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The FDA granted a positive review for an acute myeloid leukemia drug trial, with initial dosing expected in 2025.
The Food and Drug Administration granted a positive review for an acute myeloid leukemia drug trial, with initial dosing expected in 2025.
CERo Therapeutics Holdings, Inc. has recently announced that the company has received positive review from the U.S. Food and Drug Administration (FDA) on an amendment to its investigational new drug application around chemistry, manufacturing and controls (IND CMC), according to a news release from the company.
IND CMC refers to the component of an IND application that provides detailed information about the chemistry, manufacturing and control of the drug substance, drug product and placebo (if applicable), according to the FDA. It includes details on the drug's physical, chemical or biological characteristics, manufacturing processes, stability, purity, strength and quality. The CMC section ensures that proper identification, safety and regulatory compliance are maintained during clinical studies. It also addresses potential human risks related to the drug’s chemistry and composition and includes environmental assessments and labeling information.
This marks the completion of the company’s final commitment to the FDA prior to initiating patient dosing and shortens the manufacturing timeline by about a week. The company is on track to meet its anticipated timeline of dosing initial subjects during the first half of 2025 with this completion.
Overall response rate: proportion of patients with cancer reduction after treatment.
Complete response: full disappearance of cancer signs after treatment.
Composite complete response: combination of complete and partial responses, or other significant improvements.
Measurable residual disease: remaining cancer cells detectable after treatment.
“This is a key completion as we ramp up for initiating our clinical trial of CER-1236,” Chris Ehrlich, CERo Therapeutics CEO, said in the news release. “Very often there are additional delays prior to initiating a trial, including manufacturing, chemistry and other follow-on information that FDA may request at the time of or following the clearance of an IND. We have worked diligently to ensure continued progress with the FDA, avoiding additional delays. This is due to our fantastic team and top-notch consultants and partners, including UC Davis, our manufacturing partner, that have been working alongside us on this process. In the meantime, we received acceptance from the American Society of Clinical Oncology (ASCO) of an abstract, which we expect to present at the annual conference in Chicago May 30 to June 5. We will provide more updates on that presentation, as well as updating on our program development in the near term.”
CERo Therapeutics Holdings is set to begin enrollment in a phase 1 trial of CER-1236 in acute myeloid leukemia (AML) following the positive FDA review of its manufacturing process.
The first-in-human, multi-center, open-label phase 1/1b study will assess the safety and preliminary efficacy of CER-1236 in patients with relapsed or refractory measurable residual disease-positive AML. The trial will proceed in two parts, starting with dose escalation to determine the highest-tolerated dose and recommended phase 2 dose. The second part will expand the study to further evaluate safety and efficacy. Primary outcome measures include the incidence of side effects, serious side effects, dose-limiting toxicities and estimates of overall response rate, complete response, composite complete response and measurable residual disease. Secondary measures will assess pharmacokinetics.
According to the National Cancer Institute, AML is a fast-growing cancer where too many myeloblasts, a type of immature white blood cell, accumulate in the bone marrow and blood. If untreated, AML worsens quickly and can spread to other parts of the body, including the lymph nodes, spleen, liver, brain, spinal cord, skin, gums and testicles. AML is most common in older adults and is also known as acute myelogenous leukemia, acute nonlymphocytic leukemia or ANLL.
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