On February 10, 2025 AdvanCell, a clinical-stage radiopharmaceutical company specializing in targeted alpha therapies, reported an expansion to the scope and breadth of its strategic collaboration with Eli Lilly and Company to research and develop innovative treatments for various cancers (Press release, Advancell, FEB 10, 2025, View Source [SID1234650151]).

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Under this new agreement, the parties will leverage AdvanCell’s proprietary Pb-212 production technology and radionuclide development infrastructure and Lilly’s drug candidate programs and extensive expertise in drug development to facilitate the development and accelerate the clinical advancement of an expanded portfolio of targeted alpha therapies.

AdvanCell’s competitive advantage in technology development and the infrastructure it has built to accelerate early-stage clinical trials in Australia enables AdvanCell to rapidly develop and progress novel Pb-212-containing radiotherapeutics from discovery into clinical trials.

"This collaboration with Lilly represents a significant milestone for AdvanCell, recognizing our company as one of the leaders in the Pb-212 targeted alpha therapy space," said Andrew Adamovich, CEO of AdvanCell. "By combining our groundbreaking isotope production capabilities, our team’s expertise and infrastructure with Lilly’s pharmaceutical and oncology expertise and global scale, we aim to bring transformative treatments to patients with hard-to-treat cancers. It is especially pleasing to continue and expand our existing relationship."

Jacob Van Naarden, President of Lilly Oncology, added, "Partnering with AdvanCell aligns with our commitment to advancing innovative radiopharmaceuticals. We are excited to explore the potential of Pb-212-based alpha therapies as we work to bring meaningful new treatments for patients."

Financial terms of the agreement were not disclosed.

On February 10, 2025 Rondo Therapeutics, a privately held biopharmaceutical immuno-oncology company pioneering the development of next-generation T cell-engaging bispecific antibodies for the treatment of solid tumors, reported that data from preclinical studies of RNDO-564, a novel CD28 x Nectin-4 costimulatory bispecific antibody for advanced bladder cancer, is being presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, taking place February 13-15, 2025, in San Francisco, CA (Press release, Rondo Therapeutics, FEB 10, 2025, View Source [SID1234650150]).

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"CD28 co-stimulatory bispecific antibodies are designed to boost T cell-mediated tumor killing and overcome T cell exhaustion in the solid tumor microenvironment. In preclinical studies, RNDO-564 demonstrated robust anti-tumor activity in vivo and in vitro, including in an antibody drug conjugate (ADC)-resistant bladder cancer model, suggesting the ability of RNDO-564 to overcome T cell exhaustion and address limitations of ADCs, including toxicity, resistance, and sequential ADC re-challenge," said Thomas Manley, CMO of Rondo Therapeutics. "Based on these promising preclinical findings, we are advancing RNDO-564 through IND-enabling studies, with the goal of entering the clinic in advanced bladder cancer by year-end."

Key Findings

RNDO-564 is designed to elicit robust Nectin-4 and signal-1 dependent T-cell mediated killing of Nectin-4-expressing tumor cells
RNDO-564 restored tumor cell killing function of serially stimulated T cells in vitro
RNDO-564 inhibited tumors in vivo as monotherapy and in combination with checkpoint therapy in vivo
Preliminary toxicology studies support clinical evaluation of RNDO-564
RNDO-564 maintained cytotoxicity against antibody drug conjugate-resistant bladder cancer cells
Poster Session Details

Title:

A novel CD28 x Nectin-4 costimulatory bispecific antibody for advanced bladder cancer

Poster No.:

810

Session:

Poster Session B: Urothelial Carcinoma

Date/Time:

Friday, February 14, 2025 = 11:30am-12:45pm PST

Rondo Therapeutics’ proprietary platform features CD28-targeting binders with a wide range of co-stimulatory potencies designed to boost T cell-mediated tumor killing and overcome T cell exhaustion in the solid tumor microenvironment. Rondo’s platform delivers bispecific antibody therapeutics tailored to specific tumor targets, indications, and treatment regimens, offering a transformative alternative to traditional "one size fits all" strategies, unlocking the potential for durable responses in patients with solid tumors.

On February 10, 2025 Flatiron Health reported its planned presence at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), including three accepted abstracts for poster presentation (Press release, Flatiron Health, FEB 10, 2025, View Source [SID1234650149]).

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"At this year’s ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, Flatiron scientists and our collaborators are using high-quality real-world data and novel AI approaches, to advance critical understanding on how real-world patients with genitourinary cancers are being treated and the effectiveness of those strategies," said Stephanie Reisinger, Senior Vice President & General Manager, Real-World Evidence. "By applying innovative AI and our unique expertise to our worldwide network of oncology EHR real-world data, Flatiron is answering questions on treatment patterns, efficacy, and safety with an unprecedented scale, filling evidence gaps in a rapidly evolving treatment landscape."

Highlights include:

a poster presentation on machine learning’s ability to investigate the real-world treatment-emergent adverse events that over 5,200 patients experience during 1L treatments for locally advanced or metastatic urothelial carcinoma
a poster presentation identifying common real-world treatment patterns for patients diagnosed with metastatic castration-resistant prostate cancer in the community setting
a poster presentation conducting the largest real-world analysis of sacituzumab govitecan to date, building on previously reported results of efficacy and safety in treating locally advanced/metastatic urothelial cancer
To learn more about how our real-world evidence solutions support genitourinary research, register today for "Genitourinary cancer insights: Leveraging RWE to learn from the experience of every patient," a webinar to discuss research presented at ASCO (Free ASCO Whitepaper) GU, how scaled RWD can unlock biomarker-defined cohorts, and ways longitudinal patient data can provide insight into real-world treatment patterns and patient journeys.

Follow Flatiron Health on Twitter and LinkedIn for more updates on ASCO (Free ASCO Whitepaper)’s #GU25.

