Constellation Pharmaceuticals Provides Update on MANIFEST Clinical Trial of CPI-0610 in Myelofibrosis, Reviews 2018 Accomplishments, and Announces 2019 Data Disclosure Plans for Lead Programs
- Constellation CEO
Jigar Raythathawill present at the J.P. Morgan Healthcare Conferenceon Wednesday, January 9, 2019, at 4PM PST/ 7PM EST
- The presentation will include updated results from the first four patients in the MANIFEST Phase 2 clinical trial, demonstrating potentially disease-modifying effects of CPI-0610 and its potentially differentiated safety profile vs. other
- Presentations of interim clinical data from the MANIFEST Phase 2 clinical trial of CPI-0610 and the Phase 1b portion of the ProSTAR clinical trial of CPI-1205 in prostate cancer are planned for medical meetings in the second quarter of 2019
- Constellation plans to initiate a Phase 1 clinical trial of CPI-0209 in mid-2019
The Company has now opened 16 clinical trial sites in the U.S.,
Additional 2018 Accomplishments
“During 2018, we generated encouraging preliminary clinical data for both CPI-0610 and CPI-1205, which led the Company to expand both clinical programs,” said
- Constellation announced that it enhanced and expanded the MANIFEST Phase 2 trial in October to stratify for transfusion dependence status. The Company also announced the planned initiation of a new arm to determine whether the combination of CPI-0610 and ruxolitinib in ruxolitinib-naïve MF patients could improve on the benefit of ruxolitinib alone in first-line treatment of myelofibrosis.
- Constellation announced that the
FDAgranted Fast Track status for CPI-0610 in myelofibrosis in November, a designation that facilitates the development and expedites the review of drugs to treat serious or life-threatening diseases and to fill unmet medical needs.
- Thirty-six patients have been enrolled in the Phase 1b portion of the ProSTAR clinical trial of CPI-1205 in metastatic castration-resistant prostate cancer (mCRPC) in combination with either abiraterone or enzalutamide. Constellation established the safety, pharmacokinetics, and pharmacodynamics of CPI-1205 in both the enzalutamide and the abiraterone arms. The Company also observed evidence of clinical activity in both arms.
- Constellation announced the initiation of the Phase 2 portion of ProSTAR in December. Based on the clinical activity and safety profile demonstrated by CPI-1205 with either abiraterone or enzalutamide in the Phase 1b portion, Constellation expanded the Phase 2 portion of ProSTAR to study both combinations, i.e., a randomized trial of CPI-1205 + enzalutamide versus enzalutamide alone, as well as a single arm of CPI-1205 + abiraterone. While a low response rate and a short duration of response have been observed in clinical trials of second-line treatment of mCRPC generally, the unmet need in this setting is particularly great with abiraterone alone. Dosing has begun in the enzalutamide arm and will soon begin in the abiraterone arm.
- The Company nominated CPI-0209 as a development candidate in April. Preclinical data demonstrated that CPI-0209 engaged EZH2 more comprehensively and durably and produced more rapid tumor regression with lower and less frequent dosing compared with first-generation EZH2 inhibitors.
- Constellation completed a crossover financing in April and an initial public offering in July, together raising
$160 million. As a result of these successful financings, Constellation expects to be able to fund its operations into the second quarter of 2020.
- Constellation strengthened its management team by appointing a General Counsel and a Chief Scientific Officer. In addition, the Company expanded the board with appointments of two executives with extensive industry experience in prostate cancer and myelofibrosis.
A Look Ahead at 2019
“2018 was all about execution, and we reached each of the business and R&D milestones that we set out to achieve for ourselves and our shareholders,” continued Mr. Raythatha. “We expect 2019 to be an important year focused on data, as we are set up to deliver results from our ongoing studies throughout 2019.”
Constellation aims to achieve the following milestones in 2019:
- Presentation of interim data from the Phase 2 MANIFEST clinical trial of CPI-0610 is planned for medical meetings in the second quarter of 2019.
- Disclosure of additional Phase 2 data from the MANIFEST clinical trial is expected at a medical meeting in the second half of 2019.
- Presentation of the Phase 1b data from ProSTAR is planned in the second quarter of 2019.
- Disclosure of interim Phase 2 ProSTAR data is expected at a medical meeting in the second half of 2019.
- Initiation of the Phase 1 clinical trial in solid tumors with CPI-0209 is expected in mid-2019. The Company will also provide a translational science update to inform our disease indication selection strategy for CPI-0209 prior to initiating clinical development.
“With three promising clinical programs expected to be underway during 2019, we are excited about Constellation’s prospects,” Mr. Raythatha concluded. “Our clinical trials for CPI-1205 and CPI-0610 are each designed to provide multiple opportunities for success in areas of significant unmet medical need. CPI-0209 may achieve comprehensive coverage of EZH2 and address additional patient populations beyond those that have been targeted by first-generation EZH2 inhibitors. In all of these efforts, we continue to work diligently to bring important new medicines to cancer patients in need and to create value for our shareholders.”
MANIFEST is an open-label Phase 2 clinical trial of the
ProSTAR is an open-label Phase 1b/2 clinical trial of CPI-1205, a potent and highly selective small-molecule EZH2 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). The ProSTAR study is evaluating CPI-1205 in combination with either enzalutamide or abiraterone / prednisone (“abiraterone”), which are androgen receptor signaling (ARS) inhibitors, in mCRPC patients who experienced disease progression while receiving the other ARS inhibitor. Based on encouraging results from the Phase 1b portion, the Company initiated dosing in the randomized Phase 2 portion studying CPI-1205 in combination with enzalutamide versus enzalutamide alone. Constellation also expanded the Phase 2 portion of the study by adding an arm evaluating CPI-1205 in combination with abiraterone in the second-line setting.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the development status of the Company’s product candidates, the anticipated benefits of the changes to its clinical trial protocols and its anticipated achievement of milestones, including determination of proof of concept. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Constellation’s ability to: obtain and maintain necessary approvals from the
Senior Director, Investor Relations
MacDougall Biomedical Communications
Source: Constellation Pharmaceuticals