Month: December 2023

PHILADELPHIA, Dec. 14, 2023 /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 nomination of its first lead candidate under the collaboration with Moderna, Inc. (Nasdaq: MRNA). This first lead candidate will target an antigen present on a solid tumor with significant unmet medical need. This strategic collaboration brings together Carisma’s chimeric antigen receptor macrophage (CAR-M) platform with Moderna’s messenger RNA (mRNA) and lipid nanoparticle (LNP) technologies to generate and develop in vivo CAR-M therapeutics for oncology.

“Following the compelling pre-clinical proof of concept data shared at SITC 2023, we believe in vivo CAR-M therapeutics that utilize Moderna’s mRNA/LNPs have the potential to benefit patients with a broad variety of cancers,” stated Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma. “The delivery of this first candidate demonstrates our ability to create novel in vivo CAR therapies that can be advanced toward the clinic. We are proud of the significant contributions made by both of the scientific teams at Carisma and Moderna towards this exciting program. We look forward to completing IND-enabling studies with the lead candidate and are excited about the prospect of bringing this therapy forward for patients with advanced solid tumors together with Moderna.”

Lin Guey, PhD, Chief Scientific Officer of Therapeutics Research Ventures and Biotherapeutics at Moderna, stated, “We are excited with the progress we’ve made to advance in vivo cell therapy (CAR-M) in collaboration with Carisma. Combining Carisma’s deep expertise in myeloid cell biology with our mRNA/LNP platform has allowed us to quickly advance the first lead candidate and we look forward to furthering its development, along with our continued collaboration with Carisma to develop novel therapies to treat patients.”

Pre-clinical proof of concept data were recently presented at SITC 2023, demonstrating the feasibility, efficacy, and tolerability of the in vivo CAR-M platform that utilizes Moderna’s optimized mRNA encapsulated in LNPs and is designed to redirect endogenous myeloid cells to exert targeted anti-tumor activity. The highlighted data demonstrated that Carisma’s CAR-M therapy can be directly produced in vivo, or within the body, and can successfully redirect endogenous myeloid cells against tumor-associated antigens using Moderna’ mRNA/LNPs. This novel approach to cancer immunotherapy offers an off-the-shelf solution that has the potential to increase access to CAR-based therapies and to be the basis of any CAR-M programs discovered or developed under the Carisma and Moderna collaboration.

Successful primary and secondary results demonstrate proof of feasibility in male patients, paving way for launch of large-scale pivotal clinical study in the U.S. and Europe

GRENOBLE, France and MINNEAPOLIS, Dec. 13, 2023 /PRNewswire/ — UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today it has reached a significant milestone: the complete treatment cohort in the first-of-its-kind clinical feasibility study has successfully reached the six-month primary endpoints.

The feasibility assessment of the UroActive System was completed through a prospective multicenter clinical study. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI, and the only one to reach this critical milestone. The results of this initial clinical study support design and implementation of UroMems’ pivotal SUI trial in Europe and the U.S. All six men are now implanted for at least seven months and up to fifteen months, with their devices operating as expected and 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.

UroMems received very positive feedback from all patients participating in the study cohort. “You have changed my life,” stated one of the study participants. “I can do all activities again, without stress, without anxiety!”

“We’re so pleased to see that our expectations about our device’s performance were met or even exceeded and delighted to successfully treat and receive such high praise from patients who had been suffering from SUI for years,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder. “The results of this study will allow us to prepare our pivotal study which will be a major step in the development of UroActive.”

UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethral duct and is controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.

“The very compelling results of this first-in-man clinical study demonstrate the high potential of our technology and pave the way for larger clinical trials that will allow us to demonstrate all the benefits we are expecting to offer patients suffering from debilitating SUI,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “We could not have reached this important milestone without the enthusiastic participation of the men in this initial study cohort. We’re extremely grateful to them for being a vital part in bringing this potentially revolutionary treatment to market.”

SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the muscle (the sphincter) around the urethra, caused by activities involving high intra-abdominal pressure, like coughing, laughing and exercising. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma.