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Greenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial

On October 9, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the expansion of FLAMINGO-01 clinical trial to Austria (Press release, Greenwich LifeSciences, OCT 9, 2025, View Source [SID1234656534]).

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The Company’s application to European regulators has been formally approved, adding Austria as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 6,070 new cases of breast cancer were diagnosed in Austria in 2022, which is the most common cancer diagnosed in women, representing approximately 28% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Austria with 1,789 deaths in 2022.

CEO Snehal Patel commented, "We are collaborating with principal investigators at the Ordensklinikum Linz in Upper Austria. The site approached the Company after patients asked about participating in FLAMINGO-01. We recently visited the site in Linz, where we started training activities. We hope to activate the site this year and plan to further develop the geographic strategy for Austria, where we are considering additional sites in Vienna and Salzburg."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

CytoDyn to Present at the LD Micro Main Event XIX Investor Conference

On October 9, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that CFO Robert E. Hoffman will present a corporate overview at the LD Micro Main Event XIX Investor Conference from October 19 – 21, 2025 at the Hotel Del Coronado in San Diego, California (Press release, CytoDyn, OCT 9, 2025, View Source [SID1234656533]).

Presentation Date: Tuesday, October 21, 2025

Time: 9 a.m. PDT

Register to view presentation: Webcast Link

Mr. Hoffman will be available for one-on-one meetings with conference attendees. To request a meeting to discuss the Company’s current development strategy and upcoming milestones, please contact [email protected].

Bio-Techne and Oxford Nanopore Technologies Expand Agreement to Accelerate Development of Genetics Portfolio Through 2032

On October 9, 2025 Bio-Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents, and diagnostic products, reported a significant enhancement to its agreement with Oxford Nanopore Technologies (LSE: ONT) (Press release, Bio-Techne, OCT 9, 2025, View Source [SID1234656530]). The expanded agreement broadens Bio-Techne’s ability to develop a portfolio of genetic products on Oxford Nanopore Technologies platforms and extends the collaboration through 2032.

Building upon the successful launch of the AmplideX Nanopore Carrier Plus Kit in March 2025, the enhanced collaboration streamlines coordination on the development and commercialization of a broader portfolio of targeted enrichment sequencing kits for the screening and diagnosis of heritable genetic disorders.

"This expanded agreement underscores our commitment to advancing genetic testing solutions that simplify workflows and deliver richer insights for laboratories worldwide," said Matt McManus, President of the Diagnostics and Spatial Biology Segment of Bio-Techne. "By deepening our collaboration with Oxford Nanopore, we are accelerating innovation in diagnostics and creating a foundation for future portfolios."

"We’re pleased to expand our collaboration with Bio-Techne to bring new genetic testing solutions to laboratories worldwide. By combining Bio-Techne’s diagnostics expertise and innovations with our advanced molecular sensing platform, together we can make testing faster, simpler, and more accessible," said Rosemary Dokos, Chief Product and Marketing Officer of Oxford Nanopore Technologies.

AMPLIA THERAPEUTICS REPORTS ADDITIONAL RESPONSES IN ACCENT PANCREATIC CANCER TRIAL

On October 9, 2025 Amplia Therapeutics Limited (ASX: ATX), referred to as "Amplia" or "the Company", reported an update from the ongoing ACCENT clinical trial, which is investigating the company’s leading FAK inhibitor, narmafotinib, in combination with the chemotherapies gemcitabine and Abraxane for the treatment of advanced pancreatic cancer. The trial is being conducted across sites in Australia and Korea (Press release, Amplia Therapeutics, OCT 9, 2025, View Source [SID1234656519]).

LATEST TRIAL DATA AND KEY FINDINGS

An additional confirmed partial response and an unconfirmed partial response have been recorded as part of the data analysis from the ACCENT Trial following the data cut off on 25 Sept 2025. These new findings bring the Objective Response Rate (ORR) to 33%, a notable improvement over the 23% response rate previously observed with chemotherapy alone1. The objective response rate measures only the partial and complete responses that have been confirmed by an additional scan after 2 months. When all confirmed and unconfirmed responses are taken together, the response rate is 42%.

The mean duration on trial—a key indicator of the drug combination’s ability to halt cancer progression— is 219 days, which is substantially longer than the duration typically achieved with chemotherapy alone. Notably, seven patients have remained on the study for at least 12 months, and two patients have continued for more than 18 months. These results are consistent with previously reported data2 showing a median Progression Free Survival (mPFS) of 7.6 months, representing a two-month improvement compared to chemotherapy alone. There are currently nine (9) patients on study.

Immutep Announces Update for TACTI-004 (KEYNOTE-F91) Phase III Trial in First Line Non-Small Cell Lung Cancer

On October 9, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported a patient enrolment update for the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy as first line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC) (Press release, Immutep, OCT 9, 2025, View Source [SID1234656518]).

This registrational Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount necessary to conduct the futility analysis. Additionally, the number of activated clinical trial sites continues to expand at a strong pace and there are now over 100 active clinical sites across 24 countries globally.

The futility analysis will be assessed by an independent data monitoring committee (IDMC) based on the data of a predefined number of patients with sufficient follow-up (minimum 12 weeks) and predefined criteria for efficacy. The trial remains on track for the IDMC to conduct the futility analysis in the first quarter of CY2026.

Immutep Chief Executive Officer, Marc Voigt, said, "We are very pleased with the pace of enrolment in our pivotal Phase III trial that we believe has the potential to change the treatment landscape in non-small cell lung cancer, one of the largest indications in oncology with over two million diagnoses annually worldwide. The trial remains on track for key milestones ahead including futility analysis in early 2026."

Immutep CMO, Stephan Winckels, M.D., Ph.D., added, "Our engagement with the principal investigators and physicians in the lung cancer community at medical conferences throughout the year, including WCLC 2025 last month, has consistently resulted in constructive feedback. Notably, their favourable assessments of the trial design and of efti as an innovative immunotherapy—capable of safely increasing response rates and improving efficacy in non-small cell lung cancer patients regardless of PD-L1 expression—provide a strong basis for ongoing positive enrolment trends."

The TACTI-004 trial follows positive efficacy and safety results from two previous studies, TACTI-002 and INSIGHT-003, which tested efti with KEYTRUDA in 1L NSCLC. With in total over 165 patients enrolled, both trials demonstrate that efti enhances anti-PD-1 therapy regardless of PD-L1 expression levels. The novel combination of these two immunotherapies has led to high response rates and strong progression-free survival (PFS). Both trials show these responses and PFS translate into significantly improved overall survival, addressing a high unmet need for these patients.

Lung cancer is the leading cause of death among all cancer types and the incidence is set to increase to approximately 3 million cases worldwide by 2030.1 NSCLC is the most common type of lung cancer representing ~80-85% of all diagnoses.2 The condition is often diagnosed at a late stage, and less than 30% of patients are alive five years after diagnosis.3,4 There remains a high unmet need for additional treatment options for people living with NSCLC.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About TACTI-004
TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial will enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients will be randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints are progression-free survival and overall survival.

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).