On October 23, 2025 HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies, reported new results from its ongoing Phase 1 study of HCB101, a novel SIRPα-engineered Fc fusion protein, at the 13th International Conference of the Federation of Asian Clinical Oncology (FACO 2025), held October 24-25, 2025, in Shanghai, Mainland China.

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Dr. Fangling Ning, an investigator at the Affiliated Hospital of Binzhou Medical University, stated, "HCB101 is showing early promise as a differentiated therapy targeting the CD47-SIRPα axis, with encouraging signals of efficacy in both solid tumors and lymphomas. Importantly, the novel design (engineered with the help of AI) effectively mitigated anemia and cytopenias, which have been challenges with prior agents in this class. These findings provide a strong foundation for further clinical development."

The poster, titled "Phase 1 Study of HCB101, a Novel Fc-engineered CD47-SIRPα Fusion Protein, Demonstrates Favorable Safety and Confirmed Responses in Solid and Hematologic Malignancies", reported updated results from the multinational, first-in-human trial (NCT05892718). Key highlights from the study as of July 10, 2025, include:

Favorable safety profile: Among 49 patients enrolled across 10 dose levels (0.08-18.00 mg/kg, QW), only one dose-limiting toxicity (DLT) was observed, a transient Grade 3 thrombocytopenia at the 2.56 mg/kg dose level.
Consistent receptor occupancy (RO): >90% CD47 RO achieved at doses ≥1.28 mg/kg.
Encouraging antitumor activity: Two confirmed partial responses (PRs) in head and neck squamous cell carcinoma (HNSCC) and non-Hodgkin lymphoma, alongside durable disease control in multiple patients.
"The presentation of HCB101 data at FACO 2025 underscores both the scientific innovation of our FBDB platform and our commitment to developing next-generation immunotherapies with global impact," said Scott Liu, Ph.D., Chairman, CEO, and Founder of HanchorBio. "We are encouraged by the excellent safety profile and initial responses observed in heavily pretreated patients. These monotherapy data establish safety, PK/PD, and early activity, providing the foundation for our ongoing combination trials testing HCB101 layered onto standard backbones in multiple tumor types. This marks an important step toward realizing our vision of bringing transformative, differentiated treatments to patients facing cancers with high unmet need."

About HCB101: A Differentiated CD47-SIRPα Blockade
HCB101 is a 3.5th-generation, affinity-optimized SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio’s proprietary FBDB platform. It is engineered for selective CD47 targeting with low red blood cell (RBC) binding, thereby avoiding the anemia and thrombocytopenia commonly associated with earlier anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging. Key differentiators of HCB101:

Enhanced safety: Cytopenia-sparing profile, with no DLTs observed up to 24 mg/kg and >90% RO at ≥1.28 mg/kg, supporting a broad therapeutic window.
Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy.
Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma, and ovarian cancer.
Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in second-line gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in first-line TNBC and second-line HNSCC, substantially exceeding historical benchmarks.
About HCB101 Monotherapy Clinical Trial (HCB101-101; NCT05892718)
HCB101-101 is an ongoing multi-national, multi-center, open-label, dose-finding Phase 1 study evaluating HCB101 in adults with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma. Conducted across sites in Taiwan, the United States, and Mainland China, the study uses a stepwise accelerated flat-dosing adjustment strategy to optimize safety and dosing. The primary objectives are to assess safety and tolerability, while secondary endpoints include pharmacokinetics, pharmacodynamics, and antitumor activity. Early data demonstrate a favorable safety profile, dose-proportional pharmacokinetics, high-level CD47 receptor occupancy, and confirmed partial responses in heavily pretreated solid tumor and lymphoma patients. These findings support the continued development of HCB101 in expansion cohorts and future combination studies.

(Press release, Hanchor Bio, OCT 23, 2025, View Source [SID1234656958])

On October 23, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, reported that it will present new scientific data highlighting the performance of its Accum technology in enhancing the efficacy of antibody-drug conjugates (ADCs) at the 16th World ADC Conference in San Diego, CA, USA.

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Defence’s proprietary Accum platform is engineered to improve intracellular delivery and endosomal escape of therapeutic payloads, addressing a critical limitation of current ADCs and enabling higher potency with reduced off-target toxicity. The new results to be presented build on a growing body of evidence demonstrating Accum’s ability to significantly improve the therapeutic index of ADCs.

"These findings further demonstrate how Accum can unlock the full potential of ADCs by enabling more efficient delivery of their toxic payloads directly into cancer cells," said Maxime Parisotto, Chief Scientific Officer of Defence Therapeutics. "We are excited to share this data with the scientific community and continue advancing our research toward next-generation targeted therapies."

Interested attendees are invited to visit the Defence Therapeutics poster presentation at the Conference Exhibition Hall Town & Country Resort in San Diego, CA, USA on Tuesday and Wednesday November 4-5, 2025, to meet with Defence’s CSO Maxime Parisotto, PhD, MBA, and Head of Quality & Operation Mark Lambermon, Phd, to learn more about the company’s ongoing research and development efforts.

