While cancer treatment is progressing at a fast rate the world over with new targeted drugs being launched, immunotherapy and radiation, therapy resistance continues to remain an obstacle in the road to recovery of a cancer patient.
With drug resistance believed to cause a majority of cancer-related deaths, several US oncology innovators are pushing the frontiers of cancer treatment by confronting drug resistance and immune suppression head-on.
Adding to this landscape is California-based Kairos Pharma (NYSEAMERICAN: KAPA), a clinical-stage oncology company which is harnessing structural biology through its lead candidate, ENV105 which is undergoing phase 2 trials for prostate cancer and phase 1 trials for non-small cell lung cancer, supported by NIH and donor funding.
Last month, positive safety results from a clinical trial of ENV105, or carotuximab, in patients with metastatic castration-resistant prostate cancer sent the company’s stock soaring more than 65%.
“Investors understand the clinical and commercial implications of this candidate: if ENV105 can extend the useful life of multi-billion-dollar drugs, it has potential both as a standalone success and as a critical add-on in broader oncology care,” Dr John Yu, CEO of Kairos Pharma tells Invezz in an interview.
Yu, a clinical scientist also opens up about what drove the company to tackle treatment resistance, how ENV105 can add value to existing cancer drug makers, and the company’s five-year vision.
Excerpts:
Dr John S Yu, CEO, Kairos Pharma
On development status of ENV105 and other drug candidates in the pipeline
Invezz: Can you give an update on the lead drug candidates in your pipeline and their clinical development stages?
Our lead candidate, ENV105, is advancing in a Phase 2 clinical trial for prostate cancer and Phase 1 trial for non-small cell lung cancer (NSCLC).
In prostate cancer, we’re enrolling patients who have developed resistance to any number of anti-androgen therapies for prostate cancer.
The study is designed with progression-free survival and biomarker validation endpoints, and it leverages a three-gene biomarker signature we identified through our translational research.
In NSCLC, ENV105 is being studied in combination with osimertinib (Tagrisso) in EGFR-mutant patients whose disease has progressed or who have persistent circulating tumor DNA.
This line of inquiry directly targets an area of high unmet need, as nearly all patients on targeted therapies like Tagrisso eventually develop resistance.
Beyond ENV105, our pipeline includes agents that tackle other root causes of treatment failure: KROS-101, a GITR agonist that enhances T-cell activity; KROS-201, a cellular therapy for glioblastoma; KROS-401, a macrophage reprogramming peptide for triple-negative breast cancer (TNBC); and several others aimed at overcoming immune suppression or stem-like tumour transitions.
All programs are supported by a robust intellectual property portfolio and non-dilutive NIH and donor funding, which enables us to advance multiple programs without excessive capital burn.
Market response to ENV105 data validation of its science and strategy
Invezz: The market responded enthusiastically to the Phase 2 safety data for ENV-105, with your stock surging more than 65%. How do you interpret that reaction?
We see that as a strong validation of both our science and our strategy.
The data confirmed that ENV105 can be administered safely in a population that has already failed standard-of-care treatments, without introducing grade 3 or 4 toxicities.
That’s an important threshold for any agent aiming to be used in combination with existing therapies.
What we believe resonated with the market is the fact that ENV105 is not a replacement for current therapies, it’s a resistance-reversing agent that restores the effectiveness of drugs like enzalutamide and osimertinib.
Investors understand the clinical and commercial implications of this candidate: if ENV105 can extend the useful life of multi-billion-dollar drugs, it has potential both as a standalone success and as a critical add-on in broader oncology care.
While we are well-aware there is still much work to be done to get these candidates to the patients that need them the most, we’re encouraged both by the science and the response from our investors to date.
Drug development a “reactive” model; need to address drug resistance
Invezz: Kairos Pharma positions itself as tackling the root causes of cancer treatment failure — drug resistance and immune suppression. Why has the industry traditionally overlooked these in favor of developing new drugs, and what convinced you this was the right model for Kairos?
Drug development has historically been driven by a target-designed approach, with the promise of a “new” therapy.
But that’s a reactive model. When a drug stops working, the response is usually to move on to the next one.
What’s been overlooked is that cancer doesn’t simply become resistant by accident, it evolves under treatment pressure, often through predictable biological pathways.
