Vantedge Medical Completes Acquisition of Hobson & Motzer

August 20, 2024

Vantedge Medical (“Vantedge”), a portfolio company of Aterian Investment Partners (“Aterian”), is pleased to announce the acquisition of Hobson & Motzer, Inc. (“Hobson” or the “Company”).

Founded in 1912 and based in Connecticut, Hobson is a manufacturer of precision medical devices for the global surgical stapler market. 100% of Hobson’s sales stream is derived from medical consumables devices. The Company’s facilities are highly automated and house a broad set of capabilities including progressive stamping, precision electrochemical machining, coined wire as well as leading tool and die capabilities. Hobson represents the fifth medical technology add-on acquisition for Vantedge since 2018.

The acquisition of Hobson further strengthens Vantedge’s position as a nationwide manufacturing partner to blue-chip medical OEMs and broadens Vantedge’s consumable portfolio offering. Since Aterian’s acquisition of Vantedge in May 2018, Vantedge has acquired five medical technology businesses, established and fully commercialized new production facilities, completed substantial capital equipment capacity expansion and significantly invested in human capital throughout the organization. Vantedge now operates nine facilities across the United States with more than 1,200 employees.

“It gives me great pleasure to announce the union of Vantedge Medical and Hobson & Motzer. I have worked with the Hobson & Motzer team for many years, and they consistently delivered best-in-class quality, service, value, and innovation. Their depth and scale of capabilities, backed by over 100 years of experience, perfectly complements the existing Vantedge capabilities, enhances the value we bring to the world’s leading medical technology companies, and amplifies the difference we are making in the lives of patients and their families.”, commented Brian King, Vantedge Medical, Chairman & CEO.

Greg Santorno, Vantedge Medical’s Chief Commercial Officer mentioned, “Our union with Hobson & Motzer provides an expanded capability set that significantly increases the value we will deliver to our customers. Providing additional device content enables supply chain simplification, risk reduction, collaborative innovation, and accelerated time to market. The addition of precision progressive die stamping, unique value-add machining and assembly technologies, and a deep expertise in the manufacturing of surgical stapler anvils, complements our existing strengths serving the Robotic Assisted Surgery, Surgical Instrumentation, Orthopedics, Ophthalmology, Dental, Drug Delivery and Medical Diagnostics markets.”

“As I contemplated transitioning the company to new ownership, my key requirements were to find a company that shared our commitment to quality, service and innovation, had deep experience in the MedTech space and viewed our capabilities as enablers for growth. Vantedge Medical met these criteria in every way. I look forward to the continuing legacy of performance and market leadership, just at a much larger scale.”, added Bruce Dworak, President / Owner, Hobson & Motzer.

“We are excited to share the news about this transaction which we believe allows Vantedge to take the next significant step in its strategic development. Vantedge continues to evolve as a differentiated, scaled and expanding Medical Technology supplier into the industry’s most attractive OEMs across a variety of manufacturing disciplines and treatment modalities. The human health technologies that Vantedge serves on behalf of its’ customers change lives for the better, and in certain circumstances, save them. It is a privilege to wake up every day and work alongside Vantedge, and through Vantedge, our customers.”, said Brandon Bethea, Co-Founder & Partner, Aterian Investment Partners.

Weil Gotshal & Manges LLP advised Aterian on the legal aspects of this transaction.

Life Molecular Imaging and PharmaLogic announce Neuraceq® availability in Denver

August 20, 2024

Life Molecular Imaging (LMI) and PharmaLogic Holdings Corp. (PharmaLogic), a world-class contract development and manufacturing organization (CDMO) and radiopharmacy solutions provider, announce their new strategic partnership and licensing agreement to provide and distribute Neuraceq® from PharmaLogic’s radiopharmaceutical manufacturing site located near Denver, CO. The first doses were made available on August, 20th, 2024.

Neuraceq^® is an FDA-approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Neuraceq^® is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterization of patients assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases.

“By partnering with PharmaLogic and offering Neuraceq^® in Denver, Life Molecular Imaging is excited to expand access of Neuraceq^® for the detection of beta-amyloid plaques in the brain. We believe this additional access benefits physicians and patients, as well as our pharma partners for routine clinical and research use. We are excited to collaborate with Pharmalogic today and look forward to more opportunities in the future. ” said Ludger Dinkelborg, Ph.D., Managing Director at LMI.

Steve Chilinski, CEO of PharmaLogic:

“Expanding patient access to clinically-impactful radiopharmaceuticals is a core component of our mission. By partnering with Life Molecular Imaging in Denver, patients in the greater Rocky Mountain region will have even greater access to a new wave of disease targeting diagnostic radiopharmaceuticals.”

