micvotabart pelidotin (PYX-201) / Pfizer, Pyxis Oncology - LARVOL DELTA

Pyxis Oncology has received FDA alignment on the clinical trial design for a planned pivotal monotherapy study in 2L + R/M HNSCC. (The Manila Times) - "The Company is currently evaluating the path forward to pivotal studies for MICVO as monotherapy and in combination with pembrolizumab, respectively, and expects to provide additional detail in 2026."

New trial • Squamous Cell Carcinoma of Head and Neck

MICVO Next Steps (The Manila Times) - "In mid-2026, Pyxis Oncology plans to present updated data from the ongoing Phase 1 monotherapy study in 2L+ R/M HNSCC, which is expected to include additional patients and initial durability data. In the second half of 2026, the company also plans to present updated data from the ongoing Phase 1/2 study evaluating MICVO in combination with pembrolizumab, including in 1L/2L+ R/M HNSCC and other tumor types."

P1 data • P1/2 data • Squamous Cell Carcinoma of Head and Neck

Pyxis Oncology Announces Positive Preliminary Phase 1 Data for Micvotabart Pelidotin (MICVO) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (The Manila Times) - "The data below incorporate all R/M HNSCC patients dosed at 5.4 mg/kg in the MICVO Phase 1 monotherapy study...18 patients were treated at 5.4 mg/kg; intravenous (IV) dosed every three weeks (Q3W); Confirmed overall response rate (ORR) of 46% (6/13)1, including 1 complete response by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors v1.1); MICVO was generally well tolerated, with no Grade 4 ADC payload treatment-related adverse events (TRAEs) of interest observed. No Grade 5 events occurred."

P1 data • Squamous Cell Carcinoma of Head and Neck

The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA is part of a Clinical Trial Collaboration Agreement with Merck (known as MSD outside the US and Canada) and is currently in dose escalation across multiple doses and tumor types, including 1L/2L+ R/M HNSCC. (The Manila Times) - "The data below incorporate all R/M HNSCC patients dosed in the MICVO Phase 1/2 combination study at 3.6 mg/kg and 4.4 mg/kg...Confirmed overall response rate (ORR) of 71% (5/7)1...Responses occurred across a range of PD(L)-1 CPS scores (CPS ≥1 to CPS >20); MICVO was generally well tolerated, with no Grade 3 or Grade 4 ADC payload TRAEs of interest observed. No Grade 5 events occurred."

P1 data • Squamous Cell Carcinoma of Head and Neck

ANTI-TUMOR ACTIVITY OF MICVOTABART PELIDOTIN IS ASSOCIATED WITH ENZYME GENE EXPRESSION IN PATIENT-DERIVED XENOGRAFT SARCOMA MODELS (CTOS 2025) - P1, P1/2 | "Objective: Sarcomas comprise a variety of heterogeneous cancer subtypes which hinders development of effective therapies. These results demonstrate anti-tumor activity of micvo across diverse PDX sarcoma subtypes and show EDB+FN is necessary but not sufficient for micvo sensitivity. Notably, an enzyme gene signature was elevated at baseline in models with very strong response to micvo, suggesting the importance of enzymes in the mechanism of action of micvo. Broad activity in PDX models supports the ongoing clinical development of micvo for patients with sarcoma in Phase 1 monotherapy (NCT05720117) and Phase 1/2 combination with pembrolizumab (NCT06795412) trials."

Clinical • Oncology • Sarcoma • Solid Tumor • EDB-FN

FIRST-IN-CLASS NON-CELLULAR TARGETING ANTIBODY-DRUG CONJUGATE (ADC), MICVOTABART PELIDOTIN (MICVO), IN PATIENTS (PTS) WITH ADVANCED SARCOMA (CTOS 2025) - No abstract available

