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.

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!

"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 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.

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!

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 Boehringer Ingelheim and AimedBio, a biotechnology company specializing in the development of antibody-based therapeutics, reported a global collaboration and licensing agreement to develop a novel antibody-drug conjugate (ADC) therapy for a broad range of cancers. The agreement further strengthens Boehringer’s growing ADC portfolio, driven by its subsidiary, NBE Therapeutics, to achieve the company’s aim of transforming the lives of people with cancer.

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!

"ADCs are a powerful therapeutic approach that combines biological precision with chemical potency," said Vittoria Zinzalla, Global Head of Experimental Medicine at Boehringer Ingelheim. "Targeting the specific cancer surface marker with AimedBio’s ADC may expand precision medicine treatment options for currently hard to treat cancers and potentially deliver meaningful benefit to patients. We are proud to move this program into the clinic as part of our mission to transform cancer care."

ADCs harness the specificity of monoclonal antibodies and the potency of cytotoxic agents – in this case a derivative of exatecan – to selectively target and eliminate cancer cells while minimizing damage to healthy tissue. The ADC developed by AimedBio targets a protein that is highly expressed across a broad spectrum of cancers, minimally present in normal tissues, and plays a significant role in tumor growth, metastasis and resistance to therapy. Targeting this protein with an ADC is expected to enable highly specific cytotoxic action against the tumor cells, enhancing efficacy and supporting better outcomes for patients.

"We believe this program has the potential to transform the treatment landscape for many cancers that currently lack effective options. Partnering with Boehringer will help advance this program with the speed, scale, and expertise needed to validate this novel target and approach," said Do-Hyun Nam, CTO of AimedBio. "Boehringer’s strong commitment to next-generation cancer therapies makes them the ideal partner to carry this program forward into the clinic and beyond."

Under the terms of the agreement, AimedBio is entitled to receive up to $991 million in total, including an upfront payment, development and regulatory milestones, and commercial milestones, as well as separate royalty payments on net sales.

(Press release, Boehringer Ingelheim, OCT 15, 2025, View Source [SID1234656704])

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.

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!

"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 Curium Group reported that together with PeptiDream Inc. and PDRadiopharma Inc., a registrational Phase 2 clinical trial has been initiated in Japan for 64Cu-PSMA-I&T – a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

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!

64Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, 177Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma, a wholly owned subsidiary of PeptiDream, and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for 177Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan."

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan."

About Prostate Cancer

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*1), with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

*1: National Cancer Center Japan

Clinical trial progress

Phase 3 ECLIPSE trial – 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

Phase 3 trial SOLAR RECUR and SOLAR STAGE – 64Cu-PSMA-I&T trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 64Cu-PSMA-I&T and177Lu-PSMA-I&T and in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

(Press release, Curium Pharma, OCT 15, 2025, View Source [SID1234656636])