“We received FDA feedback that has been incorporated into our development program. We expect to initiate our clinical trial in 2024 and receive results in 12 months, to be followed by a Phase IIA trial in ALL patient subsets including those with T-ALL and Ph-like ALL.” Dr. Philip Breitfeld, CMO

HOUSTON (PRWEB)
May 08, 2023

Fannin Partners, LLC has received a $2 million Small Business Innovation Research (SBIR) Phase II grant from the National Cancer Institute (NCI) to advance spin-out Allterum Therapeutics’ 4A10 monoclonal antibody for the treatment of acute lymphoblastic leukemia (ALL), the most frequently diagnosed cancer in children. The SBIR grant will help support a Phase I clinical trial to assess the safety and activity of 4A10 as monotherapy and will determine pharmacokinetics, pharmacodynamics, and tumor biomarkers associated with the therapy.

Allterum’s 4A10 antibody, which was invented at NCI by senior investigator Dr. Scott Durum and his collaborators, targets CD127 (the interleukin-7 receptor subunit alpha; IL-7R). The antibody will initially be focused on patients with relapsed/refractory ALL with the expectation of expansion into the first-line setting. 4A10 is also being evaluated for the treatment of patients with other CD127-expressing malignancies.

Allterum plans to conduct its ALL Phase I trial in partnership with the Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) consortium, which includes 31 leading pediatric cancer centers, along with key adult leukemia centers such as The University of Texas MD Anderson Cancer Center. “We have completed our Pre-IND meeting and received FDA feedback that has been incorporated into our development program,” commented Dr. Philip Breitfeld, Chief Medical Officer of Allterum. “We expect to initiate our clinical trial in 2024 and receive results in 12 months, to be followed by a Phase IIA trial in ALL patient subsets including those with T-ALL and Ph-like ALL.”

“Allterum’s monoclonal antibody is a much-needed therapeutic for patients with ALL who have exhausted known effective treatment options,” said Dr. Eric Schafer, Associate Professor in the Department of Pediatrics, Section of Hematology/Oncology at Baylor College of Medicine and Texas Children’s Hospital who will serve as the Chair of the TACL study. “Current chemotherapies come with significant toxicity, which limits their effective use. Allterum’s targeted therapy is designed to be effective in these patient populations, with greatly reduced side effects.”

Since ALL is an ultra-orphan indication with an unmet medical need, Allterum has qualified for programs to facilitate and expedite development of new drugs for rare diseases. The 4A10 antibody has received Orphan Drug Designation and Rare Pediatric Disease Designation from FDA, providing an accelerated path to approval, and potentially qualifying for a Pediatric Priority Review Voucher. In addition, Allterum’s 4A10 antibody has the potential for label extension to include the front-line treatment of patients with T-cell ALL and high-risk B-cell ALL, other T-cell malignancies, and CD127-expressing subsets of other hematologic cancers.

Allterum has been spun out of Fannin, and early work was funded by a $2.9M grant from the Cancer Prevention and Research Institute of Texas (CPRIT) matched by a $1.8M Series Seed financing that was led by Fannin. This work included manufacturing scale-up and preclinical toxicology activities. The SBIR Phase II grant from NCI, together with additional fundraising, will advance the 4A10 antibody to an Investigational New Drug (IND) filing and the first-in-human clinical trial.

“We appreciate the additional validation by the NCI provided by the SBIR award and the funding that will support the further development of 4A10,” said Dr. Atul Varadhachary, Managing Partner of Fannin and President and CEO of Allterum. “We are excited about the potential for this targeted treatment modality to address the needs of patients with ALL and possibly other CD127-expressing cancers.”

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So how can one incorporate different types of data from patients into clinical trials?

TORONTO, Ontario (PRWEB)
May 08, 2023

Series Description

The value of real-world data is clear. The acceptance of real-world evidence (RWE) is growing. But is this enough to propel RWE from being a nice-to-have to a must-have? PicnicHealth is hosting a four-part webinar series to reframe the “ROI” for RWE generation and tackle the question: beyond the return on investment for RWE, what is the risk of inaction?

Webinar Description

With increasing applications of real-world data (RWD) upstream in the drug development lifecycle, it’s critical to recognize that there is no one-size-fits-all approach. So how can one incorporate different types of data from patients into clinical trials? Through conversation with a panel of experts from the biopharma industry and health technology companies, the featured speakers will discuss scenarios when patient-mediated, tokenized and/or site-based approaches are warranted. Speakers will share their unique perspectives on the importance of a tailored yet flexible strategy and the potential value this can unlock for researchers and patients alike.

