On May 27, 2025 Global pharma major Lupin Limited (Lupin) reported it will present data from its Phase 1a clinical trial evaluating LNP7457, a PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois, from May 30 to June 3, 2025 (Press release, Lupin, MAY 27, 2025, View Source;annual-meeting-2025-302465586.html [SID1234653417]). The presentation titled ‘A phase 1 dose escalation study of LNP7457 (PRMT5 inhibitor) in patients with advanced or metastatic solid tumors,’ will be featured in the Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology session. It can be viewed at Poster Board #422 on June 2, 2025, from 1.30 pm to 4.30 pm (CDT).

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!

Key findings from the study include:

LNP7457 is generally safe and well tolerated in patients with advanced or metastatic solid tumors, with desirable PK/PD profile and no impact of food on the pharmacokinetics.
The maximum tolerated dose, recommended phase 2 dose was determined based on safety, efficacy, PK/PD data, aligning with preclinical findings and the known safety profile of PRMT5 inhibitors.
"We are delighted to share the initial results from Phase I study of our PRMT5 Inhibitor, a novel epigenetic onco-therapeutic targeted for monotherapy. We are committed to innovation and advancing cutting-edge science to offer meaningful therapeutic options for patients with difficult-to-treat cancers," said Vinita Gupta, CEO, Lupin.

Current data from Lupin indicates that LNP7457 is unique within its field and appears to be safe and well-tolerated as a SAM-competitive PRMT5 inhibitor. Lupin will continue to study the efficacy of LNP7457 in its phase 1b trial in India and explore its potential for treatment of cancers with significant unmet medical needs.

Details of the Presentation:

Date and time: June 2, 2025, 1:30 pm – 4:30 pm (CDT)
Location: Hall A – Posters and Exhibits | McCormick Place, Chicago, IL
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Sub Track: Small Molecules
Clinical Trial Registration Number: CTRI/2023/07/054753
Doi: 10.1200/JCO.2025.43.16_suppl.3107
Abstract Number: 3107
Poster Board Number: 422
Abstract link: View Source

On May 27, 2025 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the clinical study of mavrostobart (PT199) in combination with chemotherapy (Press release, Phanes Therapeutics, MAY 27, 2025, View Source [SID1234653416]).

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!

Mavrostobart is an anti-CD73 monoclonal antibody with a differentiated mechanism of action and is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment (TME). Mavrostobart fully inhibits the enzyme activities of both soluble and membrane-bound CD73, unlike several other anti-CD73 antibodies which exhibit incomplete inhibition. Moreover, at higher concentrations, no loss of inhibition or "hook effect" is observed with mavrostobart. Hence, mavrostobart addresses the limitations of current CD73 inhibitors and is expected to increase antitumor immune activation, and potentially offer a new treatment option for cancer patients.

The multi-center Phase I/II clinical trial of mavrostobart (NCT05431270), known as the MORNINGSTAR study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of mavrostobart alone and in combination with a PD-1 Inhibitor or chemotherapy. A Phase I clinical trial of mavrostobart is also ongoing in China (CTR20242381).

On May 27, 2025 KAHR, a clinical-stage biotech company developing DSP107, a first-in-class bi-specific 4-1BB T-cell engager that activates innate and adaptive immunity to treat solid tumors, reported that positive results from the Phase 2 dose expansion cohort of DSP107 in combination with atezolizumab (Tecentriq), an anti-PD-L1 cancer immunotherapy, in patients with 3rd line microsatellite stable metastatic colorectal cancer (MSS-CRC) will be presented in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, KAHR Medical, MAY 27, 2025, View Source [SID1234653415]). The meeting will be held May 30 – June 3, 2025, in Chicago, Illinois and virtually. In addition to its favorable safety profile, the combination has shown anti-tumor activity and extended survival including in patients with liver metastases.

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 are happy with the opportunity to present data from the Phase 2 dose expansion cohort of DSP107 in combination with a PD1/PD-L1 checkpoint inhibitor in an oral presentation at ASCO (Free ASCO Whitepaper)’s Annual Meeting," said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR. "This recognition is evidence for the significant potential of this immunotherapy combination to benefit the treatment of MSS-CRC patients including those with active liver metastases, a devastating disease representing an unmet medical need. We look forward to sharing next week the exciting, updated, overall survival data for this combination, which has continued to improve in 2025 beyond the data published in the abstract."

