Pyxis Oncology Initiates New PYX-201 Combination Trial and Initiates Cohort Expansions of Ongoing Monotherapy Trial
Pyxis Oncology (NASDAQ: PYXS) has announced significant progress in its clinical program for PYX-201, a first-in-concept antibody-drug conjugate targeting Extradomain-B Fibronectin. The company has initiated two major developments:
1. A Phase 1/2 combination trial of PYX-201 with Merck's KEYTRUDA® in multiple solid tumors, set to begin dosing in Q1 2025. The trial will target first-line and second-line+ recurrent/metastatic head and neck squamous cell carcinoma, hormone receptor-positive and HER2-negative breast cancer, and advanced triple-negative breast cancer.
2. The expansion of its ongoing Phase 1 monotherapy trial to include cohorts for second and third-line recurrent/metastatic head and neck squamous cell carcinoma patients who have received prior treatments.
Pyxis Oncology (NASDAQ: PYXS) ha annunciato progressi significativi nel suo programma clinico per PYX-201, un coniugato anticorpo-farmaco innovativo che mira alla Fibronectina Extradomain-B. L'azienda ha avviato due importanti sviluppi:
1. Un trial di combinazione di Fase 1/2 di PYX-201 con KEYTRUDA® di Merck in diversi tumori solidi, che inizierà la somministrazione nel primo trimestre del 2025. Lo studio mirerà a carcinomi a cellule squamose della testa e del collo recidivanti/metastatici di prima linea e seconda linea+, carcinoma mammario positivo ai recettori ormonali e HER2-negativo, e carcinoma mammario triplo-negativo avanzato.
2. L'espansione del suo trial di monoterapia di Fase 1 in corso per includere coorti di pazienti con carcinoma a cellule squamose recidivante/metastatico della testa e del collo di seconda e terza linea che hanno già ricevuto trattamenti precedenti.
Pyxis Oncology (NASDAQ: PYXS) ha anunciado avances significativos en su programa clínico para PYX-201, un conjugado anticuerpo-fármaco pionero que se dirige a la Fibronectina Extradomain-B. La compañía ha iniciado dos desarrollos importantes:
1. Un ensayo de combinación de Fase 1/2 de PYX-201 con KEYTRUDA® de Merck en múltiples tumores sólidos, que comenzará a dosificar en el primer trimestre de 2025. El ensayo se enfocará en el carcinoma de células escamosas recurrente/metastásico de cabeza y cuello de primera línea y segunda línea+, el cáncer de mama positivo a receptores hormonales y HER2-negativo, y el cáncer de mama triple negativo avanzado.
2. La expansión de su ensayo de monoterapia de Fase 1 en curso para incluir cohortes de pacientes con carcinoma de células escamosas recurrente/metastásico de cabeza y cuello de segunda y tercera línea que han recibido tratamientos previos.
Pyxis Oncology (NASDAQ: PYXS)는 Extradomain-B 피브로넥틴을 표적으로 하는 개념 최초의 항체-약물 접합체인 PYX-201의 임상 프로그램에서 중요한 진전을 발표했습니다. 회사는 두 가지 주요 개발을 시작했습니다:
1. 2025년 1분기에 투여를 시작할 계획인 Merck의 KEYTRUDA®와 PYX-201의 병용 임상 1/2상 시험입니다. 이 시험은 1차 및 2차 이상 재발성/전이성 두경부 편평세포암, 호르몬 수용체 양성 및 HER2 음성 유방암, 진행된 삼중 음성 유방암을 대상으로 합니다.
2. 기존의 1상 단독 시험을 확대하여 이전 치료를 받은 2차 및 3차 재발성/전이성 두경부 편평세포암 환자를 포함하는 코호트를 추가합니다.
