On October 5, 2026 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for HCB303. The clearance enables HanchorBio to initiate its Phase 1 first-in-human clinical trial.

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HCB303 is HanchorBio’s second trispecific immunotherapy to enter clinical development and represents an innovative and differentiated approach to enhance immune response against cancer. A humanized trispecific fusion protein engineered via HanchorBio’s proprietary FBDB platform, HCB303 incorporates a TIGIT-Fc ligand-trap strategy within a single architecture that simultaneously targets the TIGIT/PVR, PD-L1/PD-1, and SIRPα/CD47 pathways.

Unlike conventional anti-TIGIT antibodies that primarily bind to TIGIT and block TIGIT receptor signaling, HCB303 is designed to intercept TIGIT ligands—including PVR/CD155 and CD112. By trapping these ligands, HCB303 is designed to reduce TIGIT-mediated inhibitory signaling while potentially preserving CD226 expression and associated activating signaling in T cells and NK cells. Combined with PD-L1 blockade and SIRPα-mediated enhancement of macrophage phagocytosis, HCB303 aims to coordinate complementary innate and adaptive antitumor immunity within the tumor microenvironment.

"We believe TIGIT-Fc offers a biologically superior strategy to conventional anti-TIGIT receptor blockade," said Scott Liu, PhD, Founder and Chairman of HanchorBio. "Simply blocking PVR signaling through an anti-TIGIT antibody may release the inhibitory signal, but it does not address the down-regulation of CD226, which is needed for enhanced activation of T and NK cells. HCB303 was designed to go further—intercepting immune-inhibiting TIGIT ligands and preserving the CD226 activating axis, while simultaneously blocking the PD-L1 and CD47 pathways. This is precisely the type of biology-driven therapeutic architecture our FBDB platform was built to create."

The FDA clearance follows pre-IND feedback from the agency in August 2026. HanchorBio will now proceed with its planned Phase 1 first-in-human, dose-escalation, multi-regional study (HCB303-ONC-101) in patients with advanced, relapsed, or refractory solid tumors who have no remaining standard treatment options. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and preliminary antitumor activity.

"HCB303 is HanchorBio’s second trispecific immunotherapy to enter clinical development, and the FDA clearance moves HCB303 from a differentiated biological hypothesis into clinical testing," added Alvin Luk, PhD, MBA, President and CMO (Group) & CEO (USA) of HanchorBio. "Our priority now is to rigorously evaluate whether its differentiated TIGIT biology and coordinated engagement of innate and adaptive immunity translate into meaningful clinical benefit for patients. With HCB301 already in clinical development and HCB303 now cleared to enter the clinic, we are advancing the potential of our FBDB platform to generate mechanistically distinct multispecific therapeutics."

About HCB303

HCB303 is an investigational, humanized trispecific fusion protein developed using HanchorBio’s proprietary FBDB platform. It is designed to simultaneously modulate the SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR immune pathways, integrating macrophage, T-cell, and NK-cell antitumor immunity within a single engineered molecule.

(Press release, Hanchor Bio, OCT 5, 2026, View Source [SID1234673194])

On October 5, 2026 Genezen, a gene therapy contract development and manufacturing organization (CDMO), and InterAct Therapeutics, a gene therapy innovation organization with a proprietary platform that pinpoints cancer targets and powers anti-metastasis therapies to save lives, reported a strategic manufacturing partnership to advance the clinical development of a therapy for breast cancer liver metastases (BCLM). InterAct Therapeutics’ lead program, IAT-S2, is an AAV8-based therapy targeting hepatocytes to modulate the liver microenvironment and suppress metastatic outgrowth.

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Metastatic disease remains a leading cause of mortality in advanced solid tumors, yet few therapies specifically target the complex interactions between tumor cells and the metastatic microenvironment. IAT-S2 emerged from research in the lab of Dr. Isaac Chan, MD, PhD of UT Southwestern Medical Center, whose team was investigating how metastatic breast cancer cells interact with healthy liver cells to establish and grow within the liver. Dr. Chan then co-founded InterAct Therapeutics to move the program forward. Rather than targeting cancer cells alone, InterAct Therapeutics’ approach is to alter the biology of the metastatic environment to eliminate metastatic growth. Liver metastases are common among patients with metastatic breast cancer, with median survival of just two to three years following diagnosis. InterAct Therapeutics is developing a one-time, disease-modifying gene therapy designed to address the tumor-liver microenvironment, for which there are currently no specifically approved therapies.

InterAct Therapeutics selected AAV8 as the delivery vector for IAT-S2 based in part on its ability to efficiently target hepatocytes, enabling a liver-directed approach to the treatment of metastatic disease. In preclinical studies, InterAct Therapeutics observed near elimination of the liver metastases across five models of liver metastasis in mice.

Following positive FDA INTERACT feedback, InterAct Therapeutics is now preparing for IND-enabling studies with manufacturing support from Genezen’s experienced viral vector team at its state-of-the-art facility in Indianapolis. Genezen will provide its platform AAV process development, scale-up, and GMP manufacturing expertise to support toxicology studies and the production of clinical material for a Phase 1 trial. The collaboration will support InterAct Therapeutics as it advances IAT-S2 toward IND submission and first-in-human clinical development.

