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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 has announced a $20 million upfront payment following a collaboration with Genentech aimed at discovering small-molecule drugs for oncology. This deal could yield up to $554 million in milestone payments based on various clinical and commercial achievements. The partnership will focus on enhancing understanding of oncogenic transcription factors using Kronos Bio's proprietary drug discovery platform. Kronos Bio will manage initial preclinical activities before Genentech takes over for further development.
Kronos Bio is presenting promising preclinical data on lanraplenib, a next-generation SYK inhibitor, showcased at the 64th ASH Annual Meeting. The data suggests that lanraplenib has significant anti-leukemic activity, particularly when combined with gilteritinib, in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML). The company plans to release initial trial data and recommended Phase 2 dose in late 2023 or early 2024. Additionally, the company emphasized its leadership in advancing measurable residual disease (MRD) as a factor in AML treatment and outcomes.
Kronos Bio, Inc. (Nasdaq: KRON) has announced its advancement to the Phase 2 stage of its clinical trial for KB-0742, a CDK9 inhibitor aimed at treating MYC-amplified tumors. The trial's Phase 1 results indicate a recommended Phase 2 dose (RP2D) of 60 mg, achieving a targeted reduction of 50% in phosphorylated Ser2 on RNA Polymerase II. The compound demonstrated a favorable pharmacokinetic profile with a long half-life of 24 hours. The company will present detailed trial results at a medical conference in late 2023.
Kronos Bio, Inc. (Nasdaq: KRON), focused on cancer treatments, announced its management team's participation in two upcoming investor conferences. The events include the Piper Sandler's 34th Annual Healthcare Conference on November 29, 2022, at 11:30 a.m. ET, and Evercore ISI's 5th Annual HealthCONx on December 1, 2022, at 1 p.m. ET. Investors can access the fireside chats live and view replays on the company's website. Kronos Bio is advancing two investigational compounds: a CDK9 inhibitor for MYC-amplified solid tumors and lanraplenib for FLT3-mutated acute myeloid leukemia.
Kronos Bio, Inc. (Nasdaq: KRON) announced the prioritization of its clinical portfolio, focusing on the next-generation SYK inhibitor, lanraplenib, and the CDK9 inhibitor, KB-0742. The company will discontinue the Phase 3 entospletinib trial due to projected enrollment delays, not due to adverse events. Financially, as of September 30, 2022, Kronos reported $270.3 million in cash and investments, enough to fund operations into Q2 2025. In Q3 2022, it recorded a net loss of $32.3 million or $0.57 per share, while R&D expenses totaled $23.4 million.
Kronos Bio has announced the discontinuation of the Phase 3 clinical trial for its SYK inhibitor, entospletinib, due to strategic reasons including enrollment challenges and the impact of COVID-19. The company will focus on its next-generation SYK inhibitor, lanraplenib, currently in a Phase 1/2b trial for relapsed/refractory AML, and its CDK9 inhibitor, KB-0742, which is also in Phase 1/2 trials. With $270.3 million in cash, Kronos Bio extends its cash runway into Q2 2025, anticipating updates on clinical progress in Q4 2023.
Kronos Bio, Inc. (Nasdaq: KRON) announced plans to present preclinical data on KB-0742, an oral CDK9 inhibitor, at the EORTC-NCI-AACR Symposium from Oct. 26-28, 2022, in Barcelona.
The data showed that KB-0742 induced regressions in neuroblastoma tumors and inhibited growth in models of Ewing sarcoma and rhabdomyosarcoma. This marks the first preclinical support for KB-0742's potential in pediatric tumors. The company aims to update on the recommended Phase 2 dose for KB-0742 in Q4 2022.
Kronos Bio, Inc. (Nasdaq: KRON) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference, with an on-demand webcast set for September 12, 2022, at 7 a.m. ET. This webcast will be accessible via the Kronos Bio website, where a replay will be available for 30 days. The company is focused on advancing three investigational compounds for cancer treatment, including entospletinib, a SYK inhibitor, currently in a Phase 3 trial for newly diagnosed NPM1-mutated acute myeloid leukemia. Kronos Bio operates from San Mateo, Calif., and has a research facility in Cambridge, Mass.
Kronos Bio, Inc. (Nasdaq: KRON) announced the initiation of a Phase 1b/2 clinical trial for lanraplenib, a next-generation SYK inhibitor, in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML). The trial will assess safety, pharmacokinetics, and anti-leukemic activity in combination with gilteritinib. This study is crucial as it aims to establish lanraplenib as a key treatment option for a significant patient population. Additionally, the company is advancing other investigational compounds, including entospletinib in a Phase 3 trial for NPM1-mutated AML and KB-0742 for MYC-amplified solid tumors.
Kronos Bio, Inc. has partnered with Invivoscribe to develop a companion diagnostic for their investigational therapy, entospletinib, aimed at treating NPM1-mutated acute myeloid leukemia (AML). This diagnostic will identify the presence of the NPM1 mutation in about one-third of AML patients and is critical for patient selection. The Phase 3 AGILITY trial is ongoing with expected efficacy data in late 2023. Both companies aim to submit the Premarket Approval application for the diagnostic alongside the New Drug Application for entospletinib.
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