A cancer diagnosis is one of the most difficult directives you can hear from your doctor, but often the cancer treatment itself that follows a prognosis can be equally as awful for those with little choice but to undergo the current standard of care.

Intensity Therapeutics Founder Lew Bender is on a mission to help cancer patients with a treatment option that works without the fear of serious harm or drastic negative side effects to their bodies. Intensity’s lead product candidate is in late-stage human clinical studies to treat refractory solid tumors like metastatic soft tissue sarcoma and localized triple-negative breast cancer.

In this CityBiz exclusive Q&A, we talked to Lew about Intensity’s foundation, the science behind its lead candidate, the indications it’s targeting, the road ahead, and more.

Can you tell us about Intensity Therapeutics, your background, and how the company got to where it is today?

Intensity Therapeutics is a late-stage clinical biotechnology company with a mission to help patients live longer, higher-quality lives by discovering, developing, and commercializing first-in-class cancer drugs that attenuate tumors with minimal side effects while simultaneously training the patient’s immune system to fight the cancer using the patient’s dying cancer cells.

I am a chemical engineer by training with over 33 years of biotech experience primarily in drug delivery. This field develops technologies to move drugs to the right place in the body at the right time at an optimized concentration. I founded the company from my basement in 2012 based on a new chemistry that I thought could solve a long-sought goal: intratumoral injection. I recognized that when immunotherapies began to gain traction, their immune-stimulating mechanisms are analogous to releasing the brakes (PD-1 antibodies) or stepping on the gas (CTLA-4 antibodies) of the immune system. I felt there needed to be a steering wheel to guide the immune cells to target the tumor more precisely. That simple idea, developed by sitting alone, has morphed into a Nasdaq-listed company with patent protection in forty-two countries, ongoing trials in nine countries, and over 225 patients enrolled to date.

We have learned that our drug stimulates a more targeted immune response and we are now in late-stage randomized controlled clinical trials, with INT230-6 in a Phase 3 trial to treat refractory sarcoma and a Phase 2 study to investigate its use in localized triple-negative breast cancer.

What is intratumoral injection, and how is it different from current cancer treatments?

Current treatments, such as chemotherapy, are systemic. That means drugs are administered either orally or by intravenous injection. The delivery is throughout the whole body, with little of the therapeutic ever reaching the tumors. I knew that intratumoral injection, i.e., directly injecting the drugs into the body, had been attempted many times before by other researchers. However, due to the high fat content, pressure, and dense structure of most solid tumors, injection of water-based products is unlikely to succeed simply because water and fat do not mix. We published data on this effect in 2020 in the International Journal of Molecular Sciences. I leveraged my previous training in drug delivery and my chemical engineering background to develop our first product, INT230-6, a formulation containing two proven cytotoxic agents (cisplatin and vinblastine) and also a dispersion and cell penetration enhancer molecule that allows the tumor’s cancer cells to absorb the potent killing agents following direct injection into tumors. Upon injection, INT230-6 disperses throughout the tumor and diffuses the killing agents into the cancer cells.

Treatments such as chemotherapy and immunotherapy impact a patient’s entire body, with toxic side effects. Intensity’s technology takes a different approach, with our drug being injected directly into the patients’ tumors; healthy cells throughout the body are spared. As the cancer cells die, the immune system begins to recognize the cancer. Essentially, we debulk the live cancer and convert a person’s tumor into their own personal anticancer vaccine, inducing a systemic adaptive immune response.

Our proprietary chemistry enables the active agents to be soluble in both fat and water simultaneously. Almost all drugs are given intravenously or orally to fight metastatic disease systemically. Our local therapy kills tumors and stimulates the immune system to attack the tumors that we do not inject. After intratumoral injection with INT230-6, the cytotoxic agents disperse throughout the tumor and diffuse into the cancer cells. The agents remain in the tumor, and side effects are minimal; the tumor dies, and the immune system recognizes the cancer and attacks the injected and uninjected tumors. Our approach is a new way to kill cancer, unlike any current therapy.

