|Over a month ago|
Cyclacel Pharmaceuticals assumed with an Outperform at Oppenheimer » 09:0107/1807/18/22
Oppenheimer analyst jeff…
Oppenheimer analyst jeff Jones assumed coverage of Cyclacel Pharmaceuticals with an Outperform rating and $17 price target due to a reallocation of the firm's analyst resources.
|Over a quarter ago|
Cyclacel Pharmaceuticals achieves key business objectives in 1H22 » 09:1706/3006/30/22
Cyclacel Pharmaceuticals announced that it has achieved key business objectives in the first half of 2022 and provided a review of progress with its two clinical stage drug candidates. Fadraciclib: Fifteen patients with advanced solid tumors and lymphomas treated with oral fadraciclib at all five dose levels as per protocol in the 065-101 dose escalation study. Demonstrated evidence of target engagement for CDK2 and CDK9 in cell assay system and patient PK data suggested that these targets are potentially inhibited at 100mg twice daily levels. A cutaneous T cell lymphoma patient achieved partial response in the first oral treatment cycle. A peripheral T cell lymphoma patient achieved 38% reduction in target lesions by PET scan in the first oral treatment cycle. An endometrial cancer patient achieved stable disease with 15% reduction of target lesions after the first oral treatment cycle. In an earlier study of intravenous fadraciclib as monotherapy, a patient with MCL1 amplified endometrial cancer achieved confirmed complete response and remains on study after two and a half years of treatment. A pancreatic cancer patient achieved stable disease by confirmatory scan for five oral treatment cycles. As no dose limiting toxicities have been observed, the Company has submitted a protocol amendment to the U.S. Food and Drug Administration to escalate to two additional dose levels before determining recommended Phase 2 dose. Based on good tolerability in 065-101, a protocol amendment in the 065-102 study of oral fadraciclib in patients with leukemia or myelodysplastic syndromes has enabled acceleration of the study by omitting dose levels two and three and now enrolling at dose level 4. CYC140: No dose limiting toxicities observed to date in 140-101, a Phase 1/2 study of oral CYC140 in solid tumors. An ovarian cancer patient in 140-101 achieved stable disease with tumor shrinkage after the first cycle. Corporate Updates: The Company is planning an R&D Day in the fall of 2022 to present updated data from the 065-101 and 140-101 clinical trials. The Company has also submitted an abstract to potentially present fadraciclib data from 065-101 at a cancer conference in the fall of 2022.
Cyclacel Pharmaceuticals announces Ferguson elected to board of directors » 07:1306/2206/22/22
Cyclacel Pharmaceuticals announced the election of Kenneth Ferguson, Ph.D., to its Board of Directors. Dr. Ferguson was elected by and will represent the 6% Convertible Exchangeable Preferred stockholders. Dr. Ferguson's professional experience includes over 30 years of scientific and drug development experience in the biopharmaceutical industry. Currently, he serves as an Operating Partner at Accelerator Life Science Partners.
Cyclacel Pharmaceuticals expects cash to fund operations through 2023 » 16:1505/1105/11/22
As of March 31, 2022,…
As of March 31, 2022, cash and cash equivalents totaled $29.6 million, compared to $36.6 million as of December 31, 2021. Subsequent to the end of the first quarter, the Company received $3.6 million of United Kingdom research & development tax credits and $1.3 million in royalty receipts providing pro forma March 31, 2022, cash and cash equivalents of $34.5 million. The Company estimates that its available cash will fund currently planned programs through June 2023.
Cyclacel Pharmaceuticals reports Q1 EPS (42c), consensus (68c) » 16:1505/1105/11/22
"We are pleased to…
"We are pleased to report another productive quarter for Cyclacel, which included continued expansion of our three, registration-directed, clinical trials and publication of research findings supporting our drug development strategy," said Spiro Rombotis, Chief Executive Officer of Cyclacel. "Oral fadraciclib, our CDK2/9 drug candidate, is proving to be well tolerated in 065-101, our Phase 1/2 solid tumor and lymphoma study, having reached dose level 5 in the dose escalation stage which provides for daily dosing over 4 out of 4 weeks. In our PLK1 program, we have dosed the first patients in the streamlined Phase 1/2 trial of CYC140 for the treatment of solid tumors and lymphomas. We have optimized the properties of CYC140 to fit its apoptosis-driven mechanism, including short half-life and differentiated structural and biological properties, compared to other PLK1 inhibitors in development. We therefore believe CYC140 has the potential to demonstrate activity across a wide range of solid tumors, as a single agent and in combinations."
