Akston Biosciences Announces Positive Interim Phase II Results from COVID “Universal” Booster Vaccine Trial

Study investigated boosting those previously vaccinated with EMA-registered vaccines 

 

  • 93% of those previously vaccinated had higher neutralizing antibody titers after a single dose of AKS-452
  • Sera collected from participants 28 days after administration of a 90 µg booster dose of the COVID-19 vaccine showed a substantial increase in neutralizing antibody response
  • No Adverse Effects and no Serious Adverse Effects attributable to AKS-452 occurred during the study

 

BEVERLY, Mass. – Nov. 1, 2022 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, today announced top-line clinical results for its Phase II COVID-19 “universal” booster vaccine, AKS-452. An interim analysis of the data found that 93% of subjects previously vaccinated with Pfizer, Moderna, Johnson & Johnson (Janssen), and AstraZeneca vaccines showed an increase in neutralizing antibody titers after receiving a single dose of AKS-452. The average neutralization titers across all subjects increased 4-fold against the Wuhan strain and 5-fold against the Omicron variants at Day 28. There were no safety issues reported..

The non-randomized, open-label, safety, and efficacy study was conducted and managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials that previously conducted Phase I and II trials for AKS-452 in the Netherlands. Seventy healthy participants between the ages of 18 and 85 received one 90 µg dose of the AKS-452 antigen. The vaccine was well tolerated with data indicating a favorable safety profile, similar to that of the registered vaccines. Antibody levels, virus neutralization activity, and T cell response will be measured at intervals over the next nine months.

“The favorable safety and immunogenicity profiles at the interim analysis of this study, particularly against variants, support a Phase III universal booster study for AKS-452,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “Immunity from infection or vaccination quickly wanes and new waves of elusive strains are presenting continuing challenges. Boosting immunity in vulnerable populations will be needed for years to come and vaccines must be low cost and easy to distribute.”

A 1,600 subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine was completed earlier this year in India. The positive results from that study have been submitted as part of an Emergency Use Application in India.

AKS-452 is a second-generation vaccine based on Akston’s novel Fc-fusion platform. Its composition provides direct presentation to the immune system and robust protection against virus variants. Using proven antibody technologies, it inherently supports high production yields and stability at high temperatures.

 

 

About Tracer TRACER Europe B.V. (“TRACER”) is a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biologic medicines and is a founding member of the COVID-19 Rapid Cure Task Force (RCTF). TRACER and its partners provide its clients with the expertise, infrastructure, and capacity to rapidly generate accurate first-in-human clinical data. www.tracercro.com.

About Akston Biosciences AAkston Biosciences Corporation leverages its novel Fc-fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston owns and operates a GMP biologics cleanroom facility that manufactures kilogram-scale batches of drug substance. This, along with its research and process development laboratories, are located at its Beverly, Mass. location. Additional information is available at www.akstonbio.com.


Akston Biosciences Receives U.S. Patent for Once-A-Week Human Insulin

BEVERLY, Mass. – August 9, 2022 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, today announced that it has recently been granted U.S. patent 11,352,407. The patent covers recombinantly manufactured ultra-long acting insulin Fc-fusion proteins for use as once-a-week insulin treatments for diabetes. These insulin Fc-fusion proteins comprise an insulin polypeptide connected via a peptide linker to an Fc-fragment of human origin.

This is the first patent granted to Akston covering once-a-week insulin Fc-fusion proteins for treating human diabetes and the lead compound covered by it, AKS-440, is in manufacturing development at Akston’s Beverly, Massachusetts facility. AKS-440 was designed using Akston’s proprietary Fc-fusion protein platform, which has been used to rapidly and efficiently generate candidate compounds for a diverse set of disease indications.

The company has previously been granted patents in both the U.S, and Europe covering once-a-week insulins for treating canine and feline diabetes. Akston has 17 issued patents world-wide covering not only these insulin therapy candidates but also a candidate in development designed to delay or prevent autoimmune diabetes, and a novel COVID-19 vaccine.  The veterinary insulins have been licensed to Dechra Pharmaceuticals PLC and the vaccine has been licensed to Biolexis, a division of the Strides Group, which plans to launch it as AmbiVax-C™ in global markets.

“This new patent demonstrates the value of Akston’s proprietary Fc-fusion protein platform,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “We utilize the platform to tailor the different components of an Fc-fusion protein to optimize safety, efficacy, and manufacturability. Once a group of promising candidates is found, variants can be designed, synthesized, and tested to improve overall performance through a rapid and iterative process. This can significantly reduce the time and cost of developing vaccines and therapies.”

 

About Akston Biosciences Akston Biosciences Corporation leverages its novel Fc-fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston owns and operates a GMP biologics cleanroom facility that manufactures kilogram-scale batches of drug substance. This, along with its research and process development laboratories, are located at its Beverly, Mass. location. Additional information is available at www.akstonbio.com.


