Relypsa (NASDAQ: RLYP) will present results of sub-group analyses from the OPAL-HK study of Veltassa (patiromer) for oral suspension at the American Society of Nephrology's (ASN) Kidney Week 2015, taking place November 3 - 8 in San Diego, CA.
The event has been added to the Binary Event Calendar.
Veltassa was recently approved by the U.S. Food and Drug Administration (FDA) as the first new medicine for the treatment of hyperkalemia in more than 50 years.
Here's the release.
Saturday, October 31, 2015
Relypsa Announces Data for Veltassa (patiromer) to be Presented at ASN Kidney Week 2015
-OPAL-HK sub-group analysis in hyperkalemic chronic kidney disease (CKD) patients age 65 or older will be featured in oral presentation
-Poster presentation will highlight data from OPAL-HK patients treated with Veltassa taking diuretics
-Company to host webcasted investor event and corporate update with Matthew R. Weir, M.D. on November 5
REDWOOD CITY, Calif., Oct. 29, 2015 (GLOBE NEWSWIRE) -- Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that the results of sub-group analyses from the OPAL-HK study of Veltassa™ (patiromer) for oral suspension will be presented at the American Society of Nephrology's (ASN) Kidney Week 2015, taking place November 3 - 8 in San Diego, Calif. Veltassa was recently approved by the U.S. Food and Drug Administration (FDA) as the first new medicine for the treatment of hyperkalemia in more than 50 years.
Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine will present results of a pre-specified sub-group analysis of hyperkalemic chronic kidney disease patients age 65 years or older who were receiving renin angiotensin aldosterone system (RAAS) inhibitor therapy during an oral presentation on Thursday, November 5, 2015. Separately, a poster presentation will highlight results of a sub-group analysis within the treatment phase of OPAL-HK, comparing the effects of Veltassa in patients taking different types of diuretics with patients not receiving diuretics.
Additionally, two new posters will be presented regarding variation of potassium levels prior to and during controlled dieting, and the association between antihypertensive medications and hyperkalemia in a large health system. Details for the oral presentation and posters are listed below.
Investor Event and Webcast, Thursday, November 5, 2015 at 3:00 p.m. PT (6:00 p.m. ET)
Relypsa will host an investor event during which Dr. Weir will share his perspective on hyperkalemia and Veltassa as a new therapeutic option. Relypsa management will also be in attendance. The presentation will be followed by a Q&A session and reception.
The event will take place Thursday, November 5, 2015 at 3:00 p.m. PT (6:00 p.m. ET). The webcast may be accessed by phone by calling (866) 410-4428 (domestic) or +1 (704) 908-0287 (international), conference code 60411058, or on the investor relations section of the Relypsa website at http://investor.relypsa.com. It will be archived for 30 days following the call.
Veltassa Oral Presentation
Abstract Title: Patiromer lowers serum K+ and prevents recurrent hyperkalemia in CKD patients ≥65 years of age on RAAS inhibitors
Presenter: Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine
Session: Clinical Trials in CKD: Pursuing a New Horizon
Number: TH-OR035
Date and Time: Thursday, November 5
Location: Room 25
Session Time: 4:30 - 6:30 p.m. PT
Presentation Time: 5:18 p.m. PT
Veltassa Poster Presentation
Abstract Title: Chronic diuretic therapy does not impair the effectiveness of patiromer in hyperkalemic patients with CKD
Presenter: Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine
Session: CKD: Clinical Trials
Number: TH-PO658
Date and Time: Thursday, November 5, 10 a.m. -- 12 p.m. PT
Hyperkalemia Poster Presentations of Interest
Abstract Title: Wide range in variation in serum potassium in hyperkalemic patients with CKD, response to a fixed 60 mEq potassium diet
Presenter: David Bushinsky, M.D., John J. Kuiper Distinguished Professor of Medicine and of Pharmacology and Physiology at the University of Rochester School of Medicine, and Chief of the Nephrology Division at the University of Rochester Medical Center
Session: Fluid, Electrolyte, and Acid-Base Disorders
Number: SA-PO924
Date and Time: Saturday, November 7, 10 a.m. — 12:00 p.m. PT
Abstract Title: Antihypertensive medications and the prevalence of hyperkalemia in a large health system
Presenter: Alex R. Chang, M.D., Geisinger Health System, Danville, Penn.
