On March 25, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company has received a clinical trial notice approving the investigational new drug application for a radionuclide-drug conjugate (RDC) drug SKB107 (formerly TBM-001) from the Center for Drug Evaluation of the National Medical Products Administration (Press release, Kelun, MAR 25, 2025, View Source [SID1234651429]). SKB107 is the first company RDC drug clinical project.

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SKB107 is jointly developed by the Company and Professor Chen Yue’s team of the Affiliated Hospital of Southwest Medical University (the "Affiliated Hospital of SMU"). It utilizes a small molecule as the targeting ligand, combined with a suitable conjugation technology, chelator, and therapeutic radionuclide, and is intended to be used for treatment of bone metastases in solid tumors. Compared with traditional external radiation therapy, the RDC drug SKB107 can benefit patients with systemic multiple bone metastases and is highly targeted, which can reduce the damage to normal tissues, and is expected to show good safety; and compared with traditional bone-modifying drugs, it can effectively kill tumor cells with bone metastases, and is expected to have potential for the treatment of bone metastases efficacy. The Company entered into an exclusive license agreement with the Affiliated Hospital of SMU for a RDC drug SKB107 on Sept. 14, 2023.

About Bone Metastasis of Malignant Tumors

Bone is the most common site of metastasis in advanced malignant tumors, and about 70%~80% of patients with advanced malignant tumors will eventually develop bone metastasis. Among common tumors, prostate cancer, breast cancer, thyroid cancer, lung cancer and kidney cancer have a higher incidence of bone metastasis, accounting for more than 80% of all bone metastatic tumors[1]. Bone metastasis can lead to serious complications such as severe bone pain and bone-related events, such as pathologic fracture and spinal cord compression, which can seriously reduce patients’ quality of life and increase the risk of death. Currently, treatments for bone metastases of malignant tumors mainly include comprehensive treatments such as analgesic therapy, radiation therapy, bone-modifying drug therapy, and surgery. However, these treatments are still limited in improving patients’ quality of life, delaying or avoiding the occurrence of SREs, and prolonging patients’ survival, and the development of new mechanisms of action and safer and more effective drugs is imminent.

On March 25, 2025 NHS Lothian, Scotland’s second largest health authority providing a comprehensive range of primary, community-based and acute hospital services, and Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported data from an abstract featuring Nucleix’s Bladder EpiCheck test presented at the 46th Annual European Association of Urology (EAU) Congress (Press release, Nucleix, MAR 25, 2025, View Source [SID1234651445]).

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The abstract titled "Bladder EpiCheck triggered Photodynamic Diagnosis biopsies detect High Grade recurrences missed by White Light Cystoscopy"i describes the implications of implementing the Bladder EpiCheck urine test as an adjunct to routine surveillance by white light cystoscopy in all high-risk non-muscle invasive bladder cancer (NMIBC) patients. In 316 patients undergoing surveillance from July 2023 until August 2024, 38 cancers were detected, of which 29 were high-grade and 13 were carcinoma in situ (CIS), an aggressive form of bladder cancer often missed by white light cystoscopy, that can progress to muscle-invasive cancer if left untreated. White light cystoscopy detected 17 (59%) of the high-grade cases and 4 (31%) of the CIS cases versus 28 (97%) and 12 (92%), respectively, detected by Bladder EpiCheck and confirmed by photodynamic diagnosis (PDD) biopsies. Specificity was 97% (261/270) for cystoscopy and 94% (253/270) for Bladder EpiCheck. Additionally, Bladder EpiCheck was able to detect 65% more high-grade disease recurrences compared to white light cystoscopy (28 vs. 17), by performing biopsy under PDD in patients with a negative white light cystoscopy and a positive Bladder EpiCheck result. Nine of the 16 (56%) patients that were missed by white light cystoscopy but detected with Bladder EpiCheck and PDD had CIS.

The abstract was presented by Professor Param Mariappan, Consultant Urological Surgeon at Western General Hospital, Edinburgh (NHS Lothian) and member of the European Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) Guidelines Committees. Professor Mariappan established the Edinburgh Bladder Cancer Surgery (EBCS) Effectiveness and Efficiency Programme (EBCS-EEP) in 2006 to improve the care of patients with bladder cancer by implementing evidence-based interventions in a systematic manner while using real-world data to inform outcomes and process. Adding Bladder EpiCheck to routine high-risk NMIBC surveillance is part of this ongoing project to improve early detection of high-grade disease recurrences.