Biolexis and Akston Biosciences Announce Encouraging Top-Line Results from Phase II/III Trial of their Thermostable 2nd Gen COVID-19 Vaccine

  • Results of 100 subjects bridging study and 1,500 subjects placebo-controlled trial of Akston’s AKS-452 announced.
  • Interim analysis shows a 91% seroconversion rate.
  • Statistically-significant high antibody titers were maintained for six months in the bridging study.
  • The vaccine was well tolerated, with no significant safety issues reported.
  • AKS-452 is shelf-stable for over six months at room temperature at 25° C and maintains potency for one month at 37° C.
  • Biolexis has licensed AKS-452 and plans to launch it as “AmbiVax-CTM” in global markets.
  • Vaccine to be produced at Stelis Biopharma, the biotech CDMO division of Strides Group.

 

BEVERLY, Mass., and BANGALORE, India – June 24, 2022 – Akston Biosciences Corporation and Biolexis, a Strides Group Company, today announced results from a Phase II/III clinical trial in India of the SARS-CoV-2 vaccine, AKS-452, in which 1,600 healthy volunteers participated – 100 in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial.

An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56. Volunteers in the bridging study had antibody titers that persisted at statistically-significant high levels through six months, with serum taken from them showing protection against variants of concern. The results will be submitted as a prime vaccine in India for Emergency Use Authorization (EUA). Later clinical studies are planned to support approval for use as a booster shot to itself and other approved vaccines. Earlier studies in the Netherlands have demonstrated robust antibody neutralization of variants, including Delta and Omicron.

Akston and Strides group have already signed a licensing, manufacturing, and commercialization agreement to launch this vaccine worldwide as AmbiVax-CTM. Under the agreement, Biolexis, the vaccine and biosimilar arm of the Strides Group, has the rights to manufacture and commercialize AmbiVax-CTM in India and over 130 countries in Asia, Latin America, and Africa, mainly covering the low-and-middle-income countries (LMICs) where a significant population lacks dependable access to vaccines as a result of insufficient infrastructure to support the cold chain requirements of other COVID-19 vaccines. The vaccine is a reliable, accessible alternative in these regions, allowing immunization and longevity of immunity with the boosters against the Covid variants of concern. The partnership will leverage the capabilities of Strides Group, which has an “in Africa for Africa” strategy and will offer the vaccine to countries with a deep market presence and established relationships.

Arun Kumar, Founder of Strides Group, added, “We are pleased to know the encouraging results from the India studies of AmbiVax-CTM, particularly the high seroconversion rate that the vaccine demonstrated. This vaccine differentiates itself by allowing room-temperature stability, higher efficacy, and safety and can offer accessibility and affordability through the economical supply chain and infrastructure requirements. As we progress to receiving the approval, we will continue exploring opportunities to fast-track its launch for the global markets.”

Todd Zion, Ph.D., President & CEO of Akston Biosciences, said, The latest clinical data demonstrate the potential of this low-cost protein vaccine intended specifically for those most in need. We are very pleased to be working closely with Biolexis and Strides Group, which can supply the vaccine at scale to countries that need a practical and affordable way to protect their populations during this worldwide pandemic.” The Phase II/III trial, managed by Ahmedabad-based Veeda Clinical Research Limited, evaluated the safety, tolerability, and humoral immunogenicity profile, i.e., SP/RBD-specific IgG titers. Of the 1,500 healthy volunteers, 1,125 received the two 90 µg doses 28 days apart, with the first dose including AKS-452 and an adjuvant, while the second dose consisted of only AKS-452. The remaining 375 also received two doses, with the first dose including placebo and the adjuvant, while the second dose consisted only of placebo. AKS-452 does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. It has been engineered to use established, low-cost antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year. Stability studies have demonstrated thermostability at room temperature for over six months at 25° Celsius (77° Fahrenheit) and maintenance of potency for one month at 37° Celsius (99° Fahrenheit).

 

About Akston Biosciences Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. It was founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.). Besides out-licensing AmbiVax-CTM to Biolexis, Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing cleanroom facility and research laboratory at its Beverly, Mass. location. Additional information is available at www.akstonbio.com.

About Strides Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets, has an “in Africa for Africa” strategy, and an institutional business to service donor-funded needs. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries. Additional information is available at www.strides.com.

About Stelis Stelis Biopharma Limited (Stelis) is an emerging global biopharmaceutical CDMO with a complete and integrated end-to-end offering. It is equipped with world-class Process Development (PD) and manufacturing infrastructure for both drug substances (mammalian and microbial-based therapeutic proteins and other emerging modalities) and drug products (lyophilized vials, liquid vials, pre-filled syringes, cartridges, and devices). Stelis offers the complete spectrum of services, from cell line tech transfer to clinical and commercial manufacturing, with in-house capability to convert drug substances to stable formulations and fill and finish in all formats. Stelis has three state-of-the-art facilities, with ~85,000 square meters of PD and manufacturing space and over 800 highly talented professionals. Its facilities are highly automated to increase accuracy, efficiency, and speed at every process stage. Additional details are available at www.stelis.com.