Session: Fluid, Electrolyte, and Acid-Base Disorders
Number: SA-PO923
Date and Time: Saturday, November 7, 10 a.m. — 12:00 p.m. PT
About Hyperkalemia
Approximately 3 million people in the United States with stage 3 or 4 CKD and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are frequently prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include RAAS inhibitors such as ARBs (angiotensin receptor blockers), AAs (aldosterone antagonists) and ACE (angiotensin-converting-enzyme) inhibitors.
About Veltassa
Veltassa is a potassium binder approved by the FDA for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Made in powder form consisting of smooth, spherical beads, this new medicine is mixed with water (90 milliliters or 3 ounces) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.
IMPORTANT SAFETY INFORMATION
The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. Other oral medications should be administered at least 6 hours before or 6 hours after Veltassa. Doctors should choose Veltassa or the other oral medication if adequate dosing separation is not possible.
Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.
Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.
Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value
Adverse Reactions
The most common adverse reactions (incidence ≥ 2 percent) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.
For additional Important Safety Information and Veltassa's full Prescribing Information, please visit www.relypsa.com/veltassa/prescribing-information.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, VeltassaTM (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.
Contact:
Charlotte Arnold
Vice President, Corporate Communications
650.421.9352
IR@relypsa.com
-Poster presentation will highlight data from OPAL-HK patients treated with Veltassa taking diuretics
-Company to host webcasted investor event and corporate update with Matthew R. Weir, M.D. on November 5
REDWOOD CITY, Calif., Oct. 29, 2015 (GLOBE NEWSWIRE) -- Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that the results of sub-group analyses from the OPAL-HK study of Veltassa™ (patiromer) for oral suspension will be presented at the American Society of Nephrology's (ASN) Kidney Week 2015, taking place November 3 - 8 in San Diego, Calif. Veltassa was recently approved by the U.S. Food and Drug Administration (FDA) as the first new medicine for the treatment of hyperkalemia in more than 50 years.
Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine will present results of a pre-specified sub-group analysis of hyperkalemic chronic kidney disease patients age 65 years or older who were receiving renin angiotensin aldosterone system (RAAS) inhibitor therapy during an oral presentation on Thursday, November 5, 2015. Separately, a poster presentation will highlight results of a sub-group analysis within the treatment phase of OPAL-HK, comparing the effects of Veltassa in patients taking different types of diuretics with patients not receiving diuretics.
Additionally, two new posters will be presented regarding variation of potassium levels prior to and during controlled dieting, and the association between antihypertensive medications and hyperkalemia in a large health system. Details for the oral presentation and posters are listed below.
Investor Event and Webcast, Thursday, November 5, 2015 at 3:00 p.m. PT (6:00 p.m. ET)
Relypsa will host an investor event during which Dr. Weir will share his perspective on hyperkalemia and Veltassa as a new therapeutic option. Relypsa management will also be in attendance. The presentation will be followed by a Q&A session and reception.
The event will take place Thursday, November 5, 2015 at 3:00 p.m. PT (6:00 p.m. ET). The webcast may be accessed by phone by calling (866) 410-4428 (domestic) or +1 (704) 908-0287 (international), conference code 60411058, or on the investor relations section of the Relypsa website at http://investor.relypsa.com. It will be archived for 30 days following the call.
Veltassa Oral Presentation
Abstract Title: Patiromer lowers serum K+ and prevents recurrent hyperkalemia in CKD patients ≥65 years of age on RAAS inhibitors
Presenter: Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine
Session: Clinical Trials in CKD: Pursuing a New Horizon
Number: TH-OR035
Date and Time: Thursday, November 5
Location: Room 25
Session Time: 4:30 - 6:30 p.m. PT
Presentation Time: 5:18 p.m. PT
Veltassa Poster Presentation
Abstract Title: Chronic diuretic therapy does not impair the effectiveness of patiromer in hyperkalemic patients with CKD
Presenter: Matthew R. Weir, M.D., professor and director, Division of Nephrology, University of Maryland School of Medicine
Session: CKD: Clinical Trials
Number: TH-PO658
Date and Time: Thursday, November 5, 10 a.m. -- 12 p.m. PT
Hyperkalemia Poster Presentations of Interest
Abstract Title: Wide range in variation in serum potassium in hyperkalemic patients with CKD, response to a fixed 60 mEq potassium diet
Presenter: David Bushinsky, M.D., John J. Kuiper Distinguished Professor of Medicine and of Pharmacology and Physiology at the University of Rochester School of Medicine, and Chief of the Nephrology Division at the University of Rochester Medical Center
Session: Fluid, Electrolyte, and Acid-Base Disorders
Number: SA-PO924
Date and Time: Saturday, November 7, 10 a.m. — 12:00 p.m. PT
Abstract Title: Antihypertensive medications and the prevalence of hyperkalemia in a large health system
Presenter: Alex R. Chang, M.D., Geisinger Health System, Danville, Penn.
Session: Fluid, Electrolyte, and Acid-Base Disorders
Number: SA-PO923
Date and Time: Saturday, November 7, 10 a.m. — 12:00 p.m. PT
About Hyperkalemia
Approximately 3 million people in the United States with stage 3 or 4 CKD and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are frequently prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include RAAS inhibitors such as ARBs (angiotensin receptor blockers), AAs (aldosterone antagonists) and ACE (angiotensin-converting-enzyme) inhibitors.
About Veltassa
Veltassa is a potassium binder approved by the FDA for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Made in powder form consisting of smooth, spherical beads, this new medicine is mixed with water (90 milliliters or 3 ounces) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.
IMPORTANT SAFETY INFORMATION
The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. Other oral medications should be administered at least 6 hours before or 6 hours after Veltassa. Doctors should choose Veltassa or the other oral medication if adequate dosing separation is not possible.
Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.
Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.
Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value
Adverse Reactions
The most common adverse reactions (incidence ≥ 2 percent) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.
For additional Important Safety Information and Veltassa's full Prescribing Information, please visit www.relypsa.com/veltassa/prescribing-information.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, VeltassaTM (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.
Contact:
Charlotte Arnold
Vice President, Corporate Communications
650.421.9352
IR@relypsa.com
Adaptimmune to Present Data at Society of Immunotherapy for Cancer Meeting
Adaptimmune (NASDAQ: ADAP) just announced an upcoming data presentation at the 2015 Annual Meeting of the Society of Immunotherapy for Cancer, or SITC. The company will present new data from its NY-ESO affinity enhanced T-cell therapy in patients with synovial sarcoma and myeloma, as well as data from preclinical safety assessments of its affinity enhanced T-cell therapy directed at MAGE A-10.
The presentations will take place at the McCormick Place exhibition center in National Harbor, MD on November 6, 2015 in the Prince George’s Exhibition Hall from 12:45 to 2:00 pm
The date has been added to the Binary Event Calendar.
Here's the release.
The presentations will take place at the McCormick Place exhibition center in National Harbor, MD on November 6, 2015 in the Prince George’s Exhibition Hall from 12:45 to 2:00 pm
The date has been added to the Binary Event Calendar.
Here's the release.
Adaptimmune Announces Upcoming Data Presentation at the 2015 Annual Meeting of the Society of Immunotherapy for Cancer (SITC)
PHILADELPHIA, Pa and OXFORD, United Kingdom, October 30, 2015 – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that it will present new data from trials of its NY-ESO affinity enhanced T-cell therapy in patients with synovial sarcoma and myeloma, as well as data from preclinical safety assessments of its affinity enhanced T-cell therapy directed at MAGE A-10, at the 2015 Annual Meeting of the Society of Immunotherapy for Cancer (SITC). SITC is the world’s leading member-driven organization specifically dedicated to professionals working in the field of cancer immunology and immunotherapy. The meeting will take place at the McCormick Place exhibition center in National Harbor, MD on November 4 through 8, 2015.
Adaptimmune’s poster presentations will take place on November 6, 2015 in the Prince George’s Exhibition Hall from 12:45 to 2:00 pm and are as follows:
Friday November 6, 2015
Poster Presentations
Presentation Time: 12:45-2:00 pm
Location: Prince George's Exhibition Hall
Track Name: Clinical Trials in Progress
Abstract number: 112286
Title: “Optimizing engineered TCR T-cell therapy for synovial sarcoma”
Sandra D’Angelo, M.D., Assistant Attending, Sarcoma Medical Oncology / Immunotherapeutics Core at Memorial Sloan-Kettering Cancer Center will provide additional data from the Company’s NY-ESO-1 synovial sarcoma study. Updates will include data on the expanded study group, longer follow-up and time-to-event, as well as updated correlative and safety data, and characterization of the product pre and post infusion.
