BMF-219 is designed to be a highly selective, orally bioavailable small-molecule irreversible inhibitor of menin. Menin, a protein involved in transcriptional regulation, impacting cell cycle control, apoptosis, and DNA damage repair, plays a direct role in oncogenic signaling in multiple cancers. The menin complex plays a critical role in MYC-dependent oncogenic signaling, whereby menin enhances MYC-mediated transcription to promote cancer progression. Inhibition of menin is a novel approach to cancer treatment. Nonclinical studies of BMF-219 have shown sustained potent abrogation of menin-dependent oncogenic signaling and pathway control in vitro and in vivo. BMF-219 demonstrated consistent on-target inhibition with a strong anti-proliferative effect on various menin-dependent acute myeloid leukemia (AML) cell lines; diffuse large B-cell lymphoma (DLBCL) cell lines representing categories of Double/Triple Hit Lymphoma (DHL/THL) and Double Expressor Lymphoma (DEL); and multiple myeloma (MM) cell lines harboring diverse mutational backgrounds, including MYC dysregulation. BMF-219 also exhibited high potency in in vitro KRAS-driven cancer cell models. MYC, which exerts much of its oncogenic activity through interaction with menin, is a major downstream effector of the KRAS pathway. As previously announced, BMF-219 was also able to normalize glucose levels in both diabetic preclinical models studied with the glucose tolerance and homeostasis effect maintained despite complete washout of BMF-219.
In 2021, Biomea transformed into a clinical stage company with the initiation of BF-MNN-101, its first Phase I clinical trial of BMF-219. The trial is designed to assess BMF-219’s control of menin’s negative impact on patients with relapsed/refractory acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL). Biomea is confirming its clinical development plans to initiate additional clinical studies of BMF-219 in the following liquid tumors —MM and DLBCL— in the first half of 2022, and the following solid tumors —non-small cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer (CRC)— in the fourth quarter of 2022. In addition, subject to submission and clearance of an IND, Biomea plans to initiate a Phase I/II clinical trial of BMF-219 in diabetes during the second half of 2022.
“The preclinical profile of BMF-219 is highly compelling due both to its strong control of the menin pathway and very favorable safety profile. I am excited for Biomea to explore the clinical potential of this first-in-class and first-in-human irreversible menin inhibitor in multiple tumor types. We now know that the menin pathway is central to multiple cancer types. Targeting menin with a covalent binder is a very innovative approach and oncologists are eager to utilize BMF-219 for these patients who have limited therapeutic options,” said
“From the very beginning, we recognized menin as a key node in the oncogenic pathways of a broad array of tumors. We are very excited about what we have learned over the past years in preclinical studies with our irreversible menin inhibitor, BMF-219. Having observed essentially complete pathway control with consistent on-target effect across multiple tumor types, these studies demonstrated that BMF-219 has the potential to irreversibly inhibit the function of menin while maintaining a wide safety margin. These results have validated our plans to pursue BMF-219 for the treatment of 7 select liquid and solid tumors which we are planning to initiate during this year,” said
About Irreversible Menin Inhibitor BMF-219 Target Indications
Acute Myeloid Leukemia (AML) and Acute Lymphocytic Leukemia (ALL)
AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the
Multiple Myeloma (MM)
MM is a cancer of plasma cells, which make antibodies (immunoglobulins) and are mainly located in the bone marrow. As cancerous cells migrate from the bone marrow, organ damage due to excess immunoglobulins in bones and blood and weakening of bones are common features. Approximately 35,000 people in the
Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is the most common subtype of Non-Hodgkin Lymphoma. DLBCL starts in white blood cells called lymphocytes and it usually grows in lymph nodes. Every year, approximately ~18,000 people in the
Non-Small Cell
Non-Small Cell
Pancreatic Cancer
Pancreatic cancer is a relatively rare form of cancer in the
Colorectal Cancer (CRC)
Colorectal cancer is the fourth most common form of cancer in the
Diabetes
Diabetes mellitus is characterized by a reduced ability to produce insulin and/or by a dysregulated response to insulin and affects nearly 34 million people in the
About
Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including BMF-219, the potential of BMF-219 as a treatment for various types of cancer and diabetes, our research, development and regulatory plans, including our plans to discuss with regulators the potential clinical development of BMF-219 and our plans to file INDs and initiate clinical trials, and the timing of such events, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.
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