On August 25, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that it will present new data at the 2025 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer, taking place September 6 – 9 in Barcelona, Spain (Press release, Natera, AUG 25, 2025, View Source [SID1234655474]). The presentations underscore the strong clinical utility of Signatera in lung cancer.

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An analysis of early-stage, resectable non-small cell lung cancer (NSCLC) patients will be featured in an oral presentation, demonstrating that Signatera status in the post-surgical molecular residual disease window is highly prognostic of recurrence-free survival and overall survival. Signatera Genome was used for this study, and the data highlights the potential of Signatera to individualize patient care by improving stratification of post-surgical recurrence risk.

"Our data at WCLC reinforces the strong clinical utility of Signatera in lung cancer, which is the most common form of cancer diagnosed worldwide," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "Notably, we look forward to sharing data on Signatera Genome that highlights its prognostic value for risk stratification in patients with early-stage, resectable NSCLC."

Full list of presentations at WCLC include:

September 7, 3:22 PM CEST | Presentation # MA03.02 (Oral Presentation)
Presenter: Gaston Becharano, M.D.
Clinical Performance of a Tumor Informed Whole Genome Based ctDNA Assay for Predicting Recurrence in Early-Stage Resectable NSCLC

September 8, 10:30 AM CEST | Presentation # P2.06.78
Presenter: Daniel Rosas, M.D.
Using a Personalized, Tumor-Informed Circulating DNA (ctDNA) to Monitor Treatment Outcomes in Lung Cancer

September 9, 10:00 AM CEST | Presentation # P3.18.04
Presenter: Ken Masuda, M.D.
MRDSEEKER (JCOG2111A): A Prospective Study to Evaluate MRD and Its Association With Prognosis in Curative-Intent NSCLC

On August 25, 2025 Varian, a Siemens Healthineers company, reported the successful completion of enrollment and treatment in its FAST-02 (Flash Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax) clinical trial (Press release, Varian Medical Systems, AUG 25, 2025, View Source [SID1234655473]). The FAST-02 study targets painful bone metastases in the thoracic region and represents a significant step toward bringing this investigational radiotherapy treatment into clinical practice.

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The trial was conducted at Cincinnati Children’s Hospital/UC Health Proton Therapy Center and enrolled 10 participants. It focused on evaluating treatment-related side effects and the efficacy of treatment, which was assessed using trial participants’ reported pain relief. FAST-02 builds upon findings from Varian’s FAST-01 trial, which evaluated clinical workflow feasibility of Flash therapy and treatment-related side effects for participants with bone metastases in the extremities. The trial is led by Principal Investigator John Perentesis, M.D., Professor and Director, Cancer and Blood Disease Institute, Cincinnati Children’s Hospital, and lead Co-Investigator Emily Daugherty, M.D., Associate Professor of Radiation Oncology, University of Cincinnati Cancer Center.

Flash therapy delivers treatment at ultra-high dose rates in typically less than one second – over 100 times faster than conventional radiation therapy—and has demonstrated potential in preclinical studies to reduce damage to surrounding healthy tissues while maintaining effective tumor control.

"Completing treatments for FAST-02 is a pivotal and progressive step in our effort to establish the safety and effectiveness of Flash radiotherapy," said John Perentesis, M.D., Professor and Director, Cancer and Blood Disease Institute, Cincinnati Children’s Hospital Medical Center (CCHMC). "This trial helps lay the groundwork needed to move Flash into more advanced clinical settings—an innovation that could redefine radiation oncology and meaningfully improve patient outcomes."

As part of the FAST-02 trial, Varian’s ProBeam proton therapy system was modified to enable ultra-high dose rate delivery for Flash treatments. In parallel, the Eclipse treatment planning system was enhanced to support planning for Flash therapy. Varian is advancing Flash therapy as an integrated system, encompassing planning, quality assurance, and treatment delivery technologies.

"The integration of treatment and planning represents a major technological achievement," said Anthony Mascia, executive director and director of medical physics of the CCHMC Proton Therapy Center. "From a physics standpoint, we’re pushing the boundaries of both planning and delivering ultra-high dose rates, and we’re doing it safely."

OSF HealthCare, a multi-site healthcare system with locations across Illinois and Michigan, collaborated in the trial and referred participants for enrollment.

