Tag: Northway Biotech

• Partnership established to develop and scale production of ATL-105, a novel recombinant version of alpha-1 antitrypsin
• Lead indication is non-CF bronchiectasis; ATL-105 targets disease drivers through a broad multimodal mechanism of action

AATec Medical GmbH (AATec), a biotech company developing a multi-product platform for the treatment of respiratory diseases, and Northway Biotech (Northway Biotech or NBT), a global Contract Development and Manufacturing Organization (CDMO), today announced a partnership for manufacturing process development and analytical development of AATec’s lead product candidate, ATL-105, a proprietary, inhaled therapy based on recombinant alpha-1 antitrypsin (AAT) for non-cystic fibrosis bronchiectasis (NCFB).

AATec Medical and Northway Biotech Announce Partnership

Under the agreement, Northway Biotech will leverage its expertise in biologics manufacturing to develop and scale the production process for ATL-105 using the Pichia pastoris expression system.

“With this partnership, we are establishing a robust and scalable production process for ATL- 105, laying the foundation for consistent quality for clinical development and commercial use,” says Rüdiger Jankowsky, PhD, co-founder and CEO of AATec, and adds: “ATL-105 represents a new generation of inhaled biologics, combining anti-protease, anti-inflammatory, and antiinfective properties in one molecule. Delivered directly to the lungs, it enables fast, targeted action with minimal systemic exposure. We believe ATL-105 can redefine care in respiratory diseases with high medical need, such as non-CF bronchiectasis.”

“We are excited to support AATec in progressing towards clinical trials”, shares Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech. “AATec is advancing a promising therapeutic solution addressing significant unmet medical needs, supported by a highly capable and dedicated team. With our decades of expertise in microbial systems, we are well-positioned to scale this program efficiently and deliver quality at every step.”

“We have recognized the opportunity to support a program that could meaningfully advance care for patients with respiratory diseases,” adds André Markmann, PhD, VP of Business Development at Northway Biotech. “Inhaled protein therapies are gaining significant traction, and ATL-105 stands out as one of the most promising approaches in this area.”

AATec develops ATL-105 to treat NCFB, a chronic inflammatory respiratory condition which affects millions of people worldwide. This debilitating disease is marked by dilated bronchi, persistent inflammation, frequent airway infections and impaired mucus clearance. In addition to NCFB, ATL-105 has therapeutic potential for a broader range of inflammatory and infectious respiratory diseases, such as COPD, ARDS and other indications, reflecting the versatility of its anti-inflammatory, immunomodulatory, and anti-infective properties.

About AATec Medical
AG AATec Medical GmbH is a biotechnology company developing a product platform based on a novel recombinant version of alpha-1 antitrypsin (AAT) for the treatment of respiratory inflammatory diseases, airway infections and rare diseases. The company has successfully demonstrated proof-of-principle in several indications and is currently preparing for a proof-ofconcept clinical trial with the first product candidate ATL-105 for inhaled application in non-CF bronchiectasis. AATec was founded by a seasoned interdisciplinary team with long-standing experience in clinical research, biopharmaceutical development and product industrialization. For further information, please visit https://www.aatec-medical.com/ and follow AATec on LinkedIn.

About Northway Biotech
Northway Biotech is a leading CDMO specializing in protein-based biologics and gene therapies, offering comprehensive, end-to-end biopharmaceutical development and manufacturing services. With deep expertise in cell line development, process optimization, and cGMP manufacturing, Northway Biotech supports programs from early-stage development through to commercial production. Founded in 2004, the privately held company operates state-of-the-art facilities in Lithuania and the United States, delivering high-quality, compliant solutions tailored to each client’s unique needs. For further information, please visit https://www.northwaybiotech.com.

