On November 7, 2025 HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported the presentation of two late-breaking abstracts on its lead asset, HCB101, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held November 5-9, 2025, in National Harbor, Maryland. Both datasets were accepted for late-breaking poster presentations, highlighting the program’s potential impact on innate immune checkpoint blockade.

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HCB101’s progress reflects its distinct engineering compared to earlier CD47-targeting approaches. First-generation CD47 antibodies, such as magrolimab and lemzoparlimab, demonstrated clinical activity but faced significant safety or efficacy challenges, leading to discontinuations or halted collaborations. Second-generation wild-type SIRPα fusions, such as maplirpacept (TTI-622), improved safety but did not deliver sufficient efficacy in solid tumors, limiting their adoption. IgG1-based fusions attempted to boost immune activation but triggered excessive Fcγ-mediated toxicity and poor tolerability, restricting their use mainly to hematologic malignancies. Third-generation engineered SIRPα fusions with inactivated IgG1 Fc improved safety in combinations but showed limited standalone efficacy.

"The acceptance of two late-breaking abstracts at SITC (Free SITC Whitepaper) for HCB101 monotherapy and combination therapy, along with our earlier preclinical abstract for HCB301, a tri-specific fusion targeting SIRPα/CD47, PD-1/PD-L1, and TGFβ, reinforces the scientific breadth of our platform across innate and adaptive immunity," said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. "HCB101 was purposely engineered to overcome the cytopenias seen with first-generation anti-CD47 antibodies while maintaining potent immune activation. In second-line gastric cancer, the combination of HCB101 with standard-of-care therapy achieved a 100% confirmed response rate in the active-dose cohort, far exceeding the 28% ORR benchmark from the RAINBOW trial. These results position HCB101 not just as a safer SIRPα-CD47 backbone, but as a next-generation macrophage checkpoint immunotherapy with best-in-class potential."

Late-Breaking Abstract Highlights (Data as of August 2025)

1. HCB101-101 Monotherapy Study (NCT05892718)

Title: HCB101, a Next-Generation Fc-Engineered SIRPα-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers

In the ongoing Phase 1a dose-escalation, no dose-limiting toxicities (DLTs) have been observed at doses up to 24 mg/kg.
CD47 receptor occupancy ≥99% achieved at doses ≥5 mg/kg, with dose-proportional pharmacokinetics.
Confirmed partial responses seen in head and neck squamous cell carcinoma (HNSCC) and marginal zone lymphoma (MZL).
Several patients achieved stable disease, with progression-free survival up to 32 weeks.
2. HCB101-201 Combination Therapy Study (NCT06771622)

Title: Phase 1b/2a Study of HCB101 Combined with Standard Therapies Demonstrates Manageable Safety and Dose-Dependent Antitumor Activity in Immunologically Cold Advanced Solid Tumors

In second-line gastric cancer (GC):
100% confirmed partial response rate (6/6 evaluable patients) at active doses when combined with ramucirumab and paclitaxel.
Tumor shrinkage up to 78%, surpassing the ~26.5% ORR benchmark from RAINBOW.
In first-line triple-negative breast cancer (TNBC):
Confirmed partial response with 73% tumor reduction at the effective dose.
Safety was manageable and consistent with the cytopenia-sparing design, with only minimal hematologic effects observed.
Dr. Fangling Ning, Investigator from the Affiliated Hospital of Binzhou Medical University, commented, "What’s unique about HCB101 is that it avoids the cytopenias that plagued anti-CD47 antibodies by minimizing red blood cell binding, while still engaging CD47 strongly on tumor cells. In our gastric cancer cohort, the responses at active doses are encouraging in a patient population that historically has had limited options. These findings validate HCB101’s unique design and suggest meaningful potential in immunologically cold tumors."

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 30 mg/kg and receptor occupancy >90% 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, TNBC, HNSCC, non-Hodgkin lymphoma, and ovarian cancer.
Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in 2L gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in 1L TNBC and 2L HNSCC, substantially exceeding historical benchmarks.