About Biolexis Biolexis Private Limited (Biolexis) is an emerging biotech and vaccine company capable of developing and commercializing products for the Global markets. The Company is a wholly-owned subsidiary of Stelis and is focused on building and in-licensing a portfolio of advanced biosimilars, peptides, and vaccines. The Company endeavors to attain leadership in commercializing its portfolio of products with a high focus on quality, affordability, and accessibility. Besides in-licensing AmbiVax-CTM from Akston, Biolexis has a proprietary platform technology to develop and commercialize recombinant insulin and insulin analogs with high purity and consistent quality. The current programs of the Company include Rh-Teriparatide (biosimilar to Forteo® and Forsteo®), Insulin glargine (biosimilar to Sanofi’s Lantus®), Insulin Lispro (biosimilar to Eli-Lilly’s Humalog®), Insulin Aspart (biosimilar to Novo Nordisk’s Novolog®), a recently filed peptide for diabetes and a novel anti-hemorrhoid.

About Veeda Clinical Research Limited Veeda Clinical Research Limited (“Veeda”) is one of the largest independent, full-service clinical research organizations headquartered in Ahmedabad, India. Veeda offers a range of bioequivalence studies and early and late phase clinical trials. Veeda has completed several regulatory inspections and is approved by USFDA, UK MHRA, ANVISA (Brazil), and WHO. Veeda has experience in conducting complex clinical studies. Visit https://www.veedacr.com.


Contact:
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com

Akston Biosciences Doses First Participants in Phase II Clinical Trial for Shelf-Stable COVID-19 Booster

  • Up to 600 volunteers will participate in an AKS-452 COVID booster study in the Netherlands to investigate boosting the immune response of those previously vaccinated with EMA-registered vaccines
  • AKS-452 has shown the ability to successfully neutralize the omicron variant of the SARS-CoV-2 virus 
  • Shelf stable at 25° Celsius (77° Fahrenheit) for at least 6 months, the low-cost SARS-CoV-2 vaccine can be efficiently manufactured anywhere in the world using standard antibody production facilities
  • AKS-452 is currently undergoing Phase II/III clinical testing in India as a primary vaccine; submission for Emergency Use Authorization (EUA) expected by Q3 2022.

BEVERLY, Mass. – May 12, 2022 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it dosed the first set of volunteers in an open-label study of AKS-452, its protein subunit COVID-19 vaccine, as a booster. The Phase II booster study is designed to investigate the response of the immune system in up to 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson & Johnson (Janssen) and AstraZeneca.

The study is being conducted at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. Schelto Kruijff, M.D. Ph.D., the principal investigator at the UMCG for the AKS-452 Phase I and Phase II primary vaccine trials, is serving in the same capacity for the booster trial.

The first volunteer receives Akston Bioscience’s COVID-19 booster vaccine, AKS-452, as part of a Phase II trial in the Netherlands. The protein-based vaccine has been shown to have the ability to successfully neutralize the omicron variant of the SARS-CoV-2 virus, and is shelf-stable for at least six months at room temperatures up to 25°C (77°F).

“AKS-452 induced a Th1/Th2 mixed immune response against the Receptor Binding Domain (RBD) of the coronavirus spike protein, according to an analysis of the Phase II study of AKS-452 as a primary vaccine,” Dr. Kruijff said. “While we still need to vaccinate millions of people with a primary COVID-19 shot, it’s also clear that we’ll need an annual booster shot, and key characteristics of AKS-452, including low price and shelf stability, could make AKS-452 an ideal solution.”

The participants, healthy adults between the ages of 18 and 85, will have had their last COVID-19 vaccine shot at least three months earlier and will not have received a COVID-19 booster shot. To determine the efficacy of the AKS-452 as a booster, the study will divide participants into four groups, each of up to 150 subjects, based on having previously received the Pfizer, Moderna, Johnson & Johnson or AstraZeneca vaccine. Each participant will receive one dose of the AKS-452 antigen (90 µg). Antibody levels, virus neutralization activity, and T cell response will be measured over nine months from samples taken in several follow-on appointments to determine the effect over time. The primary efficacy endpoint will be the antibody titer level four weeks after receiving the booster.

The dosing of all volunteers is expected by mid-June. The trial is managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials and which conducted the Phase I and II trials for AKS-452.

“Because immunity to COVID-19 wanes over time, and because new variants arise, the world will need an ongoing supply of booster vaccines. AKS-452 is cost-effective to manufacture at scale, and does not require the cold-chain necessary for mRNA vaccines. We believe AKS-452 is a practical solution to provide necessary protection, especially for difficult-to-reach populations,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences.

A 1,600 subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine is currently underway in India.

About University Medical Center Groningen
The University Medical Center Groningen (UMCG) is one of the largest hospitals in the Netherlands. The more than 12,000 employees work together on care, research, training and education with the common goal: building the future of health. Through innovative and sound research UMCG aims to understand mechanisms of disease; to push borders for diagnostics and treatment; and to help build a network for sustainable health. All of its research focuses on Healthy Ageing. Talent development and state-of-the-art infrastructure are of paramount importance to UMCG. 

About TRACER
TRACER Europe B.V. (“TRACER”) is a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biologic medicines and is a founding member of the COVID-19 Rapid Cure Task Force (RCTF). TRACER and its partners provide its clients with the expertise, infrastructure, and capacity to rapidly generate accurate first-in-human clinical data. www.tracercro.com. 

About Akston Biosciences
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing facility and research laboratory at its Beverly, Mass. location. www.akstonbio.com.