Clinical • Metastases • Oncology • Sarcoma • Solid Tumor

A Phase 1/2 study of a first-in-class non-cellular antibody-drug conjugate, micvotabart pelidotin (micvo), in combination with pembrolizumab in advanced head & neck squamous cell carcinoma (HNSCC) (SITC 2025) - P1 | "Clinical Trial Information: NCT06795412Ethics Approval The study obtained Ethics Approval from the IRB board at each institution and all participants signed an informed consent before taking part in the study. Approval number for 4 active sites are as follows: • 2024-1995 • 25-075 • NXVIR24.61 • Pro00084051"

Combination therapy • IO biomarker • Metastases • P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EDB-FN

Pyxis Oncology expects to report preliminary data from the ongoing Phase 1 clinical studies of micvotabart pelidotin (MICVO) in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) in 4Q25. (GlobeNewswire) - "Clinical update to focus on preliminary data from the Phase 1 monotherapy dose expansion study of MICVO for 2L/3L R/M HNSCC patients, including both the post platinum and anti-PD(L)-1 experienced arm and the post EGFRi and anti-PD(L)-1 experienced arm; Additional preliminary clinical data from the Phase 1/2 combination dose escalation study of MICVO and KEYTRUDA (pembrolizumab) for 1L/2L+ R/M HNSCC patients will also be provided."

P1 data • Squamous Cell Carcinoma of Head and Neck

A phase I/II study of a first-in-class non-cellular antibody-drug conjugate, micvotabart pelidotin (MICVO), in combination with pembrolizumab in select advanced solid tumors (ESMO 2025) - P1, P1/2 | "Legal entity responsible for the study Pyxis Oncology. Funding Pyxis Oncology."

Combination therapy • IO biomarker • Metastases • P1/2 data • Breast Cancer • Cervical Cancer • Gastric Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • EDB-FN • HER-2

Micvotabart pelidotin, a non-cellular targeting ADC, remodels the tumor microenvironment in tumors from participants in a phase 1 dose escalation study (AACR-NCI-EORTC 2025) - P1, P1/2 | "Micvotabart pelidotin (micvo) is an antibody-drug conjugate (ADC) that targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix that is highly expressed in tumors compared to normal adult tissues. Micvo's ability to mobilize an anti-tumor immune response is also under investigation in these biopsies. These pharmacodynamic changes will be further characterized in indication-specific expansion cohorts from the ongoing clinical evaluation of micvo as monotherapy (NCT05720117) and in combination with pembrolizumab (NCT06795412)."

Biomarker • P1 data • Tumor microenvironment • Oncology • Solid Tumor • EDB-FN

Micvotabart pelidotin induces immunogenic cell death markers and activates tumor immune cells in pre-clinical studies (AACR-NCI-EORTC 2025) - P1, P1/2 | "Micvotabart pelidotin (micvo) is an antibody–drug conjugate (ADC) that targets the non-cellular extra-domain-B of fibronectin (EDB+FN), an extracellular matrix protein highly expressed in tumors compared to normal adult tissues. Ongoing studies aim to further characterize the activation profile of both myeloid and T cell populations in vitro and in vivo. These data further provide a rationale for the on-going clinical evaluation of micvo as a monotherapy (NCT05720117) and in combination with pembrolizumab in patients with difficult-to-treat cancers (NCT06795412)."

Immune cell • Immunogenic cell death • IO biomarker • Preclinical • Oncology • CD163 • CD69 • CD80 • EDB-FN • HMGB1 • PD-L1 • SLAMF6

Mouse analog of micvotabart pelidotin sensitizes a refractory syngeneic breast cancer model to anti-PD1 therapy (AACR-NCI-EORTC 2025) - P1, P1/2 | "Background: Micvotabart pelidotin (micvo/PYX-201) is an antibody-drug conjugate that targets the non-cellular extradomain B of fibronectin (EDB+FN), an extracellular matrix protein abundantly expressed in tumors compared to normal adult tissues—making it an ideal drug delivery target. These results demonstrate that the mouse analog of micvo induced anti-tumor activity, drove tumor-immune remodeling and enabled responsiveness to anti-PD1 therapy. Ongoing studies aim to further define the activation and spatial distribution of immune and stromal cells driving this response. Nonetheless, these findings support the ongoing clinical evaluation of micvo as a monotherapy (NCT05720117) and in combination with pembrolizumab for difficult-to-treat cancers (NCT06795412)."

