Clinical catch-up date: 22.-26. November | BioSpace


Thanksgiving week was marked by numerous clinical trial announcements. Here is a look.

COVID-19 related

NRx medicinal products announced a first sample from Phase II vaccinated patients to assess the potential effectiveness of the BriLife vaccine against the Delta variant of the SARS-CoV-2 virus. Blood from an initial sample of 11 participants showed potent neutralizing antibodies against the original Wuhan wild-type strain and was tested for antibodies against Delta. Of 11 tested, 10 were able to neutralize Delta.

Ocugen reported The US Food and Drug Administration (FDA) had clinically suspended its application for a new investigational drug (IND) to evaluate its COVID-19 vaccine BBV152 (Covaxin). The vaccine is an investigational vaccine in the United States that was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). It has an emergency permit in 17 countries. Ocugen and Bharat Biotech are jointly developing the vaccine in the United States and Canada.

Clover Biopharmaceuticals initiated a Phase II study of its COVID-19 booster vaccines. The candidate, SCB-2019, will be assessed as a heterologous booster in individuals previously vaccinated with their CoronaVac or the AstraZeneca / FIocruz-Oxford COVID-19 vaccine.

Not related to COVID-19

Transgenic and NEC Corporation announced preliminary immunogenicity and clinical data on TG4050 and the first six patients treated. The drug is a customized neoantigen cancer vaccine that will be tested in ovarian cancer and head and neck cancer. The drug was well tolerated and has been linked to early signs of clinical activity in a Phase I study.

Lixte biotechnology resumed Enrollment of patients in the pharmacological study of LB-100 in patients for whom surgical removal of their cancer is indicated. It was suspended in 2020 due to the COVID-19 pandemic. LB-100 is a top class PP2A inhibitor.

Achieve life sciences announced the completion of the fifth and final review by the Data Safety Monitoring Committee (DSMC) of its Phase III ORCA 2 study of cytisinicline for smoking cessation. There were no concerns about the study and the DSMC found that study compliance is excellent and is progressing well despite COVID-19. The drug is a plant alkaloid that binds to the nicotinic acetylcholine receptor.

Intellia Therapeutics Receives Approval for the addition of NTLA-2001 to its ongoing Phase I study in the UK. It now also includes patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM). The original patient population was ATTR amyloidosis patients with polyneuropathy (ATTRv-PN). NTLA-2001 is an in vivo CRISPR / Cas9-based genome editing candidate designed to inactivate the TTR gene in liver cells to prevent the production of TTR protein.

Confirmed announced Preliminary clinical data from investigator-initiated Phase I / II study at the University of Texas MD Anderson Cancer Center of cbNK cells precomplexed with the Company’s innate cell engager AFM13. There were no serious adverse events and there was an objective response rate (ORR) of 100% with a complete response rate (CRR) of 42% in 12 patients after the first of two planned cycles at the recommended Phase II dose.

Apollomics dosed the first patient in the Phase III study of APL-106 (uproleselan injection) for adults with relapsed or refractory acute myeloid leukemia (AML) in China. The company licensed the Greater China rights to the drug from GlycoMimetics. The drug is designed to block E-selection, an adhesion molecule to cells in the bone marrow, and prevent it from binding to blood cancer cells.

Dosed diffusion pharmaceuticals the first patients in his trans-sodium crocetinate altitude study in healthy volunteers exposed to increasing physical exertion while exposed to hypoxic and hypobaric conditions, or “simulated altitude”. The idea is to determine the effectiveness of the drug in improving oxygen delivery to the blood and tissues during exercise in hypoxic conditions. Hypoxia is a serious complication of many diseases, including hypoxic solid tumors.

JAMA Neurology Released a to learn Today by researchers from Biogen, Brown University, University College London, VU University Medical Center, Amsterdam, Netherlands, California Pacific Medical Center in San Francisco, Bioclinica in Newark, California, and Cytel in Waltham, Massachusetts investigating ARIA in two phases III -Studies, ENGAGE and EMERGE. The combined studies included 3,285 participants with Alzheimer’s who received one or more doses. The researchers found 425 cases in the combined aducanumab group with an ARIA (41.3%) and ARIA edema was identified in 362 patients, or 35.2%. Of them, 94 (26%) had symptoms such as headache, confusion, dizziness, and nausea. They found ARIA microhemorrhage and ARIA superficial siderosis in 197 patients (19.1%) and 151 patients (14.7%), respectively.

The study found that most ARIA-E events were observed at the start of treatment, either while trying to find the right dose or shortly after reaching the target dose. It states: “These results are in line with clinical studies of other anti-ABeta antibodies, in which ARIA also mainly appeared within the first few months of treatment, while the risk of ARIA-E decreased as treatment progressed.”

Aptevo Therapeutics reports a clinical update for its Phase Ib expansion study of APVO436 in acute myeloid leukemia (AML). The preliminary data included a complete response. APVO436 is a CD3XCD123 bispecific ADAPTIR designed to redirect the immune system to destroy leukemia cells that express CD123 molecules on their surface.

Ocuphire Pharma enrolled the first patients in their phase III MIRA-3 study with Nyxol eye drops for the reversal of pharmacologically induced mydriasis (dilation of the pupil). It now has six patient admission sites and 10 more sites are expected soon.

Synexis released Results of its Phase III VANISH-306 study. The data showed that oral ibrexafungertp was superior to placebo for vaginal yeast infection. It showed a sustained clinical effect at day 25 follow-up with 83.9% of patients achieving complete symptom resolution.

Sterna Biologicals Authorization received in Germany to conduct a phase IIa study of SB010 in patients with moderate to severe asthma. The drug is an inhaled liquid formulation of a special type of catalytic antisense oligonucleotide.

Merck announced that it had suspended its Phase II IMAGINE-DR study of a combination of MK-8507, a non-nucleoside reverse transcriptase inhibitor, and islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, for HIV. Then, on November 23, both Gilead Sciences and Merck, announced they paused a phase II study of islatravir and lenecapavir in HIV. They stated, “This temporary hiatus was introduced out of great caution to allow companies, in light of Merck’s announcement of the 18th clinical trial evaluating the once-weekly combination of MK-8507 and islatravir.”

Kura Oncology announced the FDA had partially clinically suspended its phase Ib study KOMET-001 with KO-539 in acute myeloid leukemia (AML). The study was paused to investigate one reported fatality. KO-539 is an oral drug that targets the menin KMT2A / MLL protein-protein interaction.

Akcea Therapeutics announced a drug it licensed from Pfizer in 2019 met the primary endpoint in a Phase IIb study in patients with elevated levels of non-HDL-C and triglycerides. The drug Vupanorsen is an antisense therapy. Ionis Pharmaceuticals acquired Akcea in 2020. The drug achieved a statistically significant decrease in non-HDL-C after 24 weeks for all doses tested.

Hutchmed and AstraZeneca initiated a Phase III study by SACHI in China of Orpathys (savolitinib) in combination with Tagrisso (osimertinib) from AstraZeneca. Orpathys is an oral, potent and highly selective MET tyrosine kinase inhibitor (TKI). Tagrisso is a third generation irreversible epidermal growth factor receptor (EGFR) -TKI. You will test the combination in locally advanced or metastatic EGFR mutation positive non-small cell lung cancer (NSCLC) with MET amplification after disease progression on EGFR inhibitor therapy.


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