Don’t miss ProBio and GlyTherix Live Webinar on 6^th December

Topic 1：Development of an exciting new radioimmunotherapy for cancer patients

Speaker: Dr Brad Walsh, Chief Executive Officer, GlyTherix Ltd
Date: Dec. 06^th, 2022
Time:16:00-17:30 (AEDT)
Speaker LinkedIn profile link

Brad founded GlyTherix to bring to market an innovative antibody for treatment of solid tumours from cancers. His career in biotechnology began with a PhD in protein chemistry, he has led research groups in government agencies, universities and hospitals and was a key part of the establishment of a national proteomics facility, APAF. He continues to be active in research collaborations and academic supervision and in 2015 was a joint recipient of one of Australia’s most prestigious science awards, a Eureka Prize, for Interdisciplinary Research. He has co-authored 105 peer reviewed papers and book