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Bexion Pharmaceuticals, Inc. Announces Acceptance of Abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 28, 2025 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported that two abstracts were accepted at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30, 2025 – June 3, 2025, in Chicago, Illinois (Press release, Bexion, MAY 28, 2025, View Source [SID1234653456]). Details of the abstracts are included below.

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Abstract Details:

Title: Effect of BXQ-350, a novel sphingolipid metabolism modulator, on neuronal environments through modulation of gene pathways
Abstract Number: e24058
Author: Michael Gazda, Tariq Arshad, Jim Beach, Nikhil Wilkins, Adam Creighbaum, Timothy Stephens
Session Title: Publication Only: Symptom Science and Palliative Care

Title: A phase 1 study to evaluate the safety and tolerability of BXQ-350, a novel sphingolipid metabolism modulator, in pediatric diffuse intrinsic pontine glioma and diffuse midline glioma
Abstract Number: e14044
Author: Tariq Arshad, Michael Gazda, Jim Beach, Kathleen Dorris, Margot Lazow, Trent Hummel, Richard Curry III, Adam Creighbaum
Session Title: Publication Only: Central Nervous System Tumors

The full abstracts are currently available in the ASCO (Free ASCO Whitepaper) digital program.

About BXQ-350
Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional sphingolipid activator protein, Saposin C, and a phospholipid. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in patients treated with oxaliplatin and other chemotoxic agents.

Halozyme Announces Bristol Myers Squibb Received European Commission Approval for Subcutaneous Opdivo® (nivolumab) Co-Formulated with ENHANZE® Across Multiple Solid Tumor Indications

On May 28, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Bristol Myers Squibb received European Commission (EC) approval of a new Opdivo (nivolumab) subcutaneous formulation developed with ENHANZE, Halozyme’s proprietary recombinant human hyaluronidase enzyme (rHuPH20), for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib (Press release, Halozyme, MAY 28, 2025, View Source [SID1234653455]).

"The European approval of Opdivo SC represents an advancement for certain cancer patients, who now have the option to receive their Opdivo as a 3-to-5-minute SC injection," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval is just one of the 11 growth catalysts for our commercialized SC products expected this year."

The positive EC decision is supported by positive results from the Phase 3 CheckMate -67T trial. For more information on the study and its findings, please view Bristol Myers Squibb’s press release issued on May 28, 2025.

The approval by the EC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

On December 27, 2024, subcutaneous nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig, was approved by the U.S. Food and Drug Administration.

Biohaven Presents Oncology Program Updates and Preliminary Clinical Data Showcasing Innovative Trop2 and FGFR3 Antibody Drug Conjugates (ADCs) Incorporating Novel TopoIx Payload with Potential to Treat a Wide Variety of Tumors

On May 28, 2025 Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported an update and preliminary clinical data from its oncology development programs at Biohaven’s 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut (Press release, Biohaven Pharmaceutical, MAY 28, 2025, View Source [SID1234653454]). The presentation slides from Biohaven’s R&D day for Oncology and its other platforms will be available on the Events and Presentations page of the Biohaven website just prior to their presentations.

Biohaven reported that its novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, demonstrated encouraging preliminary clinical activity both as a monotherapy and in combination with Regeneron’s anti-PD-1 antibody cemiplimab. Early clinical data is consistent with BHV-1510’s preclinical profile showing high ADC stability, differentiated safety and efficacy, immunogenic cell death, and anti-PD-1 synergism. Monotherapy tumor reductions including partial responses have been seen in patients failing standard of care therapies. The combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study shows encouraging anti-tumor activity, with tumor shrinkage in the first 6 out of 6 patients treated, including confirmed partial responses and in patients with brain metastasis (Figure 1). The majority of patients treated with the combination had failed prior anti–PD-1/PD-L1 therapies. BHV-1510 showed a favorable pharmacokinetic (PK) profile, with very low levels of free payload. As monotherapy, the main toxicity observed thus far in the Phase 1 study has been stomatitis, an expected on-target Trop2 class toxicity that has been manageable. Importantly, there were no cases of payload-associated interstitial lung disease (ILD), and low rates of gastrointestinal (e.g., diarrhea) and hematologic toxicities observed. The combination with cemiplimab was well tolerated with no dose limiting toxicity to date in initial cohorts.

Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "The early clinical data with BHV-1510 dosed in patients who failed standard of care treatment are highly encouraging, particularly the observed potential synergy with anti-PD-1 therapy. These findings, combined with the promising efficacy and tolerability profile of our novel TopoIx payload and stable linker technology, support the potential of BHV-1510 to advance into earlier lines of therapy for challenging tumor types."

Biohaven also announced the first patient has been dosed in the Phase 1 study of BHV-1530, a potential first-in-class fibroblast growth factor receptor 3 (FGFR3)-directed ADC which utilizes the proprietary Topolx payload. BHV-1530 has potential in indications of cancers driven by FGFR3 alterations and/or upregulated FGFR3 protein expression, including urothelial cancers and other solid tumors (Figure 2). FGFR3 is a clinically validated target in oncology, with one small molecule inhibitor (erdafitinib) approved. There are no FGFR3 ADCs beyond BHV-1530 advanced in clinical testing.