James McGee, MD, founding director of the OSF Cancer Institute, stated: "We’re proud to have supported the FAST-02 trial. It is rewarding to contribute to research that further advances Flash therapy."

Added Deepak "Dee" Khuntia, MD, senior vice president and chief medical officer at Varian: "This is an exciting time for radiation oncology; completing enrollment in FAST-02 underscores our commitment to develop the evidence needed to advance technologies that have the potential to transform the future of cancer care. We are proud to collaborate with institutions that share our vision for patient-centered innovation."

Now that participant treatment is complete, data analysis of the results will inform future clinical studies and further evaluation of the potential of Flash therapy across broader treatment applications.

For information about the FAST-02 clinical trial, go to: Study Details | FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax | ClinicalTrials.gov

On August 25, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) reported its interim results for the period ending June 30, 2025, along with updates on recent achievements (Press release, Antengene, AUG 25, 2025, View Source [SID1234655472]):

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ATG-022 (CLDN18.2 ADC) has shown promising results in the ongoing Phase I/II CLINCH study, demonstrating robust efficacy and a favorable safety profile in gastric/GEJ adenocarcinoma across high, low, and ultra-low CLDN18.2 expression levels.

In moderate-to-high expressors (IHC 2+ >20%), the 2.4 mg/kg cohort achieved a 40% ORR (12/30, including 1 CR), a 90% DCR, 6.97 months of mPFS, with 6-month PFS at 51.1%, 9-month OS at 82.7%, and 12-month OS at 66.2%; the 1.8 mg/kg cohort achieved 40% ORR (10/25, including 1 CR) and 84% DCR. In low/ultra-low expressors (IHC 2+ ≤20%) treated at 1.8–2.4 mg/kg, ATG-022 achieved 33.3% ORR (6/18, including 1 CR) with 50% DCR.

Both dose cohorts were well tolerated, with no ophthalmologic toxicities or interstitial lung disease observed, and the 1.8 mg/kg dose showing particularly low rates of Grade ≥3 TRAEs

In a basket cohort of CLDN18.2-positive tumors, preliminary data showed tumor shrinkage in all 7 evaluable patients with a subtype of gynecologic cancer.

ATG-022 has also been granted Breakthrough Therapy Designation by China’s NMPA for the treatment of CLDN18.2-positive, HER2-negative, unresectable or metastatic gastric/GEJ adenocarcinoma after at least two prior therapies.
Antengene is advancing a broad development strategy in gastric cancer, including first-line ATG-022 with pembrolizumab and CAPOX/FOLFOX, second-line ATG-022 with pembrolizumab, and third-line ATG-022 monotherapy.

ATG-037 (oral CD73 small molecule inhibitor) showed robust efficacy in the Phase I/II STAMINA study. In the CPI-resistant melanoma subgroup, results were particularly encouraging, with 36.4% ORR and 100% DCR (1CR, 3PRs), in patients largely double-resistant to both anti-PD-1 and anti-CTLA-4 antibodies. Responses were durable, with the CR patient remaining on treatment for over 32 months, 2 PR patients for more than 15 months, and 1 SD patient for over 28 months. In the CPI-resistant NSCLC subgroup, ATG-037 achieved a 21.4% ORR and 71.4% DCR (3 PRs).

AnTenGager Platform is Antengene’s next-generation T-cell engager technology, featuring "2+1" bivalent binding, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to reduce CRS and improve efficacy. Broadly applicable across autoimmune diseases, solid tumors, and hematologic malignancies, the platform is open to global partnerships. ATG-201 (CD19 x CD3), the lead TCE program, expands Antengene’s pipeline into autoimmune diseases. Preclinical studies in non-human primates showed repeated dosing at 1mpk, 3mpk, and 6mpk was well tolerated with very low cytokine release, and the surrogate antibody mediated complete B-cell depletion in blood, spleen, and lymph nodes. ATG-201 is expected to enter clinical development in Q4 2025.

To learn more about the 2025 interim financial results, please see the full announcement in the "Investor Relations" section on the company’s website.

On August 25, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the upcoming investor relations events (Press release, Ideaya Biosciences, AUG 25, 2025, View Source [SID1234655471]).

