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SciNeuro Pharmaceuticals and Mabylon AG to Collaborate on Development of Novel Therapeutics for Neurological Diseases

SciNeuro Pharmaceuticals | October 26, 2021

SciNeuro Pharmaceuticals a leader in the discovery and development of innovative therapeutics for the treatment of neurological diseases, and Mabylon AG, a leader in the discovery and characterization of human-derived antibodies against therapeutic targets, today announced the establishment of a multi-program collaboration and license agreement. Under the collaboration, MabSciNeuro and Mabylon will collaborate on multiple targets that encompass serious neurological diseases including TAR DNA binding protein-43 (TDP-43) and Apolipoprotein E (APOE) for neurodegenerative diseases for which there are currently no effective treatments. Both TDP-43 and APOE have human genetic evidence causal to ALS and Alzheimer’s disease. SciNeuro will have rights to develop and commercialize resulting product(s) within Greater China, and an option to expand such rights to become worldwide.

“We are excited to be collaborating with Mabylon, a leading biotech company with deep expertise and capabilities for identification and characterization of native human antibodies with therapeutic potential. Their platform enables a deeper exploration of human immunology for therapeutic discovery Native human antibody-based approaches have proven successful for the treatment of infectious diseases including COVID-19. Discovery of auto-antibodies to treat other diseases has been more challenging, due in part to the availability of sufficiently large and high-quality sample collections. By working with companies such as Mabylon, possessing both proprietary antibody screening and cloning technology coupled with large, re-contactable patient sera repositories, we are in a strong position to test the hypothesis and exploit human immune responses for novel and differentiated therapeutic candidates for CNS diseases.”

Dr. Min Li, Founder and CEO, SciNeuro Pharmaceuticals

“Collaborating with SciNeuro and its R&D team allows full exploitation of Mabylon’s human antibody platform by seamlessly bringing our discovery research products forward to pivotal proof of concept. We are thrilled about this collaboration, which combines innovation in drug discovery with great expertise in drug development in the neurological disease area,” added Dr. Alcide Barberis, CEO, Mabylon.

About Mabylon AG
Mabylon AG is a leading Swiss biotechnology company harnessing the therapeutic potential of naturally occurring human antibodies to treat neurodegenerative diseases and allergies. Access to over 100,000 patients per year allows the discovery of extremely rare target-specific human antibodies, additionally providing information about the target’s human biology and safety profile..

About SciNeuro Pharmaceuticals
SciNeuro Pharmaceuticals is a leading neuromedicine company focused on elevating the standard of care for patients suffering from neurological diseases. With R&D capabilities located in the major life sciences hubs of Shanghai, China and Rockville, Maryland, SciNeuro is establishing a robust CNS product pipeline through internal innoylon and SciNeuro will work together to discover and develop human auto-antibodies against targets of mutual interest with a goal to develop differentiated biologic therapeutics to treat neurological diseases.

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PharmaKinnex and Data360 Team Up to Extend Client Reach and Improve Patient Access

