CAMBRIDGE, Mass. & TOKYO – October 31, 2019– Pandion Therapeutics, Inc. (“Pandion”), and Astellas Pharma Inc. (TSE: 4503, “Astellas”) announced today the signing of a License and Collaboration Agreement directed toward the research, development, and commercialization of locally acting immunomodulators for autoimmune diseases of the pancreas.

CAMBRIDGE, Mass., March 5, 2019 – AnTolRx, Inc., a private biotechnology company and a leader in immune tolerance, today announced that Pfizer Inc. (NYSE: PFE) has exercised the option granted under a June 2016 agreement to license an immune tolerance therapy from AnTolRx’s Type 1 diabetes research program.

The option gives Pfizer exclusive rights to pursue development of AnTolRx’s lead immunotherapeutic for Type 1 diabetes. Pfizer will be responsible for any further optimization, development and potential commercialization. AnTolRx will receive an upfront payment and is eligible to receive potential milestone and royalty payments from Pfizer.

AnTolRx is aiming to develop targeted antigen-specific therapies, based upon immune tolerance induction rather than broader immune suppression, for several inflammatory and autoimmune diseases.

“We are delighted to confirm that the discovery phase of the program at AntolRx has transitioned successfully to Pfizer for further development of our antigen-specific immune therapy for Type 1 diabetes,” said Mark Carthy, CEO of AntolRx.

AnTolRx is focused on building on the pioneering immunoregulatory research of Francisco Quintana, a professor of neurology at Brigham and Women’s Hospital in Boston, as well as the company’s scientific founder and Chief Scientific Advisor.

“This agreement with Pfizer supports the industry’s mounting interest in developing therapeutics based upon antigen-specific tolerance and underscores its potential to deliver innovative new medicines for patients with immunological diseases,” said Professor Quintana.

Michael Vincent, Senior Vice President and Chief Scientific Officer, Inflammation & Immunology, Pfizer said, “At Pfizer’s Immunology and Inflammation Research Unit, our ultimate goal is to advance potential cures for autoimmune disease, and we see AnTolRx’s approach to re-educate the immune response as one potentially promising strategy to achieve that goal for patients.”

JDRF, the world’s leading funder of Type 1 diabetes research and long-time supporter of Quintana’s work, applauded the transition. “There is an urgent need for disease-modifying Type 1 diabetes immune therapies to slow down the autoimmune process and delay or block progression to symptomatic insulin-dependent diabetes,” said Breakthrough T1D President and CEO Derek Rapp.

“The AnTolRx story is an excellent example of a research foundation, an academic institution, a biotech company and a major pharmaceutical company working together to advance promising translational research with the hope that it can potentially deliver key breakthroughs for the Type 1 diabetes community,” Rapp said.

About T1D

T1D is a chronic, life-threatening autoimmune disease that can strike children and adults at any age. It requires rigorous 24/7 monitoring of blood glucose levels—even overnight—to avoid potentially lethal highs and lows in blood sugar, as well as other devastating complications like kidney, eye and nerve diseases. While T1D’s causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. Its onset is sudden and is not related to diet or lifestyle. In T1D, the body’s immune system destroys cells in the pancreas that produce insulin, meaning the body produces little to no insulin to regulate blood sugar and get energy from food. There is nothing you can do to prevent T1D, and—at present—nothing you can do to get rid of it.

About AnTolRx

AnTolRx is a Cambridge, Mass.-based research and development biotechnology company focused on immune tolerance with active programs in Type 1 Diabetes, Rheumatoid Arthritis, Inflammatory Bowel Disease, Celiac Disease, and various dermatology diseases including Pemphigus Vulgaris. AnTolRx’s antigen-specific immune tolerance technology also has potential to block immune responses to foreign proteins, certain therapeutic recombinant proteins and viral gene therapy products. AnTolRx’s proprietary formulation co-delivers an immunomodulatory aryl hydrocarbon receptor agonist with specific antigens to generate disease specific Tregs to treat immunological disorders. The AnTolRx technology expects to overcome safety concerns of products that generate general immune suppression. AnTolRx expects to nominate candidates to treat additional immune disorders in 2019. AnTolRx, Inc. was founded in 2016 by Professor Francisco Quintana, Dr. Satish Jindal and Mark Carthy with initial equity investment from Pfizer Inc., Breakthrough T1D International and Orion Equity Partners, LLC.