Michael Song, M.D., Ph.D., Principal Investigator and leading medical oncologist and hematologist at NEXT Oncology with over 22 years of experience in cancer patient care and cancer research, stated, "We are excited to partner with Biohaven and dose the first patient on this important study. This is an exciting, validated target with potential to extend therapeutic benefit to several FGFR3 driven tumors."

Biohaven is also advancing a portfolio of innovative technologies to modernize next-generation ADCs through strategic collaborations with Merus and GeneQuantum (Figure 3). The preclinical programs leverage Biohaven’s differentiated ADC platform directed against undisclosed novel validated and emerging high-value targets, and incorporating the TopoIx payload that preclinically demonstrated immunogenic cell death and synergistic efficacy with PD-1/PD-L1 checkpoint inhibitors.

Brian Lestini, M.D., Ph.D., President of Oncology at Biohaven, commented, ‘We are excited to be in the clinic with two innovative ADCs and to share the early clinical experience with the first of our two programs, demonstrating the potential of our oncology portfolio to deliver a wide range of optimized, next-generation ADCs. The early clinical data from the Trop2 ADC, BHV-1510, shows the predicted profile and potential of the proprietary TopoIx payload as seen preclinically, and supports broad investigation of ADCs incorporating TopoIx and highly stable linker technologies. Similarly, initiation of the first-in-human study of BHV-1530, an FGFR3 directed ADC, demonstrates the versatility of our approach to generate novel drugs with the potential to address a wide variety of unmet needs in oncology. Together with our collaborations with Merus and GeneQuantum as well as licensed conjugation technology from Yale University, Biohaven’s platform has the potential to generate multiple differentiated mono- and bispecific ADC therapies with greater potency and selectivity over currently available ADC approaches."

Pimicotinib Demonstrates Best-in-Class Potential with Significant Efficacy and Clinically Meaningful Improvements in Patients with Tenosynovial Giant Cell Tumor

On May 28, 2025 Merck, a leading science and technology company, reported the presentation of detailed positive results from Part 1 of the global Phase 3 MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., in the treatment of patients with tenosynovial giant cell tumor (TGCT) (Press release, Merck KGaA, MAY 28, 2025, View Source [SID1234653453]). Once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo (p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT. These findings will be presented Sunday, June 1 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #11500).

"The impact that TGCT has on patients goes far beyond the physical presence of the tumor. It affects their ability to work, to move freely, and to engage in everyday activities," said Prof. Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. "In MANEUVER, we observed the highest ORR seen to date with a systemic therapy, together with statistically significant improvements in measures of pain, stiffness, and range of motion. These improvements in outcomes that matter to patients with TGCT and the physicians who care for them show the potential of pimicotinib to allow patients to go about their daily lives with fewer negative effects of their disease."

In MANEUVER, which enrolled patients from China, Europe and North America, the effect of pimicotinib had an early onset, with 41.3 % (26 of 63) of patients experiencing objective response to therapy after 13 weeks. By the data cutoff for primary analysis, nearly all patients in the pimicotinib group (58 of 63 patients; 92.1%) had a decrease in tumor size per BIRC based on RECIST v1.1; one patient achieved a complete response and 33 patients achieved a partial response. The median duration of response was not reached by the data cutoff. The analysis of tumor volume score (TVS, an endpoint designed specifically for TGCT) showed that nearly two-thirds of patients treated with pimicotinib experienced a reduction in tumor volume of at least 50% (61.9% vs. 3.2% for placebo, p<0.0001).

Pimicotinib also demonstrated statistically significant and clinically meaningful improvement across all additional secondary endpoints relevant to patients’ daily lives, and these improvements were seen regardless of achieving objective tumor response to pimicotinib. Pimicotinib improved active range of motion (p=0.0003) and physical function measured by PROMIS-PF scale (p=0.0074). Pimicotinib also reduced worst stiffness (p<0.0001) and worst pain (p<0.0001).

"TGCT, although rare, has a significant impact on the daily lives of the primarily working-age adults who live with the disease, due to swelling, pain, stiffness, and limited mobility caused by the growth of these tumors in and around the joints," said Danny Bar-Zohar, appointed CEO Healthcare and current Global Head of R&D and Chief Medical Officer. "The landmark global Phase 3 MANEUVER study data will help redefine how TGCT is treated, and we plan regulatory submissions to start this year."

Pimicotinib was well-tolerated, and the safety profile was consistent with previously reported data, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients.

About MANEUVER

The pivotal Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21).

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population. Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS).

After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About Pimicotinib (ABSK021)

Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib was recently granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with tenosynovial giant cell tumor (TGCT) who require systemic therapy. Pimicotinib has been granted breakthrough therapy designation (BTD) for the treatment of unresectable TGCT by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib.