Join today to explore design considerations for incorporating different types of real-world data into clinical trials.

Join Gaelan Ritter, Head of Analytics Innovation and Digital Health, Bristol-Myers Squibb; Andrew Larsen, VP of Partnerships, PicnicHealth; Jim Coutcher, Senior Director, Global Head of Emerging Methods and Solutions, Real World Solutions, IQVIA; and Evelyn Pyper (Moderator), Evidence Strategist, PicnicHealth, for the live webinar on Wednesday, May 24, 2023, at 12pm EDT (5pm BST/UK).

For more information, or to register for this event, visit Real-World Data By Design — Incorporating Different Data Types into Clinical Trials.

ABOUT PICNICHEALTH

PicnicHealth is a healthcare technology company that partners directly with patients to build deep real-world datasets. The company leverages state-of-the-art machine learning, combined with human curation, to port complete medical records into an easy-to-use online application. The platform gives patients unprecedented access to and control over their medical records and, with their consent, the opportunity to contribute this valuable data to further scientific research. Learn more at PicnicHealth.com.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Contact:

Vera Kovacevic

Tel: +1 (416) 977-6555 x371

Email: vkovacevic@xtalks.com

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Embark Behavioral Health Logo

“Our team is dedicated to providing compassionate and evidence-based care to support the well-being of young people and their families in our community,” said the location’s executive director, Dr. Myra Irani, who has a doctorate in clinical psychology.

DENVER (PRWEB)
May 08, 2023

To best help preteens, teens, young adults, and their families heal, Embark Behavioral Health, a leading network of mental health treatment programs for young people, is now enrolling clients at a new outpatient therapy clinic in Greenwood Village, Colo.

Conveniently located near Denver, Aurora, and Lakewood, the clinic offers a comprehensive range of services as part of the company’s robust continuum of care. Those services include a therapeutic day treatment program, also known as a partial hospitalization program (PHP), and an intensive outpatient program (IOP).

“Our team is dedicated to providing compassionate and evidence-based care to support the well-being of young people and their families in our community,” said the location’s executive director, Dr. Myra Irani, who has a doctorate in clinical psychology. “With this new facility, we hope to reach even more children and families in need and empower them on their journey toward healing and resilience.”

The Greenwood Village clinic is Embark’s first location in Colorado, located at 5340 S. Quebec St., Suite 205 N, adjacent to Highway 88 and Interstate 25.

Embark’s entry into the Denver market will support the Colorado community as the youth mental health crisis reaches alarming levels. In May 2021, Children’s Hospital Colorado announced its first-ever state of emergency for youth mental health. As a result of the alarming levels, hospitals, therapy centers, behavioral health hospitals, and local schools are overwhelmed with children and their families who are dealing with the repercussions of this escalating mental health crisis. With its new clinic, Embark can provide mental health services to those families who are actively struggling in the Denver area.

The Embark Difference

Offering programs accredited by The Joint Commission, Embark prioritizes delivering optimal care and adheres to superior safety standards. The company takes a personal approach to family therapy by treating families as a whole, emphasizing evidence-based and relationship-centered techniques. In fact, the research team collects thousands of data points and shares feedback with families so therapists can adjust treatment accordingly, ensuring families receive the best care.

Embark’s diverse programs encompass individual, group, and family therapy, therapeutic/peer mentoring, home health care services, addiction treatment, and parent coaching. These programs address a wide range of issues, such as:

• Attention-deficit/hyperactivity disorder (ADHD)
• Anger/mood Regulation  
• Anxiety  
• Bipolar disorder  
• Borderline personality disorder  
• Bullying  
• Depression  
• Family conflict  
• Self-harm/cutting  
• Social isolation  
• Substance use  
• Technology addiction  

The Greenwood Village Clinic: A Closer Look

“For adolescents, teens, and young adults living in the Denver area, our outpatient services provide an excellent option for accessing therapy conveniently and locally,” said the location’s clinical director, Emmett Wells, a licensed clinical social worker.

To celebrate the clinic’s opening, Embark is hosting a ribbon cutting and Mental Health Awareness Month kickoff on Monday, May 8, from 5-7 p.m. The event will include the contemporary story of the living Native American art form known as powwow, performed by The LaPointe-Roy family. To RSVP for the event, visit the Eventbrite page.

