Akston Begins Trials For Room Temperature Covid Shot As Next-Generation Vaccine Race Heats Up
Massachusetts-based Akston Biosciences launched mid-to-late stage clinical trials for its Covid-19 vaccine Saturday, the company told Forbes, one of several second-generation shots jostling for a share of the market as companies race to develop novel jabs and meet burgeoning demand for cheaper, more accessible shots. READ THE FULL ARTICLE
‘Looking forward to second-gen vaccines,’ says WHO chief: From nasal sprays to multivariant jabs, vaccines in development spur hope of ending the pandemic
As we approach the two-year mark since the first case of COVID-19 was diagnosed in Wuhan, China, over 50 per cent of the world’s eligible population has received, at least, a single shot of a COVID-19 vaccine.
…India, for instance, is expecting to begin clinical trials of a second-generation vaccine developed by US-based Akston Biosciences which can, reportedly, remain stable for a minimum of six months at 25 degrees Celsius. While it remains a point of debate whether this candidate will be required in India, it will certainly come as a blessing to hot lower-and-middle income countries that have fallen victim to global vaccine inequities. READ THE FULL ARTICLE
The Boss Magazine
The effort to get COVID vaccines to everyone
Making COVID-19 vaccines more shelf-stable is a project Akston Biosciences and Seppic are working on, testing and scaling production of an adjuvant that would allow vaccines to be safely stored at higher temperatures. They hope to produce 100 million doses of adjuvant per month in 2022 that could make vaccines shelf-stable for up to six months. READ THE FULL ARTICLE
The Next COVID Challenge: Building an Arsenal of Vaccines
(29-Sep-2021) By Todd Zion – For months, international partners have pressured the United States about intellectual property (IP) concerns and access to SARS-CoV-2 vaccines. As the country emerges from the worst of the pandemic, President Joe Biden now has an opportunity to shift his administration’s focus to realizing its longstanding promise of making the United States “the arsenal of vaccines for the world” (1). However, the country cannot accomplish that goal just by exporting mRNA vaccines and waiving IP protections. The current generation of vaccines simply cannot be produced, transported, and administered at the scale needed to tackle the COVID pandemic. READ THE FULL ARTICLE
Second-generation vaccines offer a chance to correct flaws in early vaccination campaigns
(Tuesday, September 7, 2021) – Alarming headlines about the Delta variant’s inexorable rise and reports of even more concerning coronavirus mutations obscure the good tidings: countries with successful vaccination campaigns are seeing remarkable reductions in hospitalisations and deaths. Iceland, for example, saw Covid cases rise to record highs this summer; with over 90% of the country’s eligible population at least partially vaccinated, however, hospitalisations remained low and deaths near zero.
…The vaccine candidate known as AKS-452, from Massachusetts-based Akston Biosciences, is one promising example of a jab which could address vaccine inequity and vaccine hesitancy alike. Following promising Phase I trial data which found that AKS-452 was safe, well-tolerated, and achieved a 100% seroconversion rate even after a single 90 µg dose, the vaccine candidate is now undergoing Phase II trials in the University Medical Center Groningen (UMCG) in the Netherlands.
The Akston vaccine has a number of characteristics which could make it eminently suitable for worldwide use. For one thing, AKS-452 remains shelf-stable for six months at 25°C—and can even be stored for a month at 37°C, making it a perfect fit for regions without the cold chain necessary to distribute more finicky vaccines. Akston’s vaccine could also be produced easily and affordably using standard low-cost techniques which could yield more than one billion doses a year from a single production line. The fact that it’s produced using more conventional techniques could also win over people sceptical of the mRNA vaccines which have formed the backbone of wealthy countries’ vaccination efforts so far.
In the pipeline: What the next wave of COVID vaccines could look like
(30-Aug-2021) By Rachel Arthur – We take a look at some of the COVID-19 vaccine candidates moving through clinical trials.
Science World Report
More accessible Covid-19 vaccines and community engagement key for rural areas
The urgent need to roll out Covid-19 vaccines around the world, even in its remotest corners, has delivered stunning scenes of healthcare workers trekking along the Amazon, crawling under barbed wire in Colombia and dog sledding over icy Alaskan tundra. While these images, recently profiled in National Geographic, speak to the strength of human tenacity in the midst of a global crisis, they also underscore the extraordinary difficulties and unique challenges in delivering the vaccines necessary to prevent Covid from ravaging rural communities where healthcare resources are often limited.
