BEIJING, Oct. 12, 2026 /PRNewswire/ -- T-MAXIMUM PHARMACEUTICAL ("T-MAXIMUM") today announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate a Phase 2 clinical study of MT027, its internally developed, B7-H3-targeted universal (allogeneic) CAR-T therapy, for the treatment of patients with brain metastases from lung cancer and breast cancer.
This is the second Phase 2 study of MT027 to receive FDA clearance. MT027 was previously cleared by the FDA to proceed with a Phase 2 study in recurrent glioblastoma, and has been granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD). With two FDA-cleared Phase 2 programs, T-MAXIMUM has established a dual-indication portfolio for universal CAR-T therapy covering both primary and metastatic intracranial solid tumors.
Brain Metastases: An Unanswered Clinical Question Despite Advances in Systemic Therapy
Brain metastases commonly arise in patients with lung cancer, breast cancer, melanoma, renal cell carcinoma, and colorectal cancer. International studies estimate that approximately 20% of cancer patients may develop brain metastases over the course of their disease, a proportion that can reach 20% to 40% among patients with advanced solid tumors.[1][2] For patients, this means far more than an additional lesion on imaging: brain metastases may be accompanied by headaches, seizures, and cognitive and motor impairment, directly affecting daily life and subsequent treatment options.
This is a truly global clinical challenge. In 2022, there were nearly 20 million new cancer cases worldwide, including nearly 2.5 million new cases of lung cancer and approximately 2.3 million new cases of female breast cancer – the two leading primary tumor types giving rise to brain metastases.[3] Asia accounts for roughly half of all new cancer cases globally;[4] in the United States, an estimated 200,000 to 300,000 patients are newly diagnosed with brain metastases each year.[2] This large patient population means brain metastasis is not a niche need, but a question that oncology worldwide must continue to answer.
Systemic therapies can help control disease throughout the body, but treatment of intracranial lesions often remains constrained by multiple factors, including the blood-brain barrier, tumor heterogeneity, and the need to preserve neurological function. This is especially true for patients who experience intracranial progression after prior therapy, for whom there remains a need for more treatment options that are validated intracranially while balancing safety and accessibility.
Consecutive Clinical Milestones Built on Long-Term Product and Translational Groundwork
MT027's recent series of regulatory milestones is no coincidence. It reflects an integrated capability across product, manufacturing, clinical development, and regulatory affairs built around intracranial solid tumors – one that is now advancing from early exploration toward more systematic clinical validation.
First, a foundation of clinical data. The company has accumulated sustained clinical experience in local delivery, repeat dosing, and safety monitoring for intracranial solid tumors. Years of clinical experience and data with MT027 have already led to two FDA-cleared Phase 2 programs. Data from an investigator-initiated trial (IIT) of MT026, a program built on the same platform, were published in Nature Communications in 2026: among 5 patients with recurrent high-grade glioma, 1 complete response and 3 partial responses were observed, for an objective response rate (ORR) of 80%, with no treatment-related Grade 3 or higher adverse events.
Early clinical data for MT027 in patients with refractory brain metastases from lung cancer were previously presented at the IASLC 2026 World Conference on Lung Cancer (WCLC 2026). Five heavily pretreated patients with no guideline-recommended subsequent treatment options completed treatment; among the 3 evaluable patients, 2 partial responses were observed. The safety profile was favorable, with no Grade 3 or higher adverse events and no graft-versus-host disease (GvHD). These rigorous exploratory clinical studies provide an important basis for the clinical translation of allogeneic, locally delivered CAR-T therapy in intracranial solid tumors.
Second, a well-defined manufacturing process. MT027 is manufactured using a fully non-viral gene-editing process – a generational departure from the industry's mainstream lentiviral vector approach – offering potential advantages in product safety, batch-to-batch consistency, and cost control. The manufacturing process was established and locked prior to entering Phase 2 clinical development.
Third, leadership measured not only by getting there first, but by advancing systematically. For an innovative cell therapy company, leadership in regulatory progress comes from coordinated advancement across product, manufacturing, clinical development, and regulatory strategy. MT027's consecutive entry into FDA-cleared Phase 2 clinical development demonstrates T-MAXIMUM's ability to translate its prior groundwork into a repeatable and scalable clinical development capability.
