Attractive safety profile demonstrated across all dosing cohorts and routes of administration (IV, SC, and IM); all reported adverse events (AEs) deemed unrelated or classified as mild to moderate and largely related to injection site and infusion reactions with no serious or severe adverse events observedFollowing a single dose, serum concentrations of VYD2311 remained high at six months with an observed half-life of the IM dose route having the longest duration at 76.0 (CI: 68.5 – 90.7) days Comprehensive ...

Core Insights - Bio-Techne Corporation has entered into a distribution agreement with the U.S. Pharmacopeia (USP) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards, enhancing support for mAb and gene therapy development globally [1] - The need for consistent mAb quality is increasingly critical as patent protections expire and biosimilars emerge, necessitating rigorous testing of quality attributes during development and manufacturing [2] - Gene therapy, utilizing recombinant AAV, is rapidly growing but faces challenges such as low yields and high costs; USP reference standards provide benchmarks for analytical testing to ensure product quality [3] - USP mAbs and AAV reference standards can be used with Bio-Techne's analytical instruments, facilitating reliable characterization of complex biologics throughout the development process [4] - The collaboration between Bio-Techne and USP aims to address quality challenges in biotherapeutics, ensuring safety and efficacy for patient care [5] Company Overview - Bio-Techne Corporation is a global life sciences company that provides innovative tools and bioactive reagents for research and clinical diagnostics, generating approximately $1.2 billion in net sales in fiscal 2024 [6]

Summary of Connect Biopharma Holdings (CNTB) Conference Call Company Overview - Connect Biopharma Holdings (CNTB) is undergoing a transformation referred to as "Connect 2.0" with a new management team focused on drug development and regulatory activities [3][4] - The lead program is retimicobart, a next-generation IL-4 receptor alpha monoclonal antibody, positioned as a second-generation alternative to Dupixent [3][4] Core Product Insights - Retimicobart shows a significant improvement in FEV1, a key measure of airway function, with one of the largest improvements seen in biologics for asthma trials [4][5] - The onset of effect occurs within 24 hours, allowing for evaluation in acute settings rather than traditional chronic studies [5][6] - There are over 1 million asthma and 1.3 million COPD patients visiting ERs annually due to acute exacerbations, indicating a substantial market opportunity [5][9] Market Opportunity - Current biologics do not have indications for acute exacerbations, creating a "white space" for retimicobart [6][22] - Market research indicates that the novel acute indication could drive significant chronic use, with a preference share of 40%-45% for acute use and 75% for chronic treatment following acute administration [10][22] - The product is expected to have a multi-billion dollar commercial potential with both acute and chronic indications [23][30] Clinical Development - Two parallel trials (cbreeze stat) for asthma and COPD are underway, with data expected in the first half of the following year [15][16] - The acute studies are designed to assess improvements in FEV1 and reduce hospitalization rates, with a focus on cost savings for hospitals [16][30] - The company has received FDA clearance to move into phase three for atopic dermatitis, pending completion of a partner study in China [21][24] Financial Considerations - Development costs for acute indications are estimated at around $50 million, while combined acute and chronic programs could reach $200 million [29] - The company has sufficient cash reserves to execute its plans into 2027, allowing for strategic development without immediate dilution [24][30] Regulatory Landscape - There is no precedent for acute indications in the biologics market, presenting both challenges and opportunities for Connect Biopharma [33] - Extensive discussions with the FDA have provided insights into potential pathways for approval [33] Conclusion - Connect Biopharma is positioned to leverage its innovative product retimicobart in a largely untapped market for acute asthma and COPD treatment, with a strong focus on rapid clinical development and strategic partnerships to enhance its market presence [22][30]

– KPL-387 Phase 2/3 trial on track to initiate in mid-2025; Phase 2 data expected in 2H 2026 – – KPL-387 Phase 1 single ascending dose data support profile for monthly dosing – – Presentation and webcast at Jefferies 2025 Global Healthcare Conference scheduled for 12:50 pm ET today– LONDON, June 05, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus ...

