Cue Biopharma: Interim Partial Response in Phase 1 Head and Neck Cancer Study

To Provide Interim Clinical Data Update

• Partial response data demonstrates activity of CUE-101 as monotherapy in patient with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC)

• The objective tumor response observed in this patient establishes initial clinical proof of concept for therapeutic modulation of the endogenous anti-tumor T-cell repertoire by the Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform

• Company will discuss results during its upcoming quarterly business update call on May 17, 2021 at 4:30 p.m. EDT

Conference Call
Cue Biopharma will discuss these new data points during its first quarter business update call and webcast on May 17 at 4:30 p.m. ET. Please check the Events page of the Investor and Media section of the Company’s website at www.cuebiopharma.com for details. A live and archived version of the webcast will be available for 30 days after the call.

https://finance.yahoo.com/news/cue-biopharma-reports-confirmed-partial-120000826.html

Argenx upped to Buy from Neutral by Wainwright

Target to $400 from $320

https://finviz.com/quote.ashx?t=ARGX

Ampio Pharma Gets OK for Phase I Long COVID-19 Trial

 An estimated 3 to 10 million patients in the USA exhibit debilitating symptoms of Post-Acute Sequelae of SARS-CoV-2

Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions for which there are limited treatment options, today announced that it has received Investigational Review Board (IRB) approval to commence enrollment in its AP-018 Phase I study using inhaled Ampion™ with patients exhibiting prolonged respiratory COVID-19 symptoms, known as long (or long-haul) COVID, or Post-Acute Sequelae of SARS-CoV-2.

"This trial is both needed and exciting in that it addresses a major current and expected ongoing unmet medical need among the estimated 3 to 10 million individuals currently suffering from long COVID," said Michael Macaluso, President and CEO of Ampio. "A significant percentage of patients who have contracted COVID-19 over the past year – even those with mild or asymptomatic cases – continue to suffer debilitating effects long after there is no detectable virus in their system. These symptoms stem from the out-of-control inflammatory immune response the virus triggers, something Ampion may be able to address."

The trial will be led by Principal Investigator Michael J. Barber, MD, PhD, FACC, FHRS, FAHA, who has more than 36 years of practice as a board-certified Internist, Cardiologist and Electrophysiologist and is the Director of Medical, Cardiovascular and Intravenous Nutritional Services for the Strata Integrated Wellness Spa.

https://finance.yahoo.com/news/ampio-pharmaceuticals-receives-investigational-review-131500630.html

Altimmune: New Preclinical Data Plus for AdCOVID Sterilizing Immunity on Single Intranasal Dose

 Data Show No Detectable Levels of Infectious Virus in Lungs of Vaccinated Mice Following Challenge with SARS-CoV-2

Sterilizing Immunity Believed to be Critical for Blocking Viral Transmission

Phase I Clinical Trial of AdCOVID Expected to Report Data in June 2021

Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced positive results from a preclinical study of AdCOVID in a SARS-CoV-2 challenge model of infection. In this study, a single intranasal dose of AdCOVID provided sterilizing immunity in the lungs of vaccinated mice, in contrast to the development of dense pulmonary infection and disease in the lungs of non-vaccinated mice following infection with SARS-CoV-2. AdCOVID is a novel, single-dose intranasal vaccine candidate for COVID-19.

“These latest data are very exciting, as they confirm and expand upon the numerous potential advantages of our differentiated intranasal vaccine approach,” said Scot Roberts, Ph.D., Chief Scientific Officer at Altimmune. “In the current study, we found a heavy burden of infectious SARS-CoV-2 virus in the lungs of non-vaccinated mice following challenge with the virus. Importantly, no detectable levels of infectious virus were observed in the lungs of AdCOVID-vaccinated animals.”

Dr. Roberts continued, “These data suggest that a single intranasal vaccination with AdCOVID may provide sterilizing immunity that neutralizes infectious virus, which is believed to be the best way to block viral transmission. Blocking transmission is critical for preventing spread of the virus and preventing the emergence of new variants of concern, both of which have the potential to prolong the pandemic. We continue to be encouraged by the accumulating preclinical data for AdCOVID and look forward to reporting the results of our ongoing Phase 1 clinical trial later this quarter.”

