Lewis H. Bender is Founder and CEO of Intensity Therapeutics, a late-stage clinical biotechnology company headquartered in Shelton, Connecticut. Bender brings more than 33 years of biopharmaceutical leadership experience to the role, including prior CEO positions at a personalized medicine company and a drug delivery company, and has led products through discovery, development, and approval using novel drug delivery techniques. He founded Intensity in his basement more than a decade ago, building the company's foundational chemistry from the ground up.
Intensity's lead candidate, INT230-6, is an intratumoral therapy engineered to saturate the dense, pressurized, high-fat environment of solid tumors, killing cancer cells directly while sparing healthy tissue, and training the immune system to attack cancer elsewhere in the body. The drug is currently in a Phase 3 trial in refractory sarcoma and a Phase 2 study in triple-negative breast cancer. In this Q&A, Bender discusses the insight behind Intensity's approach, what sets its delivery platform apart, the lessons he's learned leading a public biotech company through an IPO and late-stage trials, and what he believes needs to change across the industry to get more effective, less toxic treatments to patients faster.
Your Story
Q1. What was the defining moment or insight that led you to start — or take the helm of — your company?
I founded Intensity Therapeutics in 2012 based on an idea for a new cancer treatment. While working in drug delivery leadership at other companies, I saw that existing immunotherapies acted like a car on the road: some released the brakes, others stepped on the accelerator, but none had a steering wheel to guide the immune system to the right target. Immunotherapies that rev up the immune system can cause off-target toxicities, and patients would benefit more if the immune response could be directed precisely at cancer cells.
My idea was to inject a cytotoxic drug with a new chemistry directly into tumors to cause immunological cell death. Direct intratumoral injection had been attempted many times before, but solid tumors are pressurized, fatty biological fortresses that push traditional water-based drugs away. Drawing on my background as an MIT-trained chemical engineer, I realized that solving this incompatibility between water-based drugs and high-fat tumors could allow anti-cancer agents to saturate dense tumors directly. That insight led to INT230-6 and laid the foundation for Intensity Therapeutics.
We are now in late-stage randomized controlled trials, including a Phase 3 study in refractory sarcoma and a Phase 2 study in localized triple-negative breast cancer. Our goal is to help patients live longer by controlling tumors and activating a systemic immune response, thus creating a higher quality of life and reducing the fear of being harmed by treatment. Our lead product kills cancer cells with minimal side effects, and the dying tumor trains the patient's immune system to fight the cancer we didn't inject.
Q2. In the simplest terms, what does your company do and why does it matter for patients?
Intensity Therapeutics is pioneering an intratumoral delivery approach, along with a new methodology for setting dose based on tumor burden rather than a patient's height and weight — the standard for systemic drugs. Tumor burden and the number of metastatic sites correlate with patient outcomes; height and weight do not.
Today's systemic approaches essentially try to poison the patient without killing them, and they often fall short. Conventional cancer therapies expose healthy tissue and organs to severe toxicity, frequently leaving patients with permanent damage. By injecting INT230-6 directly into solid tumors, we achieve high therapeutic concentrations locally with minimal systemic exposure ahead of standard-of-care treatment. This approach has shown the potential to extend survival and preserve quality of life while limiting the debilitating side effects of standard treatment.
The Science & The Strategy
Q3. What is it about your approach — your platform, your technology, your pipeline — that you believe sets you apart from others working in this space?
Treatments such as chemotherapy and immunotherapy affect a patient's entire body, delivering toxic side effects throughout the system. Our approach is different: we inject our drug directly into the tumor, sparing healthy cells elsewhere in the body. As cancer cells die, the immune system begins to recognize the cancer — essentially converting a patient's tumor into their own personal anti-cancer vaccine and inducing a systemic adaptive immune response.
INT230-6 combines cisplatin, vinblastine, and a diffusion enhancer called SHAO into a water-based formulation that penetrates and saturates dense, high-pressure tumor environments. Beyond localized tumor destruction, this delivery mechanism transforms the dying mass into an in situ vaccine: as cancer cells die, they release tumor antigens that train local T-cells to enter the bloodstream and destroy matching untreated metastatic lesions throughout the body. With the right amount of drug dosed into the tumor, our therapy can cause the majority of cancer cells to die in an immunologically activating manner. That dual mechanism — debulking tumors while activating the immune system — is what sets us apart.
Q4. What has been your most important milestone to date, and what's the next one you're working toward?
Last year, we published a peer-reviewed paper in eBioMedicine (a Lancet publication) demonstrating that direct intratumoral injection drives significant tumor destruction while activating a systemic immune response, with minimal side effects, in patients with refractory, metastatic cancer who had progressed on a median of three prior therapies. As far as we know, it was the first paper to show a local therapy alone, with no other concomitant drugs, conferring a potential survival benefit in metastatic disease, with a high rate of uninjected tumors shrinking.
