On May 8, 2025 Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, reported that an abstract on abenacianine for injection (VGT-309) will be featured at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30-June 3 in Chicago (Press release, Vergent Bioscience, MAY 8, 2025, View Source [SID1234652789]). The poster will highlight data from the Phase 2B, multicenter VISUALIZE study (NCT06145048) evaluating the safety and efficacy of abenacianine in patients undergoing surgery for proven or suspected cancer in the lung. Abenacianine is an investigational tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization with minimally invasive and robotic-assisted surgical procedures.

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Following are details about the poster presentation at ASCO (Free ASCO Whitepaper) 2025:

Title:

"Phase 2 Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Abenacianine for Injection (VGT-309), a Tumor-Targeted, Intraoperative Molecular Imaging Agent, for Patients Undergoing Surgery for Cancer in the Lung"

Authors:

Luis J Herrera; Gavin M Wright, MBBS, FRACS, Ph.D.; Jae Y Kim, M.D.; Janani S Reisenauer, M.D.; David C Rice, M.D.; Sunil Singhal, M.D.

Presenter:

Sunil Singhal, M.D., director of the Center for Precision Surgery at the Abramson Cancer Center, vice chair of translational research in the Department of Surgery, chief of thoracic surgery and William Maul Measey Professor in Surgical Research at University of Pennsylvania Perelman School of Medicine

Abstract ID:

3069

Poster Board #:

384

Date and Time:

June 2, 2025, at 1:30-4:30 p.m. CT

About the VISUALIZE Clinical Trial
The Phase 2B, multicenter, open-label VISUALIZE study (NCT06145048) was designed to evaluate the efficacy and safety of abenacianine for injection in patients undergoing surgery for proven or suspected cancer in the lung. Each of the 89 patients in the study received 0.32mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor using standard surgical techniques, investigators used a commercially available near-infrared (NIR) endoscope to assess the presence of tumor tissue, which was then confirmed by pathology. The primary efficacy endpoint included localization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively.

About Abenacianine for Injection (VGT-309)
Abenacianine for injection is a tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization with open, minimally invasive and robotic-assisted surgical procedures. Abenacianine for injection is delivered to patients via a short intravenous infusion several hours to several days before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are overexpressed across a broad range of solid tumors. This approach, if successful, would provide distinct clinical advantages and position abenacianine for injection as an ideal tumor imaging agent. Abenacianine for injection’s imaging component is the near-infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is a preferred dye to minimize confounding background autofluorescence.

On May 8, 2025 OmRx Oncology, or "OmRx," a clinical-stage biopharmaceutical venture dedicated to expanding access to cancer immunotherapy worldwide, reported the initiation of a Phase 2 clinical trial of its investigational oral PD-L1 inhibitor, OX-4224, in patients with non-small cell lung cancer (NSCLC) (Press release, OmRx Oncology, MAY 8, 2025, View Source [SID1234652788]).

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OX-4224 is an investigational oral small molecule that targets the PD-1/PD-L1 immune checkpoint pathway and offers a potentially more accessible and cost-effective option compared to existing antibody-based therapies.

The open-label, randomized, Phase 2 study will enroll approximately 50 patients with metastatic NSCLC whose tumors express PD-L1 and who have not previously received immune checkpoint inhibitors, with a focus on India. The trial will assess OX-4224 as a second line monotherapy, evaluating overall response rate in addition to safety and other secondary efficacy endpoints.

"Launching this clinical trial is a key step toward fulfilling OmRx’s mission of addressing global health disparities in cancer treatment," said Isy Goldwasser, CEO, OmRx. "Checkpoint inhibitor antibodies have revolutionized cancer care in high-income countries, but remain largely inaccessible to many patients globally. With OX-4224, we have the opportunity to bring the benefits of immunotherapy to many more people."

OmRx is developing OX-4224 initially for low and middle-income countries (LMICs), where biologics are often inaccessible due to high cost and distribution challenges. OX-4224’s oral formulation removes the need for infusion centers, allows flexible dosing schedules, and offers a more scalable manufacturing model.

"This trial brings us closer to realizing a long-held vision—to offer effective, affordable, and easier-to-administer immunotherapies to the patients who need them most," said Dr. William Lee, Chairman of OmRx and former EVP of Research at Gilead Sciences. "If OX-4224 demonstrates safety and efficacy in the upcoming NSCLC study, it would provide development opportunity to meaningfully change the standard of care for patients in resource-limited settings."

In-licensed from Gilead Sciences, OX-4224 is initially being advanced to improve access to immunotherapy in low-resource settings. Positive results from this trial could also pave the way for broader global development, including in high-income countries, where OmRx aims to explore innovative, all-oral immuno-oncology combination regimens.

