The FDA has placed a clinical hold on a Phase I/II trial for HPV-related cancers of Advaxis' axalimogene filolisbac in combination with Imfinzi after a patient died due to respiratory failure but analysts at Jefferies believe the fault could lie with AstraZeneca's PD-L1 inhibitor.
Advaxis Inc. stock has taken a battering following the news that the FDA has placed a clinical hold on a Phase I/II trial of axalimogene filolisbac in combination with AstraZeneca PLC's PD-L1 inhibitor Imfinzi (durvalumab) to treat human papillomavirus (HPV)-related cancers after a patient death, although the US biotech does not believe its drug was the cause.
Shares in Advaxis fell 22% to $1.72 in after-hours trading March 12 after the company revealed that it received notification...
Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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