On October 15, 2025 Eikon Therapeutics, Inc., a late-stage clinical biopharmaceutical company dedicated to integrating advanced engineering with cutting-edge laboratory and in silico research to accelerate drug discovery, reported that new data from an ongoing Phase 2 study of EIK1001 (TeLuRide-005) will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany from October 17-21, 2025.

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The presentation, titled "TeLuRide-005: Phase II study of EIK1001, a toll-like receptor 7/8 (TLR7/8) co-agonist with pembrolizumab (pembro)+chemotherapy (chemo) as first-line (1L) therapy in stage 4 non-small cell lung cancer (NSCLC)", will be delivered by Richard J. Gralla, M.D., Albert Einstein College of Medicine, during the Mini Oral Session 2 (1850MO – NSCLC metastatic) on Monday, October 20 at 10:55AM CEST.

"EIK1001 represents a unique approach to stimulating the immune system, and we are encouraged by its potential to improve outcomes for patients with advanced non-small cell lung cancer," said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon Therapeutics. "By combining a systemically administered TLR7/8 co-agonist with standard-of-care pembrolizumab and chemotherapy, our goal is to broaden immune activation and enhance anti-tumor responses in this hard-to-treat population. These results, reviewed in a successful end-of-Phase-2 meeting with the FDA earlier this year, support the continued advancement of this program into a registration-enabling Phase 2/3 trial. We look forward to sharing these data at ESMO (Free ESMO Whitepaper)."

TeLuRide-005 (NCT06246110) is a Phase 2 study evaluating EIK1001 in combination with pembrolizumab (KEYTRUDA) and histology-appropriate chemotherapy (carboplatin plus either pemetrexed or paclitaxel) in patients with Stage 4 NSCLC. By stimulating a broad immune response through TLR7/8 co-activation, EIK1001 is designed to enhance T-cell recognition and tumor killing, potentially overcoming immune resistance often observed in advanced NSCLC. The molecule is designed to activate innate and adaptive immunity, providing both direct anti-tumor activity and complementary effects when used in combination with checkpoint inhibitors. The trial’s primary objective is to evaluate the safety and tolerability of EIK1001 in the triplet combination. In addition, Eikon hopes to explore whether the immunomodulatory mechanism of EIK1001 might improve lung cancer treatment regimens. EIK1001 is also being studied in a seamless Phase 2/3 trial (TeLuRide-006; NCT06697301) evaluating its addition to standard-of-care pembrolizumab for the treatment of patients with advanced melanoma.

"The data being presented at ESMO (Free ESMO Whitepaper) mark another step forward for EIK1001 and underscore the increasing momentum across our oncology portfolio," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer of Eikon Therapeutics. "This progress reflects the deep expertise of our team in advancing groundbreaking cancer therapies through clinical development, and we are eager to build on this foundation as we work to deliver important new medicines that address grievous illnesses."

Eikon is also advancing a portfolio of differentiated oncology programs, including both mid-stage clinical assets and internally derived candidates informed by the company’s proprietary single-molecule tracking (SMT) platform. They include:

EIK1003-001 (NCT06253130): A highly selective non-CNS-penetrant PARP1 inhibitor, currently being evaluated in a Phase 1/2 study of adults with advanced solid tumors. Initial pharmacokinetic, safety, tolerability, and early efficacy findings from the monotherapy dose-escalation cohort were reported at ASCO (Free ASCO Whitepaper) 2025.
EIK1004-001 (NCT06907043): A CNS-penetrant PARP1 inhibitor currently in a Phase 1/2 study assessing safety, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity in patients with advanced solid tumors, including those with brain metastases.
EIK1005: A novel, internally derived program targeting Werner (WRN) helicase for microsatellite unstable cancers and sensitive cancers that have other defects in DNA repair. EIK1005 is expected to begin Phase 1 clinical testing in Q4, 2025.

