Altimmune provides positive updates for AdCOVID

Altimmune Inc. (ALT) reported positive data from the preclinical studies of its lead vaccine candidate, AdCOVID. The company is carrying out these studies as part of its collaboration with the University of Alabama at Birmingham for developing a vaccine against COVID-19.

The data from the latest study demonstrated potent stimulation of antigen-specific CD4+ and CD8+ T cells in the lungs of CD-1 mice. The impact was visible as early as within 10 days of administering a single intranasal vaccination. The responses were strongly biased toward CD8+ T cells. It is likely that the mucosal T cell response in the respiratory tract depends on the intranasal route of administration.

Earlier this year, the company had reported data from the initial studies for the vaccine. The results demonstrated that the vaccine candidate stimulated a strong systemic neutralizing antibody response. Dr. Frances Lund, Charles H. McCauley Professor and Chair, Department of Microbiology at UAB, and lead investigator for preclinical testing of the AdCOVID vaccine candidates said, “The property that sets AdCOVID apart is that it has been shown preclinically to induce a potent T cell and IgA antibody response in the lungs, in addition to the systemic neutralizing antibody response induced by intramuscular vaccine candidates.”

Additional information from CD-1 mice analysis since the July 13 data reported mean serum neutralization titers 4 weeks after a single intranasal dose above 1:400 in a foci reduction neutralization assay against wild-type SARS-CoV-2 virus. Altimmune is currently producing AdCOVID for a Phase safety and immunogenicity study. The trial will likely begin in the fourth quarter of 2020.

The vaccine candidate is expected to be more user friendly as it does not require any needles or syringes for administration. Its expected room temperature stability also makes it a good candidate for mass distribution without requiring expensive logistics.

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Apart from working on developing a COVID-19 vaccine, Altimmune is developing other drug candidates as well. The company is working on ALT-801 for treating NASH. It is a balance and long-acting GLP-1/glucagon receptor dual agonist. In a Gubra mouse model, the drug candidate was administered to animals with biopsy-confirmed NASH for 12 weeks. ALT-801 showed statistically significant better decline in various parameters such as liver weight, body weight and plasma ALT in comparison to semaglutide.

The company plans to carry out the Phase 1 trial in Australia. The study will assess the safety, pharmacokinetics and activity of ALT-801 over 6 weeks treatment in overweight and obese volunteers. It is expected that the readout from the study will be available in the spring of 2021.

ALT-801 is a novel peptide-based dual GLP-1/glucagon receptor agonist. It aims to treat NASH by targeting metabolic dysfunction and obesity. NASH involves various pathways which cause toxic lipid metabolites, inflammation and abnormal buildup of liver fat.

Altimmune is a clinical stage biopharmaceutical company. It mainly works on developing immune-modulating therapies, liver disease treatments and intranasal vaccines. The company currently has a robust development pipeline with candidates such as ALT-801, T-COVID™, NasoVAX™, HepTcell™, NasoShield™ and AdCOVID™.

Ovid reports positive Phase 2 ELEKTRA study data

Ovid Therapeutics Inc. (OVID) announced encouraging topline data from the randomized Phase 2 ELEKTRA study of soticlestat. The study involves children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). The company is collaborating with Takeda Pharmaceutical Company Limited (NYSE:TAK) for developing treatment of rare developmental and epileptic encephalopathies.

The data showed that the drug candidate was able to achieve its primary endpoint for the trial. It showed statistically significant reduction in convulsive seizure and drop seizure frequency during the 12-week maintenance period. There was 27.8% median reduction from baseline in these metrics compared to a 3.1% median increase in patients taking placebo. The treatment arm also showed a 29.8% median reduction in convulsive seizure (DS) and drop seizure (LGS) frequency for the full 20-week treatment period.

The data further showed in the ELEKTRA DS cohort, the patients administered the drug candidate had a 33.8% median decrease in convulsive seizure frequency. The placebo group experienced a 7 percent median increase in the same metric during the full 20-week treatment period. Amit Rakhit of Ovid said, “We look forward to continuing our collaboration with Takeda to initiate a Phase 3 registrational program for soticlestat in patients with DS, while continuing to analyze the data from patients with LGS in the ELEKTRA and ENDYMION studies to define potential next steps.”

ELEKTRA was an international, multi-center, randomized, double-blind, placebo-controlled study. The trial aimed to assess the potential of soticlestat in treating pediatric patients, aged 2 to 17 years, with highly refractory epileptic seizures associated with DS or LGS. The trial enrolled 141 patients, out of which 126 completed the trial. The drug candidate was found to be well-tolerated, in line with previous studies. The study did not identify any new safety signals. Both the treatment and control group showed similar incidence of treatment emergent adverse events.

Bristol-Myers Squibb faces setback for Phase 3 IDHENTIFY Trial

Bristol-Myers Squibb (BMY) provided an update for its Phase 3 IDHENTIFY study evaluating IDHIFA® (enasidenib) plus best supportive care (BSC) versus conventional care regimens. The drug candidate failed to meet the primary endpoint concerning overall survival in patients suffering from relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation.

IDHIFA was approved by the FDA for treating adult patients with R/R AML with an IDH2 mutation in August 2017. Currently, it is the first and only FDA-approved therapy for treating patients with R/R AML and positive for an IDH2 mutation. Noah Berkowitz of Bristol-Myers Squibb said, “While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study.” IDHIFA is approved in Australia and Canada for certain indications.

IDHENTIFY or NCT02577406 is an international, multicenter, open-label, randomized, Phase 3 study. It is designed to compare the efficacy and safety of AG-221 versus conventional care regimens in patients 60 years or older suffering from acute myeloid leukemia refractory or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation. The standard care regimen includes azacytidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC.

The primary endpoint of the trial was overall survival. Key secondary endpoints for the trial included event-free survival, overall response rate, time to response and duration of response. The trial found the safety profile of the drug candidate to be in line with previously reported data. The company is looking to carry out a full evaluation of the trial data and then present the detailed results.

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