Cyclacel doses first patient in Phase 1/2 study of oral CYC140 » 09:1804/1904/19/22
Cyclacel Pharmaceuticals announced dosing of the first patient in the Company's streamlined, multi-cohort Phase 1/2 study of oral CYC140 in patients with advanced solid tumors and lymphomas. "With the start of this trial, Cyclacel is now enrolling patients across three registration-directed studies to evaluate safety and efficacy of our two lead drug candidates, fadraciclib and CYC140, for the treatment of various solid tumors, lymphomas and leukemias," said Spiro Rombotis, Cyclacel's President and Chief Executive Officer. "As with the fadraciclib studies, the Phase 1 stage of this trial will determine an optimal dosing regimen of oral CYC140 and provide insights with respect to safety, tolerability and clinical activity. The Phase 2 stage will enroll up to seven cohorts by histology and also a basket cohort. We expect initial data from this trial during the first half of 2023. We also look forward to reporting initial data from the fadraciclib clinical study in advanced solid tumors during the first half of 2022." The Phase 1/2 registration-directed trial, designated CYC140-101, uses a streamlined design and will first determine in a dose escalation stage the recommended Phase 2 dose for single-agent CYC140.
Fly Intel: Pre-market Movers » 08:5604/1204/12/22
AGLE, BDSX, CYCC, BCDA, OGI, ACI, KMX, MIMO, MYOV, HPE, CSCO, PFE
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Cyclacel Pharmaceuticals announces publication on fadraciclib » 07:0204/1204/12/22
Cyclacel Pharmaceuticals announced a publication in the journal Leukemia titled "Cyclin-dependent kinase inhibitor fadraciclib depletes anti-apoptotic protein and synergizes with venetoclax in primary chronic lymphocytic leukemia cells". Fadraciclib is Cyclacel's novel CDK2/9 inhibitor, currently in two Phase 1/2 trials, one for the treatment of advanced solid tumors and lymphomas and another for hematological malignancies, including patients with leukemia being treated in combination with venetoclax. "Results from this research provide further mechanistic evidence in support of our ongoing Phase 1/2 clinical study of oral fadraciclib in select hematological malignancies," said Mark Kirschbaum, M.D., Senior Vice President and Chief Medical Officer of Cyclacel. "The findings confirmed that fadraciclib suppresses MCL1 and synergizes with venetoclax, the only FDA-approved apoptosis enabling leukemia treatment. We have included a cohort within the proof-of-concept part of our Phase 1/2 study that will evaluate the combination of fadraciclib plus venetoclax in patients who have previously failed venetoclax-based regimens." Results from the study confirmed that fadraciclib inhibited CDK9 mediated transcription, reduced levels of the short-lived anti-apoptotic protein MCL1, and induced apoptosis in primary CLL cells. The data highlighted the importance of continuous treatment to prevent recovery of MCL1 protein levels. Fadraciclib was shown to combine synergistically with venetoclax. Furthermore, it was demonstrated that the best synergy, with fadraciclib and venetoclax given at the same time, was achieved in 17p deleted CLL cells, which were not sensitive to either agent alone. Fadraciclib also overcame protection mediated by stroma CLL cells and lymph node microenvironment. The data support the rationale for pursuing clinical development of fadraciclib, either alone or in combination with a BCL2 antagonist, for the treatment of CLL.
Fly Intel: After-Hours Movers » 17:3503/2803/28/22
CYCC, XOS, ZEV, PLAY, LIDR, NEO, PINS
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Cyclacel Pharmaceuticals reports Q4 EPS (54c), consensus (65c) » 16:1203/2803/28/22
As of December 31, 2021,…
As of December 31, 2021, cash and cash equivalents totaled $36.6M, compared to $33.4M as of December 31, 2020. "2021 was a year of solid execution, as the clinical and corporate objectives achieved by the Cyclacel team have positioned us to reach important milestones in 2022. These include initial data from the dose escalation stage of the ongoing Phase 1/2 study of fadraciclib, our CDK2/9 inhibitor, in advanced solid tumors," said Spiro Rombotis, president and CEO. "Enrollment has gone well with three new patients treated at dose level 4 at our two U.S. sites and two internationally recognized, cancer centers in Asia and Western Europe who recently joined the study. In 2022 we plan to report new clinical and preclinical evidence supporting the unique properties and therapeutic potential of fadraciclib. We believe that fadraciclib is emerging as the only transcriptional CDK inhibitor in development to have demonstrated single-agent activity and tolerable daily dosing by mouth in patients with solid tumors. If confirmed with additional data, fadraciclib may emerge as an important alternative for the treatment of advanced solid tumors in patients failing available therapies."