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Marengo Therapeutics to Present Key Pipeline Updates at 2025 SITC Annual Meeting and Reveal First Asset from TriSTAR™ Platform Targeting Nectin-4

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])

Tagworks Pharmaceuticals Announces CTA Authorization and Initiation of Phase 0/1 Clinical Trial for TGW211, a Radiopharmaceutical for the Treatment of HER2+ Tumors

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.

"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])

OncoHost to Present New Research on Plasma Proteomics-Based Treatment Selection in Melanoma at ESMO 2025

On October 15, 2025 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported that its latest research has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress, taking place October 17-21 in Berlin, Germany.

The study, "A plasma proteomics-based model optimizes first-line treatment decisions for metastatic melanoma," explores the potential of the company’s PROphet model—originally developed and validated in non-small cell lung cancer (NSCLC)—to inform treatment selection in melanoma, a setting where biomarkers to guide clinical decisions remain limited.

Poster Presentation

Title: A plasma proteomics-based model optimizes first-line treatment decisions for metastatic melanoma
Presenting Author: Ryan Sullivan, MD, Massachusetts General Hospital, Boston, MA, USA
Session Date & Location: October 18, 2025
Session: Melanoma and other skin tumours
Poster Number: 1680P

Study Highlights and Conclusions

PROphet is a plasma proteomic platform that leverages a panel of 388 Resistance-Associated Proteins (RAPs) to compute the probability of clinical benefit (CB) and stratify patients as PROphet POSITIVE or PROphet NEGATIVE. In NSCLC, the test has demonstrated predictive value for patient outcomes with anti–PD(L)1-based therapy.

In this real-world prospective observational study, pre-treatment plasma samples were collected from 248 patients with metastatic melanoma treated with anti-PD1 monotherapy (pembrolizumab or nivolumab) or anti-PD1 + anti-CTLA4 combination (ipilimumab + nivolumab) were analyzed.

Key findings include:

Prognostic power: The PROphet model successfully stratified melanoma patients, with PROphet POSITIVE patients showing a significant survival advantage over PROphet NEGATIVE patients (HR = 0.42, p < 0.001).
Predictive for anti-PD1 therapy: The strongest effect was observed in patients treated with anti-PD1 monotherapy, underscoring the model’s predictive utility in this setting.
Independent factor: Multivariate analysis confirmed PROphet remained significant even after adjusting for LDH, age, sex, and other variables (HR = 0.30, p = 0.04).
Treatment guidance:
PROphet POSITIVE patients (66% of cohort) achieved comparable survival with anti-PD1 monotherapy and anti-PD1 + anti-CTLA4 therapy (HR = 0.9, p = 0.35). This suggests monotherapy may be sufficient, sparing patients unnecessary toxicity from combination regimens.
PROphet NEGATIVE patients demonstrated a trend toward improved survival with the combination approach (HR = 0.64, p = 0.065).
"Selecting the right treatment modality for melanoma patients remains a significant clinical challenge," said Michal Harel, PhD, VP Translational Medicine at OncoHost. "Our findings demonstrate how plasma proteomics can provide actionable insights that inform treatment decisions and bring us closer to truly personalized care for patients facing melanoma."

(Press release, OncoHost, OCT 15, 2025, View Source [SID1234656680])

Jacobio Pharma Announces Strategic Partnership with Oceanpine Capital to Focus on Core Oncology Pipeline

On October 15, 2025 Jacobio Pharma (1167.HK) reported that its subsidiary, Beijing Jacobio Pharmaceuticals Co., Ltd. ("Beijing Jacobio"), has entered into a Capital Increase and Equity Transfer Agreement with Oceanpine Capital and an industry partner. Under the agreement, Oceanpine Capital will acquire 80% equity interest in Beijing Jacoray Pharmaceutical Technology Co., Ltd. ("Jacoray") for a total consideration of RMB 200 million (comprising RMB 125 million as the upfront payment and an additional RMB 75 million as a second instalment milestone payment). Upon completion, Beijing Jacobio, Oceanpine Capital, and the industry partner will hold 10%, 80%, and 10% of Jacoray, respectively.

Jacoray is the project company for Jacobio’s early-stage cardiovascular research program. The transaction aligns with Jacobio’s strategic focus on developing innovative oncology therapies—including KRAS and iADC —by optimizing capital allocation, enhancing operational efficiency, and adopting a risk-sharing model to retain long-term project value. Proceeds from the transaction will primarily support R&D, production, and commercialization of Jacobio’s Pan-KRAS inhibitor and other oncology assets.

