Several breakthroughs have been announced by biotechs this week, including a new MRI technique that allows a full heart scan in under a minute, gene-altering therapies, an InDevR Polio Kit that allows for a very quick vaccine characterization, and Intellia’s gene editing results. Viz.ai and 4G Clinical have successfully closed their funding rounds for stroke detecting AI software and RTSM technology respectively. In the United States, Walmart launched a much cheaper version of insulin, and the CEO of Eli Lilly that sells its insulin for nearly double the price has since given his opinion on the matter. Meanwhile, Dr. Scott Gottlie has discussed whether the Delta variant of Covid-19 can cause as much disruption as the original virus strain. Take a look at the latest biotech stories.
After its most recent funding round of $70 million, Viz.ai announced it will be expanding to Europe with its unique AI software that detects strokes. The program leverages AI to read CT angiography imaging data and use it to identify large vessel occlusions. Once a clot is detected, the program automatically alerts one of the stroke specialists that are on-call and can manually review it. On average, less than six minutes is needed for the procedure.
The initial FDA clearance for the software has been granted by the FDA at the beginning of 2018. Since then, a large study analyzing imaging data of over 2,500 patients from 139 different hospitals has been conducted and showed 96% sensitivity and 94% of specificity in identifying large vessel occlusions.
As the company has recently closed a Series C round, co-led by Scale Venture Partners and Insight Partners, and also included Greenoaks, Kleiner Perkins, Threshold Ventures, CRV, Innovation Endeavors, and Susa Ventures and providing them with $70 million of new funds, the priority has been to expand to Europe. Now, the company announced it will finally happen. The company also plans to expand its software to other areas beyond strokes, such as pulmonary or trauma care.
Today, InDevR, a life science tools company that offers analytical technologies supporting vaccine and biotherapeutics production announced they will make its quantification kit for quick and accurate assessment of polio vaccines commercially available.
The VaxArray Polio Assay provides a 10x-20x faster time to result that the traditional kits that are otherwise used. It can also be used to quantify all inactivated strains of poliovirus that are present in polio vaccines which is another competitive advantage that saves time and labor.
Erica Dawson, CTO of InDevR, noted, “The launch of the VaxArray Polio Assay represents a significant improvement in the ability to standardize D-antigen testing for polio vaccines. We hope the kit’s availability will enable expedited and multiplexed testing of critical, safer poliovirus vaccines that are being increasingly applied as the world gets nearer to complete polio eradication. We are confident that this new tool can reduce both bioprocess and release testing costs and ultimately drive down cost per dose, particularly for manufacturers in lower and middle-income countries.”
Dr. Kutub Mahmood, Scientific Director at PATH recently noted, “InDevR’s VaxArray Polio Assay is an excellent off-the-shelf kit for measuring D-antigen content, allowing global polio vaccine manufacturers to save time by multiplexing and obtaining same-day results during bioprocess R&D and quality control, with high accuracy and sensitivity for bulk substance and final vaccine product. This VaxArray Polio D-antigen test represents an excellent alternative to the traditional plate-based ELISA technology.”
Together with Spanish National Center for Cardiovascular Research, Philips introduced an innovative MRI method that allows machines to gather all the necessary cardiac data in under a minute. Such a quick scanning technique can be a tremendous help both to the patients and also healthcare providers.
“In just over 20 seconds, all the information needed to know the shape and function of the heart has been acquired,” said Philips technical leader Javier Sánchez-González.
The method is based in the fact that when a patient is asked to hold their breath and be still for a scan, the heart never stops beating and the phased-array MRI scanners can isolate the movement of the beating heart from the remaining parts of the chest. Thus, the total time saved for a patient could be up to 80%, in terms of door-to-door procedure.
“We have shown in a large group of patients that cardiac MR obtained with this new technology obtains the same parameters as the usual technique but reduces by more than 90% the time that the patient has to be inside the machine,” said Borja Ibáñez, director of the clinical research department of the Spanish National Center for Cardiovascular Research.
“It also adds the possibility to analyze the entire chest cavity in 3D and, using mathematical algorithms, to focus only on the heart and large vessels, thereby reducing the time of the study,” adds paper co-author Sandra Gómez-Talavera, a researcher at the Spanish center.
Intellia’s Gene Editing Therapy Results Exceed The Expectations By Far And The Company Stock Soars Up
The results from Intellia’s gene-editing research have exceeded experts’ expectations by far and have shown for the first time that gene editing can work in a human. Following the revelation, the stock of the Massachusetts-based biotech went up by over 55% this Monday, closing at $133.43 that day.
Together with its research partner Regeneron, Intellia showed that NTLA-2001 reduced serum levels of transthyretin, a key biomarker in the rare disease transthyretin (ATTR) amyloidosis, by 87%, besting standard-of-care therapies that typically reach 80%.
“This result surpassed our expectations and achieved our ‘home run’ scenario,” wrote JMP’s Silvan Tuerkcan, Ph.D. David Lebwohl, M.D., Intellia’s chief medical officer, told Fierce Biotech that the serum reduction was “beyond what we expected.”
Chardan Research said that Intellia’s data illustrate NTLA-2001’s possibility to become an effective cure for ATTR amyloidosis.
Startups and scientists are working hard towards achieving a cancer cure that replaces drugs with altering gene activity throughout the body so it can trick the human organism into fighting off the disease. Such a gene therapy is not conventional as it does not remove the genes that cause the disease but rather moves the expression of some genes up or down to receive an anti-cancer effect.