(Press release, Hanchor Bio, NOV 7, 2025, View Source [SID1234659650])

On November 7, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation & immunology (I&I), reported updated interim results from the ongoing Phase 2 expansion of its lead program, Invikafusp alfa (STAR0602).

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The data were presented in a late-breaking clinical oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting. This marks Invikafusp alfa’s fifth major oral presentation, underscoring continued external interest and excitement around the rapid progression of Marengo’s lead program.

"The expanded, pan-tumor single-agent activity of Invikafusp alfa in PD-1 resistant TMB-H cancers across seven major solid tumor indications reinforces our vision for developing a next-generation immuno-oncology (IO) backbone therapy," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "Paired tumor biopsy analyses provide compelling evidence that we are selectively activating and reprogramming Vβ6⁺ T cells within the TIL compartment — a critical mechanism that translates into meaningful clinical benefit. These results validate our first-in-class precision dual T cell activation platform and support our bold mission to overcome PD-1 resistance."

As of the July 15, 2025 data cutoff, 57 patients with TMB-H advanced solid tumors were enrolled across 20 histologies and 46 patients were efficacy-evaluable. Key findings are outlined below.

Pan tumor monotherapy activity in PD-1-resistant TMB-H patients:
20% ORR and 80% DCR observed across seven major tumor types — colorectal, gastric, lung, breast, GEJ, head and neck, and bladder cancers
Responses by indication include gastrointestinal (GI) tumors (28% ORR, 78% DCR), colorectal cancer (CRC) (33% ORR, 67% DCR), and non-small cell lung cancer (NSCLC) (20% ORR, 80% DCR)
Target tumor shrinkage, with 59% of patients experiencing target-lesion regression
Anti-tumor activity observed in both immune checkpoint blockade (ICB)-naïve and ICB-experienced patients, across both primary and secondary PD-1-resistant tumors
Activity in both microsatellite stable (MSS) and microsatellite instability (MSI)-H Tumors, including clinical benefit observed across a range of TMB levels, irrespective of MSI status
A safety profile consistent with the selective T cell activation mechanism of action, treatment-related adverse events (AEs) were transient and manageable with supportive care
Mechanistic activity validated in paired biopsies and blood samples, with evidence of:
Selective Vβ6⁺ T cell expansion consistent with peripheral expansion and intratumoral enrichment of Vβ6⁺ T cells observed following treatment
In vivo TIL reprogramming with robust upregulation of TCR signaling, cytotoxicity, and chemokine expression post-treatment, indicating enhanced immune activation within the tumor microenvironment
Downregulation of immune-suppressive factors and upregulation of activation and cytotoxic markers among patients who experienced tumor shrinkage
Invikafusp alfa is a first-in-class bispecific dual T cell agonist designed to selectively activate and expand Vβ6⁺/Vβ10⁺ T-cell subsets — which represent highest prevalent of tumor-infiltrating lymphocytes (TILs) — to restore and amplify anti-tumor immunity in patients who have progressed on or are insensitive to ICB.

Marengo is advancing a post–PD-1, biomarker-enriched development strategy for Invikafusp alfa, continuing the Phase 2 monotherapy expansion in TMB-H and MSI-H/dMMR solid tumors to further characterize depth and durability of response across priority indications.

To reach broader, frontline patient populations beyond the TMB-H setting, the company is also conducting a Phase 2 combination study with Trodelvy (a TROP2-directed antibody-drug conjugate) in triple-negative breast cancer (TNBC) and HR⁺/HER2⁻ breast cancer to evaluate synergy in ADC + IO combination settings. In parallel, Marengo continues to advance regulatory interactions, including recent receipt of U.S. FDA Fast Track designation for Invikafusp alfa in TMB-H metastatic colorectal cancer (mCRC).

(Press release, Marengo Therapeutics, NOV 7, 2025, View Source [SID1234659649])

On November 7, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported the presentation of Phase 1 data on DOC1021, a patient-specific dendritic cell therapy, in pancreatic ductal adenocarcinoma (PDAC) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, being held November 7-9 in National Harbor, MD.

