On February 17, 2025 Photocure ASA (OSE: PHO), The Bladder Cancer Company, reported the presentation on February 14 of a new abstract with study results from its U.S. bladder cancer patient registry at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU), in San Francisco (Press release, PhotoCure, FEB 17, 2025, View Source [SID1234650320]). The abstract discusses the role of Blue Light Cystoscopy in identifying tumors undetected by WLC leading to necessary upstaging of patient pathology. Consequently, when using Blue Light Cystoscopy with Cysview, bladder cancer management decisions can be made more appropriately.

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The poster presentation (Abstract No. 686, Poster Session B: Urothelial Carcinoma) ‘Upstaging and risk mitigation with Blue Light Cystoscopy for non-muscle-invasive bladder cancer: Results from a prospective multicenter registry’ by Alireza Ghoreifi (Duke University Medical Center).

The study looked at 2,854 NMIBC* patients from the US Blue Light Cystoscopy with Cysview Registry. A total of 201 (7%) patients had at least one malignant lesion detected exclusively by BLC while having a negative WLC. These lesions (335 in total) included carcinoma in-situ (CIS) (145; 43%), low-grade Ta in (53; 16%), high-grade Ta in (95; 28%), high-grade T1 (37; 11%), and high-grade T2 (5; 1%). As a result of BLC-enhanced detection, the rate of upgrading or upstaging to a more advanced tumor using BLC was 9.3%. The author concluded that resulting changes in grade/stage could impact patient management, such as the appropriate administration of intravesical therapy, duration of therapy, and when to perform radical cystectomy. The results are expected to form the basis for further studies on how Blue Light Cystoscopy can support precision diagnostics and improve patient management in NMIBC.

The abstract presentation included data from Photocure’s US Blue Light Cystoscopy with Cysview Registry, a large multicenter bladder cancer patient registry of real-world data, established by Photocure in 2014 and projected to enroll 4,400 patients.

See the poster here: View Source

*NMIBC: Non muscle-invasive bladder cancer

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About Bladder Cancer

Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 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. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [February 2024].
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 preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to View Source for further information on our commercial partners.

On February 17, 2025 Rznomics reported on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Hepatocellular Carcinoma (HCC) (Press release, Rznomics, FEB 17, 2025, View Source [SID1234650319]).

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This marks the second Fast Track Designation for RZ-001, following its designation in November 2023 for Glioblastoma (GBM), a hard-to-treat brain cancer.

The Fast Track program, established by the FDA, supports the development of drugs for serious or life-threatening diseases by expediting the approval process. Once a drug is designated and if relevant criteria are met, it benefits from accelerated review and approval, as well as more frequent and flexible communication with the FDA. Additionally, during the Biologics License Application review, a rolling review can be conducted for each data section, providing an advantage in the evaluation process.

RZ-001 is an anticancer drug developed using Trans-splicing Ribozyme, Rznomics’ proprietary RNA editing platform technology. It has received Investigational New Drug (IND) approval from both South Korea’s Ministry of Food and Drug Safety (MFDS) and the U.S. FDA. Currently, it is in Phase 1b/2a clinical trials for Hepatocellular Carcinoma (HCC) and Phase 1/2a trials for Glioblastoma (GBM).

Furthermore, for Glioblastoma (GBM), RZ-001 has been approved under the FDA’s Expanded Access Program (EAP), which allows compassionate use of investigational treatments outside clinical trials. The program is currently being conducted at Harvard University Hospital.

Dr. Seong-Wook Lee, CEO of Rznomics, stated, "We believe this designation recognizes the potential of RZ-001 as an innovative cancer therapy. We are committed to expediting its clinical development to provide effective treatment options for patients suffering from hard-to-treat cancers."

On February 17, 2025 Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and a part of JSR Life Sciences and Japan-based JSR Corporation, reported the complete integration of Indivumed Services (Press release, Crown Bioscience, FEB 17, 2025, View Source [SID1234650318]). This strategic move, following the acquisition in 2023, solidifies Crown Bioscience’s standing in oncology drug research and development. As a result of this merger, the Indivumed Services brand will be fully retired in February 2025.

