This week, we could see a lot of alternative therapies being approved and showing promising trial results, new high-tech devices being approved by the FDA, the Covid-19 passports being rolled out in the state of New York, and treatments that we thought were years ahead suddenly gaining the possibility to become mainstream faster than ever. What are some of the highlights that we will focus on? GE launching their newest AI-powered ultrasound device that can significantly speed up work on the Covid-19 wards, Kriya therapeutics making gene therapies go beyond rare diseases and start addressing Diabetes, obesity, or Alzheimer’s. Apart from that, we will look at Amazon getting the FDA authorization for their homegrown Covid-19 test, New York starting to use the digital Covid-19 pass, Sinopharm trying to decide if their vaccine needs an extra booster shot after the clinical results conducted overseas, and much more.
Entrada Therapeutics Raises $116 Million In Their B Round
Entrada Therapeutics has raised $116 million in their Series B investing round to develop intracellular biologics. The investment will be used for the development of a pipeline including treatments for diseases such as Duchenne Muscular Dystrophy (DMD)
The funding round was led by the Wellington Management Company and included both earlier investors and some VC newcomers. Some of the VCs participating were Redmile Group, TCG Crossover, 5 AM Ventures, MPM Capital, CureDuchenne Ventures, and the Roche Venture Fund
Entrada gets biologics across the cell membranes to hit the intracellular targets. The company currently has an exon-skipping program that will now enter the clinical trial stage (because of the investment). The program aims at improving the existing approaches to treating DMD.
Among the other products they are focusing on, Entrada looks at an enzyme replacement therapy that could be used to treat patients with mitochondrial neurogastrointestinal encephalomyopathy, also through their intracellular biologics.
GE Healthcare Comes With A New AI Ultrasound For COVID-19 Wards
GE Healthcare has revealed its AI-powered ultrasound that can support the Covid-19 wards and unburden the healthcare workers.
The announcement comes less than a month after the company has unveiled its first point-of-care ultrasound.
The newest addition to the ultrasound division of GE, Venue, is called Venue Fit and is the smallest one so far. It makes moving it around much easier. The newest cart-mounted ultrasound machine is also designed in a way that facilitates the cleaning between each patient, a very important advantage for the Covid-19 wards.
The AI counterpart will be available for the whole Venue line and will allow for real-time measurements of all the key heart, lung, and kidney functions such as ejection fraction or strength and efficiency of the cardiac muscle. A separate tool will show panoramic lung pictures that automatically show B-lines that could indicate there has been a Covid-19 related lung injury or pneumonia.
Kriya Therapeutics Making Gene Therapy Mainstream
Kriya Therapeutics is a biotech that tries to push gene therapy beyond just treating rare diseases. The startup wants to make the gene therapy treatments mainstream and target diseases such as Alzheimer’s, diabetes, or obesity.
The biggest focus for the biotech is so far its treatment KT-A112, targeting Type 1 diabetes. The KT-A112 was licensed from the Universitat Autònoma de Barcelona. The therapy delivers genes in order to create insulin and glucokinase to reverse diabetes. Based on the preliminary research conducted on small and large animal models, one muscular injection has been enough to show efficacy. While most of the research is still in the preclinical or early clinical, the company has plans to apply for FDA clinical trials permissions by the end of 2022.
What really poses a challenge for Kriya is that gene therapies are usually developed for patients suffering from very rare diseases that can touch a few hundreds of people worldwide. However, Type 1 diabetes touches more than 45 million. Thus, the CEO of Kriya, Shankar Ramaswamy, said that the company had to completely rethink the development and manufacturing of gene therapies.
“Gene therapy 1.0 has been about finding a way to make the product for a very small population at a high cost and finding a way to make up the difference by charging astronomically high prices,” Ramaswamy said in an interview. “One key element that needs to be solved is making gene therapy products more efficiently, at scale, at a lower cost. We’re investing heavily in that.”
So far, their therapy has shown promising results in mouse and monkey models of the Type 1 diabetes and since then, it has been licensed by Genprex, a gene therapy developer.
“In monkeys, we’ve consistently reduced their insulin requirements by more than 50%, but we haven’t gotten them off insulin,” George Gittes, M.D., ., of the university’s McGowan Institute for Regenerative Medicine said in an interview. “So we’re fiddling with the way the two genes are made,” by improving the “capsid,” or coating of the AAV so it penetrates alpha cells and transforms them more efficiently, he explained. He hopes to be in discussions with the FDA about starting human trials by late 2022.
“The good thing is the manufacturing technology in gene therapy is evolving positively, and we’re finding cell lines that have much higher yields than they did in the past,” Townsend said. “Manufacturing is the most significant strategic challenge we’re thinking through now, and I think we’ll be able to bring some of that new technology onboard to address it.”
