On July 5, 2016 Bristol-Myers Squibb Company (NYSE:BMY) and Cormorant Pharmaceuticals reported that Bristol-Myers Squibb has acquired all of the outstanding capital stock of Cormorant, a private, Stockholm, Sweden-based pharmaceutical company focused on the development of therapies for cancer and rare diseases (Press release, Bristol-Myers Squibb, JUL 5, 2016, View Source [SID:1234513704]). The acquisition gives Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program and the lead candidate HuMax-IL8, a Phase 1/2 monoclonal antibody targeted against interleukin-8 (IL-8) that represents a potentially complementary immuno-oncology mechanism of action to T-cell directed antibodies and co-stimulatory molecules. Schedule your 30 min Free 1stOncology Demo! IL-8 is a protein expressed by many solid tumors within the tumor microenvironment that suppresses the immune system and increases the ability of tumors to metastasize. By targeting IL-8, HuMax-IL8 offers the potential to enhance immune response and increase the efficacy of existing cancer medicines through combination therapy. The rights to HuMax-IL8 were acquired by Cormorant from Genmab A/S in 2012 under an exclusive license agreement.
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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"We believe combination therapy will be foundational to delivering the potential for long-term survival for patients, and the opportunity to develop the HuMax-IL8 antibody program together with our broad Immuno-Oncology pipeline enables us to accelerate the next wave of potentially transformational immunotherapies," said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb.
"Bristol-Myers Squibb is the ideal company to maximize the potential of both Cormorant and the HuMax-IL8 program, and bring hope to more patients," said Maarten de Château, M.D., Ph.D., chief executive officer, Cormorant Pharmaceuticals. "Bristol-Myers Squibb is the leader in the Immuno-Oncology field, with deep clinical development and regulatory expertise, and an established commercial infrastructure to deliver important new therapies to patients quickly. Bristol-Myers Squibb’s rich pipeline of clinical candidates and approved products provides even more opportunity for potential therapeutic synergy when coupled with HuMax-IL8."
The transaction includes upfront and near term contingent milestone payments of up to US $95 million and additional contingent consideration of up to US $425 million upon the achievement by Bristol-Myers Squibb of certain development and regulatory milestones.
The transaction has been approved by the boards of directors of both companies and by the stockholders of Cormorant.
Pipeline KB003
KB003 is a Humaneered, recombinant monoclonal antibody (mAb) that neutralizes soluble granulocyte-macrophage colony-stimulating factor (GM-CSF), a critical cytokine for the growth of certain hematologic malignancies and solid tumors (Company Pipeline, KaloBios, JUL 4, 2016, View Source [SID:1234513679]).
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Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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KB003 is a highly potent GM-CSF antagonist with a favorable safety profile that has previously been studied in more than 90 subjects in clinical studies in either healthy adults or adults with autoimmune diseases.
Data generated by a collaborator of the company confirm GM-CSF hypersensitivity plays an important role in inappropriate growth and survival of CMML cells, similar to juvenile myelomonocytic leukemia (JMML), in which such hypersensitivity is a hallmark of the disease.
This data also strongly suggests a role for KB003 in the treatment of CMML. Because KaloBios is now focused on oncology indications for KB003, and following discussions with clinical experts, the Food and Drug Administration, and the European Medicines Agency, the company intends to initiate study enrollment in a Phase 1 clinical trial in CMML patients to assess the safety, pharmacokinetics, and activity of KB003 in this patient population later this year.
Pipeline KB004
KB004 is a first-in-class, monoclonal antibody targeting the EphA3 receptor tyrosine kinase created using KaloBios’ proprietary Humaneered technology (Company Pipeline, KaloBios, JUL 4, 2016, View Source [SID:1234513678]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
KB004 is unique in its potential to attack tumors at their source by killing tumor cells, tumor stromal cells that protect them, and the vasculature that feeds them without killing normal cells. This unique combination of activities may provide the potential to generate durable responses. KB004 may have a similar mechanism of action in patients with solid tumors since it targets solid tumor stem cells and their microenvironment.
Takeda Submits a New Drug Application for Novel, Oral Proteasome Inhibitor Ixazomib in Japan
On July 4, 2016 Takeda Pharmaceutical Company Limited (TSE: 4502) reported that it has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan for ixazomib, the first oral proteasome inhibitor for the treatment of relapsed or refractory multiple myeloma (Press release, Takeda, JUL 4, 2016, View Source [SID:1234513676]).
The NDA was filed based on the results of TOURMALINE-MM1, a global Phase 3 trial published in the New England Journal of Medicine in April. The trial demonstrated that the all-oral triplet regimen containing ixazomib, lenalidomide and dexamethasone significantly extended the progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma, with a manageable safety profile and the convenience and practicality of oral dosing.
“Multiple myeloma remains a devastating, relapsing and incurable rare cancer. We designed our extensive global Phase 3 clinical trial program, which includes TOURMALINE-MM1, to address the unmet need for an effective, tolerable and conveniently dosed therapy that may reduce some of the burdens that patients currently face,” said Andrew Plump, M.D., Ph.D., Takeda Chief Medical and Scientific Officer. “Should it be approved, the NDA submission of ixazomib will enable the first all-oral, proteasome inhibitor-containing triplet regimen in Japan. We thank the patients and investigators who have contributed to the development of ixazomib and look forward to the opportunity of offering this innovative drug to patients in Japan.”
