Media ReleaseCOPENHAGEN, Denmark; July 1, 2025 Birgitte Stephensen, Executive Vice President and Chief Legal Officer to retire after 23 years with Genmab A/SGreg Mueller joins as new Executive Vice President, General Counsel and Chief Legal Officer, effective July 1 Genmab A/S (Nasdaq: GMAB) announced today that Birgitte Stephensen, Executive Vice President and Chief Legal Officer, will retire from Genmab after a successful tenure that spanned 23 years with the company. Greg Mueller joins Genmab A/S as Exec ...

Core Insights - Sanofi has made a strategic investment of up to US$25 million in Adagene to support the development of novel antibody-based therapies, particularly focusing on the clinical development of muzastotug (ADG126) for colorectal cancer [3][6] - Adagene will provide Sanofi with muzastotug for a phase 1/2 clinical trial involving over 100 patients to evaluate its safety and efficacy in combination with other anticancer therapies [4][6] - The partnership includes the exercise of an option for a third SAFEbody discovery program, which will utilize Adagene's proprietary technology [5][6] Financial Overview - The proceeds from Sanofi's investment, along with Adagene's existing cash and cash equivalents of US$85.2 million as of December 31, 2024, are expected to fund operations into 2027 [6] Clinical Development - Adagene's lead clinical program, ADG126, is currently in phase 1b/2 studies, targeting metastatic microsatellite-stable colorectal cancer [10] - The SAFEbody technology aims to enhance safety and tolerability in antibody therapeutics by using precision masking to minimize off-target toxicity [9][10] Strategic Collaboration - A representative from Sanofi will join Adagene's Scientific Advisory Board to provide strategic advice on scientific and clinical aspects [7] - The collaboration reinforces the shared vision of advancing ADG126's potential in treating advanced solid tumors [6]

Accessibility StatementSkip Navigation ADC Platforms Keynote speech R&D Strategy "Over the past decade, Innovent has been at the forefront of China's biopharmaceutical evolution—pioneering the PD-1 immunotherapy era and building China's leading oncology brand, with over 3 million cancer patients treated with our therapies," said Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent. "We are entering a new chapter focused on global innovation, powered by a robust pipeline and dual innov ...

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Summary of Whitehawk Therapeutics Fireside Chat - June 26, 2025 Company Overview - Whitehawk Therapeutics, formerly known as Adi Bioscience, underwent a transformation completed in Q1 2025, focusing on developing an advanced ADC (antibody-drug conjugate) portfolio after selling its mTOR inhibitor product to Kaken Pharmaceuticals for $100 million [3][4][15]. Pipeline and Technology - The company is developing a three-asset ADC portfolio targeting various cancers, including lung, ovarian, and gastrointestinal cancers, with a focus on established tumor biology and clinically validated tumor markers [4][5][14]. - All three programs are currently in preclinical stages, with IND (Investigational New Drug) filings anticipated by mid-2026 [6][13]. - The ADC platform utilizes a linker payload technology designed for greater stability, reduced off-target toxicity, and improved therapeutic index [5][12][13]. Key Programs 1. **HAWK 007 (PTK7-targeted ADC)** - PTK7 is broadly overexpressed in various solid tumors, with expression rates of 60-70% in cancer patients [20][21]. - The program aims to demonstrate differentiation from previous compounds, with a focus on lung cancer, ovarian cancer, and triple-negative breast cancer [24][26]. - Initial phase one trials will target patients with moderate to high expression of PTK7, aiming for a minimum response rate of 40% in lung cancer and 50% in ovarian cancer [56]. 2. **HAWK 016 (MUC16-targeted ADC)** - MUC16 is a circulating biomarker in ovarian cancer, with the approach focusing on targeting the membrane-bound portion to avoid complications from circulating biomarkers [60][63]. - The program will initially focus on gynecological cancers, with potential expansion into pancreatic and non-small cell lung cancers in the future [70]. 3. **HAWK 206 (SEZ6-targeted ADC)** - This program is in the early stages, with a biparatopic approach aimed at enhancing internalization and efficacy in neuroendocrine tumors and small cell lung cancer [71][78]. Competitive Landscape - The ADC market is competitive, with other companies like Zymeworks and Day One Pharmaceuticals developing next-generation ADCs. Whitehawk believes its platform offers superior optimization in terms of linker stability, hydrophilicity, and therapeutic index [36][46]. - The company aims to differentiate its products by demonstrating better efficacy and safety profiles compared to existing therapies [30][46]. Financial Position and Future Outlook - Whitehawk started Q2 2025 with approximately $185 million in cash, providing operational runway into early 2028 to generate clinical data before seeking additional funding [88][90]. - The company plans to release more preclinical data in 2026, focusing on a comprehensive view of its products' potential before public disclosures [89][90]. Conclusion - Whitehawk Therapeutics is positioned to make significant advancements in the ADC space with its innovative platform and targeted therapies. The upcoming IND filings and clinical trials will be critical in validating its approach and establishing its market presence.

