1stOncology™: Cancer Intelligence Service – Page 25 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Immutep Announces Release of CTOS 2026 Abstract Reporting First Survival Data from EFTISARC-NEO

On November 10, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) reported the release of an abstract reporting interim disease-free survival data and clinicopathological correlates from EFTISARC-NEO, the investigator-initiated Phase II trial of eftilagimod alfa (efti) plus KEYTRUDA (pembrolizumab) and radiotherapy as neoadjuvant treatment for resectable soft tissue sarcoma (STS). Further detail and analyses will be presented in a poster discussion session on 19 November 2026 at the Connective Tissue Oncology Society (CTOS) 2026 Annual Meeting, being held from 18–21 November 2026 in Seoul, South Korea.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

As reported in October 2025, EFTISARC-NEO has met its primary endpoint, with a median tumour hyalinisation/fibrosis of 51.5% in 38 evaluable patients, well above the pre-specified target of 35% and approximately 15% historically observed with radiotherapy alone.1 Health-related quality of life data presented at the ESMO (Free ESMO Whitepaper) Congress 2026 in October showed no significant deterioration during treatment and a statistically significant improvement following surgery. The U.S. Food and Drug Administration granted Orphan Drug Designation to efti for the treatment of STS in April 2026. The survival outcomes reported here are secondary endpoints of the trial.

With a median follow-up of 19.1 months, the 12-month disease-free survival (DFS), local recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) rates were 81.1%, 94.1% and 86.2%, respectively, in 38 evaluable patients (data cut-off 30 April 2026). No differences in DFS were observed across tumour grade, stage or histological subtype.

The investigators concluded that efti plus pembrolizumab on top of standard radiotherapy as neoadjuvant therapy showed promising preliminary long-term outcomes warranting registrationally relevant trials in patients with STS. The investigators reported that high infiltration by tumour-infiltrating lymphocytes (TIL) and tumour hyalinisation/fibrosis after therapy may be associated with better DFS but that longer follow-up is necessary.

Follow-up for DFS and overall survival is ongoing.

For further details see the Events section of Immutep’s website. The poster with updated data will be made available on the Posters & Publications page of Immutep’s website at www.immutep.com following its presentation at the meeting.

About EFTISARC-NEO

EFTISARC-NEO is an investigator-initiated, open-label Phase II trial evaluating eftilagimod alfa in combination with KEYTRUDA (pembrolizumab) and radiotherapy as neoadjuvant treatment for patients with resectable soft tissue sarcoma. The trial is led by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, and is primarily funded by a grant from the Polish Medical Research Agency, with Immutep supplying efti. The primary endpoint is pathological response, measured as the percentage of tumour hyalinisation/fibrosis at resection. Secondary endpoints include safety, disease-free survival, local recurrence-free survival, distant metastasis-free survival, overall survival, radiological response and health-related quality of life. Forty patients were enrolled, with enrolment completed in January 2025 (ClinicalTrials.gov: NCT06128863).

About Eftilagimod Alfa (efti)

Eftilagimod alfa (efti) is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that activates antigen-presenting cells through the MHC Class II pathway, engaging both innate and adaptive immunity, including the priming of cytotoxic CD8+ T cells and the production of co-stimulatory signals and cytokines. Its favourable safety profile enables combination with anti-PD-(L)1 therapy, radiotherapy and/or chemotherapy. Efti has received Fast Track designation from the U.S. Food and Drug Administration in first-line head and neck squamous cell carcinoma and first-line non-small cell lung cancer, and Orphan Drug Designation in soft tissue sarcoma.

(Press release, Immutep, NOV 10, 2026, View Source [SID1234674596])

TME Pharma provides further details on the exclusive negotiation agreement with TMS Co., Ltd. for NOX-A12

On November 10, 2026 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotech-company with clinical assets for brain cancer and eye diseases, reported further details regarding the exclusive negotiation agreement and non-binding term sheet signed with TMS Co., Ltd. on October 29, 2026.

Binding and non-binding terms

The exclusive negotiation period of 6 months and the non-refundable exclusivity fee of €150,000 are binding. The period may be extended by up to three months against a non-refundable payment of €50,000 per month.
The economic terms are negotiated as basis for the further discussions for a definitive license agreement; these terms are non-binding and may differ in a definitive agreement; there is no assurance that a definitive agreement will be concluded. A definitive agreement would only become effective once TMS’ Japanese Subsidiary has secured enough funding for the GLORIA Trial to be restarted.
Financial terms