"As a physician, I am concerned when metastatic breast cancer spreads to the liver, as these are among the patients I worry about the most. As a scientist, I’ve dedicated my work to understanding why these metastases are so difficult to treat and finding a fundamentally different way to approach them," said Dr. Isaac Chan, MD, PhD, Chief Scientific Officer and Co-founder of InterAct Therapeutics. "This partnership is an important step toward translating a discovery that began in our lab into a potential therapy for patients. Announcing this partnership during Breast Cancer Awareness Month is especially meaningful as we move beyond awareness toward the progress patients are waiting for."

"Genezen was built to help innovators translate promising science into therapies that can make a meaningful difference for patients," said Steve Favaloro, Chairman and Chief Executive Officer of Genezen. "We are proud to bring our deep AAV development and manufacturing expertise to this partnership and work alongside InterAct Therapeutics to help move this program forward and make an impact in the oncology space. Collaborations like this embody what drives our team every day: scientific excellence, urgency for patients and a solutions-driven commitment to our partners as we work together to bring the next generation of therapies to life."

InterAct Therapeutics selected Genezen following an evaluation of manufacturing partners, citing the company’s AAV experience, reputation, reliability and ability to support the program’s critical development timeline. The partnership builds on Genezen’s deep technical experience in AAV development and manufacturing, including its experience manufacturing a commercially approved AAV gene therapy, and positions the companies to scale manufacturing as IAT-S2 progresses through clinical development.

(Press release, Genezen, OCT 5, 2026, View Source [SID1234673193])

On October 5, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that a patient in its ongoing Phase 1, dose-escalating, clinical trial evaluating its novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer, exhibited stable disease 90 days after treatment. This represents the first such response in Anixa’s CAR-T cell therapy trial. Correlative studies evaluating presence and durability of CAR positive cells are ongoing.

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The patient was treated in the fifth dose cohort and received a dose of 1×10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion, representing the highest dose level evaluated to date in the study. To date, no dose-limiting toxicities have been observed in any patients.

The Phase 1 study is evaluating liraltagene autoleucel, or lira-cel, Anixa’s novel CAR-T therapy targeting follicle stimulating hormone receptor (FSHR), which is expressed on ovarian cancer cells but has limited expression in healthy tissues. The trial is designed to assess safety, tolerability, and preliminary signs of efficacy across escalating dose levels. The study is being conducted at Moffitt Cancer Center ("Moffitt").

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "While this Phase 1 study is primarily designed to evaluate safety, we are encouraged by our early anecdotal findings of overall survival (OS). In addition, an observation of stable disease for this duration, coupled with multiple patients having surpassed one year of survival following treatment, is very encouraging as we look forward to further evaluating lira-cel at current and future dose levels."

Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt and the principal investigator for the trial, added, "As we advance in this trial we hope to continue observing improved results in patients, from progressive disease to stable disease and eventually to radiological partial response (PR) and hopefully complete response (CR). This result, and the absence of dose-limiting toxicities observed thus far is encouraging as we continue to treat patients in the current and future dose cohorts."

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. Anixa’s CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

(Press release, Anixa Biosciences, OCT 5, 2026, View Source [SID1234673192])

On October 5, 2026 Privo Technologies reported results from the CLN-004 Phase 2 (Cohort 1) trial evaluating PRV111, a nanoengineered, cisplatin-releasing patch for the treatment of non-invasive oral cancer and high-grade dysplasia (HGD). These conditions are common, recur frequently, and typically require repeated surgical excision, which can impair speech, swallowing, and appearance.

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The CLN-004 clinical study was conducted at four major U.S. hospitals known for treating head and neck cancers. PRV111 was studied in 22 patients and achieved a 95.5% pathologic complete response (pCR) rate, defined as the absence of any residual dysplastic cells in post-treatment punch biopsy specimens, as determined by histopathology. PRV111 also eliminated the need for standard-of-care surgery in 100% of patients and demonstrated durable local control, with no recurrence observed in the treated areas. Dr. Eric Lamarre, an investigator in the study and Chief of Head and Neck Surgical Oncology at Cleveland Clinic, commented:

"The complete response rate of 95.5% and the treatment durability achieved with PRV111 is among the highest reported for localized therapies in this setting. Patients typically face repeated surgical resections, which can lead to scar formation, anatomic distortion and functional impairments that can permanently affect speech and swallowing. This non-surgical patch not only cleared the disease but preserved native tissue function without causing significant scar formation. These results reinforce PRV111’s potential to redefine the standard of care for oral carcinoma in situ and dysplasias. We are one step closer to providing patients with a non-surgical alternative to repeated operative procedures."

The CLN-004 study builds upon Privo’s earlier clinical experience with PRV111 (CLN-001), which showed promising local tumor responses with no systemic toxicity in a first-in-human setting. The results of that earlier trial were published in Nature Communications and highlighted by Forbes for their innovative approach to localized cancer drug delivery.