At Kairos, we’ve identified one such pathway involving CD105, a protein that becomes elevated after treatment with anti-androgens or EGFR inhibitors.
CD105 is more than just a biomarker, it plays an active role in driving cancer cells into a stem-like, treatment-resistant state.
Rather than abandoning effective drugs when resistance develops, our goal is to intervene at this biological switch point, stop resistance from progressing, and re-sensitize tumors to standard therapies.
This model was born out of real-world clinical frustration. As a neurosurgeon and immunotherapy researcher, I’ve seen too many patients relapse despite promising initial responses.
It became clear that we needed to change the question from “what’s next?” to “why didn’t it work longer?” We believe Kairos was built to answer that.
How ENV105 can add value to existing cancer drug makers
Invezz: If ENV105 succeeds, how might it enhance the value of existing cancer drugs from other companies like AstraZeneca or Johnson & Johnson? Are you open to partnership models?
ENV105 is designed to work in concert with standard-of-care therapies, not compete with them.
In fact, our preclinical work has demonstrated that ENV105 restores tumor sensitivity to drugs like enzalutamide and osimertinib by targeting CD105 and blocking the resistance signaling cascade.
Tagrisso alone brought in $5.8 billion in revenue in 2023, yet it lacks a targeted solution once resistance develops.
If ENV105 can extend the clinical benefit of such drugs by even a few months, that could represent significant added value for both companies and
extension of cancer-free life for patients.
While Kairos is focused on developing our drugs through the clinical trial pipeline, we are always open to exploring partnership models as they arise.
As anyone in this business will tell you, you cannot let opportunity pass you by because there’s no guarantee it will come around again.
We are constantly evaluating our strategies and searching for new ways to improve our candidates and their effectiveness, which
includes any partnership opportunities that may present themselves.
On financial backing through NIH grants and donor support
Invezz: You’ve secured quite a bit of backing through NIH grants and donor support. How has this non-dilutive funding model impacted your burn rate and runway planning?
Non-dilutive funding has been critical to our ability to scale with efficiency.
NIH grants and philanthropic support have enabled us to run high-quality clinical studies without significantly diluting shareholder equity.
It also provides an additional layer of validation for our goals, as our science has been peer-reviewed by leading experts and selected
for public investment.
This has translated into longer runway planning, a lower burn rate, and the ability to push multiple programs forward in parallel, which is uncommon for a company at our stage and our size.
It also means we’re not forced to compromise our development timelines due to capital constraints, especially in a market where biotech funding can be a challenge.
John Yu’s lessons as a clinician-scientist leading a publicly traded biotech company
Invezz: What lessons have you learned as a clinician-scientist leading a publicly traded biotech through today’s volatile market conditions?
One of the key lessons is the importance of anchoring to an unmet clinical need. When you’re grounded in patient reality, it helps you weather short-term noise and stay focused on long-term impact.
As a clinician-scientist, I approach decisions with a strong bias toward data, biology, and patient outcomes.
That perspective is incredibly useful in an environment where markets can be volatile, and sentiment can swing.
It’s also been critical to maintain clear, honest communication with investors and stakeholders.
We don’t overpromise to those invested in our work; we let the science and data speak for itself.
When you’re working on something as complex and consequential as resistance biology, that transparency builds lasting credibility.
As a neurosurgeon, I’ve seen firsthand patients who have great initial reactions to a treatment regimen, only to have that treatment fall off and the patient eventually return to my office.
Seeing that all too common reality makes it easy to remember why we’re so committed to this work. We all want these drugs to work better, longer for the patients who need them.
Kairos Pharma’s five-year vision
Invezz: Where do you see Kairos Pharma in the next five years — a standalone biotech, a platform partner, or an M&A target?
We’re building Kairos to be a long-term leader in resistance-reversal therapeutics.
Whether that path leads to becoming a platform partner or an M&A target will ultimately depend on the data and where we can make the most impact.
But what’s clear is that our approach is opening up a new therapeutic category, one focused not on replacing cancer therapies, but on making them work better, longer.
Going forward, we plan to expand our pipeline, pursue additional indications, and build out the infrastructure for late-stage trials and eventual commercialization.
Strategic partnerships will likely play a role in that growth, but we’re also committed to retaining the flexibility to complete these tasks ourselves when needed.
The goal is clear: to redefine what’s possible in the face of treatment resistance and give patients more time, more options, and more hope.
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