Track Name: Mechanisms and Responses to Immune Therapy
Abstract number: 112346
Title: “Deep phenotypic characterization of NY-ESO TCR engineered T cells and tumor in patients with advanced myeloma”
Presenter: Eduardo Davila, Ph.D., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, Program Leader for Tumor Immunology and Immunotherapy Research Program at the Greenebaum Cancer Center at the University of Maryland will present follow-up data from the recently published Nature Medicine paper, including details on NY-ESO-1 T-cell phenotyping and functional data, as well as clinical and basic correlative data in myeloma patients.
Track Name: Adoptive Immunotherapy
Abstract number: 112244
Title: “Preclinical safety testing of an affinity-optimized MAGE-A10 T cell receptor for adoptive T cell therapy”
Presenter: Andrew Gerry, Ph.D., Director of Preclinical Research, Adaptimmune Therapeutics will provide a summary of the preclinical safety testing of the Company’s next affinity optimized TCR entering clinical studies in 2015, an affinity-enhanced T-cell therapy targeting MAGE-A10 in patients with non-small cell lung cancer.
Adaptimmune’s affinity enhanced T-cell candidates are novel cancer immunotherapies that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidate, significantly impact cancer treatment and clinical outcomes of patients with multiple solid and hematologic cancers.
About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company focused on novel cancer immunotherapy products based on its T-cell receptor (TCR) platform. Established in 2008, the Company aims to utilize the body’s own machinery – the T-cell – to target and destroy cancer cells by using engineered, increased affinity TCRs as a means of strengthening natural patient T-cell responses. Adaptimmune’s lead program is an affinity enhanced T-cell therapy targeting the NY-ESO cancer antigen. Its NY-ESO TCR affinity enhanced T-cell therapy has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hematologic cancer types, including synovial sarcoma and multiple myeloma. As of June 30, 2015, 85 patients had been treated with Adaptimmune’s NY-ESO affinity enhanced T-cell therapy: 47 under Adaptimmune’s IND, and 38 under a National Cancer Institute IND. In June 2014, Adaptimmune announced that it had entered into a strategic collaboration and licensing agreement with GlaxoSmithKline (GSK) for the development and commercialization of the NY-ESO TCR program in partnership with GSK. In addition, Adaptimmune has a number of proprietary programs and its next affinity enhanced T-cell therapy, directed at MAGE A-10, is scheduled to enter the clinic in 2015. The Company has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is currently progressing 12 through unpartnered research programs. Adaptimmune has over 190 employees and is located in Oxfordshire, U.K. and Philadelphia, USA. For more information: http://www.adaptimmune.com
Forward-Looking Statements
This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “believe,” “may”, “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and other words of similar meaning. These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials; our ability to submit an IND and successfully advance our technology platform to improve the safety and effectiveness of our existing TCR therapeutic candidates; the rate and degree of market acceptance of T-cell therapy generally and of our TCR therapeutic candidates; government regulation and approval, including, but not limited to, the expected regulatory approval timelines for TCR therapeutic candidates; and our ability to protect our proprietary technology and enforce our intellectual property rights; amongst others. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 20-F filed with the Securities and Exchange Commission on October 13, 2015. We urge you to consider these factors carefully in evaluating the forward-looking statements herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Adaptimmune Contacts
Will Roberts
Vice President, Investor Relations
T: (215) 966-6264
E: will.roberts@adaptimmune.com
Margaret Henry
Head of PR
T: +44 (0)1235 430036
Mob: +44 (0)7710 304249
E: margaret.henry@adaptimmune.com
Adaptimmune’s poster presentations will take place on November 6, 2015 in the Prince George’s Exhibition Hall from 12:45 to 2:00 pm and are as follows:
Friday November 6, 2015
Poster Presentations
Presentation Time: 12:45-2:00 pm
Location: Prince George's Exhibition Hall
Track Name: Clinical Trials in Progress
Abstract number: 112286
Title: “Optimizing engineered TCR T-cell therapy for synovial sarcoma”
Sandra D’Angelo, M.D., Assistant Attending, Sarcoma Medical Oncology / Immunotherapeutics Core at Memorial Sloan-Kettering Cancer Center will provide additional data from the Company’s NY-ESO-1 synovial sarcoma study. Updates will include data on the expanded study group, longer follow-up and time-to-event, as well as updated correlative and safety data, and characterization of the product pre and post infusion.
