Therapy Areas: Autoimmune
AbbVie, I-Mab Enter Into Global Strategic Partnership for Differentiated Immuno-oncology Therapy
8 September 2020 - - US-based pharmaceutical company AbbVie (NYSE: ABBV) and China-based I-Mab (NASDAQ: IMAB) have signed a broad, global collaboration agreement for the development and commercialisation of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers, the companies said.

In addition, the two partners have the potential to expand the collaboration to additional transformative therapies.

Lemzoparlimab is one of the leading drug candidates among I-Mab's proprietary and innovative pipeline.

It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development.

Topline results of the recent phase 1 clinical trial confirm possible differentiation of lemzoparlimab in drug safety and a more favorable pharmacokinetics profile in cancer patients.

Results have shown that lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without any priming dose.

In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year.

The collaboration established TODAY provides AbbVie with an exclusive global license, excluding greater China, to develop and commercialize lemzoparlimab.

Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and to commercialise lemzoparlimab in mainland China, Macau and Hong Kong.

The collaboration also allows for potential collaboration on future CD47-related therapeutic agents.

Each party will have the opportunity subject to further licenses to explore each other's related programs in their respective territories.

The companies will share manufacturing responsibilities with AbbVie being the primary manufacturer for global supply. The collaboration will accelerate I-Mab's establishment of commercial production operations in China.

Under the terms of the agreement, AbbVie will pay I-Mab USD 180m in an upfront payment to exclusively license lemzoparlimab, along with USD 20m in a milestone payment based on the Phase 1 results, for a total of USD 200m.

In addition, I-Mab will be eligible to receive up to USD 1.74bn in success-based milestone payments for lemzoparlimab, of which USD 840m are based on clinical development and regulatory approval milestones, with the remainder based on commercial milestones.

Upon commercialisation of lemzoparlimab, AbbVie will also pay tiered royalties from low-to-mid teen percentages on global net sales outside of greater China.

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages.

CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug.

However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells.

In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.

Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies.

Today, the results of phase 1 clinical trial provide further clinical validation of this differentiation in patients with cancer.

I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumor and with Rituxan for lymphoma in US, in addition to an on-going clinical trial in patients with AML in China.

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues TODAY and address the medical challenges of tomorrow.

We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, visit us at www.abbvie.com.

I-Mab (NASDAQ: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialisation of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases.

The company's mission is to bring transformational medicines to patients around the world through innovation.

I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R and D and global partnerships.

The company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R and D capabilities, world-class GMP manufacturing facility and commercial capability.

I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States.
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