Contact:
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com

Akston Biosciences CEO to Present at the World Vaccine Congress

Akston’s AKS-452 COVID-19 vaccine is shortlisted for Best New Vaccine Technology/Platform in Vaccine Industry Excellence (ViE) Awards

BEVERLY, Mass. – April 12, 2022 Akston Biosciences Corporation, a developer of new classes of biologics, announced that its president and CEO, Todd Zion, Ph.D., has been invited to present at this year’s World Vaccine Congress (WVC).  This is the largest, most prestigious meeting dedicated to vaccines and will be held on April 18-21 in Washington, DC. In addition, the company’s Fc-fusion protein platform has been shortlisted in the best new vaccine technology category of the World Vaccine Congress Vaccine Industry Excellence (ViE) Awards.

“It’s an honor to be invited to present a clinical update of Akston’s COVID-19 vaccine at the World Vaccine Congress. AKS-452 is very cost-effective to manufacture at scale, and it does not have the cold-chain constraints of many other vaccines, so it can be a practical way to provide protection to those who are most in need,” Dr. Zion said.

Who:    Todd Zion, Ph.D., President & CEO of Akston Biosciences Corporation

What:   Clinical update on AKS-452, a low cost, shelf-stable, Fc-fusion protein COVID-19 vaccine (as part of WVC’s COVID & Beyond – M4 track)

When:  April 21 at 11:30 a.m. (ET)

Where: Independence Salon D at the Marriott Marquis in Washington, DC.

During the discussion, Dr. Zion will discuss recent clinical results including:

  • 96% (1-dose) and 100% (2-dose) seroconversion
  • Binding of a broad spectrum of variant RBDs by serum from vaccinated subjects
  • Robust IgG titer levels induced and maintained
  • Favorable Th1/Th2 response and T cell activation across variants
  • Uniquely efficient Fc-fusion protein vaccine platform

A Phase II/III double-blind, placebo-controlled registration trial for AKS-452 as a primary vaccine is underway in India, with the aim of receiving Emergency Use Authorization (EUA) this summer.

AKS-452 is currently being tested as a booster in a Phase II trial in the Netherlands with subjects that received primary vaccination with Pfizer, Moderna, Johnson & Johnson or Astra-Zeneca vaccines.

About AKS-452
AKS-452 is a first-of-its-kind, protein subunit, thermostable, COVID-19 vaccine, which is shelf stable for six months at room temperatures (25° Celsius or 77° Fahrenheit) and maintains its potency for one month at elevated temperatures (37° Celsius or 99° Fahrenheit).

AKS-452 has been shown to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. As the primary locus for infection, the RBD is highly conserved among mutated forms of the virus. Studies of AKS-452 have demonstrated robust antibody neutralization of variants, including Delta and Omicron.

It is designed as a flexible and economical vaccine for those most at risk in low- and middle-income countries, particularly those that lack cold-chain infrastructure needed for mRNA and DNA vaccines. AKS-452 uses standard antibody manufacturing techniques and equipment, so that a single 2000L production train could produce over one billion doses per year, making it less expensive to make than many other COVID-19 vaccines.

About Akston Biosciences
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing cleanroom facility and research laboratory at its Beverly, Mass. location. Additional information is available at www.akstonbio.com.


Contact:
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com

Akston Biosciences Doses First Volunteers in Phase II/III Clinical Trial of Low Cost, Shelf Stable COVID-19 Vaccine

  • 1,500 healthy volunteers to participate in a Phase II/III double-blind placebo-controlled study in India
  • Study results to be submitted for Emergency Use Authorization (EUA)
  • Vaccine is shelf stable for over six months at room temperature at 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit)

BEVERLY, Mass., and BANGALORE, India – April 7, 2022 Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first volunteers in a Phase II/III clinical study of AKS-452, its low cost, shelf stable protein subunit COVID-19 vaccine, were dosed in India. India’s Central Drugs Standard Control Organization (CDSCO) approved the double-blind, placebo-controlled trial, initiated by Ahmedabad-based Veeda Clinical Research Limited, whose data will be submitted in an application for Emergency Use Authorization (EUA).

The first volunteer receives Akston Bioscience’s COVID-19 vaccine, AKS-452, as part of a Phase II/III double-blind placebo-controlled study in India. The protein-based vaccine is shelf-stable for at least six months at room temperatures up to 25°C (77°F), and does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. (image left)

The multicenter trial will complete the enrollment of 1,500 healthy volunteers, age 18 and older, who will receive two 90 µg doses 28 days apart. Under the supervision of six principal investigators (Pravin Dinkar Supe, M.D.; Krishna Giri, M.D.; Himanshu Pophale, M.D.; Prakash Shinde, M.D.; Shrikant Deshpande, M.D.; and Kuntal Shah, M.D.), the dosing of healthy volunteers will be completed by April 15, 2022.

Of the 1,500 healthy volunteers, 1,125 will receive the two-doses of vaccine, with the first dose including AKS-452 and an adjuvant, which primes the body’s immune response, while the second dose will consist only of AKS-452. The remaining 375 will receive two doses of placebo with the first dose including placebo and the adjuvant, while the second dose will consist only of placebo. The primary objective of the study is to evaluate the safety, tolerability and humoral immunogenicity profile (i.e., SP/RBD-specific IgG titers) of AKS-452 at day 56, following a two-injection regimen in a combined bridging and a Phase II/III clinical study. Interim results of the Phase II/III trial in India are expected to be available in June 2022. This follows a successful 100-volunteer open-label bridging study by Veeda, which began in Nov. 2021.