Track Name: Mechanisms and Responses to Immune Therapy
Abstract number: 112346
Title: “Deep phenotypic characterization of NY-ESO TCR engineered T cells and tumor in patients with advanced myeloma”
Presenter: Eduardo Davila, Ph.D., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, Program Leader for Tumor Immunology and Immunotherapy Research Program at the Greenebaum Cancer Center at the University of Maryland will present follow-up data from the recently published Nature Medicine paper, including details on NY-ESO-1 T-cell phenotyping and functional data, as well as clinical and basic correlative data in myeloma patients.
Track Name: Adoptive Immunotherapy
Abstract number: 112244
Title: “Preclinical safety testing of an affinity-optimized MAGE-A10 T cell receptor for adoptive T cell therapy”
Presenter: Andrew Gerry, Ph.D., Director of Preclinical Research, Adaptimmune Therapeutics will provide a summary of the preclinical safety testing of the Company’s next affinity optimized TCR entering clinical studies in 2015, an affinity-enhanced T-cell therapy targeting MAGE-A10 in patients with non-small cell lung cancer.
Adaptimmune’s affinity enhanced T-cell candidates are novel cancer immunotherapies that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidate, significantly impact cancer treatment and clinical outcomes of patients with multiple solid and hematologic cancers.
About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company focused on novel cancer immunotherapy products based on its T-cell receptor (TCR) platform. Established in 2008, the Company aims to utilize the body’s own machinery – the T-cell – to target and destroy cancer cells by using engineered, increased affinity TCRs as a means of strengthening natural patient T-cell responses. Adaptimmune’s lead program is an affinity enhanced T-cell therapy targeting the NY-ESO cancer antigen. Its NY-ESO TCR affinity enhanced T-cell therapy has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hematologic cancer types, including synovial sarcoma and multiple myeloma. As of June 30, 2015, 85 patients had been treated with Adaptimmune’s NY-ESO affinity enhanced T-cell therapy: 47 under Adaptimmune’s IND, and 38 under a National Cancer Institute IND. In June 2014, Adaptimmune announced that it had entered into a strategic collaboration and licensing agreement with GlaxoSmithKline (GSK) for the development and commercialization of the NY-ESO TCR program in partnership with GSK. In addition, Adaptimmune has a number of proprietary programs and its next affinity enhanced T-cell therapy, directed at MAGE A-10, is scheduled to enter the clinic in 2015. The Company has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is currently progressing 12 through unpartnered research programs. Adaptimmune has over 190 employees and is located in Oxfordshire, U.K. and Philadelphia, USA. For more information: http://www.adaptimmune.com
Forward-Looking Statements
This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “believe,” “may”, “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and other words of similar meaning. These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials; our ability to submit an IND and successfully advance our technology platform to improve the safety and effectiveness of our existing TCR therapeutic candidates; the rate and degree of market acceptance of T-cell therapy generally and of our TCR therapeutic candidates; government regulation and approval, including, but not limited to, the expected regulatory approval timelines for TCR therapeutic candidates; and our ability to protect our proprietary technology and enforce our intellectual property rights; amongst others. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 20-F filed with the Securities and Exchange Commission on October 13, 2015. We urge you to consider these factors carefully in evaluating the forward-looking statements herein and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Adaptimmune Contacts
Will Roberts
Vice President, Investor Relations
T: (215) 966-6264
E: will.roberts@adaptimmune.com
Margaret Henry
Head of PR
T: +44 (0)1235 430036
Mob: +44 (0)7710 304249
E: margaret.henry@adaptimmune.com
Thursday, October 29, 2015
OncoMed to Present Multiple Abstracts at AACR-NCI-EORTC International Conference
OncoMed (NASDAQ: OMED) Announces Multiple Abstracts Accepted for Presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics:
The company will present three abstracts, including results from a Phase 1 trial with novel cancer stem cell (CSC) targeting antibody brontictuzumab (OMP-52M51, anti-Notch1) in solid tumors.
