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Details:
Under the collaboration, Vector will distribute Pepaxti (melphalan flufenamide), indicated in combination with dexamethasone, to patients in the MENA region for the treatment of patients with multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxti
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Vector Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 30, 2024
Details:
Under the agreement, Vector will distribute Pepaxti (melphalan flufenamide), indicated in combination with dexamethasone, in the MENA region for the treatment of patients with multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxti
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Vector Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 27, 2024
Details:
Pepaxto (melphalan flufenamide, also called melflufen) is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxto
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
Pepaxti (melphalan flufenamide, also called melflufen) is a lipophilic peptide conjugated alkylating drug that rapidly and selectively is delivering cytotoxic agents into tumor cells.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxto
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: European Investment Bank
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 25, 2022
Details:
Pepaxti® (melphalan flufenamide, also called melflufen) is a lipophilic peptide conjugated alkylating drug that rapidly and selectively is delivering cytotoxic agents into tumor cells. The drug is composed of a di-peptide and an alkylating moiety.
Lead Product(s): Melphalan Flufenamide,Daratumumab
Therapeutic Area: Oncology Product Name: Pepaxti
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Pepaxti (melphalan flufenamide, also called melflufen) is a lipophilic peptide conjugated alkylating drug that rapidly and selectively is delivering cytotoxic agents into tumor cells.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxti
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2022
Details:
Pepaxti (melphalan flufenamide, also called melflufen) is a lipophilic peptide conjugated alkylating drug that rapidly and selectively is delivering cytotoxic agents into tumor cells.
Lead Product(s): Melphalan Flufenamide
Therapeutic Area: Oncology Product Name: Pepaxti
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2022
Details:
The first drug coming from the PDC platform, Pepaxto® (INN melphalan flufenamide), also called melflufen was granted accelerated approval in the U.S. Oncopeptides has discontinued the marketing of Pepaxto in the US and does not intend to market Pepaxto in the US at this time.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxto
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2022
Details:
The OCEAN Phase 3 results demonstrate that melflufen (Melphalan Flufenamide) improves PFS for lenalidomide refractory RRMM patients who have received two to four prior lines of therapy with significant statistical interactions between the OS HR result.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2022
Details:
Melflufen (melphalan flufenamide) a novel class of peptidase-enhanced compounds that elicit increased cytotoxicity in target multiple myeloma cells and substantially reduced off-target cell toxicity.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2021
Details:
Melphalan flufenamide (melflufen, Pepaxto®) is a peptide conjugated alkylating drug used in combination with dexamethasone for the treatment of multiple myeloma.
Lead Product(s): Melphalan Flufenamide
Therapeutic Area: Oncology Product Name: Pepaxto
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2021
Details:
Melflufen met the primary endpoint of superior Progression Free Survival (PFS) as assessed by the Independent Review Committee (IRC), with a median PFS of 6.8 months, compared to 4.9 months for pomalidomide.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2021
Details:
The phase 3 OCEAN study is a global study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2021
Details:
Phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxto
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
In the final analysis melflufen met the primary endpoint of superior Progression Free Survival (PFS) compared to pomalidomide with a Hazard Ratio (HR) of 0.792 (95% CI 0.640-0.979, p-value 0.0311) as determined by the IRC.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2021
Details:
The HORIZON study, evaluating intravenous PEPAXTO in combination with dexamethasone, included heavily pre-treated patients with a poor prognosis.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxto
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
The study demonstrates that for patients receiving melphalan flufenamide, also known as melflufen and dexamethasone in the phase 2 BRIDGE study, the exposure to melphalan increased with reduced eGFR similar to what is observed during treatment with melphalan.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Pepaxto
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
The PORT study compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed/refractory multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2021
Details:
European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2021
Details:
The phase 3 LIGHTHOUSE study is a randomized, open-label study in patients with relapsed refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents.
Lead Product(s): Melphalan Flufenamide,Dexamethasone,Daratumumab
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2020
Details:
The phase 2 HORIZON study is a pivotal, single-arm, multicenter, phase 2 study evaluating the safety and efficacy of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
Triplet regimen with melflufen plus dexamethasone in combination with daratumumab or bortezomib in heavily pretreated patients with relapsed refractory multiple myeloma had a similar safety profile compared to doublet regimen with only melflufen plus dexamethasone.
Lead Product(s): Melphalan Flufenamide,Dexamethasone,Bortezomib
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase I/ Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2020
Details:
The updated analysis of the ongoing phase 1/2 ANCHOR study confirms the initial findings of encouraging activity as a triplet regimen with melflufen plus dexamethasone and either daratumumab or bortezomib in patients with relapsed refractory multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone,Daratumumab
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase I/ Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
The loan may be used to further support the clinical development of melflufen, and the company’s transition from a R&D company into a fully integrated global biopharmaceutical company.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: European Investment Bank
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 14, 2020
Details:
The HORIZON study demonstrates that melflufen in combination with dexamethasone has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple-class refractory myeloma and EMD.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
The Expanded Access Program is backed pivotal phase 2 HORIZON study results demonstrating that melflufen and dexamethasone combo, is a potential therapeutic option for patients with relapsed refractory multiple myeloma and other types of the disease.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2020
Details:
Last patient has been successfully enrolled in the pivotal phase 3 study OCEAN in relapsed refractory multiple myeloma (RRMM). OCEAN is a randomized, comparative study between melflufen (INN melphalan flufenamide), and pomalidomide in patients with RRMM.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 04, 2020
Details:
FDA, has granted priority review for Oncopeptides´ New Drug Application seeking approval of melflufen in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2020
Details:
This open-label, phase 1/2 study of melflufen and dexamethasone for patients with AL amyloidosis, following at least one prior line of therapy, is the first study to explore the effect of melflufen outside of multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Rare Diseases and Disorders Product Name: Melflufen
Highest Development Status: Phase I/ Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2020
Details:
The study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2020
Details:
The submission is based on the results from the pivotal phase 2 study HORIZON, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma (RRMM).
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
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 30, 2020
Details:
The results support the NDA submission to the US FDA, for accelerated approval of melflufen of company's phase 2 HORIZON study, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
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 15, 2020
Details:
Melflufen is an investigational first-in-class anticancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is in late stage clinical development for a potential treatment of patients with relapsed refractory multiple myeloma.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Melflufen
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 11, 2020
Details:
OCEAN is a randomized, comparative study between melflufen and pomalidomide in patients with relapsed refractory multiple myeloma. A recent analysis indicates that patients enrolled in the OCEAN-study continue treatment for a longer period of time than originally estimated.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
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 June 01, 2020
Details:
OCEAN is a randomized, comparative study between melflufen and pomalidomide in patients with relapsed refractory multiple myeloma (RRMM).
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2020
Details:
One of the abstracts relates to the pivotal phase 2 HORIZON study evaluating melflufen in relapsed refractory multiple myeloma (RRMM) patients.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
In the O-12-M1 study, patients receiving melflufen plus dexamethasone experienced an overall response rate of 31%, a median duration of response of 8.4 months, and overall survival of 20.7 months.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2020
Details:
The company announced delay of a number of trials due to COVID-19 pandemic.
Lead Product(s): Melphalan Flufenamide,Dexamethasone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 20, 2020
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