米兰, April 29, 2025 (GLOBE NEWSWIRE) -- 全球领先的制药合同研发生产组织 (CDMO) Olon Group 宣布任命 Jérôme Bédier 为其法国子公司的首席执行官，同时任命 Andrea Conforto 担任旗下专注于生物制剂 CDMO 服务的业务部门——Olon Biotech CDMO 事业部的市场和销售副总裁。 上述任命进一步巩固了 Olon 在抗体药物偶联物 (ADC)、高活性原料药 (HPAPI) 及微生物生物生产领域拓展能力的战略布局。 ADC、HPAPI 与微生物生物生产一体化愿景 凭借全新的领导层架构，Olon Group 正加速推进其完全一体化 ADC 服务的开发，涵盖从细胞系开发 (CLD) 到药物产品生产的完整价值链，包括有效载荷和连接子生产。 这一综合方案为生物技术公司和制药企业提供无缝衔接的 CDMO 解决方案，助力下一代靶向疗法的研发生产。 Olon Group 还充分利用其近期对意大利罗达诺工厂的投资，这些投资不仅提升了其 HPAPI 的生产能力，也与其在复杂生物制药生产领域的长期承诺高度契合。 与此同时，Olon 正在加强其微生 ...

Core Insights - Sutro Biopharma, Inc. announced promising preclinical findings for STRO-004, a novel antibody drug conjugate (ADC) targeting tissue factor, showcasing its anti-tumor activity and favorable safety profile [1][2] - The company will present its findings at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting the advantages of its XpressCF+ platform in developing dual-payload ADCs [1][2] Preclinical Findings - STRO-004 demonstrated potent, dose-dependent anti-tumor activity and a favorable safety profile across all tested doses in preclinical studies [2] - After a single dose, STRO-004 achieved promising overall response and disease control rates in Tissue Factor-positive patient-derived xenograft models across multiple cancer types [2] Technology and Platform - Sutro's XpressCF+ platform enables the creation of dual-payload ADCs with higher drug-to-antibody ratios and fully site-selective conjugation of two linker payloads [2] - The platform addresses limitations of conventional ADCs and the challenges of targeting complex disease biology, reinforcing the company's technology leadership [2] Presentation Details - The poster presentation titled "Preclinical activity and safety of STRO-004, a novel ADC targeting tissue factor for solid tumors" will take place on April 28, 2025, at the AACR meeting [3] - Another presentation will focus on enhancing Topo1i ADC efficacy through the development of homogeneous dual-payload ADCs [3] Company Overview - Sutro Biopharma is focused on discovering and developing precisely designed cancer therapeutics, leveraging its cell-free XpressCF technology for broader patient benefits [4] - The company is advancing a robust early-stage pipeline of novel exatecan and dual-payload ADCs, supported by high-value collaborations and industry partnerships [4]

Core Viewpoint - Summit Therapeutics Inc. experienced a significant stock decline of nearly 30% following the announcement that Akeso, Inc.'s ivonescimab received approval for a second indication from Chinese Health Authorities based on Phase 3 trial results [1]. Group 1: Clinical Trial Results - The HARMONi-2 trial evaluated ivonescimab, a PD-1/VEGF bispecific antibody, against Merck's Keytruda in patients with advanced non-small cell lung cancer (NSCLC) with positive PD-L1 expression [2]. - The interim analysis of overall survival (OS) showed a clinically meaningful hazard ratio of 0.777, conducted at 39% data maturity with a nominal alpha level of 0.0001 [4]. - The primary analysis for HARMONi-2 demonstrated a statistically significant improvement in progression-free survival (PFS) with a hazard ratio of 0.51 (p<0.0001) when compared to pembrolizumab [5]. Group 2: Ongoing and Future Trials - Summit is currently enrolling patients in the HARMONi-7 Phase 3 clinical trial, which is evaluating ivonescimab monotherapy against pembrolizumab in patients with advanced NSCLC with positive PD-L1 expression [6]. - HARMONi-7 is being conducted globally with registrational intent for the U.S. and other regions within Summit's license territories [7]. - The HARMONi-6 trial evaluated ivonescimab in combination with platinum-based chemotherapy against tislelizumab, meeting its primary endpoint of PFS [8]. Group 3: Market Reactions - Following the developments regarding ivonescimab, BioNTech SE's stock also saw an increase, indicating positive market sentiment towards bispecific antibody candidates in oncology [9].