“We’re unlocking new biological pathways so we can go after undruggable targets and treat diseases in very new ways,” said Robert Habib, CEO of London-based MiNA Therapeutics, in an interview. MiNA is developing a pipeline of small activating RNAs (saRNAs), which are short, double-stranded oligonucleotides designed to enter cells and boost the activity of target genes to achieve a therapeutic effect.
There is a closely related technology, small interfering RNAs (siRNAs) that has shown a great potential of shutting down cancer-promoting genes. Having said that, the struggle has been to translate it into therapies. “It has been hindered by tissue bio-accumulation—making sure the delivery system is safe and provides a wide enough therapeutic window in tissues beyond the liver,” said Anna Perdrix Rosell, Ph.D., co-founder and managing director of London-based Sixfold Biosciences, in an interview.
Despite the challenges, investors are increasingly interested in the idea of manipulating gene activity to gain an anti-cancer response.
“Many invasive carcinomas have high levels of filopodia, while normal cells typically have very few,” Andrew Jakymiw, Ph.D., an associate professor of oral health sciences, said. “So this could potentially be used as a strategy to target more aggressive forms of this type of cancer.”
Eli Lilly CEO Promises The Company Will Keep Looking For A Way To Decrease Insulin Costs As Walmart Launches A Low-Price Version
On Tuesday, Walmart announced it will start selling a lower-price version of fast-acting insulin that is known for its very high prices. Following the announcement, the CEO of Eli Lilly David Ricks said he welcomes new competition and that Eli Lilly will keep looking for ways they can lower down their prices.
“Any efforts to smash through that and deliver better value to patients, I’m for,” Ricks said in an interview Tuesday on CNBC.“We always look at new solutions ourselves, and this is an interesting development and we’ll look at further options,” he said. “If we can reach one more patient with more affordable insulin, we’re going to try to do that.”
Walmart’s version of analog insulin, developed in partnership with Novo Nordisk will cost roughly $73 for a vial or $86 for a package of prefilled insulin pens that will be available only at Walmart and Sam’s Club for customers with a prescription.
While Eli Lily’s version of insulin costs $137.35 per vial, Ricks said the company will look for ways they can reduce the cost, pointing out the launch of a half-price insulin lispro in early 2019.
Yesterday, Dr. Scott Gottlieb told CNBC the Delta variant of Covid-19 will unlikely cause as extreme of a situation that we have experienced before, due to enough of Covid immunity protection across the population.
“I don’t think it’s going to be a raging epidemic across the country like we saw last winter. I think that there’s going to be pockets of spread, and prevalence overall is going to pick up,” the former Food and Drug Administration commissioner said. “But I think in parts of the country where vaccination rates are high, and that’s certainly true in the Northeast, I think we’re largely protected — at least from the current variants that are circulating,” added Gottlieb, who serves on the board of Covid vaccine maker Pfizer.
At the same time, Gottlieb pointed out that other parts of the United States are much more vulnerable, noting Missouri is a good example.
“If you’re someone even who has been vaccinated living in those parts of the country, and there’s a dense epidemic of this new delta variant, you’re at risk as well because we know the vaccines aren’t 100% and we know in vulnerable populations — people who are immunocompromised, people who are much older — the vaccines may not work as well over time.”
“The goal should be to try to reduce transmission as much as possible here in the United States. I don’t think we should be cavalier about this,” said Gottlieb, who led the FDA from 2017 to 2019 in the Trump administration. “But we’re going to see the overall impact of the virus be substantially reduced because so many people have become vaccinated.”
The innovative randomization and trial supply management (RTSM) company that has managed to grow over 100% in the past year has just secured a $230 million growth equity investment backed by the Godlman Sachs Asset Management.
The funds will be spent on a global expansion and the company’s goal to bring the most crucial medicines as quickly as possible.
Founded back in 2015 by RTSM experts, David Kelleher and Ed Tourtellotte to accelerate clinical trials through Natural Language Processing (NLP), 4G Clinical has quickly achieved success and now, the company supports clinical trials for more than 100 biotech and pharma companies across the globe. “As life sciences, companies strive for creativity and innovation in trial designs, they cannot afford to be limited by technology,” said Ed Tourtellotte, CTO of 4G Clinical. “Our vision was to build Prancer RTSM® to handle any type of trial within any indication. We’ve held to that vision, enabling our biotech and pharma clients to let the science lead.”
“This investment is transformational,” said David Kelleher, CEO of 4G Clinical. “In just over 5 years, 4G Clinical has grown from a start-up to a globally recognized leader in RTSM, helping life sciences organizations execute clinical trials of any size and complexity throughout the drug development lifecycle. To maximize our impact on lives around the globe, we must unwaveringly drive innovation in our technology and processes to tackle clinical trial bottlenecks. This investment from Goldman Sachs ensures that we will not be constrained in any way in that effort.”
“The eClinical Solutions market has expanded rapidly over the past several years with best-in-class, tech-first solutions leading the way, presenting an exciting opportunity for Goldman Sachs,” said Jason Kreuziger, a Managing Director in Goldman Sachs Asset Management. “4G Clinical’s established reputation and global reach to date underscores their immense potential over the next few years. We are honored to partner with and help 4G Clinical accelerate their growth,” added Antoine Munfa, a Managing Director in Goldman Sachs Asset Management.
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