A recent Phase II clinical trial conducted at the University Medical Centre Groningen (UMCG) in the Netherlands showed a robust 98% seroconversion response after either two 45 μg doses (100%) or a single 90 μg dose (96%) of AKS-452 in healthy adults at 56 days. It was well-tolerated with a safety profile comparable to approved vaccines.

Additional trials are also being pursued to qualify AKS-452 as a booster to itself or to other approved vaccines.

Manufacture and Distribution Partnership
Akston recently signed a licensing, manufacturing and commercialization agreement with Strides Group subsidiary Biolexis. Under the agreement, Biolexis gains the right to manufacture and commercialize AKS-452, branded as AmbiVax-CTM in India, and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). The partnership will leverage the capabilities of Strides Group, a global pharmaceutical company headquartered in Bengaluru, India. Strides has an “in Africa for Africa” strategy and will offer the vaccine in countries where it has a deep market presence and established relationships.  

“This clinical trial represents an important step in the development of protein-based COVID-19 vaccines,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “We are working closely with Strides Group, which will manufacture AKS-452 at scale, so that it can be quickly rolled out after receiving an EUA. We look forward to being able to supply the vaccine to countries that need an affordable and effective way to protect their populations during this worldwide pandemic.”

About AKS-452
AKS-452 is a first-of-its-kind, protein subunit, thermostable COVID-19 vaccine intended specifically for those most in need. It is shelf stable for six months at room temperatures (25° Celsius or 77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit). 

AKS-452 does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus and has been engineered to use established, low-cost antibody manufacturing techniques, such that a single 2,000L production train could be capable of producing over one billion doses per year.

AKS-452 is designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. As the primary locus for infection, the RBD is highly conserved among mutated forms of the virus. Studies on AKS-452 have demonstrated robust antibody neutralization of variants, including Delta and Omicron, and it has been evaluated in safety and efficacy studies in the Netherlands and India comprising hundreds of subjects. 

AKS-452 has the potential to surmount the challenges posed in countries where a significant population lacks dependable access to vaccines as a result of insufficient cold chain infrastructure. AKS-452 could offer a flexible, reliable, and economically viable alternative in these regions, supporting accelerated vaccination of those most in need. 

About Akston Biosciences
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing cleanroom facility and research laboratory at its Beverly, Mass. location. Additional information is available at www.akstonbio.com

About Veeda Clinical Research Limited
Veeda Clinical Research Limited (“Veeda”) is one of the largest independent, full-service clinical research organizations, headquartered in Ahmedabad, India. Veeda offers a range of bioequivalence studies and early and late phase clinical trials. Veeda has successfully completed several regulatory inspections and is approved by USFDA, UK MHRA, ANVISA (Brazil), and WHO. Veeda has experience in conducting complex clinical studies. Visit https://www.veedacr.com/


Contact:
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com

Siddharth Baad
Veeda Clinical Research Limited
+91-9620213300
siddharth.b2274@veedacr.com 

 

Akston Biosciences Receives Regulatory Approval for Phase II Clinical Trial for Shelf-Stable COVID-19 Vaccine Booster

  • 600 volunteers will participate in an AKS-452 booster study in the Netherlands to investigate boosting the immune response of those previously vaccinated with EMA-registered vaccines
  • Vaccine is shelf stable for at least six months at room temperature: 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit)
  • Currently undergoing Phase II/III clinical trial in India for Emergency Use Authorization (EUA) as a primary vaccine

Beverly, Massachusetts – March 31, 2022Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it received regulatory approval in the Netherlands to conduct an open-label study of AKS-452, its protein subunit COVID-19 vaccine, as a booster. The study is designed to investigate the response of the immune system to an AKS-452 booster shot in 600 volunteers who have previously been vaccinated with EMA-registered vaccines from Pfizer, Moderna, Johnson & Johnson (Janssen) and AstraZeneca.

The trial is managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials and which oversaw the Phase I and II trials for AKS-452. The study will be conducted at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. Schelto Kruijff, M.D. Ph.D., the principal investigator at the UMCG for the AKS-452 Phase I and Phase II primary vaccine trials, will serve in the same capacity for the booster trial.

“The interim analysis of the Phase II open-label study of AKS-452 as a primary vaccine showed a robust overall 98% seroconversion response after either two 45 μg doses (100%), or a single 90 μg dose (96%) in healthy adults at 56 days. The vaccine induced a Th1/Th2 mixed immune response against the Receptor Binding Domain (RBD) of the coronavirus spike protein,” Dr. Kruijff said. “Given the apparent waning of immune response, a promising vaccine candidate like AKS-452 could be an effective booster.”

The participants, healthy adults between the ages of 18 and 85, will have had their last COVID-19 vaccine shot at least three months earlier and will have not yet received a COVID-19 booster shot. To determine the efficacy of the AKS-452 as a booster, the study will divide participants into four groups, each of 150 subjects, based on having received previously the Pfizer, Moderna, Johnson & Johnson or AstraZeneca vaccine. Each participant will receive one dose of the AKS-452 booster (90 µg), and will have antibody levels, virus neutralization activity, and T cell response measured at several follow-on appointments to determine the effect over time. The primary efficacy endpoint will be the antibody titer level four weeks after receiving the booster. Participants will have their last follow-up appointment nine months after boosting.

