Kronos Bio Announces Selection of Autoimmune Development Candidate for Sjögren’s Disease

Rhea-AI Summary

Kronos Bio has announced the selection of KB-7898, a p300 KAT inhibitor, as its first development candidate for autoimmune diseases, specifically targeting Sjögren’s disease. This candidate stems from Kronos Bio's proprietary discovery engine, which decodes complex transcription factor regulatory networks.

Preclinical data for KB-7898 will be presented at ACR Convergence 2024. The data indicate that p300 KAT inhibition can reduce antibody production in B cells and cytokine production in T cells. Kronos Bio plans to initiate IND-enabling studies of KB-7898 in Q4 2024. The company also intends to explore the candidate's utility in other autoimmune diseases in the future.

The preclinical studies showed promising results, including selective downregulation of cytokines and significant decreases in inflammation in animal models. The presentation will be available on Kronos Bio's website on November 14, 2024, and the abstract is available on the American College of Rheumatology’s website.

Positive

• Kronos Bio announced KB-7898 as its first autoimmune development candidate.
• Preclinical data showed promising results in reducing cytokine and antibody production.
• IND-enabling studies for KB-7898 to commence in Q4 2024.

Negative

• None.

Insights

Medical Research Analyst

Kronos Bio's nomination of KB-7898, a p300 KAT inhibitor, for Sjögren's disease treatment is a significant development. This candidate addresses an unmet medical need, as there are currently no approved treatments targeting the underlying cause of this chronic autoimmune condition.

Key points:

• KB-7898 is designed to inhibit p300, a cofactor for IRF4, which plays a important role in immune responses.
• Preclinical data shows promise in reducing antibody production in B cells and cytokine production in T cells.
• The compound demonstrated anti-inflammatory effects in animal models, including decreased joint swelling and reduced IL-17 levels.
• IND-enabling studies are planned for Q4 2024, indicating a relatively near-term progression to clinical trials.

While this news is promising, investors should note that the drug is still in early stages. The transition from preclinical to clinical studies is a critical hurdle and success is not guaranteed. However, if KB-7898 proves effective in human trials, it could potentially address a significant market opportunity in autoimmune diseases beyond just Sjögren's.

Financial Analyst

This announcement represents a potentially significant milestone for Kronos Bio, expanding its pipeline into autoimmune diseases. Key financial implications include:

• Diversification: Moving beyond cancer into autoimmune diseases could reduce risk and open new market opportunities.
• R&D Investment: Expect increased R&D expenses as the company prepares for IND-enabling studies in Q4 2024.
• Market Potential: The Sjögren's disease market is underserved, presenting a substantial opportunity if KB-7898 succeeds.
• Partnerships: This development may attract potential partners or collaborators, potentially leading to future licensing deals or funding.

For a company with a market cap of $57.9 million, this news could be transformative. However, investors should be cautious as clinical development is costly and risky. The company's cash position and burn rate will be critical metrics to watch in upcoming financial reports.

– KB-7898, a p300 KAT inhibitor, is the Company's first development candidate for autoimmune diseases and originates from its proprietary discovery engine that decodes complex transcription factor regulatory networks –

– Preclinical data for KB-7898 will be presented at ACR Convergence 2024 –

SAN MATEO, Calif. and CAMBRIDGE, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and autoimmune diseases driven by deregulated transcription, today 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. Systemic effects are common and impact the lungs, kidneys and nervous system in addition to extensive dryness, profound fatigue and chronic pain. There are no approved treatments that target the underlying cause of Sjögren’s disease. Kronos Bio plans to initiate Investigational New Drug (IND)-enabling studies of KB-7898 in the fourth quarter of 2024.

KB-7898 is being developed as an orally available therapy for people with Sjögren’s disease. p300 is an important cofactor for interferon regulatory factor 4 (IRF4) to enact immune responses across multiple cell types, including those that produce antibodies (B cells) and cytokines (T cells). Given this, Kronos Bio also intends to explore the utility of KB-7898 in other autoimmune diseases in the future.

"Our proprietary discovery engine has enabled us to decode the multifaceted role of p300 across multiple cell types that drive inflammation and to create our second p300 KAT inhibitor—one that may treat autoimmune diseases,” said Nobert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. “Sjögren’s disease symptomatology can significantly impact quality of life and even be life threatening, and patients do not currently have access to an approved therapy that addresses the underlying disease mechanism. KB-7898 has been shown preclinically to reduce antibody production in B cells and cytokine production in T cells, and we believe could impact the etiology of Sjögren’s disease.”

