Ona Therapeutics Strengthens Leadership Team to Accelerate First-in-Class ADCs into Clinical Development Across Cancer Types

On February 19, 2025 Ona Therapeutics ("Ona"), a global biotech company pioneering first-in-class antibody-drug conjugates (ADCs), reported key leadership appointments to support its rapid growth and pipeline advancement (Press release, Ona Therapeutics, FEB 19, 2025, View Source [SID1234650399]). Dr. Aleix Prat, a global leader in drug and biomarker development, has been appointed Chair of the Advisory Board. Additionally, Dr. Jutta Amersdorffer has joined as Chief Medical Officer and Stéphane Durant des Aulnois as Chief Financial Officer. These appointments come at a pivotal time as Ona accelerates the development of its first-in-class ADC therapeutics, targeting novel tumor-specific markers to eliminate hard-to-treat, resistant cancer cells and advance its pipeline toward clinical development across multiple cancer types.

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Specialized in understanding the biology of hard-to-treat cancers and expertise in biotherapeutic discovery, Ona is developing a pipeline of ADCs tailored to exploit the molecular underpinnings of advanced cancer. Ona´s unique strategy is enabled by analyzing scarce real-world patient biopsies to uncover novel therapeutic targets that are fundamental to the particular biology of treatment-refractory advanced cancer. Its lead ADC, ONA-255, has broad potential to treat breast, gastric, and other solid tumors, and is advancing through IND-enabling studies to initiate clinical development by the end of 2025. In parallel, Ona is developing ONA-389, a second ADC that is positioned for the treatment of advanced microsatellite stable (MSS) colon and liver cancers. This promising therapeutic is set to begin IND-enabling studies in the second half of 2025.

Ona has appointed Dr. Aleix Prat, an internationally recognized leader in precision oncology with an outstanding track record in cancer research, biomarker development, and clinical trials, as Chair of the Advisory Board. In collaboration with Ona’s Advisor, Dr. Roger Gomis, he has been instrumental in identifying the target of ONA-255 and functionally validating it, working alongside the expert team at Ona. Their combined efforts have generated critical preclinical data to support the clinical development of ONA-255. This important data which has been exclusively licensed to Ona from FCRB-IDIBAPS, IRB Barcelona, UB and ICREA, bolsters the foundation for ONA-255’s progression. Dr. Prat serves as the Director of the Clínic Barcelona Comprehensive Cancer Center, Professor of Medicine at the University of Barcelona, and is Co-Founder and Chief Scientific Officer of REVEAL GENOMICS.

With over 300 peer-reviewed publications and leadership roles in oncology research, clinical trials, and precision medicine initiatives, Dr. Prat has been at the forefront of developing and translating novel therapies and diagnostic tools into clinical practice.

Dr. Jutta Amersdorffer joins as Chief Medical Officer and brings extensive experience in translational medicine, clinical and medical development, and pharmacovigilance for innovative biologics. She previously held multiple managerial and senior clinical roles at Sandoz, MorphoSys, and Otsuka Novel Products. She holds a medical license and a Doctor of Medicine from the University of Munich and holds an MBA from the University of Applied Science.

Stéphane Durant des Aulnois has been appointed Chief Financial Officer. With over two decades of experience in finance, business development, investor relations, and private equity, Stéphane brings a wealth of expertise. He spent nine years at Ipsen, first as Vice President and Head of Investor Relations before advancing to CFO of Ipsen Iberia. His career also includes the role of CFO and Head of Alliances & Business Development at Lysogene, a Phase 3 gene therapy company listed on Euronext, roles in private equity at LaSalle Investment Management and Calyon Americas, and as a sell-side research analyst at Exane BNP Paribas. Stéphane simultaneously serves as CFO at Corteria Pharmaceuticals.

He holds an MSc in Accounting and Finance from the London School of Economics (LSE), an MSc in Management from Paris Dauphine University, and an Executive Leadership degree from Harvard Business School.

Valerie Vanhooren, Ph.D., Co-Founder and Chief Executive Officer at Ona Therapeutics, said: "ADCs have transformed cancer treatment; however, the technology has been applied to a limited number of tumor targets. These limitations restrict the number of patients who can benefit from treatments and highlight the critical need to identify new broadly expressed tumor targets. Ona’s tailor-designed ADCs have the potential to define new treatment paradigms and patient populations. With the expansion of our executive team and advisory board, Ona is well-positioned to execute our strategic vision to develop multiple first-in-class ADCs and advance our pipeline into clinical development to improve clinical results across multiple tumor types in patients."

