Latest news with #clinicaltrial
Yahoo
4 hours ago
- Business
- Yahoo
4DMT Announces Presentations at 43rd Annual Scientific Meeting of the American Society of Retina Specialists
EMERYVILLE, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced podium presentations at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) being held in Long Beach, CA, from July 30 – August 2, 2025. ASRS 2025 Presentation Details: Title: Interim Results from the SPECTRA Phase 2a Clinical Trial Evaluating Intravitreal 4D-150 in Adults with Diabetic Macular Edema* Date/Time: Thursday, July 31, 2025 (11:35 – 11:38 a.m. PT) Presenter: David Almeida, MD, MBA, PhD, DABO, FRCSC, FASRS, Erie Retina Research, PA *Includes 52-week primary endpoint analysis and 60-week analysis (all patients have reached 60 weeks as of the data cutoff date of May 2, 2025) Title: PRISM Phase 2b Clinical Trial Evaluating Intravitreal 4D-150 in Adults with Neovascular Age-related Macular Degeneration: 52-week Results Date/Time: Friday, August 1, 2025 (11:24 – 11:27 a.m. PT) Presenter: John A. Wells, MD, FACS, Palmetto Retina Center, SC The presentations will also be available on the 4DMT website: About 4DMT 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of the Company's product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company's product candidates for the therapeutic uses for which they are being studied. Learn more at and follow us on LinkedIn. Contacts: Media: Jenn Gordondna CommunicationsMedia@ Investors: Julian PeiHead of Investor Relations and Corporate 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
Reuters
8 hours ago
- Health
- Reuters
AstraZeneca's immune disorder drug succeeds in late-stage trial
July 24 (Reuters) - AstraZeneca (AZN.L), opens new tab said on Thursday its experimental therapy gefurulimab met the main goal of a late-stage study looking into improving symptoms of a chronic, autoimmune condition known as generalised myasthenia gravis in adults.
Yahoo
13 hours ago
- Business
- Yahoo
Akeso Announces First Patient Enrolled in the Phase III Trial（AK112-312/HARMONi-GI6）of Ivonescimab for First-Line Treatment of Advanced Metastatic Colorectal Cancer
HONG KONG, July 15, 2025 /PRNewswire/ -- Akeso, Inc. ( ("Akeso" or the "Company") is pleased to announce that the first patient has been successfully enrolled in the registration Phase III clinical trial (AK112-312/HARMONi-GI6) of ivonescimab in first-line treatment for advanced metastatic colorectal cancer (mCRC). This randomized, controlled, multi-center Phase III clinical trial for first-line treatment of mCRC is one of the company's key initiatives to address the significant unmet clinical need worldwide with ivonescimab. Colorectal cancer remains the third most common cancer globally and the second leading cause of cancer-related deaths. In 2022, over 1.9 million new cases were reported, with approximately 904,000 deaths. Of these, about 95% of mCRC cases are classified as microsatellite stable (MSS) or proficient mismatch repair (pMMR), which traditionally show poor responses to immunotherapy and the tumors are often referred to as an "immune desert." For first-line treatment of MSS/pMMR-type mCRC, which represents up to 95% of cases, several PD-1/L1 inhibitors have been explored in multiple international studies. However, the efficacy has been limited, and as of now, no first-line immunotherapy has been approved globally for patients with pMMR/MSS-type mCRC. Chemotherapy combined with targeted therapies (such as bevacizumab, cetuximab, etc.) remains the standard first-line treatment for mCRC, though its overall efficacy is limited, with a five-year survival rate for advanced patients of less than 20%. Bevacizumab is the most well-established and clinically impactful treatment in the mCRC space. It is also one of the core indications of bevacizumab. At the 2024 European Society for Medical Oncology (ESMO) Congress, Professor Yanhong Deng from the Sixth Affiliated Hospital of Sun Yat-sen University, presented promising Phase II efficacy data of ivonescimab in combination with chemotherapy for first-line treatment of MSS/pMMR-type mCRC. The combination of ivonescimab with FOLFOXIRI demonstrated compelling anti-tumor activity in this hard to treat patient population, with an overall response rate (ORR) of 81.8% and a disease control rate (DCR) of 100%. After a median follow-up of 9 months, the median progression-free survival (mPFS) was not reached, with a 9-month PFS rate of 81.4%. Regardless of KRAS/BRAF mutation status, patients can benefit from ivonescimab combination therapy. The results published at the 2024 ESMO suggest that ivonescimab may offer a significant improvement over existing treatment options for MSS/pMMR mCRC patients. The Phase III trial AK112-312/HARMONi-GI6 can potentially further validate the clinical benefits of ivonescimab in this setting, offering a novel first-line immunotherapy treatment option for patients with advanced mCRC. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. View original content: SOURCE Akeso, Inc. 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
15 hours ago
- Business
- Yahoo
Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
