Juno Therapeutics (JUNO) is due to receive a fee payment of $50 million from Celgene. The reason for this compensation is that Celgene has exercised its option to develop and commercialize Juno CD19 program outside North America and China.
From now on, Juno will share with Celgene the global development expenses for products in the CD19 program outside the U.S. and china and Celgene will have pay Juno a royalty at a percentage in the mid-teens on any future net sales of therapeutic products developed through the CD19 program in Celgene’s granted territories.
Juno retains commercialization rights in North America and China.
Juno has taken advantage of the announcement of the Celgene’s decision and the $50 payment to remind us of its CD19-directed product candidates in clinical development. These products comprise:
JCAR015: In a Phase 2 trial for adults with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL).
JCAR017: In two separate Phase 1 trials, one in pediatric patients with r/r ALL and another in patients with r/r non-Hodgkin lymphoma (NHL).
JCAR014: In a Phase 1 trial in three different indications, adult r/r/ ALL, r/r NHL, and r/r chronic lymphocytic leukemia (CLL), as well as a trial in combination with AstraZeneca’s investigational programmed death ligand 1 (PD-L1) immune checkpoint inhibitor, durvalumab.
Juno also reminds that its CD19-directed portfolio of drug candidates has already demonstrated encouraging efficacy and manageable toxicity in trials to date across a range of B cell malignancies.
In the same press release, Celgene’s Chief Scientific Officer Robert Hershberg, M.D., Ph.D., confirmed the firm’s intention for a long-term collaboration with Juno as its “CD19-based CAR T therapies hold great promise in B cell malignancies including acute lymphoblastic leukemia, non-Hodgkin lymphoma, and chronic lymphocytic leukemia. The experience with CD19 will inform additional targets and approaches as the Celgene-Juno collaboration evolves”, stated Cegene’s chief.
We remind the reader that Juno is one of the major firms developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute.
Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19 directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital.
Prohost Observations
Chimeric antigen receptor (CAR-T) and high-affinity T cell receptor (TCR) technologies involve genetically engineering T cells to recognize and kill cancer. The breakthrough Immunotherapy has great promises. We believe these technologies are born to survive and flourish and cross the border of the liquid cancers to treat solid cancers. The firm is managing to overcome the side effects of the approach and is working diligently towards preventing them. CAR-T and TCR products will be approved and will advance the treatment of cancer
——————————————————————————————————————————————————-
Drug Approvals
The FDA approved Venclexta (venetoclax) developed by Abbvie (ABBV) in partnership with Roche for chronic lymphocytic leukemia (CLL). The drug is for CLL patients who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. These patients lack a portion of the chromosome that acts to suppress cancer growth. This chromosomal abnormality occurs in approximately 10 percent of patients with untreated CLL and in approximately 20 percent of patients with relapsed CLL.
Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein that helps the cancer cells stay alive and supports the malignant cells’ growth. The BCL-2 protein is overexpressed in many CLL patients.
The efficacy of Venclexta was tested in a single-arm clinical trial of 106 patients with CLL who have a 17p deletion and who had received at least one prior therapy. Trial participants took Venclexta orally every day, beginning with 20 mg and increasing over a five-week period to 400 mg. Results showed that 80 percent of trial participants experienced a complete or partial remission of their cancer.
Venclexta is indicated for daily use after the detection of 17p deletion is confirmed through the use of the FDA-approved companion diagnostic Vysis CLL FISH probe kit.
The most common side effects: Venclexta side effects include low white blood cell count (neutropenia), diarrhea, nausea, anemia, upper respiratory tract infection, low platelet count (thrombocytopenia) and fatigue. Serious complications can include pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, anemia and metabolic abnormalities known as tumor lysis syndrome. Live attenuated vaccines should not be given to patients taking Venclexta.
The FDA had granted the Venclexta application breakthrough therapy designation, priority review and acceerated approval. Venclexta also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.
Prohost Observations
More and more treatments have been developed and marketed for diseases that used to be as if caused by only one mutation. The advancement ofsequencers and gene analyzers led to a capability for pinpointing various pathological pathways for the same disease. Biotech firms having sound and solid scientific fundamentals are riding the wave of the flood of knowledge being rapidly accumulating about the molecular basis of diseases.
The approval of Venclexta is great news for Abbvie and for Roche. Even if the market is small, the disease is a killer and the breakthrough drug has added validation to Abbvie’s drug design and development capabilities.
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From The FDA Committee
Clovis Oncology(CLVS): The FDA Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA should wait for more results from an ongoing study before deciding upon approving Clovis lung cancer drug rociletinib.
The requited results are expected to come from the TIGER-3, Clovis’ ongoing Phase 3, randomized, controlled trial of rociletinib. Patient enrollment for the trial is expected to complete in late 2018.
The news was disappointing for Clovis, yet, it is not a denial of approval.
Rociletinib is a novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of the cancer-causing mutant forms of epidermal growth factor receptor (EGFR). The committee review relate to the drug’s application for approval for the treatment of advanced non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations, as well as the dominant resistance mutation T790M. Rociletinib was designed to selectively target both the initial activating EGFR mutations and the dominant acquired T790M resistance mutation.
Around 15 percent of patients with NSCLC have the EGFR mutation. While the majority of these patients will respond to treatment with first- or second-generation EGFR-targeted tyrosine kinase inhibitors (TKIs), almost all patients will eventually develop acquired resistance to these therapies, predominantly due to the primary resistance mutation, T790M.