J.P. Morgan Healthcare Conference Clay Siegall, Ph.D. President and Chief Executive Officer January 11, 2021 2 Key 2020 Accomplishments Set Foundation for Continued Growth CONFIDENTIAL Forward-Looking Statements Certain of the statements made in this presentation are forward looking, such as those, among others, relating to the Company's potential to achieve the noted development and regulatory milestones in 2021 and in future periods; anticipated activities related to the Company's planned and ongoing clin ...

Core Insights - Compass Therapeutics presented promising preclinical data on CTX-471, a CD137 agonist antibody, at the AACR Annual Meeting, indicating enhanced efficacy in models of immune checkpoint failure through simultaneous blockade of neo-angiogenesis [1][2][3] Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology, with a scientific emphasis on the interplay between angiogenesis, the immune system, and tumor growth [10] Product Development - CTX-471 is currently in a Phase 1b clinical trial for patients with solid tumors that have progressed after at least three months on approved PD-1 or PD-L1 inhibitors, showing partial responses in melanoma, small cell lung cancer, and mesothelioma [5][6] - The combination of CTX-471 with tovecimig, an investigational bispecific antibody targeting DLL4 and VEGF-A, demonstrated significant anti-tumor activity in resistant murine models, suggesting potential clinical benefits for patients who have failed checkpoint inhibitors [6][9] Mechanism of Action - The combination therapy of CTX-471 and tovecimig enhances innate and adaptive anti-tumor immunity, leading to increased tumor cell killing and improved interferon signaling, which may provide therapeutic advantages in previously resistant cancer types [3][6] Clinical Trials - Tovecimig is being evaluated in the ongoing Phase 2/3 trial (COMPANION-002) in combination with paclitaxel for patients with advanced metastatic or recurrent biliary tract cancers, showing promise in heavily pre-treated patients resistant to anti-VEGF therapies [9]

Core Insights - Adagene Inc. has appointed Dr. John Maraganore as Executive Advisor to provide strategic guidance and mentorship to the company's leadership team [1][2] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4] - The company has established strategic collaborations with global partners to leverage its SAFEbody precision masking technology [4] Technology and Innovation - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody®, and POWERbody™ technologies, aimed at addressing safety and tolerability challenges in antibody therapeutics [5] - The SAFEbody technology allows for tumor-specific targeting of antibodies while minimizing on-target off-tumor toxicity in healthy tissues [5] Clinical Development - Adagene's lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 clinical studies, particularly targeting Metastatic Microsatellite-stable Colorectal Cancer [6] - The SAFEbody platform is validated for application across various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [6] Leadership and Expertise - Dr. John Maraganore previously served as CEO of Alnylam, where he led the company through the approval and commercialization of four RNA interference therapeutic medicines, creating over $25 billion in market capitalization [2][3] - He has extensive experience advising and mentoring life sciences CEOs and sits on the boards of public and private companies [3]

Core Insights - The European Commission has granted conditional marketing approval for Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory multiple myeloma, specifically for those who have undergone at least three prior therapies [1][3][5] - Lynozyfic is a bispecific antibody that targets B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells, facilitating T-cell activation and cancer cell killing [1][3] - The approval is based on the LINKER-MM1 trial, which showed a 71% objective response rate and a 50% complete response rate among patients treated with Lynozyfic [3][4] Company Overview - Regeneron Pharmaceuticals is a leading biotechnology company focused on developing innovative medicines for serious diseases, including blood cancers [17][18] - The company has a strong commitment to transforming cancer care, as evidenced by the approval of Lynozyfic as its second bispecific antibody [5][12] - Regeneron utilizes proprietary technologies, such as VelociSuite, to develop optimized fully human antibodies and bispecific antibodies [15][18] Clinical Development - Lynozyfic is currently being investigated in a broad clinical development program, including monotherapy and combination regimens across different lines of therapy for multiple myeloma [11][12] - The ongoing LINKER-MM1 trial has enrolled over 300 patients, assessing safety, tolerability, and anti-tumor activity [9][10] - The regimen for Lynozyfic includes an initial step-up dosing followed by a response-adapted schedule, allowing for convenient administration every four weeks for eligible patients [2][10] Market Context - Multiple myeloma is the second most common blood cancer, with over 35,000 new cases diagnosed annually in Europe and 187,000 globally [6][7] - Despite treatment advances, multiple myeloma remains incurable, and patients often experience relapses and require new therapies [7][8] - The introduction of Lynozyfic provides a new treatment option with a different mechanism of action, addressing the need for innovative therapies in this patient population [3][5]

