Cyclacel Pharmaceuticals Announces Completion of Enrollment in the Biomarker-Enriched Patient Cohort of Its Phase 2 Study
Cyclacel Pharmaceuticals (NASDAQ: CYCC, NASDAQ: CYCCP) has completed enrollment of 12 patients in Cohort 8 of its Phase 2 study (065-101) of fadraciclib, a CDK2/9 inhibitor, for advanced solid tumors and lymphoma. This cohort focuses on patients with CDKN2A and/or CDKN2B abnormalities. Enrollment took approximately six months, highlighting the unmet medical need for this patient group.
The company reported stable disease and tumor shrinkage in a Phase 2 squamous cell cancer patient after two cycles of oral fadraciclib. Previously, a Phase 1 patient with squamous non-small cell lung cancer and CDKN2A/B abnormalities achieved a 22% reduction in tumor burden at 4 weeks.
Updated safety and efficacy data from the study will be presented at the upcoming 36th EORTC-NCI-AACR Symposium (ENA 2024, October 23-25, 2024). The Phase 2 study includes 8 cohorts, with Cohort 8 specifically targeting CDKN2A/B abnormalities, which occur frequently in various solid tumors.
Cyclacel Pharmaceuticals (NASDAQ: CYCC, NASDAQ: CYCCP) ha completato l'arruolamento di 12 pazienti nel Coorte 8 del suo studio di Fase 2 (065-101) su fadraciclib, un inibitore di CDK2/9, per tumori solidi avanzati e linfoma. Questa coorte si concentra sui pazienti con anomalie CDKN2A e/o CDKN2B. L'arruolamento ha richieso circa sei mesi, evidenziando l'esigenza medica non soddisfatta per questo gruppo di pazienti.
La societ脿 ha riportato malattia stabile e riduzione dei tumori in un paziente con cancro a cellule squamose in Fase 2 dopo due cicli di fadraciclib orale. In precedenza, un paziente di Fase 1 con cancro polmonare non a piccole cellule squamoso e anomalie CDKN2A/B ha ottenuto una riduzione del 22% del carico tumorale a 4 settimane.
I dati aggiornati su sicurezza ed efficacia dello studio saranno presentati al prossimo 36掳 Simposio EORTC-NCI-AACR (ENA 2024, 23-25 ottobre 2024). Lo studio di Fase 2 comprende 8 coorti, con la Coorte 8 che mira specificamente alle anomalie CDKN2A/B, le quali si verificano frequentemente in vari tumori solidi.
Cyclacel Pharmaceuticals (NASDAQ: CYCC, NASDAQ: CYCCP) ha completado la inscripci贸n de 12 pacientes en el Cohorte 8 de su estudio de Fase 2 (065-101) sobre fadraciclib, un inhibidor de CDK2/9, para tumores s贸lidos avanzados y linfoma. Este cohorte se centra en pacientes con anomal铆as CDKN2A y/o CDKN2B. La inscripci贸n tom贸 aproximadamente seis meses, resaltando la necesidad m茅dica no cubierta para este grupo de pacientes.
La compa帽铆a inform贸 de una enfermedad estable y reducci贸n tumoral en un paciente con c谩ncer de c茅lulas escamosas en Fase 2 despu茅s de dos ciclos de fadraciclib oral. Previamente, un paciente de Fase 1 con c谩ncer de pulm贸n no microc铆tico escamoso y anomal铆as CDKN2A/B logr贸 una reducci贸n del 22% en la carga tumoral a las 4 semanas.
Los datos actualizados de seguridad y eficacia del estudio se presentar谩n en el pr贸ximo 36潞 Simposio EORTC-NCI-AACR (ENA 2024, 23-25 de octubre de 2024). El estudio de Fase 2 incluye 8 cohortes, con el Cohorte 8 que apunta espec铆ficamente a las anomal铆as CDKN2A/B, que ocurren con frecuencia en varios tumores s贸lidos.
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鞐瓣惮鞚� 鞐呺嵃鞚错姼霅� 鞎堨爠靹标臣 須姤 雿办澊韯半姅 雼り皜鞓る姅 鞝�36須� EORTC-NCI-AACR 鞁彫歆�鞐�鞐愳劀 氚滍憸霅� 鞓堨爼鞛呺媹雼� (ENA 2024, 2024雲� 10鞗� 23-25鞚�). 2靸� 鞐瓣惮鞐愲姅 8臧� 旖旐樃韸戈皜 韽暔霅橃柎 鞛堨溂氅�, 旖旐樃韸� 8鞚� 雼れ枒頃� 瓿犿槙 膦呾枒鞐愳劀 鞛愳＜ 氚滌儩頃橂姅 CDKN2A/B 鞚挫儊鞐� 韸鬼瀳 齑堨爯鞚� 毵烄稊瓿� 鞛堨姷雼堧嫟.