New York Will Rollout Covid-19 Passport
New York is officially the first state that launched the Covid-19 passport that consists of a smartphone wallet app for individual users and a scanner app for business. The launch was preceded by two pilots and a beta version that proved it is efficient.
In the app, the users can upload either the vaccination programs or the test results that is then turned into a QR code. The code could be used at different events to ensure safety.
All of the information in the New York pass is secured through blockchain and the app does not store private health data.
“New Yorkers have proven they can follow public health guidance to beat back COVID, and the innovative Excelsior Pass is another tool in our new toolbox to fight the virus while allowing more sectors of the economy to reopen safely and keeping personal information secure,” New York Gov. Andrew Cuomo said in a statement.
Currently, the app is only available in New York, but there is a rush in other states (as well as other countries) to develop similar versions of the app.
Amazon Gets FDA Approval For The Homegrown Covid-19 Test
FDA has granted Amazon authorization for their homegrown Covid-19 test. FDA said that the tests which are nasal swabs will be approved under a standing-order prescription and administered in person.
The test will either be done with supervision from a telehealth link or performed on one’s own. The samples will then be sent to laboratories. The employees of Amazon will have regular testing appointments every two weeks.
BioNTech’s Struengmann Family To Take A Stake In Munich Leukemia Laboratory
Struengmann’s family that is behind BioNTech, one of the Covid-19 vaccine makers is now thinking about getting a stake in Munich Leukemia Laboratory, the German diagnostics firm to add healthcare sector investments to their portfolio.
“We are fundamentally interested in deeper integration of therapy and diagnostics. That is why we are holding talks with Munich Leukemia Laboratory,” a spokesman for the Struengmann family holding Athos told Reuters.“In these discussions, we are examining how our business activities can work together more closely,” he said, adding that due to ongoing talks no further details could be disclosed.
It was reported that the Stuengmann family will take a minority stake in MLL, however, the decision is not finalized and MLL could still go with a different investor.
Currently, the Struengmann family owns just below half of BioNTech. They have also invested in biotechs such as AiCuris, Ganymed, and Nextgen.
FDA Approves The Multiple Myeloma Treatment By Bristol Myers Squibb Co And Bluebird Bio Inc
On Friday, FDA approved Abecma, the multiple myeloma treatment directed at adult patients. The therapy was developed by Bristol Myers Squibb Co partnering with bluebird bio Inc and the wholesale list price of the therapy stands at $419 500, as the companies announced on Monday.
The approval makes the Abecma the first CAR-T authorized therapy for cancer that targets plasma cells. The CAR-T therapy takes immune system cells from a patient and proceeds to re-engineer them so they can fight certain blood cancers better.
Experts claim that the newly authorized therapy can quickly take the lead among the other myeloma therapies. Brokerage Piper Sandler forecasts that the treatment will result in approximately $2.5 billion in sales by 2030.
Eli Lily And Vir Biotech Antibody Therapies Reduce Viral Load In Covid-19 Patients
On Monday, the mid-stage trial results showed that the antibody treatments from Eli Lily and Vir Biotech significantly reduce the viral load in low-risk Covid-19 patients.
The trial was testing the bamlanivimab by Lilly given in combination with the VIR-7831 by Vir and GlaxoSmithKline. Given in combination, the antibody therapies showed a whopping 70% reduction in the viral load by day seven.
The data from preliminary animal studies show that the experimental antibody treatments become increasingly stronger when given in combination and can protect against all the current variants of Covid-19. The earlier studies showed that the more contagious variants of Covid-19 are resistant to Eli Lilly’s bamlanivimab alone.
Sinopharm To Assess Overseas Results To Decide On Booster Shot Of Its Covid-19 Vaccine
On Sunday, the executive of China National Pharmaceutical Group (Sinopharm) announced that the company will be assessing the results from the Phase III clinical trials conducted overseas. After the analysis, Sinopharm will decide whether its two-shot Covid-19 vaccine should be followed by a booster shot.
“The preliminary results so far showed that the booster vaccination can effectively increase the neutralizing antibody titer and antibody persistence, and also effectively improve the vaccine’s ability to resist mutations,” Zhang Yuntao, vice president at China National Biotec Group (CNBG), an affiliate of Sinopharm, said. “Is a booster shot needed? When will the booster be given? The answer should be based on the results of future phase III clinical studies,” he added during a new conference.
If you are interested in biotech news, gene therapy news, FDA approving new experimental treatments, and more articles like this, you may also enjoy these:
Brain-Machine Interface, Precision Medicine, And Other Possibilities Of AI In Biotech
Chinese Biotech Bubble: Should MedTech Investors Worry?
How Countries Are Regulating Gene Therapy: Ethical, Medical, and Cost Issues