(Press release, Eikon Therapeutics, OCT 15, 2025, View Source [SID1234656685])

On October 15, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that six abstracts have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17–21 in Berlin, Germany.

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"We’re sharing research at ESMO (Free ESMO Whitepaper) Congress 2025, including two oral presentations, that highlight the growing role of real-world data and AI in developing more effective, personalized cancer treatments," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "These findings not only advance the development of new therapies but also equip clinicians with data-driven insights to guide patient care."

This year, Tempus will highlight its latest scientific and clinical research findings via two oral presentations and four poster presentations.

Oral Presentations:

Efficacy of Cabozantinib and Nivolumab in Cluster 1/2 Metastatic Clear Cell Renal Cell Carcinoma: Results from OPTIC RCC, a phase II trial of a novel RNAseq-based biomarker
Date/Time: October 17, 2025; 4:35 – 4:40pm CEST
Location: Karlsruhe Auditorium – Hall 5.2
Presentation 2591O
Session Name: Mini Oral session 1: GU tumours, renal & urothelial
Summary: The study reports initial results from the OPTIC RCC (NCT 05361720) phase II multicenter trial, a prospective study investigating a biomarker-driven approach to treating metastatic clear cell renal cell carcinoma. Patients are assigned to nivolumab/cabozantinib (IO/TKI) for angiogenic-driven tumors (cluster 1/2) or ipilimumab/nivolumab (IO/IO) for immune-inflamed tumors (cluster 4/5) based on RNAseq-based molecular subtyping. This presentation focuses exclusively on the 26 patients with angiogenic cluster 1/2 tumors who were treated with nivolumab/cabozantinib. Of the 21 patients who received at least one post-baseline scan to date, 100% achieved a reduction in tumor burden, resulting in a RECIST best response of 71% partial response and 29% stable disease, with no progressive disease. These initial findings suggest that using RNAseq data to assign patients with angiogenic tumors to cabozantinib/nivolumab increases the overall response rate compared to unselected historical controls.
Lymphocyte activation gene-3 (LAG3) expression patterns and immunotherapy (IO) response in metastatic renal cell carcinoma (mRCC)
Date/Time: October 17, 2025; 5:10 – 5:15 pm CEST
Location: Karlsruhe Auditorium – Hall 5.2
Presentation Number: 2593MO
Session Name: Mini Oral session 1: GU tumours, renal & urothelial
Summary: This study investigated the relationship between lymphocyte activation gene-3 (LAG3) RNA expression and outcomes in 425 clear cell metastatic renal cell carcinoma (mRCC) patients treated with first-line immunotherapy (IO), using Tempus’ de-identified multimodal data and analytical platform, Lens. The analysis revealed that LAG3 positively correlated with the expression of other immune checkpoint genes and with increased tumor-infiltrating immune cells. Crucially, while real-world overall survival was similar across LAG3 levels, low LAG3 expression was associated with a reduced real-world objective response rate compared to high LAG3. These findings suggest that LAG3 has potential utility as a marker for IO response and supports exploring combination IO strategies in RCC patients.
Poster Presentations:

Impact of tumor suppressor gene (TSG) alteration (alt) burden on outcomes in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC)
Presentation Number: 2452P
Summary: A real-world study of de-identified records from 2,173 patients with metastatic castration-sensitive prostate cancer (mCSPC) sequenced with the Tempus xT DNA assay investigated the impact of tumor suppressor gene (TSG) alterations (alt) on real-world overall survival (rwOS). The analysis was conducted in Tempus Lens Workspaces and compared the characteristics of patients with TSG alt to those with wild type TSG, identifying differences in median prostate-specific antigen (PSA) levels, visceral disease prevalence, and distinct patterns of co-occurring gene alterations. Critically, the analysis of rwOS showed that the presence of TSG alt—particularly an increased TSG alt burden—was associated with inferior survival outcomes following first-line therapy. These findings suggest that patients with mCSPC and high TSG burden constitute a high-risk group that may require biomarker-directed intensive first-line treatment, providing support for the ongoing Alliance phase 3 ASPIRE trial.
Unveiling Integrin Beta-6 (IB6): Real-World Expression from the IB6 Expression and Clinical Outcomes in Non-Small Cell Lung Cancer (BEACON) Study
Presentation Number: 1919P
Summary: Initial findings from the Integrin Beta-6 (IB6) Expression and Clinical Outcomes in Non-Small Cell Lung Cancer (BEACON) study detail a retrospective, real-world observational analysis of IB6 prevalence in patients with metastatic non-small cell lung cancer (mNSCLC). The study leveraged the Tempus de-identified database and analytical platform, Tempus Lens, to examine a preliminary cohort of 200 mNSCLC patient records, utilizing immunohistochemistry to determine IB6 expression levels. The results demonstrate not only that high IB6 expression is common in mNSCLC, but that high expression was particularly frequent in patients with non-squamous histology compared to those with squamous histology. These data underscore the potential of IB6 as a promising novel biomarker and therapeutic target in mNSCLC, supporting the rationale for continued development and investigation of IB6-directed therapies, such as the investigational agent sigvotatug vedotin.
The association between tumor immunogenomic features and first-line (1L) therapeutic outcomes in advanced biliary tract cancer (BTC)
Presentation Number: 94P
Summary: The researchers used Tempus Lens to conduct a real-world analysis of advanced biliary tract cancer (BTC) patients treated with first-line gemcitabine + cisplatin (G+C) with or without immunotherapy (ICI), investigating the association between tumor immunogenomic features and outcomes. The real-world overall survival (rwOS) for the total BTC cohort was similar between the G+C+ICI and G+C groups. The analysis also studied the natural history of patients with BTC and specific genomic alterations and found that FGFR2 fusions and HRR alterations were linked to improved rwOS, while KRAS alterations were associated with worse rwOS, regardless of the treatment regimen. These findings show that 1L regimens for BTC had similar rwOS and that genomic alterations have distinct prognostic impacts. Future analysis in clinical trials may help define new prognostic and predictive biomarkers across both early and late stage BTC.
ImmunoDriver-2: CD8 T cell and PD-L1 levels associate with first-line (1L) overall survival (OS) in immune checkpoint inhibition (ICI)-treated non-small cell lung cancer (NSCLC)
Presentation Number: 1920P
Summary: The research team conducted an analysis of de-identified records from 5,343 NSCLC patients using Tempus Lens to characterize the association of CD8 T cell (CD8T) and PD-L1 proportions with real-world overall survival (rwOS) and driver alterations (dAlts) in early and metastatic NSCLC patients treated with first-line ICI + chemotherapy (CT) or ICI alone. Using a cohort of Tempus’ de-identified data, the study found that in metastatic NSCLC, both PD-L1 and CD8T were associated with improved rwOS after 1L-ICI±CT, with CD8T further stratifying survival within PD-L1 groups. The rwOS was greatest when both CD8T and PD-L1 were high. Immunogenomic profiling showed that CD8T and PD-L1 were highest in tumors with no dAlts and those with KRAS dAlts, but were lowest in tumors with classic/non-classic EGFR dAlts. These findings suggest that the combined analysis of CD8T and PD-L1 may provide a valuable immunophenotype that applies across different disease stages and dAlt statuses to enrich for ICI efficacy.

(Press release, Tempus, OCT 15, 2025, View Source [SID1234656684])

On October 15, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported that Chairman and Chief Executive Officer Steven Quay, M.D., Ph.D. will participate in the Maxim Growth Summit on October 22–23, 2025 at the Hard Rock Hotel, New York City. Dr. Quay will also be available for one-on-one investor meetings during the conference.

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Why attend or follow along?

Clear strategy & focus: Atossa is concentrating capital on programs and data packages that can enable future regulatory submissions and potential commercialization.

Compelling thesis for new investors: Atossa believes the combination of disciplined capital allocation, clear clinical objectives, and a sizeable unmet need in breast cancer creates an attractive setup for long-term value creation.

