Workflow
Cell therapy
icon
Search documents
Legend Biotech to Host Investor Conference Call on First Quarter 2025 Results
Globenewswire· 2025-04-29 12:00
Company Overview - Legend Biotech Corporation is a global leader in cell therapy with over 2,500 employees, making it the largest standalone cell therapy company [3] - The company is pioneering treatments that aim to revolutionize cancer care, particularly through its CAR-T cell therapy [3] - CARVYKTI, a one-time treatment for relapsed or refractory multiple myeloma, is developed and marketed in collaboration with Johnson & Johnson [3] Upcoming Events - Legend Biotech will host a conference call for investors on May 13, 2025, at 8:00 am ET to review first-quarter 2025 results [1] - Senior leaders will provide an overview of the company's performance during the call [1] - A replay of the webcast and earnings news release will be available approximately two hours after the call concludes [2]
Cone Rod Dystrophy Market Report 2025-2030, with Profiles of SparingVision, Beacon Therapeutics, Nanoscope Therapeutics, MeiraGTx, Ascidian Therapeutics, jCyte, BlueRock Therapeutics and more
GlobeNewswire News Room· 2025-04-29 11:11
Dublin, April 29, 2025 (GLOBE NEWSWIRE) -- The "Cone Rod Dystrophy Market: Analysis By Type, By Treatment Type, By End User, By Region Size and Trends - Forecast up to 2030" has been added to ResearchAndMarkets.com's offering. Cone rod dystrophy represents a group of genetic eye disorders impacting the retina's cone and rod cells. The market for treating this condition is witnessing substantial growth, projected to rise from a value of US$131.29 million in 2024 to US$177.59 million by 2030. This growth is ...
ScaleReady Announces March Biosciences as Recipient of G-Rex® Grant to Advance Manufacturing of Novel CAR-T Cell Therapy
Prnewswire· 2025-04-29 11:00
ST. PAUL, Minn., April 29, 2025 /PRNewswire/ -- ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, today announced that March Biosciences has been awarded a $200,000 G-Rex® Grant. March Biosciences' G-Rex® Grant will be used to advance the manufacturing of their lead asset, MB-105, a novel investigational autologous CAR-T cell therapy targeting CD5 for patients with T-cell lymphomas. "As we ramp up clinical manufacturing and advance towards commercialization o ...
Senti Biosciences (SNTI) Update / Briefing Transcript
2025-04-28 22:19
Summary of Senti Biosciences Senti-two zero two Clinical Update Conference Call Company and Industry - **Company**: Senti Biosciences - **Industry**: Biotechnology, specifically focused on cell therapy for hematological malignancies, particularly Acute Myeloid Leukemia (AML) Core Points and Arguments 1. **Introduction of Senti-two zero two**: Senti Biosciences is developing SENTI-two zero two, a logic gated CAR NK cell therapy targeting relapsed/refractory AML and related hematological cancers, with promising preliminary results from a Phase one trial [6][7][40]. 2. **Mechanism of Action**: The therapy utilizes a unique logic gate technology that allows for precise targeting of cancer cells while sparing healthy cells, addressing the challenge of heterogeneous cancer cell populations [8][10][14]. 3. **Patient Demographics**: AML affects approximately 21,000 patients annually in the U.S., with a high relapse rate and poor prognosis, highlighting the urgent need for effective therapies [11][12]. 4. **Trial Design**: The Phase one trial is a multi-center, open-label study enrolling adult patients aged 18-75 with relapsed/refractory AML, focusing on safety, maximum tolerated dose (MTD), and efficacy [19][20]. 5. **Dosing and Administration**: The trial evaluates two dose levels of 1 billion and 1.5 billion CAR NK cells, administered in either three or five doses following lymphodepletion [22][23]. 6. **Safety Profile**: Preliminary safety data indicate that SENTI-two zero two is well tolerated, with no dose-limiting toxicities reported and adverse events primarily being hematologic in nature [26][29][40]. 7. **Efficacy Results**: Five out of seven patients achieved an overall response rate (ORR), with four achieving complete remission (CR), indicating promising efficacy in a heavily treated patient population [30][31][40]. 8. **Durability of Response**: All CR patients were minimal residual disease (MRD) negative, with ongoing responses and a median duration of response not yet reached [31][34][41]. 9. **Future Directions**: The company plans to expand the trial to include more patients and potentially explore other malignancies expressing CD33 or FLT3, such as MDS [49][62]. Other Important but Possibly Overlooked Content 1. **Logic Gate Technology**: The logic gate mechanism allows for the recognition of multiple cancer antigens, enhancing the therapy's ability to target diverse cancer cell populations [9][10]. 2. **Patient Characteristics**: The trial population had multiple adverse prognostic factors, including rapid failure of prior therapies and adverse genetic characteristics, underscoring the high unmet need in this patient group [24][25][34]. 3. **Comparison with Existing Therapies**: Current standard care for relapsed/refractory AML shows low response rates (15-25% for CR), emphasizing the need for innovative therapies like SENTI-two zero two [12][65]. 4. **Potential for Outpatient Use**: Given the favorable safety profile of NK cells, there are plans to develop SENTI-two zero two for outpatient administration [50]. 5. **Broader Applications**: The technology has potential applications beyond AML, including solid tumors, which could significantly expand its therapeutic reach [60][61]. This summary encapsulates the key points discussed during the conference call, highlighting the innovative approach of Senti Biosciences in addressing a critical need in cancer treatment.
