Boarding PassIntragel hopes to treat the 10% of inoperable cancer patients
Boarding Pass
Intragel hopes to treat the 10% of inoperable cancer patients
The company has raised a total of $2 million for its first product, TumoCure, designed for solid tumors found in more than 17 million people.
“In 2020, there were 19.3 million new cancer cases worldwide and 10 million deaths, with costs to the healthcare system reaching €199 billion [$217.7 billion] in Europe,” explained Intragel. “Based on 2017–2019 data, nearly 40% of men and women will be diagnosed with cancer during their lifetime, and this global burden is predicted to increase by more than 60%, reaching 29.4 million cases by 2040.”
According to the company, solid tumors affect about 17.4 million of the 19 million cancer patients. Almost one-third of the solid tumors cases, especially in Head and neck, lung and brain, are inoperable as they are located in areas that can harm vital organs and cause immediate death or metastasis via the lymphatic system.
Another 30% of patients are untreatable due to pre-existing health conditions or they quit the treatment due to its toxicity. As a result, an overlapping population of 10% of solid cancer patients (2 million) are inoperable and untreatable, hence, with lowest chances of survival
“One of the most challenging solid tumors to treat is head and neck cancer (HNC), accounting for 900,000 cases globally,” Intragel continued. “HNC is unique as it is usually an advanced local cancer, meaning it doesn’t develop metastasis very often, making it ideal for surgery or local therapy. However, HNC is a very stubborn cancer, as the recurrence rates after surgery and treatment reach 50%, and, in this case, doctors usually scratch their heads as they consume all available therapies.”
This means no surgery or treatment is possible, and patients are left with palliative treatments without hope of recovering. The company seeks to change this with its gel platform called SRGel, which is both injectable and hydrophobic. This gel platform is designed for sustained drug release which has the potential to replace multiple systemic treatments with a single application.
The company expects to pursue a fast-track 505(b)(2) regulatory pathway for head and neck cancer (HNC), which will be its initial indication. Its pipeline could be applied to other cancer types, such as lung, brain, colorectal, ovarian, and testicular cancer.
You can learn more about their journey below.
Company Name: Intragel Therapeutics
Sector: Pharma/Biotech
Product/Service description:
Intragel is a pharmaceutical company in the clinical stage that focuses on developing a gel platform called SRGel, which is both injectable and hydrophobic. This gel platform is designed for sustained drug release. SRGel can be easily mixed at room temperature with nearly all anti-cancer drugs, allowing for high drug loading of up to 40%. These drugs can then be injected into solid tumors reachable by biopsy using standard needles. The local application of SRGel and its long-acting properties contribute to an improved quality of life for cancer patients, particularly those who have otherwise untreatable and inoperable forms of cancer. Intragel's first product, TumoCure, combines a concentrated anti-cancer drug that has already demonstrated both safety and efficacy in animal models and clinical use. This product has the potential to replace multiple systemic treatments with a single application.
Intragel expects to pursue a fast-track 505(b)(2) regulatory pathway for head and neck cancer, which will be its initial indication. This strategy is anticipated to result in a rapid time-to-market, and Intragel is already in advanced collaboration stages with leading global pharmaceutical companies, opening up possibilities for acquisition.
Intragel is currently raising $5 million to get FDA-approved for a phase II clinical trial.
Founder Bios:
Peter Siman Ph.D., CEO, and CSO: An enthusiastic entrepreneur with over 15 years of experience in business, pharmaceuticals, chemistry, and materials sciences.
Prof. Avi Domb, Co-founder: Has previous experience successfully commercializing an oncology treatment, Gliadel.
Avner Geva: Brings experience as a seasoned entrepreneur with more than ten years in the Israeli Medtech/Pharma industry, founded and served as CEO of Vensica Therapeutics.
Year of Founding: 2021
Last Investment Round: $450,000
Last Investment Stage: Pre-Seed
Date of Last Investment: May 2023
Total investment to date: $2 million
Investors (leading and all): Israel Innovation Authority, NGT3VC, NGT II Healthcare, and private investor
Current number of employees: 5
Open positions: N/A
How was the idea born?
