This section highlights FDA-related milestones and regulatory updates for drugs developed by Kronos Bio (KRON).
Over the past two years, Kronos Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KB-0742 and KB-7898. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
KB-0742 - FDA Regulatory Timeline and Events
KB-0742 is a drug developed by Kronos Bio for the following indication: An Oral CDK9 Inhibitor Targeting MYC-amplified Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KB-0742
- Announced Date:
- September 23, 2024
- Indication:
- An Oral CDK9 Inhibitor Targeting MYC-amplified Cancers
Announcement
Kronos Bio, Inc. today highlighted new preclinical data from a study of istisociclib (KB-0742).
AI Summary
Kronos Bio, Inc. recently shared new preclinical data on istisociclib (KB-0742), a CDK9 inhibitor, at the AACR 15th Biennial Ovarian Cancer Research Symposium. The study showed that istisociclib triggered cell death in ovarian cancer models that were resistant to both platinum and PARP inhibitors. Researchers found that the drug induced DNA damage and reduced key proteins such as BRCA1 and RAD51, creating a “BRCAness” state in the cancer cells. This effect might help make these resistant cancers more sensitive to treatment. In addition, new pharmacokinetic and pharmacodynamic data demonstrated that administering istisociclib at 80mg on a schedule of 4 days on/3 days off led to long-lasting reduction of CDK9-dependent genes in blood cells. Overall, these results support further clinical studies of istisociclib in patients with platinum-resistant high-grade serous ovarian cancer.
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KB-7898 - FDA Regulatory Timeline and Events
KB-7898 is a drug developed by Kronos Bio for the following indication: Treatment of Sjögren's disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KB-7898
- Announced Date:
- October 7, 2024
- Indication:
- Treatment of Sjögren's disease
Announcement
Kronos Bio announced that plans to initiate Investigational New Drug (IND)-enabling studies of KB-7898 in the fourth quarter of 2024.
AI Summary
Kronos Bio announced plans to start Investigational New Drug (IND)-enabling studies of its development candidate KB-7898 in the fourth quarter of 2024. KB-7898 is an orally available p300 lysine acetyltransferase (KAT) inhibitor designed for treating Sjögren’s disease, a chronic autoimmune condition marked by inflammation, fatigue, and discomfort from dryness symptoms. The drug works by blocking p300, a key factor that helps drive immune responses in both B and T cells, potentially reducing overactive antibody and cytokine production that contribute to the disease. This move represents a significant step in developing a treatment that targets the root cause of Sjögren’s disease, for which no approved therapy currently exists. Future studies may also explore the use of KB-7898 in other autoimmune conditions, highlighting the promise of this new approach in addressing unmet medical needs.
Read Announcement- Drug:
- KB-7898
- Announced Date:
- October 7, 2024
- Indication:
- Treatment of Sjögren's disease
Announcement
Kronos Bio, Inc announced that Preclinical data for KB-7898 will be presented at ACR Convergence 2024 –
AI Summary
Kronos Bio, Inc. announced that its first development candidate for autoimmune diseases, KB-7898, will have its preclinical data presented at ACR Convergence 2024 in Washington, DC. KB-7898 is a p300 lysine acetyltransferase inhibitor discovered using the company’s proprietary engine that decodes complex transcription factor networks. The drug is being developed as an orally available treatment for Sjögren’s disease, a chronic condition characterized by inflammation, autoantibody production, and debilitating dryness and fatigue. Preclinical studies have shown that KB-7898 can reduce antibody production by B cells and decrease cytokine release by T cells, which are central to the autoimmune response. This presentation at ACR Convergence 2024 will highlight these promising findings and support further exploration of KB-7898’s use in treating Sjögren’s disease and potentially other autoimmune conditions.
Read Announcement- Drug:
- KB-7898
- Announced Date:
- October 7, 2024
- Indication:
- Treatment of Sjögren's disease
Announcement
Kronos Bio, Inc. announced the nomination of a development candidate, KB-7898, a p300 lysine acetyltransferase (KAT) inhibitor for the potential treatment of Sjögren's disease, a chronic autoimmune disease that is characterized by the production of autoantibodies, chronic inflammation and lymphocytic infiltration of the exocrine glands that lead to uncomfortable dryness symptoms, known as sicca.
AI Summary
Kronos Bio, Inc. has announced the nomination of KB-7898 as its first development candidate for autoimmune diseases. KB-7898 is a p300 lysine acetyltransferase (KAT) inhibitor designed to treat Sjögren’s disease, a chronic condition marked by autoantibody production, inflammation, and damage to moisture-producing glands that lead to severe dryness known as sicca. Preclinical studies have shown that KB-7898 can reduce antibody production in B cells and lower cytokine levels in T cells, suggesting it may help tackle the underlying causes of this disease. The company plans to initiate IND-enabling studies in the fourth quarter of 2024, and more preclinical data will be shared at the upcoming ACR Convergence 2024 conference. This candidate represents a promising new approach to offer relief for patients with Sjögren’s disease, who currently have no approved treatments addressing its root causes.
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