ATRA Abuzz, ATOS’ COVID-19 Med Effective, INO And VXRT On Track
Today’s Daily Dose brings you news about the near-term catalyst of Atara; promising lab study results of Atossa’s COVID-19 med; the progress in Gilead/Galapagos’ ulcerative colitis trial; the timeline of Inovio’s COVID-19 vaccine and the progress in Vaxart’s COVID-19 vaccine program.
1. Atara To Present Updated Multiple Sclerosis Data On May 22
Atara Biotherapeutics Inc. (ATRA) is scheduled to present updated safety and efficacy data from its ongoing Phase 1 study of ATA188 for the treatment of progressive forms of multiple sclerosis at the 6th European Academy of Neurology (EAN) Annual Congress on May 22nd.
ATA188 is an off-the-shelf, allogeneic T-cell activated therapy that targets Epstein-Barr Virus (EBV)-infected B cells, believed to play a role in the pathogenesis of multiple sclerosis.
ATRA closed Wednesday’s trading at $14.27, up 28.91%.
2. Atossa’s COVID-19 Med Effective In Lab Studies
Atossa Therapeutics Inc. (ATOS), which is developing a med for COVID-19, has a reason to cheer.
In in vitro testing, the Company’s proprietary COVID-19 drug candidate AT-H201 has shown to inhibit SARS-CoV-2 infectivity of VERO cells in a laboratory culture. SARS-CoV-2, also referred to as the novel coronavirus, is the COVID-19 infectious agent.
VERO cells are the standard cell types used to study the infectivity of the coronavirus.
AT-H201 is designed to act as a “chemical vaccine” by binding to the surface of the coronavirus and inhibiting the ability of the virus to enter a cell (“viral infectivity”), noted the Company.
The Company further added that AT-H201 is found to be at least four-times more potent than Gilead’s Remdesivir and at least twenty times more potent than malaria drug Hydroxychloroquine in VERO cells.
Remdesivir and Hydroxychloroquine are trialed in COVID-19 patients.
ATOS closed Wednesday’s trading at $2.20, up 25.71%.
3. Gilead/Galapagos SELECTION Trial Hits Goals
Gilead Sciences Inc. (GILD) and Galapagos NV’s (GLPG) phase IIb/III trial of Filgotinib in moderately to severely active ulcerative colitis has achieved all primary endpoints.
In the study, dubbed SELECTION, biologic-nave or biologic-experienced adult ulcerative colitis patients treated with Filgotinib 200 mg achieved clinical remission at Week 10, with the clinical remission being maintained at Week 58 in a significantly higher proportion of patients compared with placebo. But Filgotinib in a dosage of 100 mg did not achieve statistically significant clinical remission at Week 10.
Filgotinib is being co-developed by Gilead Sciences Inc. (GILD) and Galapagos in a range of inflammatory conditions.
A phase III program dubbed FINCH in rheumatoid arthritis, a phase III trial known as DIVERSITY in Crohn’s disease, a phase III program, named PENGUIN in psoriatic arthritis, as well as phase II studies in uveitis and in the small-bowel and fistulizing Crohn’s disease are the ongoing trials with Filgotinib.
GILD closed Wednesday’s trading at $73.89, up 2.14%.
4. Inovio Expects Phase I data of COVID-19 Vaccine In June
Inovio Pharmaceuticals Inc. (INO), which is developing a COVID-19 vaccine, has revealed encouraging data from a preclinical study of INO-4800, its DNA vaccine candidate against the novel coronavirus SARS-CoV-2, which causes COVID-19.
Mice and guinea pigs vaccinated with INO-4800 generated robust binding and neutralizing antibody as well as T cell responses, which could provide protection from SARS-CoV-2.
A phase I clinical trial evaluating the safety profile and immunogenicity of INO-4800 is underway in the U.S. Preliminary safety and immune response data from the phase I trial are expected in June.
If all goes well as planned, the Company plans to start a phase II/III efficacy trial of INO-4800 in July/August.
INO closed Wednesday’s trading at $15.79, up 8.45%.
5. Surface Oncology Teams Up With Merck
Surface Oncology (SURF) has teamed up with Merck (MRK) to evaluate the safety and efficacy of combining Surface’s investigational SRF617 with Merck’s blockbuster drug KEYTRUDA.
This combination will be studied as a component of a phase I/Ib study of SRF617 in patients with solid tumors, with a focus on patients with gastric cancer and those who have developed resistance.
For example, in gastric cancer, immune cells within the tumor often express high levels of CD39, which may impair an overall anti-cancer immune response even in the presence of an anti-PD-1 antibody-like Keytruda. Since SRF617 inhibits CD39, the combination of SRF617 and KEYTRUDA has the potential to overcome this barrier to immune system activation and promote anti-tumor immunity, noted the Company.
SURF closed Wednesday’s trading at $3.88, up 45.86%.
6. NuCana Faces A Busy Year Ahead
NuCana plc (NCNA), which has a couple of clinical data readouts for this year, is a stock to keep an eye on.
After a temporary pause in enrollment in April due to the pandemic, the Company has re-started new patient enrollment in clinical studies, including a Phase III study of Acelarin plus cisplatin in patients with biliary tract cancer and a Phase Ib study of NUC-3373 in patients with colorectal cancer.
The Company expects to report data from the ongoing Phase Ib study of NUC-3373 in patients with advanced colorectal cancer and data from the ongoing Phase I study of NUC-3373 in patients with advanced solid tumors this year.
Another experimental drug in the pipeline is NUC-7738, which is under a Phase I study in patients with advanced solid tumors, and data from this study is also expected this year.
As of March 31, 2020, NuCana had cash and cash equivalents of £47.6 million, which is expected to be sufficient at least into the fourth quarter of 2021.
NCNA closed Wednesday’s trading at $7.37, up 26.85%.
7. Vaxart To Begin Phase I Study Of COVID-19 Vaccine In Summer
Vaxart Inc. (VXRT) has selected its lead COVID-19 vaccine candidate and is planning to initiate a phase I study in the second half of this year, possibly in the summer.
The Company has also contracted with KindredBio to manufacture bulk vaccine to complement the manufacturing capacity of partner Emergent BioSolutions.
Vaxart’s vaccines are produced in tablet form and are not injectable vaccines.
VXRT closed Wednesday’s trading at $3.19, up 3.91%.
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