On December 11, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, reported it will present two posters at the San Antonio Breast Cancer Symposium ("SABCS"), in San Antonio, TX being held at the Henry B. Gonzalez Convention Center.

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On Friday, December 12, 2025 at 12:30 PM CST, Andreas Müller, M.D., from the Department of Medicine at the Kantonsspital Winterthur, Switzerland and Head of the Breast Center will present on behalf of the Swiss Cancer Institute abstract #1589 PS5-08-16, titled, Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer (TNBC): Early observations from INVINCIBLE-4-SAKK 66/22 (NCT06358573), a Phase II Randomized Clinical Trial. Today, December 11, 2025 at 5 PM CST, Lewis H. Bender, M.S., M.A., M.B.A., Intensity Therapeutics Founder, President and CEO, will present abstract #801 Poster PS4-10-15, titled, Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations.

INVINCIBLE-4 Study Observations

The INVINCIBLE-4 study was activated in 2024. Fourteen patients have been treated to date with 7 in each cohort. Observations to date include the following:

The safety data for the patients who received INT230-6 plus SOC ("Cohort A"), continues to be favorable compared to the standard of care ("SOC") alone ("Cohort B")
Seven patients have been treated per cohort (14 patients total); there were nine grade 3 or higher adverse events in the INT230-6 plus SOC and 20 events in the SOC alone through November 10th (see Figure below)

Cohort A – Experimental

Cohort B – SOC

(N=7)

(N=7)

SOC

Term

Grade 3

Grade 4

Overall

Grade 3

Grade 4

Overall

Blood and Lymphatic System Disorders

Anemia

1 (14.3 %)

1 (14.3 %)

Febrile neutrogenia

2 (28.6 %)

2 (28.6 %)

2 (28.6 %)

2 (28.6 %)

Ear and Labyrinth Disorders

Vertigo

1 (14.3 %)

1 (14.3 %)

General Disorders and Administration Site Conditions

Fatigue

1 (14.3 %)

1 (14.3 %)

Injection Site Reaction

4 (57.1 %)

4 (57.1 %)

Infections and Infestations

Catheter Related Infection

1 (14.3 %)

1 (14.3 %)

Infected Seroma

1 (14.3 %)

1 (14.3 %)

Skin Infection

1 (14.3 %)

1 (14.3 %)

Urinary Tract Infection

1 (14.3 %)

1 (14.3 %)

Investigation

Alanine Aminotransferase Increased

1 (14.3 %)

1 (14.3 %)

Creatinine Increased

1 (14.3 %)

1 (14.3 %)

GGT Increased

1 (14.3 %)

1 (14.3 %)

Neutrophil Count Decreased

2 (28.6 %)

2 (28.6 %)

1 (14.3 %)

2 (28.6 %)

3 (42.9 %)

Metabolism and Nutrition Disorders

Anorexia

1 (14.3 %)

1 (14.3 %)

Neoplasms Benign, Malignant and Unspecified (incl. Cysts and Polyps)

Disease Progression

1 (14.3 %)

1 (14.3 %)

Nervous System Disorders

Guillain-Barre Syndrome

1 (14.3 %)

1 (14.3 %)

Imunotherapy Related Encephalitis

1 (14.3 %)

1 (14.3 %)

Renal and Urinary Disorders

Chronic Kidney Disease

2 (28.6 %)

2 (28.6 %)

TOTAL

7

2

9

17

3

20

A patient with a 2.2 cm tumor who received one dose of INT230-6 showed skin irritation at the time of surgery. However, skin and adipose tissue necrosis on MRI scans were observed in some patients who received two doses, thereby requiring more surgery. As a result, the protocol is being modified to administer a single dose at lower volumes for each tumor size. If tumor necrosis is observed on MRI after the first dose of INT230-6 prior to the start of SOC, then a second dose will not be made.

Potential Phase 3 Clinical Study Design

If safety and efficacy trends continue in the INVINCIBLE-4 Study, a Phase 3 clinical study design may include a treatment arm using INT230-6 and SOC without anthracycline compounds such as doxorubicin, a highly cardiotoxic agent. Doxorubicin is often referred to by patients and physicians as "the red devil" because of its red color and harsh effects.

