Photocure announces the publication of the results of a preclinical study supporting the antitumor effect of hexaminolevulinate with blue light in the bladder cancer model

Oslo, Norway, February 28, 2022 /PRNewswire/ — Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces the publication of new results from its exploratory research program in the journal Biomedicines, titled “Antitumor Effect and Induced Immune Response Following Hexaminolevulinate (HAL) Exposure and Blue Light in an Orthotopic Model of Rat Bladder Cancer”. These results support the first preclinical data on the potential anti-tumor effect of HAL, which were presented at the BLADDR 2019 congress. [https://photocure.com/news/photocure-new-data-from-hexvixr-trials-presented-at-the-bladdr-2019-congress-3457632].

The aim of the study was based on the hypothesis that the positive impact on long-term outcomes in NMIBC patients who underwent blue light cystoscopy (BLC) prior to cystectomy might be caused by a direct antitumor effect and/or activation of the immune system. indicating an additional effect of Blue Light with HAL beyond pure detection. Therefore, in an exploratory preclinical study, the authors investigated whether intravesical administration of HAL followed by a diagnostic blue light illumination regimen, aiming to mimic that currently used in photodynamic diagnosis (PDD), may have anti-tumor and/or immune effects. modulating effects as seen with photodynamic therapy (PDT). Additionally, it was explored whether co-administration of a checkpoint inhibitor would increase susceptibility to PD-1/PD-L1 pathway inhibition, thereby enhancing the anti-tumor effect. Over the years, Photocure has conducted a number of experiments on the effects of HAL’s “mechanisms of action”, as well as to see if there are potential similar anti-tumor and immunomodulatory effects of PDD with light. blue, as shown with the PDT. For this study, rats were treated with HAL and blue light in an orthotopic model of bladder cancer, followed by histopathological analysis of bladder samples and further evaluation of immune markers. The co-administration of HAL and blue light with a checkpoint inhibitor was further evaluated in this model aimed at assessing the potentiation of anti-tumor effects when combined with immunotherapy.

Study results demonstrated an anti-tumor effect of HAL and blue light when aimed to mimic the dosing regimen of a photodynamic diagnostic (PDD) procedure in an orthotopic bladder cancer model in the rat.

The authors conclude “The anti-tumor effect is most likely related to stimulation of the immune system, as evidenced by tumor infiltration of CD3+ and CD8+ T lymphocytes. These results support our hypothesis that the positive impact on patient outcomes observed in patients who underwent BLC before cystectomy could be explained by systemic immune activation induced by HAL and blue light. The combination of HAL and blue light with intravesical anti-PD-L1 resulted in increased anti-tumor effects. Further studies are warranted to explore the long-term effects of HAL and blue light alone or in combination with checkpoint inhibitors which should extend to investigate any systemic (abscopal) effects. Curiously, it is also the idea that local treatment with HAL and blue light can trigger an immune response with a potential additional effect of checkpoint inhibitors.

The intriguing results of this preclinical study are encouraging and could explain an effect of HAL+BL beyond pure detection. The results motivate further research to evaluate the potential of HAL as a photodynamic therapy (PDT), which could be an innovative technique for the treatment of non-muscle-invasive bladder cancer.“said Anders Neijber, Vice President, Global Medical Affairs and Clinical Development at Photocure.

Read the full article here: https://www.mdpi.com/2227-9059/10/3/548

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About bladder cancer

Bladder cancer is the seventh most common cancer worldwide, with 1,720,000 prevalent cases (5-year prevalence rate)1a573,000 new cases and more than 200,000 deaths per year in 2020.1b

About. 75% of all cases of bladder cancer occur in men.1 It has a high recidivism rate, averaging 61% in the first year and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is an expensive and potentially progressive disease for which patients must undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both diagnosis and management of bladder cancer for the benefit of patients and health systems.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC), depending on the depth of invasion of the bladder wall. the bladder. The NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all cases and include Ta subtypes, carcinoma in situ (CIS), and T1 lesions. In MIBC, the cancer has grown into deeper layers of the bladder wall. These cancers, including the T2, T3, and T4 subtypes, are more likely to spread and are more difficult to treat.4

1 Globocan. a) prevalence over 5 years / b) incidence/mortality by population. Available at: https://gco.iarc.fr/todayaccessed [January 2022].

2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

3 Sievert KD et al. World J Urol 2009;27:295–300

4 Bladder cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html

About Hexvix®/Cysview® (Hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in bladder cancer cells, causing them to glow bright pink during blue light cystoscopy (BLC®). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves tumor detection and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview is the trade name in the United States and Canada, Hexvix is ​​the trading name in all other markets. Photocure markets Cysview/Hexvix directly in the United States and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australiaand New Zealand. Please refer to https://photocure.com/partners/our-partners for more information on our business partners.

About Photocure ASA

Photocure: The Bladder Cancer Company provides transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients around the world. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). For more information, visit www.photocure.com, www.hexvix.com, www.cysview.com

For more information, please contact:

Dan Schneider
President and CEO
photocurable AAS
Email: [email protected]

Erik Dahl
CFO
photocurable AAS
Tel: +4745055000
Email: [email protected]

David Moskowitz
Vice President, Investor Relations
photocurable AAS
Tel: +1 202 280 0888
Email: [email protected]

Media and international relations inquiries:

Geir Bjorlo
Business communication (Norway)
Tel: +47 91540000
Email: [email protected]

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