“The clinical study results so far show that AKS-452, developed with our proprietary Fc-fusion protein platform, is well tolerated and effective as a primary vaccine,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “Many people now have underlying immunity from vaccination or infection, but it is clear that immunity wanes over time and the world will need an ongoing supply of boosters. AKS-452 is very cost-effective to manufacture at scale, and it does not have the cold-chain constraints of many other vaccines, so it can be a practical way to provide protection while reducing the development and spread of new variants, by reaching difficult-to-reach populations.”

Using the serum from subjects vaccinated with AKS-452, Akston has shown the ability to successfully neutralize the omicron variant of the SARS-CoV-2 virus. The company is also testing hetero-bifunctional vaccines (RBD and N-protein) that could reduce likelihood of future variants escaping. 

A 1,600 subject Phase II/III clinical trial of AKS-452 as a two-dose primary vaccine is currently underway in India. Primary endpoint data is expected in May 2022 to support a potential EUA in H1 2022.

Akston has partnered with the Strides Group to manufacture and commercialize AKS-452, branded as AmbiVax-CTM, in India and over 130 countries in Asia, Latin America, and Africa. These include most of the world’s low-and-middle-income countries (LMICs), where Strides has a deep market presence and established relationships.

About AKS-452
AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely and widely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.

It is designed as a flexible and economical vaccine for those most at risk in low- and middle-income countries, particularly those that lack cold-chain infrastructure needed for mRNA and DNA vaccines. AKS-452 uses standard antibody manufacturing techniques and equipment, so that a single 2000L production train could produce over one billion doses per year, making it less inexpensive to make than many other COVID-19 vaccines.

Based on Akston’s proprietary Fc-fusion protein platform, AKS-452 is a SARS-CoV-2 vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. Being the primary locus for infection, the RBD is highly conserved among mutated forms of the virus, and clinical testing has demonstrated robust antibody neutralization of SARS-CoV-2 variants.

About University Medical Center Groningen
The University Medical Center Groningen (UMCG) is one of the largest hospitals in the Netherlands. The more than 12,000 employees work together on care, research, training and education with the common goal: building the future of health. Through innovative and sound research UMCG aims to understand mechanisms of disease; to push borders for diagnostics and treatment; and to help build a network for sustainable health. All of its research focuses on Healthy Ageing. Talent development and state-of-the-art infrastructure are of paramount importance to UMCG. 

About TRACER
TRACER Europe B.V. (“TRACER”) is a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biologic medicines and is a founding member of the COVID-19 Rapid Cure Task Force (RCTF). TRACER and its partners provide its clients with the expertise, infrastructure, and capacity to rapidly generate accurate first-in-human clinical data. www.tracercro.com

About Akston Biosciences
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing facility and research laboratory at its Beverly, Mass. location. www.akstonbio.com.


Contact:
Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com

Akston Biosciences and Biolexis Collaborate to Launch a Room Temperature Stable 2nd Generation COVID-19 Vaccine in 130+ Countries

  • Biolexis has in-licensed AKS-452, a room temperature stable COVID-19 vaccine developed on Akston’s proprietary Fc fusion protein platform
  • Biolexis will launch AKS-452 as “AmbiVax-CTM” for global markets where the cold chain elimination would contribute to improving immunization coverage and reducing vaccine wastage
  • Phase I and II studies of AmbiVax-CTM were completed in the Netherlands with greater than 90% seroconversion and a favorable safety profile
  • AmbiVax-CTM is currently undergoing clinical trials in India for Emergency Use Authorization (EUA) as a prime vaccine followed by planned studies for booster shot approval

Beverly, Massachusetts, and BANGALORE, India – March 17, 2022Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, and Biolexis, a division of Stelis Biopharma Limited (Stelis), announced today that they have entered into a licensing, manufacturing and commercialization agreement for Akston’s AKS-452, a protein subunit COVID-19 vaccine.  Under the agreement, Biolexis gains the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence and established relationships.

AKS-452 or AmbiVax-CTM is a first-of-its-kind thermostable COVID-19 vaccine developed for all parts of the world. AmbiVax-CTM is a SARS-CoV-2 protein subunit vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. As the primary locus for infection, the RBD is highly conserved among mutated forms of the virus. The studies on AmbiVax-CTM have demonstrated robust antibody neutralization of variants, including Delta and Omicron, and the vaccine has been evaluated in multiple safety and efficacy studies in Netherlands and India across hundreds of subjects. 

AmbiVax-CTM does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus and has been engineered to use established, low-cost antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year. AmbiVax-CTM is a twoshot vaccineinjected over 28 days, with the first shot being supported by an adjuvant. The stability studies conducted on AmbiVax-CTM have demonstrated thermostability at room temperature for over six months at 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit).  Being shelf-stable at these temperatures, AmbiVax-CTM has the potential to eliminate challenges in maintaining the cold chain, especially in low-and-middle-income countries where a significant population lacks dependable access to vaccines as a result of insufficient infrastructure to support the cold chain requirements of mRNA COVID-19 vaccines. AmbiVax-CTM would offer a flexible, reliable, and economically viable vaccine alternative in these regions, allowing the acceleration of immunization and longevity of immunity with the booster shots.