IO biomarker • Preclinical • Breast Cancer • Oncology • Solid Tumor • EDB-FN

Characterization of micvotabart pelidotin target binding properties and extracellular payload release (AACR-NCI-EORTC 2025) - P1, P1/2 | "Micvotabart pelidotin (micvo) is an antibody–drug conjugate (ADC) that targets the non-cellular extra-domain B of fibronectin (EDB+FN), an extracellular matrix (ECM) protein highly expressed in tumors compared to normal adult tissues. These studies demonstrate that micvo specifically binds to the EDB splice variant of FN in an avidity driven manner and that proteases known to be present extracellularly in the tumor ECM can cleave the linker payload of micvo to enable tumor cell killing. These findings further elucidate the non-cellular targeting and mechanism of action of micvo and support its utility as an investigational therapy for patients with difficult-to-treat cancers in the ongoing clinical trials as a monotherapy (NCT05720117) and in combination with pembrolizumab (NCT06795412)."

Oncology • EDB-FN

First- in- human study of the first-in-class non-cellular targeting antibody-drug conjugate (ADC), Micvotabart pelidotin (MICVO), in patients (pts) with select solid tumors (ESMO 2025) - P1, P1/2 | "Clinical trial identification NCT06795412 Legal entity responsible for the study Pyxis Oncology, Inc. Enrollment in tumor specific expansion cohorts including HNSCC is ongoing. A study of MICVO in combination with pembrolizumab in 1L HNSCC and other tumor types is enrolling (NCT06795412)."

Clinical • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EDB-FN

Development of multiplex immunofluorescence workflows for characterizing tumor-immune and stromal compartments for pharmacodynamic assessments of solid tumors (AACR-NCI-EORTC 2025) - P1, P1/2 | "Micvotabart pelidotin (micvo) is an antibody–drug conjugate that targets the non-cellular extradomain-B of fibronectin, an extracellular matrix protein highly expressed in tumors compared to normal adult tissues...Micvo is currently in clinical development as a monotherapy (NCT05720117) and in combination with pembrolizumab for difficult-to-treat cancers (NCT06795412)...These results demonstrate the feasibility of integrating tumor‑immune and stromal mIF panels for high‑resolution TME profiling, offering a scalable and customizable approach to investigate tumor heterogeneity and treatment response across solid tumors. The validated mIF workflow will be applied to clinical biopsies from micvo‑treated participants to characterize pharmacodynamic changes in immune and stromal compartments."

PK/PD data • Stroma • Head and Neck Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EDB-FN

Micvotabart pelidotin, an ADC targeting non-cellular EDB+FN, induces an immune response in tumors from participants in a phase 1 dose escalation study (AACR-NCI-EORTC 2025) - P1, P1/2 | "Micvotabart pelidotin (micvo) is an antibody-drug conjugate (ADC) that targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix that is highly expressed in tumors compared to normal adult tissues. Micvo's ability to remodel tumor stroma is also under investigation in these biopsies. These pharmacodynamic responses will be further characterized in tumor-specific expansion cohorts from the ongoing clinical evaluation of micvo as monotherapy (NCT05720117) and in combination with pembrolizumab (NCT06795412)."

IO biomarker • P1 data • Oncology • Solid Tumor • EDB-FN • FOXP3

Phase I expansion study of the first-in-class non-cellular targeting antibody-drug conjugate (ADC), micvotabart pelidotin (MICVO), in patients with select advanced solid tumors (ESMO 2025) - P1 | "Legal entity responsible for the study Pyxis Oncology, Inc. Funding Pyxis Oncology, Inc."

Clinical • IO biomarker • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EDB-FN • EGFR

Longitudinal changes in circulating tumor DNA in a phase I dose escalation study of micvotabart pelidotin, a first-in-human ADC targeting EDB+FN (ESMO 2025) - P1 | "Legal entity responsible for the study Pyxis Oncology, Inc. Funding Pyxis Oncology, Inc."

