Juno’s Investigational CAR T Cell Product Candidates JCAR014 and JCAR018 Demonstrate Encouraging Clinical Responses in Patients with B-Cell Cancers
— Promising accomplish response rates demonstrated in NHL and CLL —
— Clinical responses correlate with cell expansion and persistence —
— Analyst and Investor Event with Webcast on Monday, December seven at 8:30pm Eastern Time —
SEATTLE–( BUSINESS WIRE )–Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced, in partnership with its collaborators, that clinical data from a chimeric antigen receptor (CAR) T cell product candidate, JCAR014, demonstrated encouraging clinical responses in patients with relapsed or refractory (r/r) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Results will be introduced in an oral presentation today at the fifty four th Annual Meeting of the American Society of Hematology (ASH) in Orlando.
In addition, a poster presentation highlighted clinical data from JCAR018, a CAR T cell product candidate targeting CD22 that demonstrated preliminary safety and clinical activity in pediatric and youthfull adult r/r B-cell acute lymphoblastic leukemia (ALL) patients.
“Complete responses and the durability of those responses are key efficacy parameters in both NHL and CLL. The early data reported today are very encouraging and suggest that our CD19-directed CAR T product candidates have the potential to have a meaningful influence for patients with these difficult-to-treat diseases,” said Mark Frohlich, M.D., Executive Vice President, Development and Portfolio Strategy. “Our CD22-directed CAR T product candidate, JCAR018, has shown encouraging early signs of activity from the examine in pediatric patients with r/r ALL, where CD19 epitope loss with treatment emerges to be of enhancing relevance. We look forward to more data in two thousand sixteen as we proceed to treat patients at the current and higher dose levels.”
In an oral presentation on Sunday, December 6, 2015, Cameron J. Turtle, MBBS, Ph.D. of the Fred Hutchinson Cancer Research Center will present “Anti-CD19 Chimeric Antigen Receptor-Modified T Cell Therapy for B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Fludarabine and Cyclophosphamide Lymphodepletion Improves In Vivo Expansion and Persistence of CAR T Cells and Clinical Outcomes.” Dr. Turtle will be updating results on a total of forty one patients treated with JCAR014 against B-cell malignancies. Key data will include:
(1) The Two*106/kg dose highlighted in the box above represents the dose moving forward.
(Two) All patients in the Flu/Cy cohorts that achieved a CR remain in CR 2-9 months after therapy.
CR = finish response; PR = partial response
Median of five prior treatment regimens; sixteen patients failed prior autologous and/or allogeneic transplant.
29 out of thirty two patients had chemorefractory disease.
(1) All CLL patients have been previously treated with ibrutinib.
(Two) The flu/cy regimen highlighted in the box represents the conditioning regimen moving forward.
(Trio) All patients in CR remain in CR 2-14 months after therapy.
(Four) The patient died three months after therapy of pulmonary aspergillosis.
Key Takeaways include:
- JCAR014 (CD19-specific CAR T cells of defined subset composition) demonstrated potent anti-tumor activity and an acceptable toxicity profile in r/r adult B-cell NHL patients and CLL patients previously treated with ibrutinib.
- A meaningful percentage of patients achieved a finish response in both r/r NHL and r/r CLL.
- While longer follow-up is necessary to define total durability, there have been no relapses in NHL and CLL patients that achieved a accomplish response in this examine with follow-up ranging from two to fourteen months.
- The addition of fludarabine and cyclophosphamide (flu/cy) lymphodepletion improved CAR T cell peak expansion, persistence and clinical outcomes in NHL.
- Severe cytokine release syndrome and severe neurotoxicity were observed in some patients; lower doses of this defined cell product candidate appeared to correlate with lower rates of these toxicities.