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies. These malignant plasma cells have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with 114,000 new cases globally per year. It is reported that there are approximately 14,000 patients with multiple myeloma in Japan.
About ixazomib
Ixazomib is a novel oral proteasome inhibitor which is being studied in multiple myeloma and systemic light-chain (AL) amyloidosis. Ixazomib was granted orphan drug designation for the treatment of patients with relapsed or refractory multiple myeloma by the Ministry of Health, Labour and Welfare in February, 2016. In the United States, an NDA was submitted based on the data of TOURMALINE-MM1 trial in July, 2015 and the U.S. Food and Drug Administration (FDA) approval was obtained as a drug for treatment of patients with multiple myeloma who have received at least one prior therapy in November, 2015, four months prior to its Priority Review PDUFA date. Ixazomib then became available in the U.S. in December, 2015 under the trade name “NINLARO”.
About TOURMALINE Trials
The comprehensive ixazomib clinical development program, TOURMALINE, further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. TOURMALINE includes a total of five ongoing pivotal trials – four investigating every major multiple myeloma patient population and one in light-chain amyloidosis:
TOURMALINE-MM1: investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
TOURMALINE-MM2: investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
TOURMALINE-MM3: investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
TOURMALINE-MM4: investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
TOURMALINE-AL1: investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis
In addition to the TOURMALINE program, a large number of investigator initiated studies are evaluating ixazomib for patients globally.
About Orphan Drug Designation
Ixazomib was granted orphan drug designation for the treatment of patients with relapsed or refractory multiple myeloma by the Minister of Health, Labour and Welfare in February 2016.
Takeda Submits a New Drug Application for Novel, Oral Proteasome Inhibitor Ixazomib in Japan
On July 4, 2016 Takeda Pharmaceutical Company Limited (TSE: 4502) reported that it has submitted a New Drug Application ("NDA") to the Ministry of Health, Labour and Welfare in Japan for ixazomib, the first oral proteasome inhibitor for the treatment of relapsed or refractory multiple myeloma (Press release, Takeda, JUL 4, 2016, View Source [SID:1234513676]). Schedule your 30 min Free 1stOncology Demo! The NDA was filed based on the results of TOURMALINE-MM1, a global Phase 3 trial published in the New England Journal of Medicine in April. The trial demonstrated that the all-oral triplet regimen containing ixazomib, lenalidomide and dexamethasone significantly extended the progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma, with a manageable safety profile and the convenience and practicality of oral dosing.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Multiple myeloma remains a devastating, relapsing and incurable rare cancer. We designed our extensive global Phase 3 clinical trial program, which includes TOURMALINE-MM1, to address the unmet need for an effective, tolerable and conveniently dosed therapy that may reduce some of the burdens that patients currently face," said Andrew Plump, M.D., Ph.D., Takeda Chief Medical and Scientific Officer. "Should it be approved, the NDA submission of ixazomib will enable the first all-oral, proteasome inhibitor-containing triplet regimen in Japan. We thank the patients and investigators who have contributed to the development of ixazomib and look forward to the opportunity of offering this innovative drug to patients in Japan."
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of monoclonal plasma cells, or myeloma cells, becomes cancerous and multiplies. These malignant plasma cells have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with 114,000 new cases globally per year. It is reported that there are approximately 14,000 patients with multiple myeloma in Japan.
About ixazomib
Ixazomib is a novel oral proteasome inhibitor which is being studied in multiple myeloma and systemic light-chain (AL) amyloidosis. Ixazomib was granted orphan drug designation for the treatment of patients with relapsed or refractory multiple myeloma by the Ministry of Health, Labour and Welfare in February, 2016. In the United States, an NDA was submitted based on the data of TOURMALINE-MM1 trial in July, 2015 and the U.S. Food and Drug Administration (FDA) approval was obtained as a drug for treatment of patients with multiple myeloma who have received at least one prior therapy in November, 2015, four months prior to its Priority Review PDUFA date. Ixazomib then became available in the U.S. in December, 2015 under the trade name "NINLARO".
About TOURMALINE Trials
The comprehensive ixazomib clinical development program, TOURMALINE, further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. TOURMALINE includes a total of five ongoing pivotal trials – four investigating every major multiple myeloma patient population and one in light-chain amyloidosis:
TOURMALINE-MM1: investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
TOURMALINE-MM2: investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
TOURMALINE-MM3: investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
TOURMALINE-MM4: investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
TOURMALINE-AL1: investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis
In addition to the TOURMALINE program, a large number of investigator initiated studies are evaluating ixazomib for patients globally.
About Orphan Drug Designation
Ixazomib was granted orphan drug designation for the treatment of patients with relapsed or refractory multiple myeloma by the Minister of Health, Labour and Welfare in February 2016.