Hopec-Pharma | CLINICAL TRIALS

CLINICAL TRIALS

At Hopec Pharma, we are at the forefront of developing innovative immunotherapeutic treatments for Non-Muscle Invasive Bladder Cancer (NMIBC). Our commitment to advancing medical science is reflected in our meticulously planned clinical trial program, which will adhere to the highest standards of safety, efficacy, and ethical conduct.

Our Approach

Our clinical trials are strategically designed to address unmet needs in NMIBC treatment, with a focus on patients who have not responded to current therapies. By collaborating with world-renowned medical institutions, we leverage top-tier expertise to drive our research forward.

Future Plans

We are preparing to launch our first clinical trial in Q2 2025. This early-phase trial will be a crucial step in evaluating the safety and preliminary efficacy of our groundbreaking treatment. It represents a significant milestone in our mission to develop safer, more effective options for bladder cancer patients.

Partnerships and Collaborations

Hopec Pharma has established strategic partnerships with leading hospitals and research centers. These collaborations will enable us to conduct our future trials in state-of-the-art facilities, ensuring the highest standards of patient care and data quality.

Regulatory Compliance and Patient Safety

We are committed to maintaining rigorous compliance with global regulatory standards, including those set by the FDA and EMA. Patient safety and ethical integrity will be paramount in all our clinical activities, and we will adhere strictly to established guidelines for patient rights, informed consent, and data protection.

Future Directions

As we progress through our clinical development stages, we plan to expand our trial program to include additional centers worldwide. This expansion will allow us to gather diverse patient data and accelerate the global availability of our innovative therapies.

Stay Informed

We are committed to transparency in our research. As we approach the launch of our clinical trials and as they progress, we will update this page with general information about our developments and major milestones.

Our team is exploring advanced immunotherapies, combination treatments, and cutting-edge technologies to enhance efficacy, quality of life and reduce side effects. Through collaborations with leading institutions, we aim to overcome the limitations of current treatments and bring new hope to bladder cancer patients.

Our First Clinical Study is ongoing (HOPEC-01)

Bringing a new immune-based therapy to patients with non-muscle invasive bladder cancer (NMIBC)

HOPEC Pharma is advancing its first-in-human clinical study of Inactivated UPEC-FimON, a novel immunotherapy designed to offer patients with NMIBC an alternative to existing intravesical treatments such as BCG or chemotherapy.

Milestone Highlights

Ministry of Health approval – July 2025
First clinical site initiated – Hadassah Medical Center, Jerusalem – September 2025
First patient recruitment – October 2025
First patient treatment - November 2025
Second clinical site initiated – Sheba Medical Center, Tel HaShomer – November 2025

About the Study

Title:
Phase Ia/Ib open-label multicenter study evaluating the safety and tolerability of intravesical inactivated Uropathogenic E. coli (UPEC-FimON) in participants with NMIBC refractory to BCG or intravesical chemotherapy.

Primary Objectives

Evaluate safety and tolerability
Define the maximum tolerated and optimal dose

Exploratory Objectives

Characterize pharmacokinetics and immunologic biomarkers
Assess preliminary antitumor activity and quality-of-life outcomes (EORTC QLQ-NMIBC24)

Design
Open-label, multicenter, dose-escalation (Phase 1a) and dose-expansion (Phase 1b)
Up to 60 participants (30 per phase)
Six weekly intravesical instillations with 14-weeks follow-up
Tight oversight by an independent Data Safety Monitoring Board (DSMB)

Status: Recruiting since October 2025
Sites: Hadassah Medical Center | Sheba Medical Center | Additional centers under review
IL MoH Registry: MOH_2025-09-16_014344

Scientific Rationale

UPEC-FimON is a formaldehyde-inactivated Uropathogenic E. coli mutant that constantly expresses type 1 fimbriae and lacks hemolysin A.
It binds selectively to mannose-rich receptors over-expressed on bladder-cancer cells, triggering local immune activation that recruits T and NK cells to attack the tumor while maintaining a favorable safety profile.
In preclinical models, UPEC-FimON achieved tumor regression comparable or superior to BCG with markedly fewer adverse effects.

Why It Matters

There are over 700,000 people living with bladder cancer in the United States only, with NMIBC comprising roughly three quarters of newly diagnosed cases. Despite available therapies, recurrence and progression remain common, leading many patients to repeated surgeries or radical cystectomy.

HOPEC Pharma aims to change that reality.
Our goal is to deliver a new immunotherapy that:

Generates a durable immune-mediated response
Provides enhanced safety through bacterial inactivation
Reduces recurrence and preserves quality of life

For Patients and Caregivers

The study is open to eligible NMIBC patients in Israel. Recruitment is managed directly through the study sites’ investigators, see MOH_2025-09-16_014344.

Information is for educational purposes only and does not replace medical advice. Patients should consult their physician regarding their potential participation.

For Partners and Collaborators

The HOPEC-01 trial marks a pivotal milestone in our mission to transform bladder-cancer care. With regulatory approval, active enrollment, and DSMB oversight, this program establishes the clinical foundation for future growth and collaboration in immuno-oncology.

Looking Ahead