About Neuraceq (florbetaben 18F)

Indication

Neuraceq^® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations of Use

A positive Neuraceq^® scan does not establish the diagnosis of AD or any other cognitive disorder.
Safety and effectiveness of Neuraceq have not been established for:
- Predicting development of dementia or other neurologic conditions
- Monitoring responses to therapies.

Important Safety Information

Risk for Image Interpretation and Other Errors
Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.

Radiation Risk
Neuraceq, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Common Adverse Reactions
The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%).
For more information please visit: neuraceq.com

International Consortium to Revolutionize Viral Vector Manufacturing | Reports VVector Bio

August 20, 2024

In a ground-breaking collaboration, leading biotechnology companies and research organizations in UK and Canada are entering into a R&D project jointly funded by a £1.1 million grant from Innovate UK (part of UK Research and Innovation) and the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP). The project is led by VVector Bio and joined by the NRC, Revvity and Abselion.

Cell and Gene Therapies hold immense promise for curing a myriad of diseases, yet their widespread adoption is impeded by manufacturing limitations. Current methods face hurdles such as low yields, poor scalability, high costs, and quality testing challenges. Traditional approaches have yielded minimal improvements, requiring a fresh perspective.

In response, the project consortium has devised a multifaceted strategy to revolutionize viral vector manufacturing. Central to this endeavour is the genetic modification of the widely used HEK-293 cell line. By meticulously analysing the cell line’s genome and transcriptome under producing and non-producing conditions, researchers aim to identify genes directly impacting viral vector yields and quality. Combined with an innovative approach to manufacturing and process monitoring empowered by on-line process analytics, the project seeks to disrupt the existing viral vector production process.

“This project represents a paradigm shift towards improving viral vector manufacturing yields,” remarked Alina Venereo Sanchez, CEO of VVector Bio. “By integrating genomics, epigenomics, transcriptomics, metabolomics and new ways of directly integrating analytics into production, we’re poised to unlock unprecedented production capabilities.”

The project builds upon NRC’s expertise in biomanufacturing and viral vector production. “Our past achievements underscore the feasibility of our approach, and we anticipate significant enhancements” emphasized Aziza Manceur at NRC.

“Revvity is excited to be part of this consortium” commented Dr. Alan Fletcher, Revvity’s Senior Vice President, Life Sciences. “Its goal aligns with our mission to help our customers overcome the challenges they face in accelerating the creation of next-generation therapies for patients. Together, we aim to drive innovation in the cell and gene manufacturing process, which will, in turn, help get life-changing therapies in the hands of patients that need them sooner.”

“Process optimization through at-line & on-line analytics is key to redefining viral vector manufacturing.” noted Ruizhi Wang, CEO of Abselion. “This project is the ultimate opportunity to showcase how it can accelerate development and result in more efficient and robust production of the next generation of therapeutics.”

The collaboration includes organizations from both Canada and the UK. It is funded as part of the “Canada-UK: Biomanufacturing of Biologics and Advanced Therapies” programme, which is jointly funded by Innovate UK and the National Research Council of Canada Industrial Research Assistance Program. The goal of the programme is to stimulate the development and implementation of innovative technologies in biomanufacturing.

Carilion Clinic Further Expands Quality Cardiac Care Access with Latest Philips Innovations at New Regional Cardiovascular Institute in Virginia, US

August 20, 2024

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Carilion Clinic, a not-for-profit health care organization serving more than one million people in the States of Virginia and West Virginia, today announced Carilion Clinic will adopt the Philips cardiovascular care ecosystem of solutions at the future home of its Cardiovascular Institute at Crystal Spring Tower.

Carilion’s new facility will have 11 specialized Philips interventional suites, allowing physicians to treat patients with complex cardiovascular conditions closer to home while optimizing the clinical, operational and overall performance of the health system’s cardiovascular service line. This investment illustrates Carilion’s commitment to empowering its clinicians with innovative technology to provide quality care for its communities.

Carilion’s comprehensive hospital network, primary and specialty physician practices and other complementary services deliver high-quality, patient-centered care. The flagship hospital, Carilion Roanoke Memorial Hospital, totals 718 beds. The Carilion Clinic Cardiovascular Institute will relocate to this new facility and provide state-of-the art heart, lung and vascular services to the region. Services include inpatient nursing care, cardiovascular ORs, cardiac catheterization and electrophysiology labs.

Along with caring for the local community, Carilion Roanoke Memorial Hospital is the major referral center and only Level 1 Trauma Center for patients in the region who require specialized medical care. It also has the only hybrid operating rooms available in Southwest Virginia. Equipped with these new Philips solutions, the highly skilled medical staff will be able to continue handling complex cases or procedures that may not be available at surrounding healthcare facilities.

“At Carilion Clinic, we are committed to improving the health of the communities we serve. We know that collaboration is an essential component to realizing this vision,” said Marguerite Underwood, Vice President for the Carilion Clinic Cardiovascular Institute. “Working with Philips ensures that we will be able to set the standard in cardiovascular care, not only today, but well into the future.”

The new labs are the foundation of the integrated Philips ecosystem of solutions for cardiovascular care and include the Philips Azurion Image-Guided Therapy System, along with EPIQ CVx cardiology ultrasound system with ultrasound enabled AI capabilities, IntraSight with SyncVision for IVUS imaging and physiology and interventional tools. Together, the technology provides exceptional imaging with reduced X-ray dose [1], improved workflow and more efficient turnaround times [2], offering a high level of clinical confidence. A service program will reduce maintenance complexity, keeping systems up to date with the latest software. Furthermore, Carilion will be able to leverage ongoing clinical education for its staff.

“For many years, Carilion has been recognized for delivering exceptional cardiac care. Maintaining the highest standard of care means continuous growth and innovation, making healthcare delivery more efficient and effective,” said Jeff DiLullo, Chief Region Leader, Philips North America. “The Crystal Spring Tower expansion illustrates Carilion’s commitment to its staff and patients, giving clinicians access to world-class technology while providing a level of care not available anywhere else in the region.”

GrayMatters Health Expands Veteran and Civilian Access to FDA-Cleared Prism for PTSD™ Treatment

August 20, 2024

GrayMatters Health, developer of non-invasive treatments based on proprietary brain biomarkers associated with mental health disorders, today announced it is expanding its U.S. footprint with additional clinics now offering Prism for PTSD™ to patients. Prism for PTSD is the first prescribed self-neuromodulation device, cleared by the FDA to treat post-traumatic stress disorder (PTSD) as an adjunct to standard-of-care therapies.

PTSD is a mental health condition impacting 13 million Americans that develops after experiencing a life-threatening or traumatic event such as assault, abuse, combat, illness, accidents, or natural disasters. PTSD disproportionally affects women, 10% will experience PTSD in their lives compared to 3.6% of men. Among US Veterans, 7% are expected to experience PTSD in their lifetime.

Home Base, the first and largest private sector brain health clinic in America treating Veterans, Service Members, their Families and Families of the Fallen, is adding Prism as a potential supplementary treatment option to enhance their existing PTSD programs at the National Center of Excellence in Charlestown, Massachusetts. Fermata, a New York-based interventional psychiatry practice, is providing Prism treatment to help patients gain control of their PTSD symptoms. GMH is working with additional clinics to continue expanding access to Prism treatment in the coming months.

“Home Base is excited to test promising new treatments, like Prism, which aim to establish gold standard PTSD treatments for Veterans, Service Members, their Families and Families of the Fallen,” said Home Base Executive Director, Retired Brig. Gen. Jack Hammond. “Providing innovative and cutting-edge options like Prism allows us to ensure our Nation’s Heroes have access to the best mental health care treatments they have earned and deserve at no out-of-pocket cost to them.”

Prism uses a proprietary amygdala-based biomarker and computer simulation to help patients learn to control brain activity associated with PTSD symptoms, guided by a trained healthcare professional. “My patients are learning to control brain activity associated with their PTSD without reliving their trauma,” said Owen Scott Muir, MD, co-founder at Fermata, Distinguished Fellow of the American Academy of Child and Adolescent Psychiatry (DFAACAP) and editor of The Frontier Psychiatrists.

“It is remarkable that patients continue to improve after completing treatment, suggesting that what they learn in the clinic becomes part of their daily life.”

Prism for PTSD demonstrated excellent outcomes in its pivotal trial, published in the peer-reviewed Journal of Psychiatry Research. In the study, 67% of patients exhibited clinically significant symptom improvement, with response rates exceeding 80% in certain sub-populations. The trial reported a 90% compliance rate alongside high patient satisfaction. Additionally, mild side effects, such as headaches, dizziness, and fatigue, were transient and resolved post-treatment without further intervention.

Qubit Pharmaceuticals nominated for “Best start-up 2024” award by Prix Galien USA

August 20, 2024

Qubit Pharmaceuticals, a deeptech company specializing in the discovery of new drug candidates through simulation and molecular modeling accelerated by hybrid HPC and quantum computing, announces that it has been nominated for the Prix Galien USA “Best Startup Award”. This nomination is in line with Qubit Pharmaceuticals’ strategic commitment to establishing and expanding its activities in North America, a key market for biomedical and pharmaceutical research.

