Core Insights - CARsgen Therapeutics Holdings Limited has achieved a favorable outcome in opposition proceedings regarding its European patent EP3445407, which pertains to its GPC3-targeted CAR-T cell therapy [1][4] - A U.S.-based biotechnology company, the sole appellant among the original two opponents, has formally withdrawn its appeal against the EPO's decision to maintain the patent, making the decision final and binding [2][3] - The EPO granted the patent in 2022, and it was opposed by two parties in 2023, but the EPO upheld key claims related to the use of GPC3 CAR-T cell therapy for various cancers [3][4] Company Overview - CARsgen is a biopharmaceutical company focused on developing innovative CAR T-cell therapies to address unmet clinical needs, including hematologic malignancies, solid tumors, and autoimmune diseases [5] - The company has established comprehensive capabilities for CAR T-cell research and development, covering target discovery, preclinical research, clinical development, and commercial-scale production [5] - CARsgen aims to improve the safety profile, enhance efficacy in treating solid tumors, and reduce treatment costs, with a mission to become a global leader in providing innovative cell therapies [5]

Fountain Life operates four flagship longevity centers, including two in Florida, where a new state law effective July 1, 2025, authorizes licensed physicians to administer stem cell therapies to members with conditions in orthopedics, wound care, and pain management. FLORHAM PARK, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, announced today that it entered into ...

HOUSTON, July 07, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, is pleased to invite investors to a webinar on July 10, 2025, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature FibroBiologics’ Founder and Chief Executive Officer, P ...

Summary of Lyell Immunopharma (LYEL) Conference Call - June 25, 2025 Company Overview - **Company**: Lyell Immunopharma - **Focus**: Development of next-generation cell therapies for cancer, specifically targeting hematologic malignancies and solid tumors with CAR T cell therapies [4][5] Core Points and Arguments Product Development - **Lead Program**: Autologous CAR T cell therapy targeting CD19 and CD20, aimed at achieving more complete responses and longer remission periods [4][5] - **Clinical Trials**: Currently in pivotal clinical trials for relapsed/refractory large B cell lymphoma, with a focus on outpatient administration due to a favorable safety profile [6][19] Clinical Data - **Third-Line Setting**: - Presented data from 51 patients showing an 88% overall response rate and a 72% complete response rate, significantly higher than the approximately 50% seen with existing CD19 CAR therapies [15][16] - 71% of patients who achieved complete response remained in remission at six months, compared to about 40% for CD19 CARs [16][43] - **Second-Line Setting**: - First data presented showed a 91% overall response rate and a 70% complete response rate in patients with primary refractory disease [18][19] - The patient population included older patients with no upper age limit, broadening the inclusion criteria compared to competitors [18][65] Competitive Landscape - **Comparison with Competitors**: - Lyell's dual-targeting approach (CD19 and CD20) is positioned as a significant advancement over existing CD19-only therapies, which have limitations in patient response [7][26] - Notable competitors include Yescarta (Axi-cel) and Breyanzi (Liso-cel), both of which have shown similar response rates but with higher rates of neurotoxicity [21][23][31] - Lyell's safety profile shows lower rates of cytokine release syndrome (CRS) and neurotoxicity compared to competitors [31][32] Regulatory and Market Strategy - **Regulatory Designation**: Received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating strong early data and facilitating more frequent interactions with the agency [50][56] - **Pivotal Trial Design**: A seamless phase one/two design for the pivotal trial, with plans to accelerate patient recruitment by adding more centers [51][52] - **Market Opportunity**: Targeting a significant patient population in both the second and third-line settings, with an estimated 30,000 new DLBCL cases annually in the U.S. [60] Additional Important Insights - **Patient Demographics**: The focus on older patients and those with primary refractory disease highlights the unmet need in the market and the potential for Lyell's therapies to address this gap [18][62] - **Intellectual Property**: Lyell holds a strong intellectual property position, with patents originating from UCLA, which may provide a competitive edge in the market [36][37] - **Future Outlook**: The company is optimistic about the potential for national priority review vouchers, which could expedite the approval process for their therapies [56][57] This summary encapsulates the key points discussed during the conference call, highlighting Lyell Immunopharma's strategic positioning, clinical advancements, and competitive landscape in the CAR T cell therapy market.

SUNNYVALE, Calif., June 25, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the United States Patent Office has granted US Patent No. 12,311,127 titled “Radial and Trans-endocardial Delivery Catheter”. US Patent No. 12,311,127 describes the Company’s minimally invasive interventional catheter systems to deliver biologic therapies to target sites in the heart. T ...

Mark J. Bachleda, PharmD, MBA appointed as independent member of the Board of DirectorsDavid Shook, MD appointed as Chief Medical Officer, Mark Meltz, JD as General Counsel and Corporate Secretary, and Jarrad Aguirre, MD, MBA as Senior Vice-President of Medical Affairs SOUTH SAN FRANCISCO, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today announced the appoi ...

Core Insights - MiNK Therapeutics has received a non-dilutive grant from the National Institute of Allergy and Infectious Diseases (NIAID) to support the development of its allogeneic invariant natural killer T (iNKT) cell therapy platform for preventing and treating graft-versus-host disease (GvHD) in high-risk hematopoietic stem cell transplantation (HSCT) settings [1][2] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic iNKT cell therapies and precision-targeted immune technologies [4] - The company's lead asset, AGENT-797, is an off-the-shelf iNKT cell therapy currently in clinical development for GvHD, solid tumors, and critical pulmonary immune collapse [4] - MiNK is advancing a pipeline of T cell receptor (TCR)-based therapies and neoantigen discovery tools aimed at enabling tumor- and tissue-specific immune activation [4] Research and Development - The collaboration with the University of Wisconsin aims to leverage expertise in transplant immunology to enhance the efficacy of iNKT cells in managing GvHD while preserving the patient's ability to fight infections [3] - iNKT cells are recognized for their potential to regulate immune responses, promote tissue repair, and suppress inflammatory pathways, making them suitable for addressing GvHD complications [2][3] Market Need - Nearly 50% of patients undergoing allogeneic stem cell transplants are at risk for GvHD, highlighting a significant unmet medical need in this area [2]

Core Insights - SNAP Biosciences, a subsidiary of Coeptis Therapeutics, has entered into a licensing agreement with Monarch Therapeutics to develop and commercialize its Snap-Car NK cell therapy platform in oncology using Monarch's small molecule adaptor technology [1][4]. Group 1: Licensing Agreement - The agreement allows SNAP Biosciences to utilize Monarch's small-molecule adaptor technology, enhancing the functionality of the Snap-Car universal CAR-based receptor platform [2]. - Monarch's adaptor technology enables SNAP-CAR cells to be directed by small molecules, improving precision, flexibility, and modular potential across various therapeutic areas [2][3]. Group 2: Technology and Innovation - The integration of Monarch's small molecule adaptors allows Snap-Car NK cells to target multiple tumor antigens and modulate their activity in real-time, addressing tumor heterogeneity and antigen escape challenges [3]. - This collaboration aims to develop more potent, flexible, and scalable NK therapies for difficult-to-treat cancers [4]. Group 3: Financial Terms - Under the agreement, Monarch will receive an upfront licensing payment, future development milestone payments, and royalties on net sales [4]. Group 4: Company Background - Monarch Therapeutics is a pre-clinical stage biotechnology company focused on next-generation immunotherapies, particularly in solid tumors [5]. - SNAP Biosciences specializes in developing Snap-Car, a universal CAR cell therapy that allows programmable antigen targeting [6]. - Coeptis Therapeutics Holdings, Inc. focuses on innovative cell therapy platforms for cancer and other diseases, aiming to improve patient outcomes through advanced research and development [7].

Summary of Biocardia (BCDA) FY Conference Call Company Overview - Biocardia is a late-stage development company focused on autologous stem cell therapy for ischemic heart failure and chronic myocardial ischemia, located in Sunnyvale, California [1][2][5] - The company has four clinical programs at various stages of advancement [5] Core Points and Arguments Heart Failure Program - The lead indication is heart failure, specifically the BCDA DAO one cardiac phase three trial [6] - Heart failure is described as an enormous unmet medical need, with the therapy aiming to treat microvascular dysfunction by delivering high dosages of autologous cells directly into the heart muscle [6][7] - Preclinical models have shown that the therapy can reduce fibrosis and enhance capillary density [7] - The therapy includes a selection diagnostic to screen out patients who are not appropriate for treatment [7][8] Clinical Trial Data - In March, data from the heart failure one trial was presented, showing reduced mortality and improved quality of life, despite not hitting the primary endpoint [10][11] - The trial involved 115 patients and demonstrated statistical significance in secondary endpoints, including survival and reduction in major adverse cardiac events [11][12] - A one-time dosage of cells is administered, with a two-year follow-up showing robust effects [12] Upcoming Trials and Regulatory Submissions - The FDA approved a subsequent trial (Heart Failure II) to address previous enrollment challenges, with modifications to the study design [14][15] - The new trial will focus on patients with elevated markers of heart stress and aims to double the enrollment rate [19] - Biocardia is pursuing expedited approval from Japan's PMDA for cardiac cell therapy, with a submission expected within the year [21][24] - The company is also working on FDA submissions for its delivery system, which has shown excellent safety data [25] Chronic Myocardial Ischemia Program - The CardiAmp CMI program targets chronic myocardial ischemia with refractory angina, a condition poorly met by existing therapies [26][28] - There are at least one million patients in the U.S. with this condition, and Biocardia's approach aims to be the least expensive cardiac cell therapy available [30][31] - The company is working on a manuscript for early data from the low dose cohort of the CMI trial [32] Other Important Information - Biocardia has an allogeneic platform and is exploring partnerships for both cardiac and pulmonary indications [38][40] - The partnership environment is currently challenging due to market stability concerns, but Biocardia's assets are proven and in the clinic [41] - The company is focused on advancing its lead program while also exploring opportunities in other areas [39][41]

Core Insights - BioCardia, Inc. is focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [1] - The CEO, Dr. Peter Altman, will discuss recent developments in the company's therapeutic pipeline, particularly the CardiAMP autologous cell therapy for ischemic heart failure [2] Event Details - The fireside chat is scheduled for May 21, 2025, at 03:40 p.m. EDT, moderated by Jim Molloy from Alliance Global Partners [3] - The event will be available via webcast [3] Company Overview - BioCardia is headquartered in Sunnyvale, California, and is recognized as a leader in cellular and cell-derived therapeutics [3] - The company has two main biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three cardiac clinical stage product candidates in development [3] - BioCardia's therapies utilize the Helix™ biotherapeutic delivery and Morph vascular navigation product platforms [3]