Sweden

Oncopeptides AB

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Oncopeptides Completes the Extended Enrollment for the Pivotal Phase 3 Ocean Study in Relapsed Refractory Multiple Myeloma

Lead Product(s): Melphalan Flufenamide,Dexamethasone

Therapeutic Area: Oncology Product Name: Melflufen

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 04, 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.

Isofol Medical

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Strengthened Patent Protection for Arfolitixorin in Japan

Lead Product(s): Arfolitixorin,Oxaliplatin,Fluorouracil

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 01, 2020

Details:

Company has further strengthened its position in the second largest market for treatment of mCRC by obtaining two new patent grants for arfolitixorin in Japan.

Oncopeptides AB

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FDA Grants Priority Review of Melflufen for Patients with Triple-Class Refractory Multiple Myeloma

Lead Product(s): Melphalan Flufenamide,Dexamethasone

Therapeutic Area: Oncology Product Name: Melflufen

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 29, 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.

Isofol Medical

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Isofol Enters Licensing Agreement with Solasia to Develop and Commercialize Arfolitixorin in Japan

Lead Product(s): Arfolitixorin,Oxaliplatin,Fluorouracil

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Solasia Pharma KK

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 13, 2020

Details:

The license agreement is initially focused on the development and commercialization of arfolitixorin as first-line treatment for metastatic colorectal cancer (mCRC) patients in Japan, which is projected to be the second largest addressable patient market for arfolitixorin.

Oncopeptides AB

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Oncopeptides Starts the Phase 2 PORT Study Comparing Peripheral Versus Central Administration of Melflufen and Dexamethasone in Multiple Mye...

Lead Product(s): Melphalan Flufenamide,Dexamethasone

Therapeutic Area: Oncology Product Name: Melflufen

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 04, 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.

Oncopeptides AB

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Oncopeptides Submits a New Drug Application to the FDA for Accelerated Approval of Melflufen

Lead Product(s): Melphalan Flufenamide,Dexamethasone

Therapeutic Area: Oncology Product Name: Melflufen

Highest Development Status: Phase III Product 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 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).

Oncopeptides AB

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Oncopeptides Reports Positive Results From Full Data Set of Phase 2 HORIZON Trial in Triple-class Refractory Multiple Myeloma Patients

Lead Product(s): Melphalan Flufenamide,Dexamethasone

Therapeutic Area: Oncology Product Name: Melflufen

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 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.

Oncopeptides AB

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Oncopeptides Hosts a Virtual Symposium at the 25th European Hematology Association Congress on Challenges in Managing Patients with Myeloma

Lead Product(s): Melphalan Flufenamide,Dexamethasone

Therapeutic Area: Oncology Product Name: Melflufen

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 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.

Oncopeptides AB

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Oncopeptides Announces Positive Results From OCEAN Study Between Melflufen & Pomalidomide In Patients With RRMM

Lead Product(s): Melphalan Flufenamide,Dexamethasone

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product 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. A recent analysis indicates that patients enrolled in the OCEAN-study continue treatment for a longer period of time than originally estimated.

Oncopeptides AB

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Oncopeptides Completes Enrollment to the Pivotal Phase 3 Study OCEAN for Relapsed Refractory Multiple Myeloma - 450 Patients Included

Lead Product(s): Melphalan Flufenamide,Dexamethasone

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

Details:

OCEAN is a randomized, comparative study between melflufen and pomalidomide in patients with relapsed refractory multiple myeloma (RRMM).

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Oncopeptides AB

Oncopeptides Completes the Extended Enrollment for the Pivotal Phase 3 Ocean Study in Relapsed Refractory Multiple Myeloma

Isofol Medical

Strengthened Patent Protection for Arfolitixorin in Japan

Oncopeptides AB

FDA Grants Priority Review of Melflufen for Patients with Triple-Class Refractory Multiple Myeloma

Isofol Medical

Isofol Enters Licensing Agreement with Solasia to Develop and Commercialize Arfolitixorin in Japan

Oncopeptides AB

Oncopeptides Starts the Phase 2 PORT Study Comparing Peripheral Versus Central Administration of Melflufen and Dexamethasone in Multiple Mye...

Oncopeptides AB

Oncopeptides Submits a New Drug Application to the FDA for Accelerated Approval of Melflufen

Oncopeptides AB

Oncopeptides Reports Positive Results From Full Data Set of Phase 2 HORIZON Trial in Triple-class Refractory Multiple Myeloma Patients

Oncopeptides AB

Oncopeptides Hosts a Virtual Symposium at the 25th European Hematology Association Congress on Challenges in Managing Patients with Myeloma

Oncopeptides AB

Oncopeptides Announces Positive Results From OCEAN Study Between Melflufen & Pomalidomide In Patients With RRMM

Oncopeptides AB

Oncopeptides Completes Enrollment to the Pivotal Phase 3 Study OCEAN for Relapsed Refractory Multiple Myeloma - 450 Patients Included