"The ability of Bladder EpiCheck, a non-invasive urine test, to precisely identify the patients whose cancer is missed by cystoscopy, and refer them for additional workup, makes it a very effective tool for the NHS," said Professor Mariappan. "This allows us to detect and treat aggressive disease early, while containing budget and resources that are limited. Early detection allows us to treat such patients conservatively and potentially to improve patient outcome and avoid significant costs of late treatment, such as cystectomies."

"These data add an important new layer to the robust and constantly growing body of real-world evidence of Bladder EpiCheck performance and clinical utility in NMIBC monitoring," said Dr. Aharona Shuali, Vice President of Medical at Nucleix. "We are proud that leading centers, such as NHS Lothian, are choosing this test to enhance patient care."

These results are consistent with a recently published paper by Fleshner et al. in the journal Bladder Cancerii, that described a strong anticipatory positive signal for Bladder EpiCheck in NMIBC surveillance patients with a negative cystoscopy and cytology, showing a five times higher risk of recurrence in 12 months in patients who had a positive Bladder EpiCheck result versus a negative result.

On March 25, 2025 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing immunogenic small molecule approaches in oncology, reported the company will present immuno-profiling data from two Phase 2 studies of PT-112 monotherapy at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which will be held from April 25 – 30, 2025 at the McCormick Place Convention Center in Chicago, IL (Press release, Promontory Therapeutics, MAR 25, 2025, View Source [SID1234651471]).

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The poster will present immune activation effects observed with PT-112 monotherapy in patients with pretreated thymic epithelial tumors and late-line metastatic castration-resistant prostate cancer, including increases in activated T cells and NK cells, modulation of blood cytokines, and the emergence of novel T cell clones.

Poster Session Details

Title: Anti-Cancer Immune Effects of PT-112 Monotherapy Across Two Disease Indications
Location: Poster Section 28, McCormick Place Convention Center, Chicago, Illinois
Poster Board Number: C128
Published Abstract Number: 5819
Session: Immune Response to Therapies
Session date + time: 4/29/2025 2-5PM CDT

On March 26, 2025 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, reported that two of its abstracts have been accepted for presentation at the upcoming 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25–30 in Chicago, Illinois (Press release, Rakovina Therapeutics, MAR 25, 2025, View Source [SID1234651414]).

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The AACR (Free AACR Whitepaper) Annual Meeting is widely considered the most prestigious global forum for cancer research. It is where the world’s leading scientists, clinicians, and biotech innovators gather to unveil next-generation oncology breakthroughs. Rakovina’s acceptance to present, highlights growing recognition for its pioneering work at the intersection of AI technology and precision cancer therapy.

AI-Designed Therapies Poised to Transform Cancer Treatment

Rakovina will present two abstracts at the meeting, the first: Discovery of novel PARP1-selective inhibitors for treatment of brain tumors using artificial intelligence, explores the use of artificial intelligence (AI) to develop a novel, brain-penetrant, PARP1-selective inhibitor for treating brain tumors. Current PARP inhibitors face challenges such as poor blood-brain barrier (BBB) permeability and off-target effects due to PARP2 inhibition. By leveraging Deep Docking, a deep learning-based virtual screening method, alongside generative AI algorithms, researchers rapidly identified potential compounds with strong PARP1 selectivity and BBB penetration. The study presents findings from in silico screening of billions of compounds, followed by in vitro and in vivo validation of their efficacy, selectivity, and pharmacokinetic properties. This AI-driven approach enhances the efficiency of drug discovery, offering a promising new treatment option for brain tumors.

The second abstract: Utilizing artificial intelligence for the discovery of a novel CNS-penetrating ATR inhibitor, highlights the use of artificial intelligence (AI) to develop a novel CNS-penetrating ATR inhibitor for treating brain tumors. ATR plays a key role in DNA damage repair, and while ATR inhibitors show therapeutic potential, current options have poor blood-brain barrier (BBB) permeability, limiting their effectiveness against brain tumors and metastases. The Enki platform, an AI-driven approach utilizing generative models and deep learning, was employed to design de novo molecules with optimized potency, selectivity, and BBB penetration. Preliminary results include AI-generated ATR inhibitors validated for target specificity, metabolic stability, and permeability.

"This is an exceptional accomplishment for Rakovina," said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "Being selected by AACR (Free AACR Whitepaper) for two projects highlights the significance of our innovations in drug discovery and their potential to impact patients battling aggressive, treatment-resistant cancers."