About Breakthrough T1D

Breakthrough T1D is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, Breakthrough T1D has invested more than $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF

CAMBRIDGE AND BOSTON, MA – December 19, 2018 – Pandion Therapeutics, a biotechnology platform company developing therapeutics to achieve localized immunomodulation to treat autoimmune and inflammatory disease, today announced it has received an investment from the Breakthrough T1D T1D Fund. This financing will enable the company to launch a type 1 diabetes (T1D)-focused program leveraging its innovative technology platform and pipeline. Terms of the private financing were not disclosed.

Breakthrough T1D T1D Fund is a venture philanthropy fund exclusively devoted to finding and funding the best type 1 diabetes commercial opportunities. This is their first investment in Pandion, which was founded in 2017. In addition to the Breakthrough T1D T1D Fund, the company is funded by a strong syndicate of venture investors.

The investment from the Breakthrough T1D T1D Fund will fund the evaluation of Pandion’s existing molecules for T1D, and in parallel initiate the development of islet-specific tethers to pair with Pandion’s existing immunomodulators for T1D specific drugs. The company’s bispecific platform combines a powerful immune therapy and a tissue tether to stop the autoimmune attack. For those living with T1D, especially children, tissue-targeted immune therapies demonstrate a significant opportunity to provide safer and more powerful chronic-use treatment options.

“Pandion is positioned to shift the paradigm for treating inflammatory and autoimmune diseases by developing therapeutic antibodies that act at the local site of disease, offering the potential for significantly improved therapeutic options beyond systemic immunosuppressive treatments”, said Anthony Coyle, Ph.D., President and CEO of Pandion Therapeutics. “While the initial focus of the company has been to develop treatments for inflammatory bowel disease as well as liver and kidney disorders, the investment in Pandion of capital and expertise by the Breakthrough T1D T1D Fund will allow us to accelerate the development of new therapeutics for patients with T1D”, said Dr Coyle.
“We believe Pandion Therapeutics is uniquely positioned for success in the T1D space given their worldclass team and strong preliminary data in other autoimmune disease disorders that the company has seen through its preclinical work,” said Jonathan Behr, Ph.D., a Managing Director at the Breakthrough T1D T1D Fund. “Tissue-targeted delivery has been a key area of focus for the Fund and we are excited to support the company as it seeks to develop islet-targeted immunotherapies for stronger and safer T1D drugs.”

Since launching in December 2016 with $32 million of seed funding from Breakthrough T1D, the T1D Fund now manages approximately $70 million of committed capital. The Fund has invested in 12 innovative companies focused on developing life-changing solutions for T1D. Through these investments, the Breakthrough T1D T1D Fund is demonstrating to donors and to venture, corporate and foundation capital sources that attractive, impactful investment opportunities exist in the T1D space.

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About Pandion Therapeutics

Pandion Therapeutics is a biotechnology company developing a pipeline of antibody therapeutics to achieve localized immunomodulation for autoimmune and inflammatory diseases and transplantation. The company’s proprietary technology platform enables the design of bispecific antibodies with targeting fragments that bind to specific tissues at the local site of inflammatory disease, coupled with effector molecules that modulate immune activity to restore immune homeostasis.

Pandion was founded in 2017 and closed a $58M Series A financing round in early 2018 with funding from Polaris Partners, Versant Ventures, Roche Venture Fund, SR One and BioInnovation Capital. The company is headquartered in Cambridge, Massachusetts. Please visit www.pandiontx.com.

About Breakthrough T1D T1D Fund

The Breakthrough T1D T1D Fund (www.t1dfund.org) is a venture philanthropy fund accelerating life-changing solutions to treat, prevent and cure type 1 diabetes (T1D) through catalytic commercial investments. Through its investments in partnership with private capital, including venture capital, corporations and foundations, the T1D Fund seeks to attract the private investment necessary to advance drugs, devices, diagnostics, and vaccines into the hands of those living with T1D. The T1D Fund invests in areas strategically aligned with Breakthrough T1D, the leading global organization funding T1D research, with an exclusive focus on supporting the best commercial opportunities. The T1D Fund will reinvest any realized gains into new investments to further its mission.

• Enterovirus vaccine platform in-licensed from Vactech Oy will be developed to “pre-empt” type 1 diabetes by targeting coxsackie virus B infection

• Breakthrough T1D T1D Fund investment to advance Provention’s lead program, which aims to potentially reduce new type 1 diabetes cases by 50%

LEBANON, NJ and BOSTON, MA – July 18, 2017 – Provention Bio, Inc., a clinical stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced today the in-licensing of an enterovirus vaccine platform, which the company is initially developing to reduce the onset of type 1 diabetes (T1D) by vaccinating at-risk populations against coxsackievirus B (CVB) infection. Research suggests that CVB infection could be responsible for more than half of T1D cases worldwide.