Pyxis Oncology (NASDAQ: PYXS) a annoncé des avancées significatives dans son programme clinique pour PYX-201, un anticorps-conjugé médicament de première conception ciblant la fibronectine Extradomain-B. L'entreprise a lancé deux développements majeurs :
1. Un essai de combinaison de phase 1/2 de PYX-201 avec le KEYTRUDA® de Merck, dont le début des traitements est prévu pour le premier trimestre 2025. L'essai vise le carcinome épidermoïde de la tête et du cou, récurrent et métastatique, de première ligne et de deuxième ligne+, le cancer du sein positif aux récepteurs hormonaux et négatif pour HER2, et le cancer du sein triple négatif avancé.
2. L'extension de son essai de monothérapie de phase 1 en cours pour inclure des cohortes de patients présentant un carcinome épidermoïde de la tête et du cou, récurrent et métastatique, en deuxième et troisième ligne, ayant reçu des traitements antérieurs.
Pyxis Oncology (NASDAQ: PYXS) hat bedeutende Fortschritte in ihrem klinischen Programm für PYX-201, ein neuartiger Antikörper-Arzneimittel-Konjugat, das auf Extradomain-B-Fibronectin abzielt, angekündigt. Das Unternehmen hat zwei wesentliche Entwicklungen eingeleitet:
1. Eine Phase 1/2 Kombinationstudie von PYX-201 mit Mercks KEYTRUDA®, die im ersten Quartal 2025 mit der Dosisvergabe beginnen soll. Die Studie wird sich auf das wiederkehrende/metastatische Plattenepithelkarzinom des Kopfes und Halses in der ersten und zweiten Linie+, auf hormonrezeptorpositiven und HER2-negativen Brustkrebs sowie auf fortgeschrittenen dreifach negativen Brustkrebs konzentrieren.
2. Die Erweiterung ihrer laufenden Phase-1-Monotherapie-Studie zur Einschluss von Kohorten für Patienten mit wiederkehrendem/metastatischem Plattenepithelkarzinom des Kopfes und Halses in der zweiten und dritten Linie, die zuvor behandelt wurden.
- Initiation of new Phase 1/2 combination trial with Merck's KEYTRUDA®, expanding potential therapeutic applications
- Strategic collaboration with major pharmaceutical company Merck
- Expansion of ongoing Phase 1 monotherapy trial to additional patient cohorts
- None.
Insights
The expansion of PYX-201's clinical program represents a strategic acceleration in Pyxis Oncology's development pipeline, particularly noteworthy for a company with a
The targeting of EDB+FN in the tumor microenvironment is particularly innovative. Unlike traditional ADCs that target cellular proteins, PYX-201's focus on the extracellular matrix could potentially offer superior tumor specificity and reduced off-target effects. This mechanism could be especially valuable in treating 'cold' tumors that typically respond poorly to immunotherapy.
The collaboration with Merck is strategically significant for three reasons:
- Validates PYX-201's potential through partnership with a leading immunotherapy player
- Provides access to Keytruda, the gold standard in immunotherapy
- Offers potential cost-sharing benefits for the smaller biotech
The expansion into multiple indications - HNSCC, HR+/HER2- breast cancer and TNBC - targets markets with significant unmet needs. HNSCC alone represents a market expected to exceed
The timeline for initial data from these trials will be crucial. With patient dosing set to begin in Q1 2025, preliminary efficacy signals could emerge by late 2025 or early 2026, potentially serving as significant catalysts for the company's valuation.
The expansion of PYX-201's clinical program marks a pivotal moment for Pyxis Oncology's pipeline strategy. For a small-cap biotech, managing multiple clinical trials requires significant resources, but the potential return on investment could be substantial if successful.
The addressable market opportunity is compelling:
- HNSCC:
4.5B market by 2027 with7.5% CAGR - TNBC:
6.2B market by 2027 - HR+/HER2- breast cancer: Largest breast cancer subset, representing over
70% of cases
The ADC landscape is increasingly competitive, but PYX-201's unique extracellular targeting approach differentiates it from traditional ADCs. This novel mechanism could potentially command premium pricing and gain favorable reimbursement if efficacy is demonstrated.
