On March 5, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported that it will highlight progress across its clinical pipeline, including continued advancement of investigational CD47-blocker evorpacept and planned entry into the clinic of its novel EGFR-directed ADC clinical candidate ALX2004, and provide key business and financial updates in an R&D Day webcast event today (Press release, ALX Oncology, MAR 5, 2025, View Source [SID1234650898]).

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ALX Oncology leadership will be joined by external key opinion leaders in the oncology field, Paula R. Pohlmann, M.D., M.S., Ph.D., Chief, Clinical Research, Department of Breast Oncology, and Associate Professor, Department of Breast Medical Oncology and Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center, and Eric Van Cutsem, M.D., Ph.D., Professor of Gastroenterology and Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven in Leuven, Belgium.

"Our conviction in evorpacept’s potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data. These results support our confidence moving into further clinical trials evaluating evorpacept in breast and colorectal cancers and pave additional regulatory paths forward," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data. To ensure that the company is strongly positioned to focus on our highest priority programs, we are streamlining our organization and prioritizing resources to execute on our current studies, progress our de-risked anti-cancer antibody combinations for evorpacept, as well as advance our novel ADC into the clinic. In order to achieve these additional value generating milestones for breast cancer, colorectal cancer and ALX2004 with our existing cash, we are optimizing resources and making the difficult decision to reduce our workforce, primarily in preclinical research. We look forward to sharing more information at today’s R&D Day event, which provides an opportunity for our leadership team and leading clinicians to detail our most recent data, scientific progress and corporate strategy."

Evorpacept Clinical Program Updates

During the R&D Day event, ALX Oncology leadership will discuss the mechanistic rationale and clinical data that support further development of evorpacept with anti-cancer antibodies. In addition to updates on ongoing trials leveraging this combination approach, new plans will be introduced around the initiation of studies evaluating evorpacept in combination with trastuzumab in HER2-positive breast cancer and in combination with cetuximab in colorectal cancer (CRC). Both are anticipated to initiate in the first half of 2025.

Drs. Pohlmann and Van Cutsem will also discuss current treatment paradigms and unmet needs within these cancers, and how evorpacept may provide a new treatment option for patients in the future.

Introduction of New EGFR-Targeted ADC with IND Submission Planned for Q1 2025

During the R&D Day event, Jaume Pons, Ph.D., will introduce a new ALX Oncology ADC clinical candidate, ALX2004. This is a potential best- and first-in-class compound that is designed to optimize ADC-based mechanisms of anti-tumor activity and has demonstrated potent anti-tumor activity in multiple clinically relevant xenograft models. ALX Oncology intends to submit an Investigational New Drug (IND) application for ALX2004 to the U.S. Food & Drug Administration (FDA) in Q1 2025.

Corporate and Financial Updates

In order to support the newly planned clinical trial programs in breast cancer and CRC, ALX Oncology has conducted a strategic prioritization and resource optimization exercise resulting in substantial decreases in preclinical research investments, including an approximately 30% workforce reduction primarily in the preclinical research function. As a result, ALX Oncology now expects its cash runway to extend into Q4 of 2026.

R&D Day Webcast Information

The ALX Oncology virtual R&D Day will be webcast live and a replay will be available after the event by visiting the "Investors" section of ALX Oncology’s website and selecting "Events and Presentations."

Date & Time: Wednesday, March 5, 2025, 6:00 a.m. PT/9:00 a.m. ET
Webcast Access: View Source

On March 05, 2025 Nuvectis Pharma (NASDAQ: NVCT)* reported that new independent research conducted at the Lerner Research Institute, Cleveland Clinic (at Case Western Reserve University) has demonstrated the superior efficacy of NXP900 when combined with osimertinib (Tagrisso) in EGFR-mutated non-small cell lung cancer (NSCLC) models (Press release, Nuvectis Pharma, MAR 5, 2025, View Source [SID1234650914]). The peer-reviewed study, published in Molecular Cancer Research, demonstrated that the combination therapy led to decreased cancer cell proliferation and increased apoptosis compared to osimertinib alone.