In today’s presentation, Mr. Bender discusses a potential Phase 3 clinical study concept using INT230-6 with SOC with and without doxorubicin compared to SOC alone . Currently, the SOC treatment includes immunotherapy (pembrolizumab), an anthracycline (usually doxorubicin), carboplatin, cyclophosphamide, and taxane. Depending on the strength of the pCR data from the INVINCIBLE-4 Study and a lead-in cohort of patients in a potential Phase 3 trial, a three-arm randomized, controlled Phase 3 trial could be 1) INT230-6 with SOC, 2) current SOC, and 3) INT230-6 with SOC without the anthracycline.

Christine Handy, a patient advocate and co-author on the poster number PS4-10-15 noted, "I have experienced permanent cardiotoxicity using the red devil, doxorubicin, when treated for my breast cancer and know full well how that agent can disrupt the lives and health of those fighting cancer. Patients can be harmed by the treatment for this potentially deadly disease and often have to make a difficult choice as some fear the harmful effects of therapy as much as the cancer itself. I am encouraged by companies such as Intensity Therapeutics with new concepts for improving safety and efficacy for patients and am excited by the early observations of this new and novel drug treatment."

Mr. Bender concluded, "Triple Negative Breast Cancer is one of the most aggressive and difficult to treat breast cancer subtypes. While our INVINCIBLE-4 Study is still early, we are encouraged by the observed safety as reported in the PS5-8-16 poster and pCR results received to date when our drug is combined with SOC immunochemotherapy. These new safety results are consistent with the data from pre-clinical and clinical data when our drug is combined with immunotherapies. We look to restart patient enrollment in INVINCIBLE-4 study using the modified dosing regimen to improve our results as soon as possible. Should the safety and pCR results remain favorable, we plan to approach regulatory authorities with a Phase 3 study design that could yield a safer, more effective presurgical dosing regimen with good cosmetic outcomes for patients. Subject to regulatory agreement, using pCR as the surrogate endpoint could allow for an accelerated approval of a TNBC regimen without the red devil in a timeframe sooner than current trials that are evaluating event free survival."

About Triple Negative Breast Cancer in the Presurgical Setting

Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of recurrence. Approximately 11-17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, the majority of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

About a Potential INT230-6 Approval Pathway in the Presurgical Setting

The U.S Food and Drug Administration ("FDA") instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. Pathological complete response ("pCR") is an accepted FDA accelerated approval criterion for approval in high-risk breast cancer, such as TNBC subtype. Pathological complete response is defined as the absence of residual invasive and in situ cancer after evaluation of the complete resected breast specimen and lymph nodes following completion of neoadjuvant systemic therapy. If a product is approved using pCR, companies must still seek full approval using event free survival as an endpoint.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, DEC 11, 2025, View Source [SID1234661386])

On December 11, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported the presentation of final data from the Phase 1 clinical trial of its investigational breast cancer vaccine (NCT04674306) at the 2025 San Antonio Breast Cancer Symposium (SABCS). The trial was conducted in collaboration with Cleveland Clinic and funded by a grant from the U.S. Department of Defense.

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Final Phase 1 findings showed the investigational vaccine met all major primary endpoints, was safe and well tolerated at the maximum tolerated dose (MTD), and elicited protocol-defined immune responses in 74% of participants. The presentation, titled "Final Results of a Phase I Trial of Alpha-lactalbumin (aLA) Vaccine for Breast Cancer," was delivered by Justin Johnson, Ph.D., Program Manager at Cleveland Clinic and co-inventor of the breast cancer vaccine technology. The SABCS poster presentation is available at View Source

"Triple-negative breast cancer remains one of the most challenging subtypes to address, and Phase 1 trials are an important step in determining whether a new approach can be administered safely and activate the immune system as intended," said G. Thomas Budd, M.D., of Cleveland Clinic’s Cancer Institute and principal investigator of the study. "In this trial, the investigational α-lactalbumin vaccine was safe and well tolerated at the maximum tolerated dose and generated protocol-defined immune responses in 74% of participants—results that support continued clinical evaluation."

