Kairos Pharma Ltd. (NYSE: KAPA) Developing Innovative Therapies to Tackle Cancer Drug Resistance, Immune Suppression

• The company has an extensive IP portfolio, valid through 2040, and a drug pipeline in different preclinical and clinical stages, targeting cancer drug resistance and immune suppression.
• Kairos Pharma’s lead candidate ENV-105 is an antibody targeting CD105, a protein identified as a key driver of resistance to various cancer treatments.
• ENV-105 is in a Phase 2 trial for castrate-resistant prostate cancer (NCT05534646, in combination with Apalutamide) and a Phase 1 trial for EGFR-driven non-small cell lung cancer (NCT05401110, in combination with Osimertinib).
• The company is working with PreCheck Health Services to develop companion biomarkers for ENV-105, with the aim of identifying patients who will benefit most from being administered the drug candidate.
• Kairos is uniquely positioned to capitalize on the immunotherapy market, expected to reach $148 billion by 2030, as well as on the $11.3 billion prostate cancer market and the $14 billion EGFR-driven lung cancer market.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company, is dedicated to advancing innovative oncology therapies to overcome critical challenges in cancer drug resistance and immune suppression, two significant challenges to effective cancer treatment. With an extensive intellectual property portfolio valid until 2035 to 2040, the company is developing a notable pipeline of drugs tackling cancer drug resistance with a focus on overcoming impacting widespread cancers, including prostate and lung cancer, as well as reversing immune suppression.

Kairos Pharma’s pipeline includes multiple candidates in different clinical and preclinical stages:

• ENV-105: An antibody that targets CD105 — a protein identified as a key driver of resistance to various cancer treatments, this lead candidate is currently in a Phase 2 trial for castrate-resistant prostate cancer (NCT05534646 in combination with Apalutamide to overcome anti-androgen resistance) and a Phase 1 trial for EGFR-driven non-small cell lung cancer (NCT05401110 in combination with Osimertinib to address resistance).
• KROS-201: In the preclinical stage with preparation for a Phase 1 trial, this drug candidate targets glioblastoma and works by activating external T cells to target and destroy tumor cells. This candidate has received Investigational New Drug (“IND”) clearance from the Food and Drug Administration.
• KROS-101: In the preclinical stage, this drug candidate is designed to complement existing immunotherapies, showing promise in enhancing the immune system’s response by increasing the number and efficiency of T cells.
• KROS-102: In the preclinical stage, this drug candidate targets autoimmune diseases and works by decreasing T cell activity.
• KROS-301 and KROS-401: In the preclinical stage, both of these candidates focus on inhibiting cancer cell growth and tackling immune suppression in cancers such as triple-negative breast cancer.
• ENV-205: In the preclinical stage, this antibody targets Mitochondrial DNA with the goal of reversing resistance to chemotherapy in prostate cancer and others.

To achieve more accurate patient screening and monitoring for the ENV-105 Phase 1 and Phase 2 clinical trials, the company recently sealed a strategic agreement with PreCheck Health Services Inc., a CLIA-certified and CAP-accredited clinical laboratory specializing in genetic sequencing (https://ibn.fm/66UsY).

Under the terms of the partnership, PreCheck Health will focus on developing companion biomarkers for ENV-105, with the aim of advancing cancer treatment by identifying patients who will benefit most from being administered Kairos’s drug candidate. The two companies will utilize advanced molecular diagnostics to corroborate and further develop biomarkers previously identified in a Phase 2 clinical trial, with the goal of predicting patient responses to ENV-105 prior to treatment, in order to offer a more personalized approach to cancer care. The collaboration will rely on PreCheck’s proprietary SolidTumorCheck+ platform, which allows for gene expression profiling of tumor biopsies.

“This collaboration is an exciting step forward for Kairos Pharma. By working with PreCheck Health Services, we are advancing our mission to provide personalized cancer treatment solutions,” said Dr. John Yu, Kairos Pharma’s CEO. “The biomarkers we develop will enable us to tailor therapies to individual patients, improving their chances of a successful response to ENV105.”

The company also attended two major industry events in October, to discuss its drug development efforts and extensive pipeline. First, Dr. Yu participated in a fireside chat at the 2024 Maxim Healthcare Virtual Summit where he spoke with Jason McCarthy, Ph.D., Senior Managing Director, Head of Biotechnology Research at Maxim Group (https://ibn.fm/UxaE7). The summit was held virtually on Oct. 15 – 17. The Kairos Pharma CEO also presented a corporate overview at the LD Micro Main Event XVII, held on Oct. 28 – 30 in Los Angeles (https://ibn.fm/pnQmM).

With its innovative technologies to reverse key mechanisms of drug resistance and immune suppression of cancer and addressing underserved areas in cancer treatment, Kairos Pharma is strongly positioned to capitalize on the cancer therapy and immunotherapy markets by meeting substantial unmet needs. With ENV-105 in particular, the company has significant potential to capture a portion of the prostate cancer market, estimated at $11.3 billion, and the EGFR-driven lung cancer market, valued at $14 billion. The immunotherapy market, estimated to reach up to $148 billion by 2030, represents another major growth area for Kairos Pharma.

For more information, visit the company’s website at www.KairosPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to KAPA are available in the company’s newsroom at https://ibn.fm/KAPA

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