Constellation Pharmaceuticals

In July 2012, LLS began its partnership with Constellation to support three first-in-human Phase 1 clinical trials for blood cancer patients and the partnership led to the registrational trial "A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients."

Constellation Pharmaceuticals was a clinical-stage biopharmaceutical company developing novel therapeutics that selectively modulate gene expression to address serious unmet medical needs in patients with cancer. Constellation developed pelabresib (CPI-0610) which inhibits members of the BET family of chromosome-binding proteins to selectively inactivate various cancer-promoting genes, including MYC, a master control gene that plays a role in many cancers. Constellation was driving clinical development of pelabresib for the treatment of myelofibrosis in a Phase 2 clinical study (MANIFEST, NCT02158858). MorphoSys acquired Constellation in July 2021 and more recently MorphoSys was acquired by Novartis in July 2024.

Enrollment of myelofibrosis patients in the Phase 3 clinical trial (MANIFEST-2) of the BET inhibitor pelabresib (NCT04603495) has been completed. Topline data was announced on November 20, 2023, indicating achievement of the primary endpoint and full details were presented during an oral session at the 2023 ASH Annual Meeting. Myelofibrosis is characterized by four hallmarks: an enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms. In MANIFEST-2, all hallmarks of myelofibrosis were improved with the pelabresib and ruxolitinib combination versus placebo plus ruxolitinib, which is the standard of care in myelofibrosis.

In February 2024, MorphoSys announced that Novartis plans to acquire all outstanding shares for a total equity value of € 2.7 billion. The deal closed in July 2024 and Novartis expects to file a new drug application later in 2024 both in the US and Europe. 

For more information about MorphoSys, visit www.MorphoSys.com.

Recent News

• February 5, 2024 - MorphoSys announced the company entered into a Business Combination Agreement with Novartis to submit a voluntary public takeover offer for all outstanding MorphoSys shares at an offer price of € 68.00 per share in cash, for a total equity value of € 2.7 billion.
• December 10, 2023 - announced comprehensive results from the Phase 3 MANIFEST-2 study investigating pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis in an oral presentation at the ASH Annual Meeting. In MANIFEST-2, all hallmarks of myelofibrosis were improved with the pelabresib and ruxolitinib combination versus placebo plus ruxolitinib, which is the standard of care in myelofibrosis.
• April 4, 2023 - announced that enrollment is complete for MANIFEST-2, the ongoing Phase 3 study with topline data expected by the end of 2023, earlier than previously anticipated.
• December 11, 2022 - announced results from analyses of the ongoing MANIFEST study, an open-label Phase 2 clinical trial of pelabresib, an investigational BET inhibitor, in patients with myelofibrosis, a type of bone marrow cancer with limited treatment options. The latest analyses include longer-term data showing durable improvements in both spleen volume and symptom score beyond 24 weeks with pelabresib plus ruxolitinib in JAK inhibitor-naïve patients. The findings were presented during two oral sessions at the 64th American Society of Hematology (ASH 2022) Annual Meeting and Exposition in New Orleans, Louisiana.
• December 12, 2021 - presented the latest data from the ongoing MANIFEST study, an open-label, Phase 2 clinical trial of pelabresib, an investigational BET inhibitor, in patients with myelofibrosis, a rare bone marrow cancer for which only limited treatment options are available. These latest results, which included more patients and longer-term follow-up than previously reported data, suggest the potential of pelabresib in the treatment of myelofibrosis. These findings were presented during poster and oral sessions at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 11 - 14, 2021 in Atlanta, Georgia and virtually.
• July 15, 2021 - MorphoSys announced the successful completion of its previously announced cash tender offer for all outstanding shares of Constellation Pharmaceuticals, Inc. for a total equity value of the transaction of approximately $1.7 billion. MorphoSys will promptly complete its acquisition of Constellation through a second step merger of MorphoSys Development Inc. with and into Constellation resulting in Constellation surviving as an indirect wholly owned subsidiary of MorphoSys.