Intalight™ Receives CE Mark for Its Progressive DREAM OCT™ Swept Source Imaging Français
The CE mark serves as approval by the European Union (EU) to commercialize DREAM OCT, the newest version of OCT. DREAM stands for: Deep imaging depth, Rapid sweeping speed, Extensive scan range, Accurate results, and Multimodal imaging capabilities. The imaging platform provides the highest quality OCT images currently on the market.
"Intalight is incredibly proud to receive CE mark approval in Europe for our DREAM OCT," said Intalight chairman and Founder, Shawn Peng. "This achievement allows us to provide ophthalmologists in Europe with state-of-the-art technology that delivers improved results for their patients."
DREAM OCT is able to cover an ultrawide field single scan which delivers a 130° OCTA image. DREAM OCT ™ swept-source 12 mm super-depth scanning allows superior imaging of the choroid and retina, and a large portion of the vitreous space. The super-depth anterior scanning capabilities achieves 16.2 mm (in air), allowing for the complete anterior segment from the cornea to the anterior part of the vitreous to be scanned in only one scan. The longer wavelength allows for superior penetration through opacities in either lens or vitreous.
"Over the past few years, we've heard from eye care professionals that they need a solution that gets them over the imaging finish line with speed, accuracy and depth," said Intalight CEO and Co-Founder, Bing Li. "DREAM OCT delivers a full set of imaging modalities for the most challenging clinical and research applications for the retina and outperforms everything else HCP's know."
Using ultra-wide swept-source technology, DREAM OCT was developed to address the needs of retina specialists, comprehensive ophthalmologists and their patients with highly-detailed imaging capabilities for improved care and results. Currently, more than 160 peer-reviewed papers have utilized findings from DREAM OCT devices.
"This is such exciting news for Intalight that there's no more waiting in Europe, and we look forward to being able to provide this innovative solution in the US," remarked Intalight Chief Commercial Officer, Joe Garibaldi. "We look forward to continuing to grow our prestigious network of global institutions and ophthalmologists with our recent CE approval and eventually our FDA approval."
As the clinically validated leader of ultra-wide field OCTA, Intalight is currently collaborating with the top retina academic institutions and retina private practices in the United States, Europe, and Asia.
About Intalight
Intalight Inc. was founded by a group of scientists and industry veterans of Silicon Valley with a core mission to develop the most advanced ophthalmic technologies. There are now three sites in Silicon Valley, Shanghai, and Luoyang. Intalight's Swept-Source Optical Coherence Tomography (OCT) device combines Deep imaging depth, Rapid sweeping speed, Extensive scan range, Accurate lesion detection and Multimodal imaging capabilities, and is abbreviated as DREAM OCT ™. The powerful imaging device has become an indispensable tool for many ophthalmologists in not only their daily clinical use but also their exploration of the research frontiers. To learn more about Intalight and DREAM OCT, please visit our website at https://www.intalight.com and follow us on LinkedIn and Facebook.
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To address this challenge, the GHIT Fund has decided to invest JPY 800 million (USD 5.5 million 1) in a malaria vaccine development project currently in the preclinical stage. This project is being led by the European Vaccine Initiative, the Research Institute for Microbial Diseases (RIMD) at Osaka University, the University of Copenhagen, the University of Tübingen, Danish biotechnology company AdaptVac, Ajinomoto Co., Inc., and Nobelpharma Co., Ltd. This investment is a continuation of previous projects supported by GHIT, which has invested a total of approximately JPY 630 million (USD 4.3 million 1) from 2013 to 2022. The present project aims to develop a vaccine that prevents the proliferation of malaria parasites during the blood-stage of infection. The vaccine is designed to achieve higher efficacy and longer-lasting protection with fewer doses. By reducing manufacturing costs, the project also aims to improve access to vaccines in malaria-endemic regions. In addition, the GHIT Fund will invest a total of approximately JPY 260 million (USD 1.8 million 1) in the following three R&D projects: (1) Target research project for malaria diagnostics by Ehime University and Universiti Malaysia Sabah (2) Target research project for TB drug by the University of Auckland and the University of Tokyo (3) Target research project for malaria drug by Medicines for Malaria Venture (MMV), LPIXEL Inc., and University of Dundee This investment brings four new companies and universities on board. Through collaborations with 190 partners across 39 countries — including 64 Japanese and 126 non-Japanese institutions — we aim to contribute to solving global health challenges and accelerating product development. Please refer to Appendix 1 for detailed descriptions on these projects and their development stages. As of July 17, 2025, the GHIT Fund has invested in 37 projects, including 15 discovery projects, 13 preclinical projects, and 9 clinical trials. 