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BioNTech Forges Ahead in Oncology, Infectious Disease

BioNTech continues to build on the success of the company’s mRNA COVID-19 vaccine co-developed with Pfizer, rapidly expanding its investigational pipeline…

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BioNTech Forges Ahead in Oncology, Infectious Disease

 

 

BioNTech continues to build on the success of its mRNA COVID-19 vaccine co-developed with Pfizer,rapidly expanding its investigational pipeline to include additional infectious diseases and oncology with a first-in-class CAR-T program in solid tumors.

BioNTech co-founder and CEO Ugur Sahin said the Germany-based company is well-positioned for long-term growth. During a quarterly financial report call on Monday, Sahin noted that the company continues to execute its strategy across infectious disease and oncology. 

Driven by the sales of its COVID-19 vaccine, BioNTech generated €6.4 billion (about $6.75 billion). That was a significant increase over this same period in 2021, when the company saw €2.05 billion (about $2.16 billion). The difference is primarily due to the success of the company’s COVID-19 vaccine sales.

In the first quarter of this year, BioNTech invoiced approximately 750 million doses of the COVID-19 vaccine. More than 3.4 billion doses of the vaccine have been delivered across the globe. By the end of 2022, the company is on track to deliver more than two billion doses of COVID-19 vaccine to low- and middle-income countries by the end of 2022.

The success of the vaccine sales, which in the U.S. has been bolstered by an expansion of the Emergency Use Authorization to include a fourth booster shot, keeps the company in line with predicted 2022 vaccine revenue guidance of €13 billion to €17 billion. Jens Holstein, BioNTech’s chief financial officer, said the “notable financial performance” has saved millions of lives from COVID-19 and has also allowed BioNTech to invest heavily in research and development to drive continued innovation and growth.

With a sure financial footing, Sahin stated that BioNTech is positioned to “bring the next generation of immunotherapy to patients.” He also said BioNTech is becoming a “21st-century immunotherapy powerhouse” that is anchored to the company’s strong sense of global responsibility, which includes the company’s turnkey mRNA manufacturing program dubbed “BioNTainer,” which was deployed in Africa earlier this year to enable scalable mRNA vaccine production in bulk. The company aims to bring multiple infectious disease and oncology products to market over the next five to 10 years. 

BioNTech has 16 programs in 20 clinical trials in oncology, with five ongoing randomized Phase II studies. In infectious diseases beyond COVID-19, the company has one Phase I program with influenza and more than 10 preclinical programs covering a range of infectious diseases that impact lower income countries, including malaria, shingles, tuberculosis and herpes simplex virus type 2.

In oncology, BioNTech has multiple clinical-stage assets across different therapeutic classes. The company is harnessing different approaches to oncology. This includes the use of mRNA therapeutic vaccines, CAR-T immunotherapies, cell therapies, individualized neoantigen specific immunotherapies, RiboMabs, next-generation checkpoint immunomodulators, anti-tumor antibodies and small molecules. 

The company’s investigational CAR-T cell therapy candidate BNT211 continues to show encouraging clinical data. BNT211 targets CLDN6-positive solid tumors in combination with a CAR-T cell-amplifying RNA-vaccine dubbed CARVac, which encodes for CLDN6. BNT211 is designed to overcome CAR-T cell therapy limitations in patients with solid tumors.

Courtesy of Andreas Arnold/Getty Images

BioNTech presented preliminary Phase I/II data at the American Association for Cancer Research annual meeting that included data from 16 solid tumor patients who received CLDN6 CAR-T cells at two dose levels alone or combined with CARVac. The data presented at AACR showed encouraging signs of clinical activity with a disease control rate of 86% and an overall response rate of 43%.

In addition to the CAR-T program, BioNTech has two Phase II oncology programs studying FixVac, an off-the-shelf cancer immunotherapy approach, which includes one candidate in partnership with Regeneron. That study is assessing the FixVac asset BNT111 in PD1 inhibitor refractory/relapsed melanoma. The program is combining BNT116 and Libtayo as a potential treatment for advanced non-small-cell lung cancer (NSCLC). The other FixVac program is being studied in HPV16+ PDL1+ head and neck cancer.