Near term payments to TME Pharma of approximately € 10 million are conditional to signing of this definite agreement; approximately half is expected to come in cash and approximately half in equity in the Subsidiary with up to 20% shareholding. By becoming a shareholder in the Subsidiary, the potential long term value (in case of successful results from the GLORIA Trial) for TME Pharma shareholders, will increase.
Revenue potential from milestone payments is more than €100 million, thereof approximately €37 million in regulatory milestones through approval (with the potential for the earliest first payment to be received after 2 years), the remainder being milestones linked to sales. Tiered royalties on net sales (8-10%) and a share of potential sublicensing revenues would be further in the future. All milestones and royalties depend on clinical, regulatory and commercial success and may never be received. Investors can use a risk-adjusted valuation model to calculate potential value of the potential agreement, weighing future revenue streams against the risk of failing to achieve the ultimate goals.
Market size and sales estimate
TME estimates that the market for first-line treatment of newly diagnosed glioblastoma in the US and the EU-27 could be worth approximately €3 billion per year at the time NOX-A12 is launched, growing to approximately €4 billion per year by 20461. This estimate assumes a twelve-month course of treatment priced in line with atezolizumab, an approved cancer checkpoint antibody, when used in combination with bevacizumab2. Approximately 54% of newly diagnosed patients have chemotherapy refractory (MGMT-unmethylated) tumors3 for whom current treatments are least effective; this is the population studied in the GLORIA trial. Assuming successful clinical development and regulatory approval of NOX-A12, which are uncertain, and a market share of approximately half of the chemotherapy refractory patients, TME estimates annual sales of approximately €1 billion around 2040. For its internal risk-adjusted product valuation of this product, TME Pharma applies industry-standard attrition rates for oncology products4.

Diede van den Ouden, CEO TME Pharma:

"We are delighted to be collaborating with Mr. Wakabayashi and TMS Co., Ltd. We have been impressed by their professionalism, enthusiasm, and dedication. We are pleased with TMS as our partner given their experience and track record. TME Pharma will be actively involved in supporting the Subsidiary in its discussions with investors, such as venture capital firms both in and outside Japan."

Takuro Wakabayashi, CEO TMS Co., Ltd:

"After our due diligence and discussions with TME Pharma’s management, we believe in the potential of NOX-A12. Furthermore, publications in Nature Communications and the recent award (German University Medicine Prize) are consistent with the quality of the research. I am very pleased to be working with TME Pharma; we entered into this agreement with the intention of securing the funding needed to resume the GLORIA study, and are working towards that goal."

Financial visibility
TME Pharma’s financial visibility into Q2 of 2028 does not depend on a potential transaction with TMS Co., Ltd. TME Pharma announced on October 26, 2026 that it has extended the maturity of its debt until June 30, 2028 and also secured two new bonds, with further financing of €1M available at the Company’s discretion. Any cash proceeds from the license agreement would represent an additional source of cash flow on top of the existing financial situation and would further strengthen the company’s financial position.

Main risks
The definitive agreement may not be concluded, or may be concluded on different terms, and the Subsidiary may not secure the required funding. During the exclusivity period, TME Pharma cannot negotiate with other partners for NOX-A12 and TMS Co., Ltd. may end the negotiations at any time. If the transaction does not proceed, the development of NOX-A12 would remain paused until an alternative partner or financing is found. TME Pharma will inform the market of material developments in the negotiations, positive or negative, and of the terms of a definitive agreement if one is signed.

(Press release, TME Pharma, NOV 10, 2026, View Source [SID1234674595])

PDS Biotech Announces Exercise of Warrants by NantWorks for Approximately $3.9 Million in Gross Proceeds

On November 10, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer, reported NantWorks has exercised its outstanding common stock warrants to purchase an aggregate of 17,699,115 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at an exercise price of $0.22 per share. The gross proceeds to the Company from the exercise of existing warrants were approximately $3.9 million.

The Company intends to use the net proceeds from the warrant exercise, together with the net proceeds from the September 2026 private placement, to support the advancement of PDS0301 toward a Phase 3 trial in metastatic colorectal cancer, as well as the Company’s partnership strategy for PDS0101 and general corporate purposes.

The common stock warrants were issued in connection with the private placement that initially closed on September 14, 2026, in which the Company received gross proceeds of approximately $11.3 million.

The common stock warrants are subject to a 19.9% beneficial ownership limitation, which applies to the holder together with its affiliates and other attribution parties and may not be waived. In accordance with the terms of the warrants, the portion of the exercise that would have caused the holder to exceed this limitation was exercised for pre-funded warrants in lieu of shares of common stock. The pre-funded warrants have an exercise price of $0.00033 per share, do not expire and are subject to the same beneficial ownership limitation.