Commenting on the partnership, Arun Kumar, Founder, Strides Group, added, “We are very excited to partner with Akston on AmbiVax-CTM, which is a first-of-its-kind COVID-19 vaccine developed for all parts of the world. While the vaccine has demonstrated good outcomes with its safety profile and over 90% seroconversion in clinical and bridging studies, its room temperature stability offers a unique value to the global population, making it more accessible across the World. As AmbiVax-C™ expects to receive EUA as a prime vaccine in H1 of 2022, we will leverage our group capabilities to manufacture, fill-finish, and commercialize AmbiVax-CTM across all the markets. We also remain on course to get the vaccine qualified as a booster to itself and other approved vaccines in different regions.”

Todd Zion, Ph.D., President & CEO of Akston Biosciences, said, “We are very pleased to be working closely with Biolexis and Strides Group, which has the experience, know-how, and capability to produce our vaccine at scale. Just as importantly, the group can supply the vaccine to countries that need a practical and affordable way to protect their populations during this worldwide pandemic.”

AmbiVax-CTM has completed Phase I and II studies at the University Medical Centre Groningen (UMCG) in the Netherlands. The recent Phase II trial data showed a greater than 90% seroconversion rate after two 45 μg doses (100%) or a single 90 μg dose (96%) in healthy adults at 56 days. It was well tolerated with a safety profile comparable to approved vaccines.

An EUA determining Phase II/III clinical trial is currently underway in India for over 1,600 subjects. The bridging study of 100 subjects has already been completed with a favorable safety profile and greater than 90% seroconversion achieved on day 28 post two vaccines doses. Approval from the Subject Expert Committee (SEC) on vaccines of the Central Drugs Standard Control Organization (CDSCO), India, has been received to begin the dosing of the remaining 1,500 subjects. The studies are expected to conclude in April 2022 with a potential EUA within the H1 of 2022.  Besides this, additional studies are also being pursued to qualify AmbiVax-CTM as a booster to itself or other approved vaccines.

About Akston Biosciences
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing cleanroom facility and research laboratory at its Beverly, Mass. location. Additional information is available at www.akstonbio.com

About Strides
Strides, listed on the BSE (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bengaluru, India. The Company mainly operates in the regulated markets, has an “in Africa for Africa” strategy, and an institutional business to service donor-funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries. Additional information is available at www.strides.com.

About Stelis
Stelis Biopharma Limited (Stelis) is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a complete and integrated end-to-end offering. It is equipped with a world-class Process Development (PD) and manufacturing infrastructure for both drug substance (mammalian and microbial-based therapeutic proteins, viral vectors) and drug product (lyophilized vials, liquid vials, pre-filled syringes, cartridges and devices). Stelis has three state-of-the-art facilities, with ~900,000 square feet of PD and manufacturing space. More details are available at www.stelis.com.

About Biolexis
Stelis Biopharma Limited (Stelis) is a leading global biopharmaceutical Contract Development and Manufacturing Biolexis Private Limited (Biolexis) is an emerging biotech and vaccine company with the capabilities to develop and commercialize products for the Global markets. The Company is a wholly-owned subsidiary of Stelis and is focused on building and in-licensing a portfolio of advanced biosimilars, peptides, and vaccines. The Company endeavors to attain leadership in commercializing its portfolio of products with a high focus on quality, affordability, and accessibility. Besides in-licensing AmbiVax-CTM from Akston, Biolexis has a proprietary platform technology to develop and commercialize recombinant insulin and insulin analogs with high purity and consistent quality. The current programs of the Company include Rh-Teriparatide (biosimilar to Forteo® and Forsteo®), Insulin glargine (biosimilar to Sanofi’s Lantus®), Insulin Lispro (biosimilar to Eli-Lilly’s Humalog®), Insulin Aspart (biosimilar to Novo Nordisk’s Novolog®), a recently filed peptide for diabetes and a novel anti-hemorrhoid. 


Contact:
Ankit Gupta
For Stelis Biopharma Limited and Biolexis Private Limited
0091-8130923253
ankit@stelis.com

Sandeep Baid
For Strides Pharma Science Limited
Sandeep.baid@strides.com

Linda Pendergast-Savage
Birnbach Communications for Akston Biosciences
1-508-224-7905
lpendergastsavage@birnbachcom.com

Akston Biosciences Announces Publication in Vaccine of Positive Data for a Room Temperature Protein Subunit COVID-19 Vaccine

Shelf stable for at least 6 months, the low-cost SARS-CoV-2 vaccine can be efficiently manufactured anywhere in the world using abundant existing infrastructure

  • 100% seroconversion rate and high IgG titers with single 90 µg dose
  • Well-tolerated, with mild AEs, comparable to approved vaccines
  • Protein subunit vaccine, shelf stable for at least 6 months at 25o C (77o F)
  • A subsequent Phase II trial confirmed safety and efficacy

Beverly, Mass. – February 08, 2022 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced publication of positive results from a 60-subject, open-label, Phase I trial of AKS-452, its shelf stable protein subunit COVID-19 vaccine candidate. The adjuvanted vaccine was generally well-tolerated and produced a 100% seroconversion rate in the 90 µg single-dose regimen, as well as in the 45 µg and 90 µg two-dose regimens. The article in the current issue of Vaccine, is available here.