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DOC1021 was administered after neoadjuvant chemotherapy, surgery and adjuvant chemotherapy in the first group of patients. The treatment was well tolerated, with no dose-limiting toxicities observed. Favorable biomarker signatures and a promising survival signal were also seen, with five of seven patients remaining alive.

"Pancreatic cancer patients face a poor prognosis with few effective treatment options", said Jay Hartenbach, President and COO of Diakonos Oncology. "We are encouraged by these results for DOC1021, a novel and highly targeted approach which activates the patient’s own immune system in a specific manner against their cancer".

Key findings presented included:

Five of seven treated patients (3 of whom remain relapse-free) remain alive with post-operative survival times of 12.9 to 45.3 months; survival status continues to be monitored.
No dose-limiting toxicities were observed.
Most common adverse events were mild flu-like symptoms.
Post-vaccination CD127 upregulation on circulating T-cells and Granzyme B upregulation in circulating CD8+ cells were observed, suggesting enhanced T cell activity.
"Given the ongoing need for and growing excitement surrounding personalized tumor vaccination following resection of pancreatic cancer, we are very excited to continue enrolling patients in this very important trial", said Dr. Benjamin Leon Musher, Professor of Medicine-Hematology & Oncology, Barry Stephen Smith Memorial Endowed Professor, and Medical Director of Medical Oncology of the Dan L Duncan Comprehensive Cancer Center at the Baylor College of Medicine. "We are now enrolling a second group of patients where DOC1021 is given after surgery before adjuvant chemotherapy, and we look forward to further evaluation of this approach."

About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing, and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for a simple administration in the outpatient setting and broad reach via community cancer centers.

In addition to the Phase I pancreatic cancer study (NCT04157127), Diakonos recently opened a Phase 2 glioblastoma (GBM) study with DOC1021 (NCT06805305). Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company has also received Orphan Drug Designation for the GBM program in January 2024.

(Press release, Diakonos Oncology, NOV 7, 2025, View Source [SID1234659648])

On November 7, 2025 Researchers from Rutgers Cancer Institute, New Jersey’s only National Cancer Institute (NCI) – designated Comprehensive Cancer Center, and RWJBarnabas Health, along with colleagues from the National Cancer Institute, a center of the National Institutes of Health, reported findings from two HPV-related studies that highlight the potential of novel T cell therapies to achieve long-lasting remission and complete tumor regression in patients with advanced epithelial cancers. Christian Hinrichs, MD, Co-Director of the Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence at Rutgers Cancer Institute and Chief of the Section of Cancer Immunotherapy, led the studies and presented these findings at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, in National Harbor, Maryland, November 5–9, 2025.

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In one study, researchers reported encouraging interim results from a Phase II clinical trial evaluating genetically engineered T cell receptor (TCR)-T cells designed to target the HPV16 E7 oncoprotein (E7 T cells) in patients with metastatic HPV-associated cancers. The treatment consisted of a conditioning regimen, a single infusion of up to 50 billion E7 T cells, and a median of three doses of adjuvant aldesleukin. All 10 patients had advanced cancers that are generally regarded as incurable and for which there are limited treatment options. Five had head and neck cancer, two had cervical cancer, two had anal cancer, and one had esophageal cancer. The treatment was generally well tolerated, with side effects consistent with the preparative regimen and aldesleukin. Six out of 10 patients achieved substantial tumor shrinkage, including two patients who experienced complete tumor regression that remains ongoing at 11 and 12 months, respectively. Both of these patients had previously received immunotherapy and other standard therapeutic options.

"Metastatic HPV-associated cancers remain difficult to treat," said Dr. Hinrichs. "We found that E7-directed T cells can induce meaningful, and sometimes complete, responses in patients with limited options. It’s an encouraging step toward effective engineered T cell therapies for these and other epithelial cancers."