Core Insights - ADC Therapeutics presented promising data on exatecan-based antibody drug conjugates (ADCs) targeting Claudin-6, PSMA, and ASCT2 at the AACR Annual Meeting 2025, indicating their potential in treating various cancers [1][2][3] Group 1: ADC Therapeutics Overview - ADC Therapeutics is a global leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for patients with hematologic malignancies and solid tumors [5] - The company has received FDA accelerated approval for its CD19-directed ADC ZYNLONTA for treating relapsed or refractory diffuse large B-cell lymphoma [6] Group 2: Research Findings - ADCT-242, targeting Claudin-6, showed potent anti-tumor activity in ovarian and non-small cell lung cancer models, demonstrating good tolerability in preclinical studies [2][8] - ADCT-241, a PSMA-targeting ADC, exhibited antitumor activity in xenograft and patient-derived models, with well-tolerated results in rats and cynomolgus monkeys [2][3] - HuB14-VA-PL2202, an ASCT2-targeting ADC, demonstrated specific antitumor activity in both solid and hematological cancer cell lines, also showing good tolerability in cynomolgus monkeys [3]

Core Insights - Innovent Biologics is showcasing preclinical data on multiple novel bispecific antibodies, tri-specific antibodies, and bispecific antibody-drug conjugates (ADCs) at the AACR Annual Meeting 2025, highlighting its advancements in oncology research [1][2] Research Highlights - IAR037, a novel CD40/PD-L1 bispecific antibody, shows potent anti-tumor efficacy in PD-1-resistant models and has a favorable safety profile in cynomolgus monkeys [3][4] - IBI3010, a FRα targeting biparatopic ADC, demonstrates superior cytotoxicity compared to existing treatments and is being developed for FRα-expressing tumors [5][6] - IBI3014, a TROP2xPD-L1 bispecific ADC, integrates tumor killing with immune checkpoint blockade, showing promising efficacy and safety in preclinical models [8][9] - IBI3022 targets Trop2 and B7H4, exhibiting improved efficacy and safety profiles for gynecologic cancers [10][11] - IBI3026, a first-in-class anti-PD-1/IL-12 fusion protein, shows potential as a new immuno-oncology therapy with strong immune activation [12][13] - IBI3019, a tri-specific antibody for colorectal cancer, demonstrates potent efficacy and an excellent safety profile in preclinical studies [16][17] - A novel PD1-IFNα fusion protein shows superior anti-tumor efficacy compared to PD1 mAb alone, potentially benefiting patients with ICB-refractory cancers [18][19][20] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, having launched 15 products and with multiple assets in clinical trials [21]

Core Insights - Pyxis Oncology, Inc. announced robust preclinical data supporting the unique mechanism of action of micvotabart pelidotin (MICVO), an antibody-drug conjugate (ADC) targeting extradomain-B fibronectin (EDB+FN), which is highly expressed in various solid tumors [1][5] - MICVO demonstrated significant anti-tumor activity across multiple solid tumor indications, with 45% of models showing strong to very strong tumor growth inhibition (TGI) and complete responses observed in several tumor types [2][3] - The combination of MICVO with anti-PD-1 therapy showed enhanced tumor clearance and longer immunological memory compared to either treatment alone, reinforcing the potential for MICVO as both a monotherapy and in combination therapies [1][3] Preclinical Findings - Evaluation of MICVO in patient-derived xenograft (PDX) models identified gene signatures associated with anti-tumor activity, with 45% of models showing TGI between 70% and 90% or greater than 90% [2][3] - The preclinical studies indicated that MICVO is well-tolerated at a dosage of 3 mg/kg, with significant tumor regression responses confirmed in Phase 1 studies [2][4] - Upregulation of certain proteases may enhance linker cleavage, contributing to increased MICVO activity, supporting the hypothesis for its extracellular mechanism [3] Clinical Development - MICVO is currently being evaluated in Phase 1 studies as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) for advanced solid tumors, particularly recurrent and metastatic head and neck squamous cell carcinoma [4][5][8] - The company has received Fast Track Designation from the U.S. FDA for MICVO in treating adult patients with recurrent and metastatic head and neck squamous cell carcinoma whose disease has progressed after prior treatments [8]