Patent Application Submitted Covering Vaccines for Flu, Hepatitis C, Cytomegalovirus and Human Papillomavirus
Oslo 07.06.2012 - The new patent application aims to strengthen the Company`s general protection of its peptide based vaccines, and includes the four specific product patents Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV
The new patent filed 6 June aims to strengthen the Company`s general protection of its peptide based vaccine technology, including four specific product patents:
- Vacc-Flu is a universal influenza vaccine that researchers believe could produce long lasting immunity, and be effective for all seasonal variations of influenza A.
- Vacc-HCV is a vaccine that may be effective both as a therapy and for prevention of chronic liver infection. Hepatitis C (HCV) may lead to liver failure and liver cancer.
- Vacc-CMV is a vaccine for treating cytomegalovirus (CMV) infection, which has been associated with inflammatory diseases as well as aggravating various cancer forms such as brain tumors and prostate cancer.
- Vacc-HPV is a vaccine for treating throat and vaginal cancer caused by Human papillomavirus (HPV).
Bionor Pharma ASA announced today that it has initiated the international patent process for further protection of the Company`s peptide vaccine technology platforms, and for the vaccine candidates Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV. This new peptide vaccine platform submission complements the two previous filed technology platform patents covering peptide vaccines designed for generation of antibody responses and peptide vaccines designed for generating T-cell responses.
All the vaccine candidates are developed from conserved parts (proteins) of the respective viruses. By applying the platform technology to modify the peptides, the vaccines are shown to have significantly improved immune response properties as compared to the corresponding unmodified (native) peptides.
The new platform patent is also covering protection of the various administration regimes connected to the vaccines. Preclinical research is ongoing for both the influenza and the HCV vaccines.
Developing a “universal” influenza vaccine has been difficult because influenza viruses undergo constant genetic mutation. Vacc-Flu targets conserved regions, the “Achilles’ Heels” that are common to all known Influenza A viruses. The vaccine is designed to provide long-term protection over several years, reducing deaths and related illnesses caused by all current influenza A subtypes, as well as future influenza viruses that may emerge and lead to an influenza pandemic. Vacc-Flu has shown in animal studies to reduce serious flu symptoms by 25 percent over the standard flu vaccine.
“The benefits of a universal vaccine far outweigh the current seasonal vaccine development approach,” said Steen Krøyer, CEO, Bionor Pharma. “The goal is to eliminate the need for researchers to develop annual vaccines, a challenging process that requires manufacturers to operate on a tight schedule to meet WHO recommendations.”
The global market for an influenza vaccine is approximately 250 million doses corresponding to annual sale of approximately $2 billion to $2.7 billion. Today's influenza vaccines are specific only for one season and new vaccines have to be developed each year.
Bionor`s therapeutic vaccine for hepatitis C, Vacc-HCV aims to treat chronic HCV infection that affects the liver and may lead to scarring and cirrhosis with liver failure or liver cancer in advanced disease.
An estimated 150 million people are living with chronic hepatitis C and between three and four million people become infected per year. Over 350,000 deaths annually are attributed to hepatitis C-related diseases.
Although new drugs are expected to enter the market, these treatments will not be without side effects and treatment failures. This opens the door to even better stand-alone therapy or combination therapies, including a therapeutic vaccine.
Bionor’s therapeutic CMV vaccine targets diseases associated with cytomegalovirus (CMV) infection. Researchers believe that CMV may not itself be the disease causing agent, but that it aggravates disease by changing the environment, resulting in a weakened immune system. Thus CMV may be a contributing factor to inflammatory diseases or tumor growth. In a number of inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease and psoriasis, active CMV infection can be detected. In various cancer forms such as prostate, colon, breast and brain cancer, CMV can be detected in the tumor but not in the nearby tissue.
Vacc-CMV will be developed as a therapeutic T-cell (killer cell) vaccine for treatment of CMV positive patients with inflammatory diseases or cancer.
The Human papillomavirus is made up of a group of DNA viruses in the family Papillomaviridae that infect the skin and mucous membranes causing genital warts, cervical cancer and a growing number of throat cancer cases. Worldwide, cervical cancer remains the second most common malignancy in women, and is a leading cause of cancer related death for females in developing countries. Company researchers believe Vacc-HPV will be a therapeutic T-cell (killer cell) vaccine aiming to complement today`s standard of care.
About Bionor Pharma ASA
Bionor Pharma is a leading vaccine company, listed at Oslo Stock Exchange. The Company's investments in developing therapeutic vaccines exceed US$70 million.
Bionor's vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral diseases. The Company’s lead HIV vaccine, Vacc-4x, is being investigated as a therapeutic vaccine, and has completed a phase 2b randomized, multinational (USA and 4 European countries), double-blind, placebo-controlled trial. It produced a statistically significant reduction in viral load and viral load set point by killing of virus producing cells.
Bionor`s second therapeutic HIV vaccine, Vacc-C5, is developed to induce antibodies to HIV that can reduce viral production (lowering the set point) and the harmful hyperactivation of the immune system that leads to AIDS. Recently, the clinical phase I/II study with Vacc-C5 was approved by the Norwegian Clinical Board. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventative HIV vaccine.
The Company's innovative technology platform is also well suited to develop vaccines for other viral diseases, including Influenza, HCV (Hepatitis C), CMV (Cytomegalovirus) and HPV (Human papillomavirus).
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act). Vacc-4x, Vacc-C5, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are investigational treatments that have not been approved for marketing by any regulatory authority.
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Bionor Pharma ASA, Oslo: +47 23 01 09 60/ Bionor Pharma laboratories: +47 35 90 85 00
Steen Krøyer, CEO
Birger Sørensen, EVP, Head of Vaccines
David Sheon 202 422-6999