…Fortunately, many of these challenges may be alleviated when second-generation Covid vaccines come on the market. One candidate currently in Phase II trials, Akston Biosciences’ AKS-452, is shelf-stable for six months at room temperature and can even withstand temperatures up to 37°C for one month. Crucially, this allows the jab to be transported and stored for months without refrigeration.
AKS-452 is based on Akston’s Fc fusion protein platform, and stimulates a mixed immune response against the receptor-binding domain (RBD) of the Covid-19 spike protein. In layman’s terms, this means the vaccine can be produced using low-cost antibody manufacturing techniques; a single production line could potentially produce more than one billion doses per year.
Early data from the clinical trials of AKS-452 has been encouraging; in its Phase I trials, the vaccine proved safe and well-tolerated and achieved a 100% seroconversion rate both with a 90-µg single-dose regimen and with two doses of 45 µg each. “The extended shelf stability, the clinical data…and the ease of manufacturing relative to currently approved vaccines,” celebrated Akston Biosciences president and CEO Todd Zion, “indicate that our second-generation vaccine has the potential to more easily safeguard the health of populations worldwide against Covid.”
International Policy Digest
Second Wave of COVID-19 Vaccines Could Resolve Vaccine Inequity
(August 20, 2021) – The World Health Organization is urging wealthy nations to hold off from giving COVID-19 booster vaccine doses to their fully vaccinated citizens, given that billions of people around the world have yet to receive a single dose. Some WHO advisors did not mince words, such as Canadian epidemiologist Bruce Aylward, who said that the world should be “disgusted” by the current inequity in vaccine access.
…The AKS-452 candidate produced by Massachusetts-based Akston Biosciences, for example, recently entered Phase II trials at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. The fresh trials come on the heels of positive Phase I data, which demonstrated that AKS-452 was safe and well-tolerated and that a single 90 microgram dose was able to achieve 100% seroconversion, with trial participants showing significantly higher antibody levels than recovered COVID patients.
mRNA deals will not solve Africa’s vaccine shortfall, but the second generation of vaccines may
With just 5.8 doses of vaccine administered for every 100 people, the global Covid-19 vaccination drive has failed Africa. Faced with the stark inequality of vaccine distribution, South African vaccine manufacturers are now moving towards domestic production of the mRNA vaccines monopolized by American and European governments, even as Big Pharma sends mixed signals over how much control they’re willing to relinquish to the African pharmaceutical companies taking up their technologies.
…One especially promising option for overcoming sub-Saharan Africa’s logistical constraints is currently being trialled by Massachusetts-based firm Akston Biosciences, whose shelf-stable vaccine candidate entered Phase I/II trials in the Netherlands earlier this year. Akston’s AKS-452 vaccine has already shown positive results in initial analyses, producing a robust antibody response to strains of Covid such as the alpha and gamma variants.
According to the company, the simplicity of the manufacturing techniques involved in producing the AKS-452 vaccine also means a single, 2,000-litre production line could generate more than one billion doses per annum. That scalability, alongside with the vaccine’s high level of stability – remaining serviceable for four months when stored at room temperatures at 25°C, and for one month even at temperatures of 37°C – would be invaluable for nationwide inoculation campaigns in countries where infrastructural challenges and under-resourced public health services make vaccine distribution a slow-moving affair.
Could second-generation vaccines accelerate Africa’s slow immunisation drive?
(July 28, 2021) – Amidst the global pandemic, national economies are remaining resilient as vaccines roll out.
However, in recent weeks concerns have increased regarding its efficiency. With most Asian countries relying heavily on China’s Sinovac vaccine, Thailand and Indonesia have now announced that they will further immunise vaccinated health workers with a booster shot of Moderna or AstraZeneca.
…Two American vaccines which hold particular promise for African nations have come out with promising results recently. The first is AKS-452, produced by Massachusetts-based Akston Biosciences, which is well-adapted to the public health specificities of African nations. This is because the vaccine remains shelf-stable at room temperature for at least four months, making it easy to transport and store. Due to its low-cost antibody production, the vaccine can be mass-produced cheaply, with a single 2,000-litre production line able to make over one billion doses a year. READ THE FULL ARTICLE
Angel Invest Boston
Todd Zion, PhD, CEO and Repeat Founder, “Magical Proteins”
Repeat biotech founder Todd Zion on SmartCells (acquired by Merck for $500MM) and his current venture Akston Bio which is doing cool things with proteins. Todd has valuable insights on VC funding, angel investing and founding teams. This interview’s a peach!
Vaccination program in India stalls as nation faces deadly third wave
(July 11, 2021) – India has sadly joined the United States and Brazil as only the third country in the world to reach the grim milestone of 400,000 lives lost to Covid-19.
