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])

On October 23, 2025 Nantes-based biotech company XENOTHERA is accelerating its developments in oncology with several multispecific glyco humanized antibody (GH-pAb) programs, reported new clinical milestones and major publications in international journals and conferences.

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Clinical advances for XON7 in solid tumors

The XON7 program is developing a GH-pAb antibody targeting a unique combination of tumor antigens expressed in several solid cancers. The clinical trial, conducted in France and Belgium since late 2023 (FIPO trial, NCT06154291), is supported by BPI France.

In September 2025, the scientific committee approved the start of a backfilling phase at a dose of 16 mg, based on pharmacokinetic data obtained from patients.

The most recent results will be presented at the ESMO (Free ESMO Whitepaper) 2025 congress in Berlin (poster 984B, October 19, 12:00 p.m.–12:45 p.m.).

LIS22: positive signals in peripheral T-cell lymphomas

The LIS22 program, dedicated to peripheral T-cell lymphoma (PTCL) – a serious disease with high unmet medical need – has been in clinic in France and Italy since mid-2024 (PALT trial, NCT06495723), with funding from France 2030 i-DEMO program.

The scientific advisory board has recently approved the move to a 7.5 mg dose, highlighting the candidate’s lack of toxicity and therapeutic potential.

LIS22 was the subject of an oral presentation and an abstract published in the proceedings of the ICML 2025 world congress in Lugano (International Conference on Malignant Lymphoma).

International publication for XON9 in hepatocellular carcinoma

The XON9 program explores the therapeutic potential of a new GH-pAb antibody targeting hepatocellular carcinoma.

The results have just been published in the special edition on hepatology of the International Journal of Molecular Sciences (IJMS).

The article, entitled "XON9 – A Glyco-Humanized Polyclonal Antibody Effective Against Hepatocellular Carcinoma" (Royer et al.), describes the in vitro and in vivo data and demonstrates the superiority of XON9 over Sorafenib, the current standard of care for this cancer.

These results reinforce XENOTHERA’s strategy of developing a new generation of multispecific antibodies to address unmet needs in oncology.

"We are delighted to be advancing science for the benefit of patients and confirming the value of our first-in-class technology in serious cancers. The multispecific and multimodal approach represents a tremendous innovation, and we believe that the future will confirm its value for patients. These results already confirm XENOTHERA’s credibility in the field of oncology. I would like to congratulate our teams on these magnificent advances and thank the patients and investigators for their commitment to these trials." — Dr. Odile Duvaux, President of XENOTHERA

(Press release, Xenothera, OCT 23, 2025, View Source [SID1234656953])