In a poster presentation on Saturday, December Five, 2015, Terry J. Fry, M.D. of the Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, introduced “Clinical Activity and Persistence of Anti-CD22 Chimeric Antigen Receptor in Children and Youthfull Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL).” Dr. Fry reported on a first-in-human anti-CD22 CAR T cell therapy (JCAR018) in pediatric and youthful adult r/r B-cell ALL. Key takeaways include:
- JCAR018 provides a potential treatment alternative to patients with CD19 epitope loss variants, particularly relevant in pediatric ALL.
- In this Phase I dose-escalation trial, nine patients have enrolled and seven patients have been assessed to date.
- Six patients were treated with the lowest dose (Three x ten Five cells/kg), with one patient reaching MRD-negative CR, two patients having stable disease, and three patients having disease progression.
- Three patients have enrolled at the next dose (1 x ten 6 cells/kg), which is in the dose range of CD19-directed CAR T programs. One patient achieved an MRD-negative CR, and two patients are too early to assess for response.
- One patient at the lowest dose had Grade three diarrhea, and the maximum cytokine release syndrome was Grade Two.
ASH Investor and Analyst Event and Webcast
The Juno ASH Investor and Analyst Event and webcast will be held Monday, December 7, two thousand fifteen at 8:30p.m. Eastern Time. The webcast can be accessed live on the Investor Relations page of Juno’s website, www.JunoTherapeutics.com, and will be available for replay for thirty days following the event.
About Juno’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s chimeric antigen receptor (CAR) and T cell receptor technologies (TCR) genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inwards the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the figure’s immune system to treat cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next significant phases in medicine, Juno is 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 numerous cell-based product candidates to treat a multiplicity of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling evidence of tumor shrinkage in clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to leverage its cell-based platform to develop fresh product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute. Juno Therapeutics has an off the hook 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.
This press release contains forward-looking statements, including statements regarding Juno’s mission, progress, clinical benefits, clinical trial results and the implications thereof, planned presentations at ASH, clinical trial plans and emerging medical trends. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future spectacle. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno’s product development activities and clinical trials; Juno’s capability to obtain regulatory approval for and to commercialize its product candidates; Juno’s capability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno’s competitors with respect to challenging treatments and technologies; Juno’s dependence on third-party collaborators and other contractors in Juno’s research and development activities, including for the conduct of clinical trials and the manufacture of Juno’s product candidates; Juno’s dependence on Celgene for the development and commercialization outside of North America of product candidates for which Celgene exercises an option; Juno’s capability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those voiced in these forward-looking statements, as well as risks relating to Juno’s business in general, see Juno’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, two thousand fifteen and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.
Juno – s Investigational CAR T Cell Product Candidates JCAR014 and JCAR018 Demonstrate Encouraging Clinical Responses in Patients with B-Cell Cancers, Business Wire
Juno’s Investigational CAR T Cell Product Candidates JCAR014 and JCAR018 Demonstrate Encouraging Clinical Responses in Patients with B-Cell Cancers
— Promising accomplish response rates demonstrated in NHL and CLL —
— Clinical responses correlate with cell expansion and persistence —
— Analyst and Investor Event with Webcast on Monday, December seven at 8:30pm Eastern Time —
SEATTLE–( BUSINESS WIRE )–Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced, in partnership with its collaborators, that clinical data from a chimeric antigen receptor (CAR) T cell product candidate, JCAR014, demonstrated encouraging clinical responses in patients with relapsed or refractory (r/r) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Results will be introduced in an oral presentation today at the fifty four th Annual Meeting of the American Society of Hematology (ASH) in Orlando.
In addition, a poster presentation highlighted clinical data from JCAR018, a CAR T cell product candidate targeting CD22 that demonstrated preliminary safety and clinical activity in pediatric and youthfull adult r/r B-cell acute lymphoblastic leukemia (ALL) patients.