The news comes as experts caution that even this fatalities figure may be an underestimate and predict that the country – which has recorded 30 million cases – could soon suffer a deadly third wave unless its vaccine campaign is significantly accelerated.…
…India also needs to prioritise the rapid adoption of new, so-called ‘second-generation’ vaccines from a variety of manufacturers deploying multiple vaccine technologies. Specifically, India needs vaccines which can be rapidly and affordably produced and stored at room temperature for areas with infrastructure gaps – such as the promising candidate by Akston Biosciences.
University Medical Center Groningen
First results of research into new corona vaccine promising; volunteers wanted for phase 2
(July 8, 2021) – The UMCG is conducting research into a candidate vaccine against Covid-19: the AKS-452 vaccine from Akston Biosciences in the United States. The first results are positive. For the second phase of the research, the UMCG is now looking for 116 healthy volunteers who have not yet had another corona vaccine. READ THE FULL ARTICLE
Boston Business Journal
Beverly biotech shows promising Covid vaccine data, raises $19.5M
(July 8, 2021) – By Rowan Walrath; Life Sciences Reporter, Boston Business Journal – Just over a year after it expanded its mission well beyond insulin engineering, 10-year-old Akston Biosciences has revealed promising results from an early-stage study of its Covid-19 vaccine, which takes specific aim at thwarting variants. READ THE FULL ARTICLE
New vaccines should help India fill gaps in vaccination campaign
(June 7, 2021) – Even as India emerges from a brutal second wave of Covid-19, public health experts are already preparing for a third wave they anticipate will be in store by the end of this year. In the intervening months, the Union government and State governments across India have a critical window in which to vaccinate as much of the population as possible…
…In order to reach the isolated or impoverished segments of the population most at risk from Covid-19, India will need to augment this list of existing and forthcoming vaccines with alternatives that are better designed for use in places where “cold chains” cannot be maintained on account of unreliable transportation, electricity, or storage networks.
One such vaccine is the AKS-452 jab developed by US-based Akston Biosciences, which is currently undergoing Phase I/II trials in the Netherlands. Unlike all of the Covid-19 vaccines currently on the national market, AKS-452 does not require refrigeration at all, and can instead be kept shelf-stable for four months at temperatures of up to 25°C. Even in warmer climates, the vaccine retains its efficacy for a full month at temperatures of up to 37°C. READ THE FULL ARTICLE
Consumer & Society
Second-generation vaccines crucial to beating pandemic around the world
(June 28, 2021) – The news that late-stage trials of German biotech firm CureVac’s Covid-19 vaccine yielded only 47% efficacy has been met with dismay by scientists, policymakers and company shareholders alike. Falling short of the 50% efficacy threshold specified by the US’s Food and Drug Administration (FDA) and even further below the World Health Organization’s (WHO’s) 70% target, CureVac’s seeming failure is a major blow to global vaccination efforts around the globe…
…With that in mind, it’s imperative that a surge of second-generation vaccines rise to meet the demand. Thankfully, there does appear to be a raft of promising candidates in the pipeline. Massachusetts-based Akston Biosciences, for example, dosed its first patient with its next-generation vaccine AKS-452—which has already shown encouraging results in trials on non-human primates— in a phase I/II trial in the Netherlands earlier this year. Akston’s vaccine candidate, which targets a part of the coronavirus spike protein which is less likely to mutate, is capable of retaining its potency for four months at 25°C or one month at 37°C, making it particularly ideal for the developing world where storage and distribution infrastructure is sorely lacking. AKS-452 also lends itself well to rapid upscaling, with manufacturers estimating that a single 2,000-litre production line could produce up to one billion doses per year. READ THE FULL ARTICLE
Marblehead Home and Style
AKS-452: The Newest Vaccine
(Summer 2021) – COVID-19 shot developed by residents company reaches trial stage
A company co-founded by a Marblehead resident has developed a COVID-19 vaccine that is being tested on volunteers in the Netherlands. Akston Biosciences announced in mid-April that the first participants in a clinical trial have received doses of its vaccine, AKS-452. The company is hoping to get approval from European regulators and then seek approval in the United States. READ THE FULL ARTICLE
Tested in Groningen: easy-to-produce Akston vaccine should help vaccinate poorer countries quickly
(June 17, 2021) – The number of vaccinated people is rising rapidly in Europe and North America, but Asia and Africa in particular are lagging behind. Billions of vaccines are still needed to protect the entire world population, such as the new Akston vaccine that is being tested in Groningen. READ THE FULL ARTICLE
Amid surging Covid-19 cases, second gen vaccines raise hopes across the Asia-Pacific
(June 9, 2021) – The United Nations High Commissioner for Refugees sounded the alarm at the beginning of this month on the rapidly deteriorating circumstances of refugees and asylum seekers in Asia. As outbreaks surge following the spread of the new Delta strain first detected in India, displaced persons across the region are at a very high risk of contracting the deadly virus—not least because of a dearth of coronavirus vaccines throughout the Asia-Pacific. The UNHCR is renewing its appeal to countries with prior pharmaceutical agreements and successful vaccination programmes to urgently donate surplus vaccines to the besieged countries…
…One such second-generation vaccine, produced by US-based Akston Biosciences, is especially well-suited for hot regions such as ASEAN because it doesn’t require the same particular handling as first-generation vaccines like Pfizer and Moderna. In fact, Akston’s AKS-452 remains effective for a week up to 37ºC and shelf-stable for four months at 25ºC – a critical advantage in areas where refrigeration infrastructure is limited. READ THE FULL ARTICLE
How – and How not – to Vaccinate the Whole World
(June 9, 2021) – by Peter J. Pitts–The development of Covid-19 vaccines happened with impressive speed. But to end the pandemic, it’s not enough just to have invented them. The shots also have to be manufactured, shipped, stored, and injected into arms around the world.
