QUANTA™ DIALYSIS SYSTEM RECEIVES FDA CLEARANCE FOR HOME HEMODIALYSIS
QUANTA™ DIALYSIS SYSTEM RECEIVES FDA CLEARANCE FOR HOME HEMODIALYSIS
BEVERLY, Mass., Nov. 4, 2024 /PRNewswire/ — Award-winning medical technology innovator, Quanta Dialysis Technologies®, has confirmed the US Food and Drug Administration (FDA) has given 510(k) clearance for the use of its Quanta Dialysis System in the home setting. With this clearance, Quanta becomes the only company to offer a high dialysate flow (500 mL/min) system across the entire care continuum for end stage renal disease (ESRD) patients.
This significant step in Quanta’s US commercialization efforts follows another recent milestone in which the company received clearance for the first, and only, FDA-cleared device able to perform intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without any need for bags.
Based on 2022 data from the United States Renal Data System, of the 550,000 prevalent ESRD patients in the country on dialysis therapy, just 2.4% receive home hemodialysis (HHD). The Quanta Dialysis System (previously known as the SC+ Hemodialysis System) addresses this gap by providing patients access to a high-flow system in the home, the same offering as routinely provided in hospitals, post-acute facilities and in-center clinics.
“The 510(k) clearance embodies the hard work and determination of our exceptional team at Quanta,” said Quanta Chief Executive Officer Alejandro Galindo. “We recruited and executed this pivotal trial during the height of COVID-19 and have now achieved an FDA clearance few other products have obtained. As the US continues to evolve towards value-based care models, the focus for patients with chronic diseases is on minimizing complications and re-admissions.
“Our product is designed to help those patients seamlessly transition to the home and remain there as long as possible. We are currently planning our home launch with customers who have successfully implemented Quanta into acute and sub-acute settings first.”
Decades-Long Troubles with HHD Adoption
Across the US more than 70% of dialysis facilities are currently not certified to offer HHD, and almost half of those with certification have no active HHD patients. Much of this is attributed to the lack of FDA-cleared technologies, alongside challenges associated with the cost-of-therapy and patient ‘burnout’, caused by dialyzing with low flow technologies requiring frequent treatments.
“Many patients prefer the flexibility of home hemodialysis – a flexible schedule, no commute, and with more frequent therapies they feel better and need less medication,” said Quanta Chief Medical Officer Dr. Paul Komenda, MHA, FRCPC, FASN. “Expanding treatment into the home is something we are constantly asked about by clinicians, advocacy groups, providers and patients. One of our major commitments as a business is to make kidney care more accessible, and with an easy-to-train, easy-to-maintain device that accommodates a high-flow HD prescription, Quanta is poised to become the best option for the home.”
Encouraging Clinical Trial Results
An FDA Investigational Device Exemption (IDE) trial of the Quanta Dialysis System was completed in October 2023, including a multi-center, open-label assessment of efficacy and safety. The trial saw 32 patients receive standard in-center hemodialysis while training to use the Quanta Dialysis System, before transitioning to perform HHD four times per week for eight weeks. The study demonstrated the device to be safe and effective, with more than 90% of patients electing to continue using the device after completing the trial.
Study results were presented at the American Society of Nephrology meeting in 2023 and the manuscript is now under review at the Clinical Journal of the American Society of Nephrology.
“Our IDE study has clearly demonstrated best in class dialysis adequacy and high patient satisfaction. Our device gives sufficient dialysis in 3x per week therapy and the option of better outcomes with higher frequency,” added Dr. Komenda.
Notes for editors:
About the Quanta Dialysis System:
As a compact device with performance comparable to larger traditional machines, the Quanta Dialysis System provides the clinical versatility needed to deliver kidney replacement therapy across multiple care settings. With an intuitive user interface and only once-weekly hot rinse requirement, the device is designed to be operated by a broad range of users to bring dialysis directly to patients.
The Royal Academy of Engineering announced Quanta Dialysis Technologies as the recipient of the 2022 MacRobert Award (the UK’s longest running and most prestigious award for UK engineering innovation), joining the ranks of Rolls-Royce, Arup and Raspberry Pi.
To learn more about Quanta and its products, visit www.quantadt.com.
The SC+ Hemodialysis System is now known as the Quanta Dialysis System.
Indications for Use – 510(k) K242269
The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician’s prescription, by a trained clinician who is competent in the use of the device. The SC+ Hemodialysis System is also indicated for use in the home by trained patients in tandem with a trained care partner.
The SC+ Blood Tube Set is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.
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Logo: https://mma.prnewswire.com/media/2548121/Quanta_Dialysis_Technologies_Logo.jpg
SOURCE Quanta Dialysis Technologies
Aignostics Secures $34 Million Series B to Enhance Precision Medicine with AI
Aignostics Secures $34 Million Series B to Enhance Precision Medicine with AI
Investments will support new product offerings, US expansion, and development of pathology foundation models.
