On November 7, 2025 Coherus Oncology, Inc. (NASDAQ: CHRS), reported new multiomic tumor and blood-based biomarker data from the dose expansion arm of its ongoing Phase 1b clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic HNSCC. These data are being presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 5-9, 2025, in National Harbor, Maryland.

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This interim analysis from the dose expansion phase demonstrates that CHS‑114-mediated immune activation is significantly enhanced and sustained with toripalimab in HNSCC study participants. In on-treatment tumor biopsies, CHS‑114 depleted CCR8+ Tregs, but not CCR8- Tregs, and increased CD8+ T cells in the tumor microenvironment (TME), indicating TME remodeling for antitumor immune activation and establishing proof of mechanism. To date, CHS‑114, as monotherapy or in combination with toripalimab has a manageable safety profile, with promising early antitumor activity in HNSCC.

"These data extend the data we presented at AACR (Free AACR Whitepaper) and are important for 3 key development aims. Firstly, showing selective depletion of CCR8+ Tregs and not CCR8- Tregs or CD8 and CD4 T cells, shows the drug does what it was intended to do. This coupled with the acceptable safety profile further supports that CCR8 is proving to be a tumor selective target that now allows the field to remove Tregs in cancer. Secondly, showing statistically significant increase in immune activation using multiple biomarker assays further supports the development plan to advance CHS-114 in combination with toripalimab or with other immune activators. Importantly, we have seen a partial response in a refractory head and neck cancer patient in the initial testing of the safety of this combination," said Theresa LaVallee, Ph.D., Coherus Oncology’s Chief Scientific and Development Officer. "And third, the data support the 2 doses of CHS-114 are pharmacologically active leading to substantial Treg depletion in tumors and immune activation. The ongoing enrollment in the dose optimization arm of the study, evaluating CHS-114 and toripalimab, sets us up to address the FDA’s Project Optimus and define a phase 2 dose."

Multiomic Clinical Biomarker Data from CHS-114 Phase 1 Dose Expansion and Safety Arms in HNSCC Participants

Immune profiling of blood from HNSCC participants from 2 pharmacologically active doses of CHS-114 monotherapy expansion arm (n=10) and in combination with toripalimab safety arm (n=6) showed:

CHS-114 demonstrated robust depletion of target CCR8+ Tregs and spared non-CCR8+ Tregs, CD4+ T cells and CD8+ T cells in PBMCs from HNSCC participants throughout the treatment cycle.

CHS-114 demonstrated significant increases in peripheral immune activation of CD8+ T cell cytotoxicity, activation and proliferation and inflammatory cytokine levels compared with pretreatment levels.

CHS‑114 with toripalimab mediated a robust and significant increase in CD8+ T cell proliferation (Ki67) and Th1 inflammatory cytokines that was sustained through the dosing cycle.
Immune profiling of pretreatment and on-treatment tumor tissue tumor tissue samples from HNSCC participants from monotherapy expansion (n=10) and combination with toripalimab (n=2) cohorts showed:

CHS-114 treatment decreased CCR8+ Treg density by 74% and total FOXP3+ Treg density by 43%, while sparing CCR8- Tregs demonstrating selective and robust depletion of target Tregs.
Furthermore, CHS-114 treatment increased CD8+ T cell density by 73% and CD8+ T cell /CCR8+ Treg ratio by 12-fold, demonstrating a remodeling of the TME.
Data confirm CHS-114 selectivity, the 2 doses evaluated are pharmacologically active and establish proof of mechanism in tumor tissue.
SITC 2025 Presentation Details
Abstract # 640: CHS-114, an anti-CCR8 cytolytic monoclonal antibody demonstrates selective intratumoral Treg depletion and favorable immune remodeling in participants with advanced solid tumors.

Date: Saturday, November 8, 2025, 10 a.m. – 6:35 p.m. ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
About the CHS-114 Phase 1/1b Study

The Phase 1 study (NCT05635643) is a dose escalation, dose optimization, and expansion study evaluating CHS-114 as a monotherapy and in combination with toripalimab, a next-generation PD-1 inhibitor. Arm 1a (first-in-human dose escalation) enrolled 20 patients with advanced solid tumors including 2 patients with HNSCC and evaluated multiple dose levels (5-1200 mg) of CHS-114 monotherapy. Arm 1b evaluated two pharmacologically active doses of CHS-114 monotherapy in 13 HNSCC patients with required paired tumor biopsies. Arm 2 evaluated the safety of two pharmacologically active doses of CHS-114 with toripalimab in 7 patients. Arm 3 is evaluating two pharmacologically active doses of CHS-114 with toripalimab in 40 patients with second-line HNSCC. Primary objectives of the Phase 1 study are to optimize the CHS-114 dose(s) for expansion and evaluate the safety of CHS-114 with and without toripalimab. Secondary objectives are to evaluate the preliminary antitumor activity and the PK of CHS-114 with and without toripalimab and assess biomarkers, including changes in regulatory T cells (Tregs) and CD8+ T cells in paired tumor biopsies and other immune biomarkers.