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According to the company, this research from Prof. Ruth Keri’s laboratory at Cleveland Clinic provides critical independent validation of previous findings from AstraZeneca researchers, confirming that NXP900 can effectively combat resistance mechanisms that limit the effectiveness of EGFR inhibitors like Tagrisso, which generates over $5 billion in annual sales.

NXP900, an oral SRC/YES1 kinase inhibitor with a unique mechanism that inhibits both catalytic and scaffolding functions, shows promise in addressing resistance to current standard-of-care treatments. The company is also advancing NXP800, a GCN2 activator in Phase 1b trials for platinum-resistant, ARID1a-mutated ovarian cancer, with encouraging interim data showing partial response and stable disease in several patients.

Industry analysts seem to have taken notice of Nuvectis’s potential. In February 2025, Lucid Capital Markets reportedly initiated coverage with a BUY rating and an $18 price target, projecting peak sales of over $900 million for NXP900 across multiple cancer indications. This represents significant potential upside potential from current levels. With multiple catalysts expected in 2025, including completion of the NXP900 Phase 1a study, initiation of Phase 1b trials, and updated NXP800 clinical data in Q2, Nuvectis seems to be a fascinating company to watch in 2025.

On March 5, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing powerful circular RNA technology for next generation nucleic acid medicine, reported that CEO Dr. Erik Digman Wiklund and CSO Dr. Victor Levitsky are presenting updated data demonstrating the significant advantages of Circio’s circular RNA circVec platform compared to current mRNA-based vector technology (Press release, Circio, MAR 5, 2025, View Source [SID1234650899]). The data further strengthens the in vitro and in vivo validation of Circio’s platform. The presentations are being delivered at two major biopharma industry conferences in Basel, Switzerland, and Stockholm, Sweden.

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The presentations detail the advantages and potential of the circVec 3.0 generation to improve on current mRNA-based technology for a range of therapeutic applications. In vivo expression data has shown an estimated circRNA half-life of over 600 hours vs. under 10 hours for linear mRNA, which translates to over 70 times prolonged RNA durability and 15 times enhanced protein expression.

Novel systemic LNP-delivery data demonstrates robust and durable circVec expression in spleen, far outperforming equivalent mRNA-vectors. This important finding has the potential to open up attractive therapeutic opportunities for the circVec technology in several areas, such as cell therapy. Further experimental work is currently ongoing to validate and characterize these observations.

"The recent results showing efficient and specific circVec delivery to spleen are very promising and hints at novel opportunities for our circular RNA platform in cell and immune therapies," said Dr. Victor Levitsky, CSO of Circio. "A broad set of experiments to further investigate this observation, as well as in vivo testing of the novel circVec 3.0 generation, will read out over the next 6-12 weeks. The performance of circVec 3.0-AAV constructs is of particular interest, which we believe has the potential to transform current gold-standard AAV gene therapy and generate substantial partnering interest."

See below for titles and presentation materials:

RNA Leaders Europe Congress
Title: Deploying circular RNA expression to boost gene therapy – AAV and beyond
Time & place: 5 March 2025, Basel, SwitzerlandPresenter: Dr. Erik Digman Wiklund, CEO

Biologics World Nordics 2025
Title: CircVec – A Novel Payload Expression Platform Based on Circular RNA Biogenesis: Features and Opportunities
Time & place: 5 March 2025, Stockholm, Sweden
Presenter: Dr. Victor Levitsky, CSO

On March 05, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder, will provide an overview of Puma at 2:00 p.m. ET on Tuesday, March 11, at Barclays 27th Annual Global Healthcare Conference (Press release, Puma Biotechnology, MAR 5, 2025, View Source [SID1234650915]). The conference will be held at the Loews Miami Beach.

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A live webcast of the presentation will be available on the Puma Biotechnology website at View Source The presentation will be archived on the website and available for replay for 30 days.

On March 5, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will present at the Barclays 27th Annual Global Healthcare Conference on Wednesday, March 12, 2025, at 3:00 p.m. ET (Press release, CytomX Therapeutics, MAR 5, 2025, View Source [SID1234650900]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.