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CBC
an hour ago
- Business
- CBC
B.C. to open 18 long-term involuntary care beds in Metro Vancouver
The British Columbia government has created 18 new beds dedicated to long-term involuntary care at a Metro Vancouver mental health facility. The new beds at Alouette Homes in Maple Ridge, B.C., are designed for people who need involuntary care under the Mental Health Act outside the criminal justice system, Health Minister Josie Osborne told a news conference on Tuesday. "I want to be clear that while Alouette Homes is located next to the Alouette Correctional Centre, it is not the same as the involuntary care beds that were opened last month at the Surrey Pretrial Services Centre," Osborne said. "Those were beds designed specifically for individuals in custody, but Alouette Homes is different. It's for people living with complex mental health disorders who need long-term therapeutic care in a supportive home-like environment." WATCH | The CEO of the Canadian Mental Health Association's B.C. division discusses involuntary care: Who gets admitted to involuntary care spaces? Mental health advocate calls for transparency 2 hours ago Duration 2:38 B.C. Health Minister Josie Osborne says the new 'home-like' involuntary care space at Alouette Homes in Maple Ridge is designed for individuals who are certified for long-term involuntary care under B.C.'s Mental Health Act. Jonny Morris, the CEO of the Canadian Mental Health Association's B.C. division, tells BC Today host Michelle Eliot the province needs to be precise about who qualifies for this kind of care — whether it's people who are taken off the streets or those already in the system but need a more suitable alternative. Osborne said only those certified for long-term involuntary care are eligible to be placed into the new beds. Dr. Daniel Vigo, B.C.'s chief scientific adviser for psychiatry, toxic drugs and concurrent disorders, said the care offered by Alouette Homes will be the first of its kind in the province. Vigo said the beds provide an alternative to the current setup, where patients are "stuck in high-security hospital units indeterminately" because of a lack of options. When asked about how long a patient may stay in long-term involuntary care, Vigo said the time period is "indeterminate." "It takes as long as it takes for us to help that person," he said. "This is an approved home, meaning that it is a housing facility that will provide this service in an open-ended manner." The first people to use the new beds will move in as early as next week, Osborne said. The move comes after the province announced the opening of a 10-unit involuntary-care facility for people with addiction and mental health issues at the Surrey Pretrial Centre in April. The Surrey facility is meant to treat people in custody who have a combination of mental health challenges, brain injuries and addiction concerns. B.C. Premier David Eby said at the time that the unit was meant to stop people from continually cycling through the justice system without getting better. The topic of involuntary care for those suffering from drug addiction, mental illness and brain injuries has been contentiously debated due to its links to both the ongoing toxic drug crisis and public safety concerns. In addition to B.C., Ontario is also pursuing expanded involuntary treatment, while Alberta has introduced legislation that would allow family members, health workers and police to apply to order someone into addictions treatment. On Wednesday, the federal health minister, Marjorie Michel, said there is no evidence that forcing people into treatment is effective. But Michel did not weigh in on whether provinces should pursue such policies, saying every Canadian has the right to get treatment for addiction. Osborne said the B.C. government was reviewing the Mental Health Act to identify possible service gaps and potential solutions. Bonnie Wilson, a vice president with Vancouver Coastal Health, said, referrals would be considered for patients from outside the region to use the new beds. While Wilson could not share specific details about the patients who would be eligible for long-term involuntary care, she provided a "composite" of characteristics that would likely qualify. "Just think about a young individual who has been struggling with mental health for a number of years," Wilson said. During his final exams, he began to hear voices in his head encouraging him to end his life. After a suicide attempt, he had his first extended stay in hospital at the age of 19. "Between then and now, he went through many, many parts of our health-care system and also, like many people with mental illness, started to self-medicate with street drugs," she said. Wilson said the new beds would provide such a patient with "an opportunity to be in a more natural environment" after years spent in and out of hospital.