4 The total amount of investments since 2013 is JPY 39.3 billion (USD 271 million 1) (Appendix 2). 1 USD1 = JPY144.81, the approximate exchange rate on June 30, 2025. 2 These awarded projects were selected and approved as new investments from among proposals to RFP2023-002 and RFP2024-001 for the Product Development Platform and the Target Research Platform, which were open for applications from June 2023 to July 2024. 3 WHO: 4 This number includes projects in the registration phase. The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. Appendix 1. Project Details ID: G2024-201 Project Title Biomanufacture and preclinical development of the blood-stage malaria vaccine candidate SE36/cVLP Collaboration Partners 1. European Vaccine Initiative (Germany) 2. RIMD, Osaka University (Japan) 3. University of Copenhagen (Denmark) 4. AdaptVac (Denmark) 5. University of Tübingen (Germany) 6. Ajinomoto Co., Inc. (Japan) 7. Nobelpharma Co., Ltd. (Japan) Disease Malaria Intervention Vaccine Stage Preclinical Awarded Amount JPY 800,715,002 (USD 5.5 million) Status Continued project Summary [Project objective] This team's goal is to fast-track the clinical development of the SE36/cVLP vaccine candidate and obtain supporting evidence for a safe and efficacious blood-stage vaccine that could be deployed as a stand-alone or potentially combined in a second- generation multi-stage malaria vaccine. The main objectives are to: 1. Manufacture a large GMP batch of SE36 2. Produce a GMP batch of SE36/cVLP 3. Conduct a GLP-compliant nonclinical toxicology study for SE36/cVLP + Sepivac SWE adjuvant 4. 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Rapid diagnostic tests based on the pLDH biomarker show high cross-reactivity between P. vivax and P. knowlesi making them impossible to distinguish. Current diagnostic practices take time and delay patient access to treatment. Simple, accessible PoC tools are urgently required. Identification of P. knowlesi- specific diagnostic markers has been largely neglected. The serine repeat antigen (sera) multigene family has been extensively studied in P. falciparum and rodent parasite lines and plays critical roles across the parasite life cycle. The P. knowlesi Serine Repeat Antigen 3 (PkSERA3) antigen 2 has been identified as a P. knowlesi -specific exposure marker, with laboratory and population-level evaluations showing no cross-reactivity with P. vivax, a phylogenetically closely related species. The project team will use this antigen to develop reagents for a P. knowlesi PoC diagnostic test. 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The initial assay development phase will optimise methodologies for staining, fixation, and imaging of parasite-infected red blood cells, including both healthy untreated parasites and those treated with a pilot set of compounds with defined MoA. This will allow preliminary development of artificial intelligence (AI) models to classify parasite morphology across the 48 hour lifecycle, as well as the phenotypic impact of drug-treatment. Once treatment and imaging parameters have been optimised, data collection will be performed with an expanded set of compounds covering a diverse range of MoA, in order to refine and validate the development of AI models for pattern recognition. AI models will ultimately be packaged into a cloud-based, user-friendly application so that images generated by researchers can be analysed without specialist AI knowledge. *All amounts are listed at an exchange rate of USD1 = JPY144.81, the approximate exchange rate on June 30, 2025. Appendix 2. 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ORVANA REPORTS Q3 FY2025 PRODUCTION AND EXPLORATION RESULTS FROM OROVALLE, SPAIN
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Orovalle – Q3 FY2025 Production Results The mill processed approximately 116,626 tonnes, 5% higher than the prior quarter. 8,536 gold ounces produced in Q3 FY2025, 26% higher than the previous quarter. Current production estimates are tracking moderately below the lower end of the guidance range of 37,000 to 41,000 ounces. The final production level will depend on the ramp-up pace of production at Carlés starting in August. Updated estimates will be released with the third quarter financials, expected mid-August 2025. 0.9 million copper pounds produced in Q3 FY2025, in line with the previous quarter. As of the end of the third quarter, copper production has already exceeded the higher end of the 2025 production guidance of 2,400 to 2,700 K lbs. Q3 FY2025 Q2 FY2025 Q3 FY2024 YTD Q3 FY2025 FY 2025 Guidance Ore milled (tonnes) 116,626 111,272 150,843 346,547 Gold equivalent (oz) (1) 10,008 8,416 13,078 28,118 Gold Grade (g/t) 2.43 2.06 2.37 2.22 Recovery (%) 93.6 92.0 94.1 92.8 Production (oz) 8,536 6,792 10,832 22,960 37,000 - 41,000 Copper Grade (%) 0.42 0.43 0.39 0.44 Recovery (%) 82.0 84.0 76.3 83.9 Production (K lbs) 886 885 986 2,839 2,400 - 2,700 Silver Grade (g/t) 9.86 9.81 8.30 10.16 Recovery (%) 80.4 80.1 76.7 80.5 Production (oz) 29,752 28,129 30,872 91,187 (1) Gold Equivalent Ounces ("GEO") is a Non-GAAP Financial