Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)
On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25
SYDNEY, July 28, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company's Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues.
'FDA clearance to initiate our first-in-human Phase 1 clinical trial of RV-01 represents a major milestone for Radiopharm Theranostics and our joint venture with MD Anderson Cancer Center,' said Riccardo Canevari, CEO and Managing Director. 'RV-01 is the first monoclonal antibody developed through this collaboration, and we believe it has the potential to become a highly differentiated radiopharmaceutical for patients with aggressive solid tumors. We are excited to advance this program into the clinic and anticipate dosing the first patients later this year.'
'Recent reported preclinical studies demonstrated that RV-01 exhibits hepatic clearance, allowing the isotope sufficient time to effectively target tumors while potentially minimizing adverse effects such as hematological toxicities. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver—an organ known for its radio-resistance. This characteristic, combined with the shortened half-life of RV-01 and the strong affinity for the target make this agent stand out and may offer a significant advantage not just over other monoclonal antibodies but also targeted radiotherapeutics with renal excretion pathway, the latter of which are often associated with higher risk of radiopharmaceutical-induced kidney toxicity,' noted Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.
'The high affinity and selectivity of RV-01 for the 4Ig isoform of B7H3 allows the antibody to bypass the soluble 2Ig isoform in the blood, boost binding of the radiopharmaceutical to tumor targets and avoid the formation of immune complexes in circulation,' noted David Piwnica-Worms, M.D., Ph.D., Professor, MD Anderson Cancer Center, and scientific co-founder of Radiopharm Ventures.
B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is consistently correlated with enhanced tumor aggressiveness and poor clinical outcomes. Targeting the 4 Ig isoform of B7-H3 with a selective radioligand therapy may offer a novel strategy for treating refractory or high-risk tumors.
About RV-01
RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and MD Anderson Cancer Center (MDACC). RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. RV-01 has received IND-clearance from the U.S. FDA and plans to initiate a first-In-human Phase 1 study in the second half of 2025.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: rc@radiopharmtheranostics.com
Anne Marie FieldsPrecision AQ (formerly Stern IR)E: annemarie.fields@precisionaq.com
Media:Matt WrightNWR CommunicationsP: +61 451 896 420E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics: Website – https://radiopharmtheranostics.com/ X – https://x.com/TeamRadiopharmLinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/InvestorHub – https://investorhub.radiopharmtheranostics.com/
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
2 hours ago
- Business Wire
ZIPS Car Wash Celebrates Lexington Remodels with Free Washes
LEXINGTON, Ky.--(BUSINESS WIRE)--Join ZIPS Car Wash this week as they partner with the local chambers to unveil upgraded locations across Lexington with ribbon cutting ceremonies, free car washes and free ZIPS swag. Plus, ZIPS will honor local heroes and their families with academic scholarships through their national partnership with Folds of Honor. 'We're proud to spend 2025 updating locations across the country, implementing improved team member training, and engaging with the communities we serve- all in an effort to deliver the excellent car wash experience that our customers deserve,' said Pete Nani, CEO, ZIPS Car Wash. 'Our Lexington locations are the first of 35 stores receiving upgrades and we welcome back our loyal fans to try the new ZIPS experience today,' he added. Ribbon Cutting Ceremonies: Wednesday, July 30th 11am Ribbon Cutting Ceremony with Commerce Lexington ZIPS Car Wash, 440 New Circle Road in Lexington ZIPS is offering free car washes at these upgraded locations on July 30th: 2320 Grey Lag Way in Lexington 440 New Circle Rd in Lexington 2576 Richmond Rd in Lexington Thursday, July 31st 10am Ribbon Cutting Ceremony with Jessamine Chamber of Commerce ZIPS Car Wash Nicholasville, 130 Marlene Drive Free car washes all day at this location on July 31st 'Our teams and vendor partners have worked extensively to upgrade the interior and exterior of four Lexington locations, bringing together an overall improved customer experience for the greater Lexington community,' said Rebecca Latacz, Chief Marketing Officer, ZIPS Car Wash. 'We want the local community to experience the upgrades and enjoy a free car wash on us – we believe you'll see a new shine in our products and services,' she added. ZIPS is proud to partner with Folds of Honor again this year with a 2025 donation goal of $100,000. In 2024, ZIPS and its loyal customers donated over $92,000 to Folds of Honor to drive academic scholarships to military and first responder families. On Wednesday, ZIPS will recognize three local students who will be awarded $500 scholarships through ZIPS' partnership with Folds of Honor at the Ribbon Cutting: Sydney Li Breeze of Lexington, Anthony James "AJ" Swift of Hodgenville, and Stephen Paul Whitehead of Berea. Gabriela Renee Palomo of Vine Grove will be recognized at the Nicholasville Ribbon Cutting Ceremony on Thursday. Sydney is a Sophomore at Ashbury University majoring in Exercise Science. Sydney hopes to become a Physical Therapist and to facilitate the healing process for clients. She enjoys soccer, church, and family time. AJ is a Sophomore at Campbellsville University majoring in Exercise Science/Physical Therapy. AJ's goal is to graduate with his Doctorate in Physical Therapy and work with athletes. He enjoys fishing, kayaking, soccer, and being outdoors. Stephen attends the University of Kentucky majoring in Biology on a pre-med track. Stephen wants to become a pediatrician. Gabriela is a Freshman at the University of Kentucky - Lewis Honors College. She is majoring in Human Health Services. Gabriela intends to go to medical school and become an OB/GYN. She enjoys participating in girls' wrestling, marching band, and student office. ZIPS customers can make a difference for Folds of Honor families by purchasing a car wash and adding a $1, $3, or $5 Folds of Honor donation to their wash purchase at any ZIPS location or in the ZIPS mobile app. The ZIPS Car Wash app is available for free download from the App Store on IOS and the Google Play Store on Android and is packed with benefits for ZIPS customers including app-exclusive deals on single wash purchases, birthday bonuses, and many more app-only contests and offers. About ZIPS Car Wash ZIPS Car Wash, headquartered in Plano, Texas, is a privately held car wash operator, with over 200 locations across 20 states under three brands: ZIPS Car Wash, Rocket Express Car Wash, and Jet Brite Car Wash. With 20 years of car washing experience, ZIPS prides itself on providing the highest quality express tunnel car wash in the industry. ZIPS uses the latest industry technology to provide a clean, dry, and shiny vehicle, exceptional customer experiences and value through loyalty rewards in the innovative ZIPS Car Wash mobile app. The ZIPS team aims to positively impact the communities we live and serve in through key partnerships with schools, military non-profit organizations and community leaders. To learn more visit About Folds of Honor Folds of Honor is a 501(c) (3) nonprofit organization that provides educational scholarships to the spouses and children of US military service members and first responders who have fallen or been disabled while serving our country and communities. Our educational scholarships support private school tuition or tutoring in grades K-12, tuition for college, technical or trade school and post-graduate work, including a master's degree, doctorate, or professional program. Funds for a second bachelor's degree or trade/technical program certification are also available. Since its inception in 2007, Folds of Honor has awarded nearly 62,000 scholarships totaling about $290 million in all 50 states. Among the students served, 45 percent are minorities. A total of 91 percent of expenses fund our mission of providing educational scholarships to the families of our nation's heroes. It is rated a four-star charity by Charity Navigator and Platinum on Candid. It was founded by Lt Col Dan Rooney, the only-ever F-16 fighter pilot (with three combat tours in Iraq) and PGA Professional. He is serving as Commander of Recruiting for the Oklahoma Air Guard. For more information or to donate in support of a Folds of Honor scholarship visit
Yahoo
5 hours ago
- Yahoo
SIGA to Host Business Update Call on August 5, 2025 Following Release of Second-Quarter 2025 Results
NEW YORK, July 29, 2025 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (Nasdaq: SIGA), a commercial-stage pharmaceutical company, today announced that management will host a webcast and conference call to provide a business update at 4:30 P.M. ET on Tuesday, August 5, 2025. Participating in the call will be Diem Nguyen, Chief Executive Officer, and Daniel Luckshire, Chief Financial Officer. A live webcast of the call will also be available on the Company's website at in the Investor Relations section of the site, or by clicking here. Please log in approximately 5-10 minutes prior to the scheduled start time. Participants may access the call by dialing 1-800-717-1738 for domestic callers or 1-646-307-1865 for international callers. A replay of the call will be available for two weeks by dialing 1-844-512-2921 for domestic callers or 1-412-317-6671 for international callers and using Conference ID: 1130215. The archived webcast will be available in the Investor Relations section of the Company's website. About SIGA SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on orthopoxviruses, we are dedicated to protecting humanity against the world's most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. Our flagship product, TPOXX® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe, the UK, and Japan for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. For more information about SIGA, visit Contacts:Suzanne Harnettsharnett@ and Investors Media Jennifer Drew-Bear, Edison GroupJdrew-bear@ Holly Stevens, CG Lifehstevens@
Yahoo
5 hours ago
- Yahoo
Boeing posts smaller loss as jet deliveries rise
(Reuters) -Boeing reported a smaller second-quarter loss on Tuesday as the U.S. planemaker ramped up jet production and deliveries, recovering from a regulatory crisis and a major strike that halted most production last year. Shares of the company rose 1.5% in premarket trading. After years of grappling with quality issues and production delays on its flagship 737 MAX, Boeing has cautiously ramped up monthly output this year. In May, the company produced 38 737s. Production has been stable since then, according to the company. "As we continue to execute our Safety & Quality Plan, there's more stability in our operations," CEO Kelly Ortberg said in a letter to Boeing employees on Tuesday. The U.S. Federal Aviation Administration had capped the production of Boeing's best selling 737 MAX jets following a mid-air panel blowout in a nearly new jet in January 2024. "We plan to seek FAA approval to increase to rate 42 when our key performance indicators (KPIs) show that we're ready," Ortberg added. It has delivered 206 737 MAX jets through the first half of the year. Wall Street closely tracks aircraft deliveries, because planemakers collect much of their payment when they hand over jets to customers. Boeing also increased 787 production at its plant in Charleston, South Carolina, from five aircraft a month to seven a month. Through the first half of the year, the planemaker has booked 668 orders, or 625 net orders after cancellations and conversions. An improvement in deliveries marks a pivotal step in Boeing's effort to rebound from years of production disruptions and crises that piled on debt, highlighting the urgency of accelerating output to restore financial stability. The planemaker posted a net loss of $612 million, or 92 cents per share, for the quarter through June, compared with $1.44 billion, or $2.33 per share, a year earlier. However, the planemaker continues to face pressure from supply chain disruptions that have delayed production and limited its ability to meet surging aerospace demand. It posted a loss of nearly $12 billion in 2024 due to challenges across its major business units including charges on its defense programs. It also remains exposed to U.S. President Donald Trump's sweeping tariffs, which could increase parts costs and further strain an already fragile supply chain. Boeing's revenue for the quarter through June rose 35% to $22.75 billion. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