Northway Biotech Contact:
Prof. Vladas Algirdas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

AATec Medical Contact:
Dr. Rüdiger Jankowsky, CEO
info@aatec-medical.com

Media Contact:
MC Services
Katja Arnold, Julia von Hummel
aatec-medical@mc-services.eu
Phone: +49 (0)89 2102280

SOURCE: Northway Biotech

With six newly established, identical BSL-2 laboratories now operational, biologics CDMO Northway Biotech can conduct VCS programs for up to six clients simultaneously, significantly alleviating current market bottlenecks

Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), today announced the expansion of its protein-based and gene therapy service offerings with the addition of Viral Clearance Studies (VCS) capabilities. This strategic growth follows the opening of Northway Biotech’s new Gene Therapy Center with dedicated cGMP facilities for virus-related projects.

With six newly established, identical BSL-2 laboratories now operational, Northway Biotech can conduct VCS programs for up to six clients simultaneously, significantly alleviating current market bottlenecks. Additionally, the company has expanded its capabilities to perform GMP-compliant manufacturing and testing under BSL-3 conditions, further strengthening its service offering across gene therapy and broader biologics development.

Viral Clearance Studies are now offered both as part of Northway Biotech’s integrated CDMO programs and as a standalone service. This flexibility allows external clients to access VCS expertise independently, without requiring a manufacturing agreement.

Accelerated Delivery Timelines – Over One Month Faster Than Industry
Leveraging expanded infrastructure and integrated analytical capabilities, Northway Biotech is positioned to deliver Viral Clearance Studies substantially faster than the current industry standard. Comprehensive studies, assessing viral removal and inactivation, can now be completed with final regulatory-compliant reporting in under 10 weeks from initiation of project design when two model viruses are employed, and within 12 weeks when four model viruses are used.

“Our expansion into Viral Clearance Studies is a natural extension of our CDMO services, enabling us to manage these critical studies in-house and significantly reduce project timelines for our clients,” said Prof. Vladas Algirdas Bumelis, CEO of Northway Biotech. “By investing in state-of-the-art BSL-2 and BSL-3 facilities, expanding technical capabilities, and further strengthening our scientific teams, we are uniquely positioned to deliver high-quality VCS data faster – a key advantage for clients advancing through clinical development and regulatory approval.”

For more information on Northway Biotech’s Viral Clearance Study processes, service offerings, and delivery timelines, please complete the contact form to connect with the Northway Biotech team.

About Northway Biotech – https://www.northwaybiotech.com

Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced and professional team executes projects at every stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s extensive expertise and vertically integrated service offering enables rapid execution of multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and operates locations in Vilnius, Lithuania; London, United Kingdom; and Waltham, MA, USA.

Media & Business Contact:
bd@northwaybiotech.com

Prof. Vladas Algirdas Bumelis
CEO and Chairman of the Board
Northway Biotech
vladas.bumelis@northwaybiotech.com

Contact Information
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

SOURCE: Northway Biotech

Micreos Pharmaceuticals AG (Micreos), a preclinical-stage biopharmaceutical company, specializing in developing Engineered Endolysin therapies to target harmful pathogens that cause disease aggravation, has entered into a strategic partnership with Northway Biotech (NBT), a Contract Development and Manufacturing Organization (CDMO) to develop scalable cGMP production processes for Micreos’ biologic therapeutic MEndoB, which is the first-in-class dual-active domain targeted medicine that will enter the clinic in the coming months as an investigational therapeutic to treat Atopic Dermatitis.

Micreos is focused on developing best-in-class targeted therapeutics to precisely target harmful pathogens that cause disease flares to help address significant unmet medical needs in dermatology and oncology.

As part of the partnership, Northway Biotech will apply its significant expertise in biologics manufacturing to develop a scalable GMP production process for Micreos’ engineered endolysin technology. The collaboration will also include developing and validating robust analytical methods, cell bank manufacturing, technology scale-up for cGMP Drug Substance generation, and IND/IMPD supporting documentation preparation, to ensure that the production of Micreos’ engineered endolysins complies with stringent regulatory standards for clinical trials.

Matt Regan, CEO of Micreos, stated: “This partnership with Northway Biotech marks a significant milestone for Micreos as we advance our engineered endolysins into scalable therapeutics for clinical trials. By developing targeted medicines that address the underlying pathophysiology associated with disease aggravation in conditions such as atopic dermatitis and cutaneous T-Cell lymphoma, and by leveraging Northway’s significant manufacturing expertise, we are poised to make a meaningful impact on patient care in areas of great unmet medical need.”

Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, highlighted the mutual commitment to high-quality manufacturing: “We are honored to contribute to Micreos’ innovative engineered endolysin therapies. With a dedicated and highly experienced team in recombinant protein process development and scale-up, we aim to accelerate Micreos’ development by providing cGMP drug substance material available by the end of summer 2024.”

André Markmann, PhD, VP of Business Development at Northway Biotech, added: “Micreos’ engineered endolysins address critical healthcare challenges. We are excited to support Micreos in advancing their breakthrough therapy into clinical trials at a rapid pace while ensuring the highest standards.”

About MEndoB
Micreos’ MEndoB is the first-in-class and potentially best-in-class dual-active domain, targeted medicine designed for optimum activity on human skin. It works through targeted enzymatic degradation of the targets cell wall, rapidly killing the harmful pathogen, but without triggering drug resistance or having any off target affects. Micreos’ engineering expertise has enhanced drug stability and activity but has also been validated to effectively penetrate biofilms, eliminate dormant & hard to kill pathogenic cells, and potentially deliver synergies with other medications. With demonstrated preclinical efficacy, MEndoB holds significant promise for treating chronic and difficult-to-treat conditions in dermatology and oncology.

About Micreos
Micreos is a preclinical-stage biopharmaceutical company developing highly innovative, targeted therapies as a new way to treat chronic conditions in dermatology and oncology where there is a high unmet medical need. With its advanced engineering platform, Micreos is developing targeted medicines that selectively eliminate harmful pathogens while preserving the beneficial microbiome, paving the way for future indications in dermatology, oncology, and beyond.

For more information, visit www.micreos.com.

About Northway Biotech
Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced and professional team executes projects at every stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s extensive expertise and vertically integrated service offering enables rapid execution of multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and operates locations in Vilnius, Lithuania; London, United Kingdom; and Waltham, MA, USA.

For more information, please visit www.northwaybiotech.com.

Micreos Contact:
Matt Regan
CEO and Board member, Micreos Pharmaceutical AG
m.regan@micreos.com

Northway Biotech Contact:
Vladas Algirdas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

Contact Information
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

SOURCE: Northway Biotech

With Northway Biotech’s expertise in biologics manufacturing, Mallia aims to enter the multi-billion-dollar alopecia market by delivering a safe and effective topical sCD83 treatment designed to stimulate hair follicle formation and promote sustained hair growth.

Mallia Therapeutics (Mallia), a biopharmaceutical company developing novel treatments for hair loss, and Northway Biotech (NBT), a biologics Contract Development and Manufacturing Organization (CDMO), have announced a partnership for the development of the production process and manufacturing of Mallia’s soluble CD83 protein (sCD83), a treatment aimed at promoting hair follicle formation and growth.

Under the agreement, Northway Biotech will leverage its expertise in biologics manufacturing to develop the production process for the recombinant sCD83 protein for large-scale production, utilizing the Pichia pastoris expression system. This collaboration includes the development of analytical methods, technology scale-up, and the manufacturing of a cGMP Drug Substance.

Dr. Manfred Groeppel, co-founder and Managing Director of Mallia Therapeutics, said: “With this partnership, we are advancing the development of sCD83 to turn our research into a scalable treatment for patients.”

“Interestingly, sCD83’s mode of action induces both the formation of new hair follicles and thus hair growth, and has the potential to redefine treatment approaches for hormone-induced androgenetic alopecia as well as immune-mediated alopecia areata,” emphasizes Prof. Dr. Alexander Steinkasserer, co-founder and Managing Director of Mallia. “By developing a robust production process, we are ensuring the quality required for future clinical as well as commercial applications.”

Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, expressed, “We are excited to be working with Mallia on developing the manufacturing process of sCD83. Our priority is to ensure the highest manufacturing standards and maintain clear, open communication as we collaborate every step of the way.”