The shares of common stock issued upon exercise of the warrants have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, PDS Biotechnology, NOV 10, 2026, View Source [SID1234674567])

Agilent Expands Tumor Profiling Portfolio with SureSelect Cancer Research Pan Heme

On November 10, 2026 Agilent Technologies Inc. (NYSE: A) reported the SureSelect Cancer Research Pan Heme, a hybrid capture-based next-generation sequencing (NGS) research solution for comprehensive genomic profiling of hematologic malignancies. Developed in collaboration with experts at Roswell Park Comprehensive Cancer Center, the solution integrates DNA and RNA profiling, automated sample preparation and bioinformatics in a streamlined workflow.

The introduction of SureSelect Cancer Research Pan Heme expands Agilent’s tumor profiling portfolio for cancer research, providing a purpose-built solution for comprehensive profiling of hematologic tumors alongside SureSelect Cancer Research CGP for solid tumors and SureSelect Human All Exon V8 for ultra-comprehensive profiling for research across cancer types.

SureSelect Cancer Research Pan Heme interrogates 359 DNA genes and 124 RNA genes and assesses major classes of genomic alterations, including single-nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), IGH/IGK/IGL translocations and gene fusions. The solution combines Agilent SureSelect target enrichment technology with automated workflow options and integrated analysis capabilities.

"Researchers studying hematologic malignancies need comprehensive genomic information while also managing increasingly complex laboratory workflows," said Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division. "SureSelect Cancer Research Pan Heme brings together DNA and RNA profiling, walkaway automation and analysis in an integrated research workflow, helping laboratories generate deeper molecular insights while reducing hands-on demands and simplifying the path from sample to results."

The panel was codeveloped with hematologic cancer experts at Roswell Park Comprehensive Cancer Center, whose expertise informed panel content curation and assay optimization. In Roswell Park’s current implementation, the integrated laboratory and informatics workflow supports sample-to-report results in approximately 48 hours.

"Hematologic malignancies are incredibly complex, and gaining a comprehensive view often requires looking at both DNA and RNA," said Sean Glenn, Ph.D., vice chair of molecular pathology at Roswell Park Comprehensive Cancer Center. "We’ve been able to combat these limitations with Agilent to streamline comprehensive genomic profiling into an efficient automated workflow, providing insights in about 48 hours. We’re excited to see this workflow become available to researchers to help simplify and democratize a robust molecular profiling solution for hematologic cancer research."

SureSelect Cancer Research Pan Heme can be paired with the Agilent Magnis NGS Prep System for fully automated library preparation and target enrichment. Magnis uses prefilled, cartridge-based reagents to simplify workflow setup and enables walkaway operation, allowing laboratories to extend processing into unattended and overnight hours. QIAGEN Clinical Insight (QCI) supports variant analysis and reporting. Manual and semiautomated configurations are also available to support different laboratory workflow and throughput requirements.

SureSelect Cancer Research Pan Heme is For Research Use Only. Not for use in diagnostic procedures.

(Press release, Agilent, NOV 10, 2026, View Source [SID1234674594])

FDA Approves Promega OncoMate® MSI Dx Analysis System as Companion Diagnostic for KEYTRUDA® in MSI-High Solid Tumors

On November 10, 2026 The U.S. Food and Drug Administration (FDA) reported it has approved the Promega OncoMate MSI Dx Analysis System designed to identify patients with microsatellite high (MSI-H) solid tumors as a companion diagnostic designed for KEYTRUDA, Merck’s (known as MSD outside the U.S. and Canada) anti-PD-1 therapy.

OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in solid tumor tissue. MSI status can be used to inform treatment decisions and support precision oncology strategies.

"This approval reflects our dedication to providing meaningful diagnostic advances, developed to the highest quality and regulatory standards," says Alok Sharma, Global Clinical Market Director at Promega. "Our test connects patients with the therapy most likely to help them, working alongside our pharmaceutical collaborators and the clinicians who use the result."

This approval was supported through a collaboration with Merck, which markets KEYTRUDA. Together, the companies are working to advance personalized medicine and expand access to diagnostics that enable informed therapeutic choices.

OncoMate MSI Dx Analysis System was previously cleared by the FDA as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from additional testing to diagnose Lynch syndrome. It is also an approved companion diagnostic to identify patients with microsatellite stable (MSS) endometrial carcinoma who may benefit from treatment with KEYTRUDA plus LENVIMA (Lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. These approvals apply to the United States and its territories. Promega MSI technology is also CE-marked under IVDR in the European Union and has received approval from China’s National Medical Products Administration (NMPA) as a companion diagnostic to identify patients with MSI-H solid tumors who may benefit from treatment with KEYTRUDA.

KEYTRUDA is indicated for adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient cancer who have progressed following prior treatment and who have no satisfactory alternative treatment options. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Promega, NOV 10, 2026, View Source [SID1234674593])