WALTHAM, Mass., June 16, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company advancing best-in-class antibody engineering, dose optimization, and rational therapeutic combinations for the treatment of Inflammatory Bowel Disease ("IBD") and other immune-mediated diseases, today announced it will report interim results from the Phase 1 SPY002 healthy volunteer trials on Tuesday, June 17, 2025. Following the announcement, the Company will host a conference call ...

Core Insights - ADC Therapeutics announced updated Phase 2 data for ZYNLONTA® showing an overall response rate (ORR) of 85% and a complete response (CR) rate of 69% in patients with relapsed/refractory marginal zone lymphoma (r/r MZL) [1][2] - The treatment was well tolerated, with safety profiles consistent with previous data [2][6] - The study is ongoing, with plans to expand enrollment to 50 patients across multiple sites [3][4] Study Details - The Phase 2 trial is a single-arm, open-label study led by Dr. Izidore S. Lossos at Sylvester Comprehensive Cancer Center [1][3] - As of February 10, 2025, 27 adult patients were enrolled, with 26 evaluable for response [2] - Among patients assessed for response, a CR rate of 61.5% was observed in high-risk POD24 patients [6] Efficacy and Safety - The longest duration of CR was 27 months from the start of treatment, with a progression-free survival (PFS) rate of 92.9% at 12 months [6] - Adverse events were consistent with the known safety profile of ZYNLONTA, with most being grade 1 or 2 [6] - Serious adverse events included neutropenia and RSV lung infection, with some patients requiring dose reductions [6] Regulatory and Future Plans - ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Medicines Agency for treating r/r large B-cell lymphoma [7][10] - The company plans to pursue regulatory pathways based on the ongoing trial results [4] - ZYNLONTA is also being evaluated in combination studies for other B-cell malignancies [8][10] Company Overview - ADC Therapeutics is a biotechnology company focused on developing targeted antibody drug conjugates (ADCs) for cancer treatment [9][10] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [11]

Core Viewpoint - NextCure, Inc. and Simcere Zaiming have formed a strategic partnership to develop SIM0505, a novel antibody-drug conjugate targeting CDH6 for solid tumors, with clinical testing expected to begin in the U.S. in Q3 2025 [1][3]. Group 1: Partnership Details - The partnership allows NextCure to access Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage ADC developed by NextCure, while Simcere Zaiming retains Greater China rights to this ADC [4][7]. - Simcere Zaiming is eligible for payments up to $745 million throughout the development phases, including upfront payments and tiered royalties on net sales outside Greater China [5][7]. Group 2: Product Development - SIM0505 is currently undergoing Phase 1 dose escalation studies in China, with a global dose expansion study planned to include multiple tumor types [3][7]. - Preclinical studies of SIM0505 have shown robust anti-tumor activity and a promising safety profile [2][5]. Group 3: Company Background - NextCure is focused on developing innovative therapies for cancer patients who do not respond to existing treatments, utilizing differentiated mechanisms such as antibody-drug conjugates [6]. - Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, aims to develop groundbreaking therapies for cancer patients globally, leveraging its R&D and commercialization capabilities [8].

[Music] I felt out of control lying on the bathroom floor at 23 years old, tears running down my face after consuming 40 laxatives in a single day. As a dancer living on my own for the first time, my thoughts and memories constantly haunted me. This journey started when I was 7 years old when my dance teacher gently patted me on my belly and said, "Lay off the cookies." Her words struck my spirit like a bullet.But that was the day my tumultuous lovehate relationship with my body began. My freshman year of h ...