Management Commentary
"Receiving FDA clearance for two consecutive Phase 2 studies of MT027 marks a pivotal step built on our sustained work in intracranial solid tumors. From glioma to brain metastases, we have always let the data speak and put clinical value first. Going forward, we will continue to rigorously evaluate the product's safety and potential clinical value through well-designed clinical studies, steadily advancing product supply, clinical execution, and the generation of key data, as we explore new possibilities for patients who lack effective treatment options."
About MT027
MT027 is an investigational, B7-H3-targeted universal (allogeneic) CAR-T cell therapy developed by T-MAXIMUM using a fully non-viral gene-editing process and administered via local intracranial delivery. MT027 has received FDA Orphan Drug Designation and Fast Track Designation and is being evaluated in FDA-cleared Phase 2 studies in recurrent glioblastoma and in brain metastases from lung cancer and breast cancer.
About T-MAXIMUM PHARMACEUTICAL
T-MAXIMUM PHARMACEUTICAL is a clinical-stage cell therapy company focused on developing universal (allogeneic) CAR-T therapies for intracranial solid tumors with high unmet medical need, including recurrent glioblastoma and brain metastases. Through engineered cell therapies, local delivery strategies, and clinical translation capabilities, the Company is advancing more accessible treatment approaches with the potential to support repeat dosing. Its lead program, MT027, is a B7-H3-targeted universal CAR-T therapy that has received FDA clearance to initiate Phase 2 clinical studies in recurrent glioblastoma and brain metastases. MT027 has also received Orphan Drug Designation (ODD) in high-grade glioma and Fast Track Designation (FTD) for recurrent or progressive glioblastoma. T-MAXIMUM is working to translate its accumulated capabilities in product development, manufacturing, and clinical execution into continued innovation across both primary and metastatic intracranial solid tumors, with the goal of creating new possibilities for patients with limited treatment options.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the clinical development, potential therapeutic benefits, manufacturing advantages, and regulatory progress of MT027 and other product candidates. These statements are based on current expectations and are subject to risks and uncertainties, including those inherent in clinical development, regulatory review, and manufacturing, that could cause actual results to differ materially. Early clinical results from small numbers of patients may not be predictive of results in larger studies. MT027 is an investigational product, and its safety and efficacy have not been established. T-MAXIMUM undertakes no obligation to update any forward-looking statement, except as required by law.
References
| [1] Achrol AS, et al. Brain metastases. Nature Reviews Disease Primers. 2019;5:5. DOI: 10.1038/s41572-018-0055-y |
| [2] Moravan MJ, et al. Current multidisciplinary management of brain metastases. Cancer. 2020;126:1390-1406. DOI: 10.1002/cncr.32714 |
| [3] Bray F, et al. Global cancer statistics 2022. CA Cancer J Clin. 2024. DOI: 10.3322/caac.21834; IARC GLOBOCAN 2022 |
| [4] Current and future burden of breast cancer in Asia: A GLOBOCAN data analysis for 2022 and 2050. 2024 |
[1] Achrol AS, et al. Brain metastases. Nature Reviews Disease Primers. 2019;5:5. DOI: 10.1038/s41572-018-0055-y
[2] Moravan MJ, et al. Current multidisciplinary management of brain metastases. Cancer. 2020;126:1390-1406. DOI: 10.1002/cncr.32714
[3] Bray F, et al. Global cancer statistics 2022. CA Cancer J Clin. 2024. DOI: 10.3322/caac.21834; IARC GLOBOCAN 2022
[4] Current and future burden of breast cancer in Asia: A GLOBOCAN data analysis for 2022 and 2050. 2024
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T-MAXIMUM's B7-H3-Targeted Allogeneic CAR-T MT027 Receives FDA Clearance for Phase 2 Study in Brain Metastases from Lung and Breast Cancer
From the inaugural Frieze Abu Dhabi and the vibrant NOMAD Abu Dhabi to the thrill of the Formula 1 ® Etihad Airways Abu Dhabi Grand Prix and the iconic Liwa International Festival, Abu Dhabi unveils an electrifying and diverse events calendar.
ABU DHABI, UAE, Oct. 12, 2026 /PRNewswire/ -- Abu Dhabi's events season is officially underway showcasing more than 40 world-class spectacles that will captivate audiences across the emirate through early 2027.
Experience Abu Dhabi presents one of its most dynamic and exhilarating entertainment and cultural line up to date. Headline events include the Yasalam After-Race Concerts featuring acts like Lewis Capaldi and Alex Warren alongside performances throughout 2026 by Anyma, Tamer Hosny and Tamer Ashour. These experiences complement major global highlights, including Formula 1® Etihad Airways Abu Dhabi Grand Prix and Frieze Abu Dhabi.
