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US FDA grants Orphan Drug Designation to THE001 for the treatment of soft tissue sarcomas (STS)

“We see the U.S. Orphan Drug Designation as a strong regulatory validation of the potential of our innovative approach in soft tissue sarcoma,” said Dr. Pascal Schweizer, co-founder and CEO/CFO of Thermosome. “This recognition, based on preclinical and early clinical data from our Phase 1 study, marks an important milestone and is a further step into the U.S. market – the world’s most important market for patent-protected drugs. In parallel, we are evaluating strategic partnerships to advance THE001 and fully realize its therapeutic potential.”

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Ph 2 Trial evaluating the efficacy and safety of Lutetium (177Lu) rhPSMA-10.1 Injection initiated in metastatic CRPC

David Gauden DPhil, CEO of Blue Earth Therapeutics said, “This is an important step forward in the development of Lutetium (177Lu) rhPSMA-10.1 injection and builds on the strong data seen in the Phase 1 clinical trial. Commencement of treatment of patients at full intended therapeutic dosing levels provides a great

Enhertu followed by THP before surgery showed statistically significant pCR improvement high-risk HER2-positive early-stage breast cancer patients in DESTINY-Breast11 Ph 3 trial

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The clinically meaningful improvement in pathologic complete response and the safety data seen in DESTINY-Breast11 highlight the potential of Enhertu to challenge the current standard of care in early-stage HER2-positive breast cancer. Enhertu is already an important treatment option in

IND Clearance obtained for Ph 1b/2 Trial of LP-184 + ICIs in NSCLC patients with KEAP1 and/or STK11 mutations and low PD-L1 expression

“This clinical trial and the FDA clearance represents a pivotal milestone in our mission to develop precise, data-driven cancer therapies for patients with limited treatment options,” said Panna Sharma, President and CEO of Lantern Pharma. “The STK11 and KEAP1 mutant NSCLC population represents an important market opportunity and, a group

First Patient Dosed in STARt-002 Trial of Invikafusp Alfa in Combination with Trodelvy® in Metastatic Breast Cancer

“The growing body of evidence supporting combinations of ADCs and immunotherapies is encouraging, including the recent success of the ASCENT-04 trial combining sacituzumab govitecan with pembrolizumab in metastatic TNBC,” said Steven Isakoff, M.D., Ph.D., Medical Oncologist and Director of Breast Cancer Clinical Research at Massachusetts General Hospital. “Invikafusp alfa is

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Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is part of RLS Consultants, a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.