Summary of BeiGene (BGNE) Update / Briefing June 26, 2025 Company Overview - **Company Name**: B1 Medicines (formerly BeiGene) - **Focus**: Oncology, specifically in the development of innovative cancer treatments Key Points and Arguments 1. **Mission and Vision**: B1 Medicines aims to transform the R&D process in oncology, making medicines more affordable and accessible while providing superior returns to investors [6][10][11] 2. **Commitment to Oncology**: The company emphasizes its dedication to fighting cancer, especially as some competitors shift focus to other therapeutic areas [8][9] 3. **R&D Model**: B1 has developed a unique R&D model that prioritizes quality, speed, and cost efficiency, allowing for a significant increase in the number of new molecule entities entering clinical trials [25][26][27] 4. **Clinical Development**: The company has built a global clinical development team of over 3,700 professionals, enabling it to conduct trials without relying on Contract Research Organizations (CROs), thus reducing costs and improving quality [42][44] 5. **Pipeline Expansion**: B1 has a robust pipeline with 96 ongoing trials across various phases and modalities, reflecting its commitment to advancing transformative medicines [39][40] 6. **Hematology Franchise**: The company has established a strong hematology franchise with three key medicines and aims to expand its leadership in Chronic Lymphocytic Leukemia (CLL) and beyond [19][56] 7. **Innovative Treatments**: B1 is developing next-generation BCL-2 inhibitors, such as Sonorotoclax, which aim to address the limitations of existing treatments like Venetoclax [67][72] 8. **Combination Therapies**: The combination of Sonorotoclax with Zanubrutinib shows promising results in achieving high rates of undetectable measurable residual disease (MRD) and favorable safety profiles [88][90] Additional Important Content 1. **Patient Impact**: B1 has already helped 1.7 million patients and their families in the fight against cancer, showcasing its commitment to patient care [15][16] 2. **Investment in Technology**: The company has made substantial investments in various modalities, including protein degraders and antibody-drug conjugates, to enhance its drug development capabilities [26][29][33] 3. **Regulatory Success**: Burkynza, a key product, has achieved significant market penetration and has been approved in 75 markets, demonstrating its efficacy and safety compared to competitors [59][62] 4. **Market Opportunity**: Despite advancements in CLL treatment, there remains a considerable unmet medical need, particularly for fixed-duration treatments, which B1 aims to address with its innovative therapies [56][57][71] This summary encapsulates the core messages and strategic direction of B1 Medicines as presented in the briefing, highlighting its commitment to innovation in oncology and the development of impactful treatments for cancer patients.

Core Insights - Invivyd, Inc. announced full Phase 1/2 clinical data for VYD2311, a next-generation monoclonal antibody (mAb) candidate aimed at preventing and treating COVID-19 [1] - VYD2311 is structurally 99%+ identical to previous antibodies and is designed to enhance potency and resistance against SARS-CoV-2 variants [2][10] - The Phase 1/2 study demonstrated that VYD2311 was well tolerated with mild to moderate adverse events and a long half-life, suggesting potential for long-term protection [4][5] Company Overview - Invivyd, Inc. is focused on developing innovative monoclonal antibodies to combat serious viral infectious diseases, starting with SARS-CoV-2 [18] - The company utilizes a proprietary technology platform to create antibodies that can adapt to viral evolution [18] Clinical Trial Details - The Phase 1/2 study involved 40 subjects and tested various routes of administration (IV, IM, SC) and doses to maximize flexibility for future registrational pathways [3] - VYD2311 showed a half-life ranging from 61 days (IV) to 76 days (IM), significantly longer than pemivibart's 49 days [5] Safety and Efficacy - All adverse events reported were mild to moderate, with no serious adverse events linked to the study drug [4] - The modeling analysis indicated that VYD2311 could provide robust protection against symptomatic COVID-19, potentially surpassing vaccine efficacy [8][10] Regulatory Plans - Invivyd plans to engage with the FDA in early Q3 2025 to discuss registration pathways for VYD2311 and subsequent COVID-19 mAbs [6][8] - The company aims to provide non-vaccine mediated protection for vulnerable populations, including the elderly and immunocompromised individuals [8][10]

