Novocodex Biopharmaceuticals, a subsidiary of Zhejiang Medicine, and  Ambrx, a privately-held clinical stage biopharmaceutical company, have confirmed that the companies will jointly develop and commercialize Ambrx’s internally developed novel site-specific antibody-drug conjugates (ADCs) ARX305.

Under the terms of the agreement, representing a second project in which Ambrx and NovoCodex join forces, the companies will continue the development of ARX305, an ADC for the treatment of CD70 positive cancers.

ARX305 is a ‘best-in-class’ anti-CD70 ADC precision-engineered using Ambrx proprietary antibody and clinically validated drug payload. The drug is currently in preclinical development.

Strong in vitro and in vivo efficacy have been demonstrated in multiple tumor cells and models. The investigational drug is expected to deliver a direct killing to CD70-overexpressing tumor and improvement of the immune suppression in the tumor microenvironment.

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CD70 is highly expressed in multiple solid and liquid tumors such as Renal Cell Carcinoma, Multiple Myeloma, Non-Hodgkin’s Lymphoma, and AML.

Developing and Commercializing
As part of their collaboration, Novocodex will be responsible for developing and commercializing ARX305 in China while Ambrx will be responsible for developing and commercializing ARX305 outside of China.

Novocodex is also expected to fund global development activities to the end of Phase I clinical trials and pay Ambrx an undisclosed upfront payment, development milestones, and a double digit royalty on product sales in China. Novocodex is also eligible to share in undisclosed portion of ARX305 product sales outside of China.

“We are excited to initiate our second collaboration with NovoCodex following our successful collaboration with ARX788, which is currently in Phase I clinical trials for HER2 positive breast and gastric cancers,” noted Feng Tian, Ph.D., Chief Executive Officer of Ambrx.

Signing Ceremony between Ambrx an NovoCodex. Courtesy 2019 NovoCodex.
Signing Ceremony between Ambrx and Novocodex. Courtesy 2019 Novocodex.

“ARX305 is a natural extension to the first collaboration with the inclusion of another Ambrx enabled ADC that is intended to treat CD70 positive cancers such as Renal Cell Carcinoma and Multiple Myeloma,” Tian added.

“Further, we continue to align ourselves with China’s leading pharmaceutical companies. ARX305, which is expected to start Phase I clinical trials in early 2021, allows Ambrx to expand its ADC pipeline into multiple cancer types while gaining access to the Chinese market through our partnership with NovoCodex,” Tian concluded.

“The smooth progress of our first ZMC-Ambrx collaborated ADC project, ARX788, proves that Ambrx’ technology is one of the best methods to make an ADC drug. The new alliance with Ambrx on ARX305 will strengthen our leading position on ADC research, and hopefully will bring new treatment to related cancer patients,” said Chunbo Li, Chairman of Zhejiang Medicine, commenting on the new agreement.

Ongoing collaboration
The earlier collaboration between Novocodex Biopharmaceuticals and Ambrx focused on Ambrx’s anti-HER2 antibody-drug conjugate ARX788. The agreement, signed  June 2013, included joint clinical trials in Australia and the United States, and China.

Zhejiang Medicine’ subsidiary Novocodex is preparing for a Phase III clinical trial and contracted with China-based Contract Research Organization (CRO) WuXi Biologics to provide late-stage and commercial-scale manufacturing for ARX788. Manufacturing is expected to start in late October 2019 when WuXi Biologics’, the company’s manufacturing partner, will start commercial production at it’s new DP3 Current Good Manufacturing Practice (GMP)-approved antibody-drug conjugate (ADC) bulk and preparation facility.

In addition to their collaboration with Novocodex, Ambry is leveraging it’s proprietary technology platforms with joint projects with Bristol-Myers Squibb, Astellas, BeiGene and Elanco. As part of these projects, novel, investigational drugs will be developed using Ambrx’ technology in different stages of clinical trials.

Most elegant technology
Experts believe that Ambrx’ platform technology is a ‘most elegant’ way to build a site-specific antibody-drug conjugates through direct conjugation. The technology does not require complex work-arounds  (e.g. de-capping, re-oxidizing and ring opening for engineered cysteine, etc.), no ligation enzyme and its corresponding recognition sequence on antibody necessary and highly stable linker enables wild-type antibody-like in vivo pharmacokinetics (PK).

The interchangeable platform allows incorporation of other innovator technologies (e.g. payload, linker, etc.).

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