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California-based Anixa Biosciences, Inc. announced that the European Patent Office has issued and published the first European patent for its novel ovarian cancer vaccine technology.
The patent is titled "Ovarian Cancer Vaccines," and the inventors are Drs. Vincent K. Tuohy, Suparna Mazumder, and Justin M. Johnson, all of Cleveland Clinic. This technology was developed at Cleveland Clinic, and Anixa is the worldwide licensee.
"The ovarian cancer vaccine targets a protein (the Extracellular Domain of the Anti-Mullerian Hormone Receptor 2, AMHR2-ED) that is expressed only in the ovaries and only in pre-menopausal women. After menopause, the target protein disappears and is only seen again when ovarian cancer cells arise. Our vaccine targets the AMHR2-ED and trains the immune system to destroy these cancer cells as they arise," commented Dr. Vincent Tuohy of the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute in a press release issued on March 12, 2021.
"We are looking forward to our continued alliance with Anixa Biosciences to develop this technology further."
Anixa is a publicly-traded biotechnology company developing several programs addressing cancer and infectious disease.
The U.S. CDC announced today the World Health Organization had recommended the Northern Hemisphere 2021–2022 influenza vaccine composition, and the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee subsequently made the influenza vaccine composition recommendation for the USA.
The 2021–2022 U.S. influenza vaccines' composition includes updates to the influenza A(H1N1)pdm09 and influenza A(H3N2) components.
These vaccine recommendations were based on several factors, including global influenza virologic and epidemiologic surveillance, genetic characterization, antigenic characterization, and the candidate vaccine viruses for production.
U.S. egg-based influenza vaccines are recommended to contain the following:
- A/Victoria/2570/2019 (H1N1)pdm09-like virus
- A/Cambodia/e0826360/2020 (H3N2)-like virus
- B/Washington/02/2019 (B/Victoria lineage)-like virus
- B/Phuket/3073/2013 (B/Yamagata lineage)-like virus (for quadrivalent vaccines)
U.S. cell- or recombinant vaccines are recommended to contain the following:
- A/Wisconsin/588/2019 (H1N1)pdm09-like virus
- A/Cambodia/e0826360/2020 (H3N2)-like virus
- B/Washington/02/2019 (B/Victoria lineage)-like virus
- B/Phuket/3073/2013-like (B/Yamagata)-like virus (for quadrivalent vaccines)
Flu shots for the current influenza season remain available in most pharmacies in the USA.
The U.S. CDC reported today the Influenza Hospitalization Surveillance Network confirmed between October 2020 and March 6, 2021, influenza-related hospitalizations are much lower than average for this point in the annual flu season and lower than rates for any season since 2005.
Nationwide during week #9, 0.8% of patient visits reported were due to Influenza-like Illness, which is far below the national baseline of 2.6%.
And a total of one (1) influenza-associated pediatric death occurring during the 2020-2021 flu season has been reported to CDC as of March 12, 2021. During the 2019-2020 flu season, the CDC had confirmed 196 pediatric fatalities.
Separately, the European CDC reported the influenza epidemic in the European Region has usually reached its peak by this point in the year, but despite widespread and regular testing for influenza viruses reported influenza activity still remains at a very low level. Of 1,026 specimens tested for influenza viruses in week 09/2021, from patients presenting symptoms to sentinel primary healthcare sites, three were positive. No hospitalized laboratory-confirmed influenza cases were reported in week 09/2021.
Since influenza outbreaks are unpredictable, the CDC says, 'An annual flu vaccine is the best way to protect against flu and its potentially serious complications.'
Barcelona-based AELIX Therapeutics S.L. announced positive topline results in the AELIX-002 trial on March 10, 2021. The study evaluated the AELIX’s HTI T-cell therapeutic HIV vaccine candidate within early-treated people living with HIV.
Participants underwent an analytical treatment interruption (ATI) in their antiretroviral therapy (ART) for up to 24 weeks for this evaluation. During this time, plasma viral load was monitored weekly. The data show a higher proportion of participants off ART in the treated group.
This signal is strongest among participants without a favorable genetic background, i.e., participants without specific HLA class I alleles, which have been associated with spontaneous control of HIV. In these participants, 8 (40%) vaccinated participants were able to remain off ART treatment for over 22 weeks, compared to only 1 (8%) in the placebo group.
