Pyxis Oncology Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data
Pyxis Oncology (NASDAQ: PYXS) announced positive preliminary data from its Phase 1 clinical trial of PYX-201, a novel antibody-drug conjugate targeting Extradomain-B Fibronectin. The drug achieved a 50% objective response rate including one complete response in head and neck cancer patients, and 26% overall response rate across six solid tumor types. PYX-201 demonstrated a favorable safety profile and dose-dependent responses. The company also announced a new clinical trial collaboration with Merck to evaluate PYX-201 in combination with KEYTRUDA®, with dosing expected to begin in Q1 2025.
Pyxis Oncology (NASDAQ: PYXS) ha annunciato dati preliminari positivi dal suo studio clinico di fase 1 su PYX-201, un nuovo coniugato anticorpo-farmaco che mira alla Fibronectina Extradomain-B. Il farmaco ha raggiunto un tasso di risposta obiettivo del 50%, inclusa una risposta completa in pazienti con tumore della testa e del collo, e un tasso di risposta complessivo del 26% in sei tipi di tumori solidi. PYX-201 ha dimostrato un profilo di sicurezza favorevole e risposte dipendenti dalla dose. L'azienda ha inoltre annunciato una nuova collaborazione per uno studio clinico con Merck per valutare PYX-201 in combinazione con KEYTRUDA®, con l'inizio delle somministrazioni previsto per il primo trimestre del 2025.
Pyxis Oncology (NASDAQ: PYXS) anunció datos preliminares positivos de su ensayo clínico de fase 1 sobre PYX-201, un nuevo conjugado anticuerpo-fármaco dirigido a la Fibronectina Extradomain-B. El fármaco logró una tasa de respuesta objetiva del 50%, incluyendo una respuesta completa en pacientes con cáncer de cabeza y cuello, y una tasa de respuesta global del 26% en seis tipos de tumores sólidos. PYX-201 demostró un perfil de seguridad favorable y respuestas dependientes de la dosis. La compañía también anunció una nueva colaboración para un ensayo clínico con Merck para evaluar PYX-201 en combinación con KEYTRUDA®, con el inicio de la dosificación esperado para el primer trimestre de 2025.
Pyxis Oncology (NASDAQ: PYXS)는 Extradomain-B 피브로넥틴을 표적으로 하는 새로운 항체-약물 접합체인 PYX-201의 1상 임상 시험에서 긍정적인 초기 데이터를 발표했습니다. 이 약물은 두경부 암 환자에서 50%의 객관적 반응률을 달성하였고, 6가지 고형 종양 유형에서 전체 반응률은 26%에 달했습니다. PYX-201은 긍정적인 안전성 프로필과 용량 의존적인 반응을 나타냈습니다. 회사는 또한 Merck와 협력하여 PYX-201과 KEYTRUDA®의 병합 평가를 위한 새로운 임상 시험 협력을 발표했으며, 투여는 2025년 1분기부터 시작될 예정입니다.
Pyxis Oncology (NASDAQ: PYXS) a annoncé des données préliminaires positives de son essai clinique de phase 1 sur PYX-201, un nouveau conjugué anticorps-médicament ciblant la fibronectine Extradomain-B. Le médicament a atteint un taux de réponse objectif de 50%, y compris une réponse complète chez des patients atteints de cancer de la tête et du cou, et un taux de réponse global de 26% sur six types de tumeurs solides. PYX-201 a démontré un profil de sécurité favorable et des réponses dépendantes de la dose. L'entreprise a également annoncé une nouvelle collaboration pour un essai clinique avec Merck pour évaluer PYX-201 en combinaison avec KEYTRUDA®, avec un début de traitement prévu pour le premier trimestre 2025.
Pyxis Oncology (NASDAQ: PYXS) hat positive vorläufige Daten aus seiner Phase-1-Studie zu PYX-201, einem neuartigen Antikörper-Wirkstoff-Konjugat, das auf Extradomain-B-Fibronectin abzielt, bekannt gegeben. Das Medikament erzielte eine objektive Ansprechrate von 50%, einschließlich einer kompletten Remission bei Patienten mit Kopf-Hals-Krebs, und eine Gesamtansprechrate von 26% über sechs verschiedene solide Tumorarten. PYX-201 zeigte ein günstiges Sicherheitsprofil und dosisabhängige Antworten. Das Unternehmen gab außerdem eine neue klinische Studienkooperation mit Merck bekannt, um PYX-201 in Kombination mit KEYTRUDA® zu bewerten, wobei die Dosierung voraussichtlich im ersten Quartal 2025 beginnen wird.
- 50% objective response rate in HNSCC patients, including one complete response
- 26% overall response rate across six solid tumor types
- 100% Disease Control Rate in HNSCC patients
- Favorable safety profile with low incidence of treatment-related adverse events
- New collaboration agreement with Merck for combination therapy with KEYTRUDA
- Demonstrated increased stability in circulation compared to certain approved ADCs
- None.
