On May 31, 2026 NeuExcell Therapeutics reported that Dr. Yulun Huang will present the first-in-human clinical study of NXL-004 for recurrent malignant glioma as Rapid Oral presentation at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2026). ASCO (Free ASCO Whitepaper) is one of the leading global oncology conferences. With over 8,500 submissions, abstracts selected for oral presentation represents studies of significant scientific and clinical interests.

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"We are honored that our NXL-004 program has been selected for Rapid Oral Presentation at ASCO (Free ASCO Whitepaper) 2026," said Dr. Gong Chen, Founder and Chief Scientific Officer of NeuExcell. "This recognition underscores the potential of our in vivo cell conversion platform to address significant unmet needs in recurrent malignant glioma and potentially other devastating neurological diseases."

The study was conducted in collaboration with Dr. Yulun Huang and his team at the Department of Neurosurgery at the Fourth Affiliated Hospital of Soochow University.

Presentation Details

Title:
First-in-human study of AAV6-NeuroD1 trans-differentiation therapy in recurrent malignant glioma

Presenter:
Dr. Yulun Huang

Session:
Rapid Oral Abstract Session – Central Nervous System Tumors

Date & Time:
May 31, 2026 | 4:30 PM–6:00 PM CT

Abstract Number:
2012

Favorable Safety and Encouraging Efficacy

Recurrent malignant glioma remains one of the most difficult cancers to treat, with median overall survival (OS) at approximately 6-9 months. After recurrence, there is currently no established standard of care, and no therapy has demonstrated a clear survival benefit in randomized controlled studies.

NXL-004 is a first-in-class in vivo cell conversion therapy using an adeno-associated virus (AAV) vector to deliver neural transcription factor NeuroD1. The therapy is designed to reprogram proliferating glioma cells toward non-proliferating neuron-like cells or induce tumor cell apoptosis.

Results from the first-in-human study in recurrent malignant glioma showed a favorable safety profile and encouraging efficacy:

Baseline and Treatment
Eleven patients were enrolled, with a median age of 48.0 years; 81.8% male.
All patients had recurrent WHO grade 4 astrocytoma, including 10/11 with IDH-wildtype tumors and 6/11 with MGMT-unmethylated tumors.
Ten patients received repeat tumor resection plus intracavitary injection of NXL-004, and one received biopsy plus intra-tumoral injection.
Safety:
No drug-related serious adverse events (SAEs) were reported.
All AEs related to NXL-004 were grade 1–2. The most common treatment-related AEs included fever and headache.
Efficacy:
Median overall survival (mOS) of all treated recurrent glioma patients was over 13.2 months, comparing favorably with historical benchmarks of 6–9 months.
The observed one-year survival rate reached 77.9%.
All five patients enrolled between February and June 2025 were in high-dose group and remained alive at the time of this report:
Among these five patients, four already achieved OS exceeding 12 months.
One complete response (CR) and one durable stable disease (SD) were observed in the high-dose group, with ongoing progression-free survival (PFS) of 13.1 and 11.0 months.
"This study represents the first clinical evaluation of an AAV-NeuroD1 based gene therapy for glioma," said Dr. Yulun Huang, the principal investigator of the study. "The findings provide encouraging evidence supporting both the safety and therapeutic potential of this novel approach."

About NXL-004

NXL-004 is NeuExcell’s investigational gene therapy candidate based on its proprietary in vivo cell conversion platform. The therapy utilizes AAV-mediated delivery of NeuroD1 to reprogram tumor cells directly within the brain microenvironment.

(Press release, NeuExcell Therapeutics, MAY 31, 2026, View Source [SID1234666286])

On May 31, 2026 Precede Biosciences, a company powering next-generation precision medicine through its functional liquid biopsy platform, reported two new data presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29 to June 2 in Chicago, Illinois.