The Company’s preclinical data that support the role of p300 in inflammatory indications, including Sjögren’s disease, will be presented at the American College of Rheumatology's annual meeting, ACR Convergence 2024, on November 18, 2024, in Washington, DC. The data are summarized as follows:

• Inhibition of the KAT activity of p300, a critical cofactor of proinflammatory transcription factors, resulted in selective downregulation of cytokines such as TNFα, IL-23, IL-17A as well as soluble IgG
• Selective gene expression changes occurred at doses corresponding to partial inhibition of p300 KAT activity
• p300 KAT inhibition also led to significantly decreased inflammation in the rat CIA model, as measured by joint swelling, clinical score and histopathology
  

In addition, p300 KAT inhibition in vitro showed a reduction in IL-17 transcript and protein levels in Th17 cells and, in vivo, showed significant decreases in the secondary immune response (i.e. IgG production) in the KLH challenge model.

The ACR Convergence 2024 presentation will be available under the Science & Pipeline section of the Kronos Bio website on November 14, 2024. The abstract can be found on the American College of Rheumatology’s website.

About Sjögren’s Disease
Sjögren’s disease is a chronic autoimmune disease characterized by the production of autoantibodies, chronic inflammation and lymphocytic infiltration of the exocrine glands. Systemic effects are common and impact the lungs, kidneys and nervous system in addition to extensive dryness, profound fatigue and chronic pain. Complications can include pneumonia, bronchitis, kidney problems, hepatitis, cirrhosis, peripheral neuropathy and lymphomas, and lead to a 50% increase in all-cause mortality. It is estimated that there are two to four million people in the U.S. living with this disease, making it one of the most prevalent autoimmune diseases. However, given the heterogeneous symptomatology of Sjögren’s disease, it is estimated that only one million patients in the U.S. are diagnosed. The disease is significantly more common in women; most people are older than 40 when they are diagnosed. Currently there are no approved treatments that target the underlying cause of Sjögren’s disease.

About Kronos Bio
Kronos Bio is a clinical-stage biopharmaceutical company dedicated to developing small molecule therapeutics that address deregulated transcription, a hallmark of cancer and autoimmune disease. Our proprietary discovery engine decodes complex transcription factor regulatory networks to identify druggable cofactors. We screen for and optimize small molecules that target these cofactors in a disease-specific context. Kronos Bio has a pipeline of three drug candidates. Istisociclib (KB-0742) is currently enrolling ovarian cancer patients in a Phase 1/2 clinical trial. Preclinical candidate KB-9558 is being developed for multiple myeloma and HPV-driven tumors. KB-7898 is Kronos Bio’s first autoimmune development candidate and has a target indication of Sjögren’s disease. Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass. For more information, visit https://www.kronosbio.com or follow the Company on LinkedIn.

Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release, in some cases, uses terms such as “anticipate,” “believe,” “could,” “expect,” “plan,” “will,” “may,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding Kronos Bio’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the ability of KB-7898 to potentially treat Sjögren’s disease; the potential for KB-7898 to impact the etiology of Sjögren’s disease; Kronos Bio’s plans to initiate IND-enabling studies of KB-7898 in the fourth quarter of 2024; Kronos Bio’s intention to explore the utility of KB-7898 in other autoimmune diseases in the future and the potential of KB-7898 to treat autoimmune diseases; the estimated U.S. patient population with Sjögren’s disease; the potential of Kronos Bio’s product candidates, pipeline and its proprietary discovery engine; and other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: changes in the macroeconomic environment or competitive landscape that impact Kronos Bio’s business; whether Kronos Bio will be able to progress its preclinical pipeline on the timelines anticipated, including due to risks inherent in the development of novel therapeutics; the risk that results of preclinical studies, early clinical trials (including preliminary results) and pharmacokinetic modeling are not necessarily predictive of future results; and risks associated with the sufficiency of Kronos Bio’s cash resources and need for additional capital. These and other risks are described in greater detail in Kronos Bio’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 8, 2024. Any forward-looking statements that are made in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Except as required by law, Kronos Bio assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

FAQ

What is KB-7898?

KB-7898 is a p300 KAT inhibitor selected by Kronos Bio for the potential treatment of Sjögren’s disease.

When will the preclinical data for KB-7898 be presented?

The preclinical data for KB-7898 will be presented at ACR Convergence 2024 on November 18, 2024.

When will Kronos Bio start IND-enabling studies for KB-7898?

Kronos Bio plans to initiate IND-enabling studies for KB-7898 in the fourth quarter of 2024.

What are the potential benefits of KB-7898?

Preclinical data suggest that KB-7898 can reduce antibody and cytokine production, potentially impacting the underlying cause of Sjögren’s disease.