CytomX Therapeutics Announces First Patient Dosed with CX-801, a Dually-Masked Interferon-Alpha 2b PROBODY®, in a Phase 1 Study in Patients with Solid Tumors
CytomX Therapeutics (Nasdaq: CTMX) has announced the dosing of the first patient with CX-801 in a Phase 1 study for solid tumors. CX-801 is a dually-masked interferon alpha-2b PROBODY® cytokine designed to target both immune-oncology sensitive and insensitive tumors. The study (NCT06462794) will evaluate CX-801 as monotherapy and in combination with Merck's KEYTRUDA® (pembrolizumab).
The trial will focus on patients with advanced melanoma, renal cell carcinoma, and head and neck squamous cell carcinoma. CytomX aims to leverage its conditional activation platform to enhance interferon's therapeutic index, potentially making it a key component in immuno-oncology combination therapies.
CytomX Therapeutics (Nasdaq: CTMX) ha annunciato la somministrazione del primo paziente con CX-801 in uno studio di Fase 1 per tumori solidi. CX-801 è un citochino PROBODY® interferone alfa-2b a doppia maschera progettato per colpire sia i tumori sensibili sia quelli insensibili all'immuno-oncologia. Lo studio (NCT06462794) valuterà CX-801 come monoterapia e in combinazione con KEYTRUDA® di Merck (pembrolizumab).
Il trial si concentrerà su pazienti affetti da melanoma avanzato, carcinoma a cellule renali e carcinoma squamoso della testa e del collo. CytomX mira a sfruttare la sua piattaforma di attivazione condizionale per migliorare l'indice terapeutico dell'interferone, potenzialmente rendendolo un componente chiave nelle terapie combinatorie in immuno-oncologia.
CytomX Therapeutics (Nasdaq: CTMX) ha anunciado la dosificación del primer paciente con CX-801 en un estudio de Fase 1 para tumores sólidos. CX-801 es un citoquina PROBODY® interferón alfa-2b con doble enmascarado diseñado para dirigirse tanto a tumores sensibles como insensibles a la inmuno-oncología. El estudio (NCT06462794) evaluará CX-801 como monoterapia y en combinación con KEYTRUDA® de Merck (pembrolizumab).
El ensayo se centrará en pacientes con melanoma avanzado, carcinoma de células renales y carcinoma escamoso de cabeza y cuello. CytomX busca aprovechar su plataforma de activación condicional para mejorar el índice terapéutico del interferón, lo que podría convertirlo en un componente clave en las terapias combinadas de inmuno-oncología.
CytomX Therapeutics (Nasdaq: CTMX)는 CX-801 첫 번째 환자의 투여를 고형 종양을 위한 1상 연구에서 발표했습니다. CX-801은 이중 마스킹 간섭 단백질 알파-2b PROBODY® 사이토카인으로, 면역종양학에 민감한 종양과 비민감한 종양 모두를 겨냥합니다. 이 연구(NCT06462794)는 CX-801을 단독 요법 및 Merck의 KEYTRUDA® (펨브롤리주맙)와 병용하여 평가할 것입니다.
시험은 진행성 흑색종, 신세포암 및 두경부 편평세포암 환자를 대상으로 할 예정입니다. CytomX는 간섭 단백질의 치료지수를 향상시키기 위해 조건부 활성화 플랫폼을 활용하여 면역종양학 병용 요법의 핵심 구성 요소가 될 수 있도록 할 계획입니다.
CytomX Therapeutics (Nasdaq: CTMX) a annoncé la dosage du premier patient avec CX-801 dans une étude de Phase 1 pour les tumeurs solides. CX-801 est un cytokine PROBODY® interféron alpha-2b à double masque conçu pour cibler à la fois les tumeurs sensibles et insensibles à l'immuno-oncologie. L'étude (NCT06462794) évaluera CX-801 comme monothérapie et en combinaison avec le KEYTRUDA® de Merck (pembrolizumab).
Le procès se concentrera sur les patients présentant un mélanome avancé, un carcinome à cellules rénales et un carcinome épidermoïde de la tête et du cou. CytomX vise à tirer parti de sa plateforme d'activation conditionnelle pour améliorer l'indice thérapeutique de l'interféron, ce qui pourrait en faire un élément clé des thérapies combinées en immuno-oncologie.
CytomX Therapeutics (Nasdaq: CTMX) hat die Dosisverabreichung des ersten Patienten mit CX-801 in einer Phase-1-Studie für solide Tumore bekannt gegeben. CX-801 ist ein dual-maskierter Interferon-alpha-2b PROBODY® Zytokin, das sowohl immunonkologisch empfindliche als auch resistente Tumore anvisiert. Die Studie (NCT06462794) wird CX-801 als Monotherapie und in Kombination mit Mercks KEYTRUDA® (Pembrolizumab) bewerten.