The creator of Intragel technology is Professor Avi Domb, currently serving as the Chief Scientist of the Ministry of Science and Innovation. Previously, he served as head of the pharmacy school at the Hebrew University of Jerusalem. Prof. Domb is also one of the minds behind the invention of the Gliadel Wafer, which received FDA approval in 2005 as a preventive measure against the recurrence of Glioblastoma (GBM), an extremely aggressive brain tumor, following surgical removal. The Gliadel Wafer is a solid implantable wafer containing the anti-cancer agent Carmustine, strategically placed after GBM resection. The polymer segment of the wafer consists of a naturally occurring fatty acid and a synthetic component, linked together through polyanhydride bonds.
Over the past 15 years, Prof. Domb has expanded upon this concept, developing an injectable gel-like polymer with targeting capabilities, simplifying its application to various areas within the human body. His efforts culminated in the creation of a honey-like injectable polymer, composed entirely of naturally occurring fatty acids, ensuring its safety for usage.
During the COVID-19 pandemic in mid-2020, Avner Geva, a seasoned entrepreneur, and CEO of the startup Vensica, approached Prof. Domb with the intention of commercializing his technology. Together, they collaborated with the NGT incubator located in Nazareth, an early-stage medical device and life sciences venture capital fund, investing in promising technologies, to advance their idea through an IIA program. The NGT incubator endorsed and facilitated the application submission to the IIA, concurrently appointing a young CEO from the Arab community to lead the company. This strategic move paved the way for a successful funding acquisition in late November 2020.
What is the need for the product?
In 2020, there were 19.3 million new cancer cases worldwide (WHO) and 10 million deaths, with costs to the Healthcare system reaching €199 billion ($217.7 billion) in Europe (2018). Based on 2017–2019 data, nearly 40% of men and women will be diagnosed with cancer during their lifetime, and this global burden is predicted to increase by more than 60%, reaching 29.4 million cases by 2040.
Solid tumors affect about 17.4 million patients. 30% of solid tumors (2 million) are inoperable tumors located in areas that can harm vital organs and cause immediate death or cause metastasis via the lymphatic system. Another 30% are untreatable tumors because the patient would not tolerate the treatment due to their delicate health condition or they quit the treatment. As a result, 10% of solid cancer patients are inoperable and untreatable.
One of the most challenging solid tumors to treat is Head and neck cancer (HNC), accounting for 900,000 cases globally. HNC is unique as it is usually an advanced local cancer, meaning it doesn’t develop metastasis very often, making it ideal for surgery or local therapy. However, HNC is a very stubborn cancer, as the recurrence rates after surgery and treatment reach 50%, and, in this case, doctors usually scratch their heads as they consume all available therapies. Hence, no surgery nor treatment is possible, and patients are left with palliative treatments without hope of recovering. On the other hand, immunotherapy has not proven to be effective on HNC, limiting patients' and doctors' options.
How is it changing the market?
In response to the need for new formulations that enable higher drug loading, long-action, and local release of the drug instead of systemic dispersion to diminish side effects and improve efficacy, IntraGel has developed SRGel.
TumoCure will benefit and impact the healthcare system, oncologists, and patients by offering the following USPs:
- Easy to use: Injectable gel stable in a single syringe with no need for preheating or manipulation, ready to be placed in any tumor, including surgically inaccessible tumors and/or chemo/radio-resistant tumors.
- High drug loading: The hydrophobic and solvent-free composition of SRgel allows up to 50% w/w drug loading. A single dose of TumoCure can replace four courses of systemic chemotherapy.
- Long-lasting release: Biodegradable SRGel starts drug releasing during the first 24 hours, and continues to release the drug at a steady rate over the period of two months after administration.
- High drug concentration at tumor site: Once injected, SRGel sticks and releases the drug where it was injected at concentrations 100-1000 times higher than through systemic administration.
- Highly efficient: Preclinical data showed 98% tumor reduction and 80% tumor disappearance. Clinical data clearly showed 35% tumor necrosis after just one month of treatment in a compassionate use of an unresectable, radio, and chemoresistant carcinoma.
- Safe: Minimal to no systemic toxicity of cisplatin. Solvent-free.
Our technology is highly scalable as it can be combined with other anticancer drugs such as paclitaxel, which has already been successfully incorporated in SRGel with promising preclinical results, and other drugs (doxorubicin, paclitaxel, peptides, and proteins) boosting their effectivity and safety. Our pipeline has other cancer types, such as lung, brain, colorectal, ovarian, and testicular cancer.
