Pyxis Oncology to Present New Preclinical Data Supporting Development of First-In-Concept ADC Targeting EDB+FN in Tumor Microenvironment at AACR 2025
Pyxis Oncology (NASDAQ: PYXS) announced new preclinical data for micvotabart pelidotin (MICVO), their first-in-concept antibody-drug conjugate targeting EDB+FN in the tumor microenvironment. The data will be presented at AACR 2025 in Chicago.
Key highlights include:
- Patient-derived xenograft mouse models showed gene signatures associated with MICVO efficacy
- Combination of MICVO analog with anti-PD-1 therapy demonstrated enhanced tumor regression
- Phase 1 studies showed significant tumor regression across multiple tumor types
The company is advancing MICVO in clinical trials:
- Phase 1 monotherapy expansion for recurrent/metastatic head and neck cancer with preliminary data expected in 2H2025 and 1H2026
- Phase 1/2 combination study with Keytruda® with preliminary data expected in 2H2025
MICVO has received Fast Track Designation from the FDA for treating adult patients with recurrent/metastatic head and neck squamous cell carcinoma after platinum-based chemotherapy and anti-PD-(L)1 therapy.
Pyxis Oncology (NASDAQ: PYXS) ha annunciato nuovi dati preclinici per micvotabart pelidotin (MICVO), il loro primo coniugato anticorpo-farmaco concepito per colpire l'EDB+FN nel microambiente tumorale. I dati saranno presentati all'AACR 2025 a Chicago.
I punti salienti includono:
- I modelli murini xenograft derivati dai pazienti hanno mostrato firme geniche associate all'efficacia di MICVO
- La combinazione dell'analogo MICVO con la terapia anti-PD-1 ha dimostrato una regressione tumorale potenziata
- Gli studi di Fase 1 hanno mostrato una regressione tumorale significativa in diversi tipi di tumore
L'azienda sta portando avanti MICVO negli studi clinici:
- Espansione della monoterapia di Fase 1 per il cancro della testa e del collo ricorrente/metastatico, con dati preliminari attesi nel 2H2025 e 1H2026
- Studio di combinazione di Fase 1/2 con Keytruda® con dati preliminari attesi nel 2H2025
MICVO ha ricevuto la Designazione di Percorso Veloce dalla FDA per il trattamento di pazienti adulti con carcinoma a cellule squamose della testa e del collo ricorrente/metastatico dopo chemioterapia a base di platino e terapia anti-PD-(L)1.
Pyxis Oncology (NASDAQ: PYXS) anunció nuevos datos preclínicos para micvotabart pelidotin (MICVO), su primer conjugado anticuerpo-fármaco dirigido a EDB+FN en el microambiente tumoral. Los datos se presentarán en AACR 2025 en Chicago.
Los puntos clave incluyen:
- Los modelos de ratón xenoinjertados derivados de pacientes mostraron firmas génicas asociadas con la eficacia de MICVO
- La combinación del análogo MICVO con terapia anti-PD-1 demostró una regresión tumoral mejorada
- Los estudios de Fase 1 mostraron una regresión tumoral significativa en múltiples tipos de tumores
La compañía está avanzando con MICVO en ensayos clínicos:
- Expansión de monoterapia de Fase 1 para cáncer de cabeza y cuello recurrente/metastásico, con datos preliminares esperados en 2H2025 y 1H2026
- Estudio de combinación de Fase 1/2 con Keytruda® con datos preliminares esperados en 2H2025
MICVO ha recibido la Designación de Vía Rápida de la FDA para el tratamiento de pacientes adultos con carcinoma de células escamosas de cabeza y cuello recurrente/metastásico después de quimioterapia basada en platino y terapia anti-PD-(L)1.
Pyxis Oncology (NASDAQ: PYXS)는 종양 미세환경에서 EDB+FN을 표적으로 하는 첫 번째 개념의 항체-약물 접합체인 micvotabart pelidotin (MICVO)에 대한 새로운 전임상 데이터를 발표했습니다. 이 데이터는 2025년 AACR에서 시카고에서 발표될 예정입니다.
