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

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 | "The study incorporates a robust biomarker plan to evaluate EDB+FN expression. Dose expansion opened for enrollment in January 2025."

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

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 | "The first expansion cohort will focus on the combination as 1L therapy in patients with PD-L1+ HNSCC. The study opened for enrollment in January 2025."

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

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...Conclusions In this heterogeneous dataset, EDB+FN may be necessary but not sufficient to confer sensitivity to MICVO whereas in certain tumor types, features of stromal architecture detected using digital pathology may do so. Studies with participant tumor samples correlating features besides EDB+FN such as protease expression, payload sensitivity, drug resistance mechanisms, or other histologic features with sensitivity to MICVO are on-going and will be further investigated in tumor specific expansion cohorts."

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

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 | "Reductions in both ctDNA TF and bTMB, around C3D1 compared to baseline, occurred within both HNSCC and the cohort dosed at 5.4 mg/kg, which is the dose selected for expansion. Further characterization of ctDNA as a minimally invasive liquid biomarker of pharmacodynamic response to MICVO will be performed in tumor specific expansion cohorts."

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

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

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

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) - "Any additional data that will be available on a poster that is beyond what was submitted in the abstract is embargoed until Nov. 7, 2025 at 9 a.m. ET."

Combination therapy • Metastases • P1/2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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) - "Available on Wednesday, October 22, 2025 at 01:00pm EDT."

Biomarker • P1 data • Tumor microenvironment • Oncology

Micvotabart pelidotin induces immunogenic cell death markers and activates tumor immune cells in pre-clinical studies (AACR-NCI-EORTC 2025) - "Available on Wednesday, October 22, 2025 at 01:00pm EDT."

Immune cell • Immunogenic cell death • Preclinical • Oncology

Mouse analog of micvotabart pelidotin sensitizes a refractory syngeneic breast cancer model to anti-PD1 therapy (AACR-NCI-EORTC 2025) - "Available on Wednesday, October 22, 2025 at 01:00pm EDT."

Preclinical • Breast Cancer • Oncology • Solid Tumor

Characterization of micvotabart pelidotin target binding properties and extracellular payload release (AACR-NCI-EORTC 2025) - "Available on Wednesday, October 22, 2025 at 01:00pm EDT."

Oncology

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) - "Available on Wednesday, October 22, 2025 at 01:00pm EDT."

P1 data • Oncology

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

Pyxis Oncology Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Research and development expenses were $17.0 million for the quarter ended March 31, 2025, compared to $13.0 million for the quarter ended March 31, 2024. The increase was primarily due to increased clinical trial-related expenses related to monotherapy and combination therapy of micvotabart pelidotin, increase in preclinical and translation work to support clinical development of micvotabart pelidotin and increased manufacturing of drug product and drug substance."

Commercial • Squamous Cell Carcinoma of Head and Neck

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."

Preclinical • Breast Cancer • Oncology • Solid Tumor

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."

Gene Signature • Oncology • Solid Tumor

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 (Poster Board Number: 5; Published Abstract Number: 3120) (GlobeNewswire) - "MICVO demonstrated broad anti-tumor activity across ten solid tumor indications in PDX models, attributed to EDB+FN target expression, proteolytic activity for MICVO linker cleavage and tumor responsiveness to the cytotoxic Auristatin0101 payload: 45% of models demonstrated strong to very strong tumor growth inhibition (TGI%) activity (70%90% respectively), with only 25% of models showing no response (TGI90%) were found across nine out of ten solid tumor indications; Complete responses to MICVO (tumor volume reached 0mm3 for at least two consecutive measurements) were found across several tumor indications, consistent with previous analysis; MICVO was well-tolerated (3mg/kg, Q4Dx4)....Enzyme and tumor stroma gene signatures were the gene sets with the greatest number of differentially expressed genes, deepening understanding around MOA and potential patient response."

Preclinical • 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 (Poster Board Number: 4; Published Abstract Number: 3137) (GlobeNewswire) - "Combining a mouse analog of MICVO with anti-PD-1 therapy inhibited EMT6 tumor growth and improved survival: Monotherapy of mouse analog of MICVO inhibited dose-dependent tumor outgrowth of EDB+FN expressing EMT6 tumors and was well-tolerated at 6mg/kg; The mouse analog of MICVO boosted the immune response by activating dendritic cells and increasing CD45+ immune cell infiltration, including PD1+ T cells, into tumors, transforming EMT6 tumors into immune-infiltrated, 'hot' tumors; Significant TGI observed with mouse analog of MICVO (TGI=94%) and anti-PD-1 therapy (TGI=54%) as monotherapies; The combination of the mouse analog of MICVO and anti-PD-1 therapy resulted in TGI of 91% and complete response was seen in 9/15 animals – greater tumor regression and clearance than either treatment alone; Mouse analog of MICVO in combination with anti-PD1 therapy induced lasting immunological memory, enhancing tumor clearance and protecting against tumor recurrence in rechallenged mice."

Preclinical • Solid Tumor

Pyxis Oncology to Present New Preclinical Data Supporting Development of First-In-Concept ADC Targeting EDB+FN in Tumor Microenvironment at AACR 2025 (GlobeNewswire) - "Expression data from patient-derived xenograft (PDX) mouse models exposed to micvotabart pelidotin (MICVO) indicate gene signatures associated with efficacy, deepening understanding of MOA and potential patient response. Combination of a mouse analog of MICVO and a mouse anti-PD-1 therapy in a syngeneic model resulted in significantly greater tumor regression than either treatment alone. Company advances MICVO into monotherapy and combination clinical trials with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), targeting recurrent and metastatic head and neck squamous cell carcinoma; preliminary data expected in 2H2025 and 1H2026."

P2 data • Preclinical • Squamous Cell Carcinoma of Head and Neck

Pyxis Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Initiated Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial to evaluate micvotabart pelidotin in 2L and 3L R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy, and 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy. Preliminary data from patients who have received prior platinum and PD-1 inhibitor therapy are expected in the second half of 2025 and preliminary data from patients who have received prior EGFRi and PD-1 inhibitor therapy are expected in the first half of 2026....Initiated Phase 1/2 combination study of micvotabart pelidotin and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors. We aim to select a dose of micvotabart pelidotin in combination with pembrolizumab by mid-year 2025 and share preliminary data from the trial in the second half of 2025."

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

Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Pyxis Oncology, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor