prnewswire | August 28, 2023
Aspen Neuroscience today announced that it is partnering with Emerald Innovations, a pioneer in the creation of "invisible" off-body sensors for measuring health analytics, and Rune Labs, a software and data analytics company for precision neurology, to incorporate digital health (DHT) modalities in the company's Trial-Ready Screening Cohort Study.
The Trial Ready Screening Cohort study was launched in 2022 to screen, enroll and begin manufacturing cells for potential patient candidates for the future Phase 1/2a clinical trial for ANPD001, a personalized (autologous) cell therapy to treat Parkinson's disease (PD) by replacing lost dopamine neurons.
Aspen Neuroscience is advancing the collection of objective measures of motor function via passive in-home monitoring, working with Emerald Innovations' contactless biosensors, and active monitoring, working with Rune Labs' clinical development platform, StriveStudy. The use of DHT empowers trial investigators to include objective, long-term (pre-treatment) motor and sleep symptom capture, to provide data on each patient's rate of disease progression.
"Parkinson's disease is very personal in nature, and we are working to develop a personal cell therapy for PD," said Damien McDevitt, PhD, Aspen president and CEO. "Everyone with Parkinson's has a unique experience, with varied symptoms. We look forward to working closely with the innovative and collaborative teams at Rune Labs and Emerald Innovations to capture a holistic and precise pattern of motor symptom activity over time for people in our screening study."
"Parkinson's is a heterogeneous condition, adding to the challenge of assessing treatment benefit without a personalized view of each trial participant's symptom activity," said Brian Pepin, CEO of Rune Labs. "Through StriveStudy, our biopharma partners are able to collect large quantities of continuous multimodal data to characterize participant's disease activity across a range of clinical features. We are excited to collaborate with Aspen Neuroscience to help them characterize patient symptoms as they bring their personalized cell therapy into clinical testing."
"We are delighted to collaborate with Aspen Neuroscience," said Dr. Dina Katabi, MIT professor and the co-founder and president of Emerald Innovations, Inc. "A significant hurdle in Parkinson's disease clinical trials is the reliable monitoring of disease progression and medication response without the need to enroll hundreds or even thousands of patients. Empirical evidence has demonstrated that readings from the Emerald sensor offer a dependable marker for tracking disease progression. The Emerald sensor gathers this data without body contact, relying solely on the analysis of radio signals in the environment as patients go about their normal lives."
About DHT in the Trial Ready Cohort Screening Study
Aspen will partner with Rune Labs to deeply characterize each patient's symptoms in the Trial Ready Cohort, including the collection of multimodal data, thereby enabling robust disease characterization over time. This will include objective measures of tremor and dyskinesia levels captured on FDA-cleared StrivePD on the Apple Watch, medication monitoring, as well as Apple HealthKit, including global activity (e.g., daily steps).
Aspen and Emerald will collaborate to assess passive "invisible" in-home monitoring of participants enrolled in the Trial Ready Cohort. This will include gait speed measured across walking intervals, sleep onset, the amount of time between entering different sleep stages; sleep duration, sleep efficiency and WASO: the total time spent in the WAKE stage after sleep onset.
About Parkinson's Disease
Parkinson's disease is the world's second most common neurodegenerative disease, affecting more than 10 million people worldwide, including more than 1 million in the U.S., where an additional 90,000+ people are diagnosed every year. Patients can experience non-motor symptoms such as mental and behavioral changes, sleep problems, depression, memory difficulties and fatigue; and motor symptoms caused by the loss of dopamine neurons in the brain, including unintended or uncontrollable movements (dyskinesia), shaking (tremor), stiffness, and difficulty with balance and coordination, which worsen over time.
By the time of diagnosis, it is common for people to have lost the majority of cells in the brain that make dopamine. To date, there is no disease-modifying therapy that can stop, replace or prevent the loss of dopamine neurons or slow the progression of PD.
About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on personalized (autologous) regenerative medicine. The company is developing patient-derived iPSCs to create personalized cell therapies that address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson's disease and extending across the brain and affected organs.
A leading iPSC platform company, Aspen combines stem cell biology with the latest artificial intelligence and genomic approaches to investigate patient-specific, restorative treatments. The company has developed a best-in-class platform to create and optimize iPSC-derived cell therapies, which includes in-house bioinformatics, manufacturing and QC.
About Emerald Innovations, Inc.
