Clinical Trial News
FDA Grants Priority Review to Revumenib for Relapsed/Refractory KMT2Ar Acute Leukemia
- The FDA has granted Priority Review to Syndax Pharmaceuticals' NDA for revumenib, a menin inhibitor, for relapsed/refractory KMT2Ar acute leukemia.
- The NDA is supported by positive data from the AUGMENT-101 trial, which showed a 23% complete remission rate in KMT2Ar acute leukemia patients.
- Revumenib has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA for acute leukemia.
- The FDA's decision is expected by September 26, 2024, under the Real-Time Oncology Review Program, potentially expediting the drug's approval.
FDA Grants Priority Review to IntraBio's IB1001 for Niemann-Pick Disease Type C
- The FDA has accepted IntraBio's New Drug Application for IB1001, granting Priority Review for Niemann-Pick Disease Type C treatment.
- IB1001's NDA is supported by positive Phase 3 trial results, demonstrating improvements in neurological symptoms and quality of life.
- A PDUFA target action date is set for September 24, 2024, potentially expediting the availability of this oral therapy.
- IntraBio secured over $40 million in equity financing to support the commercialization of IB1001, pending FDA approval.
Avecho Launches Largest Phase III Trial of CBD for Insomnia in Australia
- Avecho has commenced patient recruitment for its pivotal Phase III clinical trial testing TPM-enhanced CBD soft-gel capsules for insomnia, with plans to enroll 519 patients across five Australian cities.
- The study will compare nightly cannabidiol doses of 75mg and 150mg against placebo over an 8-week period, representing the largest and most robust CBD trial for insomnia in Australia to date.
- Insomnia affects approximately 60% of Australians with an estimated economic impact of $19.1 billion, while the global insomnia treatment market is valued at over $4 billion.
Belumosudil Shows Promise in Chinese Patients with Chronic Graft-versus-Host Disease
- A Phase II study in China reveals belumosudil yields a 73.3% overall response rate (ORR) in patients with chronic graft-versus-host disease (cGVHD).
- The study demonstrates clinically meaningful improvements, including reduced corticosteroid dependence and enhanced quality of life for cGVHD patients.
- Belumosudil's safety profile in the Chinese cohort aligns with previous global studies, showing mostly mild to moderate treatment-emergent adverse events.
- These findings support belumosudil as a potential second-line treatment option for cGVHD patients in China who have failed corticosteroid therapy.
Highlighted Clinical Trials:
BioNova Pharmaceuticals (Shanghai) LTD.
Posted 4/27/2021
Chugai's Vabysmo Receives Japanese Approval for Retinal Vein Occlusion Treatment
- Chugai Pharmaceutical has received approval from Japan's Ministry of Health for Vabysmo (faricimab) to treat macular edema associated with retinal vein occlusion, making it the first bispecific antibody approved for this condition in Japan.
- The approval is based on positive results from the global Phase III BALATON and COMINO studies, which demonstrated Vabysmo's ability to rapidly improve vision and reduce retinal fluid in RVO patients.
- Retinal vein occlusion affects an estimated 28 million adults globally and 1.66 million in Japan, representing the second most common cause of vision loss due to retinal vascular diseases.
Pancreatic Cancer Survivor Funds Clinical Trial to Aid Future Patients
Linda Sherman, a stage three pancreatic cancer survivor, has funded a clinical trial at Mass General Cancer Center that was pivotal in her treatment. Her contribution ensures the continuation of this promising research for an additional three years, aiming to provide future patients with the same successful treatment she received.
FDA Issues Complete Response Letters for Regeneron's Odronextamab in Non-Hodgkin Lymphoma
- FDA has rejected Regeneron's marketing applications for odronextamab in treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, citing concerns about confirmatory trial enrollment status.
- The regulatory setback delays Regeneron's plans to launch odronextamab with the broadest label among CD20xCD3 bispecific antibodies, though no issues were raised regarding the drug's efficacy, safety, or manufacturing.
- The competitive CD20xCD3 market already includes three approved therapies - Roche's Lunsumio and Columvi, and AbbVie/Genmab's Epkinly - with ongoing trials aimed at expanding their indications.
Highlighted Clinical Trials:
Regeneron Pharmaceuticals
Posted 11/13/2019
Regeneron Pharmaceuticals
Posted 1/9/2015
Chemomab Secures Global Patent Protection for CM-101 Antibody Targeting Primary Sclerosing Cholangitis
- Chemomab Therapeutics has secured new patents in Brazil, Israel, and Europe for CM-101, its first-in-class monoclonal antibody targeting CCL24 for fibro-inflammatory diseases.
- The patents provide protection for CM-101's composition of matter and use in liver diseases including primary sclerosing cholangitis (PSC) until 2038, with potential five-year extensions.
- CM-101 is currently in a Phase 2 SPRING trial for PSC treatment with completed patient enrollment and topline data expected midyear 2024.
- PSC represents a significant unmet medical need as a potentially lethal condition with no FDA-approved therapies, often requiring liver transplantation.
Pharmaceutical Industry Leadership Shuffle: Major Executive Appointments Signal Strategic Shifts Across Biotech and Pharma
- AbbVie promoted long-time COO Robert Michael to CEO, marking the end of an extensive leadership search with an internal succession plan.
- Multiple European biotechs appointed new CEOs, including OneChain Immunotherapeutics, Maxion Therapeutics, and StromaCare, reflecting strategic pivots in cancer immunotherapy development.
- Astellas created its first chief digital and transformation officer role, signaling the pharmaceutical industry's increasing focus on digital transformation initiatives.
- Acumen Pharmaceuticals strengthened its Alzheimer's drug development capabilities by appointing James Doherty, a neuroscience veteran with two FDA approvals under his belt.
Antibody-Drug Conjugates: A Review of Clinical Efficacy and Recent Advances
- Gemtuzumab ozogamicin (GO), the first approved ADC, initially faced safety concerns but was later re-approved for CD33-positive AML treatment at a lower dose.
- Brentuximab vedotin (BV) has shown significant efficacy in Hodgkin lymphoma and anaplastic large cell lymphoma, improving progression-free and overall survival rates.
- Trastuzumab deruxtecan (T-DXd) has demonstrated superior outcomes in HER2-positive breast cancer, including in patients with brain metastases, compared to other therapies.
- Sacituzumab govitecan (SG) has shown promising results in metastatic triple-negative breast cancer and urothelial carcinoma, offering a new treatment option for these cancers.
Highlighted Clinical Trials:
Gilead Sciences
Posted 8/13/2018
RemeGen Co., Ltd.
Posted 12/14/2015
Seagen, a wholly owned subsidiary of Pfizer
Posted 2/27/2019
Seagen Inc.
Posted 11/30/2013
Seagen Inc.
Posted 6/12/2018
Hoffmann-La Roche
Posted 11/16/2017
ADC Therapeutics S.A.
Posted 8/1/2018
RemeGen Co., Ltd.
Posted 7/10/2018
Hoffmann-La Roche
Posted 12/23/2016