On August 13, 2025 Pilatus Biosciences, Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported a clinical trial collaboration with Roche (Press release, Pilatus Biosciences, AUG 13, 2025, View Source [SID1234655221]). Under the terms of the agreement, Roche will provide atezolizumab (Tecentriq), its anti-PD-L1 therapy, to support Pilatus’ upcoming first-in-human Phase 1 trial evaluating PLT012 in combination with atezolizumab in patients with hepatocellular carcinoma (HCC).

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PLT012 is Pilatus’ lead immunomodulatory candidate designed to reprogram the fibrotic and immunosuppressive tumor microenvironment (TME) characteristic of HCC. The investigational combination will be assessed in Pilatus-sponsored clinical trials to assess safety and tolerability.

"We are pleased to collaborate with Roche as we explore the potential synergy between PLT012 and atezolizumab in patients with HCC," said Raven Lin, Ph.D., Chief Executive Officer, Pilatus Biosciences. "Current treatments, including checkpoint inhibitors as monotherapy, often fail to generate durable responses in liver cancer. PLT012’s ability to reshape the TME may enhance immune activation and unlock deeper, more sustained responses when administered in combination with anti-PD-L1 therapies such as atezolizumab."

"This collaboration represents an opportunity to investigate how modulation of the TME can enhance immune checkpoint blockade in liver cancer," said Dr. Ann-Lii Cheng, NTU Chair professor and President Emeritus of the NTU Cancer Center of National Taiwan University, and scientific collaborator at Pilatus Biosciences. "Combining PLT012 with atezolizumab has the potential to overcome key mechanisms of resistance in HCC and potentially drive more durable patient response and potentially improve patient outcomes for this aggressive disease." Dr. Cheng also served as the global principal investigator of the landmark IMbrave150 trial (atezolizumab plus bevacizumab for HCC, published in NEJM 2020).

Atezolizumab, a standard of care treatment for first-line HCC in combination with bevacizumab (Avastin), will be provided by Genentech, a member of the Roche Group, for use in Pilatus’ clinical research. HCC is the most common type of primary liver cancer and remains one of the leading causes of cancer-related death worldwide.

Tecentriq (atezolizumab) and Avastin (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it depletes immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing anti-tumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

On August 13, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the creation of its Oncology Scientific Advisory Board (SAB) (Press release, Zai Laboratory, AUG 13, 2025, View Source [SID1234655220]). The newly formed Oncology SAB is comprised of distinguished oncology leaders and will support the advancement of the Company’s robust oncology products and pipeline, including multiple internally developed investigational therapies.

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"We are honored to bring together this esteemed group of oncology leaders who will support our continued development and advancement of innovative treatment options for patients globally," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "The formation of this Board is an important step for Zai; we know our clinical programs will benefit tremendously from the guidance and perspective of this highly regarded and experienced group of individuals."

Zai Lab’s Oncology SAB comprises the following:

Lieping Chen, M.D., Ph.D., is a United Technologies Corporation chair in cancer research, professor of immunobiology, dermatology and medicine at the Yale University School of Medicine.

Richard S. Finn, M.D., is director of the Signal Transduction Program in the Jonsson Comprehensive Cancer Center at University of California, Los Angeles (UCLA).

Thomas F. Gajewski, M.D., Ph.D., directs the Melanoma Oncology Clinic and leads the Immunology and Cancer Program at the University of Chicago Comprehensive Cancer Center.

Melissa L. Johnson, M.D., directs lung cancer research at the Sarah Cannon Research Institute.

Matthew Krebs, M.D., Ph.D., is a clinical senior lecturer in experimental cancer medicine at the University of Manchester and leads early phase clinical trials at The Christie NHS Foundation Trust, Manchester, U.K.

Patricia LoRusso, M.D., D.O., is director of the Early Phase Clinical Trials Program and Associate Center Director of Experimental Therapeutics at Yale Cancer Center.

Michael T. Lotze, M.D., FACS, is professor of surgery, immunology and bioengineering, and director of the DAMP Laboratories at the University of Pittsburgh Medical Center Hillman Cancer Center.

Timothy Yap, M.B.B.S., Ph.D., FRCP, is a medical oncologist, physician-scientist and professor at the University of Texas MD Anderson Cancer Center.

On August 13, 2025 Flatiron Health reported eight abstracts leveraging its high-quality multimodal data have been accepted for poster presentation and e-Poster presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain (Press release, Flatiron Health, AUG 13, 2025, View Source [SID1234655219]).