Emerald Innovations is a health analytics company that specializes in digital health solutions for passive, contactless in-home monitoring. Emerald seamlessly captures continuous health data from patients as they go about their normal lives. The Emerald biosensors fall under a cutting-edge category known as "Invisibles." Installed in the homes of study participants, these sensors continuously analyze surrounding radio signals. Using artificial intelligence, they extract patients' physiological data while prioritizing their privacy. Emerald simplifies clinical trials for its clients by obtaining statistically significant biomarkers, making them readily available to clinicians and data analysts, and consistently providing updates on the progress of clinical trials. Emerald's clientele encompasses big pharma, Fortune 500 pharmaceutical firms, innovative biotech companies, and leading disease research foundations.
About Rune Labs
Rune Labs is a software and data analytics company for precision neurology, supporting care delivery and therapy development. StrivePD is the company's care delivery ecosystem for Parkinson's disease, enabling patients and clinicians to better manage Parkinson's by providing access to curated dashboards summarizing a range of patient data sources, and by connecting patients to clinical trials. For therapeutics development, biopharma and medical device companies leverage Rune's technology, network of engaged clinicians and patients, and large longitudinal real-world datasets to expedite development programs. The company has received financial backing from leading investors such as Eclipse Ventures, DigiTx, TruVenturo and Moment Ventures. For more information, please visit runelabs.io and strive.group.
Globenewswire | August 23, 2023
Cabaletta Bio, Inc. a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that it has entered into certain work orders relating to Good Manufacturing Practice (GMP) manufacturing under its existing master services agreement with WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO). As part of the agreement, WuXi ATU will serve as a cell processing manufacturing partner for the planned global clinical development of CABA-201 in multiple indications, including potential late-stage clinical trials and commercial readiness activities for CABA-201.
“We have had a successful collaboration with WuXi ATU over the past two years for the GMP compliant production of novel cell therapies. Based on this initial collaboration, we chose to expand our partnership to include WuXi ATU as a manufacturer for our CABA-201 clinical programs,” said Gwendolyn Binder, Ph.D., President of Science and Technology of Cabaletta. “WuXi ATU’s dedicated production capacity for CABA-201 supports our planned global expansion and commercial preparedness efforts and will enable us to dose patients in multiple clinical trials with separate parallel cohorts, while maintaining a capital-efficient manufacturing strategy.”
Under the terms of the agreement, WuXi ATU will provide GMP manufacturing of CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to support any of Cabaletta’s planned clinical trials, including the previously announced separate Phase 1/2 clinical trials of CABA-201 for the treatment of patients with systemic lupus erythematosus and idiopathic inflammatory myopathies, or myositis. In addition, WuXi ATU will continue to serve as the Company’s cell processing manufacturing partner for the MusCAARTes™ Phase 1 clinical trial of MuSK-CAART.
“We are delighted to expand our partnership with Cabaletta to advance the development of CABA-201 for patients with autoimmune diseases,” said David Y. H. Chang, Ph.D., President and Chief Technology Officer of WuXi ATU. “We look forward to applying our expertise in cell and gene therapy manufacturing to better support our customers to bring potentially life-saving treatments faster to patients in need.”
About Cabaletta Bio
Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in systemic lupus erythematosus and myositis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.
About WuXi Advanced Therapies (WuXi ATU)
As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world.
businesswire | September 21, 2023
AbCellera announced that it has expanded its existing multi-target collaboration with Regeneron to discover therapeutic antibodies for up to eight targets selected by Regeneron, increased from the original four.
“Having successfully delivered on two challenging discovery campaigns under the original agreement, we are excited to expand the scope of our collaboration with Regeneron to include up to four additional targets,” said Carl Hansen, Ph.D., founder and CEO of AbCellera. “We look forward to using our antibody discovery and development engine to bolster Regeneron’s preclinical portfolio and help identify promising candidates for their programs.”
The collaboration, which began in March 2020, leverages AbCellera’s antibody discovery engine and Regeneron’s VelocImmune® mice to identify novel therapeutic antibodies. AbCellera has initiated programs for all four of the original targets, with Regeneron exercising its rights to advance antibody candidates into further preclinical development for the two programs that have been completed.
Under the terms of the agreement, Regeneron has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera receives research payments and is eligible to receive downstream clinical and regulatory milestone payments and royalties on net sales of products.
About AbCellera Biologics Inc.
AbCellera is breaking the barriers of conventional antibody drug discovery to bring better medicines to patients, sooner. AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.