Norroy Bioscience Initiates Pivotal Phase III Clinical Trial of 177Lu-NYM032, a PSMA-Targeted Radioligand Therapy for mCRPC

On September 2, 2026 NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, reported that it has received regulatory clearance from China’s National Medical Products Administration (NMPA) to initiate a pivotal Phase III clinical study of 177Lu-NYM032 in China. 177Lu-NYM032 is a novel investigational PSMA-targeted, small-molecule therapeutic radiopharmaceutical for radioligand therapy (RLT) independently developed in China.

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Led by the Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, a randomized, open-label, multicenter Phase III study is being conducted at multiple sites across China to evaluate the efficacy and safety of 177Lu-NYM032 in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

177Lu-NYM032 has demonstrated promising anti-tumor activities and a favorable safety profile in its Phase I/II clinical study, with the data to be disclosed in a Top-Rated Oral Presentation (TROP) at the 2026 Annual Congress of the European Association of Nuclear Medicine (EANM 26). Previously, the corresponding diagnostic radiopharmaceutical pair, 68Ga-NYM032, was dosed in the first patient in a Phase III clinical trial, marking a key milestone in the advancement of the company’s integrated prostate cancer theranostic pipeline. The 68Ga/177Lu-NYM032 theranostic pair has also received U.S. FDA Investigational New Drug (IND) clearance.

The pair of diagnostic and therapeutic agents of NYM032 are derived from the same precursor structure, enabling a fully integrated theranostic approach and offering the potential to provide patients with prostate cancer in China with a more precise and coordinated diagnosis and treatment option.

Prostate cancer is the fifth leading cause of cancer death among men worldwide. In 2022, more than 134,000 patients in China were newly diagnosed with prostate cancer, and approximately 47,500 deaths were reported. A substantial proportion of the patients will eventually progress to have metastatic castration-resistant prostate cancer (mCRPC), an aggressive late-stage form of the disease. At that stage, many patients face limited treatment options after exhausting standard-of-care therapies, thus underscoring the substantial unmet medical need for novel targeted radiopharmaceuticals in China.

(Press release, Norroy Bioscience, SEP 2, 2026, View Source [SID1234670553])

Whitehawk Therapeutics to Participate in Upcoming Investor Conferences

On September 2, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently develop improved antibody drug conjugate (ADC) cancer treatments, reported participation at the following investor conferences:

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Cantor Global Healthcare Conference 2026 – management will participate in investor meetings on September 9, 2026.

Wells Fargo 21st Annual Healthcare Conference – management will participate in investor meetings on September 10, 2026.

Morgan Stanley 24th Annual Global Healthcare Conference – management will participate in investor meetings, and Scott Giacobello, Chief Financial Officer, and David Dornan, PhD, Chief Scientific Officer, will participate in a fireside chat on September 15, 2026, at 1:05 PM ET.

A live webcast of the fireside chat can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, SEP 2, 2026, View Source [SID1234670552])

Caris Life Sciences to Present New Research Advancing Precision Oncology at the IASLC 2026 World Conference on Lung Cancer

On September 2, 2026 Caris Life Sciences (NASDAQ: CAI), a leading TechBio company, reported that researchers from Caris and the Caris Precision Oncology Alliance (Caris POA) will present seven studies at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC), taking place September 12-15, 2026, in Seoul, South Korea. Caris research includes two mini oral presentations, one Poster Tour presentation and four poster presentations highlighting how comprehensive molecular profiling and AI-driven clinico-genomic analyses are advancing understanding of lung cancer biology, immunotherapy response and precision treatment strategies.

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"This year’s presentations underscore the power of large-scale molecular and clinico-genomic datasets in revealing meaningful insights into cancer biology and therapeutic response," said George W. Sledge, Jr., M.D., Chief Medical Officer of Caris Life Sciences. "From immunotherapy biomarkers and tumor microenvironment analyses to germline testing and targeted therapy outcomes, these findings demonstrate how comprehensive molecular profiling can help inform clinical decision-making and accelerate the future of precision oncology."