Mr. Dave Chenn, Founder, CEO and Managing Partner of Oceanpine Capital, said: "Jacobio demonstrates outstanding scientific strength and strategic focus in oncology innovation. Oceanpine Capital looks forward to partnering with Jacobio to advance the globalization of China’s biotech innovation."

Dr. Yinxiang Wang, Chairman of Jacobio, said, "This partnership with Oceanpine Capital strengthens our strategic focus on oncology innovation and reinforces our commitment to advancing next-generation cancer therapies."

(Press release, Jacobio Pharmaceuticals, OCT 15, 2025, View Source [SID1234656679])

Regeneron Showcases Advances Across Oncology Portfolio and Pipeline at ESMO, Highlighting Novel and Patient-Focused Approach for Difficult-to-Treat Cancers

On October 15, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its advancing oncology pipeline will be shared in seven abstracts at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Meeting, taking place from October 17-21 in Berlin, Germany. Highlights include new Phase 3 C-POST data on an every 6-week dosing regimen for the PD-1 inhibitor Libtayo (cemiplimab) as adjuvant treatment for cutaneous squamous cell carcinoma (CSCC) with a high risk of recurrence.

"Our oncology presentations at ESMO (Free ESMO Whitepaper) represent important progress toward expanding options for people with difficult-to-treat cancers," said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. "Notably, we look forward to sharing new data on a patient-centric every 6-week dosing option from our C-POST Phase 3 trial, which recently supported the FDA approval of Libtayo as the first immunotherapy for adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation."

The new safety and pharmacokinetic data from C-POST being presented at ESMO (Free ESMO Whitepaper) showcase a patient-centric approach to dosing. Patients received either adjuvant therapy with Libtayo or placebo intravenously, starting with 350 mg every 3 weeks for 12 weeks. The majority of patients were switched to every 6-week dosing after the initial 12 weeks, and the remaining patients continued with dosing every 3 weeks throughout the trial. Treatment continued until disease recurrence, unacceptable toxicity, or up to 48 weeks of treatment. Efficacy, pharmacokinetics and immunogenicity were similar across both regimens. The safety profile of Libtayo as adjuvant treatment of patients with CSCC at high risk of recurrence after surgery and radiation is consistent with the known safety profile for Libtayo monotherapy in advanced cancers.

The full list of Regeneron presentations at ESMO (Free ESMO Whitepaper) includes:

Abstract Title Abstract Presenter Session Date/Time
(CET)
Libtayo skin cancer
Analysis of second primary cutaneous squamous cell carcinoma (CSCC) tumors (SPTs) reported during the C-POST trial, a randomized phase 3 study of adjuvant cemiplimab vs placebo for high-risk CSCC Mini-oral
presentation: 1603MO

Danny
Rischin Saturday,
October 18,
14:45-16:15
Adjuvant cemiplimab for high-risk cutaneous squamous cell carcinoma: Evaluating dosing intervals in a phase 3 trial Poster
presentation:
1660P

Danny
Rischin Monday,
October 20,
12:00-12:45
CemiplimAb-rwlc Survivorship and Epidemiology (CASE): A prospective, non-interventional study of the safety and effectiveness of cemiplimab in immunocompromised/immunosuppressed (IC/IS) patients with advanced cutaneous squamous cell carcinoma (CSCC) at 18 months’ follow-up Poster
presentation:
1666P

Soo J.
Park Monday,
October 20,
12:00-12:45
Libtayo lung cancer
Association between patient-reported outcomes (PROs) and overall survival (OS) in aNSCLC patients treated with first-line (1L) cemiplimab-based therapy Poster
presentation:
1862P

David R.
Gandara Saturday,
October 18,
12:00-12:45
Ubamatamab
Randomized Phase 2 study of ubamatamab ± cemiplimab in patients (pts) with platinum-resistant ovarian cancer (OC) Poster
presentation:
1078P

Jung-Yun
Lee Saturday,
October 18,
12:00-12:45
REGN7075
Mitigating infusion-related reactions (IRRs) with cetirizine and montelukast in patients (pts) receiving REGN7075, an EGFRxCD28 bispecific antibody (bsAb) Poster
presentation:
1558P

Neil H.
Segal Sunday,
October 19,
12:00-12:45
Additional presentations
Predicting real-world overall survival in advanced melanoma using machine learning Poster
presentation: 1632P

Fei
Wang Monday,
October 20,
12:00-12:45

The potential use of ubamatamab described above is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.

(Press release, Regeneron, OCT 15, 2025, View Source [SID1234656677])