AlivioTM Technology Platform
Our programs
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
AlivioTM Technology Platform
| Phase completed | Phase in progress |
Pioneering inflammation-targeted disease immunomodulation
Using our Alivio technology platform, we are pioneering inflammation-targeted disease immunomodulation, which involves selectively restoring immune homeostasis at inflamed sites in the body, while having the potential for minimal impact on the rest of the body’s healthy tissues, as a novel strategy to more effectively treat a range of chronic and acute inflammatory disorders. This long sought-after approach has the potential to broadly enable new medicines to treat a range of chronic and acute inflammatory disorders, including drugs that were previously limited by issues of systemic toxicity or undesirable pharmacokinetics (PK).
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Key Points of Innovation & Differentiation
- To achieve our vision of selective immunomodulation, we are advancing our Alivio technology platform centered on a class of self-assembling therapies that selectively bind to inflamed tissue. The platform allows for the development of inflammation-targeting therapeutic candidates using a wide array of active pharmaceutical ingredients (APIs) including small molecules, biologics and nucleic acids. Using this technology, we can design therapeutic candidates that have the potential to treat autoimmune diseases locally at the site of inflammation while limiting their systemic exposure, which has the potential to significantly improve both the safety and efficacy profile of the therapy.
- We believe that oral administration of therapeutic candidates generated from our Alivio technology platform can potentially overcome these challenges by targeting multiple mechanisms of disease pathogenesis and minimizing the potential for systemic side effects.
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Program Discovery Process by the PureTech Team
- A key challenge in new drug development for autoimmune and inflammatory disease is that attractive drug targets are frequently expressed in both diseased and normal tissue. Consequently, we were interested in identifying ways to address autoimmune disease in a targeted manner such that healthy cells and tissues are not impacted by the drug. We were inspired by the key observation that pathologic inflammation frequently manifests at specific sites in tissues and organs and is driven by dysfunctional immune signaling. Traditional approaches act broadly to suppress the immune system throughout the body affecting both the disease and healthy tissues. The current approaches therefore substantially limit the potential targets that can be pursued and frequently result in narrow therapeutic windows. Working with leading scientists, we identified and in-licensed a technology platform in May 2016 that was created by Jeffrey Karp, Ph.D., Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and Robert Langer, Sc.D., David H Koch Institute Professor at MIT. As demonstrated in multiple publications, our Alivio technology platform can be used to develop therapeutic candidates that selectively release drugs at inflamed sites of targeted tissues and spares healthy
tissues.
- A key challenge in new drug development for autoimmune and inflammatory disease is that attractive drug targets are frequently expressed in both diseased and normal tissue. Consequently, we were interested in identifying ways to address autoimmune disease in a targeted manner such that healthy cells and tissues are not impacted by the drug. We were inspired by the key observation that pathologic inflammation frequently manifests at specific sites in tissues and organs and is driven by dysfunctional immune signaling. Traditional approaches act broadly to suppress the immune system throughout the body affecting both the disease and healthy tissues. The current approaches therefore substantially limit the potential targets that can be pursued and frequently result in narrow therapeutic windows. Working with leading scientists, we identified and in-licensed a technology platform in May 2016 that was created by Jeffrey Karp, Ph.D., Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and Robert Langer, Sc.D., David H Koch Institute Professor at MIT. As demonstrated in multiple publications, our Alivio technology platform can be used to develop therapeutic candidates that selectively release drugs at inflamed sites of targeted tissues and spares healthy
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Patient Need & Market Potential
- Preclinical results suggest our Alivio technology platform could be applied to diseases such as IBD, inflammatory arthritis, organ transplantation and IC/BPS. These diseases collectively impact tens of millions of patients in the U.S. alone and have limited treatment options. IC/BPS is a chronic bladder condition that consists of discomfort or pain in the bladder or surrounding pelvic region and is often associated with frequent urination. It is estimated to affect four million to 12 million people in the U.S. Current treatments fail to control pain in many patients. IBD is estimated to affect approximately 3.9 million people in the U.S.
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Milestones Achieved & Development Status
- In August 2021, we announced that Imbrium exercised a license option under the companies’ research and development collaboration agreement to develop LYT-503/IMB-150. In connection with the option exercise, we received an upfront payment of $6.5 million and are eligible to receive up to $53 million in additional development milestone payments for this program as well as royalties on product sales.
- Using our Alivio technology platform, we are developing LYT-510 (see here), an oral inflammation-targeting formulation of tacrolimus, a potent immunosuppressant drug, to treat IBD and chronic pouchitis, LYT-500 (see here), an oral combination therapy for the treatment of IBD, and LYT-503/IMB-150 (see here), our therapeutic candidate being advanced in collaboration with Imbrium Therapeutics for the potential treatment of IC/BPS.
- In multiple preclinical IBD models, LYT-510 showed significant improvements in several efficacy endpoints compared to untreated controls. Furthermore, the inflammation-targeting properties were shown to result in very low systemic blood levels compared to the current immunosuppressant formulations, which minimizes the potential for systemic side effects.
- In 2020, the U.S. Department of Defense (DOD) Technology/Therapeutic Development awarded $3.3 million to support the advancement of LYT-510 into the clinic.
- We have developed an inflammation-targeting IL-22 composition with analytical data to support high IL-22 loading, high encapsulation efficiency, preservation of biologic activity, enzyme-mediated drug release and stability in simulated intestinal fluids. In addition, we have a comparable data set for an inflammation-targeting composition that combines IL-22 with an immunosuppressant drug.
- We have completed initial preclinical evaluation of an inflammation-targeting IL-22 composition in a preclinical IBD model, where we demonstrated improvement in multiple endpoints related to mucosal healing.
- We have demonstrated efficacy of the inflammation-targeting drug combination in a rodent IBD model, with improvements observed across several endpoints related to mucosal healing and inflammation.
- We have developed oral dosage forms to enable preclinical testing of the inflammation-targeting IL-22 alone and in combination with an immunosuppressant drug and have initiated animal studies to evaluate their efficacy.
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Intellectual Property
- Intellectual property portfolio covering the Alivio inflammation-targeting technology platform consists of six patent families. Collectively, across these patent families, there are 18 issued patents within and outside the U.S. with claims covering inflammation-targeting compositions, methods of making and methods of using as drug products. Within these families, there are a total of eight patent applications pending in the U.S. and foreign countries. All patents and patent applications covering the platform technologies have been obtained from the Brigham and Women’s Hospital under an exclusive licensing agreement in all territories.
Our Alivio technology platform is designed to target biologics and other drugs to sites of inflammation in a localized manner while limiting their systemic exposure, which offers the potential to significantly improve both the safety and efficacy profile of the therapy. We believe the targeted activation and oral formulation offered by Alivio offers a path to unlocking the full therapeutic potential of anti-inflammatory drugs in a way that matches the chronic, variable expression of autoimmune diseases.
Press Releases
PureTech Founded Entity Alivio Therapeutics Awarded $3.3 Million from US Department of Defense
October 5, 2020
Publications
An inflammation-targeting hydrogel for local drug delivery in inflammatory bowel disease
August 2015