Provention in-licensed the platform from Finnish biotechnology company, Vactech Oy, and will use an investment by the Breakthrough T1D T1D Fund to advance the program. The financing from the Breakthrough T1D T1D Fund is part of Provention’s $28.4 million founding financing. The investment will support the advancement of the T1D program toward an anticipated first-in-human proof-of-mechanism and proof-of-concept program. Terms of the licensing agreement with Vactech have not been disclosed.

“Creating a world without T1D includes prevention,” said Jonathan Behr, Managing Director of the T1D Fund. “Provention’s anti-viral vaccine potentially offers the prospect of drastically reducing the number of people impacted by the challenges of T1D.” The Breakthrough T1D T1D Fund is devoted to identifying and funding the best early-stage, high impact T1D commercial opportunities.

Ashleigh Palmer, co-founder and CEO of Provention Bio, stated, “We are extremely excited to be launching our lead program in type 1 diabetes and are grateful to Vactech for allowing us the opportunity to license and develop its proprietary enterovirus vaccine platform. Equally, the Breakthrough T1D T1D Fund’s confidence in our approach to reduce the impact of type 1 diabetes on a global basis leaves us deeply humbled. Imagine the possibility of reducing at least half of the world’s cases of type 1 diabetes. With the help of the Breakthrough T1D T1D Fund, Vactech, our cofounder MDB Capital Group LLC, and other founding investors, including Johnson & Johnson Innovation – JJDC, Inc., we are attempting to make this vision a reality.”

Raimo Harju, CEO of Vactech Oy, commented, “The licensing agreement with Provention and the initiation of its vaccine development program targeting type 1 diabetes is a watershed moment for Vactech as it validates our exhaustive research into the link between coxsackievirus B and type 1 diabetes, while expanding our enterovirus platform into a substantial global development and commercialization opportunity. We look forward to working closely with Provention as it seeks to change the paradigm of type 1 diabetes and initiates other clinical development programs targeting the interception and prevention of immune-mediated disease.”

Type 1 Diabetes & Coxsackievirus B Infection

T1D is a life-impacting chronic disease caused by immune destruction of the insulin-producing cells in the pancreas. Today, there is no cure. The only means for managing this devastating disease is life-long blood glucose monitoring and insulin replacement by way of injection/infusion or, potentially, whole organ pancreas or pancreatic islet cell transplantation.

However, global longitudinal studies of more than 200,000 children screened and more than 17,000 followed over two decades in Finland by Vactech’s scientific founders and their collaborators have identified CVB infection as a likely trigger for T1D onset. From this research, it was discovered that the diabetes process often starts after CVB infection. Insulin-producing cells in the pancreas express specialized receptors used for cellular infection by CVB. As a result, an exacerbated immune reaction against the virus may be involved in triggering the autoimmunity targeting the pancreas and gut, which appears to precede the onset of T1D.

Importantly, CVB-associated risk of T1D was significantly reduced in children whose mothers have had a CVB infection, thereby suggesting a transfer of protective CVB antibodies to their offspring via placenta and breast milk. This observation suggests the potential benefit of CVB vaccination for children.

Francisco Leon, MD, Ph.D., scientific co-founder of Provention, said, “By identifying and targeting potential disease precursors, such as the well-chronicled link between coxsackievirus B infection and type 1 diabetes, Provention Bio hopes to intercept, slow and reverse the progression of a variety of chronic diseases. Our coxsackievirus B vaccine, if successful, could prevent more than 50% of type 1 diabetes cases.”

About Provention Bio, Inc.
Provention Bio, Inc. is a clinical stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics and cutting-edge solutions to intercept and prevent immune-mediated disease. Our “predict and prevent” therapeutic model is focused on developing drugs that intervene before the targeted disease begins, reappears or progresses. This approach is unique in the biopharmaceutical industry and offers unprecedented potential to reduce the high morbidity, mortality and escalating costs of chronic autoimmune and inflammatory diseases, such as type 1 diabetes (T1D), Crohn’s disease, and ulcerative colitis, as well as emerging viral infections. For more information on Provention Bio, please visit www.proventionbio.com.