Our drugs are designed explicitly for intratumoral delivery. Cisplatin and vinblastine, the active cancer-killing drugs in our candidate, each have dual killing and immune-activating mechanisms of action. With the proper amount of drug dosed into the tumor, our drug can cause the majority of cancer cells to die in an immunologically activating manner. Our drug creates a personal vaccine from a patient’s tumors that leads to a T-cell attack on the injected and uninjected tumors.

Is intratumoral injection viable for all types of tumors?

It is unlikely there will be one product that can treat every type of cancer. For our product, there will be some tumors that will be inaccessible for a needle to get to for the injection. There will be instances where our approach would be unfeasible, such as when the tumors are too diffuse or too large. Blood cancers are not amenable to our approach. However, there are enough cancers that I think can be injected where this new drug could have a real impact and make a difference for patients.

There are three primary goals that people aim to achieve when undergoing cancer treatment. They want to live longer, they want to feel good, and they don’t want to have any fear about the treatment or the side effects. Our technology has the potential to help people stay alive longer, and I think we can take the pain out of the disease. Current treatments are just horrible for the patients, but they’re the best we’ve got.

What indications have you targeted for this type of treatment? Could the treatment be effective for other types of cancer?

In our phase 1/2 study, we treated over 20 different types of cancer in patients with no options left to them. We saw favorable results in many of those cancers. However, one has to choose a development pathway for marketing approval. Given a lack of resources, we have targeted advanced soft tissue sarcoma, as well as presurgical triple-negative breast cancer, for our first indications. These cancers have a high unmet medical need for improved treatments. We hope that this delivery technology will be a valuable tool across many other cancers in the future.

The other thing to consider is that cancers can develop resistance. Even if an initial drug is effective, the cancer could come back and then be resistant to the treatment. The idea is to use diffusion-based technologies like ours to overwhelm the tumor and delay or eliminate the onset of resistance. Our first product contains two of the hundreds of other drugs. There could be other active drugs we have not tested that might be better than cisplatin and vinblastine in a specific cancer. There could be a whole host of other payloads that we could load into this intratumoral delivery technology that could be effective. We are committed to seeing this drug delivery product get to the market.

Can you tell us about the progress of Intensity’s current clinical programs? When could patients expect to receive this type of care?

Currently, we have trials in both operable triple-negative breast cancer and advanced soft tissue sarcoma in progress. The INVINCIBLE-4 study is a Phase 2 randomized, open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 administered before the standard of care treatment in patients with early-stage, operable triple-negative breast cancer, compared to standard of care (SOC) alone. The primary endpoint is to determine the change in the pathological complete response rate for the combination and the SOC alone. The study is recruiting patients in Switzerland and France and is expected to enroll 54 patients. We expect data in the second half of next year.

The INVINCIBLE-3 study is a Phase 3, open-label, randomized study testing INT230-6 as monotherapy compared to SOC drugs in second- and third-line treatment for three specific soft tissue sarcoma subtypes. The study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Agency (for France, Germany, Italy, Poland, and Spain), and Australia’s Therapeutic Goods Administration. The primary endpoint in the INVINCIBLE-3 study is overall survival. We have had to pause new site activations and patient enrollments in the INVINCIBLE-3 study due to funding constraints. Still, we continue to treat all patients already enrolled, and the treatment has been effective and well-tolerated so far.

What should our readers be on the lookout for from Intensity Therapeutics this year and beyond?

Prior to the initiation of the ongoing late-stage trial, the company completed two large studies: a Phase 1/2 trial in metastatic cancers and a Phase 2 study in presurgical breast cancer. We expect to have peer-reviewed publications from these two trials. Data from the INVINCIBLE-3 and INVINCIBLE-4 trials are the most important milestones. We hope to report the data from these studies as soon as the results are available. We continue to believe in our lead candidate INT230-6.

We also continue to look for ways to enhance our visibility in the patient advocacy and cancer treatment spaces. We announced earlier this year a partnership with breast cancer survivor, patient advocate, author, model, and filmmaker Christine Handy. We plan to work with her and her team to increase awareness around the need for better treatments for cancer patients. Far too often, patients finish their treatment cancer-free but with their health damaged from the therapies themselves.

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