Artiva Biotherapeutics to Present Longer-term Phase 1/2 Data for AlloNK® in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting
Globenewswire· 2025-04-28 20:35
Prolonged duration of response, deep B-cell depletion, and well-tolerated safety profile support the potential of AlloNK® + rituximab for the treatment of B-cell driven diseases in a community setting Additional poster presentation to feature scalability and consistency of AlloNK manufacturing process SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for ...
Century Therapeutics Announces Two Upcoming Presentations at the ASGCT 28th Annual Meeting
Globenewswire· 2025-04-28 20:30
PHILADELPHIA, April 28, 2025 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in autoimmune disease and cancer, today announced two presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, which is being held from May 13-17, 2025, at the New Orleans Ernest N. Morial Convention Center in New Orleans, LA. The presentations will highligh ...
Senti Bio’s SENTI-202, a First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, Demonstrates Positive Preliminary Clinical Results in the Treatment of Patients with Relapsed/Refractory AML
Globenewswire· 2025-04-28 11:00
Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 Dose Finding completed with no dose limiting toxicities and preliminary recommended Phase 2 dose (RP2D) identified 5 of 7 best overall response evaluable patients achieved ORR (3 CR, 1 CRh and 1 morphologic leukemia-free state) across all dose cohorts, including 1 CR and 1 CRh in 3 patients in preliminary RP2D cohort 4 of 4 cCR patients were measurable residual disease (MRD) negative as assessed by local standard of ca ...
Senti Bio's SENTI-202, a First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, Demonstrates Positive Preliminary Clinical Results in the Treatment of Patients with Relapsed/Refractory AML
GlobeNewswire News Room· 2025-04-28 11:00
Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 Dose Finding completed with no dose limiting toxicities and preliminary recommended Phase 2 dose (RP2D) identified 5 of 7 best overall response evaluable patients achieved ORR (3 CR, 1 CRh and 1 morphologic leukemia-free state) across all dose cohorts, including 1 CR and 1 CRh in 3 patients in preliminary RP2D cohort Announces certain preliminary first quarter 2025 financial results and provides pipeline update SOUTH S ...
Coeptis Therapeutics, Inc. and Z Squared Inc. Announce Merger Agreement
Newsfilter· 2025-04-25 12:33
Core Viewpoint - Coeptis Therapeutics Holdings, Inc. and Z Squared Inc. have entered into a definitive merger agreement, resulting in Z Squared becoming a wholly-owned subsidiary of Coeptis, with a focus on Dogecoin mining and a planned spin-out of Coeptis' biopharmaceutical operations [1][5][10] Company Overview - Coeptis Therapeutics is a biopharmaceutical and technology company that develops innovative cell therapy platforms for cancer, autoimmune, and infectious diseases [1][6] - Z Squared Inc. specializes in digital asset mining, primarily focusing on Dogecoin, which has a market capitalization exceeding $20 billion [2][10] Merger Details - The merger will involve a wholly-owned subsidiary of Coeptis merging with Z Squared, with Z Squared shareholders receiving equity in Coeptis in exchange for 9,000 U.S.-based Dogecoin mining machines [1] - The transaction is expected to close in the third quarter of 2025, pending regulatory approvals and shareholder consent [1] Leadership Changes - Post-merger, Z Squared executives will lead the combined entity, with David Halabu as CEO and Michelle Burke as COO [3][4] - Current Coeptis CEO Dave Mehalick will exit the Board of Directors upon closing [3] Strategic Focus - The combined company aims to create the largest publicly-traded entity in the U.S. focused on Dogecoin mining, targeting both retail and institutional investors [5] - Coeptis plans to maintain its biopharmaceutical operations separately after the merger, allowing continued involvement in both sectors [5]
Gilead(GILD) - 2025 Q1 - Earnings Call Transcript
2025-04-25 05:12
Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew 4% year over year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was $1.81, with a product gross margin flat year over year at 85% [52][54] Business Line Data and Key Metrics Changes - HIV sales were up 6% year over year, with Biktarvy sales increasing by 7% [7][22] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year over year, reflecting lower rates of COVID-19 related hospitalizations [28] - Trodelvy sales were down 5% year over year, impacted by inventory dynamics and lower average realized price [29][98] - Cell therapy sales were down 3% year over year, with Yescarta sales up 2% year over year [31] Market Data and Key Metrics Changes - The HIV treatment market continues to grow at an expected rate of 23% annually [22] - Descovy sales increased by 38% year over year, driven by higher average realized price and demand [23][78] - The liver disease segment saw sales of $758 million, up 3% year over year [26] Company Strategy and Development Direction - The company is focused on multiple upcoming launches, including lenacapavir, anetocel, and Trodelvy [13][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning itself for top-line growth across therapeutic areas [14] - The company is increasing investment in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains well-positioned to adapt to potential policy outcomes in the US [14] - Management noted that the first quarter was lighter than expected but emphasized the variability of the business [54][93] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP and reimbursement dynamics - Management is excited about the upcoming PDUFA date and expects around 75% access within the first six months post-launch, reaching about 90% at the twelve-month mark [62] Question: Impact of HHS and CDC cuts on launch dynamics - Management has not seen anything that would alter plans for the lenacapavir launch and is actively engaging with policymakers [68] Question: Implications of COVID-19 on Descovy and lenacapavir - Descovy saw a 38% growth year over year, driven by market development initiatives, which supports the opportunity for lenacapavir [78] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's IP is in the US, which suggests lower value for pharmaceutical imports, and they have invested significantly in US manufacturing [86][89] Question: Cannibalization of Descovy by lenacapavir - Management believes lenacapavir will attract both switch patients from daily orals and naive patients, potentially accelerating market growth [124]