With an assortment of vaccines now proven safe and effective, global leaders are turning to these challenges. In the race to get the world inoculated, though, some bad ideas are gaining traction…
…In particular, health authorities and political leaders need to recognize that not all safe, effective Covid-19 vaccines are the same. What works best in big-city North America may not be appropriate everywhere.
For instance, the U.S.-approved Johnson & Johnson shot requires only a single dose, a boon for patients who can’t get to a clinic more than once. Akston Biosciences is pioneering a vaccine that can be stored for a month at 95 degrees Fahrenheit – ideal for hot climates. Altimmune and the University of Alabama, meanwhile, are working on a vaccine that can be self-administered as a nasal spray. READ THE FULL ARTICLE
East Africa Monitor
Shortage of vaccine doses threatens Africa’s COVID-19 immunisation program
(May 31, 2021) – Panic is spreading in Kenya as coronavirus vaccine doses are running low and many people are unable to get their second jab on schedule. Kenyan health authorities have said that less than two percent of the country’s population of more than 52 million has been vaccinated so far, with further supplies of the two-shot AstraZeneca COVID-19 vaccine delayed at least until June. While South Sudan recently decided to send 72000 doses of the vaccine to Kenya over fears Juba will not be able to administer them on time, the shortfall is still important. Some 900,000+ Kenyans vaccinated to date are at risk of failing to receive their essential second dose within the recommended window…
…Massachusetts-based Akston Biosciences, for example, is carrying out Phase I/II trials in the Netherlands on its candidate AKS-452, which demonstrated promising results in primate trials, is shelf-stable even at high temperatures and could be manufactured rapidly and cheaply. In fact, thanks to the standard antibody-manufacturing techniques used, the company claims that a single production line could be capable of producing over a billion doses per year. As the trial’s lead investigator, Dr. Schelto Kruijff, stresses: “From my volunteer work in Malawi and Kenya, I understand how important it would be to have a vaccine like this, which can be transported and stored for months without refrigeration.” READ THE FULL ARTICLE
International Business Times
The Right Shots In The Right Places
(May 30, 2021) – by Drew Johnson—Every safe and effective Covid-19 vaccine is helping to end the global pandemic. But that doesn’t mean they’re all the same. Some are harder to manufacture. Others are trickier to ship and store. There are one-dose and two-dose versions. And doctors in the United Arab Emirates found that the Chinese-made Sinopharm vaccine can require a third dose.
More remarkably, Akston Biosciences has begun human trials of a vaccine that can be transported and stored without any refrigeration, even in warm climates. The shot remains potent for one month stored at 95 degrees Fahrenheit — and for at least four months at a balmy 77 degrees. It has the potential to transform global vaccine delivery. READ THE FULL ARTICLE
The London Economic
Second Generation Vaccines: The next stage ofcoronavirus recovery
(May 18, 2021) – by Luis Auge—The news that the European Union isn’t planning to renew its COVID-19 vaccine contract with AstraZeneca comes as little surprise to anyone who has followed the mess of recriminations, lawsuits, delivery delays and back and forth over concerns about safety and efficiency which have plagued the rollout of the Anglo-Swedish firm’s vaccine, writes Louis Auge. READ THE FULL ARTICLE
Waiving Vaccine IP Protections Will Do More Harm Than Good
(May 17, 2021) – by Todd Zion, Chairman and CEO of Akston Biosciences—The Biden administration last week joined the chorus of countries calling for the suspension of intellectual property protections for Covid vaccines and pandemic-related treatments. This is unfortunate, as waiving IP rights won’t do much to get more shots in arms, but it will undermine the very system that made the rapid vaccine developments of the past year possible. READ THE FULL ARTICLE
AKS-452: The newest vaccine – COVID-19 shot developed by Beverly company reaches trial stage
(April 19, 2021) BEVERLY — A COVID-19 vaccine developed by a company in Beverly is being tested on volunteers in the Netherlands.