Yahoo
a day ago
- Business
- Yahoo
ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI343 (Novel Anti-CLDN18.2 ADC) From the Phase 1 Clinical Study in Patients with Advanced Pancreatic Cancer
SAN FRANCISCO and SUZHOU, China, June 2, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, updated the Phase 1 study results of IBI343, a novel anti-CLDN18.2 ADC, for the treatment of advanced pancreatic cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. With extended follow-up and more mature data on progression-free survival (PFS) and overall survival (OS), IBI343 has demonstrated promising therapeutic efficacy in patients with CLDN18.2-positive advanced pancreatic cancer. These encouraging results suggest the potential of IBI343 in this challenging-to-treat malignancy. Supported by these robust clinical findings, IBI343 has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA). Concurrently, the Phase 1 clinical trial of IBI343 is also being conducted in the United States, where the drug candidate has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). Pancreatic cancer is one of the most aggressive malignancies worldwide. Most patients are diagnosed in the middle and late stages and often develop resistance to standard chemotherapy, resulting in a 5-year survival rate of less than 10%1. According to the GLOBOCAN 2022 statistics2, there are approximately 510,000 new cases and 467,000 deaths globally from pancreatic cancer each year, with China accounting for 120,000 new cases and 110,000 deaths annually. This Phase 1/1b study is a multi-regional, dose escalation and expansion clinical trial (NCT05458219). Preliminary data were presented at ASCO 2025 and ESMO Asia 2024 and the updated results from the study's dose-expansion cohort were presented at the 2025 ASCO as follows: As of March 14, 2025, a total of 83 patients with pancreatic cancer had received at least one dose of IBI343 with a median follow-up time of 11.1 months. As the data cutoff date, in patients with CLDN18.2 1+2+3+≥60% expression treated at the 6mg/kg dose (N=44), the confirmed overall objective response rate (cORR) was 22.7% and the disease control rate (DCR) was 81.8%. The median progression-free survival (mPFS) was 5.4 months, and the median overall survival (mOS) was 9.1 months. Among them, 17 patients had received only one line of prior treatment, achieving a mPFS of 5.4 months and a mOS of 12.1 months; and 18 patients had received two lines of prior treatment, the mPFS was 5.3 months and the mOS was 9.1 months. The updated safety results demonstrated the favorable safety profile of IBI343 with a consistently low rate of gastrointestinal toxicity and no new safety signals. 98.8% of the patients experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, neutrophil count decreased, and white blood cell count decreased. Notably, no ≥ grade 3 nausea and vomiting occurred. Professor Xianjun Yu from Fudan University Cancer Hospital, said, "Pancreatic cancer is one of the most malignant tumors of the digestive tract. Most patients are already in the advanced stage when diagnosed, and the 5-year survival rate is only about 10%1. Currently, chemotherapy is still the main first- and second-line treatment for advanced pancreatic cancer. The clinical options for second-line treatment are particularly limited, with a chemotherapy response rate of only 6-16%, median progression free survival of 2 to 5 months, and a median survival of approximately 6 to 9 months3, representing an urgent clinical need. With longer follow-up, the mature PFS and OS data from the latest IBI343 update demonstrate promising therapeutic potential, suggesting a breakthrough in this difficult-to-treat malignancy." Dr. Hui Zhou, Senior Vice President of Innovent, said, "We are pleased to present an oral update on IBI343's clinical data at this year's ASCO conference. With the unique Fc-silent antibody design, stable linker and potent TOPO1i payload, IBI343 is the first ADC candidate to show encouraging efficacy and a favorable safety profile in the treatment of advanced pancreatic cancer. We hope to continue advancing the clinical trials of IBI343 for pancreatic cancer patients. Innovent will leverage its unique strengths in R&D innovation and clinical translation to develop a new generation of globally competitive oncology - focused innovative pipeline to benefit patients worldwide.." About IBI343（Anti-CLDN18.2 ADC） IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect". As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancer. The Phase 3 trial of IBI343 for advanced gastric / gastroesophageal junction adenocarcinoma is now recruiting patients. The relevant indication has been included in China's NMPA breakthrough therapy list. IBI343's Phase 1 trial for advanced pancreatic ductal adenocarcinoma is enrolling patients in an multi-regional study. This indication has received Fast Track designation from the FDA and been included in the NMPA's BTD list. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit or follow Innovent on Facebook and LinkedIn. Statement: 1. Innovent Biologics does not recommend the use of unapproved drugs/indications. 2. Ramucirumab injection (Ciranza®), selpercatinib capsules (Ritu®) and pirtobrutinib tablets (Capra®) were developed by Eli Lilly and Company Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References 1 Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33. doi: 10.3322/caac.21708. 2 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. 3 Jemal A, Bray F, Center MM, et al. Global cancer stastics. CA Cancer J Clin, 2011, 61(2): 69-90. View original content: SOURCE Innovent Biologics
Yahoo
a day ago
- Business
- Yahoo
CirCode Biomed gains clearance from FDA for RNA drug HM2002