Poster Discussions and Presentations
Real-world safety of first-line therapies for locally advanced or metastatic urothelial cancer in the US
Amanda Nizam, Mairead Kearney, Seyed Hamidreza Mahmoudpour, Valerie Morris, Carroline Lobo, Jason Hoffman, Ilian IIiev
Poster Session B: Urothelial Carcinoma Track
Abstract #759
Poster Bd #E21

Real-world treatment patterns in patients diagnosed with metastatic castration-resistant prostate cancer in the US, 2018-2023
Eleni Efstathiou, Weiyan Li, Nina Yeh, Stephen Corson, Kumar Mukherjee. Chinelo Orji
Poster Session A: Prostate Cancer Track
Abstract #74
Poster Bd #B20

Retrospective, observational analysis of real-world safety outcomes in sacituzumab govitecan-treated patients with locally advanced/metastatic urothelial cancer
Mamta Parikh, Peter McMahon, Susan Eng, Freda Boateng, Youssef Ghazi, Kerstin Schmidt, Michelle Brockman, Mitch Sierecki
Poster Session B: Urothelial Carcinoma Track
Abstract #709
Poster Bd #D6

On February 10, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported that data from the ARC-20 study will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium taking place February 13 – 15, 2025, in San Francisco, CA (Press release, Arcus Biosciences, FEB 10, 2025, View Source [SID1234650148]).

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The oral presentation will highlight safety and efficacy data from three cohorts of ARC-20, which evaluated casdatifan monotherapy in patients that had received both prior TKI and anti-PD-1 therapy. The presentation will include initial data for the 100mg QD tablet cohort, our selected dose and formulation for Arcus’s Phase 3 studies, as well as updated data for the 50mg BID and 50mg QD expansion cohorts of ARC-20.

"We look forward to presenting new data from our ARC-20 study evaluating our HIF-2a inhibitor, casdatifan, in an oral presentation at ASCO (Free ASCO Whitepaper) GU," said Terry Rosen, Ph.D., chief executive officer of Arcus. "The data to be shared support the differentiation of casdatifan, across all key efficacy measures, relative to published data from studies with HIF-2a inhibitors. We are continuing to rapidly advance an extensive and robust development program for casdatifan, including the planned initiation of our first Phase 3 study (PEAK-1) in the first half of this year, a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig and the addition of new cohorts to ARC-20 to evaluate casdatifan in the first-line setting. We also look forward to presenting additional data from ARC-20 throughout the year."

Study

Title

Abstract
Number

Session Type &
Title

Session Date
& Time

Casdatifan (HIF-2a Inhibitor)

ARC-20

Casdatifan (Cas) Monotherapy in Patients (pts) with Previously Treated Clear Cell Renal Cell Carcinoma (ccRCC): Safety, Efficacy and Subgroup Analysis Across Multiple Doses from ARC-20, a Phase 1 Open-Label Study

441

Rapid Oral Abstract Session C: Renal Cell Cancer and Penile Cancer

2/15/2025
12:45 PM –
12:50 PM PT

Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 331780 on Tuesday, February 18, 2025, at 5:00 AM PT / 8:00 AM ET. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2a, casdatifan is designed to shut down hypoxic oncogenesis, which blocks tumor growth and key oncogenic pathways, leading to cancer cell death. Clear cell RCC (ccRCC) is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma and other cancers.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 81,600 Americans will be diagnosed with kidney cancer in 2024. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 15%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.

On February 10, 2025 BioRay Pharmaceutical Co., Ltd. ("BioRay") reported that the National Medical Products Administration (NMPA) has accepted the clinical trial application for its self-developed Class 1 innovative therapeutic biological product, BR111 for injection (Press release, BioRay Pharmaceutical, FEB 10, 2025, View Source [SID1234650146]). BR111 is an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, intended for the treatment of ROR1-positive hematological malignancies and solid tumors.

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ROR1 is a transmembrane receptor tyrosine kinase protein that is either not expressed or expressed at low levels in normal tissues, but is highly expressed in various hematological malignancies and solid tumors, such as lymphoma, breast cancer, ovarian cancer, and lung cancer. ROR1 is involved in the non-canonical Wnt signaling pathway mediated by Wnt5a, regulating the growth and invasion of tumor cells. It is closely associated with tumorigenesis and drug resistance, making it a potential target for oncology drug development. To date, no ROR1-targeting drugs have been marketed.

BR111 utilizes BioRay’s next-generation CysX irreversible site-specific conjugation technology platform to conjugate an antibody targeting dual epitopes of ROR1 with the small-molecule toxin eribulin. It is the world’s first anti-ROR1 Bi-paratopic ADC to enter clinical trials. BR111 can recognize two non-overlapping epitopes of ROR1 on the surface of tumor cells, and dual-epitope recognition brings stronger affinity and endocytosis. Once endocytosed into ROR1-positive tumor cells, BR111 releases the small-molecule toxin in the lysosome, effectively killing tumor cells. Developed using the CysX platform, BR111 has higher homogeneity and circulating stability, significantly reducing toxin release in circulation, which enhances safety and optimizes the therapeutic window.

In preclinical studies, BR111 demonstrated superior in vivo anti-tumor efficacy compared to its clinical counterparts in multiple animal models and exhibited better safety. Additionally, BR111 can induce a bystander effect and activate immune response in the tumor microenvironment, showing potential for combination therapy with various drugs, including targeted therapies and immunotherapies.

The acceptance of this project application is a testament to BioRay’s R&D capabilities and a validation of the CysX platform technology. Moving forward, BioRay will continue to focus on clinical needs, drive innovative research, and advance biopharmaceutical technology, with the goal of delivering more effective and safer treatment options to patients through innovative drugs.