BERLIN, GERMANY and NEW YORK, NY (October 29, 2024) – Aignostics, a global artificial intelligence (AI) company that turns complex multi-modal pathology data into transformative insights, announced today that it has raised $34 million in Series B financing. This additional funding will be used to build new product offerings for biopharmaceutical clients, fuel growth within the United States (US), and develop leading foundation models for pathology in collaboration with Mayo Clinic. The oversubscribed funding round was led by ATHOS, with investments from Mayo Clinic and growth financing from HTGF, alongside support from existing investors Wellington Partners, Boehringer Ingelheim Venture Fund, CARMA Fund, and VC Fonds Technologie managed by IBB Ventures. In total, Aignostics has now raised over $55 million, reflecting investors’ confidence in its differentiated AI models and clear commercial strategy.
As precision medicine becomes more nuanced and complex, biopharmaceutical companies are increasingly turning to AI to enhance the utility, performance, and scalability of computational pathology analyses for drug development and diagnostics. In parallel, machine learning technologies are rapidly evolving, producing AI models with record accuracy and robustness, opening new avenues for biopharmaceutical research and diagnostics.
“At its core, Aignostics is a world-class machine learning company,” said Julian Zachmann from ATHOS. “The field is advancing so quickly that, in order to succeed, AI companies need to avoid flashy distractions, stay laser focused on the highest-quality science, and relentlessly innovate. Aignostics is doing just that and bringing a level of transparency and rigor to its biopharmaceutical clients that we think is truly unique.”
“We know that digital pathology, paired with the vast capabilities of AI, has immense potential to impact diagnosis and treatment for patients. Mayo Clinic is actively charting the new frontier of predictive and personalized care,” shared Jim Rogers, CEO of Mayo Clinic Digital Pathology.
The new funding will strengthen Aignostics’ offerings for target ID, translational research, and companion diagnostics (CDx), and support several strategic initiatives, including:
- Launch of scaled “plug-and-play” products for a range of indications and tasks, including tumor microenvironment and biomarker profiling.
- Continued expansion into the US with additional headcount and support for US partners.
- Collaborative development of foundation models and biopharma product offerings with Mayo Clinic.
“2024 has been a pivotal year for us that has included a major strategic collaboration with Bayer and the launch of our first foundation model, RudolfV,” said Viktor Matyas, CEO and Co-Founder of Aignostics. “With RudolfV, we’ve gained the ability to quickly develop cost-efficient algorithms that generalize to the real-world. Now with this new round of funding, we’re turning our most popular algorithms into products that will help usher in an era of truly generalizable AI for computational pathology.”
About Aignostics
Aignostics is an artificial intelligence (AI) company that turns complex multimodal pathology data into transformative insights. By combining proprietary access to multimodal clinical data, industry-leading technologies, and rigorous science, Aignostics develops best-in-class products and services for the next generation of precision medicine. Through collaborations with its biopharma partners, Aignostics supports drug discovery, translational research, clinical trials, and CDx development. Established in 2018, Aignostics is a spin-off from Charité Berlin, one of the world’s largest and most esteemed university hospitals. Aignostics is funded by leading investors and has operations in Berlin and New York.
More information at: www.aignostics.com
Follow us on LinkedIn: www.linkedin.com/company/aignostics
About ATHOS
With its heritage in healthcare and life sciences, ATHOS is a single-family office that supports entrepreneurs to positively impact health and well-being. Known to the broader public as the long-term majority investor of BioNTech, ATHOS remains committed to advancing medical innovation and building transformative companies for the future.
About HTGF – High-Tech Gründerfonds
HTGF is one of the leading and most active early-stage investors in Germany and Europe, financing start-ups in the fields of Deep Tech, Industrial Tech, Climate Tech, Digital Tech, Life Sciences and Chemistry. With its experienced investment team, HTGF supports start-ups in all phases of development into international market leaders. HTGF invests in the pre-seed and seed phase and participates significantly in further financing rounds, since 2024 with the HTGF Opportunity growth fund. Across its funds, HTGF has over 2 billion euros under management. Since its inception in 2005, HTGF has financed more than 750 start-ups and successfully sold shares in more than 180 companies. The Federal Ministry for Economic Affairs and Climate Action, KfW Capital and numerous companies are invested in the HTGF seed funds. Investors in the HTGF Opportunity growth fund include the ERP Special Fund and KfW with the resources of the Zukunftsfonds (“Future Fund”).
More information at: www.htgf.de
Follow us on LinkedIn: www.linkedin.com/company/high-tech-gruenderfonds
Seamless Therapeutics to Present New Data at ESGCT Demonstrating its Ability to Reprogram Large Serine Recombinases to Specific Target Sites in the Human Genome
Seamless Therapeutics to Present New Data at ESGCT Demonstrating its Ability to Reprogram Large Serine Recombinases to Specific Target Sites in the Human Genome
Proprietary approach enables efficient and precise integration of gene-sized DNA cargo
Seamless’ zinc-finger dependent recombinases show superior target site specificity for gene editing
Data will be presented in two presentations at the European Society of Gene & Cell Therapy Congress 2024
Dresden, Germany, and Lexington, MA, October 22, 2024 – Seamless Therapeutics today announced that it will be presenting new preclinical data, including human cell data, highlighting its unique platform’s capabilities to reprogram large serine recombinases (LSRs) to target naturally occurring loci in the human genome. The company’s recombinases are engineered to precisely excise, exchange, invert, or insert gene-sized DNA fragments in any target gene sequence, independent of the cell’s natural DNA repair pathway. In addition, Seamless will be presenting data on its engineered zinc-finger dependent recombinases, demonstrating its ability to condition the activity of the company’srecombinases to zinc-finger binding for LSRs and tyrosine recombinases (Y-SSRs). Both datasets are presented in poster sessions during the European Society of Gene & Cell Therapy Congress 2024, held from October 22 – 25, in Rome, Italy.