“Complete responses and the durability of those responses are key efficacy parameters in both NHL and CLL. The early data reported today are very encouraging and suggest that our CD19-directed CAR T product candidates have the potential to have a meaningful influence for patients with these difficult-to-treat diseases,” said Mark Frohlich, M.D., Executive Vice President, Development and Portfolio Strategy. “Our CD22-directed CAR T product candidate, JCAR018, has shown encouraging early signs of activity from the probe in pediatric patients with r/r ALL, where CD19 epitope loss with treatment shows up to be of enlargening relevance. We look forward to more data in two thousand sixteen as we proceed to treat patients at the current and higher dose levels.”
In an oral presentation on Sunday, December 6, 2015, Cameron J. Turtle, MBBS, Ph.D. of the Fred Hutchinson Cancer Research Center will present “Anti-CD19 Chimeric Antigen Receptor-Modified T Cell Therapy for B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Fludarabine and Cyclophosphamide Lymphodepletion Improves In Vivo Expansion and Persistence of CAR T Cells and Clinical Outcomes.” Dr. Turtle will be updating results on a total of forty one patients treated with JCAR014 against B-cell malignancies. Key data will include:
(1) The Two*106/kg dose highlighted in the box above represents the dose moving forward.
(Two) All patients in the Flu/Cy cohorts that achieved a CR remain in CR 2-9 months after therapy.
CR = accomplish response; PR = partial response
Median of five prior treatment regimens; sixteen patients failed prior autologous and/or allogeneic transplant.
29 out of thirty two patients had chemorefractory disease.
(1) All CLL patients have been previously treated with ibrutinib.
(Two) The flu/cy regimen highlighted in the box represents the conditioning regimen moving forward.
(Three) All patients in CR remain in CR 2-14 months after therapy.
(Four) The patient died three months after therapy of pulmonary aspergillosis.
Key Takeaways include:
- JCAR014 (CD19-specific CAR T cells of defined subset composition) demonstrated potent anti-tumor activity and an acceptable toxicity profile in r/r adult B-cell NHL patients and CLL patients previously treated with ibrutinib.
- A meaningful percentage of patients achieved a accomplish response in both r/r NHL and r/r CLL.
- While longer follow-up is necessary to define total durability, there have been no relapses in NHL and CLL patients that achieved a accomplish response in this investigate with follow-up ranging from two to fourteen months.
- The addition of fludarabine and cyclophosphamide (flu/cy) lymphodepletion improved CAR T cell peak expansion, persistence and clinical outcomes in NHL.
- Severe cytokine release syndrome and severe neurotoxicity were observed in some patients; lower doses of this defined cell product candidate appeared to correlate with lower rates of these toxicities.
In a poster presentation on Saturday, December Five, 2015, Terry J. Fry, M.D. of the Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, introduced “Clinical Activity and Persistence of Anti-CD22 Chimeric Antigen Receptor in Children and Youthful Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL).” Dr. Fry reported on a first-in-human anti-CD22 CAR T cell therapy (JCAR018) in pediatric and youthful adult r/r B-cell ALL. Key takeaways include:
- JCAR018 provides a potential treatment alternative to patients with CD19 epitope loss variants, particularly relevant in pediatric ALL.
- In this Phase I dose-escalation trial, nine patients have enrolled and seven patients have been assessed to date.
- Six patients were treated with the lowest dose (Trio x ten Five cells/kg), with one patient reaching MRD-negative CR, two patients having stable disease, and three patients having disease progression.
- Three patients have enrolled at the next dose (1 x ten 6 cells/kg), which is in the dose range of CD19-directed CAR T programs. One patient achieved an MRD-negative CR, and two patients are too early to assess for response.
- One patient at the lowest dose had Grade three diarrhea, and the maximum cytokine release syndrome was Grade Two.
ASH Investor and Analyst Event and Webcast
The Juno ASH Investor and Analyst Event and webcast will be held Monday, December 7, two thousand fifteen at 8:30p.m. Eastern Time. The webcast can be accessed live on the Investor Relations page of Juno’s website, www.JunoTherapeutics.com, and will be available for replay for thirty days following the event.