Topline Phase 1 results:

All major primary endpoints were met
74% of participants demonstrated protocol-defined immune responses; α-lactalbumin (aLA)-specific T cell responses were observed per protocol-defined criteria
Vaccine was safe and well tolerated at the MTD, with adverse events primarily injection-site irritation
Preliminary Immunohistochemistry (IHC) of primary tumors showed aLA expression ranging from absent to strong; analyses correlating expression to immune response and clinical outcomes are ongoing
Participants will be followed for five years after completing the study
Combination of Keytruda and the vaccine also generated antigen-specific T cell responses and showed no major additional side effects
Data will inform planned Phase 2 study design, including a potential Phase 2 combination study with Keytruda in the neoadjuvant setting among newly diagnosed breast cancer patients
The Phase 1 study evaluated safety and monitored immune response to an investigational vaccine targeting α-lactalbumin (aLA). The trial enrolled 35 participants across three cohorts: Cohort Ia (n=26), women who completed standard-of-care treatment, including surgery, for early-stage TNBC within three years and were tumor-free but at elevated risk of recurrence; Cohort Ib (n=4), cancer-free women with BRCA1, BRCA2, or PALB2 mutations who elected preventive mastectomy and were vaccinated prior to surgery; and Cohort Ic (n=5), women with TNBC receiving pembrolizumab (Keytruda) in the adjuvant (post-surgery) setting, with evaluation of safety of combination administration and immune responses.

In Cohort Ia, at the MTD, the vaccine was reported as safe, with no flu-like symptoms (fever and myalgias), no abnormal clinical laboratory tests, and no other observed adverse side effects in this cohort; the primary notable adverse event was injection-site irritation. Participants demonstrated aLA-specific T cell responses, including production of interferon gamma and interleukin-17.

In Cohort Ib, safety and tolerability were similar to Cohort Ia. Immunohistochemistry analyses of resected breast tissue are ongoing and will be presented in a future scientific presentation.

In Cohort Ic, a key objective was to assess whether administration of the investigational vaccine in combination with pembrolizumab could create intolerable side effects. No major adverse side effects were reported; as in other cohorts, the primary adverse event was injection-site irritation. Two participants experienced Grade 3 adverse events consisting of greater irritation at an injection site.

The investigational vaccine targets α-lactalbumin, a lactation protein generally expressed in the breast during lactation but not at other times in life or in other normal tissues. In many breast cancers, malignant cells express α-lactalbumin. The vaccine is designed to activate the immune system to direct cytotoxic T cells toward tumor cells expressing α-lactalbumin, with the goal of providing preemptive immune protection against emerging tumors that express this antigen.

The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who served as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.

"It was Dr. Tuohy’s hope that this vaccine would demonstrate the potential of immunization as a new way to combat breast cancer, and that a similar approach could someday be applied to other types of malignancies," said Dr. Johnson. "Our findings that the majority of participants across all three cohorts demonstrated an immune response to α-lactalbumin is an encouraging sign."

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "We are very encouraged that the final Phase 1 data met all major primary endpoints, with the vaccine demonstrating a favorable tolerability profile at the MTD and protocol-defined immune responses in the majority of participants. We appreciate the support provided through the U.S. Department of Defense grant that enabled this study in collaboration with Cleveland Clinic, and we look forward to engaging with regulators and advancing plans for a Phase 2 study."

(Press release, Anixa Biosciences, DEC 11, 2025, View Source [SID1234661385])

On December 11, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported it has completed its targeted full enrollment of 435 patients in the registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib, the company’s investigational oral protein kinase C (PKC) inhibitor, in combination with Pfizer’s crizotinib, an oral c-MET inhibitor, in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM). IDEAYA expects to report median progression-free survival (PFS) data from this trial in the first quarter 2026 to support a potential accelerated approval filing in the United States. Median overall survival (mOS) data from OptimUM-02, once available, will be used to support a potential full approval filing. Metastatic uveal melanoma is a rare, aggressive form of ocular cancer with limited treatment options and historically poor survival outcomes.

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"We are very pleased to announce that we have achieved the target enrollment to enable potential full approval filing in our Phase 2/3 registration-enabling trial of darovasertib in combination with crizotinib in first-line HLA*A2-negative metastatic uveal melanoma. This milestone reflects both the clear unmet need in metastatic uveal melanoma, as well as the strong clinical interest in our darovasertib program. Moreover, the promising overall survival data and broader clinical efficacy demonstrated in the recently reported median overall survival results from the Phase 1/2 clinical trial (OptimUM-01) of this combination in metastatic uveal melanoma are indicative of the clinical potential of darovasertib to meaningfully impact patients with this devastating disease. With target full enrollment now complete, we look forward to the availability of median PFS data we project from OptimUM-02 in the first quarter of next year, and, if approved, making darovasertib in combination with crizotinib available to patients with HLA*A2-negative metastatic uveal melanoma as a first-line treatment as expeditiously as possible," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

