ORION CORPORATION INVESTOR NEWS 21 MAY 2025 at 07.30 EEST Orion’s collaborator, MSD, expands clinical development program for opevesostat to women’s cancers Orion’s collaborator, MSD, has expanded the development program for opevestostat (MK-5684) to now include women’s cancers. A new Phase 2 clinical trial evaluating the safety and efficacy of opevesostat for the treatment of breast, endometrial and ovarian cancers has been posted to ClinicalTrials.gov database. The study is not yet recruiting patients. ...

Financial Data and Key Metrics Changes - The company raised $75 million recently, extending its runway into the first half of 2027, indicating strong market demand and investor support [37]. Business Line Data and Key Metrics Changes - The company is focusing on its viral drug conjugate platform, particularly Belsar, which is designed for early-stage cancer treatment, showing promising results in ocular oncology and bladder cancer [3][20]. - In the Phase II trial for choroidal melanoma, 80% of patients treated with Belsar showed complete cessation of tumor growth, and 90% preserved vision, highlighting the efficacy of the treatment [13][16]. Market Data and Key Metrics Changes - The ocular oncology market presents a significant opportunity, with over 65,000 patients across three main indications having never received therapeutic intervention [6][9]. - The company is also exploring bladder cancer treatment, with Phase I data showing complete responses in 4 out of 5 treated lesions, indicating strong immune responses [22]. Company Strategy and Development Direction - The company aims to build a franchise in ocular oncology, leveraging its tumor-agnostic platform to transform treatment paradigms for early-stage tumors [6][10]. - There is a strategic focus on expanding into gastrointestinal cancers and other solid tumors, with plans for future partnerships to enhance development [34][36]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase III program for Belsar, with a primary endpoint of time to tumor progression, and anticipates good tumor control compared to sham treatments [15][17]. - The company is committed to a focused approach on its four deliverables of data across its indications, emphasizing the importance of derisking the program before seeking partnerships [38][39]. Other Important Information - The company has a Special Protocol Assessment (SPA) agreement with the FDA for its Phase III trial, which is currently enrolling patients in 18 countries [15]. - The treatment workflow for Belsar is designed to be convenient for both patients and physicians, potentially expanding the funnel of treating physicians over time [19][30]. Q&A Session Summary Question: How does Belsar's delivery system and safety profile shift the treatment paradigm? - Management highlighted that Belsar offers a positive safety profile with minimal adverse events, allowing for earlier intervention and preservation of vision compared to traditional radiotherapy [12]. Question: What does success look like in the Phase III trial? - The primary endpoint is time to tumor progression, with hopes to achieve similar or better results than the Phase II trial, where significant tumor control was observed [14][16]. Question: How does Belsar fit into the treatment workflow for retinal specialists? - Management indicated that Belsar can be administered in a routine clinical setting, allowing for easier integration into existing practices and potentially increasing the number of treating physicians [18][19]. Question: What are the unique aspects of Belsar compared to other treatments? - The company emphasized that Belsar's mechanism allows for immediate immune response due to tumor-specific antigen release, differentiating it from traditional therapies that require tumor removal first [29][30]. Question: What can investors expect in the next 6 to 12 months? - Investors can anticipate data releases across all four indications, with a focus on ocular oncology and bladder cancer, and potential NDA filings as the company progresses [37][38].

Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the phase III STARGLO study1,2There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCLThis first-of-its-kind Columvi combination could provide a much-needed, off-the-shelf and fixed-duration treatment option for patients who face poor prognosisThe clinical and disease characteristic ...