OX-4224 is an investigational product and statements regarding its potential benefits are forward-looking and subject to risks and uncertainties.

On May 8, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that it will present multiple datasets in breast cancer together with its collaborators at the 2025 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in Munich, Germany, taking place from May 14-17, 2025 (Press release, Natera, MAY 8, 2025, View Source [SID1234652787]).

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Results from the I-SPY 2 clinical trial, sponsored and operated by Quantum Leap Healthcare Collaborative, will be shared in a mini-oral presentation on May 16, 2025. The report includes data from 712 patients with early-stage, high-risk breast cancer, and it evaluates the association of distant recurrence free survival (DRFS) with ctDNA concentration at diagnosis, before receiving neoadjuvant systemic therapy and curative-intent surgery. Key highlights include:

Signatera positive patients at diagnosis had 3x higher risk of recurrence than Signatera negative patients (HR 3.1, p< 0.001%), though the risk can be significantly reduced based on response to subsequent therapy.
Patients who were Signatera negative at diagnosis had extremely good outcomes.
Among patients who were Signatera positive at diagnosis, higher ctDNA quantities at the time of diagnosis were significantly correlated with a higher risk of recurrence. However, effective treatment can affect ctDNA levels as well as pathologic response status, both of which further refine risk of recurrence. This is the first time that pre-treatment absolute ctDNA quantity has been shown to correlate with clinical outcomes in breast cancer.
Among all clinicopathologic risk factors available at diagnosis, a multivariate analysis identified Signatera status as the most significant factor in predicting DRFS, regardless of disease subtype (p<0.001). DRFS prediction can be further refined by integrating additional variables before, during, and after treatment, including ctDNA dynamics.
"The I-SPY 2 trial is uncovering insights that may allow us to tailor treatment plans for breast cancer patients based on their individual genomic profiles and better identify patients who may be more likely to experience adverse outcomes," said Laura Esserman, M.D., MBA, and Laura van ‘t Veer, Ph.D., professors at the University of California, San Francisco, and principal investigators of the I-SPY 2 study. "Our hope is that these findings will encourage future interventional trials in breast cancer, specifically in the neoadjuvant setting."

"Signatera was able to predict excellent clinical outcomes in a high risk population at the time of diagnosis," said Angel Rodriguez, M.D., medical director, oncology at Natera. "This may give rise to new protocols, evaluating whether some patients can avoid chemotherapy or other intensive treatments, if they test Signatera-negative at diagnosis."

Natera will present an additional three abstracts at the ESMO (Free ESMO Whitepaper) Breast conference, highlighting real-world evidence and genomic landscaping from its multi-modal database of de-identified clinical and genomic data in over 200,000 early- and late-stage cancer patients.

Full list of Natera’s ESMO (Free ESMO Whitepaper) Breast presentations:

May 16, 9:40 AM CT | FPN 5MO
Presenter: Mark Magbanua, Ph.D., UCSF Helen Diller Family Comprehensive Cancer Center
Pretreatment Circulating Tumor (ct)DNA Predicts Metastatic Recurrence in Patients (pts) With High-Risk Early Breast Cancer (eBC) Enrolled in the I-SPY 2 Trial

May 15, 12:00 PM CT | FPN 115P
Presenter: Chu-Ling Yu, Merck
Real-World Testing Patterns of Circulating Tumor DNA (ctDNA) in Early-Stage Triple-Negative Breast Cancer (TNBC): a U.S. Nationwide Database Study

May 15, 12:00 PM CT | FPN 12P
Presenter: Melinda Telli, M.D., Stanford University School of Medicine
Real-world experience of longitudinal circulating tumor (ct)DNA monitoring in patients (pts) with early-stage triple-negative breast cancer (TNBC)

May 15, 12:00 PM CT | FPN 412TiP
Presenter: Thibault De La Motte Rouge, M.D., Ph.D., Comprehensive Cancer Centre Eugène Marquis (Rennes, France)
HEROES: De-escalation of medical therapies in HER2-positive metastatic breast cancer in long-term persistent response and minimal residual disease undetectable in circulating tumor DNA

May 15, 12:00 PM CT | FPN 37P
Presenter: Marla Lipsyc-Sharf, M.D., UCLA Health
Genetic Ancestry and Tumor Mutations Influence Circulating Tumor DNA (ctDNA) Detection Rates in Breast Cancer: A Large Real-World Study

May 15, 12:00 PM CT | FPN 93P
Presenter: Yara Abdou, M.D., UNC School of Medicine
Assessment of antibody-drug conjugate utilization in patients with breast cancer undergoing circulating tumor DNA testing

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On May 8, 2025 Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies (Optieum), a preclinical stage company dedicated to the discovery and development of innovative Chimeric Antigen Receptor (CAR) T cell therapies, reported a partnership for cGMP manufacturing of OPTF01, Optieum’s novel CAR-T therapy for glioblastoma treatment, a product derived from their proprietary Eumbody System (Press release, Optieum Biotechnologies, MAY 8, 2025, View Source [SID1234652786]).

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OPTF01 specifically targets Fibroblast activation protein-alpha (FAPα) a protein expressed on both tumor cells and the surrounding pericytes and Cancer-associated Fibroblasts (CAFs). Hence, OPTF01 can potentially disrupt the immunosuppressive microenvironment around the tumor while simultaneously attacking the malignant cells within the tumor. Successful development of this therapeutic approach would address a critical unmet medical need for patients with refractory glioblastoma who currently face limited treatment options with poor prognoses, as well as various other solid tumor indications.

Under this collaboration, Cellipont Bioservices will provide the technology transfer, process development, and cGMP manufacturing of Optieum’s novel OPTF01 CAR-T product. "Glioblastoma remains one of the most aggressive and difficult-to-treat cancers, demanding urgent innovation beyond traditional approaches," said Darren Head, CEO of Cellipont Bioservices. "Our collaboration with Optieum presents an exciting opportunity to leverage advanced CAR-T technologies and bring meaningful solutions to patients in need. We are honored to be part of this critical mission."

Shun Nishioka, CEO of Optieum added, "At Optieum, we are committed to redefining the future of CAR-T therapy through relentless innovation and scientific rigor. Partnering with Cellipont’s team of experts ensures that our groundbreaking therapies are manufactured to the highest standards, accelerating our progress toward delivering next-generation therapies for glioblastoma and other solid tumors."

OPTF01 is derived from the Eumbody System, a proprietary platform representing a significant advancement in CAR-T cell therapy development. This platform leverages rapid and expansive functional screening to identify and optimize CAR constructs in unprecedented fashion. By dynamically harmonizing single-chain variable fragment (scFv) sequences to enhance the functional capabilities of T cells, the Eumbody System sets a new standard in CAR-T innovation.

On May 9, 2025 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 125.3 million in the first quarter of 2025 (Q1 2024: NOK 116.8 million), and an EBITDA of NOK 1.8 million (7.9) for the company (Press release, PhotoCure, MAY 8, 2025, View Source [SID1234652785]). Photocure expects product revenue growth in the range of 7% to 11% and YoY EBITDA improvement in 2025. While the Company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestone payments this year.

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"We delivered another quarter of growth and positive EBITDA, driven by the strong performance from our European franchise. In parallel, our North American team continues the solid business development with an increasing number of accounts adopting upgrades and new tower placements expecting to drive future revenue growth. We are able to offset the expected decline in flexible cystoscopy kits and expect the U.S. unit growth to accelerate in 2025 onwards. The completion of our share buy-back programme also highlighted our capital discipline commitment as the company continues to grow," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 125.3 million in the first quarter of 2025 (NOK 118.0 million), and an EBITDA of NOK 1.8 million (7.9). The cash balance at the end of the period was NOK 259.5 million.

The company continued to execute on its plan to expand blue light cystoscopy use in Q1 2025 with the installation of 21 new Saphira towers in the U.S. — 8 new accounts and 13 blue light tower upgrades. There are now 337 active accounts in the U.S., an increase of 17% versus the first quarter of 2024.

In Europe, Photocure announced during the quarter that the availability of an Interim Flexible BLC solution to centers in all countries where System blue and Richard Wolf reusable flexible cystoscopes are cleared. The co-development with Richard Wolf for state of the art, HD Flexible cystoscope is progressing on plan. Photocure is also collaborating closely with Olympus on their recently launched high-definition Olympus Visera Elite-III equipment featuring blue light cystoscopy.

"30 Olympus systems have already been upgraded since launch, and we fully expect this new state-of-the art equipment to fuel Hexvix growth in the Nordic region and throughout continental Europe this year and beyond," Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care.

"Following an adequate stock of units already landed in the U.S, we have enough inventory to carry us through most of the year. Given our low cost of goods sold, tariffs represent a very limited impact on our U.S. profit and loss statement. Meanwhile, we remain focused on the growth of our business and investing in opportunities that can take us to the next level in 2025. In all, we delivered another quarter of growth and solid business development and reiterate our guidance of a product revenue growth in the range of 7% to 11% and year of year EBITDA improvement in 2025," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2025 financial report on page 25.

The quarterly report and presentation will be published at 07:00 CEST and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20250508_10/

The presentation is scheduled to conclude at 14:45 CEST.