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

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.

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

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.

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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.

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

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).

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March 31, 2022 – Akston Biosciences Receives Regulatory Approval for Phase II Clinical Trial for Shelf-Stable COVID-19 Vaccine Booster

BEVERLY, Mass. – March 31, 2022 – Akston 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.

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March 17, 2022 – Akston Biosciences and Biolexis Collaborate to Launch a Room Temperature Stable 2nd Generation COVID-19 Vaccine in 130+ Countries

BEVERLY, Massachusetts, and BANGALORE, India – March 17, 2022 – Akston 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-C^TM) 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.

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February 8, 2022 – Akston Biosciences Announces Publication in Vaccine of Positive Data for a Room Temperature Protein Subunit COVID-19 Vaccine

Beverly, Mass. – February 8, 2022 – Akston Biosciences, Inc. 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.

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December 22, 2021 – Akston Biosciences Announces Positive Top-Line Data from Phase II Study of COVID-19 Vaccine in the Netherlands

Beverly, Mass. – December 22, 2021 – Akston 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 45 μg doses (100%), or a single 90 μg 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.

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November 20, 2021 – Akston Biosciences Doses First Subjects in Phase II Clinical Trial in India of Second-Generation COVID-19 Vaccine

Beverly, Mass. – November 20, 2021 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first of 100 subjects were dosed in an open-label bridging study of AKS-452, its protein subunit COVID-19 vaccine candidate, in India. AKS-452 is shelf stable for at least six months at room temperatures (up to 25° Celsius or 77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit).

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August 5, 2021 – Akston Biosciences Doses First Subjects in Phase II Clinical Trial of Second-Generation Protein Subunit COVID-19 Vaccine

Beverly, Mass. – August 5, 2021 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first participants have been dosed in a Phase II open-label trial of AKS-452, its protein subunit COVID-19 vaccine candidate.

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July 21, 2021 – Akston Biosciences Announces Commercial Supply Agreement of Seppic’s Adjuvant to Formulate Akston Shelf-stable COVID-19 Vaccine at Global Scale

Beverly, Mass., USA & Paris, France – July 21, 2021 – Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, today announced a commercial agreement with Seppic S.A., a supplier of specialty healthcare ingredients, for the supply of adjuvant for use in Akston’s COVID-19 Fc fusion protein vaccine candidate, AKS-452.

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July 8, 2021 – Akston Biosciences Announces Positive Phase I Data for Second-Generation COVID-19 Vaccine Candidate

BEVERLY, Mass. – July 08, 2021 – Today, Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced positive results from a 60-subject, open-label, Phase I trial of AKS-452, its protein subunit, room temperature stable, COVID-19 vaccine candidate. The vaccine was generally well-tolerated, and produced a 100% conversion rate in the 90 microgram single-dose regimen, as well as the 45 and 90 microgram two-dose regimens.

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June 4, 2021 – Akston Biosciences Completes Series F Preferred Stock Financing

Beverly, Mass. – June 4, 2021 – Akston Biosciences has completed its $19.9 million Series F financing, including the conversion of $9.5 million from Notes sold previously. The purchasers included new investors and those who had invested before. Dr. Todd Zion, Akston’s co-founder, President and CEO said, “We appreciate the confidence shown by both our current stockholders and new investors. The proceeds will be used primarily to accelerate the clinical development of AKS-452, our SARS-CoV-2 vaccine.”

April 12, 2021 – Akston Biosciences Launches Phase I/II Clinical Trial of Second-Generation COVID-19 Vaccine

Beverly, Mass. – April 12, 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.

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Photo Credit: Rachel van de Vliert

February 9, 2021 – Akston Biosciences Completes Second Licensing and Supply Agreement with Dechra Pharmaceuticals PLC

Akston Biosciences Corporation and Dechra Pharmaceuticals PLC today announced the signing of a licensing and supply agreement for the co-development and commercialization of AKS-425c, a once-a-week, injectable insulin therapy for the treatment of diabetes in cats. The companies expect development to be completed within five years and receive marketing authorizations in the U.S., European Union, and other global markets.  The supply agreement calls for Akston to be the exclusive manufacturer of the product to be marketed by Dechra. The multi-million-dollar licensing and development agreement includes payments to Akston on signing, for development milestones, and a royalty on sales.  In 2019, the two companies concluded a similar licensing and supply agreement for AKS-321d, a once-a-week insulin therapy for dogs.

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January 5, 2021 – Akston and LakePharma Announce Strategic Partnership to Manufacture AKS-452

Akston Biosciences and LakePharma, a leading U.S.-based CRDMO serving the biotechnology community with development and production services, announced today that they have established a strategic partnership. LakePharma will manufacture commercial quantities of Akston’s adjuvated COVID-19 vaccine candidate (AKS-452), which is scheduled to begin Phase 1/2 clinical testing later this month.  A vaccine for everywhere and everyone in the world, AKS-452 is stable for weeks at room temperature, inexpensive to produce, and suitable for both first-time and booster vaccination.

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September 1, 2020 – TRACER to support Akston Biosciences’ Phase 1 clinical study of AKS-452

TRACER Europe B.V., a Clinical Research Organization (CRO) specializing in fast-track solutions for testing innovative biologic medicines, announced that it will support Akston Biosciences in the Phase 1 clinical testing in the Netherlands of Akston’s lead COVID-19 vaccine candidate, AKS-452. TRACER will provide regulatory services, oversight of local manufacturing contractors as well as Phase 1 Study preparation and clinical site management. Go van Dam, CEO of TRACER, emphasized, “At TRACER we fully understand the urgency for a fast-track development and clinical evaluation of innovative SARS-CoV-2 vaccines. We are highly motivated to support the Akston team to move AKS-452 rapidly into the clinic to test its safety and efficacy.”

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July 22, 2020 – Akston Biosciences Receives $2.5M Milestone Payment

Akston Biosciences announced that it has received a $2.5 million milestone payment from Dechra Pharmaceuticals PLC after the successful completion of Dechra’s Proof of Concept study for AKS-321d, a once-a-week canine insulin therapy. The study was conducted at several private veterinary clinics in the United States. Dr. Todd Zion, Akston’s co-founder, President and CEO said, “Successful completion of the PoC sets in motion the full commercial development of this important new therapy.”

May 27, 2020 – Akston Biosciences Awarded NIDDK Phase IIb Grant

Akston Biosciences received notice that it has been awarded $923,642 in second year funding for a Phase IIb SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The funds will be used to support IND-enabling in vivo assay validation and large-animal, safety pharmacology studies for AKS-107, the company’s lead candidate for the prevention of Type 1 Diabetes.

April 9, 2020 – Akston Biosciences Completes Series E Preferred Stock Financing

Akston Biosciences has completed its $7.6 million Series E financing, including the conversion of $2.5 million from Notes sold previously. The purchasers included those who had invested in prior rounds and new investors as well. Dr. Todd Zion, Akston’s co-founder, President and CEO said, “The continuing support from our current stockholders is very much appreciated and I am pleased to welcome many new investors as well. We will use the proceeds to continue applying our insulin engineering platform to Type 1 Diabetes prevention as well as ultra-long acting insulins for both human and veterinary applications.”

Aug. 2, 2019 – Akston Biosciences Completes Licensing and Supply Agreement with Dechra Pharmaceuticals PLC

Akston Biosciences Corporation and Dechra Pharmaceuticals PLC today announced the signing of a licensing and supply agreement for the co-development and commercialization of a patent pending, long acting protein for the treatment of diabetes in dogs. Following an initial upfront payment to Akston of US$2.0 million, there are subsequent milestone payments totaling US$14.0 million due to Akston on the achievement of major milestones in the development process, which should be completed within five years. Under the terms of the agreement Dechra also has the option to license a version for cats, which will be subject to additional milestones.

Dechra’s Chief Executive Officer, Ian Page said: “We are delighted to have secured this major development opportunity which will further enhance Dechra’s position as world leaders in veterinary endocrinology. Once approved this will become the most significant product in our portfolio as we continue to build our portfolio of novel drugs.” Akston’s Chief Executive Officer, Todd Zion said: “We are pleased to have found a strong partner in Dechra to co-develop and commercialize our novel ultra-long acting insulin technology. Once approved, this will become a key asset in our platform of engineered insulin products.” Akston were advised on the transaction by Oriole Advisors.

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July 24, 2019 – Helmsley Charitable Trust and Akston Biosciences Corporation Extend Partnership

The Leona M. and Harry B. Helmsley Charitable Trust has completed an extension of its program-related investment (PRI) with Akston Biosciences to support the process development and GMP manufacturing of AKS-107, the company’s lead diabetes candidate for the prevention of Type 1 Diabetes. As part of the agreement, Helmsley will provide an additional $3.1 million over a two-year period in the form of a loan to advance AKS-107 into a first-in-man clinical trial in 2020. Dr. Todd Zion, Akston’s CEO said, “the Helmsley Charitable Trust has been a critical and early supporter of our Type 1 Diabetes therapeutic program, and we are delighted to see their continued support of our program as we advance our lead candidate into the clinic.”

June 25, 2019 – Akston Biosciences Receives NIDDK Phase IIb Grant

Akston Biosciences received a Notice of Award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) for $978,643 in first year funding for a Phase IIb SBIR grant. The funds will be used to support IND-enabling in vivo assay validation and large-animal, safety pharmacology studies for AKS-107, the company’s lead candidate for the prevention of Type 1 Diabetes.