About CHS-114

CHS-114, an afucosylated, cytolytic CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially kill CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment. CHS-114 is currently being evaluated in combination with toripalimab in two Phase 1b clinical trials in patients with advanced solid tumors, including head and neck cancer (NCT05635643), colorectal cancer, gastric cancer, and esophageal cancer (NCT06657144).

(Press release, Coherus Oncology, NOV 7, 2025, View Source [SID1234659632])

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 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 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 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported pivotal clinical validation results from the ALTUS study (NCT: 05064553). The prospective, head-to-head trial demonstrated that the company’s Oncoguard Liver blood test delivers superior early-stage and overall sensitivity for hepatocellular carcinoma (HCC) — the most common form of liver cancer — compared to the current standard of care.1,2

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These findings will be presented as late-breaking data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting* on November 11, 2025, underscoring the Oncoguard Liver test’s potential to transform liver cancer surveillance for at-risk populations. The company intends to submit the data for publication in a peer-reviewed journal.

"Ultrasound surveillance has been the standard for liver cancer screening for decades, but it’s limited by image quality and inconsistent follow up, resulting in low detection rates and poor adherence," said Dr. Binu John, principal investigator for the ALTUS trial, associate professor at the University of Miami Miller School of Medicine, and chief of gastroenterology and hepatology at the Miami VA. "A highly sensitive blood-based alternative like Oncoguard Liver is a game changer that could make liver cancer screening more accessible, equitable, and effective for millions of at-risk patients."

Setting the new benchmark in liver cancer surveillance

The ALTUS study is the largest prospective, real-world trial of a blood test for liver cancer surveillance in the United States. More than 3,000 participants were enrolled across community practices, Veterans Affairs, and academic centers, representing the racial and ethnic diversity of high-risk patient populations.1

The Oncoguard Liver test achieved its primary endpoint, detecting three times more cancers defined as early-stage by Milan criteria compared to ultrasound (67% vs 22%).1 Milan criteria are a set of guidelines that describe eligibility for curative liver transplant.3†

Very early-stage HCC sensitivity: 64% for Oncoguard Liver vs 9% for ultrasound 1
Early-stage HCC sensitivity: 77% for Oncoguard Liver vs 36% for ultrasound 1
These findings demonstrate a seven-fold improvement in detecting liver cancers when they are most treatable and remain eligible for potentially curative options such as resection or transplant.1-3

The Oncoguard Liver test also demonstrated a specificity of 82% in the ALTUS study,1 exceeding the threshold established by experts for clinical utility.4

"These new data from the ALTUS study show that we can reliably detect liver cancer earlier, which is key to improving outcomes," said Dr. Paul Limburg, chief medical officer, screening at Exact Sciences. "With Cologuard, we have already seen what is possible, with more than 20 million tests completed and thousands of colorectal cancers prevented through early detection. The Oncoguard Liver test builds on that success, applying the same science-driven approach to another cancer in which finding disease early can help save lives."

Transforming surveillance for a growing and underserved population

Hepatocellular carcinoma is among the fastest-growing causes of cancer-related deaths in the United States.5-7 By 2040, liver cancer is expected to become the third-leading cause of cancer death, with more than 40,000 new cases and 30,000 deaths annually.5-7 Patients diagnosed at early stages of HCC experience 12 times greater survival rates than those diagnosed with distant disease,6 yet fewer than 30% of eligible individuals participate in regular surveillance, which is recommended by AASLD for people with specific risk factors, such as chronic liver disease or cirrhosis.8

The Oncoguard Liver test is a blood-based multiomics assay developed in collaboration with Mayo Clinic. It combines DNA methylation and protein markers to detect molecular signatures associated with liver cancer, using Exact Sciences’ proprietary PCR technology designed for accuracy, scalability, and broad clinical access.

The ALTUS study confirms that the Oncoguard Liver test meets consensus thresholds for blood-based surveillance established in 2025 and overcomes key barriers associated with ultrasound imaging, particularly in populations affected by obesity or other factors that limit image quality.

(Press release, Exact Sciences, NOV 7, 2025, View Source [SID1234659635])