BioNTech is also advancing two indications with the iNeST product candidate autogene cevumeran, which is being developed in collaboration with Genentech, a partnership forged in 2016. A Phase II study is being conducted for the adjuvant treatment of circulating tumor DNA positive, surgically resected Stage II/Stage III colorectal cancer. BioNTech is also conducting a Phase II study assessing its bispecific antibody checkpoint immunomodulator BNT311. 

 
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International

Tesla Rivals Challenge Its Lead as Nio Sets Encouraging Record

Tesla’s rivals are not even coming close to producing and delivering EVs at the same rate as the Austin, Texas-based market leader.

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Tesla's rivals are not even coming close to producing and delivering EVs at the same rate as the Austin, Texas-based market leader.

Electric vehicle makers have been struggling over the last two years to produce and deliver cars, trucks and SUVs despite obstacles such as supply chain disruptions, semiconductor shortages and factory shutdowns caused by the covid pandemic.

The industry's leading EV manufacturer Tesla  (TSLA) - Get Tesla Inc. Report on July 2 said that plant closures at its Shanghai gigafactory in April and May and supply chain disruptions led to a smaller number of deliveries than expected in its second quarter ending June 30 with 254,695, which was 26.7% higher than the same period in 2021, but 17.7% lower than its record of 310,048 delivered in the first quarter of 2021. Analysts were originally expecting about 295,000 deliveries.

Tesla's production declined to 258,580 vehicles in the second quarter compared to 305,407 in the first quarter. It had produced 305,840 vehicles in the fourth quarter of 2021.

Tesla's rivals are not even coming close to producing and delivering EVs at the same rate as the Austin, Texas-based market leader. But they keep trying.

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Tesla Rivals Struggle to Produce and Deliver Volume of EVs

Tesla rival Nio  (NIO) - Get NIO Inc. American depositary shares each representing one Class A 蔚来汽车 Report on July 1 said that it had delivered 12,961 vehicles in June for a 60.3% year-over-year increase and its highest number of monthly deliveries ever. The company also reported 25,059 EVs delivered in the three months ending June 2022, increasing by 14.4% year-over-year. Nio has delivered a cumulative 217,897 EVs as of June 30.

NIO on June 15 rolled out its ES7, a new mid-large five-seat smart electric SUV, which is the first SUV product based on NIO's latest technology platform Technology 2.0. NIO also launched the 2022 ES8, ES6 and EC6 equipped with the upgraded digital cockpit domain controller and sensing suite, enhancing the computing and perception capabilities as well as digital experience of the vehicles. The company expects to start deliveries of the ES7 and the ES8, ES6 and EC6 in August.

Chinese EV maker XPeng  (XPEV) - Get XPeng Inc. American depositary shares each representing two Class A 小鹏汽车 Report on July 1 said it delivered 15,295 vehicles in June, a 133% increase year-over-year; 34,422 in the second quarter ending June 30 for a 98% increase year-over-year and 68,983 in the first six months of the year for a 124% increase year-over year.

The Guangzhou, China-based company said in August it will begin accepting orders for its new G9 SUV with an official launch in September.

Beijing-based Li Auto  (LI) - Get Li Auto Inc. Report on July 1 said it delivered 13,024 EVs in June, a 68.9% increase year-over-year and 28,687 in the second quarter ending June 30 for a 63.2% increase year-over-year. The company on June 21 began taking orders for its Li L9 SUV and recorded 30,000 orders as of June 24, according to a statement. Test drives will begin July 16 with deliveries beginning by the end of August.