Summary of Corbus Pharmaceuticals Holdings (CRBP) 2025 Conference Call Company Overview - **Company**: Corbus Pharmaceuticals Holdings (CRBP) - **Date of Conference**: May 21, 2025 - **Key Speaker**: Yuval Cohen, CEO Key Points Discussed ADC CRB-701 Development - **Data Presentation**: Recent data from the first Western dataset for CRB-701 shows safety and efficacy comparable to existing treatments like PADCEV, particularly in bladder and cervical cancers [5][6] - **Ocular Prophylaxis Impact**: The use of ocular prophylaxis in Western trials resulted in significantly fewer ocular events compared to trials in China [5] - **Head and Neck Cancer**: Initial data from head and neck cancer patients is promising, with a small cohort showing encouraging results [6][8] - **Safety Profile**: CRB-701 demonstrates a markedly safer profile than PADCEV, with fewer adverse events and lower dropout rates [8] - **Market Strategy**: The company aims to target "empty swim lanes" in oncology, focusing on tumor types where PADCEV is not currently used [9][10] Future Data Expectations - **Project OPTIMIZ**: The company is conducting Project OPTIMIZ, which includes trials for bladder, head and neck, and cervical cancers, with significant patient enrollment expected [13][14] - **Data Release Timeline**: More mature data is anticipated to be presented at a major oncology conference later in the year, with a marked increase in patient numbers [14][36] Head and Neck Cancer Focus - **Market Size**: Head and neck cancer represents a significant market opportunity, with approximately 80,000 patients in the US, half of whom may become metastatic [35] - **Regulatory Path**: The regulatory path for head and neck cancer may be more complex compared to cervical cancer, which has a smaller patient population but potentially faster approval timelines [36][37] Combination Therapy Insights - **Checkpoint Inhibitor Combinations**: The company is exploring combinations of CRB-701 with checkpoint inhibitors, with a focus on patient selection based on immune-related biomarkers [23][24] - **Data-Driven Decisions**: Future strategies will be guided by data outcomes, particularly in relation to competing therapies in the market [25][27] Other Drug Developments - **CB1 Inverse Agonist (CRB-913)**: The company is developing CRB-913, which aims to have a safer profile with significantly lower brain penetration compared to competitors, potentially reducing neuropsych adverse events [41][42] - **Phase Ib Studies**: The design of Phase Ib studies will focus on safety and tolerability, with results expected in the second half of the year [49][50] Upcoming Milestones - **Phase One Data**: The company plans to present data for multiple assets in the second half of the year, indicating a busy and potentially impactful period ahead [61] Additional Insights - **Market Competition**: The competitive landscape includes other modalities targeting similar indications, with a focus on differentiating CRB-701 based on its unique safety and efficacy profile [20][21] - **Regulatory Considerations**: The company is aware of the challenges in navigating regulatory pathways, especially for larger indications like head and neck cancer [36][37] This summary encapsulates the key discussions and strategic directions of Corbus Pharmaceuticals as presented in the conference call, highlighting their focus on innovative cancer therapies and the importance of data in guiding their development strategies.

FDA acknowledges that the benefit of repeat doses of COVID-19 vaccine boosters for Americans is uncertain; the updated regulatory framework for COVID-19 vaccines articulated by the Agency generally aligns with recent Invivyd Citizen Petition requestsIn contrast to vaccine boosters, monoclonal antibody (mAb) therapies, including pemivibart, underwent contemporary randomized, placebo-controlled trials to evaluate safety, immunogenicity, and exploratory efficacy in relevant, modern Americans, against relevant, ...

Invivyd (IVVD) FY 2025 Conference May 20, 2025 11:00 AM ET Speaker0 Not ready. Okay. Hello, everyone, and welcome to the third annual, HC Wainwright BioConnect Conference. I'm Patrick Trucchio, a senior health parent at HC Wainwright. It's my pleasure to, introduce you to the management of InVivid. I'm Katie Falzoni, senior vice president of finance and Robert Allen, CSO. So first, I think it'd be good to start out with, some background on Invivid platform and on the validation of this antibody platform. Sp ...

INVIVYD Q1 2025 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS May 15, 2025 © 2025 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are ...

PEMGARDA™ (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contracted to an internalized sales forcePEMGARDA revenue re-acceleration observed in Q2 2025 to dateInvivyd continues to target near-term profitability (1H 2025) with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of operating expensesSince Emergency Use Authorization (EUA) of PEMGARDA in March 2024, no documented cases o ...

Core Viewpoint - Invivyd, Inc. has initiated a discovery program for a measles monoclonal antibody (mAb) in response to inquiries from healthcare providers, as there are currently no approved therapies for measles or post-exposure prophylaxis [1][6] Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, utilizing a proprietary integrated technology platform for developing best-in-class antibodies [7] Industry Context - There are no antiviral treatments for measles, with current options being limited to high-dose Vitamin A and human donor-derived pooled plasma immune globulin (IVIG), both of which have significant limitations [2] - Standard measles vaccines are effective but face challenges in post-exposure prophylaxis and are underutilized due to access issues and personal beliefs [3] - The resurgence of measles outbreaks globally, including in the U.S., poses a significant public health risk, with over 20 million unvaccinated Americans [5][6] Health Implications - Acute measles infection can lead to severe complications, including hospitalization in one in four cases and death in one in every 1,000 cases [4] - The decline in vaccination rates has serious health consequences, potentially leading to the reestablishment of previously eradicated pathogens like measles [3][5] Development Goals - Invivyd aims to identify a preclinical measles mAb candidate by 2025 and plans to provide updates on progress by the end of the year [6] - The company is focused on developing a safe, convenient, and highly effective mAb against measles that can be easily integrated into clinical practice [7]