The trial met all primary and secondary endpoints, indicating minimal reactogenicity and optimized immunogenicity.  These results were subsequently confirmed in a Phase II trial. 

A recombinant subunit vaccine, AKS-452 comprises an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor binding domain (RBD) antigen that is engineered to preserve effectiveness against viral variants. 

“An effective COVID vaccine that is transportable without cold chain and is substantially less expensive than current vaccines – with cost savings also attributable to Akston’s high volume, low-cost manufacturing platform – can address many of the shortcomings that have slowed distribution and vaccine access in countries around the world,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “A single production line can rapidly produce more than a billion doses of AKS-452 per year using established antibody production infrastructure available worldwide, creating an abundant vaccine resource.”

The single-center, open-label Phase I dose-finding and safety study was conducted in the Netherlands with 60 healthy adults (18–65 years) receiving one or two doses 28 days apart of 22.5 µg, 45 µg, or 90 µg of AKS-452.  A 100% seroconversion rate was achieved in the 90 µg cohort at 28 days, and in the 90- and 45 µg cohorts at 56 days.  AEs were mild and comparable to those with currently approved vaccines.  There were no SAEs.

A Phase II/III trial for primary vaccination is expected to begin in India in Q1 2022, and studies evaluating AKS-452 as a booster are being planned.

About AKS-452
Based on Akston’s proprietary Fc fusion protein platform, AKS-452 is a SARS CoV-2 protein subunit vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. As the primary locus for infection, the RBD is highly conserved among mutated forms of the virus, and preclinical studies have demonstrated robust antibody neutralization of the B.1.1.7 (Alpha) and B.1.351 (Gamma) variants. The vaccine has been engineered to use standard, low-cost, antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year.

About Akston Biosciences
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing facility and research laboratory at its Beverly, Mass. location. www.akstonbio.com


Contact:
Edna Kaplan
Birnbach Communications for Akston Biosciences
617-974-8659
ekaplan@birnbachcom.com

Akston Biosciences Announces Positive Top-Line Data from Phase II Study of COVID-19 Vaccine in the Netherlands 

  • Two 45 μg doses and single 90 μg of protein subunit vaccine AKS-452 were generally well-tolerated and showed robust neutralizing antibody titers 
  • Primary immunogenicity endpoints were met 
  • Vaccine is shelf stable for at least 6 months at 25° C (77° F) 
  • Phase II/III trial starting in India 

Beverly, Mass. – December 22, 2021Akston Biosciences, Inc. a developer of new classes of biologic therapeutics, today announced positive data from the Phase II clinical trial of its second-generation SARS-CoV2 vaccine candidate, AKS-452.

The interim analysis showed a robust overall 98% seroconversion response after either two 45μg doses (100%), or a single 90μg dose (96%) in healthy adults at 56 days. 

It showed the vaccine induced a robust Th1/Th2 mixed immune response against the Receptor Binding Domain (RBD) of the coronavirus spike protein. 

The open-label study was conducted in the Netherlands and evaluated the safety, tolerability, reactogenicity and effectiveness of two 45 µg doses of AKS-452 with an adjuvant, given to 26 healthy participants ages 18 to 72, 28 days apart. In the trial’s second arm, a 26-participant cohort received a single 90 μg, which also contained an adjuvant.   

“The positive outcome of this trial is a significant step toward providing a low-cost, quickly manufactured protein subunit COVID vaccine that addresses the fundamental need for a safe, easily transported vaccine that can be stored for long periods without refrigeration and manufactured anywhere in the world where antibodies are made,” said Todd Zion, Ph.D., President and CEO of Akston Biosciences. “We look forward to sharing data from the Phase II/III trial that will start next month in India.” 

AKS-452 was well tolerated with a safety and tolerability profile consistent with the Phase I trial. Adverse Events were generally mild. The most commonly reported local symptom was injection site reaction (24.3%) while tiredness (6.3%) and headache (6.3%) were the most reported systemic symptoms.   

Akston is testing the ability of serum from subjects vaccinated with AKS-452 to neutralize the new omicron variant of the SARS-CoV-2 virus. The company has also initiated development of an omicron-specific version of its vaccine.   

About AKS-452
The AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.

Based on Akston’s proprietary Fc fusion protein platform, AKS-452 is a SARS-CoV-2 protein subunit vaccine candidate designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. Being the primary locus for infection, the RBD is highly conserved among mutated forms of the virus, and in vitro studies have demonstrated robust antibody neutralization of variants. The vaccine has been engineered to use standard, low-cost, antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year at existing plants around the world.

About Akston Biosciences
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.), Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing facility and research laboratory at its Beverly, Mass. location. www.akstonbio.com.


Contact:
Edna Kaplan
Birnbach Communications for Akston Biosciences
617-974-8659
ekaplan@birnbachcom.com