Dr. Aleix Prat, New Chair of the Advisory Board at Ona Therapeutics, commented: "Ona’s cutting-edge technology has the potential to redefine treatments for aggressive and refractory cancers. As a strong advocate for precision oncology, I am committed to driving the development of novel, targeted therapies that improve patient outcomes. I am honored to contribute my expertise to this groundbreaking innovation."

Vir Biotechnology to Participate in TD Cowen 45th Annual Health Care Conference

On February 19, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that members of the executive team are scheduled to participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4 at 8:50 a.m. PT / 11:50 a.m. ET in Boston, Massachusetts (Press release, Vir Biotechnology, FEB 19, 2025, View Source [SID1234650397]).

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A live webcast of the fireside chat will be made available under Events & Presentations in the Investors section of the Vir Biotechnology website and will be archived for 30 days.

Reverb Therapeutics Raises USD $12 Million Seed Round Financing to Harness Cytokine Signaling With its Amplify•R™ Platform

On February 19, 2025 Reverb Therapeutics, a leader in harnessing the natural immune system and cytokine signaling to treat life-threatening diseases, reported it has closed a USD $12 Million financing led by founding investor Amplitude Ventures (Press release, Reverb Therapeutics, FEB 19, 2025, View Source [SID1234650396]). Other participants in the round include the Multiple Myeloma Research Foundation’s venture philanthropy arm, the Myeloma Investment Fund, KdT Ventures, Finchley Healthcare Ventures, InBC Investment Corp. (InBC), and Seido Capital.

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Reverb’s novel Amplify•R platform combines bispecific antibody engineering with data-driven modelling of antibody interactions to modulate the actions of endogenous cytokines and redirect them to tissues of interest. This approach avoids the hurdles that have blocked other attempts to enlist cytokines to treat disease, which include systemic toxicity, immunogenicity, and manufacturing issues. Reverb’s initial focus is on the treatment of cancer and autoimmune diseases.

In vivo preclinical studies have established proof-of-concept for the Amplify•R platform’s ability to redirect endogenous cytokines and shrink tumors. The data supports a growing body of evidence for the potency of bispecific antibodies redirecting cytokines to PD-1-positive cells. Reverb’s lead AMP01 program blocks PD-1 while delivering endogenous IL-15, a key protein that expands and activates cytotoxic T cells.

"We are excited to have the backing of this standout group of investors as we advance the Amplify•R platform," said David de Graaf, Ph.D., CEO of Reverb Therapeutics. "The Amplify•R platform has broad potential across many cytokines. With this funding, we will take our lead IL-15 bispecific program to the candidate stage and will develop additional bispecific programs spanning other cytokines and additional cellular targets."

"Since its launch, Reverb has made significant progress in demonstrating the superiority of the Amplify•R platform," said Bharat Srinivasa, Ph.D., principal at Amplitude Ventures. "The preclinical data generated to date are extremely exciting and we believe that the Amplify•R platform will enable Reverb to succeed where many attempts using exogenous cytokines ran into insurmountable obstacles."

With the financing complete, Reverb welcomes two new members to its board of directors:

Maude Tessier, Ph.D., is a longtime biopharma executive, two-time chief business officer and an experienced company builder

Stephan Kontos, Ph.D., a biotech executive and entrepreneur, chairs the scientific advisory board at Anokion.

Lantern Pharma Announces PCT Patent Application Publication for Innovative, High Performing, Machine Learning Model for Predicting Blood Brain Barrier Permeability of Drug-Candidates

On February 20, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, reported the publication of its PCT patent application (PCT/US2024/019851) covering a novel machine learning solution for predicting blood-brain barrier (BBB) permeability (Press release, Lantern Pharma, FEB 19, 2025, View Source [SID1234650395]). The application received a favorable PCT search report indicating no significant prior art, substantially strengthening its path to approval.

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The technology has demonstrated to-date exceptional performance in predicting BBB permeability across a wide range of chemical compounds, processing up to 100,000 molecules per hour with industry-leading accuracy. Notably, Lantern’s AI algorithms for BBB permeability prediction currently hold five of the top eleven positions on the Therapeutic Data Commons Leaderboard1. Lantern believes that this breakthrough capability can accelerate the drug development process by rapidly identifying compounds likely to cross the blood-brain barrier, a critical factor in developing treatments for central nervous system disorders and brain cancers. These identified compounds can then be accelerated and further developed by researchers in cancer drug development and other fields saving time and cost in early-stage molecular characterization.