Financial Data and Key Metrics Changes - The company reported approximately $193 million in cash, bolstered by a recent $75 million capital raise, which is expected to support operations into the second half of 2026 [41][42][44] - The stock price fluctuated, dropping to $4 before recovering to around $8, influencing the decision to raise funds earlier than initially planned [42][43] Business Line Data and Key Metrics Changes - The lead combination therapy ofatumumab plus defecanib received accelerated approval from the FDA for low-grade serous ovarian cancer, indicating a significant milestone for the company [1][5] - The company is actively working on the launch of the approved therapy, with initial orders and positive feedback from the physician community [10][12] Market Data and Key Metrics Changes - Approximately 80% of patients are already being tested for KRAS mutations, which is crucial for the therapy's application, indicating a well-established testing framework in the market [21][22] - The company is planning to pursue approvals in international markets, with Japan being the next target due to a relatively straightforward approval process [23][24] Company Strategy and Development Direction - The company aims to remove barriers to access for its therapies by proactively engaging with payers and large group purchasing organizations [12][14] - Future investments will focus on larger programs contingent on positive results, while the current funding supports the launch of the LGSOC business [44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch of the therapy, noting that it has gone as well or better than expected, with significant interest from healthcare providers [9][10] - The company is preparing for an upcoming ASCO conference to report data on its frontline pancreatic cancer study, which is anticipated to be a key event for the company [6][28] Other Important Information - The company is developing a companion diagnostic for the therapy, which is a post-marketing commitment but is not required for the initial launch [18][22] - The company is also exploring additional indications beyond ovarian cancer, including lung and pancreatic cancers, with promising preclinical data [26][27] Q&A Session Summary Question: What are the next steps for commercialization? - The company aims to see a good trajectory on uptake by the end of the year and is working to remove barriers with payers and large systems [12][14] Question: How important is the companion diagnostic for the drug? - The companion diagnostic is necessary for regulatory compliance, but a significant proportion of patients are already being tested for KRAS mutations [18][21] Question: What are the plans for international markets? - The company is focusing on Japan for the next approval and is also engaging with European regulators for potential orphan drug designation [23][24] Question: What is the company's cash position and runway? - The company has approximately $193 million in cash, which is expected to support operations and the launch of its therapies into 2026 [41][42][44]

Company Overview - VERAXA Biotech AG is an emerging leader in designing novel cancer therapies and is the proposed de-SPAC acquisition target of Voyager Acquisition Corp [1][4] - The company focuses on next-generation antibody-based therapeutics, including bispecific antibody-drug conjugates (ADCs) and T-cell engagers, utilizing transformative technologies [3] Leadership Appointment - Rick Austin, Ph.D., has been appointed as Chief Scientific Officer, effective May 1st, bringing over 25 years of experience in oncology discovery and early development [1][2] - Dr. Austin's previous roles include Vice President of Research at Harpoon Therapeutics and various positions at Amgen, where he led tumor immunology projects [2] Strategic Goals - The appointment of Dr. Austin is seen as pivotal for advancing VERAXA's BiTAC platform and clinical-stage pipeline, aiming to enhance the therapeutic window of cancer treatments while minimizing off-tumor toxicity [2][3] - The company is committed to tapping into the U.S. biopharma talent pool and expanding its scientific footprint [2] Business Combination - On April 22, 2025, VERAXA entered into a definitive business combination agreement with Voyager Acquisition Corp, which will lead to VERAXA becoming a publicly traded company on NASDAQ upon closing [4]

NEW YORK, May 20, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, announced today that Mai-Britt Zocca, PhD, the company’s President and CEO, along with Amy Sullivan, the company’s CFO, and Qasim Ahmad, MD, the company’s CMO, will be participating in a fireside chat at the TD Cowen 6th Annual Oncology Summit: Insights for ASCO & EHA being held virtually May 27-28, 2025. Additionally ...

Core Insights - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [2] - The company’s lead product candidate, GPS, targets the WT1 protein and has potential applications as both a monotherapy and in combination with other therapies for hematologic malignancies and solid tumors [2] - SELLAS is also developing SLS009, a differentiated small molecule CDK9 inhibitor, which shows promise in treating AML patients with unfavorable prognostic factors [2] Event Participation - Dr. Angelos Stergiou, President and CEO of SELLAS, will participate in a fireside chat at the A.G.P. Virtual Healthcare Company Showcase on May 21, 2025, at 8:20 am ET [1][2] Company Overview - SELLAS Life Sciences Group, Inc. is dedicated to the development of innovative therapeutics for a wide range of cancer types [2] - The company’s lead candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets a protein present in various tumor types [2] - SLS009 is positioned as potentially the first and best-in-class CDK9 inhibitor with reduced toxicity and increased potency compared to existing options [2]