How big is the market for the product and who are its main customers?
The SRGel platform and TumoCure belong to the solid tumors market valued at €209 billion ($228 billion) in 2021 and expected to reach €901 billion ($985 billion) by 2029 (CAGR of 20%, 2022-2029). It includes therapies such as chemotherapy, targeted therapy, and immunotherapy.
The SRGel Serviceable Available Market (SAM) was estimated based on the 50% of patients with solid tumors challenging to treat with the standard therapies, either chemotherapy or surgery. More than 8.6 million patients annually would benefit from our injectable formulation - a combination of SRGel and an antitumor drug - once we expand it to other tumor indications.
Focused on Head and Neck cancer with an incidence of 900,000 cases worldwide, our first indication will target an initial market of €11.3 billion ($12.3 billion). Due to the lack of HNC treatment, we expect an 8% market penetration of TumoCure by 2030 (5 years after the project, three years after approval). Within the project, once we finish TumoCure Ph2 trial, we expect to attract interest in our SRGel platform for other indications and have the first license revenue of SRGel.
Does the product exist already? If not - at what stage is it and when is it expected to hit the market?
Intragel, a company in the clinical stage, is currently conducting a Phase Ib study in Israel at Hadassah Ein Kerem and Galilee Medical Center in Nahariya. The company has plans to expand its reach by adding more centers to its study by the end of the third quarter of this year. This expansion is in line with Intragel's significant investment in establishing a production facility for both preclinical and clinical studies of SRGel and TumoCure (Gel-Cisplatin). Notably, TumoCure has demonstrated its safety and efficacy in reducing tumor size and impeding growth in both animal and human subjects.
A major milestone achieved by our team is bringing TumoCure into the clinical stage and successfully implementing compassionate use in a human patient, resulting in over 35% necrosis in a substantial 200cc tumor after just one month.
These accomplishments assisted Intragel to gain considerable momentum and have attracted interest from global pharmaceutical companies for the testing of the SRGel and TumoCure platform to address their specific requirements. These collaborative efforts are progressing and Intragel anticipates their maturation by the first quarter of 2024.
In order to enhance these partnerships, enable large-scale production, and pave the way for upcoming clinical investigations, Intragel has secured approval from the Ministry of Health for the conceptual design of expansive production facilities.
Finally, we anticipate reaching the market with FDA clearance in 4-5 years as Intragel follows the fast track in FDA, 505(b)(2).
Who are the main competitors in this sector and how big are they?
We identify this market as a blue ocean with low competition at the market level. Only a few players are at an advanced stage and they target different market segments. There is huge demand and an untapped need with a whole set of customers and end-users willing to pay to solve their problems and obtain the mentioned gains for every actor within the value chain. The market experience of Jelmyto and Zoladex is more advanced than ours, helping us to open the doors to alternative local chemotherapy and to implement an evidence-based pricing strategy.
Targeting unmet need and orphan diseases (neglected diseases) in the pharma industry is a competitive strategy because it is an empty niche, and the regulatory roadmap resumes the pathway to commercialization. IntraGel will be the reference partner to develop localized long-acting chemotherapy treatments for all types of solid tumors. SRGel has overcome the challenges of delivering oncology drugs effectively directly into solid tumors, allowing, for the first time, 90% drug concentration at the tumor site and limiting systemic side effects while controlling drug release. SRGel will be the base for optimizing over 95% of current chemotherapeutic agents and supporting new drug developments.
What is the added value that the founders bring to the company and the product?
Our team of highly professional and experienced scientists and business executives has a proven track record of being able to initiate clinical trials only two years after the launch of IntraGel. This success has attracted pharmaceutical companies.
- Dr. Peter Siman, CEO & CSO, is an enthusiastic entrepreneur with over 15 years of experience in business, pharmaceuticals, chemistry & materials sciences.
- Prof. Avi Domb, has previous successful experience commercializing an oncology treatment, Gliadel.
- Avner Geva, brings experience as a seasoned entrepreneur with more than 10 years in the Israeli MedTech/pharmaceutical industry.
What will the money raised during the current investment round be used for?
Intragel is aiming to raise $5 million in funding, intended to bolster FDA IND enabling studies, facilitate the establishment of the GMP facility (with Ministry of Health-approved conceptual design), and crucially, advance towards the completion of Phase II clinical trials.
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