Yahoo Finance Biomea (BMEA) Begins Dosing in Lung Cancer Study, Stock Up
Biomea Fusion, Inc. BMEA announced that it has successfully dosed its first patient in COVALENT-102, phase I/Ib study of its candidate, BMF-219. The Company’s stock jumped 11.69% in response to the news.
The COVALENT-102 study is an open-label, multi-cohort, multicenter study. In October 2022, Biomea received FDA clearance in October 2022, to initiate its phase I/Ib clinical study on BMF-219. This study will evaluate BMF-219 as a monotherapy in patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC), with any (pan) KRAS mutation.
BMF-291 is an orally bioavailable, potent, and selective covalent inhibitor of menin. Menin is a protein involved in transcriptional regulation and impacts cell cycle control, apoptosis, and DNA damage repair. It is useful in oncogenic signaling in multiple cancers.
With the COVALENT-102 study, the company is exploring the potential of BMF-219 as a pan-KRAS inhibitor in patients with three of the most common solid tumor types, including tumors that have failed to respond to investigational and approved mutation-specific KRAS inhibitors. BMF-219 is believed to possess critical advantages over late-stage, mutation-specific inhibitors of KRAS.
KRAS G12D and KRAS G12V are the most common isoforms of RAS oncogenes in human solid tumors, which are frequently mutated, and are extremely rampant in NSCLC, CRC, and PDAC. There are numerous other known activating KRAS mutations, but only two approved therapies, both of which only target KRAS G12C for locally advanced or metastatic NSCLC. Hence, there is an unmet medical need that forms a lucrative market opportunity for Biomea.
In the past year, the shares of Biomea have risen 13.6% against the industry’s fall of 8.9%.
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Biomea is simultaneously conducting a COVALENT-101 study on BMF-219 for the treatment of patients with liquid tumors. This study will have four cohorts and is currently enrolling patients.
Another phase I/Ib study, COVALENT-111, is also currently underway on BMF-219 for patients with type II diabetes. The company received Investigational New Drug (IND) clearance from the FDA in December 2022 and announced dosing its first patient on Jan 4, 2023, in the above-mentioned study. Initial phase II data from this study is expected in the first half of 2023.
The company is also currently working on a COVALENT-103 study for BMF-500 as an orally bioavailable covalent inhibitor. The preclinical findings were presented by Biomea at the 2022 ASH Annual Meeting, identifying BMF-500 as a potent, selective, and durable course of treatment. Biomea is on track to submit its IND application for BMF-500 in the first half of 2023 and plans to initiate clinical studies on BMF-500 as a single agent and in novel combinations to treat liquid tumors.
Zacks Rank and Stocks to Consider
Biomea Fusion currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are 89BIO, Inc. ETNB, Adicet Bio, Inc. ACET and ADMA Biologics, Inc. ADMA, all sporting a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the estimate for 89BIO’s 2022 loss per share has narrowed from $3.34 to $2.65. During the same period, the loss estimate per share for 2023 has narrowed from $3.59 to $2.59. In the past year, the shares of 89BIO have decreased by 10.9%.
ETNB’s earnings witnessed an average earnings surprise of 10.08%, beating three out of four estimates, in the trailing four reported quarters.
In the past 90 days, the estimate for Adicet Bio’s 2022 loss per share has narrowed from $1.63 to $1.54. During the same period, the loss estimate per share for 2023 has narrowed from $2.25 to $2.09. In the past year, the shares of Adicet have decreased by 40%.
ACET’s earnings witnessed an average earnings surprise of 54.24%, beating half of the surprise estimates in the trailing four quarters.
In the past 90 days, the estimate for ADMA Biologics’ 2022 loss per share has narrowed from $0.34 to $0.33. During the same period, the loss estimate per share for 2023 has narrowed from $0.20 to $0.19. In the past year, the shares of ADMA Biologics have risen by 144.3%.
ADMA’s earnings witnessed an average earnings surprise of 1.81%, beating three of the four estimates, in the trailing four reported quarters.
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