Core Viewpoint - ADC Therapeutics has announced a $100 million PIPE financing to support the development and commercialization of its ADC product ZYNLONTA and other strategic initiatives [1][2]. Financing Details - The PIPE involves the sale of 13 million common shares at $3.53 each and pre-funded warrants for 15.7 million common shares at $3.43 each, with gross proceeds expected to be approximately $100 million before fees [1][2]. - The financing is set to close on June 16, 2025, pending customary conditions [2]. Use of Proceeds - The net proceeds from the PIPE will be utilized for ZYNLONTA's clinical development, commercialization activities, working capital, and general corporate purposes [2]. Strategic Developments - The company will advance its preclinical exatecan-based ADC targeting prostate-specific membrane antigen (PSMA) while discontinuing other preclinical solid tumor programs [3]. - A workforce reduction of approximately 30% is planned, with the majority of this restructuring expected to be completed by September 30, 2025, incurring one-time cash charges of $6 to $7 million [3]. Long-term Growth Positioning - These strategic moves are anticipated to reduce operating expenses significantly and extend the company's cash runway into 2028 [4]. - Key anticipated catalysts include ongoing clinical trials such as LOTIS-7 and LOTIS-5, with significant data expected in the coming years [4][8]. Clinical Development Updates - LOTIS-7 Phase 1b trial data for ZYNLONTA plus glofitamab is expected in the second half of 2025, with full enrollment of 100 patients anticipated by the first half of 2026 [8]. - Topline results from the LOTIS-5 Phase 3 trial are expected in late 2025 or early 2026, with potential regulatory submissions following [8]. Company Overview - ADC Therapeutics is a leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for hematologic malignancies and solid tumors [14][15].

Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b trial, showing a 93.3% overall response rate (ORR) and an 86.7% complete response (CR) rate in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with ZYNLONTA® and glofitamab [1][3][4] Efficacy Data - Among 30 efficacy evaluable patients, 28 achieved an overall response, with 26 achieving complete responses [3] - 25 out of 26 patients who achieved CR remained in CR at the data cut-off [1][3] - Median time to CR was 80 days for the 120 µg/kg dose and 42 days for the 150 µg/kg dose [3] - 12 patients converted from stable disease or partial response to CR over time [3] - Of 6 patients previously treated with CAR-T, 5 achieved CR [3] Safety Profile - The combination treatment was generally well tolerated, with no dose-limiting toxicities (DLTs) reported [3] - Among 41 safety evaluable patients, the most common grade 3 or higher treatment-emergent adverse events (TEAEs) included neutropenia (24.4%), anemia (9.8%), and increased liver enzymes [3] - Cytokine release syndrome (CRS) was observed in 23.8% of patients at the 150 µg/kg dose, all Grade 1, while 55% experienced CRS at the 120 µg/kg dose [3] Study Expansion - The company is expanding enrollment for the LOTIS-7 trial to 100 patients at the 150 µg/kg dose of ZYNLONTA [1][4] - The updated data will be presented at the European Hematology Association 2025 Congress and the 18th International Conference on Malignant Lymphoma [4] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy [9][13] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]

AnaptysBio (ANAB) FY Conference June 11, 2025 08:40 AM ET Speaker0 All right. Good morning. And it's my pleasure to introduce Dan Vega, President and CEO of Adaptive Bio as our next speaker. Dan, welcome. It's the time for me to host you at the Goldman Sachs Conference. Conference. So thank you for being here. Before we kick off with the Q and A, I'm going to turn it to you for a quick opening remark. Speaker1 Perfect. Well, thanks for having me here today. It's my pleasure to be here. We have a lot going o ...

-- FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD) ---- Jeffrey M. Statland, M.D., Professor of Neurology, University of Kansas Medical Center, and FORTITUDE trial investigator, will present topline del-brax data from dose escalation cohorts in oral presentation ---- Stephen Tapscott, M.D., Ph.D., Professor of Human Biology and Clinical Research, Fred Hutchinson Cancer Center, will highlight results on the charac ...

