Anixa Gets European Patent for Ovarian Cancer Vaccine Tech

  Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced today that the European Patent Office has issued and published the first European patent for its novel ovarian cancer vaccine technology.  This technology was invented and developed at Cleveland Clinic and Anixa is the worldwide licensee.   

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.

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "We are pleased that the European Patent Office (EPO) has issued this patent.  This ovarian cancer vaccine has the potential to eliminate one of the deadliest malignancies in women.  Ovarian cancer is often diagnosed after it has reached Stage 3 or 4, and when it is difficult to effectively treat.  Five-year survival statistics for ovarian cancer are poor, so if this vaccine is able to eliminate the onset of ovarian cancer, the impact for women and for our healthcare system will be tremendous."

https://www.prnewswire.com/news-releases/anixa-biosciences-announces-issuance-and-publication-of-european-patent-for-ovarian-cancer-vaccine-technology-301246332.html

Cardinal Health sell its Cordis business to Hellman & Friedman

 Cardinal Health (NYSE: CAH) today announced that it has signed a definitive agreement to sell its Cordis business to Hellman & Friedman (H&F) for approximately $1 billion, which includes buyer's assumption of certain liabilities and seller's retention of certain working capital accounts. The transaction is expected to close in the first half of Cardinal Health's fiscal year 2022, subject to customary closing conditions and regulatory clearances.

https://www.prnewswire.com/news-releases/cardinal-health-signs-definitive-agreement-to-sell-its-cordis-business-to-hellman--friedman-301246432.html

S. Africa's drugs regulator to start assessing Sinovac COVID-19 vax

 South Africa’s medicines regulator SAHPRA said on Friday that it had received documentation for the COVID-19 vaccine developed by China’s Sinovac.

It added in a statement that it would now start evaluating the data and assessing the efficacy of the vaccine.

https://www.reuters.com/article/us-health-coronavirus-safrica-sinovac/south-africas-drugs-regulator-to-start-assessing-sinovac-covid-19-vaccine-idUSKBN2B40OP

Berlin talking to Washington on COVID vaccines from U.S.

 Berlin is holding bilateral talks with Washington about missing shipments of COVID-19 vaccines manufactured in the United States, a German government spokesman said on Friday.

Washington has told the European Union that it should not expect to receive AstraZeneca COVID-19 vaccines manufactured in the United States any time soon, two EU sources said on Thursday, in a new blow to the bloc’s supplies.

Steffen Seibert told a regular government news conference that the EU supplies more than 30 countries with vaccine doses, including the United States, and noted this was not the case for the United States.

“This is also an issue the government is addressing in bilateral talks,” Seibert said.

https://www.reuters.com/article/us-health-coronavirus-germany-vaccine/berlin-talking-to-washington-on-covid-vaccines-from-u-s-idUSKBN2B41GG

Doses of Russia's Sputnik V, made in Italy, to go on sale no sooner than late 2021

 Doses of Russia’s Sputnik V vaccine against COVID-19 produced in Italy by Swiss-based pharmaceutical company Adienne Pharma & Biotech will not be available on the market until at least late 2021, the TASS news agency reported on Friday.

Moscow’s RDIF sovereign wealth fund signed an agreement with Adienne earlier this week that will need approval from Italian regulators before production can be launched. It said it had also struck deals with production facilities in Spain, France and Germany.

The production agreements are the latest indication that some companies could press ahead with plans without waiting for the European Union’s regulator, the European Medicines Agency (EMA), to grant its approval to Sputnik V.

“The company will not produce batches for sale until late 2021,” TASS cited Antonio Francesco Di Naro, president of Lugano-based Adienne, as saying.