“The data that we will be presenting at the 2024 ESGCT Congress serve as an initial validation of our innovative approach and positions us at the forefront of next-generation gene editing technologies for developing therapeutics. We are showcasing our ability to program recombinases to recognize user defined target sequences, bypassing the need for preinserted target sites and enabling seamless, efficient, and precise DNA sequence integration,” said Albert Seymour, Ph.D., Chief Executive Officer of Seamless Therapeutics. “Our nearterm objective is to translate these exciting findings into an in vivo model, paving our way toward progressing to the clinic. Long-term, we aim to demonstrate the technology’s significant potential for creating a new class of therapeutics for indications affecting patient populations in areas of high unmet need.”
Presentation Details:
P0670 – Reprogramming Large Serine Recombinases for Site-Specific Integration into Mammalian Genomes
Presenter: Teresa Rojo-Romanos, PhD, Co-founder and Head of Technology & Platform Development at Seamless
Poster Session: Poster Session IV
Presentation Date & Time: Thursday, October 24, 6:00 – 7:30 pm CEST.
Presentation Location: Concourse Level -1 and Mezzanine Concourse
Seamless’ proprietary search motif enables identification of target sites in nearly all coding genes and putative human safe harbor sites, allowing for broad applicability that is not limited to pre-existing targets with high homology to wild-type recombinase recognition sites. Through directed evolution and rational design, the company engineered LSRs to recognize four natural selected target sites in the human genome. In the study, the engineered LSRs clones demonstrated high activity in bacterial cells, with good translation of activity to human cells. The selected engineered LSR, IntSTX-SH2, showed its ability to precisely integrate DNA sequences into the specific SH2 locus in human cells. Seamless further optimized the programmed LSR to IntSTX-SH2 2.0, resulting in a three-fold increase in activity as compared to the first generation and with the potential for further improvement. The company’s pioneering approach for efficient and precise integration of gene-sized DNA cargo is advancing into in vivo studies, focusing on the liver as production site for metabolic enzymes.
P0590 – Zinc-Finger Dependent Recombinases for Precision Genome Editing
Presenter: Liliya Mukhametzyanova, Sr. Scientist at Seamless
Poster Session: Poster Session IV
Presentation Date & Time: Thursday, October 24, 6:00 – 7:30 pm CEST.
Presentation Location: Concourse Level -1 and Mezzanine Concourse
In this study, Seamless identified insertion sites for zinc-finger binding domains (ZFDs) within tyrosine recombinases (Y-SSRs) and LSRs as well as evolved variants. The zinc-fingerconditioned evolved variants were shown to be inactive without the DNA target site for the ZFD and reactivated if the DNA target site was present, ensuring that gene editing only occurs at the intended sites. The company’s approach for evolving ZFDs improves the efficiency of recombinases and increases their specificity, broadening Seamless’ suite of DNA editing techniques.
About Seamless Therapeutics
Seamless Therapeutics is changing the paradigm of gene editing through a pioneering approach that has the potential to address unmet medical needs in patients with severe conditions. Our technology platform unlocks the reprogramming of recombinases, a highly versatile class of enzymes. We are applying our proprietary know-how to develop a pipeline of disease-modifying product candidates across a broad spectrum of indications to expand the therapeutic potential of gene editing.
About Seamless Therapeutics
Seamless Therapeutics is changing the paradigm of gene editing through a pioneering approach to restore health in patients with severe conditions in a safe and precise manner. Our technology platform unlocks the reprogramming of recombinases, a highly versatile class of enzymes. We are applying our proprietary know-how to develop a pipeline of disease-modifying product candidates across a broad spectrum of indications to expand the therapeutic potential of gene editing.
About Wellington Partners
Wellington Partners is a leading European venture capital firm investing in the most promising early- and growth stage life science companies in the fields of biotechnology, therapeutics, medical technology, diagnostics and digital health. With funds totaling more than €1.2 billion, thereof €590 million committed to life sciences, Wellington Partners has been actively supporting world class private companies translating true innovation into successful businesses with exceptional growth. To date, Wellington Partners has invested in 56 innovative life science companies, including Actelion (acquired by J&J), Definiens (acquired by AZ), Immatics (Nasdaq: IMTX). invendo (acquired by Ambu), MTM Laboratories (acquired by Roche/Ventana), Oxford Immunotec (acquired by PerkinElmer), Rigontec (acquired by MSD), Symetis (acquired by Boston Scientific), and Themis (acquired by MSD).
About Forbion
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio) pharmaceutical space. Forbion manages well over EUR 2.3 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 95 companies. Besides financial objectives, Forbion selects investments that will positively affect the health and wellbeing of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BioGeneration Ventures (BGV), the manager of seed and early-stage funds, especially focused on Benelux and Germany.
About BMBF GO-Bio
The BMBF funding initiative GO-Bio supports life science researchers with innovative ideas who are looking to go into business. It provides excellent conditions from an early project stage on for a successful switch from the lab to the economy.
https://www.go-bio.de/gobio/de/go-bio/go-bio/go-bio_node.html
For more information, please contact:
Seamless Therapeutics
Dr. Anne-K. Heninger, CEO
Phone: +49 351 212 469 0
Email:
Seamless Therapeutics media inquiries
Trophic Communications
Desmond James / Stephanie May
Tel: +49 1516 7859086 or +49 171 1855682
Email:
Beckman Coulter and SphingoTec Partner to Improve Kidney Health Assessment in Critical Care
Beckman Coulter and SphingoTec Partner to Improve Kidney Health Assessment in Critical Care
- Alliance marks first penKid licensing agreement for high throughput immunoassay.
- Partnership leverages SphingoTec's proficiency in acute kidney injury testing, and Beckman Coulter’s extensive, globally installed Access Family of immunoassay analyzers.
Hennigsdorf/Berlin, Germany, October 9, 2024 – Diagnostic company SphingoTec GmbH (“SphingoTec”) today announced a new partnership with Beckman Coulter Diagnostics Inc. (“Beckman Coulter”). Through this collaboration, the companies will bring an assay for SphingoTec’s innovative kidney function biomarker, Proenkephalin 119-159 (penKid), to Beckman Coulter’s extensive test menu for use on the Access Family of Immunoassay Analyzers. This alliance marks the first central laboratory license for a penKid assay and aims to significantly enhance the diagnostic capabilities for acute kidney injury (AKI) globally, by leveraging Beckman Coulter’s global installed base of instruments.
PenKid is a real-time biomarker in plasma designed to address critical gaps in the standard diagnostic practices for AKI, particularly in critical care environments. Specifically, scientific evidence shows that, unlike current methods, a penKid assay offers early detection of kidney function decline, unaffected by inflammation, potentially enabling earlier intervention and improved patient outcomes (1,2,3). The incidence of AKI is increasing in both hospital and community settings; it is estimated that more than 13 million people are affected by AKI annually worldwide (4, 5).
Under the terms of the agreement, Beckman Coulter will develop and validate a fully automated diagnostic test for penKid, leveraging SphingoTec’s IVD certified assay. This assay has already been implemented as a routine test in the first university hospitals. This collaborative effort will facilitate high-throughput availability of penKid assays in central laboratories, supporting critical care physicians with the ability for timely and precise kidney health assessment.
“Acute kidney injury exerts a profound impact on patients globally, complicates acute and chronic illnesses frequently resulting in poor outcomes, and rivals many other critical diseases in its severity and consequences,” said Kevin O’Reilly, President, at Beckman Coulter Diagnostics. “The published evidence for penKid testing combined with SphingoTec’s scientific expertise provides an exciting opportunity to improve kidney health management. Working with SphingoTec, our goal is to expand access to and improve workflow from this important kidney health innovation underscoring our commitment to enhancing patient care worldwide.”
Deborah Bergmann, Managing Director and CEO of SphingoTec, emphasized, “The development of a penKid-based assay for use on Beckman Coulter’s globally installed immunoassay platforms represents a significant step toward realizing our vision of transforming diagnostic innovation into tangible patient benefits. This partnership accelerates our mission to deliver precise, actionable insights to clinicians worldwide, ultimately improving outcomes for patients suffering from acute kidney injury.”
References:
- Beunders et al. Assessing GFR With Proenkephalin, Kidney International Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006
- Caironi et al., Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem (2018) https://doi.org/10.1373/clinchem.2018.288068
- Lin, LC., et al. Proenkephalin as a biomarker correlates with acute kidney injury: a systematic review with meta-analysis and trial sequential analysis. Crit Care 27, 481 (2023). https://doi.org/10.1186/s13054-023-04747-5
- Mehta RL et al. International Society of Nephrology’s 0by25 initiative for acute kidney injury (zero preventable deaths by 2025): a human rights case for nephrology. Lancet. 2015 Jun 27;385(9987):2616–43. http://dx.doi.org/10.1016/S0140-6736(15)60126-X
- Susantitaphong P et al. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482–93. http://dx.doi.org/10.2215/CJN.00710113
About SphingoTec
SphingoTec GmbH (“SphingoTec”; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarkers for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec’s innovative markers are made available on different IVD platforms. SphingoTec’s proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis. Discover more on www.sphingotec.com
Contact:
Ruxandra Lenz
Head of Marketing and Communication
SphingoTec GmbH
Phone +49-3302-20565-0
Email:
ONWARD® Medical Announces Third Implant of BrainComputer Interface (BCI) System to Restore Movement after Spinal Cord Injury
ONWARD® Medical Announces Third Implant of BrainComputer Interface (BCI) System to Restore Movement after Spinal Cord Injury
Company continues pioneering research on BCI-enabled system to restore mobility after spinal cord injury
EINDHOVEN, the Netherlands — September 19, 2024 — ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), announces another successful implant of its investigational ARC-BCI™ System to restore lower limb mobility after SCI.
The ARC-BCI System combines the investigational ONWARD ARC-IM® System (an implanted technology that delivers targeted stimulation to the spinal cord) with the investigational WIMAGINE® BCI from CEA-Clinatec to create a DigitalBridge™ across the injured spinal cord. The implant procedure was performed on September 12, 2024, by Jocelyne Bloch, MD, head of functional neurosurgery at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne,
Switzerland.
“The procedure went smoothly, and early signs are encouraging,” said neurosurgeon Dr. Jocelyne Bloch. “We look forward to sharing more information in the coming months as the participant progresses in their rehabilitation and we publish observations from the study.”
This implant is part of an ongoing clinical feasibility study supported by a grant from the European Innovation Council under the Reverse Paralysis project and coordinated by .NeuroRestore, a Swiss neuroscience research institute. The researchers are also exploring use of the ONWARD ARC-BCI System to address upper limb movement challenges after SCI in a separate early feasibility clinical study funded by the Christopher & Dana Reeve Foundation.
The WIMAGINE BCI from CEA-Clinatec is an epidurally-implanted device with 7 years of human safety data; ONWARD ARC-IM Therapy has now been applied in more than 30 study participants.
“While other companies race to develop BCIs to communicate with and control computers, ONWARD Medical stands alone in our commitment to exploring the potential for this promising technology to restore movement of the human body after paralysis,” said Dave Marver, CEO of ONWARD Medical. “We salute our brilliant partners at CEA-Clinatec and .NeuroRestore for their important contributions to this research.”
This latest news marks the third human implant of the WIMAGINE BCI paired with ARC-IM Therapy to restore thought-enabled movement after SCI and the second for lower limb mobility. The first human use of ARC-BCI Therapy for lower limb mobility occurred in 2021, with results describing the individual’s augmented control over when and how he moved his paralyzed legs published in Nature in May 2023. In the fall of 2023, an individual was implanted to explore the potential for ARC-BCI Therapy to restore upper extremity function after SCI.
Earlier this year, the Company announced that it has been accepted into the US FDA’s new Total Product Lifecycle Advisory Program (TAP) for its ARC-BCI platform. Prior to the acceptance, the Company announced its ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration. This is the Company’s 10th such award.
To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.
*All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARCBCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.
About ONWARD Medical
ONWARD® Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy™, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).
ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to be delivered by the Company’s external ARC-EX® or implantable ARC-IM® platforms. ARC Therapy can also be delivered by the Company’s ARC-BCI™ platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after SCI with thought-driven control.
Use of non-invasive ARC-EX Therapy significantly improved upper limb function after SCI in the global pivotal Up-LIFT trial, with results published by Nature Medicine in May 2024. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for
regulatory submission in Europe. In parallel, the Company is conducting clinical studies with its ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing clinical studies focus on using ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson’s disease as well as using the ARC-BCI platform to restore thoughtdriven movement of both upper and lower limbs after SCI.
Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Brussels and Amsterdam (ticker: ONWD).
For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.
For Media Inquiries:
Aditi Roy, VP Communications
For Investor Inquiries:
Amori Fraser, Finance Director
Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including,
but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forwardlooking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. All ONWARD Medical devices and therapies referenced here, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™ and ARC Therapy™, are investigational and not available for commercial use.
Carisma and Moderna Expand Collaboration to Develop Two In Vivo CAR-M Therapies for Autoimmune Diseases
Carisma and Moderna Expand Collaboration to Develop Two In Vivo CAR-M Therapies for Autoimmune Diseases
Building on successful pre-clinical in vivo CAR-M data in oncology, the companies will develop in vivo CAR-M for autoimmune diseases
Moderna nominated two autoimmune disease targets under the collaboration
Carisma is eligible to receive milestones and royalty payments
PHILADELPHIA, Sept. 10, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the expansion of its in vivo chimeric antigen receptor macrophage and monocyte (together, “CAR-M”) collaboration with Moderna, Inc. (Nasdaq: MRNA) to include the nomination of two targets for the treatment of autoimmune diseases. Carisma retains all rights in autoimmune disease beyond the two nominated targets, which will be exclusively partnered with Moderna.
Under this expanded collaboration, Carisma and Moderna will leverage Carisma’s proprietary CAR-M technology and Moderna’s mRNA/LNP platform to develop novel in vivo macrophage engineering approaches in the nominated autoimmune disease targets. Carisma will receive research funding and is eligible to receive development, regulatory, and commercial milestone payments, plus royalties on net sales of any products that are commercialized under the collaboration agreement. Carisma will be responsible for the discovery and optimization of development candidates, while Moderna will lead the clinical development and commercialization of therapeutics resulting from the agreement.
“We are excited to expand our collaboration with Moderna into the realm of autoimmune diseases,” said Steven Kelly, President and Chief Executive Officer of Carisma. “The nomination of the two autoimmune targets is a significant milestone in our mission to harness the power of macrophages to treat a broader range of diseases. Our innovative CAR-M technology has the potential to revolutionize the treatment landscape for patients suffering from these debilitating conditions.”
“We are excited to build on the progress of advancing in vivo CAR-M therapies with Carisma by expanding beyond oncology,” said Lin Guey, PhD, CSO of Therapeutic Research Ventures, Moderna. “We continue to believe that the combination of our platform and Carisma’s deep myeloid biology expertise could lead to innovative treatments for patients.”
The expanded collaboration between Carisma and Moderna underscores the potential of CAR-M technology to impact a diverse range of disease areas. The expansion will aim to bring transformative therapies to patients with cancer and autoimmune diseases, advancing the frontier of immunotherapy.
About Carisma Therapeutics
Carisma Therapeutics Inc. is a clinical stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of clinical trials. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) Carisma’s ability to realize the anticipated benefits of its pipeline reprioritization and corporate restructuring, (ii) Carisma’s ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (iii) Carisma’s ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials and with its current financial and human resources; (iv) Carisma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (v) Carisma’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (vi) regulatory requirements or developments and Carisma’s ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities related to its product candidates; (vii) changes to clinical trial designs and regulatory pathways; (viii) risks associated with Carisma’s ability to manage expenses; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (xi) legislative, regulatory, political and economic developments.
For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
Investors:
Shveta Dighe
Head of Investor Relations
Media Contact:
Julia Stern
(763) 350-5223
SOURCE Carisma Therapeutics Inc.
CorFlow Therapeutics AG completes €44 million Series B financing to support the advancement of a novel diagnostic and drug delivery platform for microvascular obstruction (MVO) in heart attack patients
CorFlow Therapeutics AG completes €44 million Series B financing to support the advancement of a novel diagnostic and drug delivery platform for microvascular obstruction (MVO) in heart attack patients
The Series B funding enables both an International Pivotal trial to diagnose MVO and a randomized controlled trial to evaluate therapeutic treatments for MVO through the CoFI system
BAAR, Switzerland–(BUSINESS WIRE)– CorFlow Therapeutics AG (CorFlow) announced today that it has raised €44 million in Series B funding, co-led by Broadview Ventures and Panakes Partners with strong continued support from 415 Capital, CorFlow’s initial VC investor and largest shareholder. Merieux Equity Partners, Laerdal Million Lives Fund, Wellington Partners, M&L Investments, Unorthodox Ventures, KOFA Healthcare and Monte Carlo Capital participated in the multinational syndicate.
Concurrent with the financing, David Prim of Broadview Ventures, Barbara Castellano of Panakes Partners, Yoann Bonnamour of Merieux Equity Partners, and Rhiya Pau of Laerdal Million Lives Fund have joined the CorFlow Board of Directors.
The Series B will fund the MOCA II (MVO with CoFITM System Assessment II) pivotal study intended to gain US market clearance. The trial will run in the US and Europe and aims to validate CorFlow’s CoFl system to diagnose MVO in heart attack patients immediately following stent implantation. Additionally, it will fund an adaptive platform therapy study evaluating treatment effects of therapeutic agents delivered locally through the CoFl system on heart attack patients diagnosed with MVO.
MVO affects more than half of all patients who suffer an acute heart attack and is an independent predictor for heart failure and mortality. Currently not routinely diagnosed MVO remains largely untreated, leading to poor patient outcomes, and contributing to high health care costs associated with cardiovascular disease.
CorFlow’s CoFl system is being developed to provide timely, accurate and consistent detection of MVO while patients are still in the catheter laboratory (cath lab) immediately following reopening of the larger epicardial arteries with a stent. Uniquely, the technology has been designed to also enable localized delivery of therapeutics to the microvasculature upon MVO diagnosis. CoFl also seamlessly integrates into standard workflows utilizing existing guide catheter and wire access.
“We are thrilled to have closed on this significant round of financing, backed by a top-tier global syndicate of medical technology investors,” commented Paul Mead, President and Chief Executive Officer of CorFlow. “Recent data from over 70 patients in our MOCA I first in human trial and from our extensive preclinical program support our collective confidence that we can improve outcomes in patients who suffer heart attacks, specifically those patients whose microvascular disease goes undiagnosed and untreated today. There is overwhelming evidence now that microvascular conditions are a significant root cause of adverse outcomes in heart attack patients and other cardiovascular conditions. I am grateful that our new investors have the vision to see ‘where the puck is going’ in this rapidly emerging field.”
The MOCA II IDE trial is designed to confirm the CoFl system’s accuracy in diagnosing MVO in high-risk heart attack patients. Led by Principal Investigator Dr. Tim Henry of The Christ Hospital in Cincinnati, Ohio, the trial will recruit several hundred patients undergoing stent implantation due to ST-Elevation Myocardial Infarction (STEMI) and will compare CoFl’s proprietary dynamic diagnostic measurement of MVO to post-procedure Contrast Enhanced Cardiac Magnetic Resonance Imaging (CMRI), the current gold standard for detecting MVO. The MOCA II trial leverages the learnings from the company’s First-In-Human MOCA I trial conducted in Switzerland, Lativa and the UK.
“There is increasing awareness of the impact of MVO on patient outcomes following coronary revascularization. CorFlow has the potential to be the next significant breakthrough in treating coronary artery disease, and Broadview is delighted to be supporting this impressive team and technology,” states David Prim of Broadview Ventures.
“CorFlow’s breakthrough technology has been designed by clinicians for clinicians and we are excited to support CorFlow’s mission to generate robust clinical data in order to get this much needed therapy to the patient as quickly as possible.” adds Barbara Castellano of Panakes Partners. “We also are committed to supporting the emerging field of microvascular disease in general, and this oversubscribed funding round gives us options to apply the technology in new ways, and in new geographies, where patients can benefit.”
The funding will also support a novel adaptive platform therapy trial in Europe evaluating whether localized delivery of therapeutics to the microvasculature immediately following stent implantation can improve outcomes in patients diagnosed with MVO. Led by Dr. Giovanni Luigi De Maria (Oxford University Hospitals Trust, UK) and Professor Colin Berry (University of Glasgow and NHS Golden Jubilee National Hospital, UK), this European RCT will assess the effects of several therapeutic agents with both clinical and imaging measures up to six months.
“The improvement in outcomes for heart attack patients has stagnated over many years now and we believe that real-time diagnosis and targeted therapy for MVO has the potential to save the lives of countless patients in the future.” comments Frederik Groenewegen of 415 Capital. “We have long been believers in the CorFlow technology and team, and with the support of this first-class investor syndicate we now have the opportunity to collect the clinical data required to establish a new standard of heart attack care.”
About CorFlow Therapeutics: Headquartered in Baar, Switzerland, with offices in Italy, and founded in 2016 by Dr. Rob Schwartz, Dr. Martin Rothman and Jon Hoem. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. Working in close partnership with scientists from the University of Bern, ETH Zurich and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore applications in and beyond the heart.
About Microvascular Obstruction (MVO): Often described as the “last frontier” in the treatment of acute heart attacks, MVO is characterized by blockages in the microvascular coronary arteries, which vary in size down to the circumference of a human hair. Previous research has identified that MVO is one of the most powerful prognostic indicators for future adverse outcomes – for every 1% increase in MVO, there’s a corresponding 14% increase in one-year mortality risk and 8% increase in hospitalization due to heart failure.
Media and Scientific Contact
CorFlow Therapeutics AG
Carisma Therapeutics Announces Changes to its Board of Directors
Carisma Therapeutics Announces Changes to its Board of Directors
Appointment of David Scadden, M.D. and Marella Thorell
Resignation of Regina Hodits and Björn Odlander
PHILADELPHIA, July 1, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the appointment of Marella Thorell and David Scadden, M.D., to the Company’s Board of Directors, effective June 30, 2024. Additionally, Regina Hodits and Björn Odlander have informed the Board of their intention to step down as members effective June 30, 2024, due to other professional commitments.
“We are pleased to welcome David and Marella to the Carisma Board of Directors. Their vast experience in the life sciences sector will be instrumental in advancing our cell therapy platform focused on engineered macrophages,” said Sanford Zweifach, Chair of the Carisma Board of Directors. “We would also like to thank Regina and Björn for their invaluable contributions, guidance, and leadership throughout their tenure. We wish them the utmost success in their future endeavors.”
“Dr. Scadden’s renowned expertise as a physician and medical researcher will be incredibly valuable to Carisma, and we are honored to welcome him to our Board of Directors. Ms. Thorell’s experience as a public company executive and Board Member of biotech companies will enhance the business capabilities of our Board,” said Steven Kelly, President and Chief Executive Officer of Carisma. “These new appointments enrich our Board’s diversity of experience and perspective, providing exemplary leadership as we work with urgency to bring groundbreaking immunotherapies to patients.”
About David Scadden
Dr. Scadden is the Gerald and Darlene Jordan Professor of Medicine and Professor of Stem Cell and Regenerative Biology at Harvard University. Dr. Scadden founded and directs the Center for Regenerative Medicine at Massachusetts General Hospital and co-founded and co-directs the Harvard Stem Cell Institute. Dr. Scadden is Chairman Emeritus and Professor of the Harvard University Department of Stem Cell and Regenerative Biology. Dr. Scadden has received numerous honors and awards and has served on the board of scientific counselors for the National Cancer Institute, the board of external experts for the National Heart, Lung, and Blood Institute, the board of directors of the International Society for Stem Cell Research and is an affiliate member of the Broad Institute of Harvard and MIT. He serves on multiple editorial boards, scientific advisory boards, and corporate boards. He is a scientific founder of Fate Therapeutics, Inc., and Dianthus Therapeutics, Inc., and also serves on the Board of Directors of Agios Pharmaceuticals, Inc., and Editas Medicine, Inc. Dr. Scadden received a bachelor’s degree in English from Bucknell University and an M.D. from Case Western Reserve School of Medicine.
About Marella Thorell
Marella Thorell brings more than 25 years of extensive experience in finance and operations across both public and private biotech companies. Ms. Thorell is currently the Chief Financial Officer of Seres Therapeutics. Previously, she served as the Chief Financial Officer of Evelo Biosciences. Her prior roles include Chief Accounting Officer at Centessa Pharmaceuticals, Chief Financial Officer of Palladio Biosciences prior to its acquisition by Centessa, and Chief Financial Officer and Chief Operating Officer of Realm Therapeutics. Before her time at Realm Therapeutics, Ms. Thorell held positions of increasing responsibility at Campbell Soup Company and Ernst & Young, LLP. Ms. Thorell is a Director and Chair of the Audit Committee of ESSA Pharmaceuticals and was previously Chair of the Board of Vallon Pharmaceuticals before its merger in 2023. Ms. Thorell received a bachelor’s degree in business from Lehigh University.
About Carisma
Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
UroMems Raises Record $47 million (€44 Million) in Series C Financing to Fund Pivotal Clinical Trials of the UroActive™ System, the First Smart Automated Implant to Treat Stress Urinary Incontinence
UroMems Raises Record $47 million (€44 Million) in Series C Financing to Fund Pivotal Clinical Trials of the UroActive™ System, the First Smart Automated Implant to Treat Stress Urinary Incontinence
GRENOBLE, France & MINNEAPOLIS, Minnesota (June 25, 2024) – UroMems, a global company developing innovative, implantable mechatronics technology to treat stress urinary incontinence (SUI), today announced it has raised $47 million in its Series C financing, the largest fundraising round to date for the company. The capital will support large-scale U.S. and European pivotal clinical trials of the UroActive™ implant, paving the way for regulatory submission in multiple countries. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI.
The financing round was led by Crédit Mutuel Innovation and joined by the European Innovation Council as well as the existing investors Wellington Partners, Bpifrance, Supernova Invest, Hil-Invent, b-to-v Partners and Financière Arbevel.
“We are thrilled to lead this record round for UroMems,” said Jérôme Feraud, Head of Health Division at Crédit Mutuel Innovation. “Based on very positive data and feedback from patients and physicians in the pilot clinical trials, we strongly believe that the UroActive smart implant has the potential to become the standard of care as the next-generation SUI treatment.”
Under the strong and steady leadership, energy and guidance of co-founders Chief Executive Officer Hamid Lamraoui and Chief Medical Officer Professor Pierre Mozer, UroMems has successfully surpassed critical milestones in research and development, clinical outcomes and building the organization. The funding comes on the heels of exceptionally strong results from the first-in-man multicenter clinical study six-month endpoint, and successful six-month primary endpoint for the first-ever female patient to receive the UroActive System. For all study patients the devices are operating as expected for over one year now with no need for revision nor explant. In addition, extremely positive follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.
“We’ve invested in UroMems from the start and our confidence that the UroActive System will improve patients’ lives continues to grow as the company reaches one major milestone after the other,” said Dr. Johannes Fischer, Partner at Wellington Partners. “We look forward to continue supporting the company as they move closer to bringing this promising technology to both women and men suffering from SUI.”
“On behalf of our entire exceptional team and the patients whose lives have been restored thanks to our technology, we are grateful to our investor partners for their continued support as we approach the critical milestone of launching our pivotal clinical trial,” said Lamraoui. “The confidence of our new and existing investors combined with the strength of our compelling results and tremendous physician interest shows the high potential of our technology. This brings us one step closer to delivering on the massive unmet need for men, women and physicians desperately seeking a better SUI treatment option.”
SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low selfesteem and social stigma.
About UroActive
UroActive is an active implantable electronic artificial urinary sphincter that is being developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bionic platform using embedded smart, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems technology platform is protected by more than 150 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeonconvenience. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.
For more information, please visit www.uromems.com.
Media Contact:
Shelli Lissick
651-276-6922
Carisma Therapeutics Granted FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors
Carisma Therapeutics Granted FDA Fast Track Designation for CT-0525 for the Treatment of HER2-overexpressing Solid Tumors
Fast Track designation highlights potential for CT-0525 to address unmet need for patients with solid tumors
Initial Phase 1 data expected by year-end 2024
PHILADELPHIA, June 25, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).
The FDA’s Fast Track program is aimed to facilitate the development, and expedite the review, of novel potential therapies that are designed to treat serious conditions and have the potential to address significant unmet medical need.
“Receiving Fast Track designation for CT-0525 from the FDA marks a significant milestone for Carisma, highlighting the FDA’s recognition of the serious and life-threatening nature of these malignancies and the potential of CT-0525 to meet this critical medical need,” said Eugene P. Kennedy, M.D., Chief Medical Officer of Carisma. “We are committed to working closely with the FDA to accelerate the development of CT-0525. Currently, we are enrolling patients in the Phase 1 clinical trial and remain on track to report initial clinical data by the end of 2024.”
The Phase 1 clinical trial for CT-0525 is an open-label study designed to assess the safety, tolerability, and manufacturing feasibility of CT-0525. This trial will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. The initial study design will consist of two dose escalation cohorts. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06254807.
About CT-0525
CT-0525 is a first-in-class, ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). It is being studied in a multi-center, open label, Phase 1 clinical trial for patients with advanced/metastatic HER2-overexpressing solid tumors that have progressed on available therapies. The CAR-Monocyte approach has the potential to address some of the challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the tumor microenvironment, and antigen heterogeneity. CT-0525 has the potential to enable significant dose escalation, enhance tumor infiltration, increase persistence, and reduce manufacturing time compared to macrophage therapy.
About Carisma Therapeutics
Carisma Therapeutics Inc. is a clinical stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of clinical trials. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) Carisma’s ability to realize the anticipated benefits of its pipeline reprioritization and corporate restructuring, (ii) Carisma’s ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (iii) Carisma’s ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials and with its current financial and human resources; (iv) Carisma’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (v) Carisma’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (vi) regulatory requirements or developments and Carisma’s ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities related to its product candidates; (vii) changes to clinical trial designs and regulatory pathways; (viii) risks associated with Carisma’s ability to manage expenses; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (xi) legislative, regulatory, political and economic developments.
For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, the Company’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
Investors:
Shveta Dighe
Head of Investor Relations
Media Contact:
Julia Stern
(763) 350-5223