Performance Measure. For further information and detailed reconciliations, please see the "Non-GAAP Financial Performance Measures" section of the Company's latest MD&A. GEO were calculated using the following average market prices: Q3 FY2025: $3,279.16/oz Au, $33.64/oz Ag, $4.32/lb Cu Q2 FY2025: $2,862.56/oz Au, $31.91/oz Ag, $4.24/lb Cu Q3 FY2024: $2,337.99/oz Au, $28.86/oz Ag, $4.42/lb Cu Orovalle – Q3 FY2025 Drilling Update El Valle Boinás The Q3 FY2025 drilling program focused on skarn areas, aiming to convert inferred resources into measured and indicated resources. In Boinás East, 1,561 meters of drilling defined narrow skarn mineralization in the western part of the orebody, between levels 100 and 200, which will be incorporated into the mine plan. In Boinás South, 1,192 meters were drilled to complete mineral definition around stope designs and confirm orebody geometry. A minor drilling program was also carried out in Area 208 and will continue during the fourth quarter. The drilling program in the fourth quarter of fiscal 2025 is focused on defining new resources in oxides areas and converting inferred resources in the same areas (mainly Area 208 and E2). Ortosa-Godán The Ortosa-Godan Project is located three kilometers northwest of our Carlés mine, within the same gold belt. The exploration program is currently focused on the Godán area, where FY2024 drilling proved mineralization at the contact between the intrusive and sedimentary rocks, with calcic skarn bands dipping 60-70° ESE over 200 meters of strike potential. The FY2025 drilling program is currently underway, aiming to extend the definition of skarn mineralization at depth. Based on the interpreted dip of the formation, there is potential for the Godán mineralization to connect with the Carlés skarn system, and ongoing exploration is focused on testing this possibility. Quality Control Greenfield drill hole samples were sent to an external laboratory (ALS Laboratory) for analyses. Infill and brownfield drill holes samples were analyzed in Orovalle's Laboratory. Sample preparation was carried out at the El Valle facility. All diamond core samples have been prepared using the following procedure, once split: The core samples are dried at a temperature of 105°C and then crushed through a jaw crusher to 70%<6 mm. The coarse-crushed sample is further reduced to 70%<425 microns using an LM5 bowl-and-puck pulverizer. An Essa rotary splitter is used to take a 450 g to 550 g sub-sample of each split for pulverizing. The remaining reject portion is bagged and stored. The sample is reduced by 85% to a nominal -200 mesh using an LM2 bowl-and-puck pulverizer. 150 g sub-samples are split using a special vertical-sided scoop to cut channels through the sample which has been spread into a pancake on a sampling mat. Samples are then sent to the laboratory for gold and base metal analysis. Leftover pulp is bagged and stored. After sample preparation, 30g samples are analyzed for Au by fire assay with an atomic absorption spectroscopy (AAS) finish and one-gram samples for Ag, As, Bi, Cu, Hg, Pb, Sb, Se, and Zn by ICP-optical emission spectroscopy (ICP-OES) after an aqua regia digestion. For A208 core samples is used a 1000 g sub-sample of each split and 250 g sub-samples are split. 50 g samples are twice analyzed. In case of the twice analysis don´t match, a metalling screening method is used to confirm the grade. In case of the samples sent to an external laboratory, 30 g samples are analyzed for Au by fire assay with an atomic absorption (Au AA-25) and 35 elements by ICP (ME-ICP41) after an aqua regia digestion. When Au and Ag values are >100 ppm and Cu and As values are >10,000 ppm, specific analysis methods are used to determinate the final grade. The reported work has been completed using industry standard procedures, including a quality assurance/quality control ("QA/QC") program consisting of the insertion of certified reference material, blanks and duplicates samples into the sample stream. The exploration update was prepared under the supervision of Guadalupe Collar Menéndez, a qualified person for the purposes of NI 43-101 and an employee of Orovalle Minerals S.L., a subsidiary of Orvana. Consolidated Operational and Financial Performance: Project updates for Bolivia and Argentina, and Q3 FY2025 consolidated operational and financial highlights will be released with the third quarter financials, expected mid-Aug, 2025. ABOUT ORVANA – Orvana is a multi-mine gold-copper-silver company. Orvana's assets consist of the producing El Valle and Carlés gold-copper-silver mines in northern Spain, the Don Mario gold-silver property in Bolivia, and the Taguas property located in Argentina. Additional information is available at Orvana's website ( Cautionary Statements – Forward-Looking Information Certain statements in this news release constitute forward-looking statements or forward-looking information within the meaning of applicable securities laws ("forward-looking statements"). Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, potentials, future events or performance (often, but not always, using words or phrases such as "believes", "expects", "plans", "estimates" or "intends" or stating that certain actions, events or results "may", "could", "would", "might", "will", "are projected to" or "confident of" be taken or achieved) are not statements of historical fact, but are forward-looking statements. The forward-looking statements herein relate to, among other things, Orvana's ability to achieve improvement in free cash flow; the ability to maintain expected mining rates and expected throughput rates at El Valle Plant; the potential to extend the mine life of El Valle and Don Mario beyond their current life-of-mine estimates including specifically, but not limited to, Orvana's ability to optimize its assets to deliver shareholder value; estimates of future production (including without limitation, production guidance), operating costs and capital expenditures; mineral resource and reserve estimates; statements and information regarding future feasibility studies and their results; future transactions; future metal prices; the ability to achieve additional growth and geographic diversification; and future financial performance, including the ability to increase cash flow and profits; future financing requirements; mine development plans; the possibility of the conversion of inferred mineral resources to mineral reserves. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the date of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies, which includes, without limitation, as particularly set out in the notes accompanying the Company's most recently filed financial statements. The estimates and assumptions of the Company contained or incorporated by reference in this news release, which may prove to be incorrect, include, but are not limited to the various assumptions set forth herein and in Orvana's most recently filed Management's Discussion & Analysis and Annual Information Form in respect of the Company's most recently completed fiscal year (the "Company Disclosures") or as otherwise expressly incorporated herein by reference as well as: there being no significant disruptions affecting operations, whether due to labour disruptions, supply disruptions, power disruptions, damage to equipment or otherwise; permitting, development, operations, expansion and acquisitions at El Valle, Don Mario and Taguas being consistent with the Company's current expectations; political developments in any jurisdiction in which the Company operates being consistent with its current expectations; certain price assumptions for gold, copper and silver; prices for key supplies being approximately consistent with current levels; production and cost of sales forecasts meeting expectations; the accuracy of the Company's current mineral reserve and mineral resource estimates; labour and materials costs increasing on a basis consistent with Orvana's current expectations; and the availability of necessary funds to execute the Company's plan. Without limiting the generality of the foregoing, this news release also contains certain "forward-looking statements" within the meaning of applicable securities legislation, including, without limitation, references to the results of the Company's exploration activities, including but not limited to, drilling results and analyses, mineral resource estimation, conceptual mine plan and operations, internal rate of return, sensitivities, taxes, net present value, potential recoveries, design parameters, operating costs, capital costs, production data and economic potential; the timing and costs for production decisions; permitting timelines and requirements; exploration and planned exploration programs; and the Company's general objectives and strategies. A variety of inherent risks, uncertainties and factors, many of which are beyond the Company's control, affect the operations, performance and results of the Company and its business, and could cause actual events or results to differ materially from estimated or anticipated events or results expressed or implied by forward looking statements. Some of these risks, uncertainties and factors include: the potential impact of global health and global economic conditions on the Company's business and operations, including: our ability to continue operations; and our ability to manage challenges presented by such conditions; the general economic, political and social impacts of the continuing conflict between Russia and Ukraine, our ability to support the sustainability of our business including through the development of crisis management plans, increasing stock levels for key supplies, monitoring of guidance from the medical community, and engagement with local communities and authorities; fluctuations in the price of gold, silver and copper; the need to recalculate estimates of resources based on actual production experience; the failure to achieve production estimates; variations in the grade of ore mined; variations in the cost of operations; the availability of qualified personnel; the Company's ability to obtain and maintain all necessary regulatory approvals and licenses; Orovalle's ability to complete the permitting process of the El Valle Tailings Storage Facility increasing the storage capacity; Orovalle's ability to complete the stabilization project of the legacy open pit wall; the Company's