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The data highlight how functional information beyond genomics in patients with advanced non-small cell lung cancer (NSCLC), including target expression, pathway activity, and cell-state changes associated with response and resistance to targeted therapies, can be revealed from only 1 mL of plasma using Precede Bio Insight.

"Patients with advanced NSCLC in whom MET is an important disease driver often require multiple lines of therapy, underscoring the need to better understand the biology driving response and resistance," said J. Carl Barrett, PhD, Chief Scientific Officer of Precede Biosciences. "For drug developers working to advance MET-targeted therapies, these data demonstrate the ability of our​ platform to provide a broad functional view of tumor biology from plasma that can help guide patient selection and rational therapeutic development strategies."

ASCO 2026 Presentations

Comprehensive Epigenomic Profiling of Plasma for Non-invasive Detection of MET Activation Uncovers MET-associated Biology in Patients with EGFR-mutated Advanced NSCLC and Progression on Osimertinib (Abstract 8642)
Plasma Epigenomic Profiling Identifies Mechanisms of Sensitivity and Resistance to Tepotinib in METex14 Skipping Metastatic NSCLC (Abstract 8637)

(Press release, Precede Biosciences, MAY 31, 2026, View Source [SID1234666285])

On May 31, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported updated efficacy and safety data from a clinical study of its first approved product, olverembatinib (HQP1351), as a second-line therapy in patients with chronic-phase chronic myeloid leukemia (CML-CP) were presented in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The ASCO (Free ASCO Whitepaper) Annual Meeting is the world’s most prominent scientific gathering in the clinical oncology community, showcasing cutting-edge research in clinical oncology and advanced cancer therapies. This year marks Ascentage Pharma’s ninth consecutive appearance at the ASCO (Free ASCO Whitepaper) Annual Meeting. A total of six studies involving three of the Company’s key assets were selected for presentation, including three rapid oral presentations.

Data presented in this rapid oral presentation showed that, at cycle 24, patients with CML-CP treated with olverembatinib achieved a complete cytogenetic response (CCyR) rate of 91.3% and a major molecular response (MMR) rate of 60.9%. Responses deepened over time with longer treatment duration. Olverembatinib demonstrated a stable and manageable safety profile during long-term treatment, with no new safety signals identified. This longer follow-up study has generated more mature and encouraging results, further supporting the efficacy and safety of olverembatinib in patients with CML without the T315I mutation and reinforcing its potential role as a second-line treatment option for patients with CML-CP that failed first-line TKI therapy.

Olverembatinib is a novel drug developed by Ascentage Pharma and represents the first third-generation BCR-ABL1 inhibitor approved in China. Olverembatinib is currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. The drug is currently approved in China for adult patients with tyrosine kinase inhibitor (TKI)-resistant CML-CP or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs, with all approved indications now covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting three global registrational Phase III studies to evaluate olverembatinib in multiple indications, including CML-CP, newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), with two of these studies having been cleared by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Ascentage Pharma has signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.

Professor Weiming Li, the Principal Investigator of this study from Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, stated: "Overall, with longer treatment duration, olverembatinib not only helped patients achieve deeper responses, but also continued to provide durable clinical benefit while maintaining a favorable safety and tolerability profile, resulting in good patient adherence. These findings further support its role as a potential second-line treatment option for patients with CP-CML without the T315I mutation and provide stronger evidence for clinical practice. We also look forward to additional long-term follow-up data to further validate its efficacy and safety, and to provide stronger evidence-based support for the standardized use and guideline recommendations of olverembatinib in the second-line treatment setting, helping to deliver more optimized treatment options for patients and clinicians."

Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: "The updated data presented at ASCO (Free ASCO Whitepaper) once again demonstrated the consistent performance of olverembatinib in the second-line treatment of CML, further strengthening our confidence in advancing this therapy into earlier lines of treatment. We look forward to continuously accumulating evidence from second-line and earlier-line settings to further optimize the treatment pathway for patients with CML and help to deliver greater clinical benefit, longer survival, and improved quality of life. Moving forward, we will continue to uphold our mission of addressing unmet clinical needs for patients around the world by accelerating clinical development and bringing more safe and effective therapies to patients as soon as possible."