“Growing vaccine hesitancy, which is emerging as a real problem in the fight against SARS-CoV-2, underscores the importance of developing novel vaccine approaches like AdCOVID, which is a needle-free, thermostable vaccine that may be delivered in a single-dose and has the potential to prevent SARS-CoV-2 transmission. These attributes could foster vaccine acceptance, both nationally and globally. In addition, intranasally delivered AdCOVID could play a critical role in re-vaccination campaigns to control future spread of the virus, and ultimately to help bring an end to this devastating global pandemic,” said collaborator Frances Lund, Ph.D., Charles H. McCauley Professor and Chair for the Department of Microbiology at the University of Alabama at Birmingham (UAB).

https://finance.yahoo.com/news/altimmune-announces-preclinical-data-adcovid-110000925.html

Novavax: Positive Preclinical Data for Combo Flu- COVID-19 Vax Candidate

  Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data from a preclinical study of the company's combination quadrivalent seasonal flu vaccine (NanoFlu™) and COVID-19 vaccine candidate (NVX-CoV2373). The NanoFlu/NVX-CoV2373 combination vaccine demonstrated positive immune responses to both influenza and SARS-CoV-2. A pre-print of the manuscript is available at bioRxiv.org.

The manuscript, titled 'Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M™ Adjuvant,' studied a combination vaccine comprising a quadrivalent nanoparticle influenza vaccine formulated together with a recombinant SARS-CoV-2 spike protein vaccine and Matrix-M™ adjuvant. The combination vaccine elicited robust responses to both influenza A and B and protected against the SARS-CoV-2 virus. Clinical studies of the combination vaccine are expected to begin by the end of the year.

"Despite low rates during the COVID-19 pandemic, influenza remains a significant risk to global public health and the need for versatile, more effective vaccines is as important as ever, including against the flu. This study's results build on our success to-date with NVX-CoV2373, and with NanoFlu, which successfully achieved all of its objectives in a pivotal Phase 3 trial announced last year," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "We believe that this novel combination vaccine candidate, which leverages Novavax' technology platform and Matrix-M™ adjuvant, could be an important future tool in the long-term fight against both of these harmful respiratory viruses."

https://finance.yahoo.com/news/novavax-announces-positive-preclinical-data-131200356.html

China denounces US appeal for Taiwan to join WHO meeting

 China’s government criticized U.S. Secretary of State Antony Blinken on Monday for urging the World Health Organization to invite Taiwan, the island democracy claimed by Beijing as part of its territory, to participate in a meeting this month.

Blinken’s statement Friday adds to a similar joint appeal by foreign ministers of the Group of Seven major economies this month in London. That irked the Communist Beijing government, which insists Taiwan has no right to conduct foreign relations or join global bodies.

Blinken’s appeal “seriously violates the ‘one-China principle’” and joint U.S.-Chinese declarations, said a Foreign Ministry spokesperson, Hua Chunying. “China firmly deplores and rejects it.”

Taiwan split with the Chinese mainland in 1949 after a civil war. The two sides have extensive trade ties but no official relations.

The United States and other major governments have no official ties with Taiwan, but Washington and some others have expressed growing support for Taiwan during the coronavirus pandemic and in response to Beijing’s increasing assertiveness abroad.

Blinken called Taiwan a “force for good in the world” and said it should be invited as an observer at the meeting of the World Health Assembly, the WHO decision-making body. He said it could make “valuable contributions” as the world tries to end the pandemic.

Hua accused Washington of making the appeal “for political purposes.” She said it is “detrimental to future global response to public health crises.”

Hua said Taiwan is part of China’s “core interests,” a term Beijing uses to describe issues over which it might be willing to go to war.

“China has no room for compromise on this,” she said. “We advise individual countries to immediately stop hyping Taiwan-related issues.”

https://apnews.com/article/united-nations-taiwan-china-coronavirus-pandemic-health-4beaae86c552af30248b400f629d7b09

NOVARTIS AG: Receives Buy rating from UBS

 Analyst Laura Sutcliffe from UBS research considers the stock attractive and recommends it with a Buy rating. The target price remains unchanged at CHF 96.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/NOVARTIS-AG-nbsp-Receives-a-Buy-rating-from-UBS-33209459/