Heat Biologics' Additional Preclinical COVID-19 Vaccine Results

 Spike specific CD8+ and CD4+ T-cell memory responses observed 30- and 60- days post vaccination

Heat Biologics, Inc. ("Heat")(NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, announces the publication of additional preclinical COVID-19 results in Frontiers in Immunology, a leading peer reviewed journal, which is available online.

The publication highlights additional data sets around memory T-cells that builds upon data previously reported and published in bioRxiv. Specifically, the new data demonstrates polyfunctional, anti-viral cytokine releasing, Spike protein specific CD8+ and CD4+ T-cell memory responses in the lungs and spleen of immunized animals, observed 30 days post single vaccination. Additionally, memory CD8+ T-cell responses were observed 60 days post vaccination in the lungs of mice.

The new data points to the significance of lung tissue-resident memory T-cells which are required for clearance of respiratory virus infections. Vaccination strategies that target generation of tissue-resident memory T-cells and their persistence may provide enhanced immunity compared with vaccines that rely on circulating responses.

Jeff Wolf, Heat's CEO, commented, "We are excited to announce the publication of this latest data, further reinforcing the potential of our COVID-19 vaccine to induce a durable cellular immune response and protect against reinfection."

https://finance.yahoo.com/news/heat-biologics-announces-publication-additional-123000211.html

Immutep Advances Phase II Trial For Eftilagimod Alpha In Covid-19

  Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, announced that an independent Data and Safety Monitoring Board (DSMB) has completed a safety run-in data review of the first six patients from the Phase II clinical trial of Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease (EAT COVID), being conducted by the University Hospital Pilsen, Czech Republic. Following this data review, the DSMB recommended that the study advance with enrolment for the randomised portion of the study. All six patients (age range, 50-83 years; 2 women) received the three planned 10 mg efti injections and have since been discharged from hospital. No adverse events have been reported.

https://www.globenewswire.com/news-release/2021/01/27/2165016/0/en/Immutep-Announces-Advancement-Of-Phase-II-Trial-For-Eftilagimod-Alpha-In-Covid-19-Patients-To-Randomised-Portion-Of-The-Study.html

AstraZeneca to test if longer wait between 2 COVID vax doses works better

 AstraZeneca Plc plans to conduct a global study to find the optimal interval between the two doses of its coronavirus vaccine. "The new trial will investigate a two-month gap between shots to determine whether it can provide better efficacy," chief executive Pascal Soriot told a group of European newspapers Tuesday.

The trial data published by AstraZeneca and Oxford raised questions after one arm of the study that received a half-dose followed by a full-dose of vaccine produced an efficacy of 90%, compared with 62% for two standard doses.

A panel of scientists behind the U.K. approval said in December that the higher efficacy seen from the half-dose regimen could be attributed to the gap between injections rather than dosing level.

“You get a better efficiency if you get the second dose later," Soriot told the newspapers, including Italy’s La Repubblica. “We are going to do a study in the US and globally to use two-month dose interval to confirm that this is indeed the case."

AstraZeneca executive Mene Pangalos told a UK parliamentary committee earlier this month that further analysis of the trial data suggested an increased interval raised efficacy and that an 8- to 12 week gap looked to be the “sweet spot."

United Kingdom approved the vaccine, developed with the University of Oxford and AstraZeneca, last month with a 4-to 12-week dosing interval.

India approved emergency authorisation of Covishield by Serum Institute of India. It is the local version of Oxford-AstraZeneca COVID-19 vaccine. In India, the interval between the two dosage will be four weeks.

https://www.livemint.com/science/health/astrazeneca-to-test-if-longer-wait-between-two-covid-vaccine-doses-works-better-11611757502190.html

OncoSec: 1st Dosing in Phase 1 Trial of Covid Vax

 First-in-Class Combination Vaccine Using OncoSec's IL-12 DNA Plasmid-Based Cancer Immunotherapy with the National Institutes of Health's DNA Plasmid-Based Spike Protein

OncoSec Medical Incorporated (NASDAQ: ONCS) today announced that it has dosed several subjects in its Phase 1 clinical trial of CORVax12, the only vaccine candidate to include an immunostimulatory cytokine to address COVID-19. This trial, entitled, CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2)(NCT04627675), will address safety and anti-viral immunological responses with the combination of a DNA-encodable stabilized SARS-CoV-2 spike glycoprotein and OnocSec's cancer immunotherapy candidate, TAVO™ (tavokinogene telseplasmid), a potent and well-characterized plasmid-based IL-12 cytokine.