Core Insights - Instil Bio, Inc. has appointed John Maraganore, Ph.D., to the Board of Directors of its subsidiary Axion Bio, Inc., which is focused on developing AXN-2510, a PD-L1xVEGF bispecific antibody targeting solid tumors, particularly non-small cell lung cancer (NSCLC) [1][2] - The appointment is aimed at enhancing leadership to maximize the value of the AXN-2510 program for both patients and shareholders, with expectations of redefining the standard of care for solid tumors [2] - AXN-2510 is currently in a Phase 2 trial in combination with chemotherapy for first-line NSCLC, with early signs of safety and efficacy being reported [2] Company Overview - Instil Bio is a clinical-stage biopharmaceutical company dedicated to developing novel therapies, with AXN-2510 as its lead asset [3] - Axion Bio, a wholly-owned subsidiary of Instil Bio, is specifically focused on the development of AXN-2510 for multiple solid tumors [4] Leadership Background - Dr. John Maraganore brings over 30 years of biotechnology experience, having previously served as the founding CEO of Alnylam Pharmaceuticals, where he led the company to a market capitalization exceeding $40 billion [2] - His expertise spans drug discovery, clinical development, and strategic partnerships, making him a valuable asset for guiding the advancement of next-generation cancer therapies [2]

Summary of AbCellera Biologics (ABCL) FY Conference Call - June 09, 2025 Company Overview - **Company**: AbCellera Biologics (ABCL) - **Transition**: Shifted from a platform company to a clinical-stage biotech with two internally developed agents authorized for clinical trials [3][4] Key Points and Arguments Financial Position - **Liquidity**: Company has approximately $800 million in liquidity, allowing for continued investment in pipeline development [3] Pipeline Development - **Initial Molecules**: Focus on two molecules, ABCL635 and ABCL575, entering clinical trials in Q3 2025 [3] - **Development Projects**: Over 20 development projects, with more than half targeting complex membrane protein targets [4] Target Selection Framework - **Framework Criteria**: Selection based on validated science, large commercial opportunities, differentiation, and clear development paths [5][6] ABCL635 Specifics - **Indication**: Targeting vasomotor symptoms (VMS) related to menopause, specifically hot flashes [8] - **Market Opportunity**: Estimated annual sales potential over $2 billion, with 30% of women experiencing moderate to severe VMS [10] - **Differentiation**: Antibody approach expected to have fewer safety issues compared to small molecules, with a preference for monthly dosing over daily oral administration [20][21] Market Dynamics - **Menopausal Hormone Therapy (MHT)**: Approximately 40 million women in the U.S. are of menopausal age, with 30% experiencing moderate to severe VMS. About 50% seek treatment, but 20% are contraindicated for MHT [25][26][27] - **Commercial Market**: Significant opportunity exists for alternatives to MHT, especially for the 1.2 million women contraindicated for MHT [28] ABCL575 Overview - **Mechanism**: Targets OX40 ligand, which mediates T cell expansion and survival, potentially offering safety advantages over OX40 receptor targeting [35] - **Indication**: Initially exploring atopic dermatitis, a large unmet medical need with existing successful treatments like Dupixent [38] Competitive Landscape - **Dupixent Comparison**: Dupixent generates $8 billion in sales but has limitations in patient response rates, indicating a potential market for alternative therapies like ABCL575 [41] Clinical Trials and Future Plans - **Phase One Trials**: Expected to start dosing in Q3 2025, with initial data anticipated in the first half of 2026 [49][50] - **Partnership Strategy**: ABCL635 is likely to be advanced independently, while ABCL575 may be better suited for partnership due to its broader indication potential [54][60] Legacy Business and Partnerships - **Ongoing Partnerships**: Continued investment in partnerships, including a recent collaboration with AbbVie on T cell engagers [61] - **GMP Facility**: Investment in a GMP facility expected to be operational by the end of the year, supporting clinical trial material production [62] Additional Important Content - **Patient Preferences**: Surveys indicate a preference for injectable treatments over daily oral medications among menopausal women [21][23] - **Market Segmentation**: There is room for both biologics and oral treatments in the market, with patient choice being a significant factor [32] This summary encapsulates the key insights from the conference call, highlighting the strategic direction, market opportunities, and clinical development plans of AbCellera Biologics.