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

Micvotabart pelidotin in combination with EGFR-targeted therapy improves duration of response in HNSCC PDX models (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Combination therapy • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Pyxis Oncology to Host Webcast to Present Updated Data from Phase 1 Monotherapy Study of Micvotabart Pelidotin (MICVO) in Second-Line and Beyond Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (2L+ R/M HNSCC) (GlobeNewswire) - "Event to be webcast live on September 9, 2026 at 7:30 a.m. ET....The presentation will include the scientific rationale for Pyxis Oncology’s novel ADC, MICVO; implications of the evolving treatment landscape in R/M HNSCC; detailed analyses of patients treated at 5.4 mg/kg intravenously once every three weeks with a dose equivalent to or below a dose cap; updated efficacy and safety results from the expansion trial; and next steps in clinical development."

P1 data • Squamous Cell Carcinoma of Head and Neck

Pyxis Oncology Announces Positive Updated Data from Phase 1 Monotherapy Study of Micvotabart Pelidotin (MICVO) in Second-Line and Beyond Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (The Manila Times) - "MICVO demonstrated rapid and deep responses, with a 36% confirmed objective response rate (cORR) and 94% disease control rate (DCR), with clinical activity observed across HPV status and prior-treatment subgroups; Substantial survival outcomes include median progression-free survival (mPFS) of 6.2 months and 12-month overall survival (OS) probability of 79%, with clinical activity observed across HPV status and prior-treatment subgroups; No new safety signals observed...Data support advancement of MICVO into a pivotal program in 2L+ R/M HNSCC, with initiation of Phase 3 Headliner trial planned for mid-2027"

New P3 trial • P1 data • Squamous Cell Carcinoma of Head and Neck

In vitro characterization of the mechanism of action of micvotabart pelidotin, an antibody-drug conjugate targeting extradomain-B of fibronectin (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

ADC • Preclinical • 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

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

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

Pipeline & Corporate Updates (GlobeNewswire) - "Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study for 2L+ R/M HNSCC in Fall 2026. The update is expected to include patients treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, together with detailed analyses of the dose cap impact on safety, tolerability, efficacy and initial durability...Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for 1L R/M HNSCC patients in the fourth quarter of 2026."

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

Development of a Novel Immunohistochemistry Assay to Characterize EDB+FN Protein Expression in Solid Tumors. (PubMed, Lab Invest) - P1, P1/2 | "This work demonstrates technical characterization of a research-use IHC assay for detection of EDB+FN in FFPE tumor sections, reveals broad expression of EDB+FN across cancer types, and establishes a novel approach for scoring expression of a non-cell associated protein in the tumor ECM, both by pathologists and using digital pathology."

Journal • Oncology • Solid Tumor • EDB-FN

PYX-201-101: A Study of PYX-201 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=330 | Recruiting | Sponsor: Pyxis Oncology, Inc | Trial completion date: May 2027 ➔ Jun 2028 | Trial primary completion date: Jul 2026 ➔ Apr 2027

First-in-human • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • HER-2 • PD-L1

Pyxis Oncology…expects to report updated data from the ongoing Phase 1/2 dose-escalation study evaluating MICVO in combination with pembrolizumab for first-line (1L) R/M HNSCC in the fourth quarter of 2026. (GlobeNewswire)

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

Pyxis Oncology…announced that it has entered into definitive securities purchase agreements for a private placement expected to result in gross proceeds of approximately $50 million (GlobeNewswire) - "The Company has elected to incorporate additional patient follow-up and planned analyses into its next clinical update and now expects to report updated data from the ongoing Phase 1 monotherapy study in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) in Fall 2026...The update is expected to include patients treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, along with detailed analyses of the dose cap impact on safety, tolerability and efficacy."

Commercial • P1 data • Squamous Cell Carcinoma of Head and Neck

Pipeline Updates (GlobeNewswire) - "Updated micvotabart pelidotin (MICVO) Phase 1 monotherapy data in 2L+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) on track for mid-year 2026...Completed target enrollment in Phase 1 monotherapy dose expansion study of MICVO in 2L+ R/M HNSCC in the first quarter of 2026...Updated data from MICVO Phase 1/2 dose escalation study in combination with pembrolizumab in 1L R/M HNSCC on track for the second half of 2026."