Expect a range of events across culture, sport, music, family entertainment and lifestyle experiences, promising unforgettable moments for all. This season also highlights renowned global events, including Culture Summit Abu Dhabi, Abu Dhabi Showdown Week and UFC alongside major new cultural experiences, including the opening of Guggenheim Abu Dhabi and Public Art Abu Dhabi Biennial, marking an exciting new chapter for the emirate's cultural landscape.
Here's a look at what's on:
Culture: Art, Heritage and Immersive Experiences
Abu Dhabi's cultural programme brings together the emirate's rich heritage and world-class cultural institutions, with landmark exhibitions, immersive experiences, and programmes that invite audiences to discover, engage and connect with culture in new ways.
Unmissable Art and Culture
- Public Art Abu Dhabi Biennial: Returning with new commissions, the Public Art Abu Dhabi Biennial opens on 23 October in Al Ain Region followed by Abu Dhabi from 15 November, with works remaining on display into 2027. The Biennial brings contemporary art into public spaces across the emirate, creating opportunities for audiences to experience art as part of everyday life.
- Culture Summit Abu Dhabi: Taking place from 8-10 December at Manarat Al Saadiyat and across Saadiyat Cultural District, Culture Summit Abu Dhabi brings together cultural leaders, artists, policymakers and thinkers from around the world. Under the theme Towards a Reimagined Commons, this year's programme explores the role of culture in shaping shared memories, spaces and futures.
- Guggenheim Abu Dhabi: One of the defining moments of 2026 is the opening of Guggenheim Abu Dhabi on 11 December. Designed by the late Frank Gehry, the new museum on Saadiyat Island will be dedicated to modern and contemporary art, adding another major institution to Saadiyat Cultural District and further strengthening its position as a global destination for culture and the arts.
Vibrant Cultural Festivals and World-class Fairs
- Traditional Handicrafts Festival: Celebrating the skills and traditions that have shaped Emirati cultural identity, the Traditional Handicrafts Festival brings together master artisans, live craft demonstrations and a vibrant cultural market from 23 October - 11 November. The festival offers audiences an opportunity to discover and engage with these living traditions, while supporting their transmission to new generations.
- NOMAD Abu Dhabi: An immersive international art and design fair, NOMAD Abu Dhabi will take place from 18 – 22 November at Terminal 1 of the Old Abu Dhabi Airport. Bringing together collectors, curators and cultural leaders, the fair showcases collectible design, contemporary art and architecture inside a unique historic setting.
- Frieze Abu Dhabi: Making its debut from 19 - 22 November, Frieze Abu Dhabi marks a new chapter for the emirate's international art scene. Building on nearly two decades of Abu Dhabi Art, the inaugural fair at Manarat Al Saadiyat will connect Abu Dhabi with Frieze's global network of galleries, artists and collectors.
- Al Hosn Festival: A renewed celebration of Abu Dhabi's culture, Al Hosn Festival brings generations together through experiences that reflect the authenticity of Emirati traditions, crafts and local flavours. Taking place from 15 - 30 January 2027, the festival celebrates culture, community and shares experiences at Al Hosn Cultural Site
Compelling Milestones and Celebrations on the Calendar
- Maritime Heritage Festival: The Maritime Heritage Festival celebrates Abu Dhabi's rich coastal heritage, bringing the traditions of fishing, pearl diving, seafaring, and coastal life to new generations. Now in its fifth year, the festival returns to the Corniche from 20-29 November for 10 days of live performances, artisan demonstrations, traditional storytelling and coastal cuisine.
- Al Ain Museum One-Year Anniversary: Marking one year since reopening following extensive redevelopment in October, Al Ain Museum continues to serve as a centre of knowledge on the history and heritage of Al Ain Region. Originally founded in 1969 by the UAE's Founding Father, the late Sheikh Zayed bin Sultan Al Nahyan, the museum was the nation's first and now spans more than 8,000 square metres. It features newly discovered archaeological sites and exhibits exploring the ancient falaj irrigation system that made settlement in the region possible.
- Natural History Museum Abu Dhabi One-Year Anniversary: Celebrating its first year, Natural History Museum Abu Dhabi continues to take people on a journey spanning 13.8 billion years of history. Visitors can discover rare fossils and marvel at Stan the T. rex, one of the world's most complete dinosaur skeletons, alongside the museum's unique treasures and captivating stories from our planet's past.