About Juno’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s chimeric antigen receptor (CAR) and T cell receptor technologies (TCR) genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inwards the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the figure’s immune system to treat cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next significant phases in medicine, Juno is 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 numerous cell-based product candidates to treat a diversity of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling evidence of tumor shrinkage in clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to leverage its cell-based platform to develop fresh product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute. Juno Therapeutics has an special 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.
This press release contains forward-looking statements, including statements regarding Juno’s mission, progress, clinical benefits, clinical trial results and the implications thereof, planned presentations at ASH, clinical trial plans and emerging medical trends. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future spectacle. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno’s product development activities and clinical trials; Juno’s capability to obtain regulatory approval for and to commercialize its product candidates; Juno’s capability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno’s competitors with respect to contesting treatments and technologies; Juno’s dependence on third-party collaborators and other contractors in Juno’s research and development activities, including for the conduct of clinical trials and the manufacture of Juno’s product candidates; Juno’s dependence on Celgene for the development and commercialization outside of North America of product candidates for which Celgene exercises an option; Juno’s capability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those voiced in these forward-looking statements, as well as risks relating to Juno’s business in general, see Juno’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, two thousand fifteen and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.
Juno – s Investigational CAR T Cell Product Candidates JCAR014 and JCAR018 Demonstrate Encouraging Clinical Responses in Patients with B-Cell Cancers, Business Wire
Juno’s Investigational CAR T Cell Product Candidates JCAR014 and JCAR018 Demonstrate Encouraging Clinical Responses in Patients with B-Cell Cancers
— Promising finish response rates demonstrated in NHL and CLL —
— Clinical responses correlate with cell expansion and persistence —
— Analyst and Investor Event with Webcast on Monday, December seven at 8:30pm Eastern Time —
SEATTLE–( BUSINESS WIRE )–Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced, in partnership with its collaborators, that clinical data from a chimeric antigen receptor (CAR) T cell product candidate, JCAR014, demonstrated encouraging clinical responses in patients with relapsed or refractory (r/r) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Results will be introduced in an oral presentation today at the fifty four th Annual Meeting of the American Society of Hematology (ASH) in Orlando.
In addition, a poster presentation highlighted clinical data from JCAR018, a CAR T cell product candidate targeting CD22 that demonstrated preliminary safety and clinical activity in pediatric and youthfull adult r/r B-cell acute lymphoblastic leukemia (ALL) patients.
“Complete responses and the durability of those responses are key efficacy parameters in both NHL and CLL. The early data reported today are very encouraging and suggest that our CD19-directed CAR T product candidates have the potential to have a meaningful influence for patients with these difficult-to-treat diseases,” said Mark Frohlich, M.D., Executive Vice President, Development and Portfolio Strategy. “Our CD22-directed CAR T product candidate, JCAR018, has shown encouraging early signs of activity from the explore in pediatric patients with r/r ALL, where CD19 epitope loss with treatment shows up to be of enlargening relevance. We look forward to more data in two thousand sixteen as we proceed to treat patients at the current and higher dose levels.”
In an oral presentation on Sunday, December 6, 2015, Cameron J. Turtle, MBBS, Ph.D. of the Fred Hutchinson Cancer Research Center will present “Anti-CD19 Chimeric Antigen Receptor-Modified T Cell Therapy for B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Fludarabine and Cyclophosphamide Lymphodepletion Improves In Vivo Expansion and Persistence of CAR T Cells and Clinical Outcomes.” Dr. Turtle will be updating results on a total of forty one patients treated with JCAR014 against B-cell malignancies. Key data will include:
(1) The Two*106/kg dose highlighted in the box above represents the dose moving forward.
(Two) All patients in the Flu/Cy cohorts that achieved a CR remain in CR 2-9 months after therapy.
CR = finish response; PR = partial response
Median of five prior treatment regimens; sixteen patients failed prior autologous and/or allogeneic transplant.
29 out of thirty two patients had chemorefractory disease.