OptimUM-02 is a multi-arm, multi-stage, open-label Phase 2/3 trial with patients randomized to receive either the darovasertib and crizotinib combination or investigator’s choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine). The primary endpoints are median PFS and median OS, which will be used to support a potential accelerated approval and full approval in the United States, respectively. In October 2025, IDEAYA presented data from its single-arm, Phase 2 trial (OptimUM-01) of the darovasertib and crizotinib combination at the Society for Melanoma Research (SMR) Congress that demonstrated a 21.1 month median OS and 7.0 months median PFS in 1L mUM, including both HLA*A2-negative and HLA*A2-positive patients.

Darovasertib has received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary uveal melanoma (UM) and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the U.S. FDA in UM, including in metastatic UM. IDEAYA is currently enrolling patients in a pivotal Phase 3 trial of single-agent darovasertib in the neoadjuvant setting of primary UM (OptimUM-10).

(Press release, Ideaya Biosciences, DEC 11, 2025, View Source [SID1234661384])

On December 11, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported updates across the company’s portfolio of assets, including a summary from its mini symposium held on December 5, 2025 focused on targeting VISTA in AML, the scientific rational and clinical applications in NPM1 mutated r/r AML in combination with a menin inhibitor. The company’s recently announced financing transaction, which provides for $15.6 million in gross proceeds, is expected to provide the cash runway to accomplish multiple key milestones across all three development programs.

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"2025 was a transformational year for us, having initiated our accelerated approval Phase 3 trial of IFx-2.0 as an adjunctive therapy to Keytruda in front-line MCC, having completed the merger with Kineta bringing a Phase 2 ready VISTA inhibiting antibody to our pipeline and having presented data positioning the DOR as a promising new target in overcoming resistance to checkpoint inhibitors. We were pleased to raise $15 million in our June 2025 PIPE financing and warrant exercise earlier this year and the recently announced $15.6 million equity financing transaction providing us with a cash runway to accomplish multiple key milestones across all three development programs" said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.

"We look forward in 2026 to the expected completion of enrollment for our Phase 3 study of IFx-2.0 in MCC, and anticipate receiving FDA clearance to initiate our randomized Phase 2 trial of physician’s choice of menin inhibitor vs a menin inhibitor+TBS-2025, our VISTA inhibiting antibody, in NPM1 mutated r/r AML. We also expect to present preliminary data from our IFx-2.0 basket trial; data on inhibiting DOR on MDSCs, TAMs and T regs at a scientific conference in 2Q; and proof-of-concept data in animal models for our lead ADC at a scientific conference in Q4 2026."

"In an encouraging development in our VISTA inhibiting antibody (TBS-2025) clinical program, at a mini symposium on December 5, 2025 prior to the ASH (Free ASH Whitepaper) meeting, several key opinion leaders, provided valuable insights and recommendations on our Phase 2 clinical trial plans for TBS-2025, in AML. There was clear enthusiasm for the potential of combining TBS-2025 with a menin inhibitor both in NPM1 r/r/ AML, in high-risk AML and in patients with AML who are unfit for intensive therapies. The KOLs noted that while menin inhibitors have become standard of care in NPM1 mutated AML, there still exists a significant unmet medical need, citing the relatively low CR rate and short duration of response as the two obstacles to improving clinical benefit in these patients."

Dr. Bianco continued, "The VISTA gene is the only checkpoint upregulated in patients with AML, notably among high-risk AML. It has been shown that VISTA expression on leukemic blasts is the primary culprit in the low response rate and short duration of response in AML. Targeting VISTA represents the first potential for immunotherapy to improve the treatment outcomes in AML, not just NPM1 mutated AML was the consensus opinion from the group," concluded Dr. Bianco.

Participants at the mini symposium included: Geoffrey Uy, MD, Co-chair of the Leukemia Committee for the ALLIANCE for Clinical Trials in Oncology, and Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation at Washington University School of Medicine in St. Louis; Kevin Lin, MD, PhD Student, Developmental, Regenerative, and Stem Cell Biology Program at the Washington University in St. Louis; and Tae Kon Kim, MD, PhD, Assistant Professor of Medicine, Division of Hematology and Oncology at Vanderbilt University Medical Center.