May 26, 2019 – Akston Biosciences Begins Buildout of New GMP Biologics Manufacturing Facility

Akston Biosciences has signed a lease for an additional 14,000 square feet of space at the Cummings Center in Beverly, MA and started construction of a new GMP biologics manufacturing facility, a GMP quality control laboratory, and a large scale process development laboratory. Dr. Todd Zion, Akston’s co-founder, President, and CEO stated, “These new capabilities will enable the production of GMP drug substance to support the clinical and commercial development of our therapeutics. Having our own facilities and implementing all single-use processing will allow us to better manage our manufacturing costs and timelines across our platform of human and veterinary products.”​

May 10, 2019 – Akston Biosciences Completes Convertible Note Financing

Akston Biosciences completed a new $2.5 million convertible note financing, with the size increased to accommodate additional subscription requests and a majority of purchasers being existing shareholders. Dr. Todd Zion, Akston’s co-founder, President and CEO said, “We will use these funds to accelerate development of AKS-107, our lead candidate for diabetes prevention, into IND-enabling preclinical safety studies and GMP manufacturing as we prepare for our first-in-man trial scheduled to begin late next year.”

May 17, 2018 – Akston Biosciences Completes Series D Preferred Stock Financing

Akston Biosciences completed its $3.9 million Series D financing, including the conversion of $1.9 million from Notes sold previously. Purchasers included both those who had invested in prior rounds and new investors. Dr. Todd Zion, Akston’s co-founder, President and CEO said, “I am grateful for the strong support from our current stockholders as well as the confidence shown in Akston by our new investors. We plan to use the proceeds of this round to accelerate the application of our insulin engineering platform to the treatment of diabetes and cancer.”

February 22, 2018 – Akston Biosciences Awarded Phase II SBIR by NIH/NIDDK

Akston Biosciences received notice that it has been awarded $998,998 in second year funding for a Phase II SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The grant was awarded to support IND-enabling manufacturing development, as well as toxicology and safety pharmacology studies of AKS-107, the company’s lead candidate for the prevention of Type 1 Diabetes.

March 16, 2017 – Helmsley Charitable Trust and Akston Biosciences Corporation Announce Partnership

The Leona M. and Harry B. Helmsley Charitable Trust and Akston Biosciences Corporation today announced a partnership to advance Akston’s novel insulin engineering technology to prevent the clinical onset of Type 1 Diabetes. As part of the agreement, Helmsley will provide up to $3.1 million over the next two years to support manufacturing development, preclinical safety and efficacy testing, and regulatory filings to advance AKS-107 into clinical trials. The partnership is structured as a program-related investment (PRI) in the form of a loan to Akston.

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February 2, 2017 – Akston Biosciences Awarded Phase II SBIR by NIH/NIDDK

Akston Biosciences received notice that it has been awarded $998,123 in first year funding for a Phase II SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The grant was awarded to support IND-enabling manufacturing development, as well as toxicology and safety pharmacology studies of AKS-107, the company’s lead candidate for the prevention of Type 1 Diabetes. The second year of the Phase II grant provides $998,998 in additional funding.

August 22, 2016 – Akston Biosciences Completes Series C Preferred Stock Financing

Akston Biosciences completed its $3.4 million Series C financing, with the size of the round increased to accommodate additional subscription requests. Purchasers included members of the management team, former investors in SmartCells, Inc. as well as members of Angel Healthcare Investors and the Cherrystone Angels. Dr. Todd Zion, Akston’s co-founder, President and CEO said, “I am gratified that all of the outside Series B investors participated in this round and I welcome those that are investing for the first time. We plan to use the proceeds to develop and test candidate materials for Type 1 Diabetes prevention and other applications of our insulin engineering technology.”

September 10, 2015 – Akston Biosciences Awarded Phase I SBIR by NIH/NIDDK

Akston Biosciences received notice that it has been awarded $249,821 in funding for a Phase I SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The grant was awarded to support investigation of methods for the removal of insulin-specific B-cells to prevent Type 1 diabetes in mice.

May 21, 2015 – Akston Biosciences Completes Series B Preferred Stock Financing

Akston Biosciences completed its $1.6 million Series B financing, with the size of the round increased to accommodate additional subscription requests. Purchasers included members of the management team, and former investors in SmartCells, Inc. Dr. Todd Zion, Akston’s co-founder, President and CEO said, “We welcome the first outside investment in our company and particularly the support by former SmartCells shareholders. We plan to use the proceeds to apply our insulin engineering technology to novel approaches for the prevention of Type 1 Diabetes.”

February 14, 2013 – Akston Biosciences Completes Series A Preferred Stock Financing

Akston Biosciences completed its initial (Series A) financing, raising $700,000 from the company’s management team.