Latest news with #solidtumors
Yahoo
3 days ago
- Business
- Yahoo
Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)
Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3 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 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@ Anne Marie FieldsPrecision AQ (formerly Stern IR)E: Media:Matt WrightNWR CommunicationsP: +61 451 896 420E: matt@ Follow Radiopharm Theranostics: Website – X – – –
Yahoo
17-07-2025
- Business
- Yahoo
BioAtla Announces Upcoming Oral Presentation at the 2025 European Society for Medical Oncology (ESMO) TAT Asia Meeting
SAN DIEGO, July 17, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB) (the 'Company' or 'BioAtla'), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced an oral presentation at the upcoming 2025 European Society for Medical Oncology (ESMO) TAT Asia Meeting to be held in Hong Kong Sar, China from July 18–20, 2025. Oral Presentation Details: Title: First-in-human phase I study of a dual-Conditionally Active Biologic (CAB) EpCAM x CD3 bispecific T-cell engager (TCE), BA3182, in patients with treatment refractory metastatic adenocarcinoma Authors: Jennifer B. Brooke Valerin, Jacob Thomas, J. Eva E. Selfridge, Madison Conces, Devalingam Mahalingam, Michael Cecchini, Elena G. Chiorean, Oana Danciu, Kyechin Chen, Ana Paula G. Cugnetti, Judith Llorin-Sangalang, Kartik Aysola, Alexander Starodub Presenter: Jennifer B. Brooke Valerin Presentation Number: 36O Date and Time: July 18, 2025 from 15:59‒16:06 GMT+8 A copy of the presentation materials can be accessed on the 'Publication' section of the Company's website at once the presentation has concluded. About BioAtla®, Inc. BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB platform technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB platform technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets includes methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. To learn more about BioAtla, Inc., visit Internal Contact: Richard Waldron Chief Financial Officer BioAtla, Inc. rwaldron@ 858.356.8945 External Contact: Mike Moyer LifeSci Advisors, LLC mmoyer@ in to access your portfolio
Yahoo
17-07-2025
- Business
- Yahoo
Repare Therapeutics Jumps 15% After $10M Licensing Deal With Debiopharm
Repare Therapeutics (RPTX, Financials) shares surged 15% Tuesday after the company announced a global licensing agreement with Switzerland-based Debiopharm to develop its PKMYT1 inhibitor, lunresertib a drug targeting hard-to-treat solid tumors. Warning! GuruFocus has detected 5 Warning Signs with RPTX. Under the deal, Repare will receive $10 million upfront and could earn up to $257 million in milestone payments, including $5 million in near-term payouts. The company is also entitled to single-digit royalties on future global sales of lunresertib. Debiopharm will now take over the MYTHIC study and lead all development efforts for the drug, which had previously been tested in combination with Debiopharm's own WEE1 inhibitor, Debio 0123. This deal ensures lunresertib continues development without draining internal resources, said Repare CEO Steve Forte, who also serves as president and CFO. Forte added that the drug has shown "encouraging results" in early trials. Following the deal, Repare plans to concentrate on two internal programs: RP-1664, a PLK4 inhibitor under study in the LIONS trial RP-3467, a Pol? ATPase inhibitor being tested in the POLAR trial The company expects data readouts from both studies in H2 2025. Debiopharm CEO Bertrand Ducrey called the combination of lunresertib and Debio 0123 highly synergistic and potentially capable of producing rapid and deep tumor regressions. This article first appeared on GuruFocus. 擷取數據時發生錯誤 登入存取你的投資組合 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤
Yahoo
25-06-2025
- Business
- Yahoo
H.C. Wainwright Sticks With Bullish Call on Summit Therapeutics, $44 Target
H.C. Wainwright isn't backing off Summit Therapeutics (NASDAQ: SMMT). On June 2, the firm reaffirmed its Buy rating and maintained a $44 price target, more than double the current $18.21 share price. Analyst targets for the stock now range between $30 and $44.15, with a strong Buy consensus across the board. At a market cap of $13.5 billion, Summit has the attention of the street. The reason is Ivonescimab. It's Summit's checkpoint inhibitor drug, and Wainwright believes it could end up setting a new standard in treating solid tumors. They focused on recent HARMONi trial results. It's not statistically significant on overall survival, but strong enough on other metrics to keep hopes high. A close up of a lab technician in a protective suit, working with cells in a petri dish to develop innovative therapeutics for immune-related diseases. In particular, they pointed to ivonescimab's progression-free survival hazard ratio of 0.52 when paired with chemo. That compares favorably to the 0.8 seen with Merck's KEYTRUDA in the KEYNOTE-789 trial for the same cancer type—TKI-resistant, EGFR-mutated non-small cell lung cancer. Despite a 30% drop in the stock in the week prior to the price target update, triggered by disappointment over survival stats, Wainwright argued the market is missing the point. No competing drug has hit statistical significance either. They also noted Summit's beta sits at -0.95, which means it tends to move opposite the market, which is something investors might want to consider. While we acknowledge the potential of SMMT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
25-06-2025
- Business
- Yahoo
H.C. Wainwright Sticks With Bullish Call on Summit Therapeutics, $44 Target
H.C. Wainwright isn't backing off Summit Therapeutics (NASDAQ: SMMT). On June 2, the firm reaffirmed its Buy rating and maintained a $44 price target, more than double the current $18.21 share price. Analyst targets for the stock now range between $30 and $44.15, with a strong Buy consensus across the board. At a market cap of $13.5 billion, Summit has the attention of the street. The reason is Ivonescimab. It's Summit's checkpoint inhibitor drug, and Wainwright believes it could end up setting a new standard in treating solid tumors. They focused on recent HARMONi trial results. It's not statistically significant on overall survival, but strong enough on other metrics to keep hopes high. A close up of a lab technician in a protective suit, working with cells in a petri dish to develop innovative therapeutics for immune-related diseases. In particular, they pointed to ivonescimab's progression-free survival hazard ratio of 0.52 when paired with chemo. That compares favorably to the 0.8 seen with Merck's KEYTRUDA in the KEYNOTE-789 trial for the same cancer type—TKI-resistant, EGFR-mutated non-small cell lung cancer. Despite a 30% drop in the stock in the week prior to the price target update, triggered by disappointment over survival stats, Wainwright argued the market is missing the point. No competing drug has hit statistical significance either. They also noted Summit's beta sits at -0.95, which means it tends to move opposite the market, which is something investors might want to consider. While we acknowledge the potential of SMMT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