Highlights from the Company’s mini-symposium on TBS-2025. The Company’s studies and data have shown the following:

VISTA was shown to be the only checkpoint highly upregulated in patients with AML with the highest expression in poor-risk subtypes. Its expression is seen in AML with or without common mutations like DNMT3A, NPM1, FLT-3.

VISTA expression on AML contributes to low response rate and short duration of response among patients with NPM1 mutated AML treated with menin inhibitors.

TBS-2025 provided survival advantage comparable to standard front line combination chemotherapy while significantly improving survival when used in combination with front line chemotherapy in murine model of VISTA expressing AML

Inhibition of VISTA, either through gene silencing or an inhibiting antibody, and inhibition of menin signaling pathway significantly improves survival in murine models of AML
Speaker Bios:
Tae Kon Kim, MD, PhD, Assistant Professor of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center. Dr. Kim investigates mechanisms of immune evasion in leukemia and develops new immunotherapeutic strategies. Trained under Dr. Lieping Chen, a pioneer in immuno-oncology, his work explores emerging co-inhibitory pathways and approaches to selectively prevent graft-versus-host disease while preserving graft-versus-leukemia activity. Selected Honors received by Dr. Kim include: American Society of Hematology (ASH) (Free ASH Whitepaper) Scholar Award; American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Career Development Award; Evans MDS Young Investigator Award; American Cancer Society Clinician Scientist Development Grant; Forbeck Scholar Award.

Geoffrey L. Uy, MD, Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, Research Member, Siteman Cancer Center. Dr. Uy is a hematopoietic stem cell transplant specialist and serves as Medical Director for Clinical Research in the Division of Oncology. His research centers on innovative therapies for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with a focus on improving outcomes for patients with high-risk myeloid malignancies.

Kevin Yin, MD, PhD Student, Developmental, Regenerative, and Stem Cell Biology Program Washington University in St. Louis. Dr. Yin studies how initiating mutations in AML shape immune escape mechanisms and contribute to leukemia progression. His work aims to define AML–immune interactions to support the development of next-generation immunotherapies. Dr. Yin’s research is being conducted under Timothy J. Ley, MD, group who serves as his PhD advisor. Dr Ley’s research group focuses on the genetics and genomics of acute myeloid leukemia (AML). His lab studies the development of normal and leukemic blood cells. His work is focused on identifying the mutations and epigenetic events that are responsible for the initiation and progression of AML. Dr. Ley led the team that sequenced the first cancer genome from an AML patient. He has gone on to develop projects that will use whole genome sequencing to help diagnose and treat patients with AML

Conference Call Information
Management will host a conference call and webcast today, December 11, 2025, at 8:30 am Eastern Time, to discuss the corporate update and recent financing. Call details and dial-in information are as follows:

Thursday, December 11th @ 8:30 am ET
Toll Free: 1-800-225-9448
Alternate: 1-203-518-9708

(Press release, TuHURA Biosciences, DEC 11, 2025, View Source [SID1234661383])

On December 11, 2025 HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported that new clinical data from its flagship macrophage-checkpoint program, HCB101, has been selected for a mini oral presentation at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025 in London, United Kingdom. Only 26 abstracts were chosen for mini-oral presentation this year, marking a major milestone for HanchorBio as it delivers its first-ever oral presentation of clinical data at an international oncology congress, following its prior preclinical oral presentation of HCB101 at CSCO 2022.

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The ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress is Europe’s premier meeting dedicated exclusively to immuno-oncology science, distinct from the broader ESMO (Free ESMO Whitepaper) Annual Congress. While the annual ESMO (Free ESMO Whitepaper) meeting spans all oncology disciplines, ESMO (Free ESMO Whitepaper)-IO focuses on immune mechanisms, translational innovation, and next-generation therapeutic strategies across innate and adaptive immunity.