Direct access to leadership: Conference 1x1s provide an opportunity to discuss Atossa’s development plans, milestones, and how the Company thinks about returns on R&D spend.
Call to Action
Prospective and existing investors are encouraged to visit Atossa website’s Investors section to review latest presentations, SEC filings, and FAQs, and to sign up for email alerts. Learn more about Atossa and $ATOS at www.atossatherapeutics.com (Investors → Events & Presentations).

Note to investors: To request a 1×1 meeting at the Maxim Growth Summit or to obtain the latest investor deck, please visit www.atossatherapeutics.com (Investors) or contact CORE IR at the emails below.

(Press release, Atossa Therapeutics, OCT 15, 2025, View Source [SID1234656683])

On October 15, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy approaches in oncology and inflammation & immunology (I&I), reported it will for the first time present preclinical data on its lead TriSTAR program, TriSTAR0701, a dual-payload T cell engager targeting Nectin-4, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.

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"The TriSTAR platform represents the next frontier in precision T cell engagers designed to harness the diversity of the T cell repertoire and selectively redirect unique T cell subsets against high value tumor targets," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "The disclosure of Nectin-4 as the first target of our TriSTAR platform marks an important milestone as we expand our pipeline. TriSTAR0701 exemplifies the versatility of our dual-payload design — combining targeted tumor engagement with synergistic T cell activation to unlock potent and durable antitumor activity."

TriSTAR is a first-in-class, dual-payload design that delivers two T cell activation signals to overcome exhaustion in "cold" tumors and improve therapeutic index via selective engagement of unique T cell subsets within the TIL compartment.

Presentation 1 details:

Title: TriSTAR0701, a first-in-class T cell receptor β chain-directed T cell engager, retargets Vβ T cell subsets to Nectin-4-expressing tumors to promote potent and durable antitumor activity
Conference: SITC (Free SITC Whitepaper) Annual Meeting 2025
Abstract Number: 914
Session Title: Immune-Stimulants and Immune Modulators
Session Date: Saturday, November 8
Marengo’s ongoing collaborations with Ipsen and the National Cancer Institute (NCI) are rapidly advancing a new class of immune therapies with the potential to transform outcomes across multiple solid tumor types. The company will feature four preclinical presentations in partnership with NCI evaluating rational combination strategies for Invikafusp alfa, the company’s lead clinical-stage program, with standard-of-care agents including immune checkpoint blockade (ICB), chemotherapies, HDAC inhibitors, and PARP inhibitors.

The results further validate the importance of therapeutic regimens intended to expand and sustain antitumor immune activation with Invikafusp alfa across broader patient populations and in earlier lines of therapy.

Presentation 2 details:

Title: Triple combination therapy with a TCR Vb-directed bifunctional molecule, cisplatin and anti-PD-1 in immune checkpoint blockade-refractory head and neck murine tumor models
Abstract Number: 629
Session Title: Combination Immunotherapies
Session Date: Friday, November 7
Collaboration: NIH/NCI CRADA
Presentation 3 details:

Title: A novel anti-TCR Vb targeted bispecific antibody in combination with a poly ADP-ribose polymerase inhibitor (PARPi) enhances anti-tumor immune response in prostate cancer models
Abstract Number: 916
Session Title: Immune-Stimulants and Immune Modulators
Session Date: Saturday, November 8
Collaboration: NIH/NCI CRADA
Presentation 4 details:

Title: A novel TCRβ-directed IL-2 fusion molecule promotes memory CD8+ T cells with self-renewing properties in tumor ecosystems, further expanded by HDAC inhibition to elicit effective tumor suppression
Abstract Number: 914
Session Title: Combination Immunotherapies
Session Date: Friday, November 7
Collaboration: NIH/NCI CRADA
Presentation 5 details:

Title: Epigenetic modulation synergizes with TCRβ-targeted IL-2 to yield CD8+ T cell dependent, MHC-I independent tumor control via an antibody associated mechanism
Abstract Number: 663
Session Title: Combination Immunotherapies
Session Date: Friday, November 7
Collaboration: NIH/NCI CRADA

(Press release, Marengo Therapeutics, OCT 15, 2025, View Source [SID1234656682])

On October 15, 2025 Tagworks Pharmaceuticals BV ("Tagworks"), a clinical-stage precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors, reported that the Dutch regulatory authorities approved the Clinical Trial Application (CTA) for the CleavHER Phase 0/1 clinical trial, sponsored by the Radboud University Medical Center (Radboudumc), evaluating TGW211, a first-in-class radioimmunoconjugate, in patients with HER2-positive tumors.

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"The CTA approval and initiation of our second clinical trial this year mark a major milestone for Tagworks and validate the potential of our Click-to-Release platform," said Marc Robillard, PhD, Chief Scientific Officer and Co-Founder of Tagworks. "Unlike peptides, radiolabeled monoclonal antibodies avoid high radiation doses in the kidney. Many antibody therapies show strong tumor uptake, making them ideal vehicles for targeted radiotherapy. However, their clinical use has been limited by prolonged blood circulation resulting in myelotoxicity. Our Click-to-Release technology addresses this limitation by enabling precise tumor targeting and rapid clearance from healthy tissue—broadening the therapeutic window and unlocking new potential in radioimmunoconjugate development."

Under an investigator-initiated trial agreement, Tagworks and Radboudumc have initiated the first-in-human Phase 0/1 clinical development of TGW211 in a single center, open-label imaging study in patients with HER2-positive solid tumors. The primary objectives of the study are to determine safety and tolerability of Indium-111 (111In)-labeled TGW211, and secondary endpoints include evaluating the pharmacokinetics and dosimetry of 111In-TGW211 in tumor and healthy tissue. The study is currently recruiting and aims to enroll up to 18 patients.

"The Click-to-Release platform has the potential to redefine the therapeutic window of antibodies as vectors for radioactivity and represents a paradigm shift in the use of radiolabeled monoclonal antibodies in cancer treatment by enabling selective removal of circulating radioactivity after tumor targeting, enhancing the tumor-to-blood dose ratio and reducing healthy tissue exposure," said Prof. James Nagarajah, MD, Principal Investigator of the study at Radboudumc. "We are proud to lead the first clinical evaluation of TGW211 and help advance this innovative approach for patients."

Based on preclinical data recently highlighted at the European Association of Nuclear Medicine Congress, 111In-TGW211 has shown positive results in in vitro functional assays and in vivo animal models. These results suggest that TGW211 may have a positive effect on reducing the unfavorable radiation burden in patients undergoing targeted therapy and improve imaging by reducing background noise.

Preliminary safety and dosimetry data from the Phase 0/1 clinical trial is expected in 2026 and may support continued development towards the application of a Phase 1 therapeutic study with Actinium-225 or Lutetium-177-labeled TGW211.

About TGW211
TGW211 is a radiopharmaceutical targeting Human Epidermal Growth Factor Receptor 2 (HER2), a well-validated target in multiple solid tumors. TGW211 is a HER2-directed antibody (trastuzumab) radioimmunoconjugate linked using Tagworks’ proprietary Click-to-Release linker platform. TGW211 is administered intravenous (IV) first and allowed to bind to HER2 and internalize in the tumor. Then a non-cell permeable, small molecule trigger is administered IV, resulting in selective chemical cleavage of the linker of the remaining systemically circulating TGW211, release and rapid elimination of the radionuclide from the body through the kidneys. 111In-TGW211 is under evaluation in an open-label, Phase 0/1 clinical trial (CleavHER trial) designed to evaluate safety, pharmacokinetics and dosimetry in patients with HER2-positive solid tumors.

(Press release, Tagworks Pharmaceuticals, OCT 15, 2025, View Source [SID1234656681])