PRNewswire | July 24, 2023

PharmaKinnex (PK), an inside sales solution provider for the pharmaceutical industry, and Data360, a data and engagement solutions provider for healthcare marketers, today announced a strategic partnership to further enhance client reach and improve patient outcomes. From rare disease to oncology and beyond, this unique partnership is designed to deliver increased profits to clients, enable more advanced and secure data analysis, and most importantly, connect patients with life-saving treatments. PharmaKinnex and Data360 are proud to be a part of this newest revolution in pharmaceuticals and medicine, deploying Fingerprint AI solutions. "The strategic partnership aligns perfectly with our mission to bring unprecedented value to our clients," said Michael White, CEO of PharmaKinnex. "Data360's powerful solutions to identify, target, and engage individuals, while providing valuable analytics about those audiences, will extend our reach to more potential patients and prescribers, providing a sizable edge in the rare disease sector." Integration of Data360's deep insights with PK's marketing expertise will improve PK's call plans, allowing PK to message to new audiences and reach prescribers ahead of the competition. The partnership positions PK as the only inside sales organization with access to such a high level of data, offering a unique and powerful industry advantage. "We are eager to partner with PharmaKinnex and contribute our solutions that identify and engage relevant audiences throughout their digital life, and so improve the patient journey experience," said James Miller, president & CEO of Data360. "For this unique market offering, Data360 will identify health care professionals (HCPs) and patients searching online for rare diseases by activating our Fingerprint AI solution. By providing insights for timeliness, relevance, and intent behavior, Data360 will equip PK with valuable insights and reach to elevate its services to clients." Data360's Fingerprint AI technology is sparking a revolution in healthcare marketing, fueling omnichannel programs with its ability to hyper-target both HCP and patient or caregiver audiences based on online behavior and in-market search criteria. Data360's datasets, coupled with the Fingerprint AI solution, empower brand teams, healthcare marketers, clinical trial teams, and now PK to leverage audience intent. Its service achieves high-quality, segmented, and targeted leads for HCP marketing, patient engagement, and clinical trial recruitment. About PharmaKinnex PharmaKinnex is the leading multichannel marketing company in the U.S. that exclusively serves Life Sciences clients. PK is also the longest-tenured independent company in its competitive set, with over 18 years of continuous support of its industry partners. The PK Call Center successfully executes high-ROI product detailing, inside sales and customer service programs. Each solution is designed with the support of the experienced, award-winning PK leadership team and is tailored to target every important constituency identified, including but not limited to office-based prescribers (physicians, NPs, PAs) across every specialty, hospitals and health systems. About Data360 With the mission to turn data into intelligence, Data360 provides solutions and services to effectively identify, target, and engage audiences. We empower healthcare marketers seeking broader and better access to physicians, HCPs, patients, and caregivers. We deliver unequaled first-party data, proprietary technology (Fingerprint AI) for access to audience intent and behavior, and a focus on cost-effective and compliant ways to activate and engage healthcare audiences.

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Koneksa Launches Academic Collaboration Program for Parkinson’s Disease

Businesswire | August 18, 2023

Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, today announced the first collaboration in the Koneksa Academic Partnership Program for Parkinson’s Disease (KAPP-PD) to incorporate its Neuroscience Toolkit into research programs. The first collaboration of the KAPP-PD program, with Oregon Health & Science University (OHSU), enables the inclusion of app-and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments from Koneksa’s Neuroscience Toolkit into a study comparing short-acting versus long-acting levodopa in Parkinson’s disease. Koneksa’s Neuroscience Toolkit implements a variety of digital assessments that can be combined to collect data for measures of interest. The OHSU team, led by Dr. Delaram Safarpour, MD, MSCE, FAAN, is investigating changes in the neurophysiological correlates of PD with carbidopa-levodopa immediate release compared to long-acting levodopa (Rytary), as well as changes in gait performance at intervals of 30 minutes for a total of 4 hours during each visit. This research will provide strong support for clinical profiles of short- versus long- acting levodopa in PD corresponding to objective physiological measures. “We are collaborating with Koneksa to enhance our study’s objectives: We’ll be including smartphone- and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments into our study,” said Martina Mancini, Ph.D., co-investigator of the study, director of the Balance Disorders Laboratory, and Associate Professor of Neurology, OHSU School of Medicine. “Our lab uses new technologies to better understand and measure motor impairments, with the goal of learning how to better help patients with these conditions. Novel, objective metrics, like those made possible with Koneksa’s technology and toolkit, allow us to expand upon what we’ve been able to do in the clinic. In particular, digital at-home measures of daily physical activity, gait and mobility, motor functionality, sleep, and ePRO measures of quality of life all have the potential to uniquely complement OHSU’s in-clinic assessments, offering new and real-world-setting patient insights to support the study’s objectives.” “Koneksa is proud to extend our contribution to critical neuroscience research through KAPP-PD, and we’re delighted to get the program underway with our first collaboration,” said John Wagner, MD, Ph.D., Chief Medical Officer, Koneksa. “These measures will support OHSU in both in-clinic and at-home patient monitoring of critical parameters of interest for this study. We’re committed to helping to get new and better treatments to patients faster, and that’s a vision that OHSU’s Balance Disorders Laboratory shares.” About the Koneksa Academic Partnership Program – Parkinson’s Disease The Koneksa Academic Partnership Program – Parkinson’s Disease (KAPP-PD) is a structured collaboration between Koneksa and select academic partners that enables researchers to incorporate Koneksa’s Neuroscience Toolkit into research programs focusing on Parkinson’s disease. Researchers gain access to an array of devices that capture key measures objectively and sensitively, as well as training materials for site coordinators and study subjects, a cloud-based platform for real-time monitoring, and industry-leading analytics and patented algorithms. About Koneksa Koneksa is a healthcare technology company pioneering evidence-based digital biomarkers to accelerate clinical research and guide decision making in drug development and market strategy. Our evidence-based biomarker solutions enable efficient clinical trial designs to help innovative therapies reach patients faster. Koneksa aims to revolutionize treatment effect detection in clinical research and improve patient outcomes.