Development of this treatment has been through a collaboration between the National Cancer Institute and Rutgers Cancer Institute, with the phase II study conducted at Rutgers Cancer Institute. The cell products for the study were manufactured in a Good Manufacturing Practices (GMP) facility on-site at Rutgers Cancer Institute, a part of the Duncan and Nancy MacMillan Cancer Immunology and Metabolism Center of Excellence. The Center is uniquely positioned to advance the development of novel cell therapies through its specialized research capabilities and GMP infrastructure, supporting both innovative clinical trials and the translation of laboratory discoveries into patient care.

"When I finished my treatment, I couldn’t believe how quickly I started feeling better," said Maria, a patient from Philadelphia. "Within a month, the nodules were gone, and for the first time in years, I felt free, full of energy and living the life. I can spend time with my son, do the things I love, and really enjoy life again. I’m so grateful to the team that made this possible and proud to be living proof of the difference their research can make."

In a second study, investigators reported the extraordinary finding that two patients with metastatic cervical cancer remain in complete remission 10 years after receiving a single infusion of tumor-infiltrating lymphocyte (TIL) therapy. Conducted as part of clinical trial NCT01585428, the study represents the strongest evidence-to-date that cellular therapy can produce long-term, potentially curative responses in epithelial cancers, the most common type of malignancy. A decade after treatment, patients exhibited no evidence of disease based on imaging and circulating tumor DNA analysis. Administered anti-tumor T cells underwent a temporary expansion phase that coincided with tumor shrinkage and apparent elimination. Tumor responses have continued long after the T cell responses suggesting that the tumors were cleared during the initial response.

"Findings like these highlight the importance of conducting research at an NCI-designated Comprehensive Cancer Center such as Rutgers Cancer Institute," said Steven K. Libutti, MD, FACS, William N. Hait Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "Centers like ours, the only one in New Jersey, bring together the scientific expertise, clinical resources and collaborative environment needed to translate new discoveries from the laboratory into clinical trials, and ultimately into meaningful treatments for patients."

One patient who has had an ongoing complete response is Sue of Washington, DC. "Participating in this clinical trial felt like a calling. When I joined the study, my cancer was very advanced, and I wanted to use whatever time I had left to help enhance research that could benefit others. I never imagined the treatment would work for me, but just two months after receiving my TIL infusion, my cancer was undetectable on the scans," said Sue. "Now, 12 years later, I’m still cancer-free and deeply grateful to the doctors and researchers who made that possible. It’s an incredible and unexpected blessing to see how my participation has led to new discoveries that have the potential to help other patients in the future."

"These studies indicate that one-time cell therapies can achieve durable responses in epithelial cancers, which historically have been more resistant to these treatments than blood cancers," said Dr. Hinrichs. "The decade-long complete responses to TIL therapy give hope that these patients may be cured. The E7 T cell results that include complete responses are encouraging and support continued study of the approach."

(Press release, Rutgers Cancer Institute of New Jersey, NOV 7, 2025, View Source [SID1234659647])

On November 7, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). DARZALEX Faspro is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma.

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"DARZALEX Faspro is the first approved treatment in the U.S. for adult patients with high risk smoldering multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "The approval expands the indications for DARZALEX Faspro with ENHANZE, further solidifying its role as a cornerstone therapy across all stages of multiple myeloma."

Smoldering multiple myeloma (SMM) is an asymptomatic malignancy that is genomically the same as active multiple myeloma and where these abnormal cells can be detected in the bone marrow.1,2,3 In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S., and approximately 15 percent of those are classified as smoldering.4,5 An estimated 50 percent of patients diagnosed with HR-SMM are likely to progress to active disease within two years of diagnosis.5 Currently, the standard of care for HR-SMM is active monitoring to track signs of biochemical progression and/or end-organ damage. Recent evidence suggests that people at high-risk of progressing to active multiple myeloma could benefit from earlier therapeutic intervention.5

The FDA approval is based on findings from the AQUILA study (NCT03301220), which evaluated the efficacy and safety of DARZALEX Faspro compared to active monitoring (or "Watch and Wait") in the largest Phase 3 trial in patients with HR-SMM. For more information on the study and its findings, please view Johnson & Johnson’s press release issued on November 6, 2025.

(Press release, Halozyme, NOV 7, 2025, View Source [SID1234659645])