India drug regulator asks Dr.Reddy's for more data on Sputnik V COVID-19 vax

 

An expert panel of India's drug regulator on Friday sought additional data from drugmaker Dr.Reddy's Laboratories on its Sputnik V COVID-19 vaccine trial, in its second such request after an initial evaluation in February.

The committee asked the company to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported till date.

Dr.Reddy's has been conducting small clinical trials with Sputnik V in India under a deal with Russia's wealth fund. Several Indian companies have signed deals to produce and supply over half a billion doses of the vaccine.

https://www.marketscreener.com/quote/stock/DR-REDDY-S-LABORATORIES-6492671/news/Dr-Reddy-Laboratories-nbsp-India-drug-regulator-asks-Dr-Reddy-s-for-more-data-on-Sputnik-V-COVID-1-32925494/

EU seeks new contract with Pfizer/BioNTech for up to 1.8B vaccine doses from 2022

 The European Commission is seeking EU governments’ approval to launch talks with Pfizer and BioNTech for the purchase of up to 1.8 billion doses of their COVID-19 vaccines to be delivered in 2022 and 2023, an EU official told Reuters.

Earlier on Friday, German daily Die Welt reported that the Commission was shortly to sign contracts to buy up to 1.8 billion doses, but did not say with which company.

The EU official, who asked not to be named because the matter is confidential, said the EU executive had already decided to approach Pfizer-BioNTech and that EU governments backed the plan, though there was not yet a definitive approval.

A Commission spokesman confirmed plans to buy the additional doses, of which half would be optional.

He also confirmed that the EU executive had already identified one supplier, a manufacturer of mRNA vaccines, but declined to comment on which company would be approached to negotiate the contract.

“If provided the opportunity Pfizer and BioNTech are prepared to supply Europe with hundreds of millions of doses of COVID vaccines in 2022 and 2023 produced in our manufacturing facilities in Europe,” a Pfizer spokesman said.

The two companies have the capacity to produce more than 3 billion doses of vaccine in 2022, he added.

Pfizer-BioNTech and Moderna are already supplying the EU with mRNA vaccines and German biotech firm CureVac is seeking EU approval for its mRNA shot.

The vaccines would be delivered under monthly timetables and with clauses obliging the supplier to deliver, the EU official said.

https://www.reuters.com/article/us-health-coronavirus-eu-pfizer/eu-seeks-new-contract-with-pfizer-biontech-for-up-to-1-8-billion-vaccines-from-2022-eu-source-idUSKBN2BW1VV

Biotech firm Ginkgo in talks with Harry Sloan-led SPAC for over $20B deal

 Biotech startup Ginkgo Bioworks is in talks to go public through a merger with a blank-check firm backed by former Hollywood executives Harry Sloan and Jeff Sagansky, in a deal valued at about $20 billion, a person familiar with the matter said.

The company is in exclusive talks with Soaring Eagle Acquisition Corp for a potential business combination and a deal could be announced as soon as this month, the source said on Friday.

Soaring Eagle declined to comment on the matter.

Boston-based Ginkgo is backed by Bill Gates’ private investment firm, Cascade Investment, and hedge fund Viking Global. It received a $1.1 billion loan from the U.S. government in November for COVID-19 testing and production of raw materials for therapies that may help address future pandemics.

Soaring Eagle, a special purpose acquisition company (SPAC), raised $1.7 billion through an initial public offering in February.

Sloan, a former chief executive officer of Metro Goldwyn Mayer, and Sagansky’s former SPACs took gaming firms DraftKings Inc and Skillz Inc public.

SPACs are shell companies that raise funds through an initial public offering to take a private company public through a merger at a later date.

https://www.reuters.com/article/us-ginkgo-bioworks-m-a/biotech-firm-ginkgo-in-talks-with-harry-sloan-led-spac-for-over-20-billion-deal-idUSKBN2BW2AQ

J&J COVID-19 vaccine under EU review over blood clots

 EMA says no causal link yet of blood clots to either vaccine

* Four cases of blood clots in recipients of J&J shots

* J&J says working with regulators to assess data on its vaccine

* Probe of AstraZeneca vaccine and blood clots already ongoing

Europe's drug regulator said on Friday that it is reviewing rare blood clots in four people in the United States who received Johnson & Johnson's COVID-19 vaccine.

The European Medicines Agency's safety committee has also been looking at how AstraZeneca's COVID-19 vaccine is associated with very rare cases of unusual blood clots and said it was now reviewing reports of capillary leak syndrome in people given AstraZeneca's vaccine.

Johnson & Johnson (J&J) said it was aware of the rare reports of blood clots in individuals given its COVID-19 vaccine, and was working with regulators to assess the data and provide relevant information.

"At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine," the company said in an emailed statement.

Of the four serious cases of clotting and low platelets, three occurred in the United States during the rollout of J&J's vaccine from its Janssen unit, the European Medicines Agency (EMA) said. That was in addition to one person who died from a clotting disorder reported in J&J's clinical trial.

Nearly 5 million people in the United States had received J&J's vaccine as of Thursday morning, according to the U.S. Centers for Disease Control and Prevention.

The report from the European Medicines Agency is the first to mention a probe of blood clots associated with the J&J vaccine.

The U.S. Food and Drug Administration said it would respond shortly to a request for comment.

It follows a probe of blood clots in the brain reported in people given the AstraZeneca vaccine that have caused some European countries to change their vaccine recommendations.

In its report on Friday, EMA's safety committee said unusual blood clots linked with low blood platelets should be listed as very rare side effects of the AstraZeneca vaccine.

It has also started to investigate reports of capillary leak syndrome - which causes blood vessel swelling and a drop in blood pressure - in five people who received the AstraZeneca vaccine. The safety panel said it was not clear whether these were linked with the vaccine. AstraZeneca did not immediately respond to a request for comment.

Ian Douglas, a professor of pharmacoepidemiology at London School of Hygiene & Tropical Medicine, said the reports were part of a normal process in which the EMA's safety committee reviews important safety signals as they arise.

"It’s too early to comment on the signal of capillary leak with the AZ vaccine, or clots with the Janssen vaccine, but from what we’ve seen in the last few weeks, the EMA’s PRAC (Pharmacovigilance Risk Assessment Committee) will doubtless assess all the evidence they have as thoroughly and quickly as possible," he said.

Some countries in Europe and Asia have restricted the use of AstraZeneca's vaccine, Vaxzevria, in younger people following an update by EU and UK regulators this week that found a link between the events and the shot. Regulators have said the benefits of the vaccine outweigh the risks.

Dr. Jesse Goodman, an infectious disease expert at Georgetown University in Washington D.C. and a former chief scientist for the U.S. Food and Drug Administration, said in a briefing on Thursday that he was "fairly convinced" the brain blood clots were linked with the AstraZeneca vaccine, but said the events are rare and the risk during an active outbreak from COVID "is much higher."

J&J's single-dose vaccine has been approved for EU use, but a rollout is yet to begin. It is mainly being used in the United States currently.

The J&J and AstraZeneca shots are two of the four approved COVID-19 vaccinations in Europe.

https://finance.yahoo.com/news/3-j-j-covid-19-172538947.html

Benzinga tells GeoVax vaccine innovation story

 GeoVax Labs, Inc. (NASDAQ: GOVX), a biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, presented at the Benzinga Biotech Small Cap Conference in March, with the company’s Chief Scientific Officer Mark Newman, Ph.D., participating in a panel discussion entitled, Cancer Immunotherapies: Fighting Cancer with the Power of the Immune System.

GeoVax, which utilizes Modified Vaccinia Ankara (MVA)-Virus Like Particles (VLP) as a recombinant viral vector to express vaccine antigens of interest in a format suitable for global use continues to develop new and innovative programs. Focused on preventive vaccines against COVID-19, HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines against multiple cancers, GeoVax is at the forefront of forward-thinking vaccine science.

GeoVax’s COVID-19 animal testing results, guiding its path to clinical development, will become available soon. With the many COVID strains currently out, it’s become a race between getting people vaccinated and following the many variants.

GeoVax is unique in its work in developing vaccines that get ahead of the new variant strains and could be ready to anticipate whatever the next pandemic threatens. The company is now focused on a single-dose COVID vaccine that requires no refrigeration, and after its animal testing results are completed could move into the clinic for testing very soon.

With the National Institutes of Health (NIH) asking for more vaccine proposals, GeoVax says it's poised to make new submissions. The company has recently signed two additional license agreements with the NIH allowing the use of patent rights and licensed materials in combination with its proprietary technology to develop, manufacture and commercialize a preventive vaccine against COVID-19.

The second license supports the ongoing research and development of its other infectious disease vaccine and cancer immunotherapy programs, leading to critical decisions related to clinical development. Together, these two licenses support GeoVax’s ongoing developments and progress of its product portfolio. The company adds that its goal is to pick candidates for the next clinical trial by the end of June 2021.

GeoVax has also designed a preventive HIV vaccine candidate to fight against the subtype of HIV prevalent in the commercial markets of the Americas, western Europe, Japan and Australia. Human clinical trials for this program are managed by the HIV Vaccine Trials Network (HVTN) with the support of the NIH. GeoVax’s HIV vaccine is also part of two separate collaborative efforts to combine its vaccine with gene therapy and monoclonal antibody treatments approach toward a functional cure for HIV.

The company’s Zika virus vaccine is ready to proceed into clinical development, having demonstrated excellent preclinical results, including avoiding the risk of antibody-dependent enhancement of infection against Dengue or other flaviviruses. Similarly, GeoVax’s Ebola virus vaccine is ready to proceed into clinical development and has demonstrated 100% protection from a single dose without any adjuvants.

GeoVax’s clinical success has matched its improved financial position, including its ability to enhance its capital structure, secure long-term funding, sign critical licensing agreements, accelerate its preclinical development programs toward clinical development and achieve a Nasdaq listing. The company is also expecting to reach numerous vaccine development milestones over the next 6 to 12 months.

https://finance.yahoo.com/news/geovax-vaccine-innovation-poised-save-142512540.html

Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine for ages 12-15

 Pfizer Inc and its German partner BioNTech SE said on Friday they have requested the U.S. Food and Drug Administration to expand the emergency use of their COVID-19 vaccine in adolescents aged 12 to 15.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.

Whether COVID-19 vaccines work and are safe to use on children is one of the big questions drugmakers are trying to answer. Inoculating children and young people is considered a critical step toward reaching "herd immunity" and taming the pandemic, according to experts.

The companies plan to request similar rulings by other regulatory authorities globally in the coming days.

The Pfizer/BioNTech two-shot vaccine is already authorized for use in people as young as 16.

https://finance.yahoo.com/news/1-pfizer-biontech-seek-u-172218004.html

Sanofi acquires Tidal Therapeutics, adds innovative mRNA-based research platform

 Sanofi today acquired Tidal Therapeutics, a privately owned, pre-clinical stage biotech company with a novel mRNA-based approach for in vivo reprogramming of immune cells. The new technology platform will expand Sanofi’s research capabilities in both immuno-oncology and inflammatory diseases, while likely having broad applicability to other disease areas as well. Sanofi acquired Tidal Therapeutics for an upfront payment of $160 million and up to $310 million upon achievement of certain milestones.

“We anticipate that this next generation, off-the-shelf approach has the potential to bring CAR-T cell therapy to a much broader patient population,” said Frank Nestle, Global Head of Research and Chief Scientific Officer at Sanofi. “We believe that the underlying mRNA targeting platform will create disruptive therapeutic approaches across a variety of oncology and autoimmune conditions.”

Tidal Therapeutics utilizes a novel mRNA-based approach to in vivo reprogramming of immune cells. The technology is based on proprietary nanoparticles that deliver mRNA (messages) to reprogram immune cells inside the body. The technology delivers mRNA cargos selectively to designated types of cells in the body, with initial applications targeting specific types of immune cells. The in vivo approach is designed to provide similar efficacy to current ex vivo (outside the body) approaches where immune cells are genetically modified to enhance their therapeutic properties (such as chimeric antigen receptor [CAR]-expressing T-cells), with the potential for improved safety, outpatient dosing, and repeat dosing. Currently, Tidal Therapeutics has ongoing pre-clinical programs including in vivo re-programming of T cells or other types of immune cells for cancer indications.

https://finance.yahoo.com/news/sanofi-acquires-tidal-therapeutics-adding-174500431.html