HONG KONG, July 23, 2025 /PRNewswire/ -- Akeso, Inc. ( ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by the company. The trial is investigating ivonescimab in combination with chemotherapy, with or without ligufalimab (CD47 monoclonal antibody), for the first-line treatment of metastatic pancreatic cancer. Pancreatic cancer remains one of the most challenging types of tumors to find effective treatments for. While immunotherapies have demonstrated significant efficacy in different types of of solid tumors, pancreatic cancer's unique immune evasion mechanisms and its highly immunosuppressive tumor microenvironment (TME) have rendered it resistant to current therapies. As a result, previous Phase III studies on using immunotherapies as first-line treatments for metastatic pancreatic cancer have mostly failed. To date, no immunotherapy has been approved for first line metastatic pancreatic cancer. Ivonescimab, in combination with chemotherapy and/or ligufalimab, has the potential to address the current lack of effective options in first-line immunotherapy for metastatic pancreatic cancer. This randomized, controlled, multi-center Phase III trial is a key component of Akeso's broader strategy to address the significant unmet clinical needs in global oncology. Pancreatic cancer is an extremely aggressive form of malignancy that often result in poor patient prognosis. Its global incidence is on the rise, and the mortality rate closely mirrors the incidence, resulting in alarmingly low overall survival rates. In 2022, approximately 511,000 new cases of pancreatic cancer were diagnosed worldwide, and 467,000 deaths were recorded. Early diagnosis remains challenging, with around 80% of patients being diagnosed at an advanced stage. Even those diagnosed with early-stage or locally advanced disease may see progression to metastatic pancreatic cancer within a year following surgery or other treatments. Current first-line treatments are predominantly chemotherapies and have showed very limited success, with a median overall survival (OS) of less than one year. PD-1 and VEGF are often co-expressed in the tumor microenvironment. As a PD-1/VEGF bispecific antibody, Ivonescimab can accumulate in the TME and effectively block both the PD-1 and the VEGF signaling pathways. While these pathways are independently active, they are also complementary. Inhibition of both PD-1 and VEGF enhances immune cells' ability to target and destroy tumor cells. In addition, ligufalimab binds to CD47 on tumor cells, disrupting the interaction with signal regulatory protein alpha (SIRPα) on phagocytic cells. This process boosts phagocytosis and inhibits tumor growth. The combination of ivonescimab with ligufalimab is expected to synergistically enhance anti-tumor activity, offering a potential breakthrough in the first-line treatment for metastatic pancreatic cancer. Professor Yu Xianjun, Director of Fudan University Shanghai Cancer Center, Professor Ying Jie'er from Zhejiang Cancer Hospital, and Professor Tai Sheng from Harbin Medical University Cancer Hospital are the co-principal investigators of HARMONi-GI2 study. Forward-Looking Statement of Akeso, announcement by Akeso, Inc. ( "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About AkesoAkeso (HKEX: is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. View original content: SOURCE Akeso, Inc. 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
New York Times
a day ago
- Health
- New York Times
A Pill for Sleep Apnea Could Be on the Horizon
Tens of millions of people in the United States struggle with obstructive sleep apnea, a condition that occurs when the throat muscles narrow during sleep, leading to temporary pauses in breathing that can cause people to snore and jolt awake, gasping for air. Poor sleep can leave people feeling exhausted, irritable and unfocused during the day. And if left untreated, sleep apnea can increase the risk for serious conditions like high blood pressure, Type 2 diabetes, heart attack and stroke. For decades, the primary treatment for sleep apnea has been continuous positive airway pressure (or CPAP). Before bed, those with the condition put on a face mask that is connected to a CPAP machine, which keeps the airway open by forcing air into it. The machines are effective, but many find them so noisy, cumbersome or uncomfortable that they end up abandoning them. Now, a more appealing option may be on the way, according to a news release from Apnimed, a pharmaceutical company focused on treating sleep apnea. On Wednesday, the company announced a second round of positive Phase 3 clinical trial results for a first-of-its-kind oral pill that can be taken just before bedtime to help keep a person's airway open. The full results have not yet been released, or published in a peer-reviewed journal. But the findings build on past, similarly positive conclusions from trials and studies. Sleep experts say that what they're seeing in reports so far makes them think the pill could be a game changer. Dr. Phyllis Zee, a sleep doctor and researcher at Northwestern Medicine who was not involved with the trial, said that if approved, the drug could transform the lives of many. That includes not only those who can't tolerate CPAP machines, but also those who can't — or prefer not to — use other interventions, such as other types of oral devices or weight loss medications. (Excess weight is a risk factor for sleep apnea.) Want all of The Times? Subscribe.
