On May 16, 2020 Photocure ASA (OSE: PHO) reported key data was published by the 2020 American Urological Association (AUA) Annual Virtual Meeting (Press release, PhotoCure, MAY 16, 2020, View Source [SID1234558210]). Three abstracts featured Blue Light Cystoscopy (BLC) with Cysview, and on June 27, 2020 BLC with Cysview will be included in a virtual session of the AUA program: "Surgical Techniques: Tips & Tricks Oncology: Bladder Cancer Blue Light" with Dr. Anne Schuckman.

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MP 73-11: Role of blue light cystoscopy in detecting invasive bladder tumor: Data from a multi-institutional registry View Source

MP 24-06: Gender based Variations in the Detection of Bladder Cancer with Blue Light Cystoscopy: Insights from a Multicenter Registry View Source

MP 73-02: Malignant urinary cytology of unknown origin-blue light flexible cystoscopy at the outpatient clinic may be a valuable diagnostic tool View Source

The Role of blue light cystoscopy in detecting invasive bladder tumor: Data from a multi-institutional registry showed that in the registry enrolled patients, a considerable proportion of invasive bladder tumors were detected by BLC alone: A total of 55 invasive lesions, of the 494 invasive lesions detected, were detected only by blue light cystoscopy. The benefit of using BLC in earlier detection of invasive bladder tumors could have an effect on the treatment approach and potentially lead to improved survival in the high-risk population. The study included 3514 lesions (1257 unique patients), from 9 sites in the U.S.

"Out of the overall 494 invasive lesions detected, 11% of them were only detected by BLC alone. Also, of 47 patients with BLC-only positive invasive lesions, 60% had concurrent CIS and 49% had an additional T1 lesion. Knowing when these high-risk tumors are present, especially concurrently, is critical to the optimal management of a patient’s disease. We need this information in order to make the best treatment decisions, which can have a significant impact on the prognosis and quality of life, for our patients." says Siamak Daneshmand, MD, Director of Urologic Oncology Associate Professor of Urology, USC Institute of Urology.

Gender based Variations in the Detection of Bladder Cancer with Blue Light Cystoscopy: Insights from a Multicenter Registry showed that similar to existing evidence, BLC-alone was significantly more sensitive than WLC-alone in males (91.1% vs 80.0%, p<0.001) and in females (86.7% vs 79.5%, p = 0.036). Furthermore, the sensitivity with BLC between the genders was significantly greater in males than in females (91.1% vs 86.7%, p = 0.035). Additionally, the false-positive rate in females was significantly higher than in males in BLC (35.9% vs 28.5%, p=0.008) and WLC (33.8% vs 27.4%, p=0.029). These findings highlight the differences in detection rates of NMIBC between genders, an area that warrants further investigation, and they continue to validate the existing evidence of increased sensitivity of BLC with Cysview in the detection of NMIBC.

Malignant urinary cytology of unknown origin – blue light flexible cystoscopy at the outpatient clinic, a Nordic prospective multicenter registry study, showed that the majority of patients, 93% (27/29), stated that they preferred to have BLC with Cysview performed with a flexible cystoscope at the outpatient clinic versus the operating room under general anesthesia. It was concluded that using BLC with Cysview with a flexible cystoscope at the office may be a simple way to solve unclear cases with malignant or suspicious urinary cytology.

"At a time when patients and physicians are seeking to ensure bladder cancer detection and surveillance are being maintained in appropriate intervals, it is encouraging to see more data supporting the use of BLC with Hexvix/Cysview in the office setting." says Dan Schneider, President and CEO of Photocure. "Additionally, Cysview for use in high-risk patients helps both physicians and patients make difficult decisions that can impact patients’ outcomes and quality of life. As The Bladder Cancer Company we are proud to see that more data is being collected, and that it continues to add to the already existing evidence that the use of Hexvix/Cysview can play a critical role in disease management."

About Bladder Cancer
Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000 prevalent cases (5-year prevalence rate), 550 000 new cases and almost 200 000 deaths annually in 2018.1

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

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 in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4

1 Globocan. Incidence/mortality by population. Available at: View Source
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. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that is selectively taken up by tumor cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLC with Hexvix /Cysview improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview is the tradename in the US and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview /Hexvix directly in the US and the Nordic region and has strategic partnerships for the commercialization of Hexvix/Cysview in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

On May 15, 2020 MV BioTherapeutics reported the launch of the company website that provides most relevant information on the technology and pipeline of MV BioTherapeutics (Press release, MV BioTherapeutics, MAY 15, 2020, View Source [SID1234632273]). We have changed the original name of the company from MicroVaccines to MV BioTherapeutics (from now on MV).