It will present on Sunday, November 8, 2015 12:30 pm - 3:30 pm in Exhibit hall C-D, and the date has been added to the Binary Event Calendar.
Here's the release:
REDWOOD CITY, Calif., Oct. 27, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) announced that data related to three of its clinical-stage programs will be presented at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place November 5-9, 2015 in Boston, MA.
Among the abstracts accepted for presentation are Phase 1a data for single-agent brontictuzumab (anti-Notch1, OMP-52M51) in advanced solid tumors, including initial results from an expansion cohort of patients whose tumors demonstrate an overexpression of the activated form of Notch1 as measured by a companion biomarker. In addition, biomarker data for vantictumab (anti-Fzd7, OMP-18R5) in non-small cell lung cancer, as well as results of preclinical studies for OncoMed's anti-DLL4/VEGF bispecific (OMP-305B83), will also be presented. Details for the presentation are provided below.
Friday, November 6, 2015
Abstract #A30: Predictive and pharmacodynamic biomarkers of vantictumab (OMP-18R5; anti-Frizzled) in non-small cell lung cancer
Lead author: Ann Kapoun, Ph.D., OncoMed
Poster session A: Biomarkers
Time and location: 12:15 pm - 3:15 pm / Exhibit hall C-D
Sunday, November 8, 2015
Abstract #C42: Safety and preliminary efficacy results of a first-in-human Phase I study of the novel cancer stem cell (CSC) targeting antibody brontictuzumab (OMP-52M51, anti-Notch1) administered intravenously to patients with certain advanced solid tumors
Lead author: Pamela Munster, M.D., University of California, San Francisco
Poster session C: Clinical Trials
Location and time: 12:30 pm - 3:30 pm / Exhibit hall C-D
Abstract #C164: Dual targeting of the DLL4 and VEGF pathways with a bispecific monoclonal antibody inhibits tumor growth and reduces cancer stem cell frequency
Lead author: Wang-Ching Yen, Ph.D., OncoMed
Poster session C: Therapeutic Agents: Biological
Time and location: 12:30 pm -3:30 pm / Exhibit hall C-D
The company will present three abstracts, including results from a Phase 1 trial with novel cancer stem cell (CSC) targeting antibody brontictuzumab (OMP-52M51, anti-Notch1) in solid tumors.
It will present on Sunday, November 8, 2015 12:30 pm - 3:30 pm in Exhibit hall C-D, and the date has been added to the Binary Event Calendar.
Here's the release:
REDWOOD CITY, Calif., Oct. 27, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) announced that data related to three of its clinical-stage programs will be presented at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place November 5-9, 2015 in Boston, MA.
Among the abstracts accepted for presentation are Phase 1a data for single-agent brontictuzumab (anti-Notch1, OMP-52M51) in advanced solid tumors, including initial results from an expansion cohort of patients whose tumors demonstrate an overexpression of the activated form of Notch1 as measured by a companion biomarker. In addition, biomarker data for vantictumab (anti-Fzd7, OMP-18R5) in non-small cell lung cancer, as well as results of preclinical studies for OncoMed's anti-DLL4/VEGF bispecific (OMP-305B83), will also be presented. Details for the presentation are provided below.
Friday, November 6, 2015
Abstract #A30: Predictive and pharmacodynamic biomarkers of vantictumab (OMP-18R5; anti-Frizzled) in non-small cell lung cancer
Lead author: Ann Kapoun, Ph.D., OncoMed
Poster session A: Biomarkers
Time and location: 12:15 pm - 3:15 pm / Exhibit hall C-D
Sunday, November 8, 2015
Abstract #C42: Safety and preliminary efficacy results of a first-in-human Phase I study of the novel cancer stem cell (CSC) targeting antibody brontictuzumab (OMP-52M51, anti-Notch1) administered intravenously to patients with certain advanced solid tumors
Lead author: Pamela Munster, M.D., University of California, San Francisco
Poster session C: Clinical Trials
Location and time: 12:30 pm - 3:30 pm / Exhibit hall C-D
Abstract #C164: Dual targeting of the DLL4 and VEGF pathways with a bispecific monoclonal antibody inhibits tumor growth and reduces cancer stem cell frequency
Lead author: Wang-Ching Yen, Ph.D., OncoMed
Poster session C: Therapeutic Agents: Biological
Time and location: 12:30 pm -3:30 pm / Exhibit hall C-D
Alnylam to Report New RNAi Clinical Results in Transthyretin-Mediated Amyloidosis
Alnylam Pharmaceuticals (NASDAQ: ALNY) to Report New Clinical Results with Investigational RNAi Therapeutics for the Treatment of Transthyretin-Mediated Amyloidosis at the First European Congress on Hereditary ATTR Amyloidosis
Company to Present New Data from Phase 2 Open-Label Extension (OLE) Studies with Patisiran and Revusiran
The Conference Call on Tuesday, November 3, at 7:00 a.m. ET has been added to the Binary Event Calendar.