Insights
The preliminary Phase 1 data for PYX-201 shows remarkable promise, particularly in head and neck cancer (HNSCC) with a
The collaboration with Merck to combine PYX-201 with KEYTRUDA significantly enhances the development pathway. The unique extracellular matrix-targeting mechanism differentiates it from traditional ADCs, potentially offering a new therapeutic approach for resistant cancers. Multiple planned expansion studies across various tumor types and upcoming data readouts throughout 2025 provide numerous catalysts for clinical validation.
This clinical milestone significantly derisks PYXS's lead asset and opens multiple revenue opportunities. The Merck collaboration adds substantial validation to the platform and expands market potential through combination therapy. The broad activity across six tumor types suggests a larger addressable market than initially anticipated. With multiple catalysts planned throughout 2025-2026, including expansion cohorts and combination studies, the company has several value-driving events ahead.
The positive safety profile could position PYX-201 favorably against competing ADCs, while the novel extracellular targeting approach provides differentiation in a crowded oncology market. For a company with a
— PYX-201 achieved a confirmed
— Overall,
— New Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of novel extracellular PYX-201 ADC and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) to begin dosing 1Q25 in patients with HNSCC, HR+/HER2- breast, TNBC, and sarcoma
— PYX-201 generally well-tolerated with a favorable safety profile
— Multiple data updates expected in 2025
— Company to host in-person and virtual investor event today at 4:30 p.m. ET
BOSTON, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, today announced positive preliminary data from the ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors. PYX-201, the Company’s lead clinical drug candidate, is a first-in-concept antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM).
"These positive data represent a significant milestone for Pyxis Oncology as our novel ECM-targeting ADC, PYX-201, has demonstrated clinical responses by RECIST 1.1 in six tumor types of interest: HNSCC, ovarian, NSCLC, HR+/HER2- breast, TNBC, and Sarcoma. The breadth and depth of our clinical responses clearly indicate the potential of PYX-201 to provide meaningful clinical benefits to patients with difficult-to-treat cancers," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "In addition to the monotherapy expansion studies we are launching in 1Q25 in HNSCC, I am thrilled to announce our new Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of PYX-201 and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with HNSCC, HR+/HER2- breast, TNBC and Sarcoma with first patients expected to dose in 1Q25."
In this ongoing open-label, multicenter, dose-escalation Phase 1 trial of PYX-201, 80 patients have been enrolled and dosed across multiple solid tumor types to receive doses of PYX-201 ranging from 0.3 mg/kg up to 8.0 mg/kg. The trial's main objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201. The current identified dose range for PYX-201 is 3.6 mg/kg to 5.4 mg/kg. The number of prior lines of cancer therapies for patients enrolled is a median of 4 lines and up to 10 lines in some patients. The data cutoff date for this data announcement was October 4, 2024.
Preliminary Phase 1 Clinical Response Data in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC):
Significant clinical responses were observed in HNSCC. Among evaluable HNSCC patients treated at an identified dose range of PYX-201 from 3.6 – 5.4 mg/kg (n=6), a confirmed
"These encouraging preliminary clinical data demonstrate the potential for PYX-201 to yield meaningful responses in heavily pretreated patients with head and neck cancer along with several additional solid tumor types," said Glenn J. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation (Early Drug Development Program) and Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. "The patients in the study have endured multiple rounds of therapy before treatment with PYX-201. We believe the quantity and quality of the responses, including a complete response and PYX-201's tolerability profile, highlight its promising potential across multiple indications with high unmet medical need, particularly in head and neck cancer."
Clinical Trial Collaboration Agreement with Merck’s KEYTRUDA® (pembrolizumab)
The Company additionally announces that it has entered into a Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada), for a Pyxis Oncology-sponsored study of PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with 1L and 2L head and neck squamous cell carcinoma (HNSCC), HR+/HER2- breast cancer, and triple-negative breast cancer (TNBC) and sarcoma.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Pyxis Oncology and Merck each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.
PYX-201 Development Plans in Head and Neck Squamous Cell Carcinoma (HNSCC)
The Company expects to initiate the following HNSCC Phase 1 expansion studies:
- PYX-201 and KEYTRUDA® combination dose escalation and expansion study in 1L and 2L HNSCC with preliminary clinical data readout expected in the second half of 2025;
- PYX-201 monotherapy study in 2L and 3L HNSCC patients who are platinum and PD-1 inhibitor experienced, with preliminary clinical data readout expected in the second half of 2025; and
- PYX-201 monotherapy study in 2L and 3L HNSCC patients who are EGFR and PD-1 inhibitor experienced, with preliminary clinical data readout expected in first half of 2026.
Preliminary Phase 1 Clinical Response Data in Additional Solid Tumor Types:
Encouraging confirmed and unconfirmed responses were observed in five additional solid tumor types: ovarian cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC), and sarcoma.
