Oncology | Phase II Developments | Pipeline Prospector

MEI Pharma

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MEI Pharma Announces Fast Track Designation Granted by U.S. FDA for ME-401

Lead Product(s): ME-401

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 31, 2020

Details:

MEI is conducting TIDAL, a Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma. TIDAL is intended to boost an accelerated marketing application approval by FDA.

Bristol-Myers Squibb

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Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application for Anti-BCMA CAR T Cell Therapy

Lead Product(s): Idecabtagene vicleucel

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 31, 2020

Details:

The submission is based on the data of pivotal Phase 2 KarMMa study that evaluated the efficacy and safety of ide-cel in heavily pre-treated patients with relapsed and refractory multiple myeloma.

Hutchison China MediTech Limited

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Hong Kong

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Drug Discovery Chemistry

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Chi-Med Initiates a Phase II Trial of HMPL-453 in Patients with Advanced Malignant Mesothelioma in China

Lead Product(s): HMPL-453

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 31, 2020

Details:

The study is evaluating the efficacy, safety and pharmacokinetics of HMPL-453 in historically confirmed patients with advanced malignant mesothelioma that failed at least one line of systemic therapy.

CytomX Therapeutics

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CytomX Therapeutics Announces Milestone Achievement in AbbVie CD71 Partnership

Lead Product(s): CX-2029

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: AbbVie

Deal Size: $40.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement March 30, 2020

Details:

Achievement of Phase 1 Dose Escalation Criteria in AbbVie licensing agreement on CX-2029, a CD71-Directed Probody® Drug Conjugate, triggers $40 million payment to CytomX.

Daiichi Sankyo Co Ltd

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JAPAN Japan

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Daiichi Sankyo Submits Application for CAR T Therapy Axicabtagene Ciloleucel for Treatment of Relapsed/Refractory B-cell Lymphomas

Lead Product(s): Axicabtagene Ciloleucel

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2020

Details:

NDA submission based on previous pivotal trial data and a phase 2 study in Japan in patients with certain relapsed/refractory B-cell lymphomas.

Shanghai Junshi Biosciences

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CHINA China

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Drug Discovery Chemistry

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Junshi Biosciences Receives Orphan Drug Designation from FDA for Toripalimab-Axitinib Combo

Lead Product(s): Toripalimab,Axitinib

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2020

Details:

U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma.

Aveo Oncology

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United States

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AVEO Oncology and Biodesix to Discontinue CyFi-2 Study of Ficlatuzumab in Relapsed and Refractory AML

Lead Product(s): Ficlatuzumab,Cytarabine

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 28, 2020

Details:

The decision came in line with the urgent change of clinical sites due to COVID-19, affecting the feasibility of completing the analysis during the shelf-life of the existing stock of ficlatuzumab.

CG Oncology

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United States

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CG Oncology Announces License and Commercialization Agreement with Kissei Pharmaceutical

Lead Product(s): CG0070,Pembrolizumab

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Kissei Pharmaceutical

Deal Size: $140.0 million Upfront Cash: $10.0 million

Deal Type: Licensing Agreement March 26, 2020

Details:

The licensing agreement will provide production and commercial prospects for the immunotherapy drug CG0070 from CG Oncology in Japan, South Korea, Taiwan and other Asian countries, except China.

Inovio Pharmaceuticals

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United States

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Drug Discovery Chemistry

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INOVIO Reports Positive Interim Phase 2 VGX-3100 Results In Patients with HPV-associated Anal Dysplasia

Lead Product(s): VGX-3100

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 26, 2020

Details:

VGX-3100 DNA medicine cleared high-risk HPV 16/18-associated precancerous lesions in 50% of patients, and reduced the number of lesions in 75% of patients.

Oncoceutics Inc

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Additional Composition of Matter Patent in China Expands ONC201’s Global Coverage

Lead Product(s): Onc-201

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 26, 2020

Details:

With these new patents, Oncoceutics has more than 20 patents for ONC201 issued globally with 10 patents for ONC201 issued by the United States Patent Office.

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MEI Pharma

MEI Pharma Announces Fast Track Designation Granted by U.S. FDA for ME-401

Bristol-Myers Squibb

Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application for Anti-BCMA CAR T Cell Therapy

Hutchison China MediTech Limited

Chi-Med Initiates a Phase II Trial of HMPL-453 in Patients with Advanced Malignant Mesothelioma in China

CytomX Therapeutics

CytomX Therapeutics Announces Milestone Achievement in AbbVie CD71 Partnership

Daiichi Sankyo Co Ltd

Daiichi Sankyo Submits Application for CAR T Therapy Axicabtagene Ciloleucel for Treatment of Relapsed/Refractory B-cell Lymphomas

Shanghai Junshi Biosciences

Junshi Biosciences Receives Orphan Drug Designation from FDA for Toripalimab-Axitinib Combo

Aveo Oncology

AVEO Oncology and Biodesix to Discontinue CyFi-2 Study of Ficlatuzumab in Relapsed and Refractory AML

CG Oncology

CG Oncology Announces License and Commercialization Agreement with Kissei Pharmaceutical

Inovio Pharmaceuticals

INOVIO Reports Positive Interim Phase 2 VGX-3100 Results In Patients with HPV-associated Anal Dysplasia

Oncoceutics Inc

Additional Composition of Matter Patent in China Expands ONC201’s Global Coverage