Details for the oral presentation are as follows:

Presentation information:
Title: Phase 2 dose expansion study of DSP107, a first-in-class bi-specific 4-1BB T-cell engager, with and without atezolizumab in metastatic MSS colorectal cancer patients.
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date: 6/1/2025
Session Time: 11:30 AM-1:00 PM CDT
Presenter: Anwaar Saeed, MD, Associate Professor of Medicine, University of Pittsburgh Medical Center and Director, Gastrointestinal Disease Center, UPMC Hillman Cancer Center
Abstract Number for Publication: 3517

Abstract available on the ASCO (Free ASCO Whitepaper) website

About the Phase 2 dose expansion cohort of DSP107 in combination with atezolizumab for MSS-CRC

The MSS-CRC dose expansion phase of the study was an open label, multi-center trial (NCT04440735) that enrolled patients with 3rd line MSS colorectal cancer patients, treated weekly with 10 mg/kg DSP107 infusions and atezolizumab (1200 mg) every three weeks, until disease progression. The primary objective was to determine the safety and tolerability of DSP107 in combination with atezolizumab. The secondary objective was to assess the preliminary efficacy of DSP107 in combination with atezolizumab.

About DSP107

KAHR’s lead drug candidate, DSP107, is a first-in-class bi-specific 4-1BB T-cell engager utilizing CD47 overexpression as a tumor anchor. DSP107 binds to CD47 that cancer cells express on their cell surface. Once bound, DSP107 converts the CD47 signal, which cancer uses to camouflage itself from the innate immune system, into a 4-1BB signal, which attracts and activates adaptive immune cells, primarily cancer cytotoxic CD8 T-cells. In this way, DSP107 engages both parts of the immune system in a wholistic anti-cancer response. This is particularly relevant in colorectal cancer, where 70%+ of the metastatic patients have metastases in the liver, and where liver metastases highly express CD47 in response to first- and second-line chemotherapy treatments. Previous attempts to treat colorectal cancer with immunotherapy have failed as there is a lack of immune cells in the tumor. DSP107 is unique in that it takes advantage of CD47 expression to drive immune cells into the tumor. DSP107 is also being tested in Phase 2 expansion cohort in 2L/3L PD1-experienced NSCLC.

About microsatellite stable metastatic colorectal cancer (MSS-CRC)

Microsatellite stable metastatic colorectal cancer (MSS-CRC) is a subtype of colorectal cancer that lacks deficiencies in the DNA mismatch repair system, resulting in stable microsatellite regions within the genome. Unlike microsatellite instability-high (MSI-H) tumors, MSS-CRC exhibits lower tumor mutational burden and is less responsive to immunotherapy. MSS tumors represent the majority of colorectal cancer cases and are typically more challenging to treat. Standard treatment for metastatic MSS-CRC often involves a combination of chemotherapy, targeted therapy, and in select cases, surgical intervention.

On May 27, 2025 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported that three of its research abstracts have been accepted for poster presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31–June 4 in Chicago, Illinois (Press release, OncoHost, MAY 27, 2025, View Source [SID1234653414]).

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 selected studies span multiple cancer types—including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and ovarian cancer—highlighting the broad clinical utility of plasma proteomics and the company’s continued commitment to advancing personalized treatment strategies through host-response biomarker innovation.

Poster Presentations

Title: Longitudinal Plasma Proteomic Analysis: A Monitoring Strategy for NSCLC Patients Treated with Immunotherapy
Presenter: Yehonatan Elon, PhD, CTO at OncoHost
Session Date: May 31, 2025 | 1:30 PM CDT | Hall A – Posters and Exhibits
Abstract Number: 8579 | Poster Board: 59

This study explores the use of plasma proteomic signatures to dynamically monitor treatment response in NSCLC patients receiving immune checkpoint inhibitors (ICIs). The research identified three distinct proteomic patterns—reflecting drug presence, immune activation, and lung tissue damage—and demonstrated their potential for early identification of non-responders up to 6.6 months before radiologic imaging. A comparative analysis with ctDNA will also be presented.

The abstract is available on the ASCO (Free ASCO Whitepaper) website here.

Title: A Plasma Proteomics-Based Model for Predicting Response to Neoadjuvant Chemotherapy in Ovarian Cancer
Presenter: Ofer Sharon, MD, CEO at OncoHost
Session Date: June 2, 2025 | 1:30 PM CDT | Hall A – Posters and Exhibits
Abstract Number: 3056 | Poster Board: 371

This research presents a novel computational model based on pre-treatment plasma proteomics that predicts chemotherapy response in high-grade serous ovarian cancer (HGSOC). The study demonstrates the feasibility of using plasma proteomics from pre-treatment blood samples to predict response to neoadjuvant chemotherapy in HGSOC.