Read More

Pharmacy Market

Everest Medicines Announces Commercial Launch and First Prescription for XERAVA® in China

PRNewswire | July 27, 2023

Everest Medicines a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial-stage innovative biopharmaceutical company. XERAVA® is the world's first fluorocycline antibiotic for the treatment of infections caused by susceptible gram positive, gram negative and anaerobic pathogens including multidrug resistant ("MDR") isolates. It was approved by the National Medical Products Administration ("NMPA") of China for the treatment of complicated intra-abdominal infections ("cIAI") in adult patients in March 2023, and has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections. "The commercialization of XERAVA® in China is a significant milestone for Everest as a company, as this marks the beginning of Everest as a commercial-stage biopharma company. I want to thank everyone involved in bringing XERAVA® to a successful launch," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "After the commercial launch, we will accelerate patient access to XERAVA® with a lean commercial team, following a highly efficient commercial strategy. The company will continue to advance the approval and commercialization of other first-in-class or best-in-class drug candidates such as Nefecon to further address urgent unmet needs in China and the rest of Asia." "Eravacycline has broad antibacterial spectrum and high potency against common clinical multi-drug resistant bacteria such as ESBL-producing bacteria, CRE, CRAB, MRSA and VRE," said Dr. Zhu Duming, leader and chief physician of the Critical Care Department at Zhongshan Hospital Affiliated with Fudan University. "It has been recommended by authoritative guidelines at home and abroad for the treatment of MDR Gram-negative bacterial infections. The launch of eravacycline in China will help doctors tackle the challenges of clinical drug resistance." "Patients with malignant hematological diseases have a high incidence of neutropenia and fever caused by radiotherapy, chemotherapy, and hematopoietic stem cell transplantation. Antibacterial treatment is very important for patients with neutropenia and fever as MDR/Carbapenem-resistant Organism ("CRO") infections have high mortality rates," said Sun Aining, chief physician at the First Affiliated Hospital of Soochow University. "As the world's first fluorocycline antibiotic, eravacycline has completed phase II/III clinical trials and multiple real-world studies around the world to demonstrate that it has good clinical efficacy and safety profiles. It is an innovative choice for the treatment of MDR/CRO infections." In addition to XERAVA®, Everest anticipates the launch of three additional innovative drugs in China over the next two years, including Nefecon, the first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and expected to be approved in China in the second half of this year. In the infectious disease space, Everest is actively developing other important drug candidates to meet the urgent demand for innovative antibacterial treatment. The company plans to file New Drug Application for cefepime-taniborbactam in China this year for complicated urinary tract infection. In immunology, etrasimod is a next-generation, oral selective sphingosine 1-phosphate (S1P) receptor modulator with a differentiated efficacy and safety profiles. The company aims to submit NDA in Everest territories as soon as possible. About XERAVA® XERAVA® is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive , gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections in the US, EU, GB, Singapore, mainland China, Hong Kong and the medicine is currently under review for cIAI in Taiwan region. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.

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Pharma Tech

PharmaKinnex and Data360 Team Up to Extend Client Reach and Improve Patient Access