CirCode Biomed's circular RNA drug HM2002 has received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) for the treatment of ischaemic heart disease. HM2002 has also been approved by China's National Medical Products Administration (NMPA) in January 2025. This global endorsement allows CirCode to conduct clinical studies in patients suffering from ischaemic heart disease. HM2002 offers several advantages due to its composition of circular RNAs, which provide improved stability and low immunogenicity. The drug is designed to safely and continuously express vascular endothelial growth factor (VEGF) within the myocardium. This mechanism promotes angiogenesis, enhances myocardial perfusion and aids in recovering cardiac function. CirCode CEO Dr Chenxiang Tang stated: 'To promote angiogenesis and relieve ischaemia through VEGF overexpression is a well-tested solution, but there is a tremendous challenge to achieve an efficient, persistent and controllable expression of VEGF in vivo. 'A single dose of HM2002 can express VEGF protein for a perfect time window in vivo: long enough for efficient angiogenesis, short enough for any safety concerns. Once the microcirculation is reformed, it brings long-lasting benefits to patients without the presence of HM2002 or VEGF protein.' Preclinical studies have shown that HM2002 demonstrates safety and efficacy profiles. In a first-in-human investigator-initiated trial commenced at Ruijin Hospital, China, in 2024, all subjects exhibited significant improvements in cardiac function without any reported adverse events. CirCode co-founder, chairman and chief technology officer Yun Yang stated: "CirCode's robust, proprietary circular RNA platform laid the foundation for the fast IND approval of HM2002. With the help of our AI tools, we were able to leap from a concept to IND approval of HM2002 in less than two years. 'We have now built a strong pipeline portfolio in various fields such as therapeutic proteins, vaccines and in vivo CAR-T, covering multiple therapeutic areas such as cardiovascular diseases, infectious diseases, autoimmune diseases and oncology.' "CirCode Biomed gains clearance from FDA for RNA drug HM2002" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
4 days ago
- Business
- Yahoo
CirCode Biomed Announces FDA Clearance for IND Application of HM2002, the world's first circular RNA drug being administrated in patients
SHANGHAI, May 30, 2025 /PRNewswire/ -- Shanghai CirCode Biomed Co. Ltd. (CirCode), an innovative biotech company pioneering circular RNA therapies, recently announced that its leading pipeline HM2002 received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for ischemic heart disease on May 30, 2025. With the first patient administrated on September of 2024 in an investigator initiated trial (IIT), HM2002 is the world's first circular RNA drug ever being used in patients. It received IND approval from the National Medical Products Administration (NMPA) of China on January 10th, 2025. HM2002 is currently the first circular RNA therapy to receive IND clearance in both China and the United States, and is also the only circular RNA drug globally approved for clinical study on patients with ischemic heart disease. With the global aging population, ischemic heart disease shows a steadily rising incidence, and has been the leading cause of death globally for the past decades. The current standard of care shows limited effects in promoting myocardial microcirculation reconstruction and angiogenesis, leading to suboptimal efficacy and limited benefit in 10-year survival. There is an urgent unmet medical need for next generation therapies to improve patients' prognosis and quality of life. With the advantages of improved stability and low immunogenicity from circular RNAs, HM2002 can safely and continuously express vascular endothelial growth factor (VGEF) in the myocardium, which promotes angiogenesis, improves myocardial perfusion, and facilitates cardiac function recovery. It has demonstrated excellent safety and efficacy in the preclinical studies. In the first-in-human IIT at Ruijin Hospital initiated last year, all subjects showed significant cardiac function improvement without any drug-related adverse events. "To promote angiogenesis and relief ischemia through VEGF overexpression is a well-tested solution, but there is a tremendous challenge to achieve an efficient, persistent, and controllable expression of VEGF in vivo. We find an excellent match between the need and the properties of circular RNA. A single dose of HM2002 can express VEGF protein for a perfect time window in vivo: long enough for efficient angiogenesis, short enough for any safety concerns. Once the microcirculation reformed, it brings long-lasting benefits to patients without the presence of HM2002 or VEGF protein," said Dr. Chenxiang Tang, CEO of CirCode. "The IND clearances from both NMPA and FDA for HM2002 is a strong recognition for our innovation and competitiveness in the circular RNA therapeutic industry. Dr. Yun Yang, co-founder, chairman, and chief technology officer of CirCode, stated that, "CirCode's robust, proprietary circular RNA platform laid the foundation for the fast IND approval of HM2002. With the help of our AI tools, we were able to leap from a concept to IND approval of HM2002 in less than 2 years. We now have built a strong pipeline portfolio in various fields such as therapeutic proteins, vaccines, and in vivo CAR-T, covering multiple therapeutic areas such as cardiovascular diseases, infectious diseases, autoimmune diseases, and oncology. These pipelines have showed a favorable risk benefit profile with great efficacy and safety data in preclinical settings, many of which will enter the clinical stage within the next year. We are so excited to keep pushing the frontier of circular RNA therapy forward and providing more innovative therapies for patients." About CirCode CirCode is a clinical-stage biotechnology company specializing in circular RNA therapeutics. Leveraging strong science and deep know-how, the company has built a fully integrated and proprietary platform, protected by a comprehensive global patent network, paving the way for the development of circular RNA therapeutics. Focusing on unmet medical needs, CirCode has built a robust pipeline targeting vaccines, cardiovascular diseases, autoimmune disorders, and oncology. CirCode is backed by top-tier investors and has received strong recognitions from leading pharmaceutical companies. Circode is committed to promoting the transformation of scientific and technological achievements and realizing the benefit of science and technology for mankind. More information please visit Or contact info@ for business cooperation. View original content to download multimedia: SOURCE Shanghai CirCode Biomed Co. Ltd. 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
Yahoo
6 days ago
- Business
- Yahoo
Enveric Biosciences announces results from EB-003 trial
Enveric Biosciences (ENVB) announced preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions. These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on ENVB: Disclaimer & DisclosureReport an Issue Psychedelic: atai Life Sciences reports Phase 2a study data on BPL-003 Enveric Biosciences files new provisional patent application VA secretary wants to find answers on psychedelics therapies, Politico says Psychedelic: Atai, Enveric, Incannex and Relmada report quarterly results Psychedelic: Enveric, Filament Health report earnings results
