The FDA has lifted a partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC), allowing the trial to resume with adjusted dose levels. The decision follows MediLink’s submission of a complete response addressing FDA concerns regarding potential safety risks at higher doses. The trial will focus on dose levels not exceeding 3 mg/kg, where the treatment has shown a manageable safety profile.
Turnstone Biologics Corp. (TSBX) saw its stock decline after releasing initial data from its Phase 1 STARLING trial of TIDAL-01 in metastatic microsatellite-stable colorectal cancer (MSS mCRC). The data showed positive results, including a 25% overall response rate and a 50% disease control rate, with one patient experiencing a complete response. Despite the encouraging results, the company is now focusing on colorectal, head and neck, and uveal melanoma indications, deprioritizing cutaneous melanoma and breast cancer.
SIGA Technologies’ tecovirimat, marketed as Tpoxx, failed to demonstrate a statistically significant improvement in time to lesion resolution in a preliminary analysis of the PALM 007 trial for monkeypox treatment in the Democratic Republic of Congo. While the drug did not meet its primary endpoint, it showed promise for patients with severe disease or those whose symptoms began within seven days of randomization. The trial also highlighted the importance of supportive care in improving outcomes for monkeypox patients.
Syros Pharmaceuticals has discontinued enrollment in its SELECT-AML-1 Phase 2 trial for acute myeloid leukemia (AML), citing disappointing results. The company observed similar response rates between the experimental triplet regimen and the standard doublet regimen, leading to a low probability of success in the final analysis. Despite the setback, Syros continues to evaluate tamibarotene in combination with azacitidine in a Phase 3 trial for myelodysplastic syndrome. This news has caused SYRS stock to drop significantly.
Swedish scientists have developed nanorobots armed with ‘lethal weapons’ that target and destroy cancer cells in mice without harming healthy tissue. This breakthrough, using DNA origami technology, could pave the way for less invasive and toxic cancer treatments in humans.
A groundbreaking clinical trial in Africa has shown that a new injectable drug, lenacapavir, offers complete protection against HIV infection among young women. The trial, conducted by Gilead Sciences, has yielded promising results, with zero cases of HIV infection reported among women who received the drug. This breakthrough offers hope for a significant shift in HIV prevention strategies, particularly in Africa where the burden of the disease is highest.
A Utah mother, Brianne Dressen, alleges that the pharmaceutical company AstraZeneca breached a contract that promised compensation for injuries sustained during a clinical trial for the COVID-19 vaccine. After experiencing severe adverse effects from the vaccine, Dressen was left with mounting medical bills and claims that AstraZeneca has failed to provide adequate support. The lawsuit, filed in the U.S., is the first of its kind against AstraZeneca regarding the coronavirus vaccine trial. Dressen’s aim is to hold the company accountable and raise awareness about the potential risks associated with clinical trials and the need for proper compensation for participants who suffer injuries.
Neuralink, the neurotechnology company led by Elon Musk, is inviting applications for their second human clinical trial of its brain-computer interface (BCI) implant. The PRIME Study aims to assess the safety and functionality of the N1 implant and R1 surgical robot in individuals with quadriplegia or other severe physical disabilities.
Frexalimab, an anti-CD40L monoclonal antibody, demonstrated significant and sustained improvements in disease activity and low relapse rates in patients with relapsing multiple sclerosis (MS) over approximately one year of treatment. These findings, presented at the American Academy of Neurology 2024 Annual Meeting, support the potential of frexalimab as a high-efficacy therapy for relapsing MS.
