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Nissan's CEO on leading in chaos: be fast and be flexible
CNBC· 2025-06-04 14:49
If you've just taken the top job, Nissan's new CEO Ivan Espinosa has some advice for you.Espinosa steps into the role at a turbulent time for the global auto industry — with slowing EV sales, intensifying competition from China, and new tariffs threatening profits."Keep the optimism up, because the environment is very tough, and you don't want to get overwhelmed," Espinosa told CNBC on Wednesday. "If you get overwhelmed, you can paralyze — and paralysis is not what you need in the current environment. You n ...
BioAtla Presents Phase 2 Ozuriftamab Vedotin (Oz-V) Clinical Trial Data Demonstrating Compelling Antitumor Activity in HPV-Associated Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) at the 1.8 mg/kg Q2W dosing regimen
GlobeNewswire News Room· 2025-06-02 12:00
45% overall response rate (ORR) and a 100% disease control rate (DCR) in HPV+ OPSCC patients treated with a median of 3 prior lines of therapy Marked unmet need exists in 2L+ HPV+ OPSCC patients; standard of care agents (methotrexate, docetaxel, or cetuximab) report an ORR of 3.4% Plan to finalize Phase 3 trial design in 2L+ HPV+ OPSCC with the U.S. Food and Drug Administration (FDA) SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB) (the “Company”), a global clinical-stage biotechno ...
Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy
Globenewswire· 2025-06-02 10:30
Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001)Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3 placebo-controlled trial continuesThe safety profile of atacicept was favorable, a ...
Senti Biosciences (SNTI) Conference Transcript
2025-05-29 19:40
Summary of Scenti Biosciences Conference Call Company Overview - **Company**: Scenti Biosciences - **Industry**: Biotechnology - **Focus**: Development of cell and gene therapies for incurable diseases using a synthetic biology platform called GeneCircuits [1][2] Core Technology and Product Development - **Technology**: Logic gating technology allows targeting of previously untreatable cancers, enhancing precision and control in therapy [3][4] - **Lead Program**: Santi 202, targeting relapsed/refractory Acute Myeloid Leukemia (AML) and related cancers, currently in early-stage clinical trials [4][5] - **Manufacturing**: Scalable off-the-shelf manufacturing streamlines treatment for patients [5] Clinical Data and Efficacy - **Clinical Results**: Positive data reported at AACR 2025 meeting, with five patients achieving overall response rate (ORR) and four achieving complete response [15] - **Durability**: Longest-term patient response lasted over eight months, indicating potential for outpatient use [14][15] - **Patient Population**: AML affects over 20,000 newly diagnosed patients annually, with a 60% relapse rate within 12 months [10] Mechanism of Action - **Logic Gates**: Designed to differentiate between cancerous and healthy cells, minimizing toxicity [7][8] - **Cell Engineering**: Utilizes natural killer (NK) cells genetically modified to express proteins targeting AML cells while protecting healthy cells [11][12] - **Key Proteins**: Includes activating CAR (ACAR) targeting CD33 and FLT3, and an inhibitory CAR that protects healthy cells [12][13] Clinical Trial Design - **Phase One Trial**: Multicenter, multinational study assessing two dose levels (1 billion and 1.5 billion CAR positive NK cells) [16][17] - **Dosing Schedule**: Patients receive multiple doses, with assessments for response at 28 days [18] Safety and Tolerability - **Patient Monitoring**: Recovery of healthy blood cell counts observed post-treatment, indicating maintenance of healthy bone marrow [22][23] - **Toxicity Management**: Logic gating technology aims to reduce toxicity associated with traditional therapies [7][8] Future Directions - **Expansion Plans**: Focus on increasing patient numbers and showcasing the efficacy of logic gating technology [30][31] - **Broader Applications**: Potential to apply logic gating technology to solid tumors and other cancer types [25][28] Competitive Landscape - **Differentiation**: Scenti's approach is agnostic to genetic mutations, providing a complementary mechanism to existing therapies targeting genetic mutations in AML [32] - **Comparison with CAR T**: NK cells are preferred for AML due to their rapid action and safety profile, while T cells may be more suitable for solid tumors [33][34] Conclusion - **Outlook**: Scenti Biosciences is positioned to advance its lead program Santi 202 and explore broader applications of its technology in the oncology space, with ongoing clinical trials and promising early results [27][28]
Akari Therapeutics (AKTX) Conference Transcript
2025-05-29 19:20