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"AI is a transformative force enabling scale, speed, and novel insights that were previously impossible. By harnessing advanced AI across our global network of more than five million people with cancer, we’re setting a new standard for real-world data at scale," said Nathan Hubbard, Chief Business Officer, Flatiron Health. "Our research at this year’s World Conference on Lung Cancer exemplifies how high-quality, multimodal real-world data combined with responsible AI practices can illuminate treatment patterns, measure effectiveness, and reveal where innovation is most urgently needed."

A highlight of Flatiron’s presence at WCLC 2025 is the first published research leveraging the Flatiron Health–Caris Life Sciences Clinical-Molecular Database (CMDB), the largest and most robust multimodal dataset of its kind, to identify a novel gene signature that predicts risk of liver metastasis in patients with advanced non-small cell lung cancer (NSCLC). By integrating high-quality clinical data with comprehensive molecular profiling, the research addresses a critical unmet need—providing clinicians with a new tool to identify high-risk patients and potentially enable more personalized surveillance and treatment strategies.

Additional highlights include:

a poster highlighting ongoing gaps in biomarker testing after assessing over 13,000 patients with NSCLC in the US and UK
a poster providing new insights into how NSCLC is managed in the UK, including details on the most commonly used treatments, patterns in biomarker testing, and overall survival outcomes
Schedule a meeting with Flatiron Health at WCLC 2025 and follow Flatiron Health on X and LinkedIn for more updates from #WCLC25.

Abstracts and Poster Presentations
A Novel Predictive Gene Signature for Liver Metastasis (LM) in NSCLC Using a Comprehensive Linked Clinical-Molecular Database
Partner: Caris Life Sciences
Poster
Session: P2.06 – Pathology and Biomarkers
Presentation Number: P2.06.45
Location: Exhibit Hall
Session Start/End: Monday, September 8, 10:30AM – 12PM

Real-world Biomarker Testing and Treatment Initiation in Patients with Resected Early-stage NSCLC (eNSCLC) in the US and UK
Poster
Session: P1.07 – Early-Stage Non-small Cell Lung Cancer
Presentation Number: P1.07.05
Location: Exhibit Hall
Session Start/End: September 7, 10:30AM – 12PM

Real-World Outcomes of Prophylactic Cranial Irradiation in Extensive-Stage Small Cell Lung Cancer Treated with First-Line Immunotherapy and Platinum-Etoposide
Poster
Session: P3.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: P3.13.10
Location: Exhibit Hall
Session Start/End: September 9, 10 – 11:30AM

Real-World Survival Outcomes in Non–Small Cell Lung Cancer: Insights from UK EHR-Derived Data
E-Poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.34

Disease Burden and rwPFS as a Surrogate Endpoint for rwOS in NTRK+ NSCLC and Other Advanced/Metastatic Solid Tumors
Partners: Bristol-Myers Squibb, University of Colorado Cancer Center
E-poster
Session: EP.12 – Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Presentation Number: EP.12.23

Real-World Treatment Patterns in ES-SCLC Highlight Continued Unmet Medical Need in the Era of New Therapies: ESSENCE Study
Partners: Montefiore Medical Center, GSK, Rush University
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.25

Evolving Treatment Patterns in Early-Stage Non-Small Cell Lung Cancer in the United States
Partners: Lilly
E-poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.33

Real-World Treatment Patterns and Clinical Outcomes in Patients With Metastatic Neuroendocrine Neoplasms of the Lung (NEN-L)
Partners: Merck & Co
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.44

On August 13, 2025 CIT Therapeutics, Inc. (CIT), a biotechnology company focused on developing next-generation small molecule therapies targeting SUMOylation for cancer treatment, reported a strategic partnership with the Institute for Follicular Lymphoma Innovation (IFLI) (Press release, Institute for Follicular Lymphoma Innovation, AUG 13, 2025, View Source [SID1234655218]). As part of this collaboration, IFLI will invest up to $2.5 million to support CIT’s clinical development efforts, particularly in follicular lymphoma.

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CIT is advancing a first-in-class, orally bioavailable small molecule that selectively inhibits the SUMO E1 enzyme through an allosteric covalent mechanism. This novel approach has demonstrated high specificity in proteome-wide analyses, offering a promising therapeutic strategy to both kill cancer cells and stimulate the immune system.

The investment from IFLI will support CIT’s upcoming Phase 1/1b clinical trial of its lead candidate, SB-4826, in patients with Non-Hodgkin Lymphoma, including those with relapsed or refractory follicular lymphoma.

This partnership underscores IFLI’s commitment to accelerating the development of transformative therapies for follicular lymphoma and related blood cancers. It also highlights CIT’s innovative platform as a potential game-changer in the oncology landscape.

