Why the surge in Xenetic

 

• The stock price of Xenetic Biosciences Inc (NASDAQ: XBIO) increased 27.96% after hours. Why It Happened

The stock price of Xenetic Biosciences Inc (NASDAQ: XBIO) – a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens – increased 27.96% after hours. 

Xenetic Biosciences is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas. XCART has the potential to fuel a pipeline of therapeutic assets targeting high-value oncology indications. And Xenetic is utilizing PolyXen, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

According to the Pacific Coast Business Times, Takeda Pharmaceuticals is expanding its facility in Thousand Oaks and the company is investing $126 million to build out its manufacturing operations to support new product lines.

Takeda has been in Thousand Oaks since 1996. And the expansion includes a new 15,000-square-foot manufacturing facility along with a renovation of the existing 14,000-square-foot manufacturing space.

“The most exciting part and one of the core parts of this expansion is building out our health services and therapeutics area and allow us to serve patients that we don’t currently treat and illnesses that we don’t currently treat,” said Stephen Hatke, vice president of manufacturing operations and site head of the Thousand Oaks office at Takeda via Pac Biz Times.

https://pulse2.com/xbio-stock-increased-27-96-after-hours-why-it-happened/

Alzamend: Positive Results in Toxicology Study Using Alzheimer's Transgenic Mouse Model

 -Alzamend Neuro, Inc. (Nasdaq: ALZN) ("Alzamend"), a preclinical stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received positive toxicology results for AL002 in a good laboratory practices ("GLP") toxicology study using a transgenic mouse model of Alzheimer’s disease. The study was conducted by Charles River Laboratories. AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s.

"The positive GLP toxicology results represent a key milestone for Alzamend as we continue to advance our proprietary pipeline. We believe AL002 could potentially reverse the effects of Alzheimer’s disease. We look forward to providing more details on the timeline and market opportunity as we prepare for the submission of our Pre-Investigational New Drug Application for AL002 to the U.S. Food and Drug Administration in the near future," commented Stephan Jackman, the Chief Executive Officer of Alzamend.

https://finance.yahoo.com/news/alzamend-neuro-receives-positive-results-103000326.html

Countries Move Ahead With Mix-and-Match COVID Vaccines

 While the data remain preliminary, some countries are moving ahead with mixing and matching mRNA and adenoviral vector COVID-19 vaccines, often driven by supply challenges.

Germany has recently made an official recommendation to mix-and-match, encouraging citizens to follow their AstraZeneca shots with a dose of an mRNA vaccine. Chancellor Angela Merkel led the way by following her initial AstraZeneca dose with a shot of Moderna in June.

Other countries like Canada and Thailand have started administering vaccines on a heterologous schedule.

The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), while not issuing any specific recommendations, promoted the mix-and-match approach in a recent press release.

"There are good scientific grounds to expect this strategy to be safe and effective when applied to vaccination against COVID-19," the press release stated. "Preliminary results from studies in Spain, Germany, and the U.K. suggest a satisfactory immune response and no safety concerns. More data are awaited shortly, and EMA will continue to review these as they become available."

The EMA and ECDC noted in the release that the approach "may allow populations to be protected more quickly and make better use of available vaccine supplies."

Neither the World Health Organization (WHO) nor the CDC endorse the approach, however.

Currently, the CDC's website states that getting an adenoviral vector vaccine after the first dose of an mRNA shot could be considered only "in limited, exceptional situations." Additionally, because the U.S. still has ample vaccine supply, the rush to start offering the mix-and-match approach isn't as much of a necessity as it is in countries that continue to struggle for access.

WHO's chief scientist Soumya Swaminathan, MD, said in an online briefing that the trend toward mixing and matching could lead to a "chaotic situation," Reuters reported. She later wrote in a tweet that the future of the heterologous approach should be decided by public health agencies.

"Data from mix-and-match studies of different vaccines are awaited," she said. "Immunogenicity and safety both need to be evaluated."

