On February 18, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,810,000 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, FEB 18, 2025, View Source [SID1234650352]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.87 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 20, 2025, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be $2,715,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds received from the private placement to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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 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 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 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).