Akston Biosciences announced this week that the first participants in a clinical trial have received doses of its vaccine, called AKS-452. The company is hoping to get approval from European regulators and then seek approval in the United States. READ THE ARTICLE
Second gen vaccines could hold key to vanquishing virus
(April 21, 2021) The week-long lockdown comes at a time when India is in the midst of a veritable health crisis; not only are many of its ICUs being overwhelmed by an exponential surge in cases of the virus, but the problem is also being compounded by significant vaccine shortages.
In the Netherlands, for example, Akston Biosciences are beginning clinical trials for their new candidate, named AKS-452. Capable of retaining its potency in temperatures of up to 25°C for four months and remaining shelf-stable at 37°C or below for 30 days, the vaccine could offer a substantial selling point in India’s sweltering heat. What’s more, the fact that AKS-452 dispenses with a live or weakened form of the virus in favor of conventional, low-cost manufacturing methods means that its creators claim a single, 2,000-litre production line would have the capacity to churn out over one billion doses per year. READ THE ARTICLE
Boston Business Journal
Small, local biotechs make progress on their own Covid-19 drugs
(April 16, 2021) The biggest players in the Covid-19 space are the ones that dominate the headlines: Moderna Inc. with its promising new vaccine booster shot candidates, Pfizer and BioNTech with boosters of their own in development and Gilead Sciences, Eli Lilly and Regeneron with antivirals and antibody treatments. But as the pandemic continues around the globe, small Massachusetts firms are developing potential vaccines and treatments of their own — and two of them hit milestones in that process this week. READ THE ARTICLE
Drug Discovery Today
Akston Biosciences Launches Phase I/II Clinical Trial of Second-Generation COVID-19 Vaccine
First subjects dosed with AKS-452, COVID-19 vaccine candidate in the Netherlands trial the vaccine is shelf-stable for 4 months at 25 degrees Celsius (77° Fahrenheit). 176 volunteers will participate in the clinical trial the safety and immune response read-outs expected in Q2 2021.
(April 15, 2021) – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first participants have been dosed in an open-label trial of AKS-452, its COVID-19 vaccine candidate. The trial is managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials; and is being conducted at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. It will test both one- and two-dose regimens, each at three-dose levels. READ THE ARTICLE
Africa’s need for a dedicated Covid-19 vaccine supply
(April 15, 2021) As with so many other facets of global wealth (and health) inequality, the rollout of the four Covid-19 vaccines produced by Western pharmaceutical companies and approved by American and European health officials – the “Big Four” of Pfizer/BioNTech, Moderna, Oxford/AstraZeneca, and Johnson & Johnson – has quickly became yet another tale of haves and have-nots.
Fortunately, a new slate of vaccines fit for use in the least-developed areas of sub-Saharan Africa are currently undergoing trials and could soon offer African health officials alternatives to the AstraZeneca/Johnson & Johnson duopoly. They include the AKS-452 vaccine produced by Akston Biosciences, which is currently undergoing a Phase I/II clinical trial hosted by the University Medical Center Groningen (UMCG) in the Netherlands. READ THE ARTICLE
Viral variants and vaccine nationalism pose two-pronged threat to Covid victory
(April 14, 2021) Even before the appearance of a number of worrisome variants threw a spanner into the works of the world’s coronavirus vaccine rollout, the free-for-all in which wealthy countries snapped up enough doses to inoculate their populations several times over, while some developing nations have yet to administer a single shot, had been dubbed a “catastrophic moral failure”.
Fortunately, several forward-thinking companies are already working on the second generation of Covid vaccines – shelf-stable products which could be used to decrease vaccine inequality around the globe and provide booster shots for already-vaccinated populations. Massachusetts-based firm Akston Biosciences, for example, has developed AKS-452, a recombinant subunit candidate which is easy to transport, shelf-stable for weeks at up to 37°C, and inexpensive to produce. READ THE ARTICLE