Awarded by the Fondation Galien, the world’s leading institution for honoring innovators in the field of life sciences, the Prix Galien is considered the equivalent of the Nobel Prize in biopharmaceutical research. First introduced in France in 1970, the Prix Galien is now awarded in 17 countries, including the United States since 2007. Each year, it recognizes outstanding innovations that contribute to improving the quality of public healthcare. Organized in partnership with Business France, the Startup category, which is celebrating its tenth anniversary, is designed to reward innovative French and international startups with a strong societal impact that are collaborating with an American entity in the Pharma, BioTech and Medtech fields. Prix Galien USA aims to raise the profile of startups and promote transatlantic partnerships with government, industry and academia.

As a nominee, Qubit Pharmaceuticals will participate in industry meetings, workshops and conferences around the US healthcare ecosystem to explore potential strategies for development in North America. The Startup Award ceremony will take place on November 7 at the Museum of Natural History in New York.

Robert Marino, CEO Qubit Pharmaceuticals, states : “We are extremely pleased to be nominated for this prestigious award. Beyond the sense of pride, this recognition once again underlines the excellence of our technology, and will be a powerful source of visibility in the U.S. for potential international partnerships”.

Accelerating drug discovery with hybrid HPC and quantum computing

With a team of 60 specialists in quantum chemistry, computational chemistry, machine-learning and medicinal chemistry, and thanks to the hybrid use of HPC (High Performance Computing) supercomputers and quantum algorithms, Qubit Pharmaceuticals has developed its revolutionary drug discovery software platform, Atlas, which aims to reduce by a factor of 2 the time needed to screen, select and optimize a drug candidate of interest, and by a factor of more than 10 the investment required. Qubit Pharmaceuticals manages a portfolio of 7 drug discovery programs, with a focus on targets recognized as complex in fields such as oncology and chronic inflammatory diseases. Qubit Pharmaceuticals also has an innovative program focused on the discovery of new treatments using RNA.

Providing Safe and Accessible Options for Women’s Reproductive Care

August 19, 2024

Women’s Reproductive Healthcare Options – A Growing Need

Women’s reproductive health has long been the under supported area of the healthcare system. Historically, optionality and resources to support women in their reproductive journeys have been overlooked as more and more women struggle to get the care they need and deserve.

According to the CDC, over 10 million women struggle with infertility in the U.S. Forty-three U.S. states have recorded their lowest fertility rate in the last three decades according to the Pew Charitable Trusts and the WHO estimates 60-80 million couples worldwide currently suffer from some form of infertility. In addition, many individuals are waiting until later to start relationships and some couples are delaying beginning their families. The result is that so many women are struggling to find solutions beyond expensive and invasive in vitro fertilization (IVF).

But the lack of quality options for reproductive care doesn’t end there. On the other side of the spectrum, more women are also looking for permanent birth control options these days, having already started their family or having no interest in children at all, with online searches and phone inquiries skyrocketing in recent years. The only permanent birth control option requires surgery and general anesthesia, which is both expensive and invasive. From one end of the reproductive journey to the other, women have struggled with options that are painful, leave permanent scars, cost outrageous amounts, and so much more.

Growing Legislative Attention

A large focus of our national psyche is currently on women’s health and specifically reproductive health. From the Supreme Court’s decision to allow emergency abortions in Idaho and upholding access to mifepristone to the recent two-year anniversary of Roe v. Wade being overturned to the Alabama ruling in IVF treatment that sparked outrage resulting in narrow protection for IVF providers, women’s healthcare is in the news as are differing viewpoints on the type of healthcare they can receive.

While politicians argue about what’s right and what’s wrong, it is our job to work tirelessly to make sure women have more options for their reproductive care. It is our goal to advance solutions that are safe, accessible, effective, and affordable for both ends of the reproductive care journey, whether a woman seeks to have a child or to prevent having one.

For too long, women have had the same lackluster options when it comes to both ends of the reproductive journey. The focus must be on innovation and funding for late-stage biomedical companies with solutions that make a serious impact on women’s reproductive health. Because time and time again, we are reminded that investing in women leads to outsized results throughout the community, as those women impact the lives of their friends, children, and colleagues.

Femasys – Filling a Void in Reproductive Healthcare

Like many women, I was worried about balancing my career goals with the desire to have a family. After having my two daughters, I considered permanent birth control but realized what was available carried much more risk than I was willing take for a basic healthcare need. I did not want to undergo general anesthesia and have incisions or have a coil as a permanent implant (which is no longer available for safety reasons). My frustration with the options available to me were that they carried too much risk.