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The merger unifies the strengths of both entities, offering pharmaceutical and biopharmaceutical partners a powerful toolkit of integrated platforms and services, including biospecimen solutions, to enhance the oncology drug development process from discovery through to clinical stages. Crown Bioscience will maintain operations across 11 locations in the United States, Europe, and the Asia-Pacific region and will continue to be dedicated to consistently delivering expanded services and leading research platforms on a global scale.

On February 16, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, reported that its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, has received its second Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) (Press release, Innovent Biologics, FEB 16, 2025, View Source [SID1234650312]). This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy. IBI363 has demonstrated encouraging efficacy and safety across multiple solid tumor types. Currently, Innovent is conducting Phase 1/2 clinical trials of IBI363 mainly in China and the U.S.

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At the World Conference on Lung Cancer (WCLC) in September 2024, IBI363 presented promising efficacy signals in patients with sqNSCLC who had previously received immunotherapy:

In the 3 mg/kg dose group, among patients with at least 12 weeks of follow-up or study completion (n=18), the objective response rate (ORR) was 50.0%, and the disease control rate (DCR) was 88.9%. The median progression-free survival (PFS) has not yet been reached and remains under follow-up.
In the 1/1.5 mg/kg dose group, the median PFS was 5.5 months (95% CI: 1.5, 8.3), with a 12-month PFS rate of 30.7%, highlighting the potential long-term benefits of immunotherapy.
Across the 1/1.5/3 mg/kg dose groups, patients with PD-L1 TPS<1% (n=22) and those with PD-L1 TPS≥1% (n=22) achieved encouraging ORRs of 36.4% and 31.8%, respectively, suggesting IBI363’s potential advantage in PD-L1 low-expression populations.
Dr. Hui Zhou, Senior Vice President of Innovent, stated, "We are pleased that IBI363 has been granted Fast Track Designation by the FDA for sqNSCLC, following its previous designation for melanoma. Earlier, we reported that in an expanded cohort of sqNSCLC patients, IBI363 showed a trend toward improved ORR and DCR at higher doses, along with a manageable safety profile. The latest PFS data from the 3 mg/kg dose group after longer follow-up further strengthens our confidence in IBI363’s potential as an immunotherapy offering long-term benefits to patients. We will present the relevant data at upcoming academic conferences this year. More encouragingly, IBI363 has demonstrated potent anti-tumor activity regardless of PD-L1 expression levels. This suggests that IBI363 may not only advance treatment for immunotherapy-resistant populations but also for cold tumors with low or no PD-L1 expression. In addition to lung cancer, we have observed encouraging efficacy signals in cold tumors, including colorectal cancer and mucosal melanoma, with melanoma already advancing to pivotal clinical stages. Moving forward, we will continue to explore IBI363 in early-line treatment and in combination therapies."

Fast Track Designation (FTD) is a regulatory process designed to expedite the clinical development and review of drugs intended to treat serious conditions and address unmet medical needs. Drug candidates granted FTD benefit from increased communication with the FDA throughout subsequent drug development, potentially accelerating their clinical development and approval process.

About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein))

IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. It is a PD-1/IL-2 bispecific antibody fusion protein designed to enhance efficiency while minimizing toxicity. The IL-2 arm of IBI363 has been engineered to optimize therapeutic effects with reduced side effects, while the PD-1 binding arm enables PD-1 blockade and selective IL-2 delivery. By simultaneously inhibiting the PD-1/PD-L1 pathway and activating the IL-2 pathway, IBI363 facilitates more precise and efficient targeting and activation of tumor specific T cells. Preclinical studies have shown that IBI363 exhibits strong anti-tumor activity across multiple tumor-bearing pharmacological models, including those resistant to PD-1 inhibitors and metastatic models. Additionally, it has demonstrated a favorable safety profile in preclinical models. Clinical trials are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies.

About Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Lung cancer is the most common and deadliest malignancy worldwide, including in China[1], posing a significant public health challenge. Non-small cell lung cancer (NSCLC) accounts for more than 80% of all lung cancer cases[2], with squamous cell carcinoma being one of its two major subtypes[2]. In recent years, immune checkpoint inhibitors have transformed the treatment landscape for NSCLC. However, for patients with NSCLC who have failed immunotherapy and lack driver gene mutations, there remains a significant and urgent unmet need for effective treatment options. The standard second- or third-line treatment, docetaxel, offers limited efficacy, with a median progression-free survival (PFS) of less than four months[3],[4]. While antibody-drug conjugates (ADCs) have shown promise, two large Phase 3 studies in squamous NSCLC have yet to demonstrate satisfactory efficacy.

On February 15, 2025 Samsung Bioepis Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV (denosumab-dssb; SB16; 60 mg pre-filled syringe) and XBRYK (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia and Xgeva respectively (Press release, Samsung BioLogics, FEB 15, 2025, View Source [SID1234650314]). In addition, the FDA granted a provisional determination for both Ospomyv and Xbryk’s interchangeability designation.

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OSPOMYV, referencing Prolia, has been approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

XBRYK, referencing Xgeva, has been approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

"The FDA approval of OSPOMYV and XBRYK marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the US. By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life," said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. "This achievement underscores our commitment to healthcare innovation through biosimilars and our mission to meet the growing needs in critical therapeutic areas."

The FDA approval was based on totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-blind, three-arm, parallel group, single-dose Phase 1 study demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants. The primary PK endpoints were met, in terms of area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration.1 In addition, a randomized, double-blind, multi-center Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, PK, and pharmacodynamics (PD) profiles between SB16 and reference denosumab (DEN) in postmenopausal osteoporosis (PMO) patients. The primary endpoint was met in terms of percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 12, and a follow-up up to Month 18 demonstrated switching to SB16 from DEN were comparable up to Month 18 in terms of efficacy, PK, PD, safety and immunogenicity.2,3

OSPOMYV and XBRYK, marks Samsung Bioepis’ 9th and 10th FDA approved medicines as well as the company’s first FDA approval for an endocrinology biosimilar, setting another milestone for the company to broaden its biosimilar portfolio that cover a spectrum of therapeutic areas including immunology, oncology, ophthalmology, hematology and endocrinology.

OSPOMYV (denosumab-dssb) injection, for subcutaneous use

Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment:

of postmenopausal women with osteoporosis at high risk for fracture
to increase bone mass in men with osteoporosis at high risk for fracture
of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
SELECTED SAFETY INFORMATION

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE

See full prescribing information for complete boxed warning.

Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia.
Prior to initiating Ospomyv in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Ospomyv in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.

CONTRAINDICATIONS

Hypocalcemia
Pregnancy
Known hypersensitivity to denosumab products
WARNINGS AND PRECAUTIONS

Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Ospomyv. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium.
Same Active Ingredient: Patients receiving Ospomyv should not receive other denosumab products concomitantly.
Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs.
Osteonecrosis of the jaw: Has been reported with denosumab products. Monitor for symptoms.
Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture.
Multiple vertebral fractures have been reported following treatment discontinuation. Patients should be transitioned to another antiresorptive agent if Ospomyv is discontinued.
Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
Dermatologic reactions: Dermatitis, rashes, and eczema have been reported. Consider discontinuing Ospomyv if severe symptoms develop.
Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop.
Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression.
These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV HERE, which includes the Boxed Warning, Medication Guide and Instructions for Use.

XBRYK (denosumab-dssb) injection, for subcutaneous use

Xbryk is a RANK ligand (RANKL) inhibitor indicated for:

Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

Hypocalcemia
Known clinically significant hypersensitivity to denosumab products
WARNINGS AND PRECAUTIONS

Same Active Ingredient: Patients receiving Xbryk should not receive other denosumab products concomitantly.
Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs.
Hypocalcemia: Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating Xbryk. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D.
Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting Xbryk. Monitor for symptoms. Avoid invasive dental procedures during treatment with Xbryk.
Atypical femoral fracture: Evaluate patients with thigh or groin pain to rule out a femoral fracture.
Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons: Monitor patients for signs and symptoms of hypercalcemia, and manage as clinically appropriate.
Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation: When Xbryk treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.
These highlights do not include all the information needed to use XBRYK safely and effectively. See full prescribing information for XBRYK HERE, which includes the Boxed Warning, Medication Guide and Instructions for Use.