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Kronos Bio, Inc. (Nasdaq: KRON) is a clinical-stage biopharmaceutical company committed to transforming patient outcomes through the discovery and development of novel cancer therapeutics. With a focus on modulating historically challenging cancer targets, the company leverages industry-leading high-throughput screening strategies and its proprietary small molecule microarray (SMM) platform. Kronos Bio's core business revolves around developing therapies that target the deregulated transcription processes fundamental to many cancers.
The company's most prominent projects include KB-0742, an inhibitor of CDK9, which has shown promising anti-tumor activity and a manageable safety profile in early trials involving patients with transcriptionally addicted solid tumors. The ongoing phase 1/2 trial has recently escalated dosing to 80 mg, with expansion cohort data anticipated in mid-2024.
Another key development is KB-9558, targeting the lysine acetyltransferase (KAT) domain of p300, a crucial component in the IRF4 transcription regulatory network. This molecule is currently in IND-enabling studies, expected to be completed by Q4 2024. KB-9558 aims to provide a novel treatment for multiple myeloma, a disease driven by IRF4, for which existing therapies are not curative.
Despite deciding not to advance the phase 1b/2 trial of lanraplenib in combination with gilteritinib for FLT3-mutated relapsed/refractory acute myeloid leukemia (AML) to phase 2, Kronos Bio remains open to further developing lanraplenib with a partner. The company emphasizes its strong biological rationale and engagement in target modulation in AML, even though it did not observe sufficient response in the study population.
Under the leadership of President and CEO Dr. Norbert Bischofberger, Kronos Bio continues to innovate, focusing on mapping transcription regulatory networks (TRNs) to identify and target key modulators, ultimately leading to the development of novel drug candidates. The company's latest structural and leadership changes are designed to streamline operations and ensure efficient delivery on business objectives.
Kronos Bio is based in San Mateo, Calif., with a research facility in Cambridge, Mass. For more information, visit https://www.kronosbio.com/ or follow the company on LinkedIn.
Kronos Bio reported significant developments and financial results for 2020. They achieved an End-of-Phase 2 meeting with the FDA for entospletinib, targeting NPM1-mutated acute myeloid leukemia, and initiated a Phase 1/2 trial for KB-0742, a CDK9 inhibitor. The company ended 2020 with $462.1 million in cash and equivalents. For Q4 2020, R&D expenses totaled $13.1 million, with a net loss of $33.2 million ($0.70 per share). The company aims for a Phase 3 trial launch mid-2021, anticipating MRD negative CR data by late 2023.
Kronos Bio, Inc. (Nasdaq: KRON) has announced the presentation of pre-clinical data for KB-0742, a selective CDK9 inhibitor aimed at treating MYC-amplified solid tumors, at the AACR Annual Meeting 2021 from April 10-15. The study indicates that MYC genomic amplification may affect tumor sensitivity to CDK9 inhibition. A Phase 1/2 clinical trial for KB-0742 began earlier this year, with initial safety and pharmacokinetic data expected in Q4 2021, and expansion cohort data anticipated in 2022.
Kronos Bio announced its Phase 3 trial to assess measurable residual disease (MRD) negative complete response (CR) as the primary endpoint for potential accelerated FDA approval of entospletinib in newly diagnosed NPM1-mutated acute myeloid leukemia (AML). The trial is set to begin in mid-2021, with data expected in late 2023. This trial is notable as it marks the first use of MRD as a primary endpoint in AML, aimed at addressing the high mortality rate of this aggressive cancer. MRD negativity is linked to prolonged remissions and improved survival rates.
Kronos Bio has initiated a Phase 1/2 clinical trial for KB-0742, a selective CDK9 inhibitor targeting MYC-amplified solid tumors. The trial, involving 100 patients, aims to assess safety and pharmacokinetics, with initial data expected in Q4 2021. MYC-amplified tumors comprise approximately 30% of solid tumors, presenting a significant treatment opportunity. KB-0742, developed from Kronos' microarray platform, leverages its oral bioavailability and selectivity for CDK9, aiming to advance cancer treatment.
Kronos Bio, Inc. (Nasdaq: KRON) announced its participation in the Cowen 41st Annual Health Care Conference, set for March 1-4, 2021. The company's CEO, Norbert Bischofberger, Ph.D., will contribute to a panel on "Novel Oncology Targets" on March 1 at 1:20 p.m. ET. Additionally, investor meetings are scheduled for March 2 and 3. Kronos Bio focuses on developing therapies targeting dysregulated transcription factors, with lead drug entospletinib aimed at NPM1-mutated acute myeloid leukemia, and KB-0742 for MYC-amplified solid tumors.
Kronos Bio, Inc. (Nasdaq: KRON) announced the appointment of Marianne De Backer, Ph.D., to its board of directors, bringing over 20 years of healthcare industry experience. Rebecka Belldegrun, M.D., has resigned to pursue other opportunities. Dr. De Backer's extensive background includes leadership at Bayer AG and Johnson & Johnson, where she managed over 200 strategic alliances. She will contribute to the board's compensation committee as Kronos Bio approaches clinical testing for two investigational therapies targeting cancer treatment.
Kronos Bio, Inc. (Nasdaq: KRON) has appointed Pasit Phiasivongsa, Ph.D., as senior vice president of pharmaceutical development. With over 20 years in the biopharmaceutical field, he is expected to enhance the company's manufacturing processes as they prepare for clinical tests of KB-0742 and entospletinib. Dr. Phiasivongsa has a rich background in overseeing CMC strategies and has held significant roles in various companies. His appointment comes at a crucial time as Kronos Bio embarks on important clinical trials targeting cancer therapies.
Kronos Bio, Inc. (Nasdaq: KRON) has received FDA clearance for its Investigational New Drug (IND) application for KB-0742, an inhibitor targeting cyclin dependent kinase 9 (CDK9), aimed at treating MYC-amplified solid tumors. A Phase 1/2 clinical trial is set to commence in Q1 2021, assessing safety and pharmacokinetics. Approximately 30% of solid tumors exhibit MYC amplification, which is a key driver of cancer. Initial data from the trial is expected later in 2021, highlighting the company's commitment to developing innovative cancer therapies.
Kronos Bio, Inc. (Nasdaq: KRON) announced participation in two upcoming investor conferences. On Dec. 2, 2020, at 2:15 p.m. ET, management will engage in a virtual fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference. Additionally, on Dec. 3, 2020, meetings will take place at the Piper Sandler 32nd Annual Virtual Healthcare Conference, featuring a pre-recorded fireside chat available from 10 a.m. ET. The events will be accessible via the company’s website, with replays available for one month.
Kronos Bio, Inc. reported significant advancements in its business on November 18, 2020, including the acquisition of SYK inhibitors from Gilead Sciences and plans for late-stage clinical testing of its lead therapy, entospletinib, for NPM1-mutated acute myeloid leukemia. The company raised $287.5 million from its upsized IPO on October 14, 2020, strengthening its financial position. Despite a net loss of $39.7 million for Q3 2020, Kronos is well-capitalized for ongoing research and development, showing promising growth potential.
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