Key highlights from the study presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:
Updated efficacy and safety of Olverembatinib (HQP1351) as second-line therapy in patients with chronic-phase chronic myeloid leukemia (CP-CML)
Abstract #: 6510
Format: Rapid oral presentation
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
First Author: Weiming Li, MD, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Key Highlights:

Research Background: This is a single-arm, multicenter, open-label study conducted in China, evaluating the efficacy and safety of olverembatinib as a second-line treatment.
Efficacy Data: Among 42 evaluable patients, olverembatinib demonstrated significant and progressively deepening anti-tumor activity, with a best CCyR rate of 76.2% and a best MMR rate of 47.6% at study cutoff. Responses continued to improve with longer treatment duration, reaching 91.3% and 60.9%, respectively, at cycle 24. High response rates were also observed in patients previously treated with second-generation TKIs.
Safety Data: In terms of safety, the overall incidence of treatment-related adverse events was 89.4%, most of which were manageable low-grade events, primarily including but not limited to skin hyperpigmentation, hyperuricemia, and increased creatine phosphokinase. Although some grade ≥3 hematologic toxicities were observed, they were all recoverable through supportive treatment.
Conclusion: Overall, olverembatinib demonstrated durable and progressively deepening efficacy while maintaining a manageable safety profile, highlighting its promising clinical potential.
* Olverembatinib is currently under investigation and has not yet been approved by the US FDA.

(Press release, Ascentage Pharma, MAY 31, 2026, View Source [SID1234666284])

On May 31, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, reported that the Company presented its first dataset of alrizomadlin (APG-115), an MDM2-p53 inhibitor from the Company’s apoptosis-targeted pipeline, as monotherapy or in combination with lisaftoclax (APG-2575) in pediatric patients with relapsed/metastatic rhabdomyosarcoma (RMS) or other soft-tissue sarcomas (STSs), in a rapid oral presentation at the 62nd American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The ASCO (Free ASCO Whitepaper) Annual Meeting showcases cutting-edge research in clinical oncology and advanced cancer therapies and is the world’s largest gathering of the clinical oncology community. This year marks Ascentage Pharma’s ninth consecutive appearance at ASCO (Free ASCO Whitepaper). A total of six studies involving three of the Company’s key assets were selected for presentation, including three rapid oral presentations.

The data presented demonstrated preliminary antitumor activity and a manageable tolerability profile of alrizomadlin in pediatric solid tumors. Results showed that alrizomadlin monotherapy demonstrated initial clinical benefit in pediatric rhabdomyosarcoma (RMS), with one pediatric patient achieving a complete response (CR). In combination with investigational selective Bcl-2 inhibitor lisaftoclax, encouraging antitumor activity was observed, with an objective response rate (ORR) of 23.5% among 17 response-evaluable patients, including one complete response in a patient with Ewing sarcoma and three partial responses (PRs). In terms of safety, alrizomadlin, either as monotherapy or in combination with lisaftoclax, demonstrated a manageable safety profile in pediatric patients with solid tumors.

Alrizomadlin is an orally administered, highly selective MDM2-p53 inhibitor independently developed by Ascentage Pharma. It is the first investigational agent of its class to enter clinical development in China and has global first-in-class potential. By blocking the MDM2-p53 protein-protein interaction, alrizomadlin restores the tumor suppressor activity of p53 and induces apoptosis in tumor cells. Recently, alrizomadlin was officially included by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in the Pilot Program for the Support of Anti-tumor Drugs R&D for Kids, also known as the "SPARK Plan," for development in pediatric solid tumors including neuroblastoma, rhabdomyosarcoma, and Ewing sarcoma.