Similar to other current vaccines, CORVax12 expresses a stabilized SARS-CoV-2 spike protein which trains the immune system to recognize the virus that causes COVID-19. However, the addition of IL-12 may augment the depth and type of immune response, which may enhance long-term anti-viral immunity. This coordinated cellular and humoral immunity is a hallmark of IL-12 and may not only provide for a better vaccine, but could significantly benefit patients with cancer who may not mount an effective immune response via a traditional vaccine approach.

Recent preclinical data on CORVax12 presented at the Society for Immunotherapy of Cancer (SITC)'s 35th Anniversary Annual Meeting demonstrated that CORVax12 induced a strong immune response in mouse models by leading to the production of anti-spike IgG antibodies capable of disrupting the receptor-binding domain of the spike protein.

Additionally, preliminary preclinical data has demonstrated that CORVax12 administered into tumor tissue not only yields a productive anti-viral response, but also a strong anti-tumor response. If these preclinical observations are supported with positive clinical data, this vaccine strategy may be developed to directly treat patients with tumors. Thus, CORVax12 has the potential to effectively combine OncoSec's powerful oncology platform with a strong vaccination.

https://finance.yahoo.com/news/oncosec-announces-first-subjects-dosed-140000640.html

T2 cut to Neutral from Buy by Alliance Global

 Target to $2.40 from$2.60.

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

Immunocore IPO filing reveals kickback scheme, Immatics row, phishing attacks

 Immunocore’s filing for a $100 million IPO has revealed a range of issues affecting the TCR bispecific immunotherapy developer, including a kickback scheme run by a former employee and a trademark row with Immatics.

The kickback scheme involved an Immunocore employee and two third-party vendors. From 2018 to 2020, the parties allegedly took advantage of a weakness in Immunocore’s procurement processes. Immunocore estimates the kickback scheme was worth up to £1.8 million ($2.5 million). 

Immunocore began looking into the activities last year in response to a whistleblower complaint, leading to the resignation of the employee and termination of the one vendor contract that was still open. Last month, Immunocore recovered £1.8 million from the former employee and third-party vendors. 

The investigation showed Immunocore’s internal controls “did not operate effectively to prevent or timely detect unauthorized contracts and purchase orders.” In light of those shortcomings, the U.K. biotech has added personnel to implement procurement controls and improved its purchase order software. The procurement process now features additional layers of contract review. 

Immunocore disclosed the kickback scheme in IPO paperwork that also detailed other issues relevant to potential investors. For example, Immunocore revealed its U.S. trademark application for ImmTAX, the name of its TCR bispecific immunotherapies, is subject to an opposition filed by Immatics. The biotechs are both working on TCR bispecifics. Immunocore warned the dispute may force it to change the branding of the ImmTAX platform, incurring costs and affecting name recognition in the process.  

Finally, Immunocore disclosed “two minor phishing attack incidents” dating back to 2018 and 2019. The IPO filing lacks further details of the attacks but talks in general about the cyberthreats to Immunocore, explaining that “the risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased.”  

https://www.fiercebiotech.com/biotech/immunocore-ipo-filing-reveals-kickback-scheme-immatics-row-and-phishing-attacks

Just - Evotec Expands DoD Contract for Manufacturing Monoclonal Antibodie

 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that the U.S. Department of

Defense ("DOD") awarded its Seattle, Washington-based subsidiary, Just - Evotec Biologics, Inc., an agreement worth 
USD28.6 million for the production of monoclonal antibodies ("mAbs") for use in the development of a treatment and/or 
prophylaxis for COVID-19. 
The DOD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense ("JPEO-CBRND") is 
executing this effort in coordination with the Office of the Assistant Secretary of Defense for Health Affairs ("OASD 
(HA)") and the Defense Health Agency ("DHA"). 
Under the agreement, the DOD will have access to pivotal manufacturing capacity for anti-SARS-CoV-2 mAbs and priority 
access to future biomanufacturing capacity over a period of seven years in the soon-to-be-completed J.POD^(R) facility 
in Redmond, Washington. The agreement represents the continuation of DOD's collaboration with Just - Evotec Biologics. 
The collaboration started in July of 2020 and involved the selection of anti-SARS-CoV2 mAbs, resulting in rapid process 
development and manufacture of high yielding mAbs against SARS-CoV-2. 

https://www.marketscreener.com/quote/stock/EVOTEC-SE-436047/news/PRESS-RELEASE-Just-Evotec-Biologics-Expands-Contract-with-the-Department-of-Defense-for-Manufactu-32283987/