PRNewswire | July 24, 2023

PharmaKinnex (PK), an inside sales solution provider for the pharmaceutical industry, and Data360, a data and engagement solutions provider for healthcare marketers, today announced a strategic partnership to further enhance client reach and improve patient outcomes. From rare disease to oncology and beyond, this unique partnership is designed to deliver increased profits to clients, enable more advanced and secure data analysis, and most importantly, connect patients with life-saving treatments. PharmaKinnex and Data360 are proud to be a part of this newest revolution in pharmaceuticals and medicine, deploying Fingerprint AI solutions. "The strategic partnership aligns perfectly with our mission to bring unprecedented value to our clients," said Michael White, CEO of PharmaKinnex. "Data360's powerful solutions to identify, target, and engage individuals, while providing valuable analytics about those audiences, will extend our reach to more potential patients and prescribers, providing a sizable edge in the rare disease sector." Integration of Data360's deep insights with PK's marketing expertise will improve PK's call plans, allowing PK to message to new audiences and reach prescribers ahead of the competition. The partnership positions PK as the only inside sales organization with access to such a high level of data, offering a unique and powerful industry advantage. "We are eager to partner with PharmaKinnex and contribute our solutions that identify and engage relevant audiences throughout their digital life, and so improve the patient journey experience," said James Miller, president & CEO of Data360. "For this unique market offering, Data360 will identify health care professionals (HCPs) and patients searching online for rare diseases by activating our Fingerprint AI solution. By providing insights for timeliness, relevance, and intent behavior, Data360 will equip PK with valuable insights and reach to elevate its services to clients." Data360's Fingerprint AI technology is sparking a revolution in healthcare marketing, fueling omnichannel programs with its ability to hyper-target both HCP and patient or caregiver audiences based on online behavior and in-market search criteria. Data360's datasets, coupled with the Fingerprint AI solution, empower brand teams, healthcare marketers, clinical trial teams, and now PK to leverage audience intent. Its service achieves high-quality, segmented, and targeted leads for HCP marketing, patient engagement, and clinical trial recruitment. About PharmaKinnex PharmaKinnex is the leading multichannel marketing company in the U.S. that exclusively serves Life Sciences clients. PK is also the longest-tenured independent company in its competitive set, with over 18 years of continuous support of its industry partners. The PK Call Center successfully executes high-ROI product detailing, inside sales and customer service programs. Each solution is designed with the support of the experienced, award-winning PK leadership team and is tailored to target every important constituency identified, including but not limited to office-based prescribers (physicians, NPs, PAs) across every specialty, hospitals and health systems. About Data360 With the mission to turn data into intelligence, Data360 provides solutions and services to effectively identify, target, and engage audiences. We empower healthcare marketers seeking broader and better access to physicians, HCPs, patients, and caregivers. We deliver unequaled first-party data, proprietary technology (Fingerprint AI) for access to audience intent and behavior, and a focus on cost-effective and compliant ways to activate and engage healthcare audiences.

Read More

Pharmacy Market

Koneksa Launches Academic Collaboration Program for Parkinson’s Disease

Businesswire | August 18, 2023

Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, today announced the first collaboration in the Koneksa Academic Partnership Program for Parkinson’s Disease (KAPP-PD) to incorporate its Neuroscience Toolkit into research programs. The first collaboration of the KAPP-PD program, with Oregon Health & Science University (OHSU), enables the inclusion of app-and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments from Koneksa’s Neuroscience Toolkit into a study comparing short-acting versus long-acting levodopa in Parkinson’s disease. Koneksa’s Neuroscience Toolkit implements a variety of digital assessments that can be combined to collect data for measures of interest. The OHSU team, led by Dr. Delaram Safarpour, MD, MSCE, FAAN, is investigating changes in the neurophysiological correlates of PD with carbidopa-levodopa immediate release compared to long-acting levodopa (Rytary), as well as changes in gait performance at intervals of 30 minutes for a total of 4 hours during each visit. This research will provide strong support for clinical profiles of short- versus long- acting levodopa in PD corresponding to objective physiological measures. “We are collaborating with Koneksa to enhance our study’s objectives: We’ll be including smartphone- and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments into our study,” said Martina Mancini, Ph.D., co-investigator of the study, director of the Balance Disorders Laboratory, and Associate Professor of Neurology, OHSU School of Medicine. “Our lab uses new technologies to better understand and measure motor impairments, with the goal of learning how to better help patients with these conditions. Novel, objective metrics, like those made possible with Koneksa’s technology and toolkit, allow us to expand upon what we’ve been able to do in the clinic. In particular, digital at-home measures of daily physical activity, gait and mobility, motor functionality, sleep, and ePRO measures of quality of life all have the potential to uniquely complement OHSU’s in-clinic assessments, offering new and real-world-setting patient insights to support the study’s objectives.” “Koneksa is proud to extend our contribution to critical neuroscience research through KAPP-PD, and we’re delighted to get the program underway with our first collaboration,” said John Wagner, MD, Ph.D., Chief Medical Officer, Koneksa. “These measures will support OHSU in both in-clinic and at-home patient monitoring of critical parameters of interest for this study. We’re committed to helping to get new and better treatments to patients faster, and that’s a vision that OHSU’s Balance Disorders Laboratory shares.” About the Koneksa Academic Partnership Program – Parkinson’s Disease The Koneksa Academic Partnership Program – Parkinson’s Disease (KAPP-PD) is a structured collaboration between Koneksa and select academic partners that enables researchers to incorporate Koneksa’s Neuroscience Toolkit into research programs focusing on Parkinson’s disease. Researchers gain access to an array of devices that capture key measures objectively and sensitively, as well as training materials for site coordinators and study subjects, a cloud-based platform for real-time monitoring, and industry-leading analytics and patented algorithms. About Koneksa Koneksa is a healthcare technology company pioneering evidence-based digital biomarkers to accelerate clinical research and guide decision making in drug development and market strategy. Our evidence-based biomarker solutions enable efficient clinical trial designs to help innovative therapies reach patients faster. Koneksa aims to revolutionize treatment effect detection in clinical research and improve patient outcomes.