"We are pleased to collaborate with CIT in their mission to improve outcomes for patients with follicular lymphoma," said Dave McCullagh, Managing Director of IFLI.

"This partnership represents a significant step forward in bringing SUMOylation-targeted therapies to the clinic. We are proud to support CIT in pioneering this new therapeutic modality. Inhibiting SUMOylation can reprogram tumor microenvironments, sensitize tumors to chemo and radiotherapy, and suppress oncogenic signaling" Michel Azoulay, MD, Chief Medical Officer of IFLI.

"Our vision is to transform cancer care by developing therapies that target novel biological mechanisms, which aligns with that of IFLI," said Yuan Chen, PhD, Founder and CEO of CIT Therapeutics and Professor and Chief in the Division of Surgical Sciences and Professor in the Division Surgical Oncology in the Department of Surgery at University of California, San Diego (UCSD) and Moores Cancer Center. "We are excited for this partnership and eager to start our clinical trial to deliver meaningful benefit to patients."

On August 13, 2025 OncoBeta GmbH, a medical device company specialising in innovative epidermal radioisotope therapies, reported 12-months interim results from its international Phase IV, multi-centre clinical trial evaluating the efficacy and safety of Rhenium-SCT (Skin Cancer Therapy) in patients with non-melanoma skin cancer (NMSC) (Press release, OncoBeta, AUG 13, 2025, View Source [SID1234655217]).

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The EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT for the Treatment of Non-Melanoma Skin Cancer) is designed to assess treatment efficacy and safety, as well as key patient-reported outcomes including quality of life, treatment comfort, and cosmetic results.1 The study is based on the clinically validated effect of the beta-emitter rhenium-188 in treating basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).2

Treatment data is available for 184 adult patients (with 254 lesions) across 7 study centres in Australia, Austria, Germany, the United Kingdom, and South Africa. All participants had histologically confirmed stage I or II NMSC. The median patient age was 70.3 years (range 27–95 years), and 53.3% of participants were male. Patients had one (71.2%), two (19.6%), or three (9.2%) lesions treated, which were located on the head & neck (11.8%), trunk (11.8%), lower limbs (11.8%), or upper limbs (9.1%).1

Treatment & Methodology

Rhenium-SCT was administered as a single 50-Gy topical dose of rhenium-188 embedded in a resin applied via adhesive film to the lesion site. Efficacy was assessed using modified RECIST criteria, at 12 months follow-up. Quality of life was assessed using the Skin Cancer Index (SCI) at baseline, 6 months, and 12 months. Treatment comfort was assessed using a patient questionnaire, whilst patient- and clinician-evaluated cosmetic outcomes were determined using a visual analogue scale (VAS) grading of 0-10 (0 = very poor; 10 = no wound detectable). Safety was assessed via treatment-emergent adverse events (TEAEs) and CTCAE (Common Terminology Criteria for Adverse Events) grading.

Key 12-Month Results:1

Overall response rate: 97.3%
Complete response rate: 94.1%
Partial response rate: 3.2%
Mean improvement in quality of life: +10.55 points from baseline
Pain/discomfort during treatment: None reported
Cosmetic outcomes: Favourable results reported by both patients and clinicians
Most common toxicity (12-month): Grade 1 hypopigmentation (60.4%)
No CTCAE toxicities above Grade 2 observed at 12 months
These findings confirm that Rhenium-SCT, administered in a single session, delivers sustained high efficacy and improved quality of life, with excellent cosmetic outcomes and minimal adverse effects.

"Rhenium-SCT has consistently demonstrated effectiveness and safety in prior studies," said Dr. Gerhard Dahlhoff, Medical Director at OncoBeta. "This 12-month interim data further reinforces its value as a non-invasive, targeted treatment option for NMSC, particularly for patients seeking alternatives to surgery due to cosmetic or health-related concerns."

"The 12-month results from the EPIC-Skin Study represent a major milestone for OncoBeta," added Shannon D. Brown III, CCO OncoBeta & Managing Director Europe. "These results support the efficacy, safety, and patient satisfaction associated with Rhenium-SCT. These are the three foundational pillars of our patient-first vision, emphasising not only clinical outcomes, but also the patient experience in achieving them."

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans.3 The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.4
The Rhenium-SCT is a painless*, non-invasive‡ therapy that provides aesthetic results, even in cases otherwise considered difficult to treat.1,5,6 The Rhenium-SCT utilises the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The Rhenium-SCT is a precise, personalised therapy2 that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient’s skin and the application is safe and simple for the applying physician. Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.