This personal journey with reproductive health inspired me to focus my product and life science background on creating and developing better, safer, more efficient, and readily accessible women’s reproductive healthcare solutions to ensure that my daughters, as well as women everywhere, have more and improved options for their basic healthcare needs.

I am grateful every day for my daughters, ages seven and four at the time of founding Femasys in 2004, who have provided endless inspiration and sparked my interest in launching a biotech to make a difference in women’s health for the many generations to come. They have been my rock and foundation through the ups and downs of running the company. I am especially thankful that my work at Femasys stimulated them both to have careers in healthcare and to be motivated to make a difference in others’ lives, as they work to achieve their goals.

Femasys is a disruptive biomedical company focused on addressing significant unmet reproductive health needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products. We are committed to providing women with revolutionary products as they seek solutions throughout their reproductive journey.

We are thrilled to bring to market our revolutionary product FemaSeed®, a next generation artificial insemination solution, where sperm is delivered directly and safely into the fallopian tube, where conception occurs. FemaSeed is a highly cost-effective, convenient approach to enhance natural fertilization. As a first-line infertility treatment, it has significant advantages, including being more affordable and having fewer risks than IVF and intracytoplasmic sperm injection (ICSI). As a therapeutic option, FemaSeed is the catalyst for Femasys to initiate commercial efforts within the U.S. and ultimately scale globally, having already received CE Mark approval in the European Union and approval in Canada.

We also have a lead product candidate, FemBloc® permanent birth control, in late-stage clinical development. We are conducting a multi-center pivotal trial and believe FemBloc will be revolutionary for women seeking a non-surgical method for permanent contraception that is accessible, cost-effective, and has substantially fewer risks than the surgical alternative. We are working diligently to make this much-needed option available to women worldwide.

Our other commercially available products are FemVue®, a contrast-generating device for ultrasound evaluation of a woman’s fallopian tubes; FemCath®, a selective delivery catheter to aid in selective fallopian tube and uterine cavity evaluation; and FemCerv^®an endocervical tissue sampler for diagnosis of cervical cancer.

As an innovator in women’s healthcare, we are continuing to develop technologically advanced medical solutions while we work to improve the lives of women around the world. We hold over 100 patents for our products as well as product candidates that we hope to bring to women in the near future.

When you take on a mission that has the potential to positively impact our society, especially one that can reasonably affect the lives of so many women searching for better options, the responsibility of that decision weighs heavy. I am fueled and humbled by the support of many as we ensure women tomorrow have better options than we had for ourselves.

Editor’s Note: Kathy Lee-Sepsick founded Femasys in February 2004. Ms. Lee-Sepsick has served as a senior executive in the medical technologies industry for nearly three decades, compiling a successful track record in growing emerging companies and corporate operating divisions. She holds over 100 patents globally for Femasys’ products and product candidates. Ms. Lee-Sepsick was instrumental in the various stages of product and company life cycles with strategic, operational, and executive responsibilities, at start-ups Novoste Corporation, developer of intravascular therapy solution and SaluMedica, biomaterial developer of artificial cartilage. At the onset of her career, Ms. Lee-Sepsick served in a product management role at Terumo Medical Corporation, where she was integral in the management of strategic partner, Boston Scientific Corporation. Ms. Lee-Sepsick also serves on the Board of Directors of Georgia Bio. Ms. Lee-Sepsick holds a BS in Biochemistry and an MBA from Rutgers University.

About Femasys

Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada and Europe. FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis.

Crossject Appoints Tony Tipton as U.S. Chief Operating Officer in Preparation for Commercialization of ZEPIZURE® Epilepsy Rescue Treatment

August 19, 2024

Crossject (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company developing medicines for emergency situations harnessing its award-winning needle-free auto-injector ZENEO®, announces the appointment of the deeply experienced healthcare executive Tony Tipton as U.S. Chief Operating Officer.

Tony Tipton has over 25 years of experience across the key pillars of commercial pharmaceuticals business, encompassing corporate leadership, business development, market access, sales force leadership, marketing and trade operations. He joins Crossject from his role as Chief Operating & Commercial Officer at Xequel Bio, where he led commercialization strategy, pre-commercial activities for BARDA/NIH funded assets, and commercial assets through acquisition. Mr. Tipton’s appointment will strengthen Crossject’s U.S. pre-commercial activities as the company prepares the ZEPIZURE® U.S. marketing authorization application submission.

Tony Tipton previously served in several senior commercial roles in large international specialty pharmaceutical companies, including Interim Chief Commercial Officer and Vice President, Market Access & Trade Channels at Santen Pharmaceuticals, via the acquisition of Eyevance Pharmaceuticals. In this role, Mr. Tipton led US commercial functions, achieving over $70 million in gross revenue for the US commercial business. He has also held a Director’s position for Health Systems Accounts for Sunovion Pharmaceuticals, a role in which he launched a new epilepsy drug, Aptiom, and several sales and marketing positions at Galderma Laboratories.

“Tony brings to Crossject a proven track record of excellence and highly relevant experience across all facets of precommercial, sales and marketing in the specialty pharmaceutical industry and, specifically, for emergency medicines comparable to ZEPIZURE®. His leadership, knowledge and experience are a perfect fit and further inform and de-risk our move towards commercialization of ZEPIZURE® in the US, our key market. We look forward to the dynamic contributions he will bring to our team,” said Patrick Alexandre, CEO of Crossject.

“My senior leadership roles in preparing companies for commercialization have provided me with relevant experience, valuable networks and strategic insights, all of which I leverage in my role at Crossject. Joining Crossject at this pivotal time is a responsibility that I am ready to embrace with energy and enthusiasm as we bring lifesaving, innovative rescue medicines like ZEPIZURE® to market. The ZENEO® technology platform and Crossject’s exciting pipeline offer multiple rapid expansion opportunities. I look forward to leveraging my background in commercial strategies and partnering with the talented team at Crossject as we focus on bringing the company’s first rescue therapy to market,” commented Tony Tipton, COO of Crossject U.S.

Jung+ Launches Holistic Longevity Program, Offering an Accessible, One-Stop-Shop for the Cutting Edge of Longevity Science

August 19, 2024

Jung+, a science-backed, human-forward company rewriting the standard approach to longevity care, announces its launch after completing a successful private beta phase with a 10,000-strong community.

Founded by Simon Sakhai, a University of Oxford alum and former President of the Oxford Society of Ageing and Longevity, Jung+ brought together high-profile global longevity experts, scientists, and doctors. With five years of research and development, Jung launched its Total Longevity System™, a seamless system that allows users to create a holistic longevity regimen tailored to their lifestyle and goals. The products have been engineered with ingredients backed by science to target the drivers of aging and optimize human performance.

While high-end longevity clinics offer annual programs costing $100,000+, Jung+ democratizes longevity solutions through its three-step system, which offers the majority of results at a fraction of the cost. Jung+ is currently available DTC and will soon be available to functional doctors and preventative clinicians as a tool for patients.

Customers start their regimen with a master longevity formula, the Longevity Foundation, a two-part around-the-clock supplement protocol that addresses all 12 drivers of aging. With ingredients administered at times that are naturally tailored to the body’s rhythm, the Longevity Foundation’s approach is designed to coincide with biological mechanisms for maximum impact.

Longevity cannot be tackled with a one-size-fits-all approach. To personalize the program, customers select from longevity boosters: individual supplements & coaching protocols that target longevity goals. Boosters include:

Fasting Tonic: Intermittent fasting and calorie restriction are among the most powerful longevity hacks. This precision drink mix is engineered to ease and enhance the intermittent fasting experience, promoting feelings of fullness, replenishing important nutrients lost while fasting, and safeguarding against muscle loss.

Advanced Sleep Repair: Known as nature’s longevity miracle, sleep optimizes almost every biological and cognitive process, making quality sleep an essential part of the longevity lifestyle. Advance Sleep Repair enhances sleep’s regenerative mechanisms, leading to restful sleep that balances natural melatonin and neurotransmitter levels, optimizes nocturnal DNA and tissue repair and more.

Cellular Skin Renewal: Superior to topical creams and serums, this is the only skin supplement to leverage cutting-edge longevity science to combat biological skin aging from the inside out. The formula addresses every hallmark of skin aging, such as depleted NAD+ levels, building senescent cells, decline in fibroblasts, and symptoms like wrinkles, elasticity and skin tone/texture.

Glucose Blocker: This supplement protects against one of the most damaging, age-accelerating lifestyle issues: an excess of carbs and sugar in a diet. By regulating post-meal glucose levels, it provides steady energy, aids in anti-aging by switching on longevity mechanisms, supports healthy weight management, targets inflammation, and tempers the formation of AGEs which drive wrinkles.

Recognizing that science is constantly changing, Jung+ continuously reviews formulations based on the latest scientific research, ensuring customers benefit from the most up-to-date advancements without the need to navigate the complex landscape of longevity science alone.

“At Jung+, we’re on a crusade to liberate human longevity for all, translating the latest scientific advancements in aging research into products and technologies that can slow aging and extend healthy lifespan,” said Simon Sakhai, CEO & Founder of Jung+. “With longevity gaining popularity, it’s imperative that experts ensure that living a longer life is accessible for everyone.”

TEPKINLY (epcoritamab) Receives Second European Commission Approval for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma

August 19, 2024

Genmab A/S (Nasdaq: GMAB) today announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.

“Follicular lymphoma can be challenging to treat and today’s approval of TEPKINLY for the treatment of relapsed/refractory follicular lymphoma after two or more lines of systemic therapy marks an important milestone for patients in the European Union who are in need of more options offering a balance of meaningful efficacy and favorable safety,” said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. “Alongside our partner AbbVie, we are committed to exploring the continued development of epcoritamab as a potential core therapy across B-cell malignancies.”

FL is typically a slow-growing form of Hodgkin’s lymphoma (NHL) that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases, and represents 10-20 percent of all lymphomas in the western world.ⁱ FL is considered incurable, and there is no standard of care treatment for third-line or later FL.^i,ii Patients who achieve remission also often experience relapse.^iii,iv,v

The conditional marketing authorization is supported by data from the Phase 1/2 EPCORE^® NHL-1 clinical trial: an open-label, multi-cohort, multicenter, single-arm trial that evaluated TEPKINLY as monotherapy in patients with R/R FL after two or more lines of prior systemic therapy. Patients included in the study were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent (70% having double refractory disease), patients who were refractory to last prior treatment (82%), and patients whose disease progressed within two years of initiating first systemic therapy (52%). The results published in the Lancet Haematology showed that patients treated with TEPKINLY (n=128) had an overall response rate (ORR) of 83% and a complete response (CR) rate of 63%. At a median follow-up of 16.2 months, the median duration of response was 21.4 months (13.7, NR). Duration of complete response (DOCR) was not reached.

The study included a planned separate optimization cohort, which evaluated 86 patients with the recommended 3-step-up doses for cytokine release syndrome (CRS) mitigation. Hospitalization was not mandatory in the cycle 1 optimization cohort. With the optimized regimen, 40% of patients experienced Grade 1 CRS and 9% experienced Grade 2 (no Grade 3 or higher CRS were reported). No immune effector cell-associated neurotoxicity syndrome (ICANS) cases were reported in this cohort.

The safety profile of epcoritamab in the pivotal cohort was similar to reports of epcoritamab monotherapy in the pivotal EPCORE NHL-1 diffuse large B-cell lymphoma (DLBCL) cohort. In the pooled safety population (n=382), the most common adverse reactions (≥ 20%) with TEPKINLY were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhea. The most frequent serious adverse reaction (≥ 10%) was cytokine release syndrome (34%). Fourteen patients (3.7%) experienced a fatal adverse reaction (pneumonia in 9 (2.4%) patients, viral infection in 4 (1.0%) patients, and ICANS in 1 (0.3%) patient.

“The approval of epcoritamab by the European Commission is a promising update for the lymphoma community,” said Kate Rogers, CEO of the Follicular Lymphoma Foundation. “Given that relapsed or refractory follicular lymphoma can be a very challenging form of cancer to treat, especially in later lines of therapy, it is critical that patients and physicians have additional options when it comes to treating this type of cancer.”

About the EPCORE^® NHL-1 Trial

EPCORE^® NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a dose escalation part; an expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The expansion part generated pivotal data from patients with FL and DLBCL. The optimization part evaluated additional CRS mitigation strategies during cycle 1. The primary endpoint of the expansion part was overall response rate (ORR) as assessed by an Independent Review Committee (IRC). Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints. The primary endpoint of the optimization part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab.

About Epcoritamab

Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody^® technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.^vi

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

EU Indications and Important Safety Information about Tepkinly^®(epcoritamab)

Indications

Tepkinly (epcoritamab) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Important Safety Information

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Cytokine release syndrome (CRS)

CRS, which may be life-threatening or fatal, occurred in patients receiving Tepkinly. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia. Other signs and symptoms of CRS in more than two patients include chills, tachycardia, headache and dyspnoea.

Most CRS events occurred in Cycle 1 and were associated with the first full dose of Tepkinly. Administer prophylactic corticosteroids to mitigate the risk of CRS. Patients should be monitored for signs and symptoms of CRS following Tepkinly administration. At the first signs or symptoms of CRS, institute treatment of supportive care with tocilizumab and/or corticosteroids as appropriate. Patients should be counselled on the signs and symptoms associated with CRS and patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Management of CRS may require either temporary delay or discontinuation of Tepkinly based on the severity of CRS. Patients with DLBCL should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of CRS.

