On February 17, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved the registrational Phase III clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with BTK inhibitor orelabrutinib as a first-line therapy for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients in China (Press release, InnoCare Pharma, FEB 17, 2025, View Source [SID1234650321]).

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ICP-248 (Mesutoclax) is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. ICP-248 exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. The fixed-duration treatment of ICP-248 in combination with orelabrutinib will provide deeper remission for treatment-naïve CLL/SLL patients without drug-resistant mutations, bringing hope of clinical cure to treatment-naïve CLL/SLL patients and becoming a treatment option with great potential.

ICP-248, in combination with orelabrutinib, has demonstrated promising efficacy and a favorable safety profile in Phase II trial in treatment-naïve CLL/SLL patients. Market approval of the combination therapy will provide better treatment options for treatment-naïve CLL/SLL patients.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "ICP-248 is an important global asset in our hemato-oncology portfolio. We are rapidly advancing multiple clinical trials of ICP-248 globally, including the treatment of non-Hodgkin’s lymphoma, and acute myeloid leukemia (AML). Our hemato-oncology pipeline is designed for strong synergy, especially with the combination of BTK and BCL2 inhibitors, which has the potential to deliver improved outcomes for patients."

CLL/SLL, one of the most prevalent forms of leukemia, is an indolent malignancy of B lymphocytes. Globally, there are 191,000 newly diagnosed CLL cases each year, with 61,000 related deaths1. The incidence rate of CLL/SLL is on the rise in China2.

Orelabrutinib has been approved for marketing in China and Singapore, and all three approved indications have been included in the National Reimbursement Drug List (NRDL) in China, including relapsed/refractory (r/r) CLL/SLL, r/r mantle cell lymphoma (MCL) and r/r marginal zone lymphoma (MZL).

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.