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Details:
Cladribine, an oral dissolvable film product, is incorporated into DNA strands where it inhibits DNA synthesis and repair, it is being developed for the treatment of Multiple Sclerosis.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Cladribine-Generic
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2024
Details:
Cladribine-Generic is a ribonucleoside-diphosphate reductase inhibitor. Its orodispersible film is being evaluated in precinical studies for the treatment of Multiple Sclerosis.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Cladribine-Generic
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2024
Details:
Cladribine-Generic is a ribonucleoside-diphosphate reductase inhibitor. Its orodispersible film is being evaluated in precinical studies for the treatment of Multiple Sclerosis.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Cladribine-Generic
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 07, 2024
Details:
The net proceeds will be used for the development and commercialization of cladribine. It involves targeting the cells of the adaptive immune system with minimal impact on innate immune cells for the treatment of multiple sclerosis (MS).
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Cladribine-Generic
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $1.1 million Upfront Cash: Undisclosed
Deal Type: Private Placement January 29, 2024
Details:
Cladribine based oral dissolvable drug film (ODF) reformulation is being evaluated for the treatment of Multiple Sclerosis (MS). Preclinical work is underway with comparative pharmacokinetic and local toxicity studies in animal models having already commenced in Europe.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Cladribine-Generic
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2023
Details:
Under the agreement, BioNxt acquires intellectual property rights and joint development of an oral dissolvable drug reformulation using the active pharmaceutical ingredient Cladribine.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bionxt Solutions
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 13, 2023
Details:
Actimab-A (lintuzumab-Ac-225) is an Actinium-225 based antibody radiation conjugate targeting CD33, a validated target that is expressed in virtually all patients with AML. Actimab-A due to its radiation modality is agnostic to cytogenetics.
Lead Product(s): Lintuzumab-Ac225,Cladribine,Cytarabine
Therapeutic Area: Oncology Product Name: Actimab-A
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Columbia University
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 08, 2022
Details:
Patients on study of Actimab-A (Lintuzumab-Ac225) received a median of 2 lines of prior therapy with 57% receiving prior treatment with venetoclax and 67% had adverse cytogenetics with 52% of patients having a TP53 mutation.
Lead Product(s): Lintuzumab-Ac225,Cladribine,Mitoxantrone
Therapeutic Area: Oncology Product Name: Actimab-A
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
New real-world data show MAVENCLAD® (cladribine tablets) had lower annualised relapse rates and longer time to first relapse and time to switch than fingolimod, dimethyl fumarate and teriflunomide in relapsing multiple sclerosis patients.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Mavenclad
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2022
Details:
The company entered into an agreement to secure the global rights by acquiring Chord Therapeutics, a company focused on rare neuroinflammatory diseases. Acquisition provides opportunity to develop cladribine in Myasthenia Gravis and Neuromyelitis Optica Spectrum Disorder.
Lead Product(s): Cladribine
Therapeutic Area: Immunology Product Name: Mavenclad
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 20, 2021
Details:
81.2% of cladribine tablets-treated patients did not require an ambulatory device. CLASSIC-MS investigated the long-term efficacy in 435 patients with RMS – 90.6% of whom were exposed to cladribine tablets during the CLARITY and CLARITY Extension trials.
Lead Product(s): Cladribine
Therapeutic Area: Immunology Product Name: Mavenclad
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
The combination of uproleselan with a standard salvage regimen of mitoxantrone, etoposide and cytarabine (MEC) demonstrated a substantial improvement in both response rate and survival in relapsed/refractory AML patients.
Lead Product(s): Uproleselan,Cladribine,Cytarabine
Therapeutic Area: Oncology Product Name: GMI-1271
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 September 23, 2021
Details:
The study is designed to evaluate both the safety and tolerability of the combination therapy, as well as to identify a recommended Phase 2 dose of the uproleselan triple combination approach in patients with ts-AML.
Lead Product(s): Uproleselan,Cladribine,Cytarabine
Therapeutic Area: Oncology Product Name: GMI-1271
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: The University of Texas MD Anderson Cancer Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
MAGNIFY-MS retrospective analysis demonstrates patients develop protective antibody levels for at least six months following seasonal influenza and varicella zoster vaccines, irrespective of vaccine timing relative to MAVENCLAD dosing.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Mavenclad
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2021
Details:
The Phase 2 clinical trial, ChariotMS, will test whether Mavenclad (cladribine) can slow a worsening of hand and arm function in people with progressive multiple sclerosis (MS) and very limited walking abilities.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Mavenclad
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
Across all three cohorts, 67% or 10/15 patients treated with 0.25, 0.50 and 0.75 uCi/kg of Actimab-A and the standard regimen of CLAG-M achieved a Complete Remission (CR) or Complete Remission with inadequate hematopoietic recovery (CRi).
Lead Product(s): Lintuzumab-Ac225,Cladribine,Mitoxantrone
Therapeutic Area: Oncology Product Name: Actimab-A
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
The financing will allow the company to progress CRD1 through Phase 2 proof of concept clinical development. The potential of CRD1 to address unmet medical needs in rare autoimmune disorders was identified by Chord Therapeutics‘ founder, Dr. Arthur Roach.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: CRD1
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Omega Funds
Deal Size: $16.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing October 13, 2020
Details:
The arrangement aims to provide financial compensation for Blue Plans that is dependent on the rate at which their members discontinue the two-year treatment with MAVENCLAD or switch to a different MS therapy at any point over the typical course of treatment.
Lead Product(s): Cladribine
Therapeutic Area: Neurology Product Name: Mavenclad
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: EMD Serono
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 08, 2020
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