Circulating tumor DNA • First-in-human • P1 data • Tumor mutational burden • Head and Neck Cancer • Hematological Malignancies • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EDB-FN • TMB

Histological biomarker analysis of nonclinical and baseline tumor samples from the phase I dose escalation study assessing micvotabart peliodotin (MICVO) in advanced solid tumors (ESMO 2025) - P1 | "Background Micvotabart pelidotin (MICVO/ PYX-201) is an antibody-drug conjugate that targets the non-cellular extradomain-B of fibronectin (EDB+FN), an extracellular matrix protein (ECM) that is highly expressed in tumors compared to normal adult tissues...Clinical trial identification NCT05720117 Legal entity responsible for the study Pyxis Oncology, Inc. Funding Pyxis Oncology, Inc."

Biomarker • Metastases • P1 data • Oncology • Solid Tumor • EDB-FN

Breakthrough clinical research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) will be in the spotlight this week in Berlin at the European Society of Medical Oncology (ESMO) Congress 2025. (PRNewswire) - "Among the 23 studies co-authored by FCS physician investigators selected for presentation to oncology experts worldwide, one has earned the distinction of being featured as an oral presentation and four as poster presentations by FCS first authors."

Clinical data • Platinum resistant • pMMR • Cervical Cancer • Endometrial Cancer • Ovarian Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Pyxis Oncology to Present Translational Data and Key Biology Findings Elucidating the Mechanism of Action of MICVO at Upcoming Medical Meetings (GlobeNewswire) - "The poster presentations at the ESMO and AACR-NCI-EORTC meetings provide deeper insights into the pharmacodynamic responses of tumors to MICVO as well as MICVO’s unique mechanism of action and its potential to exert anti-tumor activity through three mechanisms: direct tumor cell killing, bystander killing and immunogenic cell death....Three additional posters will also be presented, including two trial-in-progress posters for ongoing clinical studies of MICVO in monotherapy and in combination with pembrolizumab in HNSCC, as well as previously reported Phase 1 monotherapy dose-escalation data in HNSCC."

Clinical data • Trial status • Squamous Cell Carcinoma of Head and Neck

Pyxis Oncology Reports Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Pyxis Oncology anticipates having preliminary data from the Phase 1/2 combination study of MICVO in combination with...KEYTRUDA (pembrolizumab), in R/M HNSCC and other advanced solid tumors in the second half of 2025."

P1/2 data • Squamous Cell Carcinoma of Head and Neck

Pipeline Updates (GlobeNewswire) - "Pyxis Oncology anticipates having preliminary data from the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial evaluating MICVO in 2L and 3L R/M HNSCC patients...in the second half of 2025. Preliminary data from the trial in 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy are anticipated in the first half of 2026."

P1 data • Squamous Cell Carcinoma of Head and Neck

Pyxis Oncology updates patient enrollment for Phase 1 trial of micvotabart pelidotin (Investing.com) - "Pyxis Oncology , Inc...announced Monday that revisions to patient enrollment for its Phase 1 monotherapy clinical trial of micvotabart pelidotin (MICVO), formerly known as PYX-201, were posted on ClinicalTrials.gov on July 31...The trial is a first-in-human, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MICVO in participants with advanced solid tumors. The study includes a dose escalation phase and a dose expansion phase (NCT05720117)...the revision reflects the maximum number of patients permitted to enroll in the trial according to the study protocol. Pyxis Oncology confirmed that its previous guidance regarding the estimated number of head and neck squamous cell carcinoma patients to be included in the dose expansion phase remains unchanged..."

Enrollment status • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

PYX-201-101: Study of PYX-201 in Solid Tumors (clinicaltrials.gov) - P1 | N=330 | Recruiting | Sponsor: Pyxis Oncology, Inc | N=120 ➔ 330

Enrollment change • Breast Cancer • Hepatocellular Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • Triple Negative Breast Cancer • HER-2