주요 하이라이트는 다음과 같습니다:
- 환자 유래 이식 쥐 모델에서 MICVO 효능과 관련된 유전자 서명이 나타났습니다
- MICVO 유사체와 항-PD-1 요법의 조합이 종양 퇴행을 강화하는 것으로 나타났습니다
- 1상 연구에서 여러 종양 유형에서 유의미한 종양 퇴행이 관찰되었습니다
회사는 임상 시험에서 MICVO를 진행하고 있습니다:
- 재발/전이성 두경부암에 대한 1상 단독 요법 확장, 2025년 하반기와 2026년 상반기에 초기 데이터가 예상됩니다
- Keytruda®와의 1/2상 조합 연구, 2025년 하반기에 초기 데이터가 예상됩니다
MICVO는 FDA로부터 백금 기반 화학요법 및 항-PD-(L)1 요법 후 재발/전이성 두경부 편평세포암 치료를 위한 신속 심사 지정(Fast Track Designation)을 받았습니다.
Pyxis Oncology (NASDAQ: PYXS) a annoncé de nouvelles données précliniques pour micvotabart pelidotin (MICVO), leur premier conjugué anticorps-médicament ciblant EDB+FN dans le microenvironnement tumoral. Les données seront présentées à l'AACR 2025 à Chicago.
Les points clés comprennent:
- Des modèles murins de xénogreffes dérivés de patients ont montré des signatures géniques associées à l'efficacité de MICVO
- La combinaison de l'analogue MICVO avec une thérapie anti-PD-1 a démontré une régression tumorale améliorée
- Les études de Phase 1 ont montré une régression tumorale significative dans plusieurs types de tumeurs
L'entreprise fait progresser MICVO dans les essais cliniques:
- Expansion de la monothérapie de Phase 1 pour le cancer de la tête et du cou récurrent/métastatique, avec des données préliminaires attendues au 2H2025 et 1H2026
- Étude de combinaison de Phase 1/2 avec Keytruda®, avec des données préliminaires attendues au 2H2025
MICVO a reçu la désignation Fast Track de la FDA pour le traitement des patients adultes atteints de carcinome épidermoïde récurrent/métastatique de la tête et du cou après chimiothérapie à base de platine et thérapie anti-PD-(L)1.
Pyxis Oncology (NASDAQ: PYXS) hat neue präklinische Daten für micvotabart pelidotin (MICVO) angekündigt, ihren ersten Antikörper-Wirkstoff-Konjugat, das auf EDB+FN im Tumormikroumfeld abzielt. Die Daten werden auf der AACR 2025 in Chicago präsentiert.
Wichtige Highlights sind:
- Patientenabgeleitete Xenotransplantationsmausmodelle zeigten Gen-Signaturen, die mit der Wirksamkeit von MICVO assoziiert sind
- Die Kombination des MICVO-Analogs mit einer Anti-PD-1-Therapie zeigte eine verbesserte Tumorrückbildung
- Phase-1-Studien zeigten eine signifikante Tumorrückbildung bei mehreren Tumorarten
Das Unternehmen bringt MICVO in klinischen Studien voran:
- Phase-1-Erweiterung der Monotherapie für wiederkehrenden/metastatischen Kopf-Hals-Krebs, mit ersten Daten, die im 2H2025 und 1H2026 erwartet werden
- Phase-1/2-Kombinationsstudie mit Keytruda®, mit ersten Daten, die im 2H2025 erwartet werden
MICVO hat von der FDA die Fast-Track-Designierung zur Behandlung von erwachsenen Patienten mit wiederkehrendem/metastatischem Plattenepithelkarzinom des Kopfes und Halses nach platinbasierter Chemotherapie und Anti-PD-(L)1-Therapie erhalten.
- Fast Track Designation received from FDA
- Positive preclinical data showing enhanced tumor regression in combination therapy
- Multiple ongoing clinical trials with data readouts expected in 2025-2026
- Demonstrated significant tumor regression across multiple tumor types in Phase 1
- Final clinical trial results still pending
- Commercial launch timeline uncertain
Insights
Pyxis's data on micvotabart pelidotin (MICVO) represents a significant advancement in targeted cancer therapy through its novel approach targeting EDB+FN in the tumor microenvironment. This mechanism is particularly noteworthy as it addresses the extracellular matrix rather than cancer cells directly—a potentially transformative approach for overcoming treatment resistance.
The preclinical findings demonstrate two critical advantages: First, the identified gene signatures associated with efficacy provide potential biomarkers for patient selection, addressing a major challenge in precision oncology. Second, the synergistic effect when combined with anti-PD-1 therapy suggests MICVO could enhance immunotherapy responses, potentially overcoming a common resistance mechanism in head and neck cancers.
The Fast Track Designation for recurrent/metastatic HNSCC validates the clinical potential and addresses a significant unmet need in a difficult-to-treat population that has progressed after standard therapies. The multi-cohort development strategy targeting both platinum and EGFR inhibitor pre-treated patients is strategically sound, maximizing the compound's potential applications.
