On November 5, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has executed a data transfer agreement ("DTA") with Cleveland Clinic, as a key step in the process of transferring the breast cancer vaccine clinical trial data and sponsorship to Anixa for future clinical development.

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With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. The IND, currently sponsored by Cleveland Clinic, is in the process of being transferred to Anixa. The DTA will allow for the transfer of all relevant data and information, collected and generated from the Phase 1 clinical trial, to Anixa.

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein.

"Execution of the DTA represents a significant step in the transfer of IND sponsorship to Anixa. We look forward to completing the remaining steps with Cleveland Clinic, and eventually advancing to a Phase 2 trial under our sponsorship," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We are pleased with the progress and preliminary findings from our Phase 1 clinical trial, and are excited about the presentation of the final Phase 1 data, by Cleveland Clinic, at the San Antonio Breast Cancer Symposium on December 11."

(Press release, Anixa Biosciences, NOV 5, 2025, View Source [SID1234659490])

On November 5, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported its participation at the upcoming Society of Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting and American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting. The company will present new preclinical and translational data supporting the advancement of its clinical pipelines, SynKIR-110 and SynKIR-310.

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The company’s presentations will include:

SITC 2025 Annual Meeting

November 7-9, 2025 – Gaylord National Resort and Convention Center, National Harbor, Maryland

Verismo’s team will deliver three presentations:

An oral and a poster presentation on new preclinical in vitro and in vivo results to investigate functionality, safety and tumor killing of SynKIR-110, Verismo’s lead pipeline targeting mesothelin
Location: Gaylord National Resort & Convention Center, National Harbor 2-3
Abstract Number: 298
Abstract Title: A Novel NK-cell based Split-Signaling Killer Immunoglobulin Receptor (KIR)-Based CAR T Targeting Mesothelin, SynKIR-110, Shows Increased Safety Profile and Increased Efficacy in vitro and in vivo
Presenting Author: Nora Yucel, PhD
Oral Session Title: Oral Abstract Session 2
Oral Session Date and Time: Friday, Nov. 7, 2025: 4:45PM – 5:00PM
Poster Session Title: Exhibits and Poster Viewing
Poster Session Date and Time: Saturday, Nov 8, 2025: 12:15 – 1:45 PM, 5:10 – 6:35 PM

A poster presentation on immunohistochemistry (IHC) detection of mesothelin to support further development of CAR T cell therapy in cholangiocarcinoma.
Location: Prince George ABC Exhibit Halls Gaylord National Resort and Convention Center
Abstract Number: 1238
Abstract Title: Histopathologic analysis of mesothelin expression in cholangiocarcinoma supports inclusion in biomarker-targeted clinical trials
Presenting Author: Adina Vultur, PhD
Session Title: Exhibits & Poster Viewing
Session Date and Time: Saturday, Nov. 8, 2025: 12:15 – 1:45 PM, 5:10 – 6:35 PM

A poster presentation highlighting key considerations for ensuring the timely release of patient materials to support clinical development.
Location: Prince George ABC Exhibit Halls Gaylord National Resort and Convention Center
Abstract Number: 591
Abstract Title: The Need for Speed Without Compromising Quality in Manufacturing Autologous Cell Therapy Products
Presenting Author: Jacqueline Stief
Session Title: Exhibits and Poster Viewing
Session Date: Friday, Nov. 7, 2025: 12:1 5- 1:45 PM, 5:35 – 7 PM
ASH 2025 Annual Meeting

December 6-9, 2025 – Orange County Convention Center, Orlando, Florida

Verismo’s team will deliver a poster presentation highlighting the potent antitumor activity of SynKIR-310, a novel CD19-targeted KIR-CAR T cell therapy, in a preclinical mouse model.

Location: Orange County Convention Center – West Halls B3-B4
Abstract Number: 4103
Abstract Title: SynKIR-310 split-signaling based KIR-CAR T cell therapy achieves faster and deeper anti-B cell tumor efficacy with reduced cytokine levels
Presenting Author: Megan Blair, PhD
Session Title: 702. CAR-T Cell Therapies: Basic and Translational: Poster II
Session Date and Time: Sunday, Dec. 7, 2025: 6:00 PM – 8:00 PM

(Press release, Verismo Therapeutics, NOV 5, 2025, View Source [SID1234659489])

On November 5, 2025 Precision Biologics, Inc. reported in vitro and in vivo efficacy of its novel tumor-specific ADC (PB-vcMMAE-5) against human carcinomas expressing truncated core 2 O-glycans. Recent data for several human cancer types expressing truncated core 2 O-glycans will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 7th, 2025, National Harbor, MD, USA.

