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Thursday, June 17, 2021

Synaptogenix funding to support NIH Alzheimer's trial

 Synaptogenix, Inc. (Nasdaq: SNPX), an emerging biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced that it has executed securities purchase agreements to raise gross proceeds of approximately $12.5 million in a private placement financing of common stock and warrants ("Units"). The financing was led primarily by existing institutional shareholders.

Synaptogenix intends to use the net proceeds from the private placement to support the ongoing development of Bryostatin-1, which is currently in a Phase 2b National Institutes of Health ("NIH") sponsored Alzheimer's disease ("AD") trial, as well as additional research and development for new indications.

https://finance.yahoo.com/news/synaptogenix-announces-12-5-million-130000689.html

Midatech Pharma Stock Jumps After Breakthrough Data

 

  • Midatech Pharma PLC (NASDAQ: MTP) has announced a breakthrough in vitro data utilizing Q-Sphera technology and progress across multiple other programs.

  • The technology showed potential to formulate proteins into long-acting injectable products.

  • Q-Sphera can encapsulate drugs in polymer-based bioresorbable microspheres, which may be injected to form depots in the body that release drugs over predictable, sustained periods from one week to several months.

  • Pipeline Update:

    • Monoclonal antibody (mAb) formulation: The Company is working on an exemplar mAb and has demonstrated encapsulation of the mAb, preservation of functional integrity, and antigen-binding in vitro.

    • MTX214 and MTX216: The Company has manufactured and delivered proof of concept formulations to the collaboration partner. Dosing for in vivo studies will start in the next few weeks.

    • MTD211: MTP has developed a long-acting formulation of brexpiprazole.

    • In in vivo studies, MTD211 was well tolerated and demonstrated that a single dose could deliver therapeutic blood levels of brexpiprazole over three months.

    • Marketed under the brand name Rexulti, brexpiprazole is indicated to treat schizophrenia and adjunctive treatment of major depressive disorder and is available as an immediate release oral tablet.

    • MTX110: Formulated panobinostat administered through convection-enhanced delivery, is in clinical development for intractable brain cancers including Diffuse Intrinsic Pontine Glioma (DIPG) and Glioblastoma Multiforme (GBM).

    • Phase 2 study in DIPG will start later this year.

    • Midatech Pharma's strategy is to develop each program to proof-of-concept before seeking licensing partners for later-stage development and commercialization.

  • The Company hosted a webinar at 9.00 am EST today.

Ocugen jumps on choosing partner to make Covid vax

 Shares of clinical-stage biopharmaceutical company Ocugen Inc.  (OCGN) - Get Report jumped Tuesday after the company announced that it has selected a manufacturing partner for Covaxin, a coronavirus vaccine candidate. 

Ocugen said it will partner with Jubilant HollisterStier of Spokane, Wash. to prepare for the potential commercial manufacturing of Covaxin for the U.S. and Canadian markets. 

"We are fully committed to bringing Covaxin to the U.S. and Canadian markets because we believe it has the potential to save lives by adding a weapon to the arsenal in the fight against emerging variants [of COVID-19],” said Ocugen Senior VP J.P. Gabriel. 

Ocugen shares jumped 8.2% to $6.64 per share Tuesday morning. They are up almost 2

In May, the company said that a new study found its coronavirus-vaccine candidate was potentially effective against the Brazil variant of COVID-19.

“Securing U.S.-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada," Gabriel said. 

Covaxin was initially developed by India's Bharat Biotech in collaboration with the Indian Council of Medical Research. The vaccine has an efficacy rate of 78% overall and 100% against severe COVID-19 disease

"Based on Bharat Biotech’s strong track record of developing and commercializing vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition U.S. manufacturing of Covaxin to our new partner," Gabriel noted.. 

"With two facilities in North America working to manufacture multiple COVID-19 vaccines and therapies, we remain committed to supporting efforts to eradicate this global pandemic,” said Jubilant CEO Pramod Yadav.

The vaccine generates strong immune response against multiple antigens and has been shown to generate memory T cell responses. 

https://www.thestreet.com/investing/ocugen-jumps-after-choosing-partner-to-make-covid-19-vaccine

Japan to ease state of emergency, focus on Games spectators

 Japan said on Thursday it will ease emergency coronavirus curbs in nine prefectures including Tokyo while keeping some measures, including limiting spectator numbers at big events, amid fears that next month's Olympics could trigger new infections.

Media reported that the government was considering allowing up to 10,000 spectators in stadiums during the Games, in line with a plan endorsed by health experts https://www.reuters.com/lifestyle/sports/japan-considering-limited-domestic-spectators-olympics-media-2021-06-15 on Wednesday for events.

Prime Minister Yoshihide Suga announced that authorities were lifting a state of emergency for Tokyo and eight other places but would maintain "quasi-emergency" measures in seven prefectures including Tokyo. The state of emergency had been set to expire on Sunday.

Polls have shown most Japanese remain wary about the possibility that the Games will spread coronavirus infections, particularly as vaccination rates are still lower than in other wealthy countries.

The seven prefectures would keep the lower level restrictions until July 11 to prevent a rebound in coronavirus infections.

But with the pace of decline in new infections in Tokyo slowing in recent days, some experts warned of a likely rebound and stressed the need to respond quickly through further curbs or even the reinstatement of a state of emergency in the capital, Economy Minister Yasutoshi Nishimura said earlier.

The Games, postponed last year, are due to start on July 23.

Asked whether the government would ask the International Olympic Committee (IOC) to cancel or postpone the Games even after they have started if there was a threat to public health and lives, Nishimura said: "The IOC has the final say."

"Our top priority is to protect life and health. We will do our utmost to control infection and secure hospital beds."

THE WISDOM OF CROWDS

Having barred foreign spectators, Japan is due to decide this month on whether to allow domestic spectators at the Games and looks likely to keep some restrictions on crowd numbers.

Australia limits use of AstraZeneca COVID-19 vaccine to people above 60

 Australia will recommend that only people above the age of 60 receive AstraZeneca's COVID-19 vaccine, the country's Minister for Health Greg Hunt said on Thursday (Jun 17), following a spate of blood clots in those who have received the inoculation.

Australia has administered 3.3 million doses of the AstraZeneca vaccine, and it has been linked to 60 cases of blood clots, the government has said. So far, two people have died, which Hunt said has driven the policy shift.

"The government places safety above all else," Hunt told reporters in Canberra.

"This updated advice received today is based on new evidence demonstrating a higher risk for the very rare (thrombocytopenia syndrome) condition in the 50- to 59-year-old age group."

Australia in April moved to limit the use of the AstraZeneca vaccine to people above 50 years old.


Several European Union member states have stopped administering the AstraZeneca vaccine to people below a certain age, usually ranging from 50 to 65, restricting its use to older people, due to very rare cases of blood clotting, mainly among young people.

Hunt said the recommendation would not delay its inoculation timetable, which has a target of giving at least one COVID-19 vaccine dose to every Australian before the end of 2021.

Australia in April expanded its order of Pfizer's COVID-19 vaccine to 40 million doses, while it has also ordered 25 million shots from Moderna .

Australia's amended vaccine policy comes as the country's most populous state battles to contain a cluster of COVID-19 cases.

New South Wales said it now recorded four local cases of COVID-19, with the source of the outbreak still unclear.

"At this stage, we are all on high alert," NSW state Premier Gladys Berejiklian told reporters in Sydney.


A man in his 60s, who works as a driver for international airline crews, was detected with the virus on Wednesday, the state's first case in more than a month, and his wife has since tested positive. 

Genetic tests found the man has the Delta virus strain, officials said.

The Delta variant, which has been classified by the World Health Organisation (WHO) as among the four COVID-19 variants of concern due to evidence that they spread more easily, likely caused the latest devastating outbreak in India.

Nearly a dozen venues in Sydney including a cinema in a shopping centre in the popular tourist spot of Bondi and a supermarket have been listed as virus hotspots.

Australia has successfully suppressed past outbreaks through snap lockdowns, swift contact tracing and tough social distancing rules. It has reported just under 30,300 cases and 910 deaths since the pandemic began.

https://www.channelnewsasia.com/news/world/australia-limits-astrazeneca-covid-19-vaccine-aged-60-above-15031816

China Disease Expert Says COVID-19 Origins Probe Should Shift to U.S. Global Times

 A senior Chinese epidemiologist said the United States should be the priority in the next phase of investigations into the origin of COVID-19 after a study showed the disease could have been circulating there as early as December 2019, state media said on Thursday.

The study, published this week by the U.S. National Institutes for Health (NIH), showed that at least seven people in five U.S. states were infected with SARS-CoV-2, the virus that causes COVID-19, weeks before the United States reported its first official cases.

A China-World Health Organization (WHO) joint study published in March said COVID-19 most likely originated in the country's wildlife trade, with the virus passing into humans from bats via an intermediary species.

But Beijing has promoted the theory that COVID-19 entered China from overseas via contaminated frozen food, while a number of foreign politicians are also calling for more investigations into the possibility it leaked from a laboratory.

Zeng Guang, chief epidemiologist with the Chinese Center for Disease Control and Prevention, told state-owned tabloid the Global Times that attention should shift to the United States, which was slow to test people in the early stages of the outbreak, and is also the home of many biological laboratories.

"All bio-weapons related subjects that the country has should be subject to scrutiny," he was quoted as saying.

Commenting on the U.S. study on Wednesday, foreign ministry spokesman Zhao Lijian said it was now "obvious" the COVID-19 outbreak had "multiple origins" and that other countries should co-operate with the WHO.

The origin of the pandemic has become a source of political tension between China and the United States, with much of the recent focus on the Wuhan Institute of Virology (WIV), located in Wuhan where the outbreak was first identified in late 2019.

China has been criticised for its lack of transparency when it comes to disclosing data about early cases as well as the viruses studied at WIV.

A report by a U.S. government national laboratory concluded that it was plausible that the virus had leaked from the Wuhan lab, the Wall Street Journal reported earlier this month.

A previous study has raised the possibility that SARS-CoV-2 could have been circulating in Europe as early as September, but experts said this didn't necessarily mean it did not originate in China, where many SARS-like coronaviruses have been found in the wild.

https://www.usnews.com/news/world/articles/2021-06-16/china-disease-expert-says-covid-19-origins-probe-should-shift-to-us-global-times

Verve Therapeutics Prices IPO

 Verve Therapeutics, a biotech company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced the pricing of its initial public offering of 14,035,789 shares of its common stock at a price to the public of $19.00 per share. The gross proceeds to Verve from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $266.7 million. All of the shares are being offered by Verve. In addition, Verve has granted the underwriters a 30-day option to purchase up to an additional 2,105,368 shares of its common stock at the initial public offering price less the underwriting discounts and commissions.

The shares are expected to begin trading on the Nasdaq Global Select Market on June 17, 2021, under the ticker symbol “VERV.” The offering is expected to close on June 21, 2021, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Jefferies, Guggenheim Securities and William Blair are acting as joint book-running managers for the offering.

https://www.businesswire.com/news/home/20210616006042/en/Verve-Therapeutics-Announces-Pricing-of-Initial-Public-Offering