The preliminary evidence cited by health agencies that have adopted the strategy includes Oxford's Com-COV study, which was submitted to the Lancet's preprint server. The single-blind randomized trial in 830 participants found that mixing Pfizer and AstraZeneca produced a more robust antibody response than two doses of AstraZeneca.

Similar results were seen in recent German studies. A small trial conducted by a team from Saarland University in Hamburg found that "in all parameters that we looked at, [the heterologous regimen] was similar or superior to the homologous mRNA regimens," co-author and immunologist Martina Sester, PhD, told MedPage Today.

"What was strikingly different to both homologous regimens was that the T cells were significantly better [in the heterologous regimen] than both the homologous Astra and the homologous mRNA regimen," she said.

Gregory Poland, MD, of the Mayo Clinic's vaccine research group, told MedPage Today that mixing and matching on a large scale is "pretty much inevitable."

"Many people will not know what [vaccine] they got and many locales won't necessarily have good records," Poland said. "So, by necessity and practicality, it's going to happen."

He noted that there's still much to learn about the safety to mixing and matching, however. Findings from the Com-COV study suggested the strategy may increase symptoms such as chills, fatigue, headaches, and muscle aches. It's also possible that there could be rare adverse events resulting from a mix-and-match strategy, he said, but it would take time and millions of doses to find that out.

https://www.medpagetoday.com/special-reports/exclusives/93706

Israel Finds Pfizer Jab Only 39% Effective At Stopping Delta Variant

 Over the past month, Israel, the world's most heavily vaccinated country (with leading mRNA jabs, no less) has seen the number of positive COVID tests has risen by more than 30x as the number of active infections in the country has surpassed 10K.

Meanwhile, the Israeli Health Ministry, which has previously estimated the true efficacy of the Pfizer jab against the delta variant at only 64% (while still more than 90% effective at preventing serious illness and death), just released new data purporting to show that while the Pfizer jab is still 88% effective at preventing serious illness, it's only 39% effective at preventing infection with delta.

Alex Berenson, a former NYT journalist who has often reported on scientific findings that don't support the official narrative on masks and vaccines, shared the findings in a tweet, and speculated that the true efficacy in offering protection against the Delta variant might be even lower - perhaps as low as 30%.

Even Bloomberg acknowledged that the Israeli data "could be skewed because of different ways of testing vaccinated groups of people versus those who hadn't been innoculated, according to the report.

"The heavily skewed exposure patterns in the recent outbreak in Israel, which are limited to specific population sectors and localities," means the analysis may not be able to take all factors into account, said Ran Balicer, chairman of Israel’s national expert advisory team on Covid-19 response. "We are trying to complement this research approach with additional ones, taking additional personal characteristics into account. But this takes time and larger case numbers."

BBG also acknowledged that the data "are likely to fuel debate over whether booster shots should be given to people who've already been vaccinated - something Pfizer has said it plans to request..."

But Dr. Anthony Fauci, the FDA and the CDC have all said that there's no evidence yet that a third "booster" shot would be necessary. Israel has already ordered a round of booster shots that it plans to start distributing to the most vulnerable patients Aug. 1.

The Israeli numbers are much lower than other recent studies, including one study recently published in the New England Journal of Medicine, which found that two doses offers 88% protection against the Delta variant causing symptomatic disease, while offering 94% protection against the alpha variant.

But never mind all that: As President Biden said earlier this week, "if you are vaccinated, you are safe." Unless you're not.

https://www.zerohedge.com/covid-19/israel-finds-pfizer-jab-only-39-effective-stopping-delta-variant

Medigus: Investment’s innovative technology effective against coronavirus in pre-clinical study

 Medigus Ltd. (Nasdaq: MDGS), a technology company engaged in advanced medical solutions, innovative internet technologies and electric vehicle and charging solutions, today announced that Polyrizon Ltd., a privately held company (which Medigus owns 33.24% of its share capital) engaged in developing highly differentiated biological gels for the purpose of protecting patients against biological threats and external pathogens, reported pre-clinical data from its previously announced pre-clinical study showing that its proprietary technology has the potential to reduce the risk of an infection with Human coronavirus and may also prevent COVID-19. Polyrizon develops an innovative technology, designed to safely prevent allergens and virus intrusion through the upper airways and eye cavities. Polyrizon’s technology is comprised of a bio-gel that is applied topically, and can be formulated both for wet and dry administration.

Polyrizon’s cell-culture study was conducted in Israel and lasted one month. The trial tested a number of different formulations of its highly differentiae biological gel comparing to controlled groups for protection against coronavirus, and screening several new formulations designed to prevent coronavirus from effecting epithelial cells.

Data from Polyrizon’s cell-culture study confirms that its innovative product works in a dose-dependent manner to effectively reduce the infection of cells from the human coronavirus 229E, a species of coronavirus which infects humans and associated with a range of respiratory symptoms, ranging from the common cold to high-morbidity outcomes such as pneumonia and bronchiolitis.

https://finance.yahoo.com/news/medigus-polyrizon-innovative-proprietary-technology-114800482.html

Acorda to Commercialize INBRIJA for Parkinson's in Spain

 Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has entered into distribution and supply agreements with Esteve Pharmaceuticals S.A (ESTEVE) to commercialize INBRIJA® 33 mg (levodopa inhalation powder, hard capsules) in Spain. INBRIJA is indicated in the EU for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. (1)

Under the terms of the supply agreement, ACORDA will receive a significant double-digit percent of the selling price of INBRIJA in Spain in exchange for supply of the product. ESTEVE will have the exclusive distribution rights to INBRIJA in the territory and ACORDA will supply the product to ESTEVE. ESTEVE expects to launch INBRIJA in Spain in the fourth quarter of 2022.

According to current population estimates, there are at least 300,000 people living with Parkinson's disease in Spain, and there is one new case per 10,000 people per year; these incidence and prevalence rates are similar to those in the rest of Europe.

https://finance.yahoo.com/news/acorda-therapeutics-announces-agreement-commercialize-200100662.html

Ocular Therapeutix prelim Q2 results

 Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today reported preliminary net product revenue for the quarter ended June 30, 2021, and in-market unit sales for June 2021.

The Company is reporting preliminary second quarter 2021 total net product revenue of approximately $11.7 million, representing a greater than 600% year-over-year increase versus the second quarter 2020 and an approximately 60% sequential increase over the first quarter of 2021. Net product revenue of DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg for the quarter ended June 30, 2021 is estimated to be $11.1 million, and net product revenue of ReSure® Sealant for the quarter ended June 30, 2021 is estimated to be $0.6 million.

DEXTENZA second quarter, in-market unit sales are projected to set a record of 24,990 billable inserts, an approximately 50% sequential increase over the first quarter of 2021. The Company believes this growth reflects the strong end-user demand for DEXTENZA driven by an increase in cataract procedure volumes and market share gains. June 2021 in-market unit sales are projected to set a monthly record of 9,779 billable inserts as cataract volumes continued to increase through the second quarter of 2021 after the slowing of procedures earlier in the year as a result of regional COVID surges. As previously reported, April and May in-market unit sales were 8,025 and 7,186 billable inserts, respectively. Notably, each month of the second quarter of 2021 exceeded the last month of the first quarter of 2021, which included increased end-of-the-quarter in-market unit sales to ambulatory surgical centers under the Company’s rebate program.

“We are pleased by DEXTENZA’s performance in the quarter and believe that continued physician interest and more normalized cataract procedure volumes bode well for strong growth through the remainder of the year,” said Antony Mattessich, President and CEO. “What gives us the greatest satisfaction however is knowing that more and more patients are enjoying a better experience following their ophthalmic surgeries.”

The Company expects to report quarterly financial results for the second quarter 2021 on August 9th following the close of market and provide a comprehensive business update on a conference call the same day.

https://www.businesswire.com/news/home/20210722005952/en/Ocular-Therapeutix%E2%84%A2-Announces-Second-Quarter-2021-Preliminary-Net-Product-Revenue-of-11.7-Million