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About Kronos Bio, Inc.
Kronos Bio, Inc. (Nasdaq: KRON) is a clinical-stage biopharmaceutical company dedicated to developing innovative small molecule therapeutics that address cancers and autoimmune diseases driven by deregulated transcription. Transcriptional dysregulation is a hallmark of many complex diseases, and Kronos Bio employs its proprietary discovery engine to decode transcription factor regulatory networks, identifying druggable cofactors that play critical roles in disease progression. By targeting these cofactors in a disease-specific context, the company aims to transform patient outcomes in areas of significant unmet medical need.
Proprietary Technology and Expertise
Kronos Bio's competitive edge lies in its proprietary discovery platform, which integrates high-throughput screening strategies and small molecule microarray (SMM) technology. This platform enables the company to identify and optimize small molecules that specifically target transcriptional drivers of disease. The focus on transcription factor regulatory networks allows Kronos Bio to address historically recalcitrant targets, opening new therapeutic possibilities in oncology and autoimmune diseases.
Pipeline and Therapeutic Focus
The company's pipeline includes multiple drug candidates at various stages of development:
- Istisociclib (KB-0742): A CDK9 inhibitor designed to address MYC deregulation in solid tumors, currently being evaluated in a Phase 1/2 clinical trial for platinum-resistant high-grade serous ovarian cancer.
- KB-9558: A p300 lysine acetyltransferase (KAT) inhibitor targeting IRF4 dependence in multiple myeloma and HPV-driven tumors, with preclinical data demonstrating potential tumor suppression through restoration of p53 and Rb pathways.
- KB-7898: Kronos Bio's first autoimmune development candidate, targeting Sjögren’s disease. This p300 KAT inhibitor modulates inflammatory signaling pathways and has shown preclinical efficacy in reducing inflammatory cytokines and antibody production.
By focusing on these disease-specific mechanisms, Kronos Bio aims to provide therapeutic solutions for patient populations with limited or no treatment options.
Market Position and Challenges
Operating within the highly competitive biopharmaceutical industry, Kronos Bio faces challenges such as the inherent risks of drug development, regulatory hurdles, and the need for substantial financial resources. However, its emphasis on transcriptional dysregulation as a therapeutic target sets it apart from competitors, offering a unique value proposition. The company's focus on oncology and autoimmune diseases—markets with high unmet medical needs—positions it as a key player in these segments.
Commitment to Innovation
Kronos Bio's mission is underpinned by a commitment to scientific excellence and innovation. By leveraging its advanced discovery engine and expertise in transcriptional biology, the company continues to push the boundaries of what is possible in drug discovery and development. Its efforts are directed toward creating first-in-class therapies that have the potential to significantly improve the lives of patients worldwide.
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.