Veracyte Announces Multiple Abstracts To Be Presented at ASCO, Demonstrating Power of Decipher GRID to Advance New Prostate and Bladder Cancer Research

On May 28, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that eight abstracts featuring data derived from testing with its Decipher Prostate and Decipher Bladder genomic classifiers will be presented at ASCO (Free ASCO Whitepaper), the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held May 30-June 3 in Chicago (Press release, Veracyte, MAY 28, 2025, View Source [SID1234653452]). Key findings shed new light on which patients with prostate or bladder cancer may be more likely to respond to specific therapies based on their tumors’ molecular make-up.

"These new findings underscore the power of our whole-transcriptome-based Decipher GRID, or Genomic Resource for Intelligent Discovery, research tool to help advance understanding of urologic cancers at the molecular level," said Phil Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer. "We are pleased to share this resource with the research community to help reveal new insights that could one day enable more-personalized care and outcomes for patients with prostate or bladder cancer."

The following Decipher Prostate GRID-focused abstract will be shared in a podium presentation at the McCormick Place convention center:

Title:

Transcriptome classification of PTEN inactivation to predict survival benefit from docetaxel at start of androgen deprivation therapy (ADT) for metastatic prostate cancer (PC): an ancillary study of the STAMPEDE trials.

Presenter:

Emily Grist, Ph.D., University College London Cancer Institute

Format:

Oral Abstract Presentation

Abstract #:

5003

Date/Time:

Tuesday, June 3; 9:45 a.m. – 12:45 p.m. CDT

Room:

Hall D

Researchers found that patients whose metastatic prostate cancer had a PTEN-inactive gene expression signature were more likely to benefit from the addition of the chemotherapy, docetaxel, to standard androgen deprivation therapy (ADT), compared to those with PTEN-active tumors. Specifically, the PTEN-inactive patients had a 43% reduction in risk of death (HR=0.57, 95% 0.42-0.76), unlike PTEN-active patients where no benefit from docetaxel was observed (HR=1.05, 95% CI 0.77-1.43), with a significant interaction observed between docetaxel and PTEN status (p=0.002). Additionally, docetaxel benefited patients with PTEN-inactive tumors regardless of whether they had high- or low-volume prostate cancer. Finally, patients with tumors that were both PTEN-inactive and had high Decipher Prostate test risk scores had the greatest benefit from the addition of chemotherapy.

The study involved 832 patients with metastatic prostate cancer who were followed for a median of 14 years as part of STAMPEDE—a large, multi-center, randomized Phase 3 clinical trial that aims to determine the best way to treat men with newly diagnosed advanced or metastatic prostate cancer. Previously presented data showed that patients with high Decipher Prostate Genomic Classifier risk scores were more likely to benefit from the addition of docetaxel to ADT, compared to those with low Decipher test scores.1

"It’s well known that adding docetaxel to ADT increases survival for some patients with metastatic prostate cancer. The challenge has been knowing which patients will benefit and which ones will not so the latter can avoid unnecessary toxicity," said Emily Grist, Ph.D., of the University College London Cancer Institute who will present the new findings at the ASCO (Free ASCO Whitepaper) meeting. "Our results help to further elucidate molecular features of advanced prostate cancer, which may help us better select treatments for our patients."

The following Decipher Bladder GRID-focused abstract will be shared in a podium presentation at the ASCO (Free ASCO Whitepaper) meeting:

Title:

First results of SURE-02: A Phase 2 study of Neoadjuvant Sacituzumab Govitecan (SG) plus Pembrolizumab (Pembro), followed by response-adapted bladder sparing and adjuvant Pembro, in patients with muscle-invasive bladder cancer (MIBC)

Presenter:

Andrea Necchi, M.D., IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy

Format:

Rapid Oral Abstract Presentation

Abstract #:

4518

Date/Time:

Saturday, May 31; 1:15 – 2:45 p.m. CDT

Room:

Arie Crown Theater

This study evaluated whether patients with muscle-invasive bladder cancer (MBIC) could potentially benefit from treatment with Sacituzumab Govitecan (SG) plus Pembrolizumab (Pembro), rather than standard-of-care chemotherapy, prior to radical cystectomy (RC). It also used the Decipher Bladder GRID research tool to identify patients who were more likely to achieve clinical complete response (cCR), based on the molecular underpinnings of their tumor.

"Interim results from SURE-02 trial revealed that neoadjuvant Sacituzumab Govitecan plus Pembrolizumab, followed by bladder sparing in complete responders and maintenance pembrolizumab was a safe and effective strategy in patients with MIBC," said Andrea Necchi, M.D., of IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University in Milan, Italy, who presented the findings. "Preliminary biomarker data developed by Veracyte as part of its Decipher Bladder test and GRID research tool, revealed associations between Luminal subtype and clinical complete response, or cCR, and immune signatures linked to the EFS gene that could ultimately help improve outcomes in molecularly-selected patients."

A more complete list of Decipher-focused abstracts to be presented at the ASCO (Free ASCO Whitepaper) meeting can be found on Veracyte’s website here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.