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"During the past years we have developed therapeutic live biotherapeutics with different mode of action as compared to the original live attenuated microbial vaccines, which were exemplified as microvaccines" says Dr. Fabio Grassi, founder and Chairman of MV.

"With two lead indications and potential future developments of this promising application, it was important to characterize the company as non-exclusively dedicated to vaccines that is a very specific pharmaceutical area."

The abbreviation MV is directly related to the two patented microorganisms ApyraMed and ApyraVax

On May 15, 2020 Affibody AB ("Affibody") and Inmagene Biopharmaceuticals ("Inmagene") reported a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases (Press release, Affibody, MAY 15, 2020, View Source [SID1234575707]). Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide.

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Under the terms of the agreement, Affibody will receive a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory and sales milestones, plus royalties on sales in Inmagene’s commercialization territory. Additionally, Inmagene will share the global development costs of select clinical trials and be eligible to receive payments and royalties from Affibody relating to certain global development and commercialization milestones. Affibody will be responsible for the manufacturing and supply of ABY-035 for development and commercialization worldwide and is not precluded from additional collaboration and licensing agreements in territories not covered by this agreement.

Currently in Phase 2 development, ABY-035 is an innovative fusion protein targeting IL-17. ABY-035 combines Affibody’s proprietary protein therapeutics platform (Affibody technology), which confers greater potency in a small molecular format, and the Albumod technology which provides a long half-life. Together, these features provide the potential for best-in-class efficacy in a convenient, less frequent and at-home subcutaneous administration. In the ongoing Phase 2 Psoriasis Trial, ABY-035 has demonstrated a strong safety profile and clear clinical benefits.

"Based on ABY-035’s strong clinical data and significant advantages over antibody-based IL-17 therapies, we believe it has the best-in-class potential," said Jonathan Wang, Ph.D., Inmagene’s Chairman and CEO. "ABY-035 may provide affordable solutions to Chinese patients with high unmet medical needs and become a key pillar for Inmagene to establish a leadership position in China’s immunology related therapeutic areas."

With rich experience in bringing multiple relevant biologics targeting IL-17, IL-1, IL6, T cell and B cell to China as well as the US and Europe markets, the Inmagene clinical development team will work closely with Affibody to conduct global trials in multiple regions to shorten the development timelines. Inmagene will take the lead of the global development strategy and implementation in two indications.

"This creative alliance between Affibody and Inmagene is poised to deliver on ABY-035’s best-in-class potential by accelerating the time to commercialization across multiple indications and accessing a significant market opportunity in Greater China" said David Bejker, CEO of Affibody. "With the extensive track record of the Inmagene team, we will be able to leverage access to the Chinese market, providing additional opportunities for development and commercialization. The team’s vision of creating the leading Chinese immunology company is one we are excited to be a part of."

About ABY-035

ABY-035 is a novel bispecific agent, potently targeting both subunits of IL-17A as well as albumin, which has been specifically designed to utilize the strengths of Affibody’s technology platform to create a very small protein drug (18 kDa, an eighth of the size of an antibody) with very high apparent affinity to IL-17A (KD ~300fM) and antibody-like half-life due to the strong (KD ~50pM) binding affinity to serum albumin.

Accumulated patient data from ~150 psoriasis patients, some of which have been dosed for more than two years, support a safe and efficacious product profile with best-in-class potential.

ABY-035 is currently being evaluated in an open-label extension of the double-blinded, placebo controlled, 52 week, Phase 2 proof-of-concept study (AFFIRM-35, NCT03591887) which has enrolled 108 moderate-to-severe psoriasis patients in centers throughout Germany to evaluate the efficacy, safety and tolerability of ABY-035. The primary efficacy measure is PASI 90 at twelve weeks. Secondary endpoints include absolute and relative PASI-measures at weeks 12, 24, and 52; DLQI; itch and pain VAS; safety and tolerability, and pharmacokinetics.