(Press release, Defence Therapeutics, OCT 23, 2025, View Source;utm_medium=rss&utm_campaign=defence-to-present-new-scientific-data-on-its-adc-enhancing-accum-technology-at-the-world-adc-conference-in-san-diego-usa-november-4-5-2025 [SID1234656942])

On October 23, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, reported positive topline results from the registrational ChonDRAgon study (n= 206) investigating ozekibart (INBRX-109) as a single agent versus placebo in patients with advanced or metastatic, unresectable chondrosarcoma. The Company also provided updates on the ongoing expansion cohorts investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma.

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Chondrosarcoma

The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options.

The benefit of ozekibart was consistent across all pre-specified subgroups, including patients with IDH-wild-type and IDH-mutant tumors. Other key secondary endpoints, including disease control rate (54% vs 27.5%), and delay to deterioration in pain and physical function, further supported the clinical benefit observed with ozekibart.

Ozekibart was generally well tolerated, with a manageable safety profile. The most common treatment-related adverse events were fatigue, constipation, and nausea. Hepatotoxicity, a known risk for this mechanism of action, occurs during the first treatment cycle and is in patients with underlying hepatic impairment. One hepatotoxicity-related fatal event occurred early in the study, prior to the implementation of mitigation measures. Over the course of the ChonDRAgon study, this risk was effectively mitigated by excluding patients with severe liver impairment and by implementing close monitoring during early treatment cycles, allowing for prompt management of liver enzyme elevations. This approach resulted in a low overall incidence of treatment-related hepatic adverse events, 11.8% compared to 4.5% in the placebo arm, the majority of which were Grade 1 or 2 in severity.

"I am very encouraged and enthusiastic about ozekibart and the impact I have seen on my sarcoma patients," said Dr. Robin Jones, head of the sarcoma unit at The Royal Marsden Hospital in London, United Kingdom. "With no approved treatments available, we have observed that ozekibart helps to keep the cancer from growing, improves how patients feel, and restores a sense of hope for my patients."

Detailed results from this trial will be presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting on November 14, 2025.

Colorectal Cancer

Based on initial results from the Phase 1 trial of ozekibart in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal cancer (CRC), Inhibrx initiated an expansion cohort enrolling 44 patients, as a fourth line of therapy for approximately 70% of patients and as a third line of therapy for approximately 30% of patients. 80% of patients had been previously treated with regimens containing irinotecan. Efficacy, based on RECIST v1.1 criteria, was assessed in 26 evaluable patients to date who had at least one post-baseline scan. The results show a 23% overall response rate (ORR) and an overall disease control rate of 92%. These outcomes are highly encouraging in a heavily pretreated CRC population, where responses are rare (5-6%) and outcomes are generally poor with the current standard of care.

Ozekibart, in combination with FOLFIRI, was well tolerated. The most common treatment-emergent adverse events included anemia, diarrhea, nausea, and fatigue, with the majority being low-grade and consistent with the known safety profile of FOLFIRI.

Ewing Sarcoma

Based on initial results from the Phase 1 trial of ozekibart in combination with irinotecan and temozolomide (IRI/TMZ) for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma, Inhibrx initiated an expansion cohort which is expected to enroll up to 50 patients. Of the 33 patients recruited to date, more than half were third or fourth line patients. Among the 25 evaluable patients to date, Inhibrx observed a 64% overall response rate (ORR), and a disease control rate of 92%, with the majority of patients experiencing measurable tumor reduction. These outcomes are highly encouraging in this difficult-to-treat patient population as compared to the response rate typically observed with standard IRI/TMZ (15-30%).

Overall, ozekibart in combination with IRI/TMZ was well tolerated. The most common adverse events were diarrhea, nausea, anemia, and fatigue, all consistent with the known safety profile of IRI/TMZ.

"We are excited by these results which suggest the potential of ozekibart to expand not only in sarcomas but also in high unmet need solid tumor indications," said Mark Lappe, CEO and Co-Founder of Inhibrx. "We look forward to working with the FDA to deliver ozekibart to patients as swiftly as possible."

The Company will host a live webcast presentation today, October 23rd, 2025, at 1:30 p.m. Pacific Time to further discuss the results.

About the Conference Call

Investors may join via the web: View Source or may listen to the call by dialing (1-888-880-3330). Please refer to Inhibrx Biosciences, Inc. or the conference ID 9577647 when calling in. Following the webcast, the presentation may be accessed through a link on the investors section of Inhibrx’s website at View Source The webcast will be available for 60 days following the event. Following the presentation, Inhibrx will update its corporate presentation within the "Investors" section of its website at www.inhibrx.com.

About ozekibart (INBRX-109)

Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registrational trial of ozekibart in metastatic, unresectable conventional chondrosarcoma. The trial enrolled a total of 206 patients across 67 different sites worldwide. The primary objective of the trial was the evaluation of the efficacy of ozekibart as measured by median PFS, assessed by central real-time independent radiology review per RECIST 1.1. Secondary objectives were the evaluation of overall survival, median PFS by investigator assessment, quality of life, objective response rate, duration of response, disease control rate, safety and tolerability, pharmacokinetics and anti-drug antibodies to ozekibart.