PYX-201 Development Plan in Additional Tumor Types
Exploratory PYX-201 Phase 1 monotherapy expansion cohorts are planned in ovarian cancer, NSCLC, HR+/HER2- breast cancer, TNBC, and sarcoma, with preliminary clinical data expected in the second half of 2025.
The Company also expects to initiate the following clinical combination studies:
- PYX-201 and KEYTRUDA® combination study in HR+/HER2- breast cancer, TNBC, and sarcoma with preliminary clinical data expected in the second half of 2025 and the first half of 2026.
- Preclinical studies of PYX-201 in combination with other agents in ovarian cancer and NSCLC to commence in 2025 to be followed by clinical studies with preliminary clinical data expected in 2026.
Summary of Preliminary Phase 1 Safety and Pharmacokinetics (PK) Data:
PYX-201 demonstrated favorable preliminary tolerability profile data with low incidence of dose discontinuation, interruptions or delays due to treatment-related adverse events (TRAE). Low incidence of Grade 3 or Grade 4 payload-related TRAEs within the identified dose range reinforce PYX-201’s differentiated construct enabling enhanced molecular stability and differential expression of Extradomain-B (EDB) in tumor tissue with negligible expression in normal tissues. The low incidence of Grade 1 or Grade 2 adverse events points to an attractive safety, given that it has been well tolerated and suitable for both monotherapy and combination therapy development.
With respect to PK data, PYX-201 demonstrated increased stability in circulation, which we believe is due to its proprietary design of site-specific conjugation chemistry as compared to certain approved val-cit-monomethyl auristatin E (MMAE) ADCs with non-site-specific conjugation chemistry.
"PYX-201 is an innovative investigational therapy designed with a unique extracellular mechanism of action, unlike any other ADC currently on the market or in development. These initial clinical data, demonstrating tumor shrinkage across a broad range of solid tumors with a differentiated safety profile indicate a significant opportunity to further develop PYX-201 across a variety of tumor types in both the mono and combo therapy settings," said Anthony Tolcher, M.D., FRCPC, FACP, Founder and Chief Executive Officer of NEXT Oncology and PYX-201 Study Investigator. "Additionally, the encouraging safety data support the potential for PYX-201 to be safely combined with other agents, including checkpoint inhibitors, to drive further patient responses."
Additional details and analyses beyond what have been included in this press release will be presented during the Company's preliminary PYX-201 Phase 1 data investor event today.
In-person and Virtual Investor Event Information
Pyxis Oncology will host a virtual and in-person investor event to discuss the preliminary Phase 1 data today, Wednesday, November 20, 2024, at 4:30 p.m. ET at Venue 42 by Convene, located at 5 Times Square in New York City. Anyone interested in attending the live event should RSVP to pyxis.oncology.data.event.
Pyxis Oncology’s members of executive management team will be joined by the following physician thought leaders to discuss preliminary data from the Phase 1 trial:
- Anthony Tolcher, M.D., FRCPC, FACP, Founder and Chief Executive Officer, NEXT Oncology
- Glenn J. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation (Early Drug Development Program) and Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School
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 mono and combination therapies. PYX-201, an antibody-drug conjugate (ADC) that uniquely targets EDB+FN, a non-cellular structural component of the tumor extracellular matrix, and PYX-106, a fully human Siglec-15-targeting antibody designed to block suppression of T-cell proliferation and function, are being evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors. Pyxis Oncology’s therapeutic candidates are designed to directly kill tumor cells and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. Pyxis Oncology’s ADC and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care. To learn more, visit www.pyxisoncology.com or follow us on X (formerly known as Twitter) and LinkedIn.
Forward Looking Statements
This press release contain 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. All statements other than statements of historical facts contained in this presentation and press release, including without limitation statements regarding the Company's plans to develop, manufacture and commercialize its product candidates, including PYX-201; initial results, timing and progress of the Company's ongoing clinical trials; the expected results of the Company's clinical trials; the ability of initial and topline clinical data to de-risk PYX-201 and be confirmed with clinical trial progression, including the safety, tolerability, and potential efficacy of PYX-201; the potential differentiation, advantage or effectiveness of PYX-201 compared to other approved products or products in development; the dosage and treatment potential of PYX-201; the size and future of the market; the plans and objectives of management, and the future results of operations and financial position of the Company, are forward-looking statements. These statements are neither promises nor guarantees, but are statements that involve known and unknown risks, uncertainties and other important factors that are in some cases beyond the Company's control that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in drug research and development, the Company's projected cash runway and potential needs for additional funding; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; the Company's reliance on third parties and collaborators to conduct clinical trials, manufacture their product candidates, and develop and commercialize their product candidates; and the Company's ability compete successfully against other drug candidates. Accordingly, investors should not rely upon forward-looking statements as predictions of future events. Except as required by applicable law, the Company undertakes no obligation to update publicly or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Pyxis Oncology Contact
Pamela Connealy
CFO and COO
ir@pyxisoncology.com
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