Summary of Akari Therapeutics Conference Call (May 29, 2025) Company Overview - **Company**: Akari Therapeutics (AKTX) - **Focus**: Development of antibody drug conjugates (ADCs) with novel immuno-oncology payloads aimed at improving cancer treatment outcomes [2][5] Key Points and Arguments Novel Approach to ADCs - Akari is innovating ADCs by using immuno-oncology payloads that differ from traditional cytotoxic agents, aiming to enhance efficacy and safety in cancer treatment [3][5] - The lead asset, AKTX-101, targets TROP-2, a marker on cancer cells, and is conjugated with a novel payload called pH-1 [9][10] Mechanism of Action - The pH-1 payload targets the spliceosome, leading to cancer cell death and priming the immune system to attack similar cancer cells [8][27] - This approach aims to create immunological memory, allowing the immune system to recognize and attack cancer cells upon re-exposure [34] Clinical Development and Safety - Preclinical data shows robust activity for AKTX-101 as a single agent and in combination with checkpoint inhibitors, with favorable safety profiles observed in nonhuman primate studies [10][12] - Akari is advancing its lead ADC into IND-enabling studies to prepare for Phase 1 trials [20] Market Potential and Competitive Landscape - The ADC market is experiencing significant interest, with major pharmaceutical companies investing heavily in this space, indicating a strong opportunity for Akari's differentiated approach [22][23] - Akari's unique payload distinguishes it from competitors, which primarily use microtubule inhibitors or topo-I inhibitors [24][27] Future Directions - Akari plans to explore additional targets for its pH-1 payload, including colon, lung, and prostate cancers, which represent significant unmet medical needs [12][20] - The company is open to partnerships for further development and commercialization of its ADC platform [21][36] Additional Important Content - The transition from an inflammation-focused portfolio to oncology was driven by the potential of the pH-1 platform and the strategic direction of the company [39] - Akari's leadership team includes experienced professionals from major pharmaceutical companies, enhancing its capability to execute its vision [14][15][18] Conclusion - Akari Therapeutics is positioned to leverage its innovative ADC platform to address significant challenges in cancer treatment, with a focus on enhancing patient outcomes through novel immuno-oncology strategies [36][37]
CytomX Therapeutics to Present at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-29 12:00
SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025, at 2:35 p.m. ET. A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In ...
Apogee Therapeutics to Participate at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-29 11:30
SAN FRANCISCO and BOSTON, May 29, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), today announced that members of management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025, at 10:30 a.m. E.T. A live and archived webcast of the fireside chat will be available via the News & Events page in the Investors section of the Apogee Therapeutics website. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancin ...
Candel Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for CAN-2409 for the Treatment of Prostate Cancer
Globenewswire· 2025-05-28 12:05
NEEDHAM, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company’s biological immunotherapy lead candidate, for the treatment of newly diagno ...
Candel Therapeutics to Host Investor Conference Call Featuring Expert Clinical Perspectives on CAN-2409 Phase 3 Prostate Cancer Data Following 2025 ASCO Presentation
Globenewswire· 2025-05-27 12:05
Core Insights - Candel Therapeutics announced positive phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer, showing a statistically significant 30% reduction in disease recurrence compared to placebo when combined with standard-of-care radiation therapy [1][10] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to combat cancer [11] - The company has established two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 being the lead candidate from the adenovirus platform [11] Clinical Development - CAN-2409 (aglatimagene besadenovec) is designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumors, inducing a systemic immune response against cancer [8] - The investigational therapy has shown encouraging results in monotherapy and combination settings with standard treatments, with over 1,000 patients dosed and a favorable tolerability profile [9][10] - Candel is also evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) [10] Regulatory Status - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including PDAC and stage III/IV NSCLC, and has been granted Orphan Drug Designation for PDAC [10] Upcoming Events - Candel will host a webcast and conference call on June 3, 2025, to discuss the phase 3 clinical results and insights from leading prostate cancer specialists [1][5]
兴业证券:供给侧改革、技术变革和海外变局是光伏行业当前关注的重点
智通财经网· 2025-05-27 01:42
智通财经APP获悉,兴业证券发布研报称,供给侧改革、技术变革和海外变局是光伏行业当前关注的重 点。行业经历2020-2023年大周期调整后,目前处于主链全行业亏现金流状态,部分环节二三线企业持 续亏损近两年,产业处于盈利周期底部。2025年3月以来受抢装潮影响,企业利润逐步向上修复,利润 的修复短期看价格,长期看需求。 兴业证券主要观点如下: 供给侧改革预期增强,光伏行业有望逐步复苏 行业经历2020-2023一轮大周期,目前处于主链全行业亏现金流状态,部分环节二三线企业持续亏损近 两年,产业处于盈利周期底部。2025年3月以来受抢装潮影响,企业利润逐步向上修复,利润的修复短 期看价格,长期看需求。自2024年10月18日,协会发布"反内卷"倡议以来,自律联盟、配额减产,新产 能投产限制等措施正在逐步推行,预计未来也将陆续会有渐进式政策推出,一方面控制产能无序增长、 防止内卷,另一方面解决装机痛点,扩大需求等方式进行产业链价格托底,目标是让行业回归至合理盈 利水平。2025年光伏行业政策的核心在于引导行业从"规模扩张"转向"质量优先",从供需两端推动行业 高质量发展,加强能耗控制,优化市场机制,提高技术创新, ...