Di Naro said the company still needed to complete the process of exchanging technology to produce Sputnik V, test its production, and transfer data to national regulators before the shot could go on sale.

https://www.reuters.com/article/us-health-coronavirus-russia-italy/doses-of-russias-sputnik-v-made-in-italy-to-go-on-sale-no-sooner-than-late-2021-tass-idUSKBN2B40YI

Sanofi, Translate Bio launch human trial of mRNA COVID-19 vaccine

 Sanofi and Translate Bio said on Friday they had started a human trial of their mRNA COVID-19 vaccine candidate, the French drugmaker's second vaccine project, which follows a protein-based shot hit by a delay last year.

It is the latest vaccine candidate based on a new technology known as messenger RNA. Shots by Pfizer/BioNTech and Moderna were launched after clinical trials showed high efficacy rates.

Real-world data from the rollout of the Pfizer shot in Israel and Britain have also been encouraging.

Sanofi and Translate Bio expect interim results of the phase I/II study, which will enroll 415 healthy adults across 13 sites, during the third quarter.

Participants will receive either a single dose of the vaccine or two doses 21 days apart while three dose levels will be examined, the companies said.

Sanofi did not give further indication on the timeline of the project.

In December 2020, Sanofi had said it was eyeing "earliest potential approval" of its mRNA vaccine in the second half of 2021, following positive preclinical data, but Sanofi's Chief Executive Paul Hudson told Le Journal du Dimanche newspaper last month the vaccine "will not be ready this year."

Last month, Sanofi and GlaxoSmithKline launched a new clinical trial of a protein-based COVID-19 vaccine candidate in a attempt to revive their efforts against the pandemic after a setback in December delayed the shot's launch.

To appease critics after the delay, Sanofi said earlier this year it agreed to fill and pack millions of doses of vaccines made by Pfizer/BioNTech and Johnson & Johnson.

Global coronavirus infections have exceeded 118 million. Highly transmissible variants of the virus are prompting governments to speed up vaccination.

Sanofi and Translate Bio said ongoing preclinical studies would continue to evaluate whether their vaccine candidate, as well as other mRNA vaccine candidates, would be efficient against variants.

The companies added they were targeting a -20 degrees Celcius storage temperature of the vaccine at launch but that they were also working at enabling the product to be stable at a 2-8 degrees temperature.

https://news.trust.org/item/20210312045708-ihx43/

Altimmune to Expand AdCOVID Manufacturing with Lonza

 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has expanded its previously-announced AdCOVID manufacturing collaboration with Lonza. Under the expanded agreement, Lonza will commission a dedicated manufacturing suite for clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate for COVID-19, at its facility near Houston, Texas.  

“Manufacturing capacity for COVID-19 vaccines has been severely constrained, and this limitation has presented considerable challenges for vaccine developers,” said Dr. Vyjayanthi Krishnan, Ph.D., Vice President of Product Development for Altimmune. “By expanding our Lonza collaboration and commissioning our own dedicated manufacturing suite, we are building extra capacity and redundancy into our manufacturing to support potential late-stage clinical trials with AdCOVID and potential future commercial supply. Lonza continues to be an outstanding partner in this mission, and we are pleased to have the opportunity to further our relationship with this world class team.”

Alberto Santagostino, SVP, Head of Cell and Gene Technologies for Lonza, commented, “Altimmune’s COVID-19 vaccine candidate could be a complete game-changer in the fight against COVID-19. Our reinforced commitment is to enable the team at Altimmune to scale-up production as needed and deliver vaccines at a global scale when ready.”

AdCOVID is a COVID-19 vaccine candidate that is administered via nasal spray. In preclinical studies, AdCOVID was shown to activate systemic immunity (neutralizing antibodies and T cell responses) and mucosal immunity in the respiratory tract. Activation of mucosal immunity may prevent both SARS-CoV-2 virus infection and transmission. In preclinical studies, AdCOVID stimulated a 29-fold increase in mucosal IgA, well above the level associated with protection in clinical studies of influenza.

https://www.globenewswire.com/news-release/2021/03/12/2191849/0/en/Altimmune-Expands-AdCOVID-Manufacturing-Collaboration-with-Lonza.html