Altimmune: FDA Clears AdCOVID™ IND Application; Enrolls Phase 1 trial of intranasal COVID vax

 Altimmune, Inc.. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 1 clinical trial of AdCOVID, a novel, single-dose, intranasal COVID-19 vaccine candidate. Altimmune expects to commence patient enrollment in the Phase 1 clinical trial in the coming week.

“We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic,” said Vipin K. Garg, President and Chief Executive Officer of Altimmune. “FDA clearance of the IND marks an important step in developing a safe and effective vaccine designed to stimulate mucosal as well as systemic immunity following intranasal administration. Developing vaccines that can effectively prevent transmission is a growing imperative to block the spread of disease and combat the emergence of new variants. We look forward to the data from this trial in the coming weeks.”

The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55. Volunteers will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses.

https://www.biospace.com/article/releases/altimmune-announces-fda-clearance-of-adcovid-ind-applicationenrollment-in-phase-1-clinical-trial-of-single-dose-needle-free-intranasal-covid-19-vaccine-candidate-set-to-begin-in-the-coming-week/

FDA Grants Amgen Sotorasib Priority Review for Lung Cancer

 Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.

The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for sotorasib is Aug. 16, 2021, which is four months earlier than the standard review cycle.

The New Drug Application (NDA) is based on the Phase 2 results from the CodeBreaK 100 clinical trial that studied patients with locally advanced or metastatic NSCLC whose cancer had progressed despite treatment with chemotherapy and/or immunotherapy. Full results from the study were recently presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC).

Amgen submitted the sotorasib NDA on Dec. 16, 2020. The NDA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen submitted a Marketing Authorization Application (MAA) in the EU in Dec. 2020. Additionally, Amgen submitted MAAs for sotorasib in Australia, Brazil, Canada and the United Kingdom in Jan. 2021 to participate in the FDA's Project Orbis initiative. Sotorasib has achieved Breakthrough Therapy Designation in the U.S. and China.

https://www.prnewswire.com/news-releases/fda-grants-sotorasib-priority-review-designation-for-the-treatment-of-patients-with-kras-g12c-mutated-locally-advanced-or-metastatic-non-small-cell-lung-cancer-301229256.html

IMU-838 Data In COVID-19 Study Fails To Cheer Immunic Investors

 

• Immunic Inc (NASDAQ: IMUX) completes the main analysis of Phase 1 CALVID-1 trial evaluating its lead asset, IMU-838. It is a selective oral DHODH inhibitor used in hospitalized patients with moderate COVID-19.
• Though the data from 204 patients showed evidence of clinical activity, compared to placebo, the numbers were not very different in both arms. IMU-838 was found to be safe and well-tolerated.
• 18.5% of the IMU-838 treated patients reached clinical recovery at day 7, compared with 12.8% in the placebo arm. On day 28, 71.3% of the IMU-838 treated patients had recovered compared with 66.7% in the placebo arm. 
• Time to clinical improvement was found to be shorter in the IMU-838 treatment arm than placebo, and the incremental benefit increased over time.
• 42.7% of patients in the treatment arm reached clinical improvement, versus 38.5% in placebo. On day 28, the numbers were 90.9% and 87.4%, respectively.
• The relative proportion of patients not improving was 6.8% greater in the placebo arm than the IMU-838 treatment arm at 14 days and 27.7% greater at 28 days.
• Initial data from a post hoc analysis of "Long COVID" symptoms that remain even after elimination of the COVID-19 virus indicated that IMU-838 could potentially be an option for the prevention of long-term fatigue.
• High-risk patients and patients aged over 65 years experienced a more substantial treatment benefit from IMU-838 than in the general patient population.
• An anti-viral effect of IMU-838 on SARS-CoV-2 was observed by viral titers at the end of the treatment period (day 14) and the end of the study (day 28).
• The final analysis of the complete randomized patient population of 223 is expected in the second quarter of 2021. This supplemental data set will contain full efficacy, virology, and drug trough level data, as well as the safety follow-up until day 60.
• Price Action: IMUX slipped 16.6% at $21.1 in premarket trading on the last check Wednesday.

https://www.benzinga.com/general/biotech/21/02/19700954/imu-838-data-in-covid-19-study-fails-to-cheer-immunic-investors-stock-tanks

Glaxo, Vir Biotech to expand COVID-19 research partnership for other diseases

 GlaxoSmithKline and Vir Biotechnology Inc will expand an existing partnership developing antibody therapies for COVID-19 to other diseases, the companies said on Wednesday.

FILE PHOTO: Company logo of pharmaceutical company GlaxoSmithKline is seen at their Stevenage facility, Britain October 26, 2020. REUTERS/Matthew Childs

As a part of the deal to research and develop monoclonal antibody treatments for influenza and other respiratory illnesses, GSK will make a further $120 million equity investment in Vir and an additional upfront payment of $225 million.

Shares of San Francisco-based Vir, which is run by former Biogen Inc Chief Executive Officer George Scangos, rose 12.4% before the opening bell.

The companies announced a partnership last year to research COVID-19 treatments. Unlike vaccines, antibody treatments are designed to be given to patients who have been diagnosed with the illness, with the aim of decreasing the severity of the disease.

One of the companies’ experimental therapies for COVID-19 is currently being studied in two global final-stage trials. Results from one of these studies are expected in the first quarter of 2021.

The pandemic has spurred large pharma companies’ interest in researching new ways to combat infectious pathogens, including influenza.

The effectiveness of standard flu vaccines varies year to year based on how well researchers are able to predict that season’s dominant strains months in advance.

The effectiveness of the vaccine can also vary depending on the age of the recipient and other factors, according to the U.S. Centers for Disease Control and Prevention.

The companies said they would work to further develop Vir’s experimental treatment for influenza A, one of the viruses that causes flu.