“Mallia’s team and their innovative solution make this project particularly appealing to us given its huge potential and the large need from people all over the world for treatment. The strong and transparent collaboration we have established allows us to support Mallia with confidence as we move forward together quickly,”added André Markmann, PhD, VP of Business Development at Northway Biotech.

About Mallia Therapeutics GmbH
Mallia Therapeutics GmbH is a biopharmaceutical company focused on developing novel treatments for patients suffering from hair loss. The Company was founded in 2023 in Erlangen, Germany, and is led by an experienced management team and worldwide leading experts in the field of CD83, with more than 60 CD83-related publications and 20 years of experience in the field.

With sCD83, a potential treatment for hair loss in preclinical development, Mallia aims to enter the multi-billion-dollar alopecia market and provide patients with a safe and effective topical treatment.

Connect with us on LinkedIn or find out more here: https://mallia-therapeutics.com/

About Northway Biotech
Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced and professional team executes projects at every stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s extensive expertise and vertically integrated service offering enable rapid execution of multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and operates locations in Vilnius, Lithuania; London, United Kingdom; and Waltham, MA, USA. For more information, please visit www.northwaybiotech.com.

Mallia Therapeutics Contact:
Mallia Therapeutics GmbH
info@mallia-therapeutics.com

International Media Contact:
MC Services AG
Dr. Regina Lutz / Katja Arnold
Tel.: +49 (0)89 210 228 0
E-Mail: mallia-therapeutics@mc-services.eu

Contact Information
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

SOURCE: Northway Biotech

Northway Group is embarking on a project to establish Europe’s largest biotechnology hub, BIO CITY, in Vilnius, the capital of Lithuania. It includes 6 large biotechnological complexes – 4 state-of-the-art GMP manufacturing plants and 2 advanced scientific research centres – that will be built in an area equivalent to 10 football fields. The total investment for this biotech campus is projected to reach approximately 7 billion euros over the next decade.

Northway Group is in the process of constructing Europe’s largest biotechnology hub, with the inaugural Gene Therapy Center set to be operational in 2024.

“A science-based economy, supported by bright minds and intelligent entrepreneurs, is the foundation for Lithuania’s long-term economic prosperity. In the past, our growth was constrained by a lack of fossil resources, but today, we are boldly moving forward, relying on modern technologies. The new biotechnology hub embodies the direction of Lithuania’s innovative economy. It also promises new inventions that will enable people with serious illnesses to become full members of society, thereby reducing exclusion,” says the President of the Republic of Lithuania, Gitanas Nausėda.

Prof. Vladas Algirdas Bumelis, founder and CEO of Northway Biotech and Celltechna, key components of the Northway Group, highlighted Lithuania’s strong global standing in biotechnology. The aim of the BIO CITY project is to further solidify this position with four advanced biomanufacturing facilities and two innovative research centres, significantly boosting Lithuania’s prominence in the international biotech sphere.

The Speaker of the Seimas, parliament of Lithuania, states that the new biotech city being developed in Vilnius will strengthen the competitiveness of our country. “Lithuanian life sciences industry has ambitions and potential to become a global leader in this field: a leader who will significantly contribute to the development of scientific research for the well-being of man, nature and planet, and will facilitate new opportunities to deal with global health, sustainable development and other challenges,” says Viktorija Čmilytė-Nielsen.

Vision of BIO CITY: A European Biotechnology Leader
“We envision BIO CITY as a frontrunner in the European biotechnology, by uniquely integrating various biotech segments into a single, synergistic ecosystem. This multifunctional complex will catalyse interdisciplinary collaborations, the quick realisation of ideas and technological advancements. Our unique model, which brings together diverse biotechnology fields in one location, is set to revolutionise the European biotech landscape,” said Prof. V. A. Bumelis.

Gene Therapy Centre will Open in 2024
The first facility to open its doors in the biotech hub BIO CITY will be the Gene Therapy Centre, which is currently under construction and is being built by Northway Group’s subsidiary, Celltechna. This centre, the first and so far the only one of its kind in the Baltic States, will bolster Lithuania’s role in gene therapy, addressing the needs of the 280 million individuals worldwide who are affected by genetic diseases.

