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]).

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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.

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"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]).

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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]).

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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.

On May 27, 2025 AbbVie (NYSE: ABBV) reported that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3, 2025) (Press release, AbbVie, MAY 27, 2025, View Source [SID1234653412]). These new data highlight significant progress in AbbVie’s robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers.

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"The data we’re presenting at this year’s ASCO (Free ASCO Whitepaper) reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs."

An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase:

Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO (Free ASCO Whitepaper).

Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie’s investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC.
"The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis."

Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123:

In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO (Free ASCO Whitepaper).

This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors.

Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4

Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO (Free ASCO Whitepaper).

PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia.
"Over the past few years, we’ve significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited."

Further information on AbbVie clinical trials is available at View Source

Additional details on key presentations at ASCO (Free ASCO Whitepaper) are available below and the full ASCO (Free ASCO Whitepaper) Annual Meeting 2025 abstracts are available here.

Title

Date/Time

Session

Abstract
Number

Telisotuzumab adizutecan (ABBV-400; Temab-A)
monotherapy vs trifluridine/tipiracil plus bevacizumab in
patients with refractory metastatic colorectal cancer with
increased c-Met protein expression: An open-label,
randomized, phase 3 trial.

Saturday, May 31,

9:00 AM – 12:00
PM CDT

Poster Board: 303a

TPS3635

Telisotuzumab adizutecan (ABBV-400; Temab-A) in
combination with fluorouracil, leucovorin, and budigalimab
in locally advanced/metastatic gastric, gastroesophageal
junction, or esophageal adenocarcinoma (a/m GEA).

Saturday, May 31,

9:00 AM – 12:00
PM CDT

Poster Board: 491b

TPS4202

Efficacy and safety of first-line ibrutinib plus venetoclax in
patients with mantle cell lymphoma (MCL) who were older
or had TP53 mutations in the SYMPATICO study.

Saturday, May 31,

9:12 – 9:18 AM
CDT

Rapid Oral Abstract
Session

Hematologic Malignancies—
Lymphoma and
Chronic
Lymphocytic
Leukemia

7017

LUMINOSITY, a phase 2 study of telisotuzumab vedotin in
patients with c-Met protein–overexpressing non-
squamous EGFR-wildtype advanced NSCLC: Efficacy
outcomes by prior therapy.

Saturday,

May 31,

1:30 – 4:30 PM CDT

Poster Board: 98

8618

Long-term efficacy and safety of etentamig, a B-cell
maturation antigen (BCMA) bispecific antibody in patients
with relapsed/refractory multiple myeloma (RRMM).

Sunday,

June 1,

9:00 AM – 12:00
PM CDT

Poster Board: 95

7527

Novel analysis of 3-y results from the pivotal EPCORE
NHL-1 study: Outcomes in patients (pts) with
relapsed/refractory large B-cell lymphoma (R/R LBCL)
and complete response (CR) at 2 y with epcoritamab
(epcor) monotherapy.

Sunday,

June 1,

9:00 AM – 12:00
PM CDT

Poster Board: 226

7043

Folate receptor alpha (FRα; FOLR1) expression and
persistence in ovarian cancer in clinical trial samples and
real-world patient cohort.

Sunday,

June 1,

9:00 AM – 12:00
PM CDT

Poster Board: 489

5591

Efficacy of third-line and later (3L+) therapies post poly
(ADP-ribose) polymerase inhibitor (PARPi) exposure in
recurrent platinum-sensitive ovarian cancer (PSOC): A
pooled clinical trial database analysis.

Sunday,

June 1,

9:00 AM – 12:00
PM CDT

Poster Board: 477

5579

A phase 1 first-in-human study evaluating safety,
pharmacokinetics, and efficacy of ABBV-291, a CD79b-
targeting antibody-drug conjugate, in patients with
relapsed/refractory B-cell non-Hodgkin lymphoma.

Sunday,

June 1,

9:00 AM – 12:00
PM CDT

Poster Board: 271a

TPS7093

Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met
protein–targeting antibody-drug conjugate (ADC), in
patients (pts) with advanced EGFR-mutated (MT) non-
squamous (NSQ) non-small cell lung cancer (NSCLC):
Results from a phase 1 study.

Monday,

June 2,

8:00 – 8:06 AM
CDT

Rapid Oral Abstract
Session

Lung Cancer—
Non-Small Cell
Metastatic

8512

Phase 1, open-label, first-in-human study of ABBV-969, a
dual variable antibody-drug conjugate, in
patients with metastatic castration-resistant prostate
cancer.

Monday,

June 2,

9:00 AM – 12:00
PM CDT

Poster Board: 309b

TPS5111

A phase 2, open-label, randomized study of livmoniplimab
in combination with budigalimab versus chemotherapy in
patients with metastatic urothelial carcinoma.

Monday,

June 2,

9:00 AM – 12:00
PM CDT

Poster Board: 414b

TPS4618

Safety and efficacy of ABBV-706, a seizure-related
homolog protein (SEZ6)- targeting antibody-drug
conjugate, in high-grade neuroendocrine neoplasms.

Monday,

June 2,

10:09 – 10:21 AM
CDT

Oral Presentation

Clinical Science
Symposium – ADC
2.0: Discovering
the Targets That
Will Change the
Game

105

Efficacy and safety of pivekimab sunirine (PVEK) in
patients (pts) with blastic plasmacytoid dendritic cell
neoplasm (BPDCN) in the CADENZA study.

Monday,

June 2,

3:24 – 3:36 PM
CDT

Oral Presentation

Oral Abstract
Session –
Hematologic
Malignancies—
Leukemia,
Myelodysplastic
Syndromes, and
Allotransplant

6502

Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies.

Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses.

EPKINLY/TEPKINLY (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

VENCLEXTA/VENCLYXTO (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

IMBRUVICA (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.