Key catalysts to monitor include:
- Initial safety data from the combination trial (expected late 2025)
- Preliminary efficacy signals from expansion cohorts
- Potential additional partnership announcements
The collaboration with Merck significantly de-risks the development program and could lead to further partnership opportunities. However, investors should note that the company's current market cap suggests significant execution risk is still priced in.
- Initiation of Phase 1/2 combination trial with PYX-201, an extracellular ADC targeting Extradomain-B Fibronectin (EDB+FN) and Merck’s KEYTRUDA® (pembrolizumab) in multiple solid tumors
- Phase 1 monotherapy trial expanded to include cohorts in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)
- Ongoing commitment to innovative cancer therapies for patients with limited treatment options
BOSTON, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced significant progress in its clinical program for PYX-201, a first-in-concept antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM), which is highly expressed in various tumor types.
Two PYX-201 trials are now actively recruiting and are designed to evaluate PYX-201 as monotherapy in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) and PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors. The combination trial is part of a recently announced Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada).
The Phase 1/2 combination study, PYX-201-102, is now actively recruiting and is on track to initiate dosing patients in Q1 2025 as planned. This Pyxis Oncology sponsored trial is investigating the novel extracellular targeting ADC PYX-201 in combination with pembrolizumab in multiple indications including but not limited to:
- First-line (1L) and second line + (2L+) R/M HNSCC
- Hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2- BC) breast cancer
- Advanced or metastatic triple-negative breast cancer (TNBC)
"PYX-201 is designed to specifically deliver its AUR-0101 payload within the tumor microenvironment (TME) and has been shown to induce immunogenic cell death. When combined with pembrolizumab, PYX-201 may have the potential to enhance the oncologic responses observed with pembrolizumab, by allowing activated T cells to infiltrate TMEs that are often inaccessible and inhospitable," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. Dr. Sullivan continued, “Treatment options for many patients with advanced solid tumors remain limited, and we are eager to explore this promising therapeutic approach.”
In addition, the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 PYX-201-101 study have begun enrolling patients. The expansion phase includes the following cohorts across sites in the US, EU and other countries:
- PYX-201 monotherapy for 2L and third line (3L) R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy
- PYX-201 monotherapy for 2L and 3L R/M HNSCC patients who have received prior EGFR and PD-1 inhibitor therapy
Pyxis Oncology is committed to delivering innovative therapies for cancer patients with limited treatment options. These ongoing trials represent a critical step forward in advancing PYX-201 as a potential breakthrough treatment for a broad range of cancers.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About PYX-201-101 Clinical Study
PYX-201-101 (NCT05720117) is an ongoing Phase 1 dose escalation (Part 1) and dose expansion (Part 2) study evaluating PYX-201 monotherapy in participants with advanced solid tumors predicted to express EDB+FN, an extracellular matrix protein that is highly expressed in tumor stroma across several human cancer types.
About PYX-201-102 Clinical Study
PYX-201-102 (NCT06795412) is a Phase 1/2, open-label, global, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201 in combination with pembrolizumab in participants with advanced solid tumors. Patients with histologically or cytologically confirmed advanced solid tumors, including first-line (1L) R/M head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple-negative breast cancer (TNBC), hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) R/M HNSCC are eligible to enroll.
About PYX-201
PYX-201, an antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM), is the company’s lead clinical drug candidate.
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. PYX-201, an antibody-drug conjugate (ADC) that uniquely targets EDB+FN, a non-cellular structural component of the tumor extracellular matrix, is being evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors. Pyxis Oncology’s therapeutic candidates are designed to directly kill cancer cells and to address factors in the microenvironment that enable the uncontrolled proliferation and immune evasion of malignant tumors. Pyxis Oncology’s ADC and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant or refractory 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 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 Quarterly Report on Form 10-Q filed with SEC on November 12, 2024, 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
FAQ
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