Among the highlights are two mini oral presentations evaluating the impact of molecular and immune biomarkers in non-small cell lung cancer (NSCLC), a Poster Tour presentation examining transcriptomic subtypes in mesothelioma, and multiple studies leveraging the Caris clinico-genomic database to characterize genomic alterations, germline variants and treatment outcomes across thoracic malignancies.

Mini Oral Presentations:
Impact of Protein Arginine Methyltransferase 5 (PRMT5) Expression and MTAP Deletion on Overall Survival and Immune Cells in NSCLC
Session: MO05 – Evolving Pathological Grading and Molecular Profiling for Lung Cancer Risk Stratification and Treatment | Presentation: MO05.09
Monday, September 14, 2026 | 12:58 PM – 1:03 PM KST
Key Findings

Analysis of 39,124 NSCLC samples found that MTAP-deleted tumors demonstrated higher PRMT5 expression.
PRMT5-high/MTAP-deleted tumors were associated with the shortest overall survival across molecular subtypes.
Among patients treated with immune checkpoint inhibitors, PRMT5-high/MTAP-deleted tumors were associated with shorter overall survival than PRMT5-high/MTAP-non-deleted tumors.
PRMT5-high/MTAP-deleted tumors exhibited fewer CD8+ T-cells and other adaptive immune cells, suggesting a less favorable immune microenvironment.
Prevalence of Immunotherapy (IO) Biomarkers, Tumor Microenvironment (TME) Composition and Survival by Race/Ethnicity in NSCLC
Session: MO13 – Global Challenges and Solutions in Lung Cancer Management | Presentation: MO13.09
Tuesday, September 15, 2026 | 11:58 AM – 12:03 PM KST
Key Findings

Evaluation of 43,261 NSCLC samples identified race- and ethnicity-associated differences in tumor genomics, immune microenvironment composition and clinical outcomes.
Non-Hispanic Asian Pacific Islander patients demonstrated longer overall survival and fewer genomic alterations associated with resistance to immunotherapy than non-Hispanic White patients.
Among immunotherapy-treated patients, non-Hispanic Black patients achieved longer survival despite a higher prevalence of immunotherapy-resistance molecular alterations.
Poster Tour:
Transcriptomic Subtypes Predict Frontline Therapy Response in Pleural (MPM) and Peritoneal Mesothelioma (MPeM)
Session: PT2.05 – Mesothelioma, Thymoma, and Other Thoracic Tumors | Presentation: PT2.05.03
Monday, September 14, 2026 | 2:01 PM – 2:09 PM KST
Key Findings

Transcriptomic analysis of 386 mesothelioma samples identified three biologically distinct clusters with unique molecular features and treatment outcomes.
Chemotherapy, with or without bevacizumab, was associated with longer overall survival than immune checkpoint inhibitor therapy in two of the three clusters.
If validated prospectively, the identified transcriptomic subtypes could help inform therapeutic decision-making and support a more personalized treatment approach for mesothelioma.
Posters Include:
Prevalence and Spectrum of Germline Variants in Non-Small Cell Lung Cancer: Insights from a Large-Scale CARIS Analysis | Presentation: P2.097

Clinically relevant germline alterations were identified in 12.2% of 3,609 NSCLC patients.
Frequently altered genes included MUTYH, CHEK2, ATM, BRCA2 and MITF.
Among patients with linked tumor profiling, 45.8% of pathogenic, likely pathogenic or risk germline variants had a matching tumor variant.
Germline Alterations in Small Cell Lung Cancer Identified Through Blood-Based Profiling | Presentation: P2.098

Clinically relevant germline alterations were identified in 13.4% of 149 small cell lung cancer patients with germline findings.
Common alterations included MUTYH, APC, ATM, BRIP1 and CHEK2.
In patients with linked tumor sequencing, more than half of pathogenic, likely pathogenic or risk germline variants had corresponding tumor variants.
Clinico-Biological Characteristics and Treatment Outcomes in Patients With RET+ Lung Cancer with Non-LUAD Histology | Presentation: P2.102

Among 588 RET-positive patients in the RET-MAP registry, 45 patients, or 7.7%, had non-lung adenocarcinoma (LUAD) histology.
Non-LUAD histology was independently associated with shorter progression-free and overall survival following both selective RET inhibitors and first-line chemotherapy.
Patients with large cell neuroendocrine carcinoma demonstrated a 75% objective response rate encouraging responses to selective RET inhibitors, with survival outcomes comparable to LUAD.
ITGB6 Expression and Real-World Outcomes in Non-Small Cell Lung Cancer | Presentation: P3.252

Analysis of 34,022 NSCLC samples demonstrated that ITGB6 expression varies by histology and genomic context.
High ITGB6 expression was associated with improved overall survival in lung adenocarcinoma but poorer outcomes in lung squamous cell carcinoma.
These opposing prognostic associations support further evaluation of ITGB6 across molecularly defined NSCLC populations.
Research highlights will be available at Caris’ booth #813. The full abstracts are available on the Caris website.

(Press release, Caris Life Sciences, SEP 2, 2026, View Source [SID1234670551])

Nuvation Bio to Participate in Upcoming Investor Conferences

On September 2, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in fireside chats and one-on-one meetings at the following conferences:

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Citi’s 2026 Biopharma Back to School Conference – fireside chat on Wednesday, September 9, 2026, at 9:20 a.m. ET in New York, NY

2026 Cantor Global Healthcare Conference – fireside chat on Thursday, September 10, 2026, at 1:35 p.m. ET in New York, NY
Live webcasts of each fireside chat will be available on the Investor Relations section of the Nuvation Bio website. An archived recording will be available for 90 days following each event.

(Press release, Nuvation Bio, SEP 2, 2026, View Source [SID1234670550])

Ivonescimab Meets Overall Survival Key Secondary Endpoint in Interim Analysis of Phase III HARMONi-2 Study, Demonstrating Statistically Significant and Clinically Meaningful Benefit Versus Pembrolizumab in First-Line PD-L1-Positive NSCLC

On September 2, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that a pre-specified interim analysis of overall survival (OS) in the HARMONi-2 (AK112-303) trial, as assessed by the Independent Data Monitoring Committee (IDMC), met the key secondary endpoint of OS. The results demonstrated that ivonescimab showed statistically significant and clinically meaningful improvement over pembrolizumab.

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HARMONi-2 is a randomized, double-blind, multicenter, registrational Phase III trial evaluating ivonescimab, Akeso’s first-in-class PD-1/VEGF bispecific antibody, versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (TPS ≥1%).

Detailed data from the interim OS analysis will be presented at an upcoming international medical conference and published in a peer-reviewed journal.

In May 2024, at a prespecified interim analysis conducted by the IDMC, ivonescimab met its primary endpoint of progression-free survival (PFS) in the HARMONi-2 study, with a median PFS of 11.14 months versus 5.82 months for pembrolizumab. HARMONi-2 is the first randomized, double-blind Phase III trial to show a significant positive outcome against pembrolizumab in this setting.

In 2025, this indication received regulatory approval in China. The approval removed previous restrictions on the use of VEGF-targeted agents in patients with squamous histology and provided a chemotherapy-free treatment option that has been well received in clinical practice.

Dr. Yu Xia, Founder, Chairwoman, President and Chief Executive Officer of Akeso:

"We are pleased that the fourth Phase III study of an ivonescimab-based regimen has now demonstrated statistically significant benefit in both overall survival and progression-free survival. These results further reinforce the clinical value of ivonescimab in the treatment of lung cancer.

We thank the investigators, clinical teams and patients who participated in the HARMONi-2 study for their important contributions.

To date, ivonescimab has achieved dual positive OS and PFS outcomes across multiple Phase III head-to-head trials versus PD-1/PD-L1 therapies. This growing body of evidence strengthens our confidence in its potential across a broader range of solid tumors. With its unique dual mechanism of action combining immunotherapy and anti-angiogenesis, we believe ivonescimab offers a more effective treatment option for patients and will contribute meaningfully to the evolving oncology treatment landscape."

(Press release, Akeso Biopharma, SEP 2, 2026, View Source [SID1234670549])