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Cantor Global Healthcare Conference 2025
Wednesday, September 3rd, 2025 at 9:10 AM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Li Watsek, Director, Biotechnology Analyst
IDEAYA Biosciences 10-Year Anniversary R&D Day
Monday, September 8th, 2025 at 8:00 AM ET

The Company will host an in-person and virtual R&D Day to share multiple clinical data updates across the pipeline, outline upcoming catalysts and key growth drivers, and review its long-term portfolio strategy.
The event will feature key opinion leader (KOL) Dr. Arun D. Singh, Director of the Department of Ophthalmic Oncology at the Cole Eye Institute, Cleveland Clinic, who will join members of the company’s leadership team.

Morgan Stanley 23rd Annual Global Healthcare Conference
Tuesday, September 9th, 2025

Management will be participating in one-on-one investor meetings.
A live audio webcast of the conference events, as permitted by the conference host, will be available at the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of available webcasts will be accessible for 30 days following the live event.

On August 25, 2025 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported the first patient has been successfully dosed in the Phase Ⅱ trial of LBL-034 (GPRC5D/CD3 BsAb) following strong Phase Ⅰ data (Press release, Nanjing Leads Biolabs, AUG 25, 2025, View Source;trial-302537572.html [SID1234655470]). This milestone endows LBL-034 with the potential to become the first domestic T-cell engager (TCE) therapy targeting GPRC5D.

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Innovative Design with Best-in-Class Potential

LBL-034 is a GPRC5D/CD3 bispecific T-cell engager with a uniquely designed 2:1 format. By optimizing anti-CD3 affinity and steric hindrance, LBL-034 effectively redirects and activates T cells to target GPRC5D+ cancer cells, being less prone to inducing nonspecific T-cell activation. This dual advantage—robust antitumor efficacy combined with favorable safety—positions LBL-034 as a best-in-class candidate.

Outstanding Phase Ⅰ Data with Initial Evidence of CAR-T-Like Efficacy

LBL-034 has demonstrated strong efficacy signal and favorable safety profile among over 50 enrolled patients at dose levels up to 1200 μg/kg in its open-label, multi-center, dose-escalation/expansion phase Ⅰ trial for the treatment of relapsed/refractory multiple myeloma (MM). At higher doses, LBL-034 showed a robust objective response rate (ORR) similar to CAR-T treatment. Notably, promising efficacy was also observed in the subgroup of patients with difficult-to-treat extramedullary (EMD) plasmacytomas. Furthermore, the minimal residual disease (MRD) negativity rate was also significantly higher than with current standard of care. The detailed results of this study, including efficacy, safety, PK/PD, biomarker, and exposure-response analyses, will be presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

Phase Ⅱ Trial Initiated

The Phase Ⅱ trial of LBL-034 is a multi-center, single-arm, multi-cohort clinical trial led by Professor Lu Jin of Peking University People’s Hospital, with participation from over 20 hospitals across China. The trial aims to evaluate the efficacy and safety of LBL-034 in patients with various relapsed/refractory plasma cell neoplasms.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The successful dosing of the first Phase Ⅱ patient marks a critical step in our TCE pipeline and validates our unique molecular design. We will continue advancing clinical development with high standards to deliver China’s first GPRC5D-targeted TCE therapy, offering patients safer and more effective options."

Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "LBL-034’s exceptional Phase Ⅰ data and smooth Phase Ⅱ initiation underscore the core advantage of our Leadsbody platform—conditional activation. This success bolsters confidence in our broader pipeline and accelerates breakthroughs in TCE therapies for solid tumors, hematologic malignancies, and autoimmune diseases. We remain committed to driving innovation and delivering transformative treatments globally."

About LBL-034

LBL-034 is a bispecific T-cell engager targeting both GPRC5D and CD3 developed using Leads Biolabs’ proprietary LeadsBody platform. LBL-034 is designed with a 2:1 format, with two binding sites targeting GPRC5D and one targeting CD3. This design enables LBL-034 to effectively redirect and activate T cells to target GPRC5D+ cancer cells, being less prone to inducing T cell exhaustion and cell death and minimizing the risk of cytokine release syndrome and immunotoxicity.

LBL-034 has exhibited promising efficacy signals in our preclinical studies. According to Frost & Sullivan, as of November 2024, LBL-034 is the second most clinically advanced GPRC5D-targeted CD3 T-cell engager globally and the first in China in terms of clinical progress, and is expected to become the first domestic TCE therapy targeting GPRC5D. LBL-034 obtained the orphan drug designation from the FDA for the treatment of MM in October 2024.