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])

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 MIT reported the pills are by far the most convenient form of cancer treatment, but most oral cancer drugs quickly dissolve in the stomach, delivering a burst of chemicals into the bloodstream all at once (Press release, Enzian Pharmaceutics, OCT 23, 2025, View Source [SID1234656957]). That can cause side effects. It also may limit the drug’s effectiveness because its concentration in the blood may become too low after the initial burst.

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Now, the startup Enzian Pharmaceutics, founded by Aron Blaesi PhD ’14 and former principal research scientist Nannaji Saka ScD ’74, is developing an oral tablet that delivers drugs into the gastric fluid and the blood steadily over time. The company’s tablets use tiny 3D-printed fibers that turn into a gel-like substance when exposed to water. The tablets have been shown to stay in the stomach of animals for up to a day, slowly degrading while releasing the drug in controlled quantities.

The company is currently validating its tablets’ ability to stay in place in a small number of healthy human volunteers. In about a year, it plans to begin testing the technology’s ability to improve the effectiveness and safety of cancer drugs in patients.

"A lot of orally delivered cancer drugs could benefit from this," says Blaesi, who incorporated the company in 2016. "Right now, soon after someone has taken a cancer drug, its concentration in the blood can be up to 50 times greater than when they are supposed to take the next pill. During the peak, the drug goes into the heart, it goes into the liver, the brain, and it can cause a lot of problems, while at the end of the dosing interval the concentration in the blood may be too low. By taking out that peak and increasing the time the drug is released, we could improve the effectiveness of treatments and mitigate certain side effects."

In search of innovation
When Blaesi came to MIT, he knew he wanted his mechanical engineering PhD work to form the basis of a company. Early on, as part of the Novartis-MIT Center for Continuous Manufacturing, he worked on manufacturing pills with an injection molding machine that melted and solidified the material, in contrast to the traditional process of compacting powder. He noticed injection molding made the pills far less porous.

"If you put a typical pill into a fluid or into the stomach, the fluid percolates the pores and quickly dissolves it," Blaesi explains. "That’s not the case when you have an injection molded product. That’s when Dr. Saka, who I met almost daily to discuss my research with, and I started to realize that microstructure is very important."

The researchers began exploring how different tablet microstructures changed the rate at which drugs are released. For more precision, they moved from injection molding to 3D printing.

Using MIT machine shops, Blaesi built a 3D printer and produced tightly wound microstructures that could carry the drugs. He focused on fibrous structures with space between the fibers, because they would allow gastrointestinal fluid to percolate the pill and dissolve rapidly. He tested the structures in both his Cambridge, Massachusetts, apartment and at MIT’s shared facilities.

Blaesi then experimented with different carrier materials, finding that the higher the molecular weight, the longer it took the pill to dissolve because the material would absorb water and expand before degrading.

"Initially I thought, ‘Oh no, the drug isn’t being dissolved fast enough anymore,’" Blaesi recalls. "Then we thought, ‘Everything has its place.’ This could stay in the stomach for longer because of the expansion. Then it could release the drug over time. We realized this wouldn’t just improve manufacturing, it would improve the product."

In 2019, Blaesi and Saka published the first paper on their expandable fibrous tablets for prolonged drug delivery. It received a mixed reception.

"Some reviewers said, ‘Research on similar gastroretentive dosage forms has been done for 40 years and no one’s really succeeded,’" Blaesi recalls. "People said, ‘It will never work. Do experiments in animals and then we’ll talk.’"

Blaesi moved back to Switzerland during the Covid-19 pandemic and ran his animal experiments there.

"The reviewers were right: What we had didn’t work," Blaesi says. "But we adjusted the design and showed we could make the pill stay in the stomach for longer."

Inside Enzian’s final tablet design, tiny fibers are arranged in a grid. When water flows into the spaces between the fibers, they expand to form a strong gel-like substance that slowly erodes in the stomach, steadily releasing the drug. In animal studies, Enzian’s team showed its technology allowed tablets to remain in the stomach for 12 to 24 hours before being safely excreted.

The team soon found cancer drugs would be a good fit for their technology.

"A lot of cancer drugs are only soluble in acidic solutions, so they can only be absorbed while the drug is in the stomach," Blaesi explains. "But on an empty stomach, the drug may be in the stomach for just 30 or 40 minutes at present. For a full stomach, it’s a few hours. And because you have a short time to deliver the drug, you need to release a high dose immediately. That shoots up the blood concentration, and if you dose every 12 hours, the concentration is going down during the other 10 hours."

