On March 5, 2025 Akeso, Inc. (9926. HK) ("Akeso" or the "Company") reported the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world’s first PD-1/CTLA-4 bispecific antibody independently developed by the company, as an adjuvant treatment for hepatocellular carcinoma (HCC) with high recurrence risk following curative resection or ablation (Press release, Akeso Biopharma, MAR 5, 2025, View Source [SID1234650916]).

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The completion of patient enrollment in the COMPASSION-22/AK104-306 trial marks a significant milestone in the clinical development of cadonilimab for HCC. In addition to this Phase III study, another Phase III trial investigating cadonilimab in combination with lenvatinib and transarterial chemoembolization (TACE) for the treatment of unresectable intermediate to advanced HCC is currently progressing on schedule. The extensive exploration of combination therapies involving cadonilimab for HCC is expected to offer more effective treatment options for both early-stage and advanced HCC patients.

HCC is one of the most common malignant tumors globally. According to 2024 data, there are about 865,000 new cases of liver cancer worldwide, with 370,000 occurring in China. The recurrence rate after surgery is high, especially in patients with high-risk factors, with a five-year recurrence rate exceeding 70%. Currently, no standard adjuvant treatment exists for HCC in clinical practice. Identifying effective adjuvant therapies to reduce recurrence risk and extend survival is a critical unmet need in HCC treatment.

Cadonilimab is the world’s first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and favorable safety profile in treating HCC. Research presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Annual Meeting demonstrated that cadonilimab combined with FOLFOX-HAIC as neoadjuvant therapy for resectable multinodular HCC achieved a 100% disease control rate (DCR) with manageable safety. Furthermore, data from the 2023 ESMO (Free ESMO Whitepaper) Congress highlighted that cadonilimab combined with lenvatinib as a first-line treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options.

Akeso will continue to advance cadonilimab clinical development for multiple malignant tumors, with the aim to provide more therapeutic options for patients worldwide. Currently, cadonilimab is currently involved in over 23 clinical studies across 16 indications, including gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. It has already received approval for the treatment of recurrent/metastatic cervical cancer and first-line gastric cancer. The sNDA for cadonilimab for the treatment of first-line cervical cancer is currently under review. Additionally, five Phase III trials for HCC, non-small cell lung cancer (NSCLC), and gastric cancer are underway. Studies across multiple indications, including cervical cancer, gastric cancer, and NSCLC, have shown that cadonilimab offers meaningful efficacy benefits in all patient populations, regardless of PD-L1 expression levels (high, low, or negative). These patient data indicates that cadonilimab can also significantly broadens the eligible patient population that can benefit from cancer immunotherapies.

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 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 05, 2025 Anova Enterprises, Inc. (Anova), a technology-enabled CRO dedicated to accelerating promising treatments, reported enrollment of the first two patients in the highly anticipated study of DB107 for the treatment of brain tumors (Press release, Denovo Biopharma, MAR 5, 2025, View Source [SID1234650913]). The Phase 1/2a clinical trial is a multicenter, open-label study designed to confirm whether treatment DB107, when added to standard-of-care (SOC), provides clinical benefit to patients with newly diagnosed high-grade gliomas (HGG) when compared to historical performance.

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The study is funded with a California Institute for Regenerative Medicine (CIRM) grant to advance the development of DB107 in patients with newly diagnosed high-grade glioma. Led by Noriyuki Kasahara, MD, PhD, Principal Investigator, Brain Tumor Research Center (BTRC) at University of California, San Francisco (UCSF), the study is also enrolling at the University of Southern California (USC) and the University of California at San Diego UCSD, and will enroll 70 participants over the coming months.

"Enrolling our first patients is an important milestone in our mission to advance treatment options for patients with high- grade glioma," said Nicholas Butowski, MD, Neuro-Oncologist and Lead Investigator at UCSF. "We are optimistic this trial will provide valuable insights into how we can better treat patients and improve survival in newly diagnosed patients."

High- grade gliomas remain one of the most challenging cancers to treat, with limited treatment options and a high degree of complexity. Treatment for the disease has not changed in 20 years. DB107 is an investigational gene therapy being developed by Denovo Biopharma for the treatment of HGG, including glioblastoma multiforme (GBM). It comprises two components: DB107-RRV (vocimagene amiretrorepvec), a retroviral replicating vector designed to selectively infect and change cancer cells, and DB107-FC, an extended-release oral formulation of 5-fluorocytosine (5-FC), which is converted into a chemotherapeutic agent within the tumor. This combination aims to eradicate tumor cells while stimulating a robust and durable anti-cancer immune response with minimal toxicity.

Chris Beardmore said, "This is revolutionary science where the treatment infects cancer cells and genetically changes them to make chemotherapy inside of the infected cells. This is known to reduce systemic toxicity commonly seen with systemic treatments. It also has a chance to infect cells that cannot be removed by surgery and other interventions to improve outcomes in newly diagnosed brain tumor patients."

The clinical trial is currently recruiting eligible patients who meet the study criteria at UCSF, USC and UCSD. Individuals interested in participating or learning more about the trial can contact the study team at [email protected].

To find out more, contact [email protected].

About Denovo’s RRV Platform and DB107

DB107 is an innovative approach utilizing a proprietary gene therapy platform, recombinant retroviral vector (RRV) bearing cytosine deaminase, combined with a prodrug of 5-FU (5-FC), to selectively infect and kill cancer cells while stimulating a robust and durable anti-cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high-grade GBM and colorectal cancer, most recently in a randomized 403-patient Phase 3 trial. DB107 received Orphan Drug Designation in GBM from the FDA and EMA, and Fast Track Designation from the FDA.

On March 5, 2025 Ataraxis AI, the leading AI precision medicine company, reported its $20.4 million Series A financing led by AIX Ventures with participation from Floating Point, Thiel Bio, Founders Fund, Bertelsmann Investments, and existing investors, Giant Ventures and Obvious Ventures (Press release, Ataraxis AI, MAR 5, 2025, View Source [SID1234650912]). The round also received backing from angel investors and healthcare pioneers, including Mario Schlosser, co-founder and former CEO of Oscar Health (NYSE: OSCR), Ryan Fukushima, COO of Tempus, and others. Leading researchers from OpenAI and DeepMind also participated.

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Founded by Jan Witowski, MD, PhD, and Krzysztof Geras, PhD, Ataraxis AI is reshaping cancer diagnostics with a frontier AI foundation model called Kestrel. The capital infusion comes as the company’s first offering, Ataraxis Breast—the world’s first AI-native prognostic/predictive platform for breast cancer—was clinically validated in a landmark study to be 30 percent more accurate than the current standard of care for breast cancer. Ataraxis AI is on track to launch Ataraxis Breast for clinical use later this year for oncologists across the United States. This new financing will also support the continuing development of offerings by expanding treatment selection capabilities within and beyond breast cancer as well as the development of next-generation AI foundation models.

"This investment is a testament to the groundbreaking work our team is accomplishing and the immense potential of AI in precision medicine. It also reflects our progress, securing funding just a few months after receiving clinical validation," said Jan Witowski, MD, PhD, co-founder and CEO, Ataraxis AI. "With this capital, we are on track to further accelerate our mission to change how cancer is treated and ultimately impact at least 50 percent of new cancer cases by 2030."

Through novel optimization strategies and methodological sophistication, Kestrel beats existing state-of-the-art models with less required data and computational power. The model outperforms existing approaches by uncovering complex, previously undetectable patterns linked to patient outcomes across all disease types. Kestrel is the first of Ataraxis’ foundation models, which will power the development of treatment selection tools for all cancer types.

Ataraxis AI also announced its Clinical Advisory Board, which boasts an impressive roster of medical oncology key opinion leaders from top health systems, including: Dr. Francisco Esteva (Chief of Hematology and Medical Oncology at Northwell Lenox Hill), Dr. Lajos Pusztai (Co-Leader Genetics, Genomics and Epigenetics Program at Yale Cancer Center), Dr. Adam Brufsky (Co-Director of the Cancer Therapeutics Program at the UPMC Hillman Cancer Center), and Dr. Freya Schnabel (Director of Breast Surgery, NYU). These additions join Yann LeCun, PhD, Chief AI Scientist at Meta and Turing Award Laureate, who serves as the company’s AI advisor.

"In the next five years, the world’s leading oncology centers won’t just have top physicians—they’ll have AI copilots revolutionizing diagnosis and treatment. Ataraxis AI is at the forefront of this transformation, and its breakthrough platform, Kestrel, is setting a new standard for precision oncology," said Krish Ramadurai, Partner at AIX Ventures. "Jan and his team aren’t just building another AI tool—they’re redefining how cancer is detected and treated, with the potential to improve millions of lives. We couldn’t be more excited to back them on this journey."