The company’s proprietary integration of Deep Docking and Enki AI platforms allows its scientists to evaluate billions of potential compounds at 100x the speed of traditional methods, with 6,000x greater enrichment of viable candidates. These innovations are further supported by Rakovina’s access to the University of British Columbia’s state-of-the-art wet lab infrastructure, enabling rapid in-house testing and optimization.

"What we’re seeing with Rakovina’s AI-enabled pipeline is the future of oncology—faster, smarter, and more precise," said Dr. Mads Daugaard, President and CSO of Rakovina "This integration of generative AI and biological insight is transforming how—and how quickly—we can identify and advance new therapies."

With a world-class team, including the creator of Deep Docking and a former AstraZeneca DDR program director, Rakovina is driving innovation in a space projected to reach $18 billion annually by 2030. The company’s preclinical pipeline is focused on therapies that target DNA-repair vulnerabilities present in up to 75% of solid tumors, with an emphasis on hard-to-treat cancers such as breast, ovarian, prostate, and brain.

On March 25, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported it will present new data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, (April 25-30, 2025) in Chicago, IL (Press release, Adcentrx Therapeutics, MAR 25, 2025, View Source [SID1234651430]).

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The company will deliver an oral presentation on ADRX-0405, its clinical-stage STEAP1 ADC, and a poster presentation on ADRX-0134, its preclinical NaPi2b ADC. The presentations will underscore the versatility of Adcentrx’s ADC platform, showing advancements in therapeutic window expansion, bystander effect optimization, and payload delivery improvements for targeted cancer therapy. These innovations are powered by Adcentrx’s proprietary i-Conjugation technology, which integrates stable conjugation chemistry and a cleavable linker to optimize ADC properties, ensuring optimal payload delivery and therapeutic efficacy.

ADRX-0405, Adcentrx’s second clinical program and potential first-in-class STEAP1 ADC, has the opportunity to expand treatment options for metastatic castration-resistant prostate cancer (mCRPC) and other STEAP1-expressing tumors, where targeted therapy options remain limited. Featuring a novel topoisomerase inhibitor linker-payload, ADRX-0405 represents a distinct therapeutic approach for this disease with a high unmet need for more tolerable and effective therapies.

ADRX-0134 is a preclinical NaPi2b ADC incorporating AP052, the same clinically validated microtubule inhibitor payload used in Adcentrx’s lead program, ADRX-0706 (Nectin-4 ADC), currently enrolling patients in Phase 1b (NCT06036121). ADRX-0134 offers a differentiated approach for patients with lung and ovarian cancers, where few viable treatment options are available.

Details of the oral and poster presentations are as follows:

Oral Presentation
Title: Preclinical characterization of a novel STEAP1 antibody-drug conjugate ADRX-0405 for the treatment of mCRPC
Abstract Number: 1159
Session Date & Time: Sunday, April 27, 3:25 p.m. – 3:40 p.m. CST
Session Title: Antibody-Based Cancer Therapeutic Agents

Poster Presentation
Title: ADRX-0134 as a novel auristatin-based NaPi2b antibody-drug conjugate with widened therapeutic window
Abstract Number: 1563
Session Date & Time: Monday, April 28, 9:00 a.m. – 12:00 p.m. CST
Session Title: Antibody-Based Cancer Therapeutics 1

About i-Conjugation Technology
Adcentrx’s proprietary i-Conjugation technology platform is an important component in the design of the company’s ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload.

About ADRX-0405
ADRX-0405 is a clinical-stage next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers with limited expression in normal healthy tissue. The ADC is composed of a humanized IgG1 antibody and novel topoisomerase inhibitor linker-payload conjugated at a drug-to-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.

About ADRX-0134
ADRX-0134 is a state-of-the-art preclinical ADC targeting NaPi2b, a cell surface sodium-dependent phosphate transporter expressed in lung and ovarian cancers with minimal expression in normal healthy tissues. The ADC is a human IgG1 antibody conjugated at DAR8 with Adcentrx’s clinically validated AP052 tubulin inhibitor payload, substantially expanding the therapeutic window of auristatin-based ADCs beyond existing vedotin technology. ADRX-0134 preclinical studies have demonstrated strong efficacy in lung and ovarian tumor models, and the ADC’s pharmacokinetics and safety profile are also favorable.