In addition to launching Embark’s first Colorado outpatient clinic, recent Embark milestones include:

• Embark Outpatient Clinic in Berwyn, PA earned Main Line Parent’s “Best Mental Health Services Provider for Teens” in their area for the second consecutive year.
• Adding a Scottsdale outpatient therapy clinic featuring an IOP and a therapeutic day treatment program.
• Expanding online services with Embark Virtual IOP. Virtual IOP is an insurance-reimbursable program available to residents in various states across the country. It’s ideal for preteens, teens, and young adults as part of an after- and continuing-care plan ─ for example, when they’re stepping down from a higher level of care, such as residential treatment or wilderness therapy, or up from a lower level of care, such as weekly individual therapy.

For more information about Embark Behavioral Health, visit the website.

ABOUT EMBARK BEHAVIORAL HEALTH

Embark Behavioral Health is a leading network of outpatient centers and residential programs offering premier mental health treatment for preteens, teens, and young adults. Dedicated to its big mission of reversing the trends of teen and young adult anxiety, depression, and suicide by 2028, Embark offers a robust continuum of care with different levels of service and programming; has a deep legacy of over 25 years serving youths; works with families to adjust treatment in real time to improve results; treats the entire family using an evidence-based approach; and offers the highest levels of quality care and safety standards. For more information about Embark or its treatment programs, including virtual services, intensive outpatient programs (IOPs), therapeutic day treatment programs, also known as partial hospitalization programs (PHPs), short-term residential treatment, wilderness therapy, and long-term residential treatment, visit http://www.embarkbh.com.

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Wilhelm Muehlhausen, SAFIRA Clinical Research Co-founder

‘We’re delighted to welcome Willie Muehllhausen as a Scientific Advisor. He has a remarkable track record of advancing technologies that make clinical trials run faster and smoother for sponsors, CROs, sites and patients.’ -uMotif CEO Steve Rosenberg

BOSTON (PRWEB)
May 08, 2023

uMotif – one of the clinical trial technology market’s fastest growing companies – reiterated its status as the pacesetter in next-generation eCOA/ePRO by welcoming SAFIRA Clinical Research Co-founder and international eClinical technology expert Willie Muehlhausen as a Scientific Advisor.

uMotif’s highly scalable eCOA/ePRO platform combines deep clinical knowledge and consumer design expertise to deliver unprecedented levels of patient compliance, regularly achieving greater than 90% data capture in real-world studies. Over 20+ years, Willie Muehlhausen has earned a reputation as a strategic thinker, serial entrepreneur and visionary in patient-facing clinical research technologies at organizations in Germany, the UK, Ireland and the US. He is known for his ability to ideate and develop groundbreaking new product lines and commercial models.

uMotif CEO Steve Rosenberg (LinkedIn) said, “We’re delighted to welcome Willie Muehllhausen to uMotif as a Scientific Advisor. He has a remarkable track record of advancing technologies that make clinical trials run faster and smoother for sponsors, CROs, sites and patients. And he’s earned a stellar reputation as an independent arbiter of emerging eClinical technologies.”

As early as 2004, Muehlhausen’s insights into patient-centric questionnaire validation had a positive impact on the way regulators and the industry approached eCOA, which paved the way for the BYOD (Bring Your Own Device) research model. He co-founded SAFIRA Clinical Research in 2021 to offer services to decentralized clinical trial technology vendors, sponsors and CROs. SAFIRA Clinical Research has become the go-to organization for providing unbiased, independent, scientific technology and product evaluations.

Prior to SAFIRA Clinical Research, Muehlhausen was Founder and Managing Director of Muehlhausen Ltd, where he advised sponsors, vendors, investment companies and researchers on digitization strategies for remote and virtual clinical trials. He conducted pioneering research on direct-to-patient models including BYOD, eCOA and wearables.

Also previously, Muehlhausen was with ICON plc for several years, most recently as VP and Head of Innovation. His achievements included the ICONIK toolset for proactively managing clinical trials; ICON’s eCOA solution; ICHOM GLOBE, a leading initiative in healthcare and outcomes research; and wearable devices.