Read More

Pharmacy Market

Everest Medicines Announces Commercial Launch and First Prescription for XERAVA® in China

PRNewswire | July 27, 2023

Everest Medicines a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial-stage innovative biopharmaceutical company. XERAVA® is the world's first fluorocycline antibiotic for the treatment of infections caused by susceptible gram positive, gram negative and anaerobic pathogens including multidrug resistant ("MDR") isolates. It was approved by the National Medical Products Administration ("NMPA") of China for the treatment of complicated intra-abdominal infections ("cIAI") in adult patients in March 2023, and has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections. "The commercialization of XERAVA® in China is a significant milestone for Everest as a company, as this marks the beginning of Everest as a commercial-stage biopharma company. I want to thank everyone involved in bringing XERAVA® to a successful launch," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "After the commercial launch, we will accelerate patient access to XERAVA® with a lean commercial team, following a highly efficient commercial strategy. The company will continue to advance the approval and commercialization of other first-in-class or best-in-class drug candidates such as Nefecon to further address urgent unmet needs in China and the rest of Asia." "Eravacycline has broad antibacterial spectrum and high potency against common clinical multi-drug resistant bacteria such as ESBL-producing bacteria, CRE, CRAB, MRSA and VRE," said Dr. Zhu Duming, leader and chief physician of the Critical Care Department at Zhongshan Hospital Affiliated with Fudan University. "It has been recommended by authoritative guidelines at home and abroad for the treatment of MDR Gram-negative bacterial infections. The launch of eravacycline in China will help doctors tackle the challenges of clinical drug resistance." "Patients with malignant hematological diseases have a high incidence of neutropenia and fever caused by radiotherapy, chemotherapy, and hematopoietic stem cell transplantation. Antibacterial treatment is very important for patients with neutropenia and fever as MDR/Carbapenem-resistant Organism ("CRO") infections have high mortality rates," said Sun Aining, chief physician at the First Affiliated Hospital of Soochow University. "As the world's first fluorocycline antibiotic, eravacycline has completed phase II/III clinical trials and multiple real-world studies around the world to demonstrate that it has good clinical efficacy and safety profiles. It is an innovative choice for the treatment of MDR/CRO infections." In addition to XERAVA®, Everest anticipates the launch of three additional innovative drugs in China over the next two years, including Nefecon, the first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and expected to be approved in China in the second half of this year. In the infectious disease space, Everest is actively developing other important drug candidates to meet the urgent demand for innovative antibacterial treatment. The company plans to file New Drug Application for cefepime-taniborbactam in China this year for complicated urinary tract infection. In immunology, etrasimod is a next-generation, oral selective sphingosine 1-phosphate (S1P) receptor modulator with a differentiated efficacy and safety profiles. The company aims to submit NDA in Everest territories as soon as possible. About XERAVA® XERAVA® is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive , gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections in the US, EU, GB, Singapore, mainland China, Hong Kong and the medicine is currently under review for cIAI in Taiwan region. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.

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