Immune effector cell-associated neurotoxicity syndrome (ICANS)

ICANS, including a fatal event, have occurred in patients receiving Tepkinly. ICANS may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema. The majority of cases of ICANS occurred within Cycle 1 of Tepkinly treatment, however some occurred with delayed onset. Patients should be monitored for signs and symptoms of ICANS following Tepkinly administration. At the first signs or symptoms of ICANS treatment with corticosteroids and non-sedating-anti-seizure medicinal products should be instituted as appropriate. Patients should be counselled on the signs and symptoms of ICANS and that the onset of events may be delayed. Patients should be instructed to contact their healthcare professional and seek immediate medical attention should signs or symptoms occur at any time. Tepkinly should be delayed or discontinued as recommended. Patients with DLBCL should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of ICANS .

Serious infections

Treatment with Tepkinly may lead to an increased risk of infections. Serious or fatal infections were observed in patients treated with Tepkinly in clinical studies. Administration of Tepkinly should be avoided in patients with clinically significant active systemic infections. As appropriate, prophylactic antimicrobials should be administered prior to and during treatment with Tepkinly. Patients should be monitored for signs and symptoms of infection, before and after Tepkinly administration, and treated appropriately. In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids and other supportive care, according to local guidelines.

Tumour Lysis Syndrome (TLS)

TLS has been reported in patients receiving Tepkinly. Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function. Patients should be monitored for blood chemistries and abnormalities should be managed promptly.

Tumour flare

Tumour flare has been reported in patients treated with Tepkinly. Manifestations could include localized pain and swelling. Consistent with the mechanism of action of Tepkinly, tumour flare is likely due to the influx of T-cells into tumour sites following Tepkinly administration. There are no specific risk factors for tumour flare that have been identified; however, there is a heightened risk of compromise and morbidity due to mass effect secondary to tumour flare in patients with bulky tumours located in close proximity to airways and/or a vital organ. Patients treated with Tepkinly should be monitored and evaluated for tumour flare at critical anatomical sites.

CD20-negative disease

There are limited data available on patients with CD20-negative DLBCL and patients with CD20-negative FL treated with Tepkinly, and it is possible that patients with CD20-negative DLBCL and CD20-negative FL may have less benefit compared to patients with CD20-positive DLBCL and patients with CD20-postitive FL, respectively. The potential risks and benefits associated with treatment of patients with CD20-negative DLBCL and FL with Tepkinly should be considered.

Immunisation

Live and/or live-attenuated vaccines should not be given during Tepkinly therapy. Studies have not been conducted in patients who received live vaccines.

Fertility, pregnancy and lactation

Tepkinly is not recommended during pregnancy and in women of childbearing potential not using contraception.

Effects on ability to drive and use machines

Tepkinly has minor influence on the ability to drive and use machines. Due to the potential for ICANS, patients should be advised to exercise caution while (or avoid if symptomatic) driving, cycling or using heavy or potentially dangerous machines.

Undesirable effects

Summary of the safety profile

The safety of Tepkinly was evaluated in 382 patients with relapsed or refractory large B-cell lymphoma (N=167), FL (N=129) and FL (3-step step-up dose schedule N=86) after two or more lines of systemic therapy and included all the patients who enrolled to the 48 mg dose and received at least one dose of TEPKINLY. The most common adverse reactions (≥ 20%) were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia, and diarrhoea.

Serious adverse reactions occurred in 50% of patients. The most frequent serious adverse reaction (≥ 10%) was cytokine release syndrome (34%). Fourteen patients (3.7%) experienced a fatal adverse reaction (pneumonia in 9 (2.4%) patients, viral infection in 4 (1.0%) patients, and ICANS in 1 (0.3%) patient). Adverse reactions that led to discontinuation occurred in 6.8% of patients. Discontinuation of Tepkinly due to pneumonia occurred in 14 (3.7%) patients, viral infection in 8 (2.1%) patients, fatigue in 2 (0.5%) patients, and CRS, ICANS, or diarrhoea, in 1 (0.3%) patient each.

Dose delays due to adverse reactions occurred in 42% of patients. Adverse reactions leading to dose delays (≥ 3%) were viral infections (17%), CRS (11%), neutropenia (5.2%), pneumonia (4.7%), upper respiratory tract infection (4.2%), and pyrexia (3.7%).

This is not a complete summary of all safety information.

See Tepkinly^® full Summary of Product Characteristics (SmPC) at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

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