“These encouraging efficacy data demonstrate that the HTI vaccine was able to modulate an individual’s HIV-specific immune response, in a way that can contribute to a better HIV control in the absence of ongoing antiretroviral therapy,” commented Dr. Beatriz Mothe, principal investigator of the study at Fundació Lluita contra la Sida i les Malalties Infeccioses and associate researcher at the IrsiCaixa AIDS Research Institute, located at the Hospital Germans Trias i Pujol, in Badalona, Spain.
Key results of the AELIX-002 Phase I/IIa trial include:
- A total of 45 participants received DDDMM (n=30) or PPPPP (n=15). Of the 45 participants, 41 further completed the CCM (n=26) or PPP (n=15) regimen and entered the ATI
- Immunizations were well tolerated, with neither unexpected nor related serious adverse events (SAEs), and were immunogenic in 97% of vaccine recipients (defined by a >2-fold increase in HTI-specific T cell responses compared to baseline)
- For participants without beneficial HLA class I alleles (32 of the 41); 8 of the 20 vaccinees (40%) versus 1 (8%) of the 12 placebo recipients were able to remain off ART for 22 weeks (∆ 32%, 80% CI [7.6; 55.7]); with pVL <2,000 copies/mL being observed in 5 vaccines and 1 placebo recipient, respectively
- The magnitude of HTI-specific responses at the time of ATI start correlated with time off ART in vaccinees (Rho 0.65, p<0.01).
“The AELIX-002 data are super exciting, this is the first time we have seen this impact on viral replication. I think the study has convincingly shown that the HTI vaccines can generate immune control; it is clear that they should be considered as a backbone for future HIV cure eradication trials,” said Prof Sharon Lewin, director of the Peter Doherty Institute for Infection and Immunity and professor of medicine at the University of Melbourne, Australia.
The U.S. Centers for Disease Control and Prevention (CDC) adjusted the Travel Health Advisory Notice for Bermuda on March 1, 2021, upgrading its status from Level 4 to Level 3.
The CDC says the COVID-19 risk in Bermuda remains moderate. However, it recommends avoiding nonessential travel. And, check the vaccines and medicines list and visit your doctor at least a month before your trip. Use the CDC's Healthy Travel Packing List for Bermuda for a list of health-related items to consider packing for your trip.
The U.S. Consulate continues to engage with the CDC and Department of State, providing updates on Bermuda’s status during the pandemic, safety protocols, and testing regime for residents and visitors.
Furthermore, the State Department offers the Smart Traveler Enrollment Program is a free service to allow U.S. citizens and nationals traveling and living abroad to enroll with the nearest U.S. Embassy or Consulate. Enrollees receive important information from the Embassy about safety conditions in your destination country, helping you make informed decisions about your travel plans.
And travelers to Bermuda must follow the requirements in the Quarantine (No.3) Order 2020. Both visitors and residents must apply for a Bermuda COVID-19 Travel Authorisation 1 to 3 days before departure and cannot travel to Bermuda without an approved Travel Authorisation. Submission of a Travel Authorisation within 24 hours of your travel date will not be approved.
Immunized visitors are required to wear a red Traveler Wristband until they receive their second negative test result.
U.S. Consulate General Hamilton recommends exercising caution when traveling abroad due to the unpredictable nature of the pandemic. As conditions evolve, the CDC and Department of State will regularly update advice to U.S. travelers. Visit the Consulate at 16 Middle Road, Devonshire, DV 03, Bermuda.
France-based Transgene announced the expansion of Phase II clinical trial of therapeutic vaccine TG4001 combined with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital cancers. Patient enrollment is expected to start in Q2 2021.
The trial will focus on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases, including cervical, vulvar, vaginal, penile, and anal cancer.
The initial Phase Ib/II trial conducted in France and Spain was amended to include a randomized comparison of TG4001 with avelumab versus avelumab monotherapy in anogenital cancers. The submission of the amended protocol has been initiated in Europe. Also, Transgene received U.S. FDA clearance of the protocol under TG4001 IND.
This randomized Phase II trial will be supported by continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab. Transgene retains all rights to TG4001.
Commenting on this novel investigational immunotherapy regimen, Prof. Christophe Le Tourneau, M.D., Head of the Department of Drug Development and Innovation at the Curie Institute and Principal Investigator of the trial, added: “The promising data that we generated in the Phase Ib/II part of this study, in patients without liver metastases, gives me confidence that the amended study can generate the additional data needed to confirm the treatment benefits of the combination of TG4001 and avelumab in this patient population with very limited therapeutic options.”
TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector (MVA), which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens that can be found in HPV16-related tumors and to further stimulate the infection-clearing activity of the immune system through interleukin 2.
Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies to treat cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.