GM Follows Behind Tesla and Other Rivals

General Motors  (GM) - Get General Motors Company Report had 7,300 EV sales in the second quarter, according to a July 1 statement. The Detroit automaker's sales included deliveries of the BrightDrop Zevo 600 delivery van, GMC Hummer EV pickup, and the resumption of the Chevrolet Bolt EV and Bolt EUV production.

GM said the Cadillac Lyriq production is accelerating, with initial deliveries in process. Orders for the 2023 model year sold out within hours and preorders for the 2024 model opened on June 22.

The company said it will gradually increase production of the Cadillac Lyriq and GMC Hummer EV Pickup in the second half of 2022. 

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Tesla EV deliveries fall nearly 18% in second quarter following China factory shutdown

Tesla delivered 254,695 electric vehicles globally in the second quarter, a nearly 18% drop from the previous period as supply chain constraints, China’s…

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Tesla delivered 254,695 electric vehicles globally in the second quarter, a nearly 18% drop from the previous period as supply chain constraints, China’s extended COVID-19 lockdown and challenges around opening factories in Berlin and Austin took their toll on the company.

This is the first time in two years that Tesla deliveries, which were 310,048 in the first period this year, have fallen quarter over quarter. Tesla deliveries were up 26.5% from the second quarter last year.

The quarter-over-quarter reduction is in line with a broader supply chain problem in the industry. It also illustrates the importance of Tesla’s Shanghai factory to its business. Tesla shuttered its Shanghai factory multiple times in March due to rising COVID-19 cases that prompted a government shutdown.

Image Credits: Tesla/screenshot

The company said Saturday it produced 258,580 EVs, a 15% reduction from the previous quarter when it made 305,407 vehicles.

Like in other quarters over the past two years, most of the produced and delivered vehicles were Model 3 and Model Ys. Only 16,411 of the produced vehicles were the older Model S and Model X vehicles.

Tesla said in its released that June 2022 was the highest vehicle production month in Tesla’s history. Despite that milestone, the EV maker as well as other companies in the industry, have struggled to keep apace with demand as supply chain problems persist.

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International

If You’re A Saudi Cocaine-User, Move To Uruguay

If You’re A Saudi Cocaine-User, Move To Uruguay

According to the latest edition of the United Nations World Drug Report, 284 million people…

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If You're A Saudi Cocaine-User, Move To Uruguay

According to the latest edition of the United Nations World Drug Report, 284 million people used illegal drugs in the last year, while around 21 million of them used cocaine.

The use of the drug has risen in the past decade, according to the report, but slowed somewhat in the Covid-19 pandemic. However, as Statista's Katharina Buchholz details below, with global cocaine production reaching new highs, cocaine supply chains to Europe have been diversifying, which is driving prices down and pushing quality up, potentially increasing the level of harm caused by use of the drug in the region.

You will find more infographics at Statista

In the United Kingdom, for example, cocaine prices fell from the equivalent of $178 to $103 between 2019 and 2020. The country continues to have a high cocaine retail street price in a global comparison, however, with prices lower in most European countries.

In developed economies outside of Europe, a higher premium is usually charged for cocaine, like in Hong Kong ($145 per gram), Japan ($188 per gram), Israel ($205 per gram) or Australia ($242 per gram). For the United States, no 2020 numbers were reported, but in 2019, the price for a gram of cocaine stood at $200 per gram.

Prices were even higher in Arab countries, which have strict laws forbidding drug use and trade.

A gram of cocaine can be found for a fraction of its price on the Persian Gulf in some parts of Europe, such as in the Netherlands and Portugal where UNODC states it has a retail street price of $58 and $38 per gram, respectively. The later country has recently radically decriminalized the use of even class A drugs.

Uruguay, one of the few Latin American countries for which data was available, came in at the very bottom of the list.

Cocaine is expensive in the only African country on the list, Algeria. India was included in the report for the first time this year, with the price of cocaine set at an average $67 per gram. While this is rather low by international standards, attainability is likely lower than in Europe due to the differences in purchasing power in the country.

Tyler Durden Sat, 07/02/2022 - 07:35

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