Kairos Pharma Presents ENV-105 Clinical Progress and Positive Interim Phase 2 Results at International Cancer Research Conference
Kairos Pharma, Ltd., a clinical-stage biopharmaceutical company focused on developing innovative treatments to overcome drug resistance in cancer, has announced that Neil Bhowmick, President and Chief Scientific Officer, is presenting the company’s latest clinical developments and interim efficacy findings for its lead drug candidate, ENV-105, at the United Scientific Group’s 11th International Conference on Cancer Research & Drug Development (Cancer R&D 2026). The international scientific conference is being held in Houston, Texas, bringing together oncologists, cancer researchers, pharmaceutical industry representatives, and other experts to discuss emerging developments in cancer research and therapeutic innovation.
The presentation highlights the clinical progress of ENV-105, a first-in-class CD105/BMP signaling inhibitor being investigated for its potential to address one of the most significant challenges in cancer treatment: resistance to established therapies. Kairos Pharma is developing ENV-105 across multiple clinical programs, including a Phase 1 clinical trial in patients with EGFR-driven non-small cell lung cancer (NSCLC) and a Phase 2 study evaluating the drug candidate in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
A central focus of the presentation is the positive interim efficacy analysis from the Phase 2 prostate cancer trial. The findings demonstrated a statistically significant improvement in progression-free survival (PFS) among patients receiving ENV-105 in combination with apalutamide compared with patients treated with apalutamide alone. According to the interim results, the combination treatment achieved a median PFS of 17.7 months, compared with just 2 months for apalutamide monotherapy. The difference was statistically significant, with a reported p-value of 0.0008.
These findings provide clinical evidence supporting Kairos Pharma’s approach of targeting CD105-mediated signaling pathways to potentially overcome mechanisms responsible for treatment resistance. The company believes that inhibiting CD105 may help restore or enhance the effectiveness of existing cancer therapies, potentially offering a new strategy for patients whose cancers develop resistance to conventional treatment approaches.
ENV-105 Targets Cancer Treatment Resistance
ENV-105, also known as carotuximab, is an investigational first-in-class CD105-targeting therapeutic candidate designed to inhibit CD105/BMP signaling. The candidate is being developed to interfere with biological mechanisms that allow cancer cells to survive and progress despite treatment with established therapies.
Drug resistance remains a major obstacle in oncology, particularly among patients receiving targeted therapies and treatments designed to block specific molecular pathways involved in tumor growth. Although many cancer therapies initially produce meaningful clinical responses, some tumors eventually develop adaptive mechanisms that enable malignant cells to survive treatment pressure. As resistance emerges, patients may experience disease progression and diminishing benefits from their original treatment regimens.
Kairos Pharma’s research focuses on identifying and disrupting these resistance mechanisms. CD105, also known as endoglin, is a protein associated with cellular signaling pathways that can contribute to tumor survival and treatment resistance. According to the scientific rationale supporting ENV-105 development, CD105 expression increases in response to standard androgen receptor inhibition and ionizing radiation.
This increase in CD105 activity can activate pro-survival signaling mechanisms involving bone morphogenetic protein (BMP) and SMAD pathways. These signaling processes may help cancer cells adapt to therapeutic stress, allowing them to survive and potentially continue growing even when exposed to treatments intended to suppress tumor activity.
By targeting CD105, ENV-105 is designed to interrupt these resistance-associated signaling pathways. The company’s therapeutic strategy is based on the hypothesis that blocking CD105-mediated activity could make cancer cells more vulnerable to established treatments and potentially improve treatment outcomes.
The approach is particularly relevant in cancers where resistance to targeted or hormone-based therapies represents a substantial clinical challenge. Kairos Pharma is investigating whether ENV-105 can provide additional therapeutic benefits when administered alongside existing treatment options.
Positive Interim Results in Phase 2 Prostate Cancer Trial
One of the most significant developments highlighted at Cancer R&D 2026 is the positive interim analysis from Kairos Pharma’s Phase 2 clinical trial evaluating ENV-105 in combination with apalutamide in patients with metastatic castration-resistant prostate cancer.