“Our state-of-the-art facility will be instrumental in both research and production, offering new treatments for previously incurable diseases. This will not only augment our CDMO (Contract Development and Manufacturing Organisation) capabilities, but also position us for global competition and collaborations,” added Prof. V. A. Bumelis.

The Gene Therapy Centre, which is expected to become operational in the second quarter of 2024, will specialise in gene therapy research and GMP manufacturing. Representing an investment of 50 million euros, the facility will span 8,000 square metres and is anticipated to create over 100 high-value jobs. The centre will work in synergy with Northway Biotech. Established in 2004, Northway Biotech is a leading provider of CDMO services in the field of biologics, with a focus on the development and manufacturing of recombinant proteins and antibodies.

A Comprehensive Lithuanian Biotech Hub
By 2030, BIO CITY will see the inauguration of five additional complexes, including centres for R&D and Virology, Life Sciences Industry Smart Services, Stem Cell Research and 3D Bioprinting, as well as two large-scale production centres for mammalian and microbial products. The entire BIO CITY complex will span an area equivalent to 10 football fields, with the total investment expected to reach around 7 billion euros over the next decade.

“We will not only focus on contract development and manufacturing services, but will also invest significantly in the operation of scientific research centres. Scientific activity enhances a country’s competitiveness and generates value in various forms, beyond just the economic aspect. Modern biotechnologies, such as gene editing and cell therapies, are advancing rapidly. Lithuania can pride itself on having some of the most talented scientists and robust expertise in these areas. The development of the biotech campus in Vilnius means we are poised to foster new partnerships with innovative startups, research institutions and pharmaceutical companies on a global scale. We are actively seeking partnerships and offer a warm invitation to investors who are enthusiastic about joining this exciting venture,” said Prof. V. A. Bumelis.

Upon its completion, BIO CITY is expected to offer employment to approximately 2,100 highly skilled professionals, including scientists, biotechnologists, and medical engineers.

Lithuania is Among the Leaders in the Global Biotechnology Market
The global biotechnology market, currently valued at over 1,130 billion euros, is anticipated to grow to be worth more than 2,775 billion euros by 2030. Lithuania holds a strong position in this market, ranking among the Top 35 innovative countries in the biotechnology field, according to Scientific American Worldview.

“Every year, Lithuania is mentioned in the field of Life Sciences more often, and the ambitious BIO CITY project will contribute to our leadership. Our vision is coming to life – we are talking about world-class Life Sciences infrastructure and a competitive sector capable of building innovative products. In 2022, companies in the sector posted combined revenues of 1.5 billion euros, while exporting their goods to more than 100 countries. Overall, Life Sciences is a leading sector in Lithuania, when it comes to creating and implementing innovative solutions,” states Aušrinė Armonaitė, the Minister of the Economy and Innovation.

Over 80 life science companies operate in Lithuania, contributing about 2.5% to the country’s GDP. The Northway group, a key player in Lithuania’s biotech sector, manages seven companies: five in Lithuania and one each in the UK and the US, with the US entity being recognised as the largest biotech investor from the Baltic region in recent years. Employing more than 200 specialists, these companies provide services to a diverse array of international biopharmaceutical firms, ranging from small to large enterprises, predominantly operating in both Europe and the US.

BIO CITY Contacts:
Vladas Algirdas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

Contact Information:
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

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• iTOL-100 technology has broad applicability and can be applied to both allogenic and stem cell-derived organoids across a number of diseases. Manufacturing agreement supports advancement of iTolerance’s development of iTOL-100 towards first in human clinical study for lead program, iTOL-102.

iTolerance, Inc. (iTolerance or the Company), an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, and Northway Biotech, an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), today announced they have entered into a partnership agreement for the manufacturing of iTolerance’s Streptavidin-FasL (SA-FasL) fusion protein, a crucial component of the proprietary iTOL-100 platform technology. The SA-FasL fusion protein has shown great potential in pre-clinical studies, establishing durable, localized immune tolerance and enabling implanted tissue, organoid, or cell therapy to function as a viable replacement for damaged native cells.