Cyclacel Pharmaceuticals (NASDAQ: CYCC, NASDAQ: CYCCP) a termin茅 l'enr么lement de 12 patients dans la Cohorte 8 de son 茅tude de Phase 2 (065-101) sur le fadraciclib, un inhibiteur de CDK2/9, pour des tumeurs solides avanc茅es et des lymphomes. Cette cohorte se concentre sur les patients pr茅sentant des anomalies CDKN2A et/ou CDKN2B. L'enr么lement a pris environ six mois, soulignant le besoin m茅dical non satisfait pour ce groupe de patients.
La soci茅t茅 a rapport茅 une maladie stable et une r茅duction des tumeurs chez un patient atteint de cancer 脿 cellules squameuses apr猫s deux cycles de fadraciclib oral. Auparavant, un patient de Phase 1 atteint d'un cancer du poumon non 脿 petites cellules squameux et d'anomalies CDKN2A/B avait obtenu une r茅duction de 22% de la charge tumorale en 4 semaines.
Les donn茅es mises 脿 jour sur la s茅curit茅 et l'efficacit茅 de l'茅tude seront pr茅sent茅es lors du prochain 36猫me Symposium EORTC-NCI-AACR (ENA 2024, 23-25 octobre 2024). L'茅tude de Phase 2 comprend 8 cohortes, la Cohorte 8 visant sp茅cifiquement les anomalies CDKN2A/B, qui se produisent fr茅quemment dans divers tumours solides.
Cyclacel Pharmaceuticals (NASDAQ: CYCC, NASDAQ: CYCCP) hat die Rekrutierung von 12 Patienten in Kohorte 8 seiner Phase 2-Studie (065-101) zu Fadraciclib, einem CDK2/9-Inhibitor, f眉r fortgeschrittene solide Tumoren und Lymphom abgeschlossen. Diese Kohorte konzentriert sich auf Patienten mit CDKN2A- und/oder CDKN2B-Abnormalit盲ten. Die Rekrutierung dauerte etwa sechs Monate und verdeutlicht den ungedeckten medizinischen Bedarf f眉r diese Patientengruppe.
Das Unternehmen berichtete von stabilem Krebs und Tumorverkleinerung bei einem Patienten mit Plattenepithelkarzinom nach zwei Zyklus oralem Fadraciclib. Zuvor erzielte ein Phase-1-Patient mit nicht-kleinzelligem Lungenkrebs und CDKN2A/B-Abnormalit盲ten eine 22%ige Reduktion der Tumorb眉rde nach 4 Wochen.
Aktualisierte Sicherheits- und Wirksamkeitsdaten aus der Studie werden beim kommenden 36. EORTC-NCI-AACR Symposium (ENA 2024, 23.-25. Oktober 2024) pr盲sentiert. Die Phase-2-Studie umfasst 8 Kohorten, wobei die Kohorte 8 spezifisch auf CDKN2A/B-Abnormalit盲ten abzielt, die h盲ufig bei verschiedenen soliden Tumoren vorkommen.
- Completed enrollment of 12 patients in Cohort 8 of Phase 2 study for fadraciclib
- Observed stable disease and tumor shrinkage in a Phase 2 squamous cell cancer patient
- Previously reported 22% tumor burden reduction in a Phase 1 NSCLC patient
- Rapid enrollment (6 months) indicates high unmet medical need
- Study data accepted for presentation at upcoming ENA 2024 symposium
- None.
Insights
The completion of enrollment in Cohort 8 of Cyclacel's Phase 2 study for fadraciclib is a significant milestone. This cohort specifically targets patients with CDKN2A and/or CDKN2B abnormalities, which are prevalent in various solid tumors. The rapid enrollment pace (about six months) indicates high unmet medical need in this patient population.
Early efficacy signals are promising:
- Stable disease and tumor shrinkage observed in a Phase 2 squamous cell cancer patient after two cycles
- Previously reported 22% tumor reduction in a NSCLC patient with CDKN2A/B abnormalities
The study's design, using a Simon 2-stage approach and biomarker selection, increases the likelihood of demonstrating efficacy. Fadraciclib's dual inhibition of CDK2/9 and oral administration are potential advantages. However, more mature data from Cohort 8 is needed to fully assess its potential impact on treatment paradigms for CDKN2A/B-abnormal cancers.