MICVO's previously observed tumor regression activity across multiple tumor types indicates broader potential beyond HNSCC, potentially establishing a platform approach for Pyxis's technology. The Merck collaboration for combination studies provides both validation and accelerated development pathways that a small biotech couldn't achieve independently.
Pyxis's announcement demonstrates meaningful progress for MICVO with multiple catalysts ahead. The preliminary data expected in 2H2025 and 1H2026 create a clear value-inflection timeline for this asset. The Fast Track Designation provides regulatory advantages including potential for accelerated approval, priority review, and more frequent FDA communication.
The collaboration with Merck for combination trials represents significant external validation, potentially sharing development costs while accelerating the path to market. This approach targets head and neck squamous cell carcinoma—a challenging indication with effective treatments post-immunotherapy failure—providing differentiation in a competitive ADC landscape.
MICVO's first-in-concept mechanism targeting EDB+FN creates potential patent exclusivity advantages and positioning as a first-mover in this specific approach. The preclinical data showing synergy with immunotherapy could significantly expand the addressable market by potentially overcoming PD-1 resistance mechanisms common in many solid tumors.
With MICVO's previously demonstrated monotherapy effect and now combination potential with an established blockbuster therapy (Keytruda), Pyxis is building a compelling case for its lead asset. For a company with ~$75M market cap, successful advancement of MICVO could drive significant revaluation, particularly if clinical data supports the preclinical findings. The strategic focus on biomarker-guided development could increase probability of success compared to broader approaches.
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
BOSTON, March 25, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, announced today that the Company will present new, positive preclinical data highlighting the potential of micvotabart pelidotin (MICVO, formerly referred to as PYX-201), a first-in-concept antibody-drug conjugate (ADC) that targets EDB+FN, a non-cellular structural component of the tumor extra-cellular matrix. These data will be presented in two poster sessions at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, held from April 25 to 30, 2025.
"We are thrilled to present new preclinical data at AACR25 that further elucidate the innovative mechanism of action of MICVO, our first-in-concept EDB+FN targeting ADC, which leverages a unique non-cellular mechanism to drive anti-tumor activity,” said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. “As we advance MICVO both as a monotherapy and in combination with anti-PD-1 therapy in the clinic, we remain confident in our multi-pronged development strategy in recurrent and metastatic head and neck squamous cell carcinoma where we believe altering the extra-cellular matrix may effectively address a main cause of resistance to other therapies.”
In a previous Phase 1 dose escalation study, it was established that MICVO has profound monotherapy effect on multiple tumor types with significant tumor regression. The Company has initiated the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial to evaluate MICVO in 2L and 3L recurrent and metastatic head and neck squamous cell carcinoma (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. Additionally, the Company initiated a Phase 1/2 combination study of MICVO and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors, with the goal of identifying the recommended Phase 2 dose by mid-year 2025 and a readout of preliminary data in the second half of 2025.
MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy.
Presentation details at AACR are listed below, with all times in Central Time (CT):
| • | Title: 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 | |
| Session Category: Experimental and Molecular Therapeutics Session Title: Therapeutic Approaches to Attack the Tumor Microenvironment Session Date and Time: Monday, April 28, 2025, 2:00 PM – 5:00 PM Location: Poster Section 24 Poster Board Number: 5 Published Abstract Number: 3120 | ||
| • | Title: 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 | |
| Session Category: Experimental and Molecular Therapeutics Session Title: Therapeutic Approaches to Attack the Tumor Microenvironment Session Date and Time: Monday, April 28, 2025, 2:00 PM – 5:00 PM Location: Poster Section 24 Poster Board Number: 4 Published Abstract Number: 3137 | ||
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. The company is efficiently building next generation therapeutics that hold the potential for monotherapy and combination indications. The lead product candidate, micvotabart pelidotin (“MICVO” formerly PYX-201), is an antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extra-cellular matrix. MICVO has been evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors with a go-forward development focus on treating patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) based on the strength of the HNSCC signal that emerged. MICVO is designed to generate a multi-pronged attack on difficult-to-treat cancers by directly killing cancer cells, reducing extra-cellular matrix density, inhibiting tumor angiogenesis and mobilizing an anti-tumor immune response.
To learn more, visit www.pyxisoncology.com or follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part II, Item 1A. of the Company’s Annual Report on Form 10-K filed with SEC on March 18, 2025, and our other filings, each of which is on file with the Securities and Exchange Commission. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date hereof and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
Pyxis Oncology Contact
Pamela Connealy
CFO and COO
ir@pyxisoncology.com
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