"The publication of this PCT patent application represents a significant advancement in our AI-driven approach to drug development," stated Panna Sharma, Chief Executive Officer of Lantern Pharma. "This innovative technology not only enhances our internal development capabilities but also offers transformative potential for our partners and collaborators across the pharmaceutical industry. The system’s exceptional speed and accuracy in predicting BBB permeability positions Lantern at the forefront of CNS-targeted therapeutic development. We look forward to deploying this high-performing BBB model in collaboration with pharmaceutical partners and techbio-driven companies who seek to accelerate their development timelines while working with a partner committed to excellence, especially in the area of high-performing, predictive models for drug development."

The proprietary technology integrates advanced molecular representation techniques with synthetic data augmentation from features engineered from the chemical structure and bioactivity data which are then processed by leading-edge machine learning algorithms. Through integration with Lantern’s RADR AI platform, the system enables rapid and comprehensive assessment of both drug candidates and other molecules of interest for BBB permeability.

Lantern’s wholly-owned subsidiary, Starlight Therapeutics, intends to implement this technology to advance the development of STAR-001 and evaluate additional drug candidates. In addition, Lantern is actively expanding the system’s capabilities through the development of sophisticated sub-models that account for complex biological factors affecting BBB permeability. These enhancements are expected to further refine predictions by incorporating advanced features such as protein binding, active transport mechanisms, and disease-state modifications of the blood-brain barrier. This continued evolution of the technology demonstrates Lantern’s commitment to maintaining its leadership position in AI-driven drug development.

The PCT application enables Lantern to pursue patent protection in major markets worldwide, with potential coverage extending 20 years from the filing date. The company has initiated expedited review in the United States to accelerate market deployment.

This technological advancement reinforces Lantern’s position as an innovator in AI-driven drug development and strengthens its ability to develop more effective, targeted CNS cancer therapies. The company expects this development to significantly impact both its internal drug development pipeline and future collaboration opportunities.

Photocure ASA: Results for the fourth quarter of 2024

On February 19, 2025 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 128.6 million in the fourth quarter of 2024 (Q4 2023: NOK 114.2 million) and EBITDA of NOK 8.5 million (NOK 29.9 million) (Press release, PhotoCure, FEB 19, 2025, View Source [SID1234650394]). Photocure expects product revenue growth in the range of 7% to 11% and year-over-year 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 milestones this year.

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"We delivered strong performance in the fourth quarter of 2024 with 13% growth in Hexvix/Cysview revenue, 11% unit sales growth, and EBITDA of NOK 8.5 million. For the full-year 2024, we grew product revenue by 10% and generated EBITDA of NOK 49.2 million. We continue to execute on growing our Hexvix/Cysview business and have consistently produced positive EBITDA over the last 7 quarters," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 141.7 million in the fourth quarter of 2024 (NOK 142.5 million), and EBITDA* of NOK 8.5 million (Q4 2023: NOK 29.9 million), while Hexvix/Cysview revenues grew to NOK 128.6 million in the quarter (NOK 114.2 million). The EBIT was NOK 1.2 million (NOK 22.5 million) and the cash balance at the end of the period was NOK 293.8 million (NOK 259.5 million).

At the end of the fourth quarter of 2024, the installed base of rigid blue light cystoscopy (BLC) systems in the U.S. was 390, up 11% since the same period in 2023. This includes 18 ForTec Medical mobile towers. Photocure estimates that 25 flexible BLC towers remain in the U.S. market.

During the quarter, Olympus launched its high-definition blue light cystoscopy upgrade for its state-of-the-art Viscera Elite III endoscopic platform, which Photocure believes will increase the use of Hexvix in certain Nordic countries and elsewhere in Europe. Also, subsequently in February, Photocure provided an update from its collaboration with Richard Wolf disclosing that a flexible BLC interim solution is now available in Europe.

"We remain focused on the growth of our business and investing in opportunities that can take Photocure to the next level in 2025. Supporting our expected growth this year, our U.S. business is performing well as we continue to increase the base of active accounts using BLC, and mobile tower adoption is anticipated to outweigh remaining declines in flexible BLC usage. New therapeutics entering the market to treat NMIBC** are expected to continue raising the awareness of precision bladder cancer management and emphasizing the importance of better detection with BLC and Hexvix/Cysview. Additionally, the launch of Olympus’ upgraded BLC equipment in Europe is now underway, and our partnership with Richard Wolf is progressing well with a flexible BLC interim solution available sooner than expected," 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. 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 milestones this year.

"We reported our strongest revenue ever in Q4 2024, and our full year revenue and EBITDA results demonstrate Photocure’s ability to execute through headwinds, generate growth and create significant opportunities for the Company," 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 fourth quarter 2024 financial report on page 23.

The quarterly report and presentation will be published at 08:00 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 CET.

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/20250219_4/

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