Under the terms of the agreement, Northway Biotech will leverage its expertise to develop a robust manufacturing process for the SA-FasL fusion protein. This involves producing a Master Cell Bank (MCB), developing and qualifying analytical methods, optimizing the formulation, development and scaling up of the production process, and manufacturing a cGMP drug substance batch for clinical studies.

“We believe this strategic partnership is not only a significant step for iTolerance, but also in developing advanced regenerative medicine technologies. We are incredibly delighted to establish this important partnership with Northway Biotech, a pre-eminent CDMO, to manufacture the clinical supplies necessary for our first in human clinical study for our lead program, iTOL-102,” commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. “We look forward to working closely with the Northway Biotech team to advance our iTOL-100 technology and progress towards providing treatment options that have the potential to cure diseases without the need for chronic immunosuppression.”

“We are excited to be working with Northway Biotech on this critical component of our iTOL-100 technology. Northway has unique experience working with our cell line which we believe will accelerate our ability to prepare cGMP protein to support our planned first in human clinical study,” added Dennis M. Hester, PhD, SVP of Chemistry, Manufacturing and Controls at iTolerance, Inc.

Prof. Vladas Algirdas Bumelis, Chief Executive Officer and Chairman of the Board at Northway Biotech expressed his enthusiasm, stating, “We are delighted to embark on this dynamic project focused on producing the SA-FasL fusion protein for iTolerance. We believe this partnership is an exciting development in the regenerative medicine field, and we are honored to play a role in advancing this important work. With a commitment to meeting contractual timelines, our primary objective is to ensure the punctual delivery of these crucial materials to our esteemed partners at iTolerance.”

Andre Markmann, PhD, VP of Business Development at Northway Biotech, added, “The partnership with iTolerance has been smooth sailing from the start. We are pleased to commence this project built on mutual trust and a collaborative spirit that drives both companies to perform at the highest level and deliver exceptional results.”

About iTOL-100
iTolerance’s iTOL-100 immunomodulatory technology is a biotechnology-derived Streptavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. This proprietary technology has broad applicability and can be applied to allogenic and stem cell-derived organoids across several diseases.

About iTolerance, Inc
iTolerance is an early-stage privately-held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company’s lead program, iTOL-102, leverages significant advancements in stem cells to derive pancreatic islets, which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit www.itolerance.com.

About Northway Biotech
Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring complete process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and Waltham, MA, US. Further information can be found on Northway’s website at www.northwaybiotech.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon iTolerance’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company’s platform technology. Consequently, forward-looking statements should be regarded solely as the Company’s current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Northway Biotech Contacts:
Vladas Algirdas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

iTolerance Contacts:
Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
iTolerance@jtcir.com

Media Contact
Susan Roberts
T: 202.779.0929
sr@roberts-communications.com

Contact Information:
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), established in 2004, with an EMA and FDA-compliant, state-of-the-art cGMP manufacturing site in Vilnius, Lithuania, announced the completion of its expansion project for cGMP manufacturing facilities in Waltham, Massachusetts. This significant accomplishment further solidifies Northway Biotech’s standing as an influential player in the global biopharmaceutical landscape.

This recent growth is an extension of the successful launch of Northway Biotech’s process and analytical development laboratories in Waltham (Greater Boston area) in 2020. The expanded facility now includes state-of-the-art cGMP suites, marking a significant milestone in the company’s journey. The newly established cutting-edge biomanufacturing suites host a microbial fermentation train with up to 450 liters of volume capacity, and a mammalian production train with the ability to handle volumes of up to 2,000 liters. Northway Biotech has further established a specialized, fully automated fill and finish line to accommodate its clients’ varied needs, supporting high-throughput filling into vials, syringes, and cartridges.