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Poster title: In vitro and in vivo efficacy of the antibody-drug-conjugate (ADC) PB-vcMMAE-5 against human carcinoma expressing truncated core 2 O-glycans

Presentation of the poster will be made in person on the following date and location:

Friday, November 7th,  12:15pm – 1:45pm ET; & 5:35pm – 7pm ET

Gaylord National Resort and Convention Center,  National Harbor, MD, USA

Lower Level Atrium – Prince George’s ABC

Primary Category: Immuno-Conjugates and Chimeric Molecules

Abstract Number: 949

BACKGROUND:

Solid tumors remain largely unresponsive to immune checkpoint inhibitors, in part due to their ability to suppress the cytotoxic activity of immune cells infiltrating the tumor microenvironment. One of the disrupted pathways in these cancers is O-glycosylation, a feature particularly associated with cancer progression, metastasis, and poor prognosis.

One strategy to overcome resistance of solid tumor to immunotherapy is the employment of antibody-drug-conjugates (ADCs) selectively targeting cancer cells and not healthy tissues. We developed an ADC, designated PB-vcMMAE-5, composed of the following:

The monoclonal antibody (mAb): We used PB-223, an innovative mAb developed through affinity maturation of clinical stage mAb NEO-102 (Ensituximab), a chimeric human IgG1 mAb that targets truncated core 2 O-glycans, specifically expressed by cancer cells and not by healthy tissues. PB-223 does not bind to normal tissues and it internalizes into human cancer cell lines expressing its target.
The payload: Monomethyl auristatin E (MMAE) was used as payload. MMAE is a potent antimitotic agent that inhibits cell division by blocking the polymerization of tubulin and is the most common ADC payload used to be linked to antibodies in clinical development for oncologic applications.
The linker: mc-vc-PABc was used as a cleavable linker. PB-223 was conjugated to the linker-payload through a cysteine-based conjugation method.
The drug-to-antibody ratio (DAR) of PB-vcMMAE-5 is 3.92.

Study presented at SITC (Free SITC Whitepaper) Annual Meeting 2025 includes the following data:

PB-223 specific binding to human tumor tissues by immunohistochemistry (IHC): PB-223 binds selectively to human tumor tissues and not to human normal tissue. PB-223 strongly reacted with colorectal, pancreatic, lung, prostate, and ovarian tumor tissues.
In vitro  efficacy of PB-vcMMAE-5 against several human cancer cell lines: The in vitro cytotoxicity of PB-vc-MMAE-5 was evaluated in 9 human cancer cell lines, including prostate (PC-3, LnCAP), triple negative breast (HCC1937, MDA-MB-231), ER+,PR+,HER2+ breast (BT-474), squamous cell carcinoma of the lung (NCI-H226), ovarian (OV-90), colorectal (SW403), and pancreatic (CFPAC-1) cancer cell lines. This study shows that PB-vcMMAE-5 effectively killed all cell lines tested, with the highest percentage of killing observed against MDA-MB-231 (triple negative breast), LnCAP (prostate), OV-90 (ovarian), and NCI-H226 (lung) cancer cell lines.
In contrast, naked PB-223 mAb showed no killing in all cell lines tested.

In vivo safety of PB-vcMMAE-5 in mice: NOD-SCID mice bearing OV-90 (ovarian) xenografts were treated with weekly doses of PBS, MMAE alone, or PB-vc-MMAE-5 (1, 3, 6, or 9 mg/kg) for five weeks. Animal body weight was monitored regularly, twice a week, as an indirect measure of toxicity. The ADC PB-vcMMAE-5 was well tolerated in mice. No sign of distress and no loss of body weight were observed.
No significant changes in body weight, blood parameters including hematology and clinical chemistry, nor pathological changes in the liver, spleen, brain, or heart of mice treated with efficacious doses of the ADC were observed compared with control groups.
In vivo  efficacy of PB-vcMMAE-5 in mice: The efficacy of the ADC PB-vcMMAE-5 was assessed in OV-90 (ovarian) subcutaneous xenograft model established in NOD-SCID mice. The ADC PB-vcMMAE-5 was administered intravenously at doses 1, 3, 6 or 9 mg/kg, once per week for five weeks.
On day 31 from the first ADC infusion, most alive mice were sacrificed, and tumors were excised for histological analysis using Ki-67 staining to assess proliferating viable tumor cells. To further assess systemic toxicity and prolonged efficacy, three mice each from the 6 and 9 mg/kg groups were followed to day 45.

Data presented in this study show that PB-vcMMAE-5 induced significant tumor growth inhibition compared to controls in a dose-dependent manner.
The highest tumor growth inhibition was observed at 6 and 9 mg/kg doses.

In addition, analysis of tumors at day 45 showed absence of viable tumor cells and presence of tumor cells in necrosis, in mice treated with PB-vcMMAE-5 at 9 mg/kg.
Findings from this study showed that PB-vcMMAE-5 can kill human cancer cells expressing PB-223’s target, is not toxic in vivo in mice, and is highly effective in vivo at 9 mg/kg in NOD-SCID mice bearing human ovarian cancer. In addition, in a poster presented at AACR (Free AACR Whitepaper) Annual Meeting 2025 we reported that PB-vcMMAE-5 is stable in human plasma.

All these data suggest that PB-vcMMAE-5 has promising potential as a therapeutic option for a range of human malignancies expressing core 2 O-glycans.

The PDF of the poster will be available starting from November 5th, 2025, at the following link:

View Source

(Press release, Precision Biologics, NOV 5, 2025, View Source [SID1234659488])

On November 5, 2025 HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported that the preclinical data on HCB301, a novel tri-specific immunotherapeutic fusion protein, has been accepted for presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 5-9, 2025, in National Harbor, Maryland. Featured in a poster presentation, the data highlight HCB301’s differentiated design and multi-pronged antitumor mechanism, which engages both innate and adaptive immunity.

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HCB301 is designed to simultaneously:

Block SIRPα-CD47 interaction to enable macrophage-mediated phagocytosis
Block PD-1-PD-L1 signaling to restore exhausted T-cell function
Trap TGFβ to overcome stromal and immune exclusion in tumor microenvironment (TME)
This tripartite approach aims to overcome the limitations of existing checkpoint inhibitors by activating both arms of the immune system, especially in tumors with immunologically ‘cold’ or suppressive tumor microenvironments (TMEs) resistant to current treatments.

In addition to the HCB301 preclinical poster presented on November 5, HanchorBio will also present two late-breaking abstracts on November 7 to showcase clinical data on its SIRPα-Fc fusion protein HCB101. Together, the three posters underscore the breadth and translational strength of HanchorBio’s proprietary Fc-Based Designer Biologics (FBDB) platform across innate and adaptive immune pathways.

Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio, commented: "HCB301 builds directly on the foundation of HCB101, our clinical-stage SIRPα-engineered fusion protein. By integrating PD-1 blockade and TGFβ neutralization into a single molecule, HCB301 represents what we believe to be the first-in-class tri-specific fusion protein that simultaneously targets immune checkpoints, immune suppression, and macrophage dysfunction. This design reflects our commitment to building modular, next-generation immunotherapies with global translation potential. With IND clearance and first-patient dosing now achieved in both the US and China, HCB301 demonstrates the scalability of our FBDB platform and the executional readiness of our team across regions. As we advance HCB301 into the clinical stage, this milestone further positions HanchorBio as a long-term innovation partner for global co-development, particularly in cancers with high resistance to conventional immunotherapies."

Preclinical highlights of HCB301 (SITC Poster #P321)
Title: HCB301, a tri-specific fusion protein targeting SIRPα/CD47, PD-1/PD-L1, and TGFβ, promotes anti-tumor macrophage and T cell activity in preclinical models of solid tumors

Strong immune activation: HCB301 induced robust antibody-dependent cellular phagocytosis (ADCP), activated tumor-associated macrophages, and increased CD8+ T cell infiltration.
Synergistic antitumor efficacy: In CT26, MC38, and B16F10 models, HCB301 demonstrated superior tumor growth inhibition compared with single- or dual-arm comparators.
TGFβ suppression: HCB301 potently neutralized active TGFβ, reversing TME immunosuppression, and restoring T cell function.
Fc-effector tuning: Selective Fc engineering optimized immune activation while minimizing off-target toxicity.
"HCB301 was purpose-built to break through the resistance barriers that limit current PD-1 or CD47 monotherapies," remarked Wenwu Zhai, Ph.D., Chief Scientific Officer of HanchorBio. "Each of its three arms addresses a key axis of tumor immune evasion: CD47 for innate immune clearance, PD-1 for adaptive immune reactivation, and TGFβ for TME remodeling. Our preclinical data show that HCB301 delivers synergistic immune activation and tumor control, strongly supporting its advancement into the clinic."

About HCB301
Based on company analysis, HCB301 is the first clinical-stage tri-specific recombinant Fc-fusion protein that simultaneously targets SIRPα/CD47, PD-1/PD-L1, and TGFβ. It was designed using HanchorBio’s FBDB platform, which enables modular multi-arm immunotherapies with tunable Fc regions and enhanced manufacturability.

