: City of Hope]

 

 

 

 

The Phase 1 clinical trial testing the safety of a potentially cancer-stopping therapeutic in people with reoccurring solid tumors is expected to continue for the next two years. The investigational pill developed by City of Hope has been effective in preclinical research treating cells derived from breast, prostate, brain, ovarian, cervical, skin, and lung cancers.

Linda Malkas, Ph.D., professor in City of Hope's Department of Molecular Diagnostics & Experimental Therapeutics, has been working on the research and subsequent discovery and development of AOH1996 for 20 years. AOH1996 is named after Anna Olivia Healey, a 9-year-old girl born in 1996 who was not able to beat cancer. AOH1996 is exclusively licensed by City of Hope to RLL, LLC, a biotechnology company that Malkas co-founded.

Malkas believed that proliferating cell nuclear antigen (PCNA), which plays an essential role in the replication and repair of cells, would be a less toxic cancer therapy that targets mutated cancer cells while leaving normal cells alone. The treatment has been shown in preclinical research to target PCNA and inhibit the growth and spread of a broad range of human cancer cells. The research protocol notes that AOH1996 is not toxic to healthy cells and that treatment with this medicine both pauses cell DNA synthesis and inhibits DNA repair, leading to a type of cell death known as apoptosis in the cancer cells.

"Imagine cancer as the water filling up a bathtub. Left unchecked, the tumors or water will eventually overflow and damage other parts of your home. The treatment my team at City of Hope created is akin to a watchful homeowner who shuts the water off -- stopping the spread of tumors to other parts of the metaphorical house -- and then drains the tub, eliminating the cancer," said Malkas, co-investigator in the trial and the M.T. & B.A. Ahmadinia Professor in Molecular Oncology.

Vincent Chung, M.D., added, "By targeting PCNA, we are inhibiting the complex machinery to stop cellular growth and proliferation. This is a new way of trying to kill cancer cells, or at least to slow it down." Chung is a research professor in City of Hope's Department of Medical Oncology & Therapeutics Research and principal investigator in the clinical trial.

The Phase 1 clinical trial is open at City of Hope Los Angeles. Its objective is to determine the maximum tolerated dose of the investigational pill, AOH1996, and to evaluate the medicine for preliminary efficacy. Eligible patients include adults with solid tumors who have not found standard treatments effective. Participating patients will be asked to take the medication in pill form twice a day.

"Since many patients' cancers become resistant to our standard therapies, we need new therapeutics with new mechanisms of action -- for example, non-cross resistant. AOH1996 is just that kind of new therapy," said Daniel Von Hoff, M.D., of the Molecular Medicine Division at the Translational Genomics Research Institute, part of City of Hope, and an advisor on the study.

Malkas said other targeted therapies, like checkpoint inhibitors, that inhibit the growth and spread of cancer have helped innumerable cancer patients, adding that perhaps one day AOH1996 will be a U.S. Food and Drug Administration-approved inhibitor that could be used in combination with existing therapies to both enhance cancer-killing effects as well as decrease side effects related to life-saving cancer treatments.

With the infrastructure and support of City of Hope, Malkas was able to commercialize her basic research, moving her promising laboratory discovery into a clinical trial for people who need the therapies of tomorrow today. City of Hope provided structure, experts, and even GMP (good manufacturing practice) facilities to manufacture her medicine.

Individuals interested in this clinical trial should review the eligibility requirements at clinicaltrials.gov. If they believe they are eligible, they can call 626-218-1133 or visit City of Hope's clinical trials web page.

Source: City of Hope

Published November 2022

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