While this news doesn't include financial figures, it represents a positive development for Cyclacel Pharmaceuticals (NASDAQ: CYCC). Key points for investors:
- Milestone achievement in a Phase 2 study, potentially accelerating the development timeline
- Targeting a specific genetic abnormality (CDKN2A/B) present in multiple cancer types, expanding the potential market
- Early efficacy signals in difficult-to-treat cancers like squamous cell and NSCLC
- Oral administration, which could be a competitive advantage in the market
For a small-cap biotech (
- Patients are preselected for CDKN2A and/or CDKN2B abnormalities -
- Safety and efficacy data to be reported at an upcoming oncology medical conference -
BERKELEY HEIGHTS, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative cancer medicines, today announced that enrollment of 12 patients has been completed as per protocol in Cohort 8 of its Phase 2 stage, proof of concept 065-101 study of fadraciclib (鈥渇adra鈥�), a CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma. Enrollment of Cohort 5 in patients with T-Cell Lymphoma is continuing.
鈥淲e are pleased to report that the Cyclacel team has achieved another important milestone by completing enrollment of the patient cohort with CDKN2A/B abnormalities,鈥� said Spiro Rombotis, President and Chief Executive Officer. 鈥淭he rapid pace of enrollment of approximately six months, since opening the cohort in mid-May, underscores the great unmet medical need of cancer patients with CDKN2A/B abnormalities. Updated safety and efficacy data from the 065-101 study of fadra has been accepted for presentation during the upcoming 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024, October 23-25, 2024).鈥�
鈥淲e are grateful to the patients and their families, international investigator group and our collaborators participating in the 065-101 study for their support in achieving target enrollment of Cohort 8,鈥� said Brian Schwartz, M.D., interim Chief Medical Officer. 鈥淲e are excited to observe stable disease and tumor shrinkage in a Phase 2 squamous cell cancer patient with unknown primary and CDKN2A abnormalities after two cycles of fadra oral tablets. As previously reported at ASCO 2024, in the Phase 1 study of oral fadra a patient with squamous non-small cell lung cancer (NSCLC) and CDKN2A/B abnormalities achieved
065-101 Study of Oral Fadraciclib
The Phase 2 part of the 065-101 study of oral fadra, a CDK2/9 inhibitor, is designed to evaluate fadra safety and efficacy in up to 8 cohorts defined by histology and/or biomarkers of interest. The 7 histology-based cohorts include: Cohort 1: endometrial and ovarian; 2: cholangiocarcinoma or biliary tract; 3: hepatocellular; 4: breast, including HR positive, HER2 negative, triple negative, and HER-2 positive; 5: T-Cell lymphoma; 6: B-Cell lymphoma; and 7: colorectal cancers. Cohort 8 is biomarker selected, specifically including patients with CDKN2A and/or CDKN2B abnormalities. The Phase 2 part of the study employs a Simon 2-stage design and is powered to demonstrate response in the molecular subtype suggested by the Phase 1 data and others that may be sensitive.
The Phase 1 dose escalation part of the study enrolled a total of 48 unselected, all comer patients with advanced solid tumors and lymphoma who were treated with oral fadra as monotherapy. Recommended Phase 2 dose (RP2D) was determined as 100mg twice daily for 5 days per week, 4 out of 4 weeks.
To date single agent activity with oral or intravenous fadra, including CR, PR and SD, has been observed in patients with advanced endometrial, squamous NSCLC lung cancer and T-cell lymphoma. Encouraging signals of activity were observed in patients with advanced cervical, hepatocellular, ovarian and pancreatic cancers.
The Company believes that fadra鈥檚 inhibition of CDK2 and CDK9 may be superior to inhibiting either CDK2 or CDK9 alone. Fadra tablets can be given orally with repeat dosing which has led to transient suppression of anti-apoptosis proteins with generally good tolerability and no Grade 3 or higher hematological toxicity in the first cycle.
CDKN2A, CDKN2B Abnormalities
The most frequent CDKN2A or CDKN2B abnormalities are deletions or loss of function. CDKN2A gene deletions occur in over
About Cyclacel Pharmaceuticals, Inc.
Cyclacel听is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies.听Cyclacel's听strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit听.听
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements related to Cyclacel鈥檚 future plans and prospects, Cyclacel鈥檚 anticipated cash runway and the planned timing of data results and continued development of fadraciclib. Factors that may cause actual results to differ materially include market and other conditions, the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling,听Cyclacel听may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates and Cyclacel鈥檚 ability to regain and maintain compliance with Nasdaq鈥檚 continued listing requirements. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the听Securities and Exchange Commission听and are available at听. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact
| Company: | Paul McBarron, (908) 517-7330,听IR@cyclacel.com |
| 听 | 听 |
漏 Copyright 2024 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel庐 are trademarks of Cyclacel Pharmaceuticals, Inc.
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FAQ
What is the purpose of Cyclacel's Phase 2 study of fadraciclib (CYCC)?
How many patients were enrolled in Cohort 8 of Cyclacel's fadraciclib study (CYCC)?
When will Cyclacel (CYCC) present updated data from the fadraciclib study?
What preliminary results has Cyclacel (CYCC) observed in the fadraciclib study?