The abstract is available on the ASCO (Free ASCO Whitepaper) website here.

Title: Genomic and Proteomic Predictors of Sites of Metastases in Renal Cell Carcinoma
Presenter: Clara Steiner, MD, Postdoctoral Research Fellow at Dana-Farber Cancer Institute
Session Date: June 2, 2025 | 9:00 AM CDT | Hall A – Posters and Exhibits
Abstract Number: 4538 | Poster Board: 338

Through multi-omics profiling of metastatic RCC patients, this study identifies genomic alternations and circulating proteins associated with specific metastatic sites, including lung, bone, and liver. These findings support the development of non-invasive predictors of metastatic organotropism and may inform future site-specific treatment strategies.

The abstract is available on the ASCO (Free ASCO Whitepaper) website here.

"Our expanding clinical pipeline and participation in ASCO (Free ASCO Whitepaper) 2025 represent critical milestones in the evolution of precision oncology," said Ofer Sharon, MD, CEO of OncoHost. "By combining advanced proteomic technologies with AI-driven analytics, we continue to demonstrate the versatility of our platform across tumor types and treatment settings—reinforcing our commitment to amplifying oncologist’s insights in making more personalized and effective treatment decisions."

On May 27, 2025 GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported the publication of a peer-reviewed study in the International Journal of Biological Macromolecules (309, 143176) involving a prototype of GNX201 (L-HKM4) (Press release, GlycoNex, MAY 27, 2025, View Source [SID1234653413]).

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 article presents preclinical findings on a prototype of GNX201 in a series of in vitro and in vivo models to test its ability to selectively target tumor-associated glycans while avoiding normal tissues. GNX201 is based on GNX’s HKM4 antibody but modified with a protease-cleavable masking domain, developed in collaboration with PrecisemAb Biotech Co.,Ltd.’s "Universal Antibody Lock Technology". This design blocks its activity until the antibody reaches tumor sites rich in matrix metalloproteinases. The goal of this pro-antibody approach is to improve the therapeutic window of glycan-targeting therapies by minimizing off-tumor binding in normal tissues.

"These findings support the potential of protease-activated antibodies to overcome longstanding safety concerns associated with glycan-targeting therapies," said Dr. Mei-Chun Yang, CEO of GlycoNex. "This work marks an important milestone in our efforts to develop tumor-selective anti-glycan therapies and expands the therapeutic possibilities for hard-to-treat gastrointestinal cancers."

Building on these promising results, GNX201 is being further developed as a next-generation antibody-drug conjugate (ADC) candidate. With its demonstrated tumor specificity and favorable safety profile, GNX201 provides a robust foundation for ADC construction aimed at delivering potent cytotoxic payloads selectively to tumors, while minimizing systemic toxicity.

Dr. Mei-Chun Yang added: "We are honored to collaborate with PrecisemAb Biotech and successfully integrate its Universal Antibody Lock platform. The development of GNX201 is expected to provide patients with a safer therapeutic option."

Pro-Antibody technology has emerged as a next-generation strategy in antibody drug development, offering an effective solution to reduce the toxicity commonly associated with conventional antibody therapies. This publication marks the first report globally to validate the successful application of the Pro-Antibody strategy to glycan-targeting antibodies. It addresses the longstanding challenges of limited selectivity and normal tissue toxicity often observed in glycan antigen-targeted therapies, presenting significant scientific and commercial value.

Looking ahead, GlycoNex will continue the development of GNX201 and actively seek clinical and strategic partners to accelerate translational advancement and licensing opportunities.

About GNX201
GNX201 is an anti-TACA pro-antibody that applies PrecisemAb Biotech’s proprietary "Antibody Lock" technology, by fusing a masking peptide to the variable region of the anti-TACA mAb via a cleavable linker. By design, the generated pro-antibody is "turned on" by dropping the masking peptide in the tumor microenvironment whereas in circulation it remains in an off state with the masked domain. This selective activation in tumors allows GNX201 to accurately target tumors rather than doing harm to antigens in normal organs. In pre-clinical studies, GNX201 has demonstrated an ability to lower normal tissue reactivity, enhance the capability of tumor-localized activation, and improve comparable tumor growth inhibition in vivo to the unmasked mAb in xenograft models.