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CARGO Therapeutics Enters into Agreement to Be Acquired by Concentra Biosciences for $4.379 in Cash per Share Plus a Contingent Value Right
Globenewswire· 2025-07-08 10:00
SAN CARLOS, Calif., July 08, 2025 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (“CARGO” or the “Company”) (NASDAQ: CRGX), a biotechnology company that has focused on developing CAR T-cell therapies, today announced that it has entered into a definitive merger agreement (the “Merger Agreement”) with Concentra Biosciences, LLC (“Concentra”), whereby Concentra will acquire CARGO for $4.379 in cash per share of CARGO common stock, par value $0.001 per share (“CARGO Common Stock”), plus one non-transferable cont ...
Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-101 (IL13Ra2-targeted CAR T-cells) to Treat Astrocytomas and Glioblastoma
Globenewswire· 2025-07-07 12:30
In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable disease or better with two partial responses and two complete responses lasting 7.5 and 66+ months, respectively Preclinical data support a novel combination of MB-101 (IL13Rα2‐targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus) to optimize clinical results FDA previously granted Orphan Drug Designation to Mustang for MB-108 for the treatment of malignant glioma WORCESTER, Mas ...
Xenetic Biosciences (XBIO) Earnings Call Presentation
2025-07-07 08:37
DNase I Oncology Platform - The company is focused on advancing its proprietary DNase I technology platform to address multiple high-value cancer indications[2, 5] - DNase I targets Neutrophil Extracellular Traps (NETs) to improve immunotherapies and chemotherapies[2, 5] - DNase I digests both double and single-stranded DNA, as well as DNA:RNA hybrids, exposing cancer cells to the immune system and reducing therapy resistance[6] - Systemic administration of DNase I improves the efficacy of PD-1 blockade, resulting in the lowest tumor volume growth compared to either DNase I or anti-PD-1 alone[19] Pipeline and Clinical Development - The company's lead program, XBIO-015, combines systemic DNase I with chemotherapy for pancreatic carcinoma[7] - A Phase 1 study is planned, featuring dose escalation and expansion in subjects with locally advanced or metastatic solid tumors, with pancreatic cancer and other solid tumor indications[2, 40] - The company believes that an ORR greater than 50% or PFS greater than 9 months would be a meaningful improvement to the current standard of care for pancreatic cancer[45] Market Opportunity - The company is initially targeting pancreatic carcinoma, a multi-billion-dollar indication with significant unmet need, with a projected market of $48 billion by 2025[2, 39] - Approximately 62,000 people are diagnosed with pancreatic cancer annually, and approximately 50,000 die from it annually[39] - There were approximately 19 million new solid tumor cases in the U S in 2022, leading to approximately 6 million solid tumor-related deaths[46] Collaboration and Intellectual Property - The company is collaborating with VolitionRX to develop proprietary adoptive cell therapies potentially targeting multiple solid cancer types[2, 58] - VolitionRX is expected to fund the research program, with both parties sharing proceeds from commercialization or licensing of any resulting products[60] - The company has an IP portfolio covering the co-administration of Systemic DNase I with ICIs, radiation, and chemo, as well as DNase I for pancreatic cancer and DNase I-secreting CAR T cells[62, 64]
Zoomcar Partners with CARS24 to Raise the Bar on Self-Drive Car Quality and Safety through Tech-Enabled Inspections
Prnewswire· 2025-07-01 11:00
BENGALURU, India, July 01, 2025 /PRNewswire/ -- Zoomcar Holdings, Inc. ('Zoomcar' or the 'Company') (OTCQX: ZCAR), India's largest peer-to-peer car-sharing marketplace, today announced a strategic partnership with CARS24, a leading platform for used car transactions in India, to bring industry-grade vehicle inspection and tracking standards to the self-drive car-sharing space.As part of this collaboration, CARS24 will conduct Pre-Delivery Inspections (PDIs) and install GPS tracking devices on newly onboarde ...
Anixa Biosciences (ANIX) Update / Briefing Transcript
2025-06-26 19:00
Anixa Biosciences (ANIX) Update Summary Company Overview - Anixa Biosciences was reinvented in 2017 as a biotechnology company focusing on cancer therapies, with a robust pipeline of products currently in clinical trials [5][6] - The company has established partnerships with leading organizations such as the Cleveland Clinic and Moffitt Cancer Center, and receives funding from the U.S. Department of Defense and the National Cancer Institute [6][7] Financial Position - Anixa maintains a strong balance sheet with over two years of cash on hand, allowing for significant clinical milestones without frequent capital raises [8][12] - The company has a clean capital structure with 32 million shares of common stock and no warrants or preferred stock [10][11] Clinical Programs CAR T Therapy for Ovarian Cancer - The CAR T therapy targets terminally ill ovarian cancer patients and is currently in clinical trials at Moffitt Cancer Center [17][19] - The therapy utilizes a unique target, the follicle stimulating hormone receptor (FSHR), which is only found on ovarian cells and tumor blood vessels, allowing for a dual mechanism of action [29][31] - Early results show promising outcomes, with some patients living significantly longer than expected [39][41] - The FDA has approved the possibility of administering a second dose to patients showing initial responses, which is a rare approval for CAR T therapies [41][80] Breast Cancer Vaccine - The breast cancer vaccine aims to treat and prevent breast cancer, particularly targeting triple-negative breast cancer [42][43] - The vaccine is based on the alpha lactalbumin protein, which is produced during lactation and is found in many breast cancer cells [43][44] - Initial Phase I trials have shown strong immune responses and safety, with plans for a Phase II trial to compare the vaccine's effectiveness against standard care [51][55] - The vaccine has the potential to change the paradigm of cancer prevention, aiming for primary prevention in women without a history of cancer [59][60] Market Opportunities - Anixa is addressing large markets, including breast and ovarian cancer, with plans to expand into lung, prostate, and colon cancer [7][20][61] - The company anticipates significant market opportunities if their therapies prove successful, particularly in the context of the breast cancer vaccine [58][61] Strategic Partnerships and Funding - Discussions with potential pharmaceutical partners for both the CAR T therapy and breast cancer vaccine are ongoing, with hopes for fruitful collaborations in the near future [68] - The U.S. Department of Defense has funded the breast cancer vaccine study, recognizing its potential to change cancer treatment landscapes [70][71] Key Milestones and Future Outlook - Upcoming milestones include comprehensive clinical data presentations at the San Antonio Breast Cancer Conference and ongoing updates on patient outcomes for the CAR T therapy [64][66] - The company is optimistic about the potential for partnerships and funding based on the promising early results from their clinical trials [68][86]
Lyell Immunopharma (LYEL) Conference Transcript
2025-06-25 17:00
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.
Allogene Therapeutics (ALLO) Earnings Call Presentation
2025-06-19 13:45
Cema-cel & ALPHA3 Trial - The ALPHA3 trial is designed to predict and intervene BEFORE relapse in LBCL patients, using cema-cel as a 1L consolidation treatment for MRD+ patients[16] - Phase 1 data showed cema-cel achieved a 100% CR rate in patients with low disease burden, paving the way for ALPHA3[19] - The ALPHA3 trial aims to enroll ~240 LBCL patients in CR/PR at the end of 1L therapy with MRD across ~50 US cancer centers and additional international sites[41] - The ALPHA3 addressable population creates a ~$5 billion potential market opportunity in the US and EU5[44, 92] ALLO-329 - Phase 1 Rheumatology Basket Trial for ALLO-329 was IND cleared in Jan 2025, with trial initiation expected in mid-2025 and potential clinical and biomarker PoC data in 1H 2026[52] - ALLO-329 is a dual CD19/CD70 allogeneic CAR T with Dagger® technology, designed to maximize CAR T expansion and potentially eliminate the need for lymphodepletion[54] - The RESOLUTION basket study will address four large diseases: Lupus (SLE) with an estimated US diagnosed prevalence of 330,000, Lupus Nephritis with 90,000, Systemic Sclerosis with 100,000 and Myositis with 70,000[63] ALLO-316 - The TRAVERSE Ph1 trial supports the potential of ALLO-316 in CD70+ RCC, with encouraging activity in solid tumors and FDA RMAT designation[64] - ASCO 2025 will feature the next Ph1b data update for ALLO-316[65] - The TRAVERSE addressable population creates a >$3.5 billion global market opportunity[65, 97] Financial Position - Allogene has a strong financial position with $335.5 million in cash, cash equivalents, and investments at the end of Q1 2025, projecting runway into 2H 2027[78]
Lyell(LYEL) - 2025 FY - Earnings Call Transcript
2025-06-11 15:00
Lyell Immunopharma (LYEL) FY 2025 Conference June 11, 2025 10:00 AM ET Speaker0 Great. Good morning, everyone. Thank you so much for joining us. I'm Salveen Richter, biotechnology analyst at Goldman Sachs. I'm really pleased to have with me the Lyle team. So next to me is Lynn Sealy, President and CEO of the company, and Charlie Newton, CFO. So maybe to start here for both of you, could you give us an overview of where your programs currently stand today and your key focus areas heading into the half of the ...
Lyell Immunopharma Strengthens Clinical and Commercial Capabilities with Key Board and Executive Appointments
Globenewswire· 2025-06-09 20:05
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 ...
Lyell Immunopharma to Participate in the Goldman Sachs Global Healthcare Conference
Globenewswire· 2025-06-04 20:05
SOUTH SAN FRANCISCO, Calif., June 04, 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, announced today that members of its senior management team will present and participate in the Goldman Sachs 46th Annual Global Healthcare Conference on Wednesday, June 11th at 10:00 am ET. A live webcast of the presentation can be accessed through the Investors section of the Company's website ...