HCB301 integrates:

A high-affinity SIRPα domain that binds cancer cells’ CD47 to promote macrophage phagocytosis
A PD-1 extracellular domain that blocks PD-L1 and restores T-cell effector function
A TGFβRII domain that traps active TGFβ to alleviate immunosuppressive signals in the tumor microenvironment
The protein shows a favorable safety profile in repeat-dose toxicology studies in cynomolgus monkeys. Its differential tumor vs. RBC binding profile may reduce the risk of anemia, thrombocytopenia, or other cytopenia while maintaining potent anti-tumor activity.

HCB301 achieved IND clearance and first-patient dosing in both the US and China in 2025. The ongoing Phase 1 study (HCB301-101; NCT06487624) is a multi-regional, multi-center, open-label, dose-finding, first-in-human trial evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical efficacy of HCB301 in patients with advanced solid tumors or relapsed and refractory classical Hodgkin lymphoma.

(Press release, Hanchor Bio, NOV 5, 2025, View Source [SID1234659487])

On November 5, 2025 BioDlink (1875.HK) reported to have congratulated its partner Lepu Biopharma (2157.HK) on receiving conditional marketing approval from China’s National Medical Products Administration (NMPA) for MEIYOUHENG (Becotatug Vedotin injection). This Class 1 innovative antibody-drug conjugate (ADC) targets the epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). Significantly, this is the world’s first approved non-photoimmunological EGFR-targeted ADC and a first-in-class innovation. This project is BioDlink’s first commercial ADC manufacturing initiative globally, validating its robust capabilities in the commercialization of complex biologics.

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This approval builds on BioDlink’s earlier success with Lepu Biopharma’s ADC program that achieved 100% first-pass success across technology transfer, Process Performance Qualification (PPQ), and Pre-Approval Inspection (PAI).

The program, designated as a Breakthrough Therapy Project, required rapid tech transfer and full production line delivery from monoclonal-antibody Drug Substance through ADC Drug Product.

BioDlink’s performance in this project secured BLA approval on October 30, 2025, demonstrating its capacity to meet aggressive regulatory timelines and ensure commercial readiness for global markets.

ADC manufacturing is technologically demanding, requiring exceptional process capabilities and robust quality systems. BioDlink participated in the entire development and production cycle, from technology transfer, process development, and analytical method establishment to clinical sample and GMP-compliant commercial batch manufacturing. This reflects the company’s end-to-end capabilities in supporting complex biologics from R&D to market launch.

Through close coordination with Lepu Biopharma and multiple regulatory authorities, BioDlink established an integrated quality management system. This system ensures seamless coordination across the entire production chain—accelerate the timeline for pivotal clinical batch production and subsequent PPQto meet aggressive regulatory submission goals and aligns with global GMP standards, including those of China, the U.S., and the EU. BioDlink’s manufacturing facilities have obtained GMP certifications from several countries and Foreign Manufacturer Approval from Japan’s PMDA. This collaboration sets a practical model for efficient multi-party industry collaboration and resource integration in the biopharma sector.

BioDlink’s manufacturing facilities have obtained GMP certifications from China, Brazil, Argentina, Indonesia, Egypt, Colombia, Pakistan and Thailand, as well as Foreign Manufacturer Approval from Japan’s PMDA. And also passed EU-QP 5 times in these years. This achievement marks a major step forward for ADC commercialization and demonstrates a practical model for multi-party industry collaboration and efficient resource integration.

Dr. Ziye Sui, Executive Director and CEO of Lepu BioPharma, commented: "We sincerely thank the BioDlink team for their outstanding CDMO services and strong collaboration. This approval also establishes a practical pathway for multi-party collaboration, offering new hope for R/M NPC patients who have failed anti-PD-(L)1 and platinum-based therapies."

Dr. Jian Zhang, Chief Operating Officer, BioDlink, noted: "The approval of this pilot batch highlights the increasing technical and quality coordination demands placed on both the Marketing Authorization Holder (MAH) and the CDMO. Moving forward, we will continue working closely with our partners to accelerate the launch of innovative medicines to benefit patients worldwide."

About Becotatug Vedotin

MEIYOUHENG (Becotatug Vedotin injection) is an ADC comprised of an EGFR-targeted monoclonal antibody conjugated with the potent microtubulin inhibiting payload monomethyl auristatin E via a valine-citrulline linker. It is the world’s first approved EGFR-targeted ADC and a first-in-class innovation, for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).

It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment.

(Press release, BioDlink, NOV 5, 2025, View Source [SID1234659486])