Here's the release.
Company to Present New Data from Phase 2 Open-Label Extension (OLE) Studies with Patisiran and Revusiran
The Conference Call on Tuesday, November 3, at 7:00 a.m. ET has been added to the Binary Event Calendar.
Here's the release.
Isis Pharmaceuticals Will Review ISIS-TTR Rx Data and Provide Phase 3 Development Plan Update
Isis Pharmaceuticals to Host Webcast to Review ISIS-TTR Rx Data
This data was Presented at 1st European Congress of Hereditary ATTR Amyloidosis. The company will also Provide Phase 3 Development Plan Update
The Webcast is scheduled on Tuesday, November 3 at 8:00 a.m. Eastern Time and has been added to the Binary Event Logger Calendar below.
Here's the release.
This data was Presented at 1st European Congress of Hereditary ATTR Amyloidosis. The company will also Provide Phase 3 Development Plan Update
The Webcast is scheduled on Tuesday, November 3 at 8:00 a.m. Eastern Time and has been added to the Binary Event Logger Calendar below.
Here's the release.
Tuesday, October 27, 2015
Agios to Present Clinical Data from Ongoing AG-120 Phase 1 Trial in Advanced Solid Tumors
Agios Pharmaceuticals (NASDAQ:AGIO) will present the first results from the Phase 1 study of AG-120 in patients with IDH1-mutant positive advanced solid tumors in an oral presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place November 5-9, 2015, in Boston.
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.
"We look forward to sharing the first clinical data for AG-120 in patients with advanced solid tumors as we continue to understand the potential of this investigational medicine," said Chris Bowden M.D., chief medical officer at Agios. "This is an important step toward our long-term vision of making a difference for people with a broad range of hematologic and solid tumor cancers that harbor IDH mutations."The date has been added to the Binary Event Logger calendar.
Go ahead and add it to your
.
Monday, October 26, 2015
Celgene's Phase 2 Maintenance Data from Ozanimod in Ulcerative Colitis Impresses Again
Celgene (NASDAQ: CELG) presented results from the maintenance phase of the TOUCHSTONE phase 2 trial of Ozanimod in patients with moderate to severe ulcerative colitis. The abstract wowed the crowd and won a "Top Abstract" prize at the United European Gastroenterology Week in Barcelona, just days after impressing at the American College of Gastroenterology Meeting in Honolulu.
Touchstone evaluated safety and efficacy of 0.5 mg and 1.0 mg doses of the SP1 modulator. The larger dose met its endpoints during the 8-week induction phase stage of the trial, but it's the maintenance data that's most promising. After 32 weeks results point to a sustained effect that should give Celgene all it needs to confidently go forward with a larger phase 3 trial and hopefully an eventual NDA. At Week 32, clinical remission occurred in 20.9% receiving 1.0 mg (p=0.0108 vs. placebo), 26.2% receiving 0.5 mg (p=0.0021), and 6.2% receiving placebo.
Here's the winning abstract.
Touchstone evaluated safety and efficacy of 0.5 mg and 1.0 mg doses of the SP1 modulator. The larger dose met its endpoints during the 8-week induction phase stage of the trial, but it's the maintenance data that's most promising. After 32 weeks results point to a sustained effect that should give Celgene all it needs to confidently go forward with a larger phase 3 trial and hopefully an eventual NDA. At Week 32, clinical remission occurred in 20.9% receiving 1.0 mg (p=0.0108 vs. placebo), 26.2% receiving 0.5 mg (p=0.0021), and 6.2% receiving placebo.
Here's the winning abstract.
Saturday, October 24, 2015
What it's all about
Here's a place to see what's coming up, and what's recently taken place, in the world of biotechnology and pharmaceutical stock catalysts.
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