News & Comments
April 13, 2016
Good News from Juno Therapeutics and from Abbvie. Disappointing News for Clovis Oncology
Juno Therapeutics (JUNO) is due to receive a fee payment of $50 million from Celgene. The reason for this compensation is that Celgene has exercised its option to develop and commercialize Juno CD19 program outside North America and China.
From now on, Juno will share with Celgene the global development expenses for products in the CD19 program outside the U.S. and china and Celgene will have pay Juno a royalty at a percentage in the mid-teens on any future net sales of therapeutic products developed through the CD19 program in Celgene’s granted territories.
Juno retains commercialization rights in North America and China.
Juno has taken advantage of the announcement of the Celgene’s decision and the $50 payment to remind us of its CD19-directed product candidates in clinical development. These products comprise:
JCAR015: In a Phase 2 trial for adults with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL).
JCAR017: In two separate Phase 1 trials, one in pediatric patients with r/r ALL and another in patients with r/r non-Hodgkin lymphoma (NHL).
JCAR014: In a Phase 1 trial in three different indications, adult r/r/ ALL, r/r NHL, and r/r chronic lymphocytic leukemia (CLL), as well as a trial in combination with AstraZeneca’s investigational programmed death ligand 1 (PD-L1) immune checkpoint inhibitor, durvalumab.
Juno also reminds that its CD19-directed portfolio of drug candidates has already demonstrated encouraging efficacy and manageable toxicity in trials to date across a range of B cell malignancies.
In the same press release, Celgene’s Chief Scientific Officer Robert Hershberg, M.D., Ph.D., confirmed the firm’s intention for a long-term collaboration with Juno as its “CD19-based CAR T therapies hold great promise in B cell malignancies including acute lymphoblastic leukemia, non-Hodgkin lymphoma, and chronic lymphocytic leukemia. The experience with CD19 will inform additional targets and approaches as the Celgene-Juno collaboration evolves”, stated Cegene’s chief.
We remind the reader that Juno is one of the major firms developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute.
Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19 directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital.
Prohost Observations
Chimeric antigen receptor (CAR-T) and high-affinity T cell receptor (TCR) technologies involve genetically engineering T cells to recognize and kill cancer. The breakthrough Immunotherapy has great promises. We believe these technologies are born to survive and flourish and cross the border of the liquid cancers to treat solid cancers. The firm is managing to overcome the side effects of the approach and is working diligently towards preventing them. CAR-T and TCR products will be approved and will advance the treatment of cancer
——————————————————————————————————————————————————-
Drug Approvals
The FDA approved Venclexta (venetoclax) developed by Abbvie (ABBV) in partnership with Roche for chronic lymphocytic leukemia (CLL). The drug is for CLL patients who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. These patients lack a portion of the chromosome that acts to suppress cancer growth. This chromosomal abnormality occurs in approximately 10 percent of patients with untreated CLL and in approximately 20 percent of patients with relapsed CLL.
Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein that helps the cancer cells stay alive and supports the malignant cells’ growth. The BCL-2 protein is overexpressed in many CLL patients.
The efficacy of Venclexta was tested in a single-arm clinical trial of 106 patients with CLL who have a 17p deletion and who had received at least one prior therapy. Trial participants took Venclexta orally every day, beginning with 20 mg and increasing over a five-week period to 400 mg. Results showed that 80 percent of trial participants experienced a complete or partial remission of their cancer.
Venclexta is indicated for daily use after the detection of 17p deletion is confirmed through the use of the FDA-approved companion diagnostic Vysis CLL FISH probe kit.
The most common side effects: Venclexta side effects include low white blood cell count (neutropenia), diarrhea, nausea, anemia, upper respiratory tract infection, low platelet count (thrombocytopenia) and fatigue. Serious complications can include pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, anemia and metabolic abnormalities known as tumor lysis syndrome. Live attenuated vaccines should not be given to patients taking Venclexta.
The FDA had granted the Venclexta application breakthrough therapy designation, priority review and acceerated approval. Venclexta also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.
Prohost Observations
More and more treatments have been developed and marketed for diseases that used to be as if caused by only one mutation. The advancement ofsequencers and gene analyzers led to a capability for pinpointing various pathological pathways for the same disease. Biotech firms having sound and solid scientific fundamentals are riding the wave of the flood of knowledge being rapidly accumulating about the molecular basis of diseases.
The approval of Venclexta is great news for Abbvie and for Roche. Even if the market is small, the disease is a killer and the breakthrough drug has added validation to Abbvie’s drug design and development capabilities.
——————————————————————————————————————————————
From The FDA Committee
Clovis Oncology(CLVS): The FDA Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA should wait for more results from an ongoing study before deciding upon approving Clovis lung cancer drug rociletinib.
The requited results are expected to come from the TIGER-3, Clovis’ ongoing Phase 3, randomized, controlled trial of rociletinib. Patient enrollment for the trial is expected to complete in late 2018.
The news was disappointing for Clovis, yet, it is not a denial of approval.
Rociletinib is a novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of the cancer-causing mutant forms of epidermal growth factor receptor (EGFR). The committee review relate to the drug’s application for approval for the treatment of advanced non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations, as well as the dominant resistance mutation T790M. Rociletinib was designed to selectively target both the initial activating EGFR mutations and the dominant acquired T790M resistance mutation.
Around 15 percent of patients with NSCLC have the EGFR mutation. While the majority of these patients will respond to treatment with first- or second-generation EGFR-targeted tyrosine kinase inhibitors (TKIs), almost all patients will eventually develop acquired resistance to these therapies, predominantly due to the primary resistance mutation, T790M.
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