Catalent to manufacture first-in-class mAb targeting solid tumours

11 Feb 2020

ZM008 could have potential benefits for the treatment of prostate cancer.

Catalent has signed an agreement with Zumutor Biologics to manufacture Zumutor’s lead candidate, ZM008, for the treatment of solid tumours.

Catalent to manufacture first-in-class mAb targeting solid tumours

ZM008 is a first-in-class monoclonal antibody (mAb) targeting tumour cell receptors that block natural killer (NK) cell inhibitory signals and enables NK cell activation to generate a potent immune response. NK cells are a type of cytotoxic lymphocyte (white blood cell) and are a critical component in the innate human immune system, which ZM008 can utilize to target solid tumour cells for diseases such as prostate cancer.

“We were able to fast track the development of ZM008 by leveraging INABLR, our proprietary antibody discovery platform,” stated Kavitha Iyer, Founder & CEO of Zumutor Biologics. “Robust preclinical data for ZM008 demonstrates tumour cell death, immune cell infiltration, and tumour growth inhibition. In vivo studies demonstrate anti-tumour efficacy as a monotherapy or in combination with immune checkpoint inhibitors. Development is on track for investigational new drug filing by the end of 2020, and we have placed our trust in Catalent to deliver on-time and with the highest quality in true partnership.”

Under the terms of the agreement, Catalent Biologics will provide process optimization and drug substance manufacturing services from its site in Madison, Wisconsin. The site is currently undergoing a significant expansion, with the build-out of two new suites, each with a 2 x 2,000-L single-use bioreactor system, providing additional clinical and commercial production. The expansion is scheduled to be completed by mid-2021 and will more than double Catalent Biologics’ commercial biomanufacturing capacity.

“Catalent values the long-standing partnership and technical relationship that we have developed with Zumutor over the years,” commented Mike Riley, Region President, Catalent Biologics, North America. “We are excited to work on this innovative lead candidate as the company prepares to take it into the clinic and beyond and look forward to working closely with Zumutor to support its clinical development and commercialization needs.”

Read More

Related news

Novartis receives EC Approval for next-gen anti-VEGF treatment for wet AMD

Novartis receives EC Approval for next-gen anti-VEGF treatment for wet AMD

21 Feb 2020

Beovu is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on 3-month dosing intervals immediately after the loading phase.

Read more 
BD completes clinical trial for its wearable injector

BD completes clinical trial for its wearable injector

11 Feb 2020

The pre-filled, pre-assembled injector is designed to prioritize safety, convenience and usability while delivering high-value drug treatments in the comfort of an in-home environment.

Read more 
New Velesco Pharma clinical manufacturing facility begins operations

New Velesco Pharma clinical manufacturing facility begins operations

5 Feb 2020

The facility will triple the company’s cGMP clinical trial manufacturing capacity.

Read more 
Inovio and Beijing Advaccine to advance vaccine against Coronavirus

Inovio and Beijing Advaccine to advance vaccine against Coronavirus

30 Jan 2020

Agreement will facilitate clinical trial translations in China.

Read more 
First human trial of monoclonal antibody to prevent malaria opens

First human trial of monoclonal antibody to prevent malaria opens

28 Jan 2020

If proven safe and effective, mAb CIS43LS might be used prophylactically by tourists, medical workers or military personnel who travel to areas where malaria is common.

Read more 
Thermo launches next-generation, compressor-free plate sealer

Thermo launches next-generation, compressor-free plate sealer

28 Jan 2020

Features new functionalities and capabilities making it versatile for a variety of both manual and automated microplate processing life science applications.

Read more 
Merck invests in biotech development facility in Switzerland

Merck invests in biotech development facility in Switzerland

27 Jan 2020

€250 million to be invested during the 2019-2022 period in new facility bridging research and manufacturing.

Read more 
Grey Wolf Therapeutics secures funding for cancer therapies development

Grey Wolf Therapeutics secures funding for cancer therapies development

21 Jan 2020

The company targets ERAP antigen presentation pathways with the aim of ‘illuminating’ non-responsive tumours for attack and destruction by the immune system.

Read more 
Diabetes diagnosis - now a matter of sweat and tears?

Diabetes diagnosis - now a matter of sweat and tears?

21 Jan 2020

No need to draw blood; researchers develop smart technology to diagnose diabetes and treat diabetic retinopathy.

Read more 
BioMarin gets go-ahead to start gene therapy clinical trials

BioMarin gets go-ahead to start gene therapy clinical trials

15 Jan 2020

BMN 307 represents a potential third PKU treatment option from BioMarin and its second gene therapy clinical program.

Read more