Core Insights - Alpha Tau Medical Ltd. has reported significant interim results from trials of its Alpha DaRT® therapy for pancreatic cancer, achieving over 90% disease control rate and a 75% systemic objective response rate in combination with Keytruda® [1][3][13] - The company has received FDA approvals for multiple Investigational Device Exemptions (IDE) to conduct clinical studies in pancreatic cancer and recurrent glioblastoma multiforme (GBM) [5][6][13] - Alpha Tau completed a $36.9 million financing round to support its ongoing clinical and manufacturing activities [6][11] Company Developments - The CEO of Alpha Tau highlighted the company's progress in expanding manufacturing capabilities and preparing for commercial activities, with four active U.S. IDEs approved by the FDA [3] - The company achieved MDSAP certification for its Jerusalem facility, which may expedite the commercialization process in multiple international markets [5][6] - Alpha Tau is set to begin U.S. trials for newly diagnosed pancreatic cancer and recurrent GBM patients soon [3][5] Financial Performance - For Q1 2025, Alpha Tau reported R&D expenses of $7.2 million, an increase from $6.4 million in Q1 2024, primarily due to higher employee compensation and production costs [8] - The company recorded a net loss of $8.7 million, or $0.12 per share, compared to a net loss of $8.0 million, or $0.11 per share, in the same period last year [10][22] - As of March 31, 2025, Alpha Tau had cash and cash equivalents totaling $54.8 million, down from $62.9 million at the end of 2024 [11] Clinical Trial Updates - Interim results from trials showed a 37.5% complete response rate in a combination trial of Alpha DaRT with Keytruda for head and neck squamous cell carcinoma, significantly higher than historical benchmarks [1][13] - The company announced the initiation of a U.S. pilot study for Alpha DaRT in combination with first-line chemotherapy for newly diagnosed pancreatic cancer, expanding the trial from 12 to 30 patients [13] - Alpha Tau is also preparing for a multicenter clinical trial in France for locally advanced pancreatic cancer [13]

Core Insights - Mainz Biomed N.V. plans to provide an interim readout of its eAArly DETECT 2 feasibility study by the end of summer 2025, with top-line results expected in Q4 2025 [1][2] - The study aims to validate a next-generation colorectal cancer screening test that combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test on approximately 2,000 average-risk patients [1][3] - The company is on track to initiate its U.S. pivotal trial, ReconAAsense, in 2026 based on the outcomes of the eAArly DETECT 2 study [2][3] Study Details - The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, targeting the reporting of top-line results by Q4 2025 [2] - The study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown the ability to identify advanced adenomas and early-stage colorectal cancer [3] Company Mission - The company aims to advance its mission of eliminating colorectal cancer and reducing global cancer mortality rates through precise detection of advanced precancerous lesions and early-stage colorectal cancer [3]

【总编辑圈点】 DiffInvex通过分析重要编码基因区域与非编码区域的突变情况，确定了"中性"突变率的基线。这种 方法消除了评估中的不确定性。通过对来自约30种组织类型的11000多个人类基因组的数据进行分析， DiffInvex鉴定出了11个在特定类型化疗后突变频率显著增加的基因，其中包括IK3CA、SMAD4和 STK11等已知的关键驱动基因。 此外，该研究还对比了1722个来自健康组织和相应肿瘤类型的基因组，进而发现一些所谓的癌症驱 动因子可能是进化的产物，而不是疾病启动的直接原因。 这一研究为合理设计药物组合提供了可能性，例如将标准的化疗与针对PIK3CA或STK11信号通路 的抑制剂结合使用，或会延缓或阻止癌症复发。其同时有助于改进早期检测方法，减少患者的不必要焦 虑。 西班牙巴塞罗那生物医学研究所团队开发出一种名为DiffInvex的创新计算框架，其可追踪健康细胞 转变为肿瘤，以及肿瘤在化疗过程中的基因进化压力。DiffInvex被应用于超过11000个样本，涵盖了大 约30种不同组织类型的人类癌症和健康组织的基因组数据，成功识别出导致肿瘤对治疗"负隅顽抗"的路 径，并指出了哪些基因可能引发耐药 ...