GSK and Vir said people 65 and older with underlying conditions have a higher risk of dying of the virus and historically, vaccines have had lower efficacy in this group.

https://www.reuters.com/article/us-health-coronavirus-gsk-vir-biotech/gsk-vir-biotech-to-expand-covid-19-research-partnership-for-other-diseases-idUSKBN2AH1IG

UK gives go-ahead to expose volunteers to COVID in medical trial

 Britain on Wednesday became the first country in the world to allow volunteers to be exposed to the COVID-19 virus to advance medical research into the pandemic.

The trial, which will begin within a month, will see up to 90 healthy volunteers aged 18-30 exposed to COVID-19 in a safe and controlled environment to increase understanding of how the virus affects people, the government said.

In order to make the trial as safe as possible, the version of the virus that has been circulating in England since March 2020 will be used rather than one of the new variants.

The study will initially seek to establish the smallest amount of virus needed to cause infection, it said. Volunteers could then be given vaccine candidates before being exposed to the virus.

The volunteers will be compensated for taking part.

British Business Secretary Kwasi Kwarteng said the study would help to find the best and most effective vaccines for use over the longer term.

“These human challenge studies will take place here in the UK and will help accelerate scientists’ knowledge of how coronavirus affects people and could eventually further the rapid development of vaccines,” he said.

The government’s vaccines task force, Imperial College London, the Royal Free London NHS Foundation Trust and clinical company  hVIVO, which has pioneered viral human challenge models, are working on the study.

https://www.reuters.com/article/us-health-coronavirus-britain-challenge/uk-gives-go-ahead-to-expose-volunteers-to-covid-in-medical-trial-idUSKBN2AH17H

Treating COVID-19 long-haulers with Amgen's sleeper heart drug Corlanor

 When Amgen won FDA approval for Corlanor (ivabradine) to treat chronic heart failure in 2015, it didn’t generate much enthusiasm in the cardiology community and was quickly overtaken by Novartis’ Entresto, which was seen as having a better risk-benefit profile.

Now, researchers at the University of California, San Diego (UCSD) say they may have found a new market for Corlanor: to treat COVID-19 “long haulers.”

The team made the proposal after completing a small study of Corlanor in 22 patients with postural orthostatic tachycardia syndrome (POTS), a disorder that causes a spike in heart rate while standing along with other symptoms like fatigue, weakness and brain fog. Some COVID-19 patients complain of similar symptoms for months after they’ve recovered from the virus.

Patients in the trial who received Corlanor twice a day for one month saw their standing heart rate drop from between 100 and 115 beats per minute to 77 as compared to people taking a placebo, the UCSD team reported in the Journal of the American College of Cardiology. Patients taking the Amgen drug reported no significant side effects and an increased quality of life.

The study was led by Pam Taub, M.D., a cardiologist at the Cardiovascular Institute at UCSD Health and a consultant for Amgen. Although Corlanor is not approved to treat POTS, “we thought it could be helpful for patients with POTS as it reduces heart rate without impacting blood pressure," Taub said in a statement. Other drugs to treat the condition, such as beta blockers, can cause depressed blood pressure and fatigue.

Drug repurposing has been embraced as a potential strategy for addressing the COVID-19 pandemic, as public health officials struggle to meet demand for vaccines while simultaneously confronting new variants of the virus. Last month, researchers at the Icahn School of Medicine at Mount Sinai and UC San Francisco published a preclinical study suggesting that PharmaMar’s multiple myeloma drug plitidepsin outperformed Gilead Sciences' remdesivir in battling the original strain of SARS-CoV-2 as well as a variant that originated in the U.K.

PTC Therapeutics and Veru are both testing their early-stage cancer drugs in COVID-19. Last week, shares of Veru skyrocketed on phase 2 data showing its drug significantly reduced the days on ventilation for severely ill COVID-19 patients. Veru is planning a phase 3 trial.

Before POTS was spotted as a potential symptom in COVID-19 long-haulers, it was most commonly seen in young, active women who had recovered from other viral infections, trauma or surgery. There are no FDA-approved drugs to treat POTS.

The UCSD researchers hope physicians treating POTS patients will consider using Corlanor off-label, they said, and that future studies will be designed to further investigate the potential of Amgen’s drug in addressing symptoms of the disease.

https://www.fiercebiotech.com/research/treating-covid-long-haulers-amgen-s-sleeper-heart-drug-corlanor

AstraZeneca: Lynparza Breast Cancer Drug Trial Results to Be Reported Early

 AstraZeneca PLC said Wednesday that an independent committee has concluded the Phase 3 OlympiA trial of its early breast cancer treatment, Lynparza, will be analyzed and reported early.

The British pharmaceutical giant said the independent data monitoring committee has concluded that Lynparza has crossed the superiority boundary for it primary endpoint of invasive disease-free survival, outperforming placebos. The Phase 3 trial will now move to early primary analysis and reporting.

The drug targets mutations in the BRCA1 and BRCA2 genes, the most common cause of hereditary breast cancer--itself the most common cancer in the world for women. Around 2.3 million women were diagnosed with breast cancer world-wide in 2020, and up to 65% of women with a BRCA1 mutation and around 45% of women with a BRCA2 mutation will develop breast cancer before the age of 70.

The independent data monitoring committee didn't raise any additional concerns and the trial will continue to assess key secondary endpoints of overall survival and distant disease-free survival, AstraZeneca said.

The OlympiA Phase 3 trial is a partnership between Breast International Group, NRG Oncology, the US National Cancer Institute, Frontier Science & Technology Research Foundation, AstraZeneca and Merck & Co., Inc.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Lynparza-Breast-Cancer-Drug-Trial-Results-to-Be-Reported-Early-32458512/