Presentation Details:

Abstract ID: 242MO
Title: HCB101, a Differentiated SIRPα Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity Across Solid Tumors and Lymphoma
First Author: Dr. Fangling Ning, Affiliated Hospital of Binzhou Medical University
Date / Time: 11 December 2025 / 11:45 – 12:45 GMT
Location: Whittle Room, Queen Elizabeth II Centre, London
Presenter: Alvin Luk, PhD, MBA, CCRA – President & CMO (Group) and CEO (U.S.A.), TIME100 Health 2025 Honoree

"For nearly a decade, CD47 therapies were held back not by flawed biology but by flawed molecules, which struggled to balance safety and efficacy at the same time, especially in immunologically cold tumors," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "HCB101 was engineered from the ground up to solve that problem. Using AI-guided structural modeling, we identified three core mutations that reshape SIRPα’s interaction with CD47, allowing us to combine the strengths of first- and second-generation approaches into a single, differentiated molecule. Being selected as one of only 26 mini-oral presentations at ESMO (Free ESMO Whitepaper) Immuno-Oncology reinforces the field’s recognition of this effort and redefines the CD47 therapies. With its clean safety profile, strong target engagement, and early activity in cold tumors, HCB101 is emerging as a true macrophage-checkpoint backbone – much like the transformative PD-1/PD-L1 therapies that were based on T-cell checkpoint inhibition."

Key Findings Highlighted in the Mini-Oral

Monotherapy (HCB101-101; NCT05892718)

Clean, cytopenia-sparing safety across 12 cohorts up to 36 mg/kg QW
No bleeding events or immune-related toxicities, with the majority of treatment-related adverse events being Grade 1-2
Linear PK (T1/2 ~3 days) with receptor occupancy (RO) >99% at ≥8 mg/kg
Durable antitumor activity, including confirmed PRs in:
HNSCC -Head and neck squamous cell carcinoma (~42% tumor regression, ≥32 weeks)
MZL – Marginal zone lymphoma (~89% tumor regression, ≥16 weeks)
Stable disease ≥4-9 months across colorectal cancer (CRC), ovarian cancer, non-small cell lung cancer (NSCLC), and sarcoma
Combination Therapy (HCB101-201; NCT06771622)
Well-tolerated across gastric cancer (GC), triple-negative breast cancer (TNBC), CRC, and HNSCC
No new safety signals across all evaluated combinations
Cytopenias fully attributable to chemotherapy, not HCB101
2L GC:
58.3% ORR (7/12) for all cohorts evaluated, 77.8% ORR (7/9) for mid-dose cohorts, and 100% DCR
Tumor shrinkage up to -78.2%
1L HER2+ GC: 33% ORR (1/3)
1L TNBC: 50% ORR (3/6) and 100% DCR
Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, "The early efficacy signals from HCB101 are unusually compelling for this stage of development. In second-line GC, where standard therapy achieves an ORR of about 27%, HCB101 combinations exceed 78% ORR, achieve 100% disease control, and result in tumor reduction approaching -78%. These results are not incremental; they meaningfully exceed expectations and reflect robust macrophage checkpoint engagement. With clean safety and sustained receptor occupancy, the data give us confidence to anchor development in second-line disease and expand into first-line and perioperative settings where depth and durability of response matter most."

About HCB101: A Next-Generation SIRPα Fc-Fusion Protein

HCB101 is a 3.5th-generation engineered SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio’s FBDB platform to selectively target tumor CD47 while minimizing binding to red blood cells. This design avoids the anemia and thrombocytopenia that limited early anti-CD47 programs, while preserving potent macrophage activation and downstream T-cell engagement. Key differentiators include:

Cytopenia-sparing safety up to 30-36 mg/kg
Receptor occupancy (RO) >99% at clinically active exposures
Strong macrophage and downstream T-cell activation
Broad antitumor activity across >80 PDX/CDX models and multiple clinical tumor types
Robust early combination efficacy in tumors that historically respond poorly to immunotherapy
Unlike earlier approaches, HCB101’s safety, target selectivity, and RO profile support its use as a macrophage-checkpoint backbone – analogous to how PD-1/PD-L1 inhibitors function as foundational T-cell backbones in oncology. HCB101 is designed for broad combinability across established and emerging treatment modalities, including:

Chemotherapy
Antibody-drug conjugates (ADCs)
Anti-PD-1/anti-PD-L1 checkpoint inhibitors
Anti-VEGF inhibitors
Anti-EGFR therapies
Anti-HER2 regimens
This versatility positions HCB101 as a modular, next-generational immuno-oncology component capable of enhancing the efficacy of multiple therapeutic backbones across solid tumors and hematologic malignancies.

(Press release, Hanchor Bio, DEC 11, 2025, View Source [SID1234661382])