Professor Yizhuo Zhang, principal investigator of the study from the Department of Pediatric Oncology at Sun Yat-sen University Cancer Center, said: "Relapsed/refractory pediatric sarcomas are associated with extremely poor prognosis and substantial unmet medical needs. The data presented at the ASCO (Free ASCO Whitepaper) meeting demonstrated a favorable tolerability profile and promising anti-tumor effect for alrizomadlin both as monotherapy and in combination with lisaftoclax, with the complete response (CR) cases being particularly encouraging. As a key candidate included in the SPARK Plan, alrizomadlin has the potential to become a first-in-class therapy, address unmet medical needs, and bring new hope for long-term survival to pediatric patients."

Professor Yi Zhang, investigator of the study from the Department of Pediatrics at Beijing Tongren Hospital, Capital Medical University, said: "Treatment options for pediatric solid tumors, especially advanced soft-tissue sarcomas, remain very limited. The clinical data generated by the alrizomadlin combination regimen are therefore particularly meaningful. This apoptosis pathway-targeting therapy demonstrated favorable tolerability and encouraging objective response rates, further supporting the therapeutic potential of dual-target combination approaches in refractory pediatric tumors and providing valuable direction for future precision drug development in pediatric oncology."

Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: "Pediatric solid tumors continue to represent an area of significant unmet medical need. The data presented at ASCO (Free ASCO Whitepaper) mark our first presentation of alrizomadlin clinical data in pediatric solid tumor patients and demonstrated encouraging preliminary clinical benefit and tolerability. Importantly, alrizomadlin has already been included by the CDE in the SPARK Plan for potential development in multiple pediatric solid tumors. The data presented provide initial clinical evidence supporting this development strategy. We will continue to advance the related clinical studies with the goal of bringing new treatment options to pediatric patients in urgent need."

Key highlights from the study presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:

Alrizomadlin (APG-115) alone or in combination with Lisaftoclax (APG-2575) for the treatment of pediatric patients with relapsed/metastatic rhabdomyosarcoma (RMS) or other soft-tissue sarcomas (STSs)
Abstract #: 10012
Presentation Type: Rapid Oral Presentation
Session Title: Pediatric Oncology II
First Author: Yizhuo Zhang, MD, Department of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine
Key Highlights:

Research Background: This multicenter clinical trial conducted in China evaluated the safety and preliminary efficacy of alrizomadlin (APG-115) as monotherapy or in combination with lisaftoclax in heavily pretreated pediatric patients with relapsed/metastatic RMS, Ewing sarcoma (EWS), neuroblastoma (NB), and other solid tumors.
Efficacy Data: In the monotherapy arm, 1 patient with refractory RMS achieved CR. In the combination arm, among 17 response-evaluable pediatric patients with relapsed/refractory solid tumors, the ORR was 23.5%, including 1 CR in a patient with EWS, as well as PRs in 2 patients with RMS and 1 patient with NB. The disease control rate (DCR) was 70.6%.
Safety Data: No dose-limiting toxicities (DLTs) were observed in either the monotherapy or combination arm. Adverse events were primarily gastrointestinal and hematologic, with few serious adverse events and no treatment-related deaths or discontinuations.
Conclusion: The regimen demonstrated a manageable safety profile and preliminary antitumor activity in pediatric solid tumors, supporting further investigation.

* Alrizomadlin is currently under investigation and has not yet been approved by the US FDA.

(Press release, Ascentage Pharma, MAY 31, 2026, View Source [SID1234666283])

On May 31, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the pricing of a best-efforts offering of 1,449,300 common shares. Each common share is being sold at an offering price of $3.25 per share. All of the common shares in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting placement agent’s fees and other offering expenses, are expected to be approximately $4.7 million. The offering is expected to close on June 2, 2026, subject to satisfaction of customary closing conditions. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity is acting as sole placement agent for the offering.

The securities described above are being offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering is being made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and can be accessed for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, BriaCell Therapeutics, MAY 31, 2026, View Source [SID1234666282])