MaaT013 Shows Potential in First U.S. Treatment of Refractory Graft-Versus-Host Disease
Under the FDA’s Expanded Access Program, a patient with difficult-to-treat acute graft-versus-host disease (aGvHD) received the first treatment with MaaT013 in the United States. This groundbreaking treatment took place at the renowned City of Hope Hospital in California, highlighting the potential of MaaT013 as a new therapeutic avenue for this severe complication.
A New Hope for Patients Facing a Grim Diagnosis
aGvHD is a potentially life-threatening complication that can occur after a stem cell or bone marrow transplant. The patient treated had previously exhausted several standard treatment options, including steroids and ruxolitinib. Facing limited choices, they turned to MaaT013 through the compassionate use program.
Leaders in Immunotherapy
The patient was treated by a team of leading experts at City of Hope, including Dr. Monzr M. Al Malki, Director of Non-Donor Hematopoietic Cell Transplantation Program, and Dr. Ryotaro Nakamura, professor and director of the Hematopoietic Cell Transplant Center. City of Hope is highly regarded for its advanced cancer treatment and research, consistently ranking among the top cancer centers nationwide.
“We are pleased to have access to MaaT013 to treat this patient with refractory GvHD,” said Dr. Nakamura. Dr. Al Malki added: “We are convinced that immune modulation through the gut microbiota represents a promising avenue for the treatment of GvHD, and we look forward to exploring the potential of MaaT013 to treat GvHD and improve patient survival.”
MaaT013: Harnessing the Power of the Gut Microbiome
Developed by MaaT Pharma, MaaT013 is a Microbial Ecosystem Restorative Therapy (MET). METs leverage the beneficial bacteria living in the gut to restore a healthy immune balance.
“The availability of MaaT013 under compassionate access in the United States highlights the urgent global need to develop innovative therapies in the treatment of refractory aGvHD,” said Hervé Affagard, Managing Director and co-founder of MaaT Pharma. “It also reflects the growing international recognition of MaaT013 as a potential new hope for patients facing this deadly disease.”
Leading Clinical Trials Continue
MaaT Pharma is actively advancing clinical development of MaaT013.
The Phase 3 ARES trial is ongoing in Europe (NCT – 04769895), with patient recruitment complete and primary results anticipated in January 2025.
Additionally, MaaT Pharma is preparing to initiate a US-based Phase 3 trial focusing on MaaT013 in aGvHD with gastrointestinal involvement in patients who are refractory to or intolerant of ruxolitinib.
Further Evidence to Come
Clinical batches of MaaT013 are readily available for use under the FDA’s Expanded Access Program, ensuring access to this potentially life-saving treatment for patients in need.
Additional efficacy, safety, and long-term follow-up data from the European compassionate access program will be presented at the annual meeting of the American Society of Hematology in December 2024.
“We are dedicated to making restorative therapies like MaaT013 accessible for those who need them most,” said Hervé Affagard.
How does MaaT013 differ from traditional treatment approaches for aGvHD?
## Interview with Dr. Ryotaro Nakamura on MaaT013
**(News Anchor):** Welcome back to our health segment. Today, we’re discussing groundbreaking news in the field of cancer treatment. Joining us is Dr. Ryotaro Nakamura, Professor and Director of the Hematopoietic Cell Transplant Center at City of Hope Hospital. Dr. Nakamura, thank you for being with us.
**(Dr. Nakamura):** My pleasure.
**(News Anchor):** Let’s talk about MaaT013 and this first-in-the-U.S. treatment for refractory graft-versus-host disease, or aGvHD. What can you tell our viewers about this condition and why this development is so important?
**(Dr. Nakamura):** Graft-versus-host disease, or GvHD, is a serious complication that can occur after stem cell or bone marrow transplants. Essentially, the donor’s immune cells see the recipient’s cells as foreign and attack them. aGvHD is the acute form, and it can be life-threatening.
Currently, few options exist for patients who don’t respond to standard treatments, like steroids or ruxolitinib. So, being able to offer MaaT013 through the FDA’s Expanded Access Program provides a new ray of hope for these individuals.
**(News Anchor):** Can you explain how MaaT013 works differently?
**(Dr. Nakamura):** MaaT013 is a Microbiome Ecosystem Therapy. It leverages the power of a patient’s own gut microbiome – the trillions of bacteria that live in our digestive system. By restoring a healthy balance in the microbiome, we aim to modulate the immune system and reduce the severity of aGvHD. [ [1](https://www.biospace.com/press-releases/maat-pharma-announces-first-u-s-patient-treated-at-city-of-hope-under-single-patient-expanded-access-for-maat013-in-acute-graft-versus-host-disease)]
**(News Anchor):** That’s fascinating. City of Hope is renowned for cutting-edge research and treatment. How significant is this development for your center?
**(Dr. Nakamura):** It’s incredibly significant. We are committed to bringing the most innovative therapies to our patients.
Being able to offer MaaT013 aligns with our mission and demonstrates our commitment to finding new and effective ways to combat this challenging disease.
**(News Anchor):** Dr. Nakamura, thank you for shedding light on this promising development. We will certainly be watching for updates on MaaT013 and its impact on the lives of aGvHD patients.