Die Studie konzentriert sich auf Patienten mit fortgeschrittenem Melanom, Nierenzellkarzinom und Plattenepithelkarzinom des Kopf-Hals-Bereichs. CytomX möchte seine Plattform für konditionierte Aktivierung nutzen, um den therapeutischen Index des Interferons zu verbessern, was es zu einem Schlüsselbestandteil in immunonkologischen Kombinationstherapien machen könnte.
- Initiation of Phase 1 clinical trial for CX-801, expanding CytomX's pipeline
- Potential for broad applicability in both immune-oncology sensitive and insensitive tumors
- Collaboration with Merck for combination therapy with KEYTRUDA®
- CX-801 designed to maintain potency while reducing toxicities associated with systemic interferon-alpha-2b administration
- Early-stage clinical trial with no guarantee of success
- Potential competition in the immuno-oncology space
- Possible safety concerns or side effects yet to be determined in human trials
The initiation of the Phase 1 study for CX-801 marks a significant milestone in the development of masked cytokine therapies. This dually-masked interferon alpha-2b PROBODY® represents a novel approach to harnessing the potent anti-tumor effects of interferon while potentially mitigating its systemic toxicities.
The study design, encompassing both monotherapy and combination with pembrolizumab, is strategically sound. It allows for evaluation of CX-801's standalone efficacy and its potential synergy with checkpoint inhibition. The focus on melanoma, renal cell carcinoma and head and neck cancers is well-justified, given historical interferon efficacy in these indications.
If successful, CX-801 could address a critical unmet need in oncology by expanding the therapeutic window of interferon therapy. This could potentially lead to improved outcomes in both "hot" and "cold" tumor types, representing a significant advancement in immuno-oncology.
The initiation of the CX-801 Phase 1 trial is a positive development for CytomX Therapeutics, potentially de-risking their pipeline and validating their PROBODY® platform. This milestone could attract investor interest and potentially lead to increased valuation.
Importantly, the collaboration with Merck for the combination arm with KEYTRUDA® adds significant credibility to the program. Such partnerships often include milestone payments and royalties, which could provide near-term cash infusions and long-term revenue streams if the drug succeeds.
However, investors should remain cautious. Early-stage oncology trials carry high risk and positive results are far from guaranteed. The company's financial position and burn rate should be closely monitored as the trial progresses. Overall, this news represents a step forward but doesn't fundamentally alter CytomX's risk profile in the short term.
SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, today announced that the first patient has been dosed with CX-801 monotherapy in a Phase 1 study (NCT06462794) in patients with solid tumors. CX-801 is a dually-masked interferon alpha-2b PROBODY® cytokine with potential broad applicability in both traditionally immune-oncology sensitive as well as insensitive (cold) tumors.
The CX-801 Phase 1 dose escalation study is designed to evaluate safety and signs of clinical activity for CX-801 as monotherapy and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab). In dose escalation, the Phase 1 study will enroll patients with select solid tumors including advanced melanoma, renal cell carcinoma, and head and neck squamous cell carcinoma to inform a potential decision to move into Phase 1b indication-specific dose expansion cohorts.
“Interferon-alpha-2b is a powerful immune-modulating cytokine that has demonstrated clinical activity in multiple cancer types such as metastatic melanoma, renal cancer and bladder cancer but its clinical benefit has been limited by significant toxicities when administered systemically. CX-801 utilizes CytomX’s industry leading conditional activation platform to maintain potency and expand interferon’s therapeutic index to potentially become a foundational component of immuno-oncology combination regimens,” said Wayne Chu, M.D., chief medical officer of CytomX Therapeutics.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
About CytomX Therapeutics.
CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY® therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-904, CX-2051 and CX-801. CX-904 is a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells. CX-904 is partnered with Amgen in a global co-development alliance. CX-2051 is a conditionally activated ADC directed toward epithelial cell adhesion molecule, EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CX-2051 was discovered in collaboration with Immunogen, now part of AbbVie. CX-801 is an interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter).
CytomX Therapeutics Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-801, CX-904, and CX-2051, the potential benefits or applications of CytomX’s PROBODY® therapeutic platform, CytomX’s or its collaborative partners’ ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-801, and the timing of initial and ongoing data availability for CX-801, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel PROBODY® therapeutic technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial CX-904 results, may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-904 CX-2051 and CX-801; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in the United States and foreign countries; and the risk that we may incur higher costs than expected for research and development or unexpected costs and expenses. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on August 8, 2024. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc.
Company Contact:
Chris Ogden
Chief Financial Officer
cogden@cytomx.com
Investor Contact:
Precision AQ (formerly Stern Investor Relations)
Stephanie Ascher
stephanie.ascher@precisionaq.com
Media Contact:
Redhouse Communications
Teri Dahlman
teri@redhousecomms.com
FAQ
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