Core Insights - Corbus Pharmaceuticals has initiated the dosing of the first participant in the PD-1 combination arm of its Phase 1 study for CRB-701, targeting solid tumors [1] - The company is experiencing a strong enrollment rate in the CRB-701 program, with a focus on advanced solid tumors associated with high Nectin-4 expression [2] Company Overview - Corbus Pharmaceuticals is a clinical-stage company focused on oncology and obesity, aiming to develop innovative treatments targeting well-understood biological pathways [4] - The company's pipeline includes CRB-701, an antibody-drug conjugate targeting Nectin-4, CRB-601, an anti-integrin monoclonal antibody, and CRB-913, a CB1 receptor inverse agonist for obesity [4] Study Details - The Phase 1 study (NCT06265727) consists of three parts: Part A (dose escalation), Part B (dose optimization), and Part C (dose expansion), with the company expecting to provide a data update and establish the recommended Phase 2 dose in Q4 2025 [2] - The initial dose escalation evaluated four doses: 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg, and 4.5 mg/kg [2] Product Information - CRB-701 (SYS6002) is a next-generation antibody-drug conjugate that utilizes a cleavable linker and a homogeneous drug-antibody ratio of 2, with MMAE as the payload [3] - Nectin-4 is recognized as a clinically validated tumor-associated antigen in urothelial cancer [3] Enrollment and Data Update - Over 100 participants have been dosed in the monotherapy cohort, with a priority focus on Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer [7] - A data update is scheduled for later this year [7]

Core Insights - The FDA has granted orphan drug designation to riliprubart for treating antibody-mediated rejection (AMR) in solid organ transplantation, highlighting a significant unmet need in transplant medicine [1][2] - Riliprubart is a first-in-class IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway [3] - Sanofi is conducting multiple clinical studies for riliprubart, including a phase 2 study for kidney transplant recipients and two phase 3 studies for chronic inflammatory demyelinating polyneuropathy (CIPD) [2][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, leveraging deep understanding of the immune system [5] - The company is committed to addressing urgent healthcare challenges and has a robust pipeline aimed at high unmet medical needs [5] Industry Context - Antibody-mediated rejection is a serious complication post-organ transplantation, where the recipient's immune system attacks the transplanted organ, leading to potential organ failure if untreated [4] - The orphan drug designation reflects the rarity of conditions like AMR, affecting fewer than 200,000 people in the US, and underscores the need for effective treatments in this area [1]

Core Insights - AstraZeneca (AZN) received FDA approval for its cancer drug Datroway for non-small cell lung cancer (NSCLC), expanding its label for a second indication [1][3] - The approval was based on clinical studies showing a 45% objective response rate (ORR) [2][7] - Datroway is the first TROP2-directed therapy approved in the U.S. for lung cancer [3] Company Performance - Year-to-date, AstraZeneca's shares have increased by 8%, while the industry has seen a 3% decline [4] Product Development - Datroway is the second antibody-drug conjugate (ADC) developed under the AstraZeneca-Daiichi partnership, following Enhertu [6] - The companies are jointly responsible for the development and marketing of Datroway, except in Japan where Daiichi has exclusive rights [6] - AstraZeneca and Daiichi are conducting extensive clinical trials for Datroway across multiple cancer indications, including eight late-stage studies in lung cancer and five in breast cancer [8] Market Potential - Datroway is projected to achieve peak annual sales of at least $5 billion, contributing to AstraZeneca's goal of reaching $80 billion in annual revenues by 2030 [9] - ADCs like Datroway are considered disruptive innovations in the pharmaceutical industry, enhancing cancer treatment through targeted delivery of cytotoxic drugs [9]