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Details:
The disappointed outcome of the confirmatory trials leads to voluntarily withdraw, in the U.S., accelerated IMBRUVICA® (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma who have received at least one prior therapy and with marginal zone lymphoma.
Lead Product(s): Ibrutinib,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2023
Iran Expo
Not Confirmed
Contact SupplierDetails:
Bendamustine hydrochloride is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring, which can lead to cell death via several pathways. It is active against both quiescent and dividing cells.
Lead Product(s): Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
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 26, 2023
Details:
Under the settlement agreement, Dr. Reddy’s has the right to market its product BENDEKA® (bendamustine hydrochloride), an alkylating drug, indicated for treatment of patients with Chronic lymphocytic leukemia.
Lead Product(s): Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Bendeka
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Dr. Reddy\'s Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 05, 2023
Details:
The results demonstrated TT11 to be well-tolerated with promising efficacy in relapsed or refractory (r/r) CD30-positive classical Hodgkin lymphoma (cHL). The CD30.CAR-T cell therapy was demonstrated to be well tolerated with no unexpected safety signals.
Lead Product(s): CD30.CAR-T,Fludarabine Phosphate,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: TT11
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2022
Details:
CYT-0851 is in a Phase 1/2 clinical trial as both a monotherapy and in combination with standard of care chemotherapy and has the potential to be a first-in-class MCT inhibitor. By impairing monocarboxylate transporter-mediated lactate transport, CYT-0851 disrupts glycolysis.
Lead Product(s): Rad51-IN-2,Rituximab,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: CYT-0851
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 October 12, 2022
Details:
TT11 – is an autologous CD30 targeting CAR-T therapy currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma.
Lead Product(s): CD30.CAR-T,Fludarabine Phosphate,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: TT11
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
Tessa plans to use the proceeds from the financing to advance the ongoing clinical development of the company’s autologous CD30-CAR-T therapy (TT11) and allogeneic CD30.CAR EBVST therapy (TT11X) programs.
Lead Product(s): CD30.CAR-T,Fludarabine Phosphate,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: TT11
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Polaris Partners
Deal Size: $126.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing June 09, 2022
Details:
Data for CYT-0851 show that the drug has performed well in cancer patients: it has desirable pharmacologic properties with an estimated half-life of three days, dose proportional exposure, and a dose dependent, predictable, and favorable safety profile.
Lead Product(s): Rad51-IN-2,Rituximab,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: CYT-0851
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 June 05, 2022
Details:
With a median follow-up of 84.7 months, the IMBRUVICA (Ibrutinib) plus BR and rituximab maintenance combination showed a statistically significant and clinically meaningful 2.3-year improvement in median PFS.
Lead Product(s): Ibrutinib,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Imbruvica
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 03, 2022
Details:
ADI-001 exhibited robust in vitro and in vivo tumor growth inhibition in multiple human lymphoma cell lines, with adaptive and innate mechanisms contributing to its anti-tumor activity.
Lead Product(s): ADI-001,Fludarabine Phosphate,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: ADI-001
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a treatment for B-cell non-Hodgkin's lymphoma. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors.
Lead Product(s): ADI-001,Fludarabine Phosphate,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: ADI-001
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
ADI-001 is an investigational immunotherapy composed of allogeneic gamma delta T cells that is being evaluated as a potential treatment for patients diagnosed with B cell malignancies.
Lead Product(s): ADI-001,Fludarabine Phosphate,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: ADI-001
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ibrutinib in combination with bendamustine and rituximab in adult patients with previously untreated mantle cell lymphoma.
Lead Product(s): Ibrutinib,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Imbruvica
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 March 08, 2022
Details:
The sNDA is supported by clinical results from the randomized, multicenter, global Phase 3 SEQUOIA trial, comparing BRUKINSA to bendamustine in combination with rituximab (B+R) in patients with treatment-naïve CLL.
Lead Product(s): Zanubrutinib,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2022
Details:
Eagle had asserted several Orange Book-listed patents against Slayback Pharma LLC, Apotex Inc. et al, Mylan Laboratories Limited, and Fresenius Kabi USA, LLC, related to their respective abbreviated new drug applications referencing BENDEKA.
Lead Product(s): Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Bendeka
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Details:
The PRIME designation was granted to TT11 by EMA on the back of promising clinical data from two Phase I/II trials in R/R cHL conducted at Baylor College of Medicine and University of North Carolina Lineberger Comprehensive Cancer Center.
Lead Product(s): CD30.CAR-T,Fludarabine Phosphate,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: TT11
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2021
Details:
Longer-term data from the GO29365 study and results from 106 additional patients show continued survival benefit of this fixed-duration, off-the-shelf, Polivy combination.
Lead Product(s): Polatuzumab Vedotin,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Polivy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2020
Details:
Health Canada has granted market authorization to Polivy™(polatuzumab vedotin), in combination with bendamustine and rituximab (BR) for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL).
Lead Product(s): Polatuzumab Vedotin,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Polivy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
With this approval, SymBio will convert its current lyophilized formulation of TREAKISYM to the new RTD liquid formulation upon launch in January 2021.
Lead Product(s): Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Treakisym
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SymBio Pharmaceuticals
Deal Size: $17.5 million Upfront Cash: $12.5 million
Deal Type: Licensing Agreement September 23, 2020
Details:
SymBio Pharmaceuticals Limited has completed patient enrollment in a clinical trial for TREAKISYM rapid infusion in Japan. Company plans to submit a New Drug Application for the product.
Lead Product(s): Bendamustine Hydrochloride
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 March 30, 2020
Details:
Both the MZL and FL cohorts of the UNITY-NHL trial met their primary endpoints .
Lead Product(s): Umbralisib,Ublituximab,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2020
Details:
Polatuzumab vedotin in combination with bendamustine and rituximab achieved complete response rate in patients with relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Polatuzumab Vedotin,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2020
Details:
Drug manufacturer TG Therapeutics, Inc., initiated a rolling application of an NDA for umbralisib seeking rapid FDA approval of the drug for the intended clinical use.
Lead Product(s): Umbralisib,Ublituximab,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2020
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