On October 20, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The findings demonstrate that Signatera can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab (Tecentriq) in MIBC, resulting in improved disease-free survival (DFS) and overall survival (OS). Results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

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Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.

IMvigor011 prospectively evaluated adjuvant atezolizumab versus placebo in patients with MIBC who were identified as Signatera-positive based on serial testing up to 7 times in the first year post-cystectomy.

Study highlights:

761 patients were enrolled in surveillance, of whom half tested Signatera-positive and 250 were randomized to atezolizumab vs. placebo.

Signatera-positive patients treated with atezolizumab experienced a >2x increase in median DFS compared to placebo. Median DFS was 9.9 months for patients treated with atezolizumab vs 4.8 months for placebo (HR: 0.64; P=0.005). Signatera-positive patients in the treatment arm also had a statistically significant and clinically meaningful improvement in OS (median of 32.8 months vs. 21.1 months; HR: 0.59; P=0.01).

Signatera-negative patients had excellent outcomes without adjuvant immunotherapy. Patients who remained persistently Signatera-negative during surveillance without adjuvant treatment had very low recurrence risk (DFS of 95.4% at 1 year and 88.4% at 2 years). OS outcomes were also incredibly strong, sparing patients from unnecessary treatment and potentially associated toxicity.
"IMvigor011 has delivered practice-changing evidence in bladder cancer," said Professor Thomas Powles, lead principal investigator of IMvigor011, professor of genitourinary oncology, chair of Barts Cancer Centre at St. Bartholomew’s Hospital. "Patients who tested Signatera-positive clearly benefitted from atezolizumab, while those who remained Signatera-negative had excellent outcomes without additional treatment. This is the most impactful data to date for personalized MRD testing, reinforcing Signatera’s predictive abilities to transform care."

"This is the first study to demonstrate that the adjuvant treatment decision window can be safely extended to one year post-surgery, minimizing overtreatment and allowing therapy to be precisely guided by Signatera results," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "These findings can redefine the standard of care in muscle-invasive bladder cancer and also underscore the broader potential for Signatera-guided management across multiple tumor types."

Data from IMvigor011 will support Natera’s premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for the selection of patients with MIBC to be treated with atezolizumab after cystectomy.

(Press release, Natera, OCT 20, 2025, View Source [SID1234656851])

On October 20, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Chinese National Intellectual Property Administration (CNIPA) has issued Patent Number ZL2020800215666, covering key aspects of the Company’s breast cancer vaccine technology.

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Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein vaccine strategy aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue. The vaccine was invented at Cleveland Clinic, and this patent—along with others related to this technology—has been exclusively licensed to Anixa Biosciences.

This patent issuance builds upon the Company’s broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the 2040s in multiple jurisdictions throughout the world. By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies.

"This newly issued patent further demonstrates the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this patent further strengthens our ability to pursue strategic global opportunities in regions with a high incidence of breast cancer."

A Phase 1 clinical trial of Anixa’s breast cancer vaccine has been recently completed and Cleveland Clinic will present full clinical results at the San Antonio Breast Cancer Symposium on December 11, 2025.

(Press release, Anixa Biosciences, OCT 20, 2025, https://www.prnewswire.com/news-releases/anixa-biosciences-announces-issuance-of-chinese-patent-covering-breast-cancer-vaccine-technology-302588477.html [SID1234656836])

On October 20, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen. The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.

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"We are pleased the agency has accepted the resubmission of our BLA for RP1," said Sushil Patel, Ph.D., CEO of Replimune. "RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy. We look forward to working closely with the agency to expedite this review as much as possible for patients’ benefit."

During the past few months, Replimune has been working to address agency feedback. Additional information, data and analyses were included in the resubmission which will be part of the BLA review. The FDA indicated this resubmission is considered to be a complete response to the complete response letter received in July 2025.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, OCT 20, 2025, View Source [SID1234656821])

On October 20, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) reported the latest results from the ongoing Phase I/II CLINCH study of ATG-022 (CLDN18.2 ADC), were presented in a Poster Presentation at ESMO (Free ESMO Whitepaper) 2025.

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Details of the Poster Presentation:
Title: Phase I/II study of CLDN18.2 ADC ATG-022 in patients with advanced gastric/gastroesophageal junction cancer (CLINCH)
Abstract Number: 2907
Presentation Number: 2113P

ATG-022 and CLINCH Study Overview

ATG-022 is a CLDN18.2-targeted ADC with sub-nM affinity and fast internalization. Using a VC-MMAE linker-payload (DAR 4), ATG-022 has demonstrated potent activity across tumors with high/low/ultra-low CLDN18.2 expression.
The ongoing Phase I/II CLINCH study consists of dose escalation and dose expansion phases. In dose escalation, patients with advanced solid tumors regardless of CLDN18.2 expression receive ATG-022 (0.3-3.0 mg/kg Q3W) to evaluate safety, tolerability, and pharmacokinetics; CLDN18.2-positive (≥IHC 1+, 1%) patients are treated at 1.8 or 2.4 mg/kg in dose expansion to evaluate the efficacy and safety.
Key Results Presented

Efficacy:
Among GC/GEJC patients with moderate/high CLDN18.2 expression (IHC 2+ >20%), the 2.4 mg/kg dose cohort observed 1 CR, 11 PRs and 15 SDs, resulting in 40% ORR (12/30) and 90% DCR (27/30). The median PFS was 6.97 months and the 12-month OS rate was 66.2%. In the 1.8 mg/kg dose cohort, there were 1 CR, 9 PRs, and 11 SDs, giving a 40% ORR (10/25) and 84% DCR (21/25).
Among GC/GEJC patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤20%), patients treated at the efficacious dose of 1.8-2.4 mg/kg achieved 1 CR and 5 PRs, resulting in 33.3% ORR (6/18) and 50%DCR (9/18). The CR patient has demonstrated durable response and has been on the study for 22+ months.
Safety:
At 2.4 mg/kg in the dose expansion, 45.8% of patients had ≥1 TEAEs, 60.4% of patients had grade ≥3 TEAEs.
In the dose-expansion phase, the 1.8 mg/kg cohort demonstrated excellent safety and tolerability, with only 13.6% of patients reporting serious TEAEs and 18.2% reporting Grade ≥3 TEAEs. The favorable safety profile of this dose level support its potential use in first-line combination regimens with chemotherapy and immune checkpoint inhibitors.
Conclusions and Outlook

ATG-022 demonstrated a manageable safety profile and encouraging antitumor effects in GC/GEJC adenocarcinoma patients with a broad range of CLDN18.2 expressions, thus supporting further clinical investigation in patients with variable CLDN18.2 expressions.
Preliminary efficacy has also been observed in other non-GI tumor types which will be reported at upcoming conferences.
The 2.4 mg/kg cohort showed a favorable safety profile, while the 1.8 mg/kg cohort demonstrated even better safety and tolerability. These findings provide strong support for advancing ATG-022 in combination with immune checkpoint inhibitors and chemotherapy in first-line treatment settings, paving the way to significantly expand its clinical reach and commercial potential.

(Press release, Antengene, OCT 20, 2025, View Source [SID1234656837])

On October 19, 2025 NETRIS Pharma, a clinical-stage biotechnology company pioneering novel therapies targeting Netrin-1 to overcome resistance to chemotherapy and immunotherapy, reported the presentation of the first results from its ongoing Phase 2 clinical trial IMMUNONET. The Study evaluates NP137 in combination with anti–PD-1/PD-L1 therapies with advanced solid tumors. The data will be shared in a poster session at the upcoming ESMO (Free ESMO Whitepaper) Oncology Congress 2025 in Berlin, Germany.

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Resistance to Immune Checkpoint Inhibitors (ICI) remains a major challenge in the treatment of solid tumors such as non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). Netrin-1, an embryonic guidance factor re-expressed in various cancers, contributes to tumor resistance and epithelial-to- mesenchymal transition (EMT). NP137, a first-in-class monoclonal antibody targeting Netrin-1, has demonstrated the ability to inhibit EMT and modulate the tumor microenvironment, thereby potentially restoring sensitivity to immunotherapy.

IMMUNONET (NCT05605496) was designed to evaluate whether NP137 was able to (re)-sensitize solid tumors to ICI. Patients who had progressed under a prior anti–PD-1/PD-L1 were enrolled to receive NP137 as an add–on to their immunotherapy. They were enrolled in 3 distinct cohorts depending on their best response and time to progression (cohort 1, stable disease; cohort 2, primary refractory and cohort 3, secondary refractory). The study was designed as a 2-stage adaptive design. This poster reports the results of stage 1. In cohort 3 (secondary refractory) where a majority of NSCLC and HNSCC patients were enrolled, the primary endpoint of Progression-Free Rate at 12 weeks (PFR-12W) was met ahead of stage 2. These results strongly suggest the efficacy of combining NP137 with anti–PD-1/PD-L1 therapy in this difficult-to-treat population and warrant further controlled studies to confirm these findings.

Importantly, the combination of NP137 with ICI was very well tolerated. « These preliminary results are particularly encouraging » said Dr Jérome Fayette, M.D., Ph.D., Principal Investigator of the study. « Patients who have progressed after prior anti–PD-1/PD-L1 therapy represent one of the most difficult populations to treat. The encouraging efficacy and safety results observed in this study strongly support the continued clinical development of NP137. Advancing to a confirmatory randomized study will allow to further validate these findings and better define the therapeuticpotential of NP137 in combination with immune checkpoint inhibitors for patients with advanced solid tumors ».

« Observing durable disease control in this setting supports the concept that targeting Netrin-1 can re-sensitize tumors to immune checkpoint inhibition » added Dr. Sébastien Hazard, Chief Medical Officer of NETRIS Pharma. « Combining NP137 with checkpoint inhibitors may offer a new option for patients who no longer benefit from standard immunotherapy ».

Poster Details

Title: NP137 combined with anti–PD-1/PD-L1 therapy in ICI-pretreated solid tumors: Interim efficacy and safety results from the IMMUNONET study
Session: 966P
First Author: Dr. Jerome Fayette
About EIC Accelerator

The EIC Accelerator supports individual Small and Medium Enterprises (SMEs), in particular Startups and spinout companies to develop and scaleup game-changing

innovations. ImmunoNET is co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or NETRIS Pharma. Neither the European Union nor NETRIS Pharma can be held responsible for them.

(Press release, Netris Pharma, OCT 19, 2025, View Source [SID1234656772])