Key enrollment criteria in order for patients to qualify for inclusion in the trial were grade 2 or 3 unresectable or metastatic conventional chondrosarcoma. Patients received either ozekibart or placebo every three weeks at a randomization of 2:1, stratified by the line of therapy, grade and IDH1/2 mutation status.

Patients randomized to the placebo arm were allowed to crossover to receive ozekibart upon confirmation of progression as reported by central independent radiology review.

In addition to the registrational trial, Inhibrx is advancing ongoing expansion cohorts, evaluating ozekibart in combination with irinotecan-based regimens in Ewing sarcoma and colorectal cancer. Encouraging early signals support further exploration of ozekibart’s potential in these difficult-to-treat tumor types with high unmet medical need.

(Press release, Inhibrx, OCT 23, 2025, View Source [SID1234656959])

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On October 23, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators will present positive preclinical data at the upcoming 2025 AACR (Free AACR Whitepaper)-NCI-EROTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place October 22-26, 2025 at the Hynes Convention Center in Boston. The collaborators will present positive preclinical data from a study of Genprex’s lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of ALK-EML4 positive non-small cell lung cancer (NSCLC).

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"We are delighted to have our academic partners present this compelling preclinical evidence that supports the therapeutic use of REQORSA in ALK Positive NSCLC," said Ryan Confer, President and Chief Executive Officer at Genprex. "Our researchers found that REQORSA alone or in combination with alectinib was able to shrink tumors by 79 percent, suggesting that REQORSA may be active as a single agent and may also be an ideal companion drug for patients with advanced disease. These data support a pathway for a potential future clinical trial for REQORSA."

The featured Genprex-supported poster to be presented at the 2025 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics:

Title: "Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma induces apoptosis and is highly effective in preclinical studies"

Collaborator: The University of Michigan Rogel Cancer Center

Session: Poster Session C

Session Date and Time: Saturday, October 25, 2025 from 12:30 – 4:00 p.m. ET

The featured Genprex-supported abstract to be presented at the 2025 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics:

NSCLC bearing the EML4-ALK fusion (Echinoderm microtubule-associated protein-like 4- Anaplastic Lymphoma Kinase) occurs in approximately 5% of NSCLC. Tumors bearing the fusion are sensitive to ALK Tyrosine Kinase Inhibitors (TKIs), that form the first and second line of treatment for these patients. However, ALK+ lung cancers invariably develop resistance to ALK inhibitors, creating the need for newer treatment strategies.

Tumor Suppressor Candidate 2 (TUSC2) is a tumor suppressor gene that is known to have low endogenous expression in NSCLC. REQORSA Gene Therapy, referred to as quaratusugene ozeplasmid (QO) in the abstract and developed by Genprex, is a gene therapy (TUSC2 plasmid encapsulated in non-viral lipid nanoparticles) that upregulates TUSC2 expression in cancer cells by delivering the functional TUSC2 gene.

Researchers evaluated TUSC2 expression in several ALK+ cell lines and patient derived organoids (PDOs), both before and after exposure to QO. The studies indicate that QO mediated overexpression of TUSC2 significantly induced apoptosis in ALK+ cell lines and PDOs, as demonstrated by increase in caspase 3/7 activity of the cells, increased protein expression of pro-apoptotic markers, reduced colony formation ability of the cells, and increased DNA fragmentation. Furthermore, researchers have observed a robust pro-apoptotic response in ALK+ NSCLC cell lines with acquired resistance to the ALK inhibitor, alectinib, resulting in reduced cell viability when treated with QO and alectinib in combination. To better understand how QO and alectinib work in combination, researcher subcutaneously injected NCI-H2228 ALK+ cells into nude mice and when the tumors developed to approximately 100mm3, mice were randomized into 4 groups. Mice from group 1 were treated with vehicle control, group 2 were treated with QO (25ug/mouse, i.v., every three days), group 3 were treated with alectinib (0.5mg/kg/mouse, oral gavage, every day) and group 4 were treated with QO and alectinib in combination at the same concentration and frequency of dosing for up to a month.

The results showed that alectinib shrunk tumors by 60% (group 3). However, QO alone (group 2) and in combination with alectinib (group 4) were able to shrink the tumors by 79%. This finding showed that QO has a 23% improved outcome than alectinib, leading to the hypothesis that QO may be an ideal companion drug for patients with advanced disease or a treatment for patients who cannot tolerate alectinib. Researchers are also currently monitoring the mice for survival, and tumor measurements recorded at 2 weeks after the end of treatment indicate that tumors in mice that received single drug treatment are regrowing faster than tumors in mice that received combined treatment of QO and alectinib, further emphasizing the clinical relevance of this novel combination in ALK+ NSCLC.

Taken together, the in vitro and in vivo data suggest that QO mediated overexpression of TUSC2 in ALK+ NSCLC is effective in decreasing growth and proliferation through the activation of apoptotic pathways, thereby paving the way for a potential clinical trial.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

(Press release, Genprex, OCT 23, 2025, View Source [SID1234656943])