Willie Muehlhausen commented, “I have always been impressed by uMotif’s insights and expertise, and their ability to consistently take important steps forward in delivering next-generation eCOA/ePRO solutions that make quantifiable improvements in research, by truly engaging patients. For example, late last year SAFIRA Clinical Research independently and scientifically validated the Motif data capture method as the first alternative to text-based instruments for clinical, post-marketing and real-world research. It gives researchers a new way to encourage patients to capture data, through a more visually appealing interface.”

At ISPOR 2023, May 8 in Boston, Muehlhausen will present a poster, “The First Validated Innovation in Scale Design Since the Migration to Screens: Results of an Equivalence Study, Testing a New Graphical Version of the Widely Used Verbal Rating Scale,” based on SAFIRA’s evaluation of the Motif.

Muehlhausen has served as Vice Director of the eCOA Consortium/Critical Path Institute (C-Path). His industry recognition includes being named one of the PharmaVOICE 100 most influential people in life sciences, and winning a CenterWatch Top 20 Innovator award.

About uMotif

Putting patients first is in uMotif’s DNA. The uMotif eCOA/ePRO platform delivers faster, quality clinical trials and real-world studies by putting patients at the core of research. Through cloud hosting in the US, Europe and China, the GCP, 21 CFR Part 11 and GDPR-compliant platform supports any study or trial, from Clinical Phase I, II and III studies through to decentralized or virtual real-world studies. Find out how uMotif can improve your clinical research programs and real-world studies at http://www.umotif.com

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“By working with Veramed, we can offer customers significant increases in the benefit they get from collecting and analyzing huge volumes of solid eCOA/ePRO data, for any therapeutic area, geography, or patient population.” -uMotif CEO Steve Rosenberg

BOSTON (PRWEB)
May 08, 2023

uMotif – one of the clinical trial technology market’s fastest growing companies – continues to redefine how eCOA/ePRO data is collected, reported, visualized and analyzed with the announcement of a strategic partnership with advanced biostatistics consultancy Veramed.

The highly-scalable uMotif eCOA/ePRO platform combines the industry’s most innovative eCOA/ePRO technology with an unmatched focus on true patient centricity. The modern platform consistently achieves greater than 90 percent compliance, generating double the expected volume of data in real-world studies.

Veramed brings people, innovation, and technology together to accelerate evidence generation and advance patient health, with end-to-end biometrics and engaging data visualizations that help organize large amounts of data and speed decision making for key stakeholders. Veramed’s in-house analysis and visualization platform seamlessly pulls together and compares data collected in clinical trials for a number of different treatments, performing network meta-analysis with the click of a few buttons.

Together, uMotif and Veramed generate high quality, actionable insights to drive quantifiable improvements in clinical research. Through the partnership with Veramed, sponsors get the unique advantages of the industry’s most advanced data analysis and visualization support on top of uMotif’s market-leading platform for ePRO/eCOA data capture, reporting, and analytics.

During ISPOR 2023, May 7-10 in Boston, uMotif (Booth #923) and Veramed (Booth #1225) will demonstrate an example of their combined capabilities with a must-see data visualization of the large-scale “100 for Parkinson’s” study which engaged more than 4,200 participants to capture ePRO, symptom, device and motor-testing data over 100 days.

Matt Jones, Veramed Co-founder and CEO, commented, “Working with a partner like uMotif enables us to help customers understand and act on massive volumes of quality eCOA/ePRO data in ways that were not possible before.”

uMotif CEO Steve Rosenberg (LinkedIn) said, “By working with Veramed, we can offer customers significant increases in the benefit they get from collecting and analyzing huge volumes of solid eCOA/ePRO data, for any therapeutic area, geography, or patient population.”

About Veramed

Veramed is a people-focused clinical research organization and certified B Corp that provides its clients with the assurance and close collaboration across mid-stream, analysis and reporting, as well as post-reporting and submission stages of the clinical trial process. Headquartered in London, we serve clients around the world from offices in the UK, US, EU, and Ukraine. http://www.veramed.co.uk

About uMotif

Putting patients first is in uMotif’s DNA. The uMotif eCOA/ePRO platform delivers faster, quality clinical trials and real-world studies by putting patients at the core of research. Through cloud hosting in the US, Europe and China, the GCP, 21 CFR Part 11 and GDPR-compliant platform supports any study or trial, from Clinical Phase I, II and III studies through to decentralized or virtual real-world studies. Find out how uMotif can improve your clinical research programs and real-world studies at http://www.umotif.com

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