From the lab to patients
In upcoming human trials, Enzian plans to use its tablets to deliver a drug for prostate cancer that Blaesi says is currently dosed at several hundred milligrams a day. He hopes to get down to about a tenth of that with a better therapeutic effect.

Enzian also believes its technology could improve treatments for blood, skin, and breast cancers.

"This could really be used to improve treatment for a variety of cancers," Blaesi says. "We believe this is a more efficient and effective way to deliver drugs."

Maximizing effectiveness and minimizing side effects is also important in clinical trials, where a new drug’s superiority over existing treatments must be shown, and a single adverse event can end its development.

The upcoming move into patients is the culmination of more than a decade of work for Blaesi, who is confident Enzian can deliver on its promise of improving treatments.

"The opportunity is enormous," Blaesi says. "So many oral cancer drugs have this delivery problem. We still have to do the efficacy and safety studies on patients, but we expect this to be a game changer."

On October 23, 2025 Orion Corporation ("Orion") and Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, reported that Orion has obtained an exclusive, focused commercial license to one of Abzena’s monoclonal antibodies (mAbs) that targets a cancer of high clinical unmet need. The antibody will strengthen Orion’s broad oncology-focused drug Research and Development pipeline.

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The antibody was designed and developed at Abzena’s Cambridge, UK, early phase R&D facility using their proprietary Composite Human Antibody (CHAb) technology as part of an integrated developability platform approach to select a superior lead candidate. Abzena’s scientists screened antibodies against a number of parameters including functionality, safety, and manufacturability to identify a lead candidate devoid of risks that could impact downstream development processes and ultimately affect the clinical outcome of the antibody. Leveraging the AbZelectPRO cell line development (CLD) platform a highly stable and productive manufacturing cell line for this antibody was generated for manufacture.

Campbell Bunce, Chief Scientific Officer of Abzena, said, "We are delighted to have partnered with Orion on the design and development of our CHAb-designed mAb to support their extensive oncology-focused Research and Development pipeline. Using our uniquely integrated developability approach along with our streamlined AbZelectPRO CLD platform, we were able to design a de-risked lead antibody that offers Orion’s program the best chances of success in the clinic."

Antti Haapalinna, Vice President, External Science and Partnering, R&D, Orion Corporation, said, "We are very satisfied with the excellent and transparent collaboration and the results it has delivered in our common antibody program."

Abzena has over 20 years of experience designing, developing, and manufacturing monoclonal antibody programs. The organization can support antibody programs at its Cambridge, UK, and San Diego, USA facilities, with downstream process development and GMP manufacturing activities taking place in the US up to 2,000 litre in scale.

(Press release, Orion, OCT 23, 2025, View Source [SID1234656956])

On October 23, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, reported that three abstracts featuring its investigational intravenous Deciparticle everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), to be held December 9-12, 2025, at the Henry B. Gonzalez Convention Center, San Antonio, Texas. Sapu Nano is the developer of Deciparticle and is part of Sapu family of companies and a joint venture between Oncotelic (OTCQB:OTLC) and Dragon Oversea.

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Sapu003 is a novel Deciparticle formulation of everolimus for intravenous administration, designed to overcome the pharmacologic limitations of oral mTOR inhibitors (Afinitor), including poor bioavailability, dose-limiting toxicity, and restricted tumor penetration. Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor-positive (HR )/HER2 metastatic breast cancer.

Presentation Details

Presentation Session:
Thursday, December 11, 2025 | 5:00 PM – 6:30 PM CST

Abstract Number Presentation Number Title
1834 PS4-04-04 High RICTOR / Low RPTOR Gene Expression Signature as a Predictive Biomarker for Intravenous Everolimus Nanoparticle (Sapu003): Rationale for the First in Human Trial
1702 PS4-04-21 Deciparticle Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing
1811 PS4-06-05 Sapu003: Everolimus for Injection – Pharmacokinetic Rationale for Phase I Evaluation in HR /HER2 Metastatic Breast Cancer

"These three accepted abstracts underscore the breadth and innovation of our Deciparticle nanomedicine platform," said Dr. Vuong Trieu, CEO of Sapu Nano. "Sapu003 represents the first intravenous everolimus formulation with the potential to deliver robust mTOR inhibition and direct tumor cytotoxicity. We are honored to share these findings with the global oncology community at SABCS."

The studies were conducted in collaboration with Southern Oncology Clinical Research Unit (SOCRU), Ingenu CRO, and Medicilon, and reflect a coordinated clinical-translational effort bridging molecular biomarker discovery, pharmacokinetic modeling, and scalable GMP manufacturing of Deciparticle everolimus.

(Press release, Oncotelic, OCT 23, 2025, View Source [SID1234656955])