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Details:
The acquisition strengthens Sobi’s leading haematology franchise by adding Vonjo (pacritinib), a novel oral kinase inhibitor that inhibits JAK2, IRAK1 and ACRV1, while sparing JAK1, for the treatment of adults with myelofibrosis. Vonjo obtained accelerated approval by the FDA.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: $1,700.0 million Upfront Cash: $1,700.0 million
Deal Type: Acquisition June 26, 2023
Details:
The acquisition will diversify Sobi's portfolio of leading hematology medicines through CTI's lead product, VONJO® (pacritinib), which is FDA-approved for the treatment of adult myelofibrosis patients with a platelet count below 50 x109/L.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: $1,700.0 million Upfront Cash: $1,700.0 million
Deal Type: Acquisition May 10, 2023
Details:
Vonjo (Pacritinib) is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form, IRAK1, ACVR1 (ALK2) and FMS-like tyrosine kinase 3 (FLT3).
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
On duplicate assays, Vonjo (pacritinib) was shown to be a more potent inhibitor of ACVR1 compared to momelotinib, with a half maximal inhibitory concentration (IC50) of 10.8 and 22.6 nM versus34.9 and 70.2 nM, respectively.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
Vonjo (pacritinib) is an oral kinase inhibitor with activity against wild type JAK2, mutant JAK2V617F form and FMS-like tyrosine kinase 3 (FLT3), which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
Vonjo (Pacritinib) is an oral kinase inhibitor with activity against wild type JAK2, mutant JAK2V617F form and FMS-like tyrosine kinase 3, which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2022
Details:
At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2022
Details:
FDA’s approval of VONJO (pacritinib) is based upon results of PERSIST-2 clinical trial indicate that 29% of myelofibrosis patients with baseline platelet levels of less than 50 x 109/L obtained spleen volume reductions of at least 35% during first six months of VONJO therapy.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: CTI BioPharma Corp
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2022
Details:
Vonjo (pacritinib), is an oral kinase inhibitor with activity against wild type JAK2, mutant JAK2V617F form and FLT3, contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Vonjo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
Pacritinib, a JAK 2/interleukin-1 receptor–associated kinase 1 (IRAK1) inhibitor that does not inhibit JAK1, is in development for use in patients with myelofibrosis who have thrombocytopenia.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: PAC203
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2021
Details:
In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential in conditions such as acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia and chronic lymphocytic leukemia, due to its inhibition of c-fms, IRAK1, JAK2 and FLT.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: PAC203
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R, but not JAK1 used in hospitalized patients with severe COVID-19.
Lead Product(s): Pacritinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2021
Details:
In the same population of patients treated with pacritinib, adverse events were generally low grade, manageable with supportive care, and rarely led to discontinuation. Platelet counts and hemoglobin levels were also stabilized.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: PAC203
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
The Phase 1 portion of the trial evaluated safety of pacritinib + sirolimus + low-dose tacrolimus after allogeneic hematopoietic cell transplantation. A 3+3 dose escalation design identified PAC 100 mg twice a day was well-tolerated dose for further study.
Lead Product(s): Pacritinib,Sirolimus,Tacrolimus
Therapeutic Area: Immunology Product Name: PAC
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
Abstract titled "Biological and Clinical Impact of JAK2/mTOR Blockade in GVHD Prevention: Preclinical and Phase I Trial Results" will be presented at the 62nd American Society of Hematology Meeting.
Lead Product(s): Pacritinib,Sirolimus,Tacrolimus
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
CTI BioPharma today announced that it has commenced a rolling NDA submission to the U.S. Food and Drug Administration seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L).
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Details:
The NDA will be based on the available data from the Company's completed Phase 3 PERSIST-1 and PERSIST-2 trials and the Phase 2 PAC203 dose-ranging trial.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
Details:
PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care versus placebo and standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer.
Lead Product(s): Pacritinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
The Interim data from EPYDIS Phase 3 trial shows that the trial is NOT FUTILE and the Independent Data Monitoring Committee recommends trial continuation.
Lead Product(s): Pacritinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2020
Details:
CTI will amend the PACIFICA pivotal Phase 3 trial protocol to allow for the primary analysis of SVR rates on the first 168 patient.
Lead Product(s): Pacritinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2020
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