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

KEYNOTE-G17: Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=220 | Recruiting | Sponsor: Pyxis Oncology, Inc

New P1/2 trial • Breast Cancer • Gastric Cancer • Head and Neck Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • HER-2

Mouse analog of micvotabart pelidotin, an antibody-drug conjugate targeting extradomain-B of fibronectin, demonstrates anti-tumor efficacy in an immunotherapy-refractory syngeneic head and neck squamous cell carcinoma model (AACR 2026) - P1, P1/2 | "Head and neck squamous cell carcinoma (HNSCC) is a difficult-to-treat indication, with current standard of care providing limited long-term survival, underscoring the need for more effective treatment options. Ongoing studies aim to determine whether maMICVO synergizes with anti-PD1 to enhance efficacy in this immunotherapy-refractory MOC2 model and to further define the immune changes driving this response at the cellular, molecular, and spatial levels. Collectively, these findings support the continued clinical evaluation of MICVO both as a monotherapy (NCT05720117) and in combination with pembrolizumab (NCT06795412) in difficult-to-treat HNSCC."

ADC • IO biomarker • Preclinical • Breast Cancer • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD8 • EDB-FN • PD-L1

Pyxis Oncology to Present New Preclinical Data Showing Synergistic Anti-Tumor Activity in a HNSCC model with maMICVO in Combination with Anti-PD-1 at AACR 2026 (GlobeNewswire) - "Mouse analog of MICVO (maMICVO) monotherapy produced dose-dependent inhibition of tumor growth in a syngeneic preclinical model of HNSCC. maMICVO monotherapy modulated the tumor-immune environment in a syngeneic preclinical model of HNSCC toward a more favorable immune-permissive environment for immunotherapy. maMICVO in combination with anti-mouse PD-1 worked synergistically to produce greater anti-tumor activity compared with either treatment alone in an immune-refractory syngeneic preclinical model of HNSCC."

Preclinical • Squamous Cell Carcinoma of Head and Neck

Evaluation of PYX-201, an EDB+FN-targeting ADC, in a comprehensive PDX mini-trial study enables identification of gene signatures associated with anti-tumor activity (AACR 2025) - P1 | "Overall, PYX-201 showed broad anti-tumor activity in PDX pre-clinical models, suggesting it is a promising ADC for further testing across solid tumor indications. Furthermore, tumor stroma and protease genes were associated with PYX-201 activity in PDX models, providing further insight into PYX-201 mechanism of action."

ADC • Gene Signature • Oncology • Solid Tumor

PYX-201, a stroma-targeting ADC composed of an anti-EDB+FN antibody conjugated to Auristatin0101, demonstrates strong anti-tumor efficacy across multiple human cancer indications in pre-clinical PDX tumor models (AACR 2024) - P1 | "Altogether, PYX-201 was well tolerated and demonstrated strong anti-tumor efficacy in a variety of pre-clinical human PDX models. PYX-201 is a promising and innovative ADC which is currently under investigation in a Phase I clinical trial (NCT05720117)."

ADC • Preclinical • Stroma • Breast Cancer • Oncology • Solid Tumor

The combination of anti-PD1 and a mouse analog of PYX-201, an antibody-drug conjugate targeting the extra-domain B splice variant of fibronectin (EDB+FN), shows greater anti-tumor efficacy than either treatment alone (AACR 2025) - P1 | "Further studies are underway to characterize changes in the activation status and tumor localization of these lymphocytes after treatment. Overall, these results provide compelling evidence that combining PYX-201 with anti-PD1 is a highly effective and promising strategy for improving outcomes in patients with difficult-to-treat cancers."

ADC • Preclinical • Breast Cancer • Oncology • Solid Tumor

Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and KEYTRUDA for 1L/2L+ R/M HNSCC patients in 2H26. (GlobeNewswire)

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

Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC mid-year 2026. (GlobeNewswire) - "Part 2, a dose expansion study at 5.4 mg/kg IV Q3W in 2L+ R/M HNSCC, is currently ongoing. The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post platinum & anti-PD(L)-1 experienced patients (Arm 1) and post EGFRi and/or anti-PD(L)-1 experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20. Total study target enrollment of n=~40 was completed in 1Q26."

P1 data • Trial status • Squamous Cell Carcinoma of Head and Neck

PYX-201-102: Phase 1/2 Study of PYX-201 in Combination with Pembrolizumab in Advanced Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=21 | Recruiting | Sponsor: Pyxis Oncology Inc.

New P1/2 trial • Oncology • Solid Tumor

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