About Vactech Oy
Vactech develops and licenses vaccines and novel technologies for vaccines and diagnostics with a pipeline of early stage product candidates focused on Type 1 Diabetes, Celiac Disease, Asthma & Allergy and diagnostics. Vactech’s flagship project is a patented enterovirus based preventive Type 1 Diabetes (T1D) vaccine, similar to the widely used enterovirus vaccine against polio. The vaccine, which has been licensed to Provention Bio, Inc., is a traditional inactivated vaccine that has been proved to be safe and effective in mice. In addition, Vactech’s IMAVAC™ product line uses Virus Like Particle (VLP) technology which is essential for other vaccines, immunomodulators and diagnostic applications. Vactech is a privately-owned company with a track record of collaboration with big pharma on the level of Good Laboratory Practice (GLP). For more information on Vactech, please visit www.vactech.fi.

About The Breakthrough T1D T1D Fund
The Breakthrough T1D T1D Fund (www.t1dfund.org) is a venture philanthropy fund accelerating life-changing solutions to treat, prevent, and cure type 1 diabetes (T1D) through catalytic commercials investments. Through its investments in partnership with private capital, including venture capital, pharma and foundations, the T1D Fund seeks to attract the private investment necessary to advance drugs, devices, diagnostics, and vaccines into the hands of those living with T1D. The T1D Fund invests in areas strategically aligned with Breakthrough T1D, with an exclusive focus on the best commercial opportunities. The T1D Fund will reinvest any realized gains into new investments to further its mission.

Media Contact:
Jason Rando
EVP & COO
Tiberend Strategic Advisors, Inc.
T: 212 375 2665
jrando@tiberend.com

Investment to Further the Development of Type 1 Diabetes Immunotherapy

BOSTON, MA – May 2, 2017 – TetraGenetics, a biopharmaceutical company developing novel therapeutics for autoimmune diseases, today announced it has received an investment in the company’s type 1 diabetes (T1D) program from the Breakthrough T1D T1D Fund, a venture philanthropy fund exclusively devoted to finding and funding the best early-stage T1D commercial opportunities. Financial terms of the investment were not disclosed.

In T1D, a subset of immune cells (antigen-specific T-cells referred to as effector memory T-cells) attack and destroy insulin-producing beta cells in the pancreas. These effector memory T-cells are associated with the autoimmune cascade that causes type 1 diabetes and they contain high levels of the Kv1.3 ion channel proteins. The Kv1.3 ion channel has been well studied, but developing drug candidates that block its activity has been difficult. TetraGenetics used its proprietary technology to discover a pool of novel monoclonal antibodies that inhibit Kv1.3 activity. The monoclonal antibodies discovered by TetraGenetics can target the Kv1.3 ion channel proteins, thus having the potential to blunt the body’s attack on its own healthy beta cells. This therapy could play a role in secondary prevention and treatment of T1D, and may contribute, in combination with other therapies, to an eventual cure.

“This has the potential to be a first-in-class disease modifying immune therapy for T1D,” said Jonathan Behr, Managing Director of the T1D Fund. “We are excited to invest in the critical work necessary to advance delivery of potentially transformational therapeutics for those with T1D.”

Douglas Kahn, Chairman and CEO of TetraGenetics said, “Support from the Breakthrough T1D T1D Fund couldn’t have come at a better time, enabling us to select the best of our antibodies and advance our lead drug candidate in preparation for clinical trials. The investment funding and access to Breakthrough T1D experts will significantly accelerate our T1D drug development program.”

About TetraGenetics
TetraGenetics uses proprietary technology (TetraExpress™) to discover large molecule drugs that target ion channel membrane proteins. The company’s drug discovery focus is on new biologics for autoimmune diseases and pain. For more information, please visit: www.tetragenetics.com.

About The Breakthrough T1D T1D Fund
The Breakthrough T1D T1D Fund (www.t1dfund.org) is a venture philanthropy fund accelerating life-changing solutions to treat, prevent, and cure type 1 diabetes (T1D) through catalytic commercial investments. Through its investments in partnership with private capital, including venture capital, pharma and foundations, the T1D Fund seeks to attract the private investment necessary to advance drugs, devices, diagnostics, and vaccines into the hands of those living with T1D. The T1D Fund will invest in areas strategically aligned with Breakthrough T1D, with an exclusive focus on the best commercial opportunities. The T1D Fund will reinvest any realized gains into new investments to further its mission.

Media Contacts:
TetraGenetics
Suzanne Gibbons-Neff
Suzanne@sgnpr.com
203-858-1325

Breakthrough T1D T1D Fund
Amy Montalto, National Director
amontalto@BreakthroughT1D.org
617-910-7542