Detailed Results:

Twenty-two patients with biopsy-confirmed non-invasive oral cancer or high-grade dysplasia received a single cycle of PRV111. Twenty-one patients achieved centrally confirmed pathologic complete responses; the remaining patient was downstaged to low-grade dysplasia, eliminating the need for standard-of-care surgery. All treated lesions resolved, and mucosal surfaces regenerated without scarring or distortion. At a median follow-up of about 14 months, no recurrences were observed; several patients have maintained responses beyond 14 months, and the longest ongoing response is now greater than 21 months. No systemic toxicities or dose-limiting toxicities were reported. Treatment-related events were primarily mild, transient oral symptoms.

Transforming the Treatment Paradigm:

"We at Privo and the investigators in our CLN-004 study are excited by these encouraging results. We are one step closer to providing patients with a non-surgical alternative to repeated operative procedures." said Manijeh Goldberg, PhD, MBA, CEO, President and Founder of Privo Technologies.

Current management of non-invasive oral cancer and HGD relies on surgical excision, which is associated with high recurrence rates and morbidity. PRV111 is designed to deliver high concentrations of cisplatin directly into dysplastic tissue through a brief, outpatient procedure, avoiding systemic side effects associated with traditional chemotherapy and standard-of-care surgery.

About PRV111:

PRV111 is a nanoengineered, polymeric topical patch designed to deliver high-dose cisplatin directly into oral lesions and adjacent mucosa while minimizing systemic exposure. The patch adheres to the lesion, achieves rapid drug permeation into dysplastic tissue and regional lymphatics, and is removed after treatment.

(Press release, Privo Technologies, OCT 5, 2026, View Source [SID1234673191])

On October 5, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported it will present additional data from both the NHS-Galleri trial and the PATHFINDER 2 study further evaluating the Galleri multi-cancer early detection (MCED) test at the Early Detection of Cancer Conference (EDCC) in Edinburgh, the United Kingdom, taking place Oct. 6-8, 2026, and at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain taking place Oct. 23-27, 2026.

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Data across both meetings will include:

A rapid oral presentation highlighting the efficiency and safety of Cancer Signal Origin (CSO) guided diagnostic workups.
A poster showing Galleri cancer detection of more than 200 cancers across histologically distinct cancer types, including rare cancers.
A poster showing Galleri cancer detection performance and accuracy across self-reported racial and ethnic groups.
A poster presenting new NHS-Galleri data on the preclinical window for cancer detection with findings compatible with annual MCED screening.
A poster showing a reduction of cancer diagnoses in emergency presentations associated with annual Galleri screenings.
"Ongoing analyses of PATHFINDER 2 and NHS-Galleri trial data continue to strengthen the evidence for integrating multi-cancer early detection into routine care," said Josh Ofman, MD, MSHS, CEO at GRAIL. "Across large, diverse populations, these data continue to demonstrate Galleri’s strong performance and favorable safety profile, and reinforce its potential to fundamentally improve how we screen for cancer by finding more cancers, before symptoms are present, in early stages, when there is the greatest opportunity for curative intent treatment."

EDCC Data Presentations

Title: Estimating Preclinical Detection Window, Multi-Cancer Early Detection (MCED) Test Sensitivity, and Episode Sensitivity in the NHS-Galleri Trial Using the Incidence Method
Presentation Type: Poster
Date: Oct. 6

Title: Spectrum of Histologically Distinct Cancer Types Detected by a Methylation-Based Multi-Cancer Early Detection (MCED) Test
Presentation Type: Poster
Date: Oct. 7

Title: Performance of a multi-cancer early detection (MCED) test across racial and ethnic groups: Descriptive report from PATHFINDER 2
Presentation Type: Poster
Date: Oct. 7

Title: Loss of Life Expectancy by Stage at Diagnosis and Cancer Type in England: Illustrating the Burden of Premature Mortality From Late-Stage Cancer
Presentation Type: Poster
Date: Oct. 6

Title: High adherence to mammography screening before and after MCED testing
Presentation Type: Poster
Date: Oct. 7

Title: Population Impact of MCED Screening by Reducing the Diagnosis of Cancer in Emergency Settings in England
Presentation Type: Poster
Date: Oct. 7

More information about timing of the EDCC presentations can be found here.

ESMO Data Presentations

Title: Efficiency and Safety of Cancer Signal Origin (CSO)-Guided Diagnostic Workups Following Multi-Cancer Early Detection (MCED) Testing: Results from PATHFINDER 2 (PF2)
Abstract Number: 1151
Presentation Type: Rapid Oral
Date/Time: Oct. 26, 2:45 p.m.-4:15 p.m.
Location: Salamanca Auditorium, Hall 10

Title: Diagnostic Workups Following a Positive Multi-Cancer Early Detection (MCED) Blood Test in Clinical Practice
Presentation Number: 1164P
Presentation Type: Poster
Date/Time: Oct. 25, 12 p.m.-12:45 p.m.

More information about timing of the ESMO (Free ESMO Whitepaper) presentations can be found here.

(Press release, Grail, OCT 5, 2026, View Source [SID1234673190])