(1) All CLL patients have been previously treated with ibrutinib.
(Two) The flu/cy regimen highlighted in the box represents the conditioning regimen moving forward.
(Three) All patients in CR remain in CR 2-14 months after therapy.
(Four) The patient died three months after therapy of pulmonary aspergillosis.
Key Takeaways include:
- JCAR014 (CD19-specific CAR T cells of defined subset composition) demonstrated potent anti-tumor activity and an acceptable toxicity profile in r/r adult B-cell NHL patients and CLL patients previously treated with ibrutinib.
- A meaningful percentage of patients achieved a finish response in both r/r NHL and r/r CLL.
- While longer follow-up is necessary to define utter durability, there have been no relapses in NHL and CLL patients that achieved a finish response in this explore with follow-up ranging from two to fourteen months.
- The addition of fludarabine and cyclophosphamide (flu/cy) lymphodepletion improved CAR T cell peak expansion, persistence and clinical outcomes in NHL.
- Severe cytokine release syndrome and severe neurotoxicity were observed in some patients; lower doses of this defined cell product candidate appeared to correlate with lower rates of these toxicities.
In a poster presentation on Saturday, December Five, 2015, Terry J. Fry, M.D. of the Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, introduced “Clinical Activity and Persistence of Anti-CD22 Chimeric Antigen Receptor in Children and Youthful Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL).” Dr. Fry reported on a first-in-human anti-CD22 CAR T cell therapy (JCAR018) in pediatric and youthfull adult r/r B-cell ALL. Key takeaways include:
- JCAR018 provides a potential treatment alternative to patients with CD19 epitope loss variants, particularly relevant in pediatric ALL.
- In this Phase I dose-escalation trial, nine patients have enrolled and seven patients have been assessed to date.
- Six patients were treated with the lowest dose (Trio x ten Five cells/kg), with one patient reaching MRD-negative CR, two patients having stable disease, and three patients having disease progression.
- Three patients have enrolled at the next dose (1 x ten 6 cells/kg), which is in the dose range of CD19-directed CAR T programs. One patient achieved an MRD-negative CR, and two patients are too early to assess for response.
- One patient at the lowest dose had Grade three diarrhea, and the maximum cytokine release syndrome was Grade Two.
ASH Investor and Analyst Event and Webcast
The Juno ASH Investor and Analyst Event and webcast will be held Monday, December 7, two thousand fifteen at 8:30p.m. Eastern Time. The webcast can be accessed live on the Investor Relations page of Juno’s website, www.JunoTherapeutics.com, and will be available for replay for thirty days following the event.
About Juno’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s chimeric antigen receptor (CAR) and T cell receptor technologies (TCR) genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inwards the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on revolutionizing medicine by re-engaging the assets’s immune system to treat cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next significant phases in medicine, Juno is 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 numerous cell-based product candidates to treat a multiplicity of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling evidence of tumor shrinkage in clinical trials in refractory leukemia and lymphoma conducted to date. Juno’s long-term aim is to leverage its cell-based platform to develop fresh product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world’s leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children’s Research Institute, and The National Cancer Institute. Juno Therapeutics has an off the hook 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.
This press release contains forward-looking statements, including statements regarding Juno’s mission, progress, clinical benefits, clinical trial results and the implications thereof, planned presentations at ASH, clinical trial plans and emerging medical trends. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future spectacle. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno’s product development activities and clinical trials; Juno’s capability to obtain regulatory approval for and to commercialize its product candidates; Juno’s capability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno’s competitors with respect to challenging treatments and technologies; Juno’s dependence on third-party collaborators and other contractors in Juno’s research and development activities, including for the conduct of clinical trials and the manufacture of Juno’s product candidates; Juno’s dependence on Celgene for the development and commercialization outside of North America of product candidates for which Celgene exercises an option; Juno’s capability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those voiced in these forward-looking statements, as well as risks relating to Juno’s business in general, see Juno’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, two thousand fifteen and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.