ability to use cyanide in its mining operations; risks generally associated with mineral exploration and development, including the Company's ability to continue to operate the El Valle and/or ability to resume operations at the Carlés Mine; the Company's ability to successfully implement an acid leaching circuit and ancillary facilities to process the current oxides stockpiles at Don Mario; the Company's ability to successfully carry out development plans at Taguas; sufficient funding to carry out exploration and development plans at Taguas and to process the oxides stockpiles at Don Mario; EMIPA's ability to finalize the OSP financial model and subsequently complete the required funding for the OSP; the Company's ability to acquire and develop mineral properties and to successfully integrate such acquisitions; the Company's ability to execute on its strategy; the Company's ability to obtain financing when required on terms that are acceptable to the Company; challenges to the Company's interests in its property and mineral rights; current, pending and proposed legislative or regulatory developments or changes in political, social or economic conditions in the countries in which the Company operates; general economic conditions worldwide; the challenges presented by global health conditions; fluctuating operational costs such as, but not limited to, power supply costs; current and future environmental matters; and the risks identified in the Company's disclosures. This list is not exhaustive of the factors that may affect any of the Company's forward-looking statements and reference should also be made to the Company's Disclosures for a description of additional risk factors. Any forward-looking statements made herein with respect to the anticipated development and exploration of the Company's mineral projects are intended to provide an overview of management's expectations with respect to certain future activities of the Company and may not be appropriate for other purposes. Forward-looking statements are based on management's current plans, estimates, projections, beliefs and opinions and, except as required by law, the Company does not undertake any obligation to update forward-looking statements should assumptions related to these plans, estimates, projections, beliefs and opinions change. Readers are cautioned not to put undue reliance on forward-looking statements. The forward-looking statements made in this information are intended to provide an overview of management's expectations with respect to certain future operating activities of the Company and may not be appropriate for other purposes.
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Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER. BC, July 16, 2025 /CNW/ -- As lawmakers weigh potential cuts to scientific research funding, the outlook for developing cancer cures faces growing uncertainty. The situation is further complicated by renewed regulatory scrutiny of mRNA vaccines at both federal and state levels, casting a shadow over ongoing cancer research efforts. Meanwhile, the incidence of cancers—especially gastrointestinal and colorectal cancers among younger populations—is on the rise, heightening the need for new therapeutic approaches. In response, a new generation of biotech companies is stepping forward with promising clinical milestones on the horizon, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Zai Lab Limited (NASDAQ: ZLAB), GeoVax Labs, Inc. (NASDAQ: GOVX), OS Therapies (NYSE-American: OSTX), and SELLAS Life Sciences Group, Inc. (NASDAQ: SLS). Industry forecasts suggest the global oncology drug market could climb past US$900 billion by 2034. Within that, next-generation cancer treatments —powered by advances in personalized and precision medicine—are expected to reach US$175.2 billion, according to Precedence Research, growing at a compound annual rate of 7.35%. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just rolled out an expanded translational data review package that tightens the scientific case for pelareorep, its intravenously delivered oncolytic virus. Fresh analyses from the GOBLET gastrointestinal‑cancer study and the AWARE‑1 breast‑cancer study shows pelareorep actively replicating inside tumors, switching on interferon signaling in the immune system, and drawing tumor‑infiltrating lymphocytes into the cancer microenvironment. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Investigators also recorded a clear increase in PD‑L1 expression, a checkpoint marker that helps immune cells recognize tumors, and tracked newly expanded T‑cell clones in the blood that matched those inside shrinking lesions. Together, these findings suggest pelareorep can convert "cold" tumors into "hot" ones that respond better to modern immunotherapies. "The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs." Two GOBLET cohorts—metastatic pancreatic ductal adenocarcinoma (mPDAC) and anal cancer—remain open. Management plans to outline the next clinical milestones before the end of the third quarter. Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a two‑year overall‑survival rate of 21.9%, compared with the historical benchmark of 9.2%. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective response rate. No immune checkpoint therapy is approved in this cancer today, which makes the signal especially noteworthy. Progress extends to hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC). Across two randomized trials, pelareorep added more than ten months of median overall survival. In BRACELET‑1, the drug nearly doubled median progression‑free survival to 12.1 months versus 6.4 months in the control arm, suggesting durable disease control. Next week, Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep's data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial's primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep's mechanism and outcomes. To steer these data toward value‑creating deals and late‑stage trials, Oncolytics Biotech strengthened its leadership earlier this year. The board tapped industry veteran Jared Kelly for the CEO seat and named Andrew Aromando Chief Business Officer. Both executives helped guide Ambrx Biopharma into a $2‑billion sale to Johnson & Johnson, giving them a playbook for capital‑efficient development and strategic partnering. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe. In other recent industry developments and happenings in the market include: Zai Lab Limited (NASDAQ: ZLAB) recently reported that its Phase 3 FORTITUDE‑101 study found bemarituzumab plus mFOLFOX6 significantly improved overall survival over chemotherapy alone in first‑line fibroblast growth factor receptor 2b (FGFR2b)‑positive gastric and gastroesophageal junction cancers. The antibody becomes the first FGFR2b inhibitor to post a statistically and clinically meaningful survival benefit, and the company plans a rapid regulatory filing in China under its Breakthrough Therapy designation. "Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible." GeoVax Labs, Inc. (NASDAQ: GOVX) recently stated that the FDA's curative‑intent approval of Keytruda for head and neck cancer strengthens the rationale for its planned Phase 2 trial combining Gedeptin and pembrolizumab. "We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed," added Dr. Kelly McKee, GeoVax's Chief Medical Officer. "We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease." The study, expected to launch in 2026, will give Gedeptin intratumorally before surgery to trigger local cytotoxicity, then add checkpoint inhibition to boost systemic immunity. Endpoints include pathologic response, recurrence rates, and immune biomarkers, aligning with guidance in a recent New England Journal of Medicine editorial. OS Therapies (NYSE-American: OSTX) has locked in an End‑of‑Phase 2 FDA meeting for 27 August 2025 to discuss a rolling Biologics License Application for OST‑HER2 in recurrent, lung‑metastatic osteosarcoma, while parallel regulatory consultations are set with the EMA and the UK MHRA. "We are making significant progress towards our primary objective of obtaining regulatory approval for OST-HER2 in recurrent, pulmonary metastatic osteosarcoma prior to the sunsetting of the rare pediatric disease priority review voucher ("PRV") program," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "We strongly believe in the promise of the listeria immunotherapy platform to help prevent and treat cancer, and intend to judiciously deploy our capital to focus on the OST-HER2 approval while advancing our other clinical programs without deploying significant capital or running other clinical studies while we wait for the OST-HER2 approval and related PRV sale." The company is also advancing a Phase 1 prostate‑cancer immunotherapy, OST‑504, with full data expected later in 2025. OST‑HER2 already carries Rare Pediatric Disease, Fast Track, and Orphan Drug designations, positioning the program for a potential Priority Review Voucher and accelerated approvals in multiple markets. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) met every primary endpoint in its Phase 2 trial of SLS009 in relapsed/refractory acute myeloid leukemia-myelodysplasia-related changes (AML MR), delivering a 44% overall response rate at the optimal 30 mg twice‑weekly dose and a median overall survival of 8.9 months—far above the 2.4 month historical benchmark. The CDK9 inhibitor also showed a 50% response rate in high‑risk ASXL1‑mutated and M4/M5 subgroups, with no dose‑limiting toxicities reported. "We are excited to report that our Phase 2 trial met all key endpoints, with clinical responses and survival outcomes that exceed targeted expectations and historical benchmarks," said Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS. "AML remains an area of urgent unmet medical need, particularly for patients with relapsed or refractory disease, where standard treatments are often ineffective and poorly tolerated. What sets SLS009 apart is its consistent efficacy across a broad range of molecular subtypes." Following FDA guidance, the company will launch an 80‑patient randomized study in newly diagnosed first‑line AML by Q1 2026 to support a potential New Drug Application. DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. 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Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. 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