VRise Therapeutics Secure Exclusive License for KQ-2003 world's first parallel-enhanced dual-targeted CAR-T in India

KQ-2003 is a clinically validated first-in-class Dual BCMA-CD19 CAR-T, with demonstrated best-in-class responses in patients with r/r MM and POEMS syndrome

CAMBRIDGE, MA, UNITED STATES, September 29, 2025 /EINPresswire.com/ -- VRise Therapeutics Inc. (“VRise”) announced an exclusive license agreement with Novatim Immune Therapeutics (Zhejiang) Co., Ltd. (“Novatim”) for the development and commercialization of KQ-2003, a first-of-its-kind Dual BCMA-CD19 CAR-T therapy, in India.

KQ-2003 has demonstrated a strong safety profile and significant clinical benefit in studies outside India. By simultaneously targeting BCMA and CD19, this dual CAR-T therapy offers a transformative treatment option for patients with r/r MM and POEMS, who have exhausted existing therapies. KQ-2003 is also expected to advance into clinical development for autoimmune disorders, including patients with refractory systemic lupus erythematosus (SLE).

Under the terms of the agreement, Novatim will receive an upfront payment, as well as development, regulatory, and commercial milestone payments, in addition to tiered royalties ranging from the higher single digits to low teens on net sales in India. Through its affiliates, VRise will work closely with regulators, leading clinical centers, and manufacturing partners to ensure the therapy is introduced swiftly, reliably, and in a patient-focused manner, while remaining accessible and affordable to patients across the country.

“Securing this license represents a defining milestone for advanced therapies in India. KQ-2003 combines proven global innovation with the potential to significantly improve patient outcomes locally,” said Prashant Bhavar, Co-Founder of VRise. “It reflects our commitment to delivering cutting-edge treatments to patients who currently have limited options.”

“KQ-2003’s clinical performance sets it apart from other BCMA-targeted CAR-T therapies in development, demonstrating robust efficacy and a favorable safety profile in heavily pretreated patients,” said Uday Kumar S., Co-Founder & Chief Development Officer of VRise. “This dual BCMA/CD19 CAR-T is poised to transform the treatment paradigm for multiple myeloma, providing renewed hope to patients with few alternatives.”

About KQ-2003:

KQ-2003 cell therapy is uniquely engineered to target two distinct antigens BCMA-CD19, positioning it as a next-generation CAR-T product capable of addressing multiple indications in the hematology and autoimmune disorders. KQ-2003 is designed to overcome tumor heterogeneity and antigen escape. By integrating dual antigen recognition within a single construct, KQ-2003 aims to deliver deeper and more durable responses compared to single-antigen CAR-T approaches.

Clinical data from over 34 Patients (and ongoing) have shown compelling efficacy, with an overall hematological overall response rate (ORR) of 96.6%, and 89.7% Complete Response (CR) / Stringent Complete Response (sCR), supported by a favorable safety profile. With an efficient and scalable manufacturing process that offers potential cost savings, KQ-2003 is well-positioned as a differentiated, transformative therapy for patients and an attractive opportunity for value creation.

Beyond multiple myeloma, KQ-2003 is also being investigated in POEMS syndrome and in selected autoimmune disorders, including systemic lupus erythematosus (SLE), reflecting its promise to expand the clinical impact of dual-antigen CAR-T therapy into additional hematologic and immune-mediated diseases.

About VRise Therapeutics Inc.

Founded in 2021, VRise is an innovation-driven biotechnology company dedicated to developing transformative therapies in oncology, immunology, and hematology. Headquartered in India with a global outlook, VRise is advancing a diversified pipeline that spans small molecules, and next-generation cell and gene therapies to address some of the most urgent unmet medical needs worldwide.

Driven by modern technology and a strong commitment to novel modalities, VRise envisions pioneering a breakthrough dual CAR-T therapy, while also expanding into solid tumors. Its portfolio also includes VRTX126, a best-in-class candidate for non-small cell lung cancer (NSCLC), and VRTX531, a first-in-class candidate under development for breast and ovarian cancers. Guided by a vision to bring breakthrough treatments from discovery to patients, VRise combines cutting-edge global science with strong local execution to deliver therapies that aim not only to treat but to transform outcomes for patients across oncology and immune-related diseases.

About Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

Founded in 2018, Novatim is a biomedical technology enterprise focusing on the research and development and clinical application of innovative drugs for tumor immunotherapy. With unmet clinical needs as its core goal and differentiated R&D advantages, the company has laid out three core technology platforms: bifunctional antibody platform, nano bispecific antibody ADC platform, and enhanced dual-target CAR-T platform, and has independently developed more than 10 potential FIC/BIC pipelines.

Rishi Rahangdale
VRise Therapeutics Inc.
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