Looking ahead, our focus is on advancing key late-stage clinical readouts: Phase 2 pathological complete response data from the INVINCIBLE-4 study in presurgical triple-negative breast cancer, and continued progress in the Phase 3 INVINCIBLE-3 trial evaluating overall survival in metastatic soft tissue sarcoma, where we continue to see positive data and proof points.
Q5. What is the biggest scientific or business challenge you're facing right now, and how are you tackling it?
Like most biotech companies in the public market today, our largest obstacle is fundraising. The current investment climate is cautious, with a greater emphasis on unit economics and clear return on investment. I believe our return potential is significant, given that INT230-6 can work across multiple types of solid cancers, including nonimmunological ones. Current treatments are often harmful and lose effectiveness as tumors grow large; our therapy represents a new way to kill tumors that could allow patients to live longer, healthier lives.
That said, there is substantial uncertainty industry-wide about the potential for meaningful breakthroughs and long-term revenue right now. We work every day to showcase the progress of our development and our product's potential to reach approval. Alongside fundraising, a consistent challenge for our team is finding better ways to communicate the value and risk reduction Intensity has created.
Leadership & Ecosystem
Q6. What has surprised you most about being a CEO in life sciences — something you didn't fully appreciate until you were in the role?
The most difficult part of running a public biotech company is focusing the team and its communications toward outside investors and pharmaceutical partners. The people inside the building — the people working on our therapeutics — are all believers. The challenge is turning others in the industry into believers too. Clearly and effectively communicating the path forward is the hardest part of our job every day.
One example: during our IPO, our bankers heard the pitch and told me to cut all the science. But how could I cut the fundamental element of the company? Instead, I changed the pitch to describe in human terms the potential benefits of our approach, our timeline, our focus, and how and when investors could make money. The IPO was upsized and priced at the top of the range, at a time when very few IPOs were getting done.
Broad acceptance of a novel therapeutic concept requires immense time and persistence, even with compelling clinical data behind it. Taking a basement discovery to a global Phase 3 biotech company demands constant focus on capital strategy, which can pull you away from the very data that will get you across the finish line. Walking that tightrope while communicating your vision to investors is just as essential as advancing the science, since securing funding directly dictates how fast life-saving treatments reach patients.
Q7. How would you describe the culture you're building at your company, and why does that matter for the science?
Intensity Therapeutics fosters a mission-driven, patient-centric culture dedicated to humanizing oncology care. Seeing patients suffer permanent organ damage from toxic standard-of-care regimens reinforces our collective resolve to develop safer alternatives. This culture directly shapes our scientific approach, pushing the team to prioritize focused execution on our two studies and one drug, including a Phase 3 randomized controlled trial comparing INT230-6 to the best systemic standard of care, with an endpoint of overall survival, reduced treatment toxicity, and preserved quality of life.
Beyond that, nobody at our company is above constructive criticism, myself included, and no one is shy about giving it to me. I think that's been key to building a culture where everyone knows they have a vital role in our path forward.
Looking Ahead
Q8. Where do you see your company in three years, and what will have to go right to get there?
Ideally, we'll have positive data from the ongoing INVINCIBLE-3 and INVINCIBLE-4 trials, more peer-reviewed publications from our first two completed trials, and additional studies underway in other cancer types. We continue to believe in INT230-6.
Clinically, our transition to an intratumoral delivery approach that activates a systemic immune response addresses the therapeutic window problem — the narrow margin between a dose that kills cancer and a dose that harms the patient. By delivering therapy directly to the tumor, we can achieve local drug concentrations often 100 times higher than what's possible via IV, with only a fraction of the systemic circulation. This allows us to use more aggressive, multi-drug killing agents in the injected product while significantly reducing the risk of organ stress and chronic fatigue.
Intratumoral injection isn't a panacea for every cancer, but there are many cancers where it can make a real, meaningful difference. That should be the main goal of cancer researchers today: helping patients live longer, with a high quality of life, and without fear of being harmed by their treatment.
Q9. What is one thing about the life sciences industry today that you would change if you could — and what gives you optimism despite it?
The biggest thing I'd change is smaller companies' ability to access the capital they need. A lot of money is spent on me-too products. How many PD-1 antibodies does the world really need? I'd also like to see the regulatory process improved to bring promising drugs to market more quickly. The industry's reliance on rigid, traditional trial designs often slows development timelines and exposes patients to underperforming treatment protocols for too long. We need broader adoption of adaptive trial designs that let sponsors learn and course-correct mid-trial without sacrificing scientific rigor.
My optimism comes from growing regulatory support for adaptive frameworks. I'd also want the biotech investment community to hold onto the long-term goal of making less invasive cancer treatments a reality. Patients undergoing cancer treatment want three things: to live longer, to feel good, and to have no fear of the treatment or its side effects. Current treatments are too often debilitating, and we have to do better. Investors need to identify technologies with the greatest potential to solve these problems and hold onto them until they prove viable or not, because the constant buying in and out of biotech stocks ultimately hurts our chances of finding the treatments that are best for patients.
About The Big4Bio CEO Weekly Q&A
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