In a Phase 1/2 study, ABY-035 demonstrated favorable safety and tolerability across multiple doses and dosing regimens with rapid and sustained efficacy in patients. The primary objective of this study was to evaluate mechanism of action, safety, tolerability and pharmacokinetics of ABY-035.

On May 15, 2020 LegoChem Biosciences, Inc. ("LCB") (KOSDAQ:141080), based in Daejeon, South Korea, reported that a worldwide license agreement with Iksuda Therapeutics ("Iksuda") for the development and commercialization of LCB73, a CD19-targeted ADC candidate for hematological tumors. (Press release, LegoChem Biosciences, MAY 15, 2020, View Source [SID1234573676]).

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Under the terms of the agreement, Iksuda will make an upfront payment of USD 5 million and LCB is eligible to receive development, regulatory and commercial milestone payments of up to USD 222 million as well as royalties on commercial sales. LCB is also entitled to receive a prearranged percentage of sublicense revenue if Iksuda enters into license agreement with third party companies. All payments will be shared with LCB’s partner Light Chain Bioscience (Novimmune SA).

LCB73 has been generated in a partnership between LCB and Swiss-based Light Chain Bioscience’s (Novimmune SA) by combining LCB’s cancer-selectively activated next-generation linker and toxin platform with Light Chain Bioscience’s proprietary antibody targeting CD19. Preclinical data of LCB73 along with the clinical outcome of other CD19-targeted therapies suggest that the ADC may be an effective treatment option for various B-cell hematological cancers including diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma.

We are very pleased to expand our partnership with Iksuda to advance the development of LCB73, in addition to the recent license agreement which enables the application of our ADC platform to Iksuda’s pipeline of Next Generation ADCs," said Dr. Yong-Zu Kim, CEO & President of LCB. "This particular ADC program will set a significant milestone as it is our first lead ADC candidate utilizing our next-generation prodrug payload, whose commercial and clinical potential will be explored through this collaboration."

"We have been very impressed with preclinical data using LCB73 which have demonstrated significant single-agent anti-cancer activity in B cell malignancies and a competitive toxicity profile," said Dr. David Simpson, CEO of Iksuda. "We look forward to advancing this candidate into the clinic in the most efficient manner, utilizing our extensive UK and US based ADC expertise to drive preclinical and clinical development activities."

On May 15, 2020 LegoChem Biosciences, Inc. ("LCB"), based in DaeJeon South Korea, reported a worldwide license agreement with Iksuda Therapeutics ("Iksuda") for the development and commercialization of LCB73, a CD19-targeted ADC candidate for hematological tumors (Press release, Light Chain Bioscience, MAY 15, 2020, View Source [SID1234562776]).

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Under the terms of the agreement, Iksuda will make an upfront payment of $5 million and LCB is eligible to receive development, regulatory and commercial milestone payments of up to $222 million as well as royalties on commercial sales. LCB is also entitled to receive a prearranged percentage of sublicense revenue if Iksuda enters into License agreement with third party companies. All payments will be shared with LCB’s partner Light Chain Bioscience (Novimmune SA).

LCB73 has been generated in a partnership between LCB and Swiss-based Light Chain Bioscience (Novimmune SA) by combining LCB’s cancer-selectively activated next-generation linker and toxin platform with Light Chain Bioscience’s proprietary antibody targeting CD19. Preclinical data of LCB73 along with clinical outcome of other CD19-targeted therapies suggest that the ADC may be an effective treatment option for various B-cell hematological cancers including diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma.

"We are very pleased to expand our partnership with Iksuda to advance development of LCB73, in addition to the recent license agreement which enables application of our ADC platform to Iksuda’s pipeline of Next Generation ADCs ." said Dr. Yong-Zu Kim, CEO & President of LCB. "This particular ADC program will set a significant milestone as it is our first lead ADC candidate utilizing our next-generation prodrug payload, whose commercial and clinical potential will be explored through this collaboration."

"We have been very impressed with preclinical data using LCB73 which have demonstrated significant single-agent anti-cancer activity in B cell malignancies and a competitive toxicity profile" said Dr. David Simpson, CEO of Iksuda. "We look forward to advancing this candidate into the clinic in a the most efficient manner, utilizing our extensive UK and US based ADC expertise to drive pre-clinical and clinical development activities."