Prof. Vladas Algirdas Bumelis, CEO of Northway Biotech, shared his insights regarding this accomplishment, stating, “The addition of GMP suites in our US site represents a transformative step for our organization, enabling us to provide comprehensive end-to-end solutions from our second site now. We are poised to transition current process development projects into the cGMP manufacturing phase in a timely manner, in line with our clients’ committed schedules. Additionally, our longstanding US partners who have engaged with our Lithuanian site can now also take advantage of the geographical convenience of our modern facilities located in the Greater Boston Area. With our fully functional and technologically advanced manufacturing site at our disposal, Northway Biotech is perfectly positioned to take on manufacturing projects aimed at both clinical and commercial supply.”

To commemorate this significant expansion and express gratitude to its valued partners and industry leaders, Northway Biotech will be hosting a grand opening event for its cGMP suites on June 8. This event promises to be an occasion of celebration and networking, providing an opportunity for attendees to witness firsthand the state-of-the-art facilities and engage in meaningful discussions within the biotech community.

About Northway Biotech – https://www.northwaybiotech.com
Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately-owned company founded in 2004 and located in Vilnius, Lithuania; London, United Kingdom; and Waltham, Massachusetts, United States.

For Further Information, Contact:
Prof. Vladas Algirdas Bumelis
CEO and Chairman of the Board
Northway Biotech
vladas.bumelis@northwaybiotech.com

Contact Information
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

tiakis Biotech AG (tiakis), in collaboration with its CDMO partner Northway Biotech, is pleased to announce the successful completion of a technology transfer and ramp-up of manufacturing capabilities for Tiprelestat, a pioneering anti-inflammatory and tissue-protective drug being developed for the prevention of postoperative inflammatory complications following major surgery, treatment of COVID-19 and pulmonary arterial hypertension. For the first time worldwide, a clinical trial is being supported by Tiprelestat study material produced at an industrial fermentation scale, representing a ten-fold increase in manufacturing potential to 3,000 L.

“The marked increase in manufacturing capabilities lays the foundation for the next stage of tiakis’ development programs, with the recent start of our COMCOVID phase Ib/II clinical trial being a prime example,” said Martin Voss, tiakis Biotech AG co-CEO.

The enhanced production capabilities is a result of the successful completion of a technology transfer and subsequent ramp-up program, achieved in a short time through close collaboration with end-to-end biologics CDMO Northway Biotech, based in Vilnius, Lithuania.

Reflecting on this milestone, Vladas Algirdas Bumelis, CEO of Northway Biotech, stated: “The confidence our partners have placed in our two-decade-long expertise has enabled us to collaboratively scale up the process and meet tiakis’ deadlines. Our state-of-the-art 3,000 L stainless-steel fermenter train was utilized to carry out the implementation successfully. We extend our sincere well-wishes to our partners as they move forward with their innovative drug through clinical trials, and we look forward to future collaborations.”

Andre Markmann, VP Business Development of Northway Biotech, added: “This partnership exemplifies our commitment to assist our partners in achieving their objectives by leveraging our technical expertise and operational capabilities. We are immensely proud to be part of this groundbreaking project, which addresses a significant unmet medical need.”

By attaining this pharmaceutical and technological milestone, tiakis and Northway Biotech have demonstrated their capabilities to pave the way towards groundbreaking achievements as pioneers in their respective fields. The success of this fast-paced project is characterized by strong collaborative interaction, mutual trust, and flexibility between the two companies.

About Tiprelestat
tiakis biopharmaceutical drug candidate Tiprelestat promises an excellent therapeutic benefit-risk profile for use as an anti-inflammatory and tissue-protective drug. Tiprelestat is identical to the human protein elafin with high specificity for tissue-destroying and inflammation-promoting proteases. The development program of Tiprelestat is focused on the late-stage development of Tiprelestat in major surgery and early-stage development in pulmonary arterial hypertension (PAH) and COVID-19.

About tiakis Biotech AG
tiakis focuses on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Tiprelestat for life-threatening surgeries and life-threatening diseases such as PAH and COVID-19. tiakis seeks partners and investors for the development, commercial-scale manufacturing, marketing and distribution of the product. The company tiakis Biotech AG is located in Kiel, Germany (www.tiakis.bio).

About Northway Biotech
Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and in Waltham, MA, US. Further information can be found on Northway’s website www.northwaybiotech.com.

Contact Information
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com