- Zayed National Museum One-Year Anniversary: Marking its first anniversary, Zayed National Museum remains a landmark institution in Saadiyat Cultural District, tracing 300,000 years of human history on the land and honouring the life and vision of the UAE's Founding Father, the late Sheikh Zayed bin Sultan Al Nahyan, through six galleries exploring the nation's history and heritage.
Entertainment: Music, Sport & Big-ticket Experiences
From chart-topping performances to world-class sporting action, Abu Dhabi's entertainment line-up brings major names and events to the emirate, creating memorable experiences across some of its iconic venues.
Thrilling Headline Events
- Abu Dhabi Showdown Week (UFC): UFC®, the world's premier mixed martial arts organisation, returns to Abu Dhabi this October for a week of action-packed events. At Etihad Arena, UFC featherweight champion Alexander Volkanovski will defend his title against Movsar Evloev, while champion Petr Yan faces Merab Dvalishvili in a trilogy fight on 24 October. Beyond the main events, fans can catch open workouts, weigh-ins and fan zones across the city.
- Formula 1® Etihad Airways Abu Dhabi Grand Prix: Since 2009, the Abu Dhabi Grand Prix has welcomed fans from around the world to Yas Island each year. This year's edition takes place from 3–6 December, combining high-speed racing with one of Abu Dhabi's biggest weeks of live entertainment. The Yasalam After-Race Concerts will feature Lewis Capaldi, Imagine Dragons, The Chainsmokers and The Script, while Anyma will headline the Official After-Party on 4 December, with more artists to be announced.
- Liwa International Festival: Taking place every December in Al Dhafra desert, Liwa International Festival brings together, adventure, motorsports, music and family entertainment around the iconic Tal Moreeb, the UAE's tallest dune at 300 metres. Previous editions have featured hot air balloon rides, farm-to-table dining, Monster Jam shows and freestyle drifting. As part of the festival, Liwa Village returns with its own mix of Emirati heritage and entertainment, from a lively marketplace and traditional performances to family-friendly activities set against the backdrop of the dunes.
Events for the Super Fans
- Saadiyat Nights: Saadiyat Nights returns for its fourth season, bringing a line-up of legendary musicians and live performances to Abu Dhabi's iconic open-air amphitheatre on Saadiyat Island. Set against the island's coastal backdrop, this concert series welcomes internationally acclaimed artists for memorable evenings of live entertainment under the stars.
Fun, Fashion and Laughter
- Abu Dhabi Comedy Season: Abu Dhabi Comedy Season returns to Etihad Arena on Yas Island, starting from October, bringing together a series of international comedy performances. This year's line-up features Russell Peters, Morgan Jay, Mo Amer and Maz Jobrani, with more acts to be announced.
- Mother of the Nation (MOTN) Festival: Named in honour of Her Highness Sheikha Fatima bint Mubarak, the Mother of the Nation Festival returns with a programme of family activities, global cuisine, live entertainment and art installations across Abu Dhabi, Al Ain Region and Al Dhafra Region. Previous editions have included interactive workshops, outdoor cinema and inflatables zone, alongside more than 40 food concepts from regional and international vendors.
With more than 40 events spanning culture and entertainment from now through early 2027, Abu Dhabi's calendar offers a diverse programme experiences for residents and visitors to discover and enjoy.
For more information on events, dates, and tickets: visitabudhabi.ae/en/events
About the Department of Culture and Tourism – Abu Dhabi:
The Department of Culture and Tourism – Abu Dhabi (DCT Abu Dhabi) drives the sustainable growth of Abu Dhabi's culture and tourism sectors and its creative industries, fuelling economic progress and helping to achieve Abu Dhabi's wider global ambitions.
By working in partnership with the organisations that define the emirate's position as a leading international destination, DCT Abu Dhabi strives to unite the ecosystem around a shared vision of the emirate's potential, coordinate effort and investment, deliver innovative solutions, and use the best tools, policies and systems to support the culture and tourism industries.
DCT Abu Dhabi's vision is defined by the emirate's people, heritage and landscape. We work to enhance Abu Dhabi's status as a place of authenticity, innovation, and unparalleled experiences, represented by its living traditions of hospitality, pioneering initiatives and creative thought.
For more information about the Department of Culture and Tourism – Abu Dhabi and the destination, please visit: dct.gov.ae and visitabudhabi.ae.
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Mark Your Calendars: Abu Dhabi Unveils Its Spectacular Events Season
Mark Your Calendars: Abu Dhabi Unveils Its Spectacular Events Season