The study is designed to investigate whether inhibiting CD105 can improve the effectiveness of androgen receptor-targeting treatment. Apalutamide is an androgen receptor inhibitor used in prostate cancer treatment, while ENV-105 is intended to target a complementary biological mechanism associated with resistance to androgen receptor inhibition.
The interim analysis demonstrated a substantial difference in progression-free survival between patients receiving the combination therapy and those treated with apalutamide alone.
Patients receiving ENV-105 plus apalutamide achieved a median progression-free survival of 17.7 months. In comparison, patients receiving apalutamide alone had a median progression-free survival of 2 months. The reported statistical significance of the difference was P=0.0008.
The results suggest that adding ENV-105 to apalutamide may provide a meaningful improvement in disease control compared with apalutamide treatment alone. The substantial difference in median PFS supports further investigation of CD105 inhibition as a potential strategy for addressing resistance in metastatic prostate cancer.
Progression-free survival is an important clinical measure that evaluates the length of time patients live without their disease worsening or progressing. Improvements in this measure can indicate that a treatment combination is helping patients maintain disease control for a longer period.
For patients with metastatic castration-resistant prostate cancer, treatment resistance is a particularly important concern. The disease can continue progressing despite androgen deprivation and other hormone-directed therapies. As cancer cells develop alternative survival mechanisms, treatments that initially suppress tumor growth may become less effective.
Kairos Pharma’s combination strategy is intended to address this challenge by targeting CD105-related signaling alongside androgen receptor inhibition. The interim findings provide clinical support for the company’s hypothesis that disrupting CD105-mediated resistance pathways may enhance the activity of established prostate cancer therapies.
Expanded Clinical Development Strategy in Prostate Cancer
Following the positive interim analysis, Kairos Pharma plans to focus the Phase 2 clinical development program on first-line treatment after enzalutamide, incorporating first-line resistance in a larger patient group.
This strategic direction is intended to further investigate the potential role of ENV-105 in patients who experience resistance to androgen receptor-directed treatment. By evaluating the candidate in a larger group, the company aims to generate additional clinical evidence regarding its potential effectiveness and the biological mechanisms influencing treatment response.
The planned focus on patients following enzalutamide treatment reflects the company’s interest in addressing resistance at an earlier point in the treatment pathway. Understanding how CD105 expression and associated signaling pathways contribute to resistance could help identify patient populations that may benefit from the addition of ENV-105.
The company expects that further clinical investigation will help clarify the potential contribution of CD105 inhibition to prostate cancer treatment and support decisions regarding the future development of the candidate.
The reported interim results are encouraging; however, additional clinical evaluation will be important to establish the durability of the observed benefit, characterize the treatment’s safety profile, and determine whether the improvement in progression-free survival can be confirmed in a larger patient population.
ENV-105 Development in EGFR-Driven Non-Small Cell Lung Cancer
In addition to its prostate cancer program, Kairos Pharma is evaluating ENV-105 in a Phase 1 clinical trial involving patients with EGFR-driven non-small cell lung cancer.
NSCLC is the most common form of lung cancer, and a subset of patients has tumors driven by mutations in the epidermal growth factor receptor (EGFR) gene. These molecular alterations can promote cancer cell growth and survival, making EGFR-targeted therapies an important treatment option for eligible patients.
Despite advances in targeted treatment, acquired resistance remains a major challenge in EGFR-driven NSCLC. Patients who initially respond to EGFR-targeting drugs may eventually experience disease progression as cancer cells develop alternative pathways that allow them to bypass treatment effects.
Kairos Pharma’s investigation of ENV-105 in this setting is based on the broader objective of identifying and disrupting biological pathways associated with cancer cell survival and resistance. By targeting CD105/BMP signaling, the company aims to explore whether ENV-105 can complement existing therapeutic approaches and potentially improve the response to established cancer treatments.
The Phase 1 program represents an important component of the company’s broader development strategy, allowing researchers to investigate ENV-105 in another cancer type where treatment resistance remains a significant unmet medical need.
The development of ENV-105 across prostate cancer and EGFR-driven NSCLC also reflects the potential relevance of CD105-mediated resistance mechanisms across different tumor types. Further research will be needed to determine how these pathways influence treatment outcomes in individual cancer settings.
Previous Research Supports Potential Radiation Sensitization
Kairos Pharma’s development strategy for ENV-105 is also supported by previously published preclinical research demonstrating the candidate’s potential role in radiation sensitization in prostate cancer models.
Radiation therapy is an established treatment approach used in several cancer types, including prostate cancer. However, cancer cells can activate protective signaling mechanisms in response to radiation exposure, potentially reducing treatment sensitivity and contributing to disease persistence or recurrence.
Previous research conducted in preclinical prostate cancer models demonstrated the potential efficacy of ENV-105 in radiation sensitization. The findings provide additional scientific rationale for investigating CD105 inhibition as a strategy to interfere with cellular responses that contribute to treatment resistance.
The underlying research has identified CD105 upregulation following exposure to ionizing radiation, as well as in response to standard androgen receptor inhibition. Increased CD105 activity can promote pro-survival BMP-SMAD signaling, which may help cancer cells withstand therapeutic stress.
By blocking CD105-associated activity, ENV-105 is being investigated for its potential to interrupt these protective signaling mechanisms. This approach could potentially increase cancer cell sensitivity to radiation and other established treatment modalities.
The preclinical findings complement the company’s clinical development efforts and reinforce its broader research focus on overcoming resistance through targeted intervention in tumor-associated signaling pathways.
Leadership Highlights Clinical Progress at International Conference
Commenting on the presentation and the company’s clinical progress, Neil Bhowmick, President and Chief Scientific Officer of Kairos Pharma, emphasized the importance of sharing the ENV-105 findings with the international cancer research community.
“We are excited to present the clinical progress of ENV-105 at this international platform of oncologists, researchers, and industry leaders,” shared Neil Bhowmick. “These findings support our hypothesis that CD105-targeting interrupts an important mechanism of treatment resistance to restore sensitivity to established cancer therapies.”
Bhowmick’s presentation at the United Scientific Group’s 11th International Conference on Cancer Research & Drug Development provides an opportunity to communicate the company’s research findings and clinical development strategy to specialists working across oncology, drug development, and translational research.
The conference serves as a platform for discussing emerging scientific discoveries, clinical advances, and innovative therapeutic approaches aimed at improving cancer treatment. Kairos Pharma’s participation highlights its efforts to contribute to the development of new strategies for addressing treatment resistance.
Advancing a Targeted Approach to Cancer Drug Resistance
Kairos Pharma’s clinical development strategy centers on addressing drug resistance, a persistent challenge that limits the long-term effectiveness of many cancer therapies. Through its investigation of ENV-105, the company is pursuing an approach that targets CD105/BMP signaling to potentially improve the effectiveness of existing treatments.
The positive interim Phase 2 findings in metastatic castration-resistant prostate cancer represent an important development milestone for the program. The reported median PFS of 17.7 months with ENV-105 plus apalutamide, compared with 2 months with apalutamide alone, provides encouraging evidence supporting further investigation of the combination.
The company’s next steps include expanding its clinical focus toward first-line treatment following enzalutamide, with a larger patient group, while continuing the Phase 1 investigation of ENV-105 in EGFR-driven NSCLC.
Together with previously published preclinical findings involving radiation sensitization, these programs form part of Kairos Pharma’s broader effort to develop therapies that target mechanisms underlying cancer treatment resistance.
As clinical research progresses, additional data will be important to establish the therapeutic potential of ENV-105, better understand its role in combination treatment strategies, and determine whether CD105 inhibition can become a meaningful component of future cancer treatment approaches.
About Cancer R&D 2026
The 2026 International Conference on Cancer Research and Development (Cancer R&D 2026) is a prestigious three-day congress devoted to advancing the field of basic, preclinical, and translational cancer research. Hosted by United Scientific Group, a distinguished non-profit organization committed to the progression of cancer research, Cancer R&D serves as a platform to foster innovation, cultivate knowledge, and encourage meaningful connections and collaborations within the global cancer research community.
About Kairos Pharma Ltd.
Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Kairos Pharma’s lead candidate, ENV-105 (carotuximab), is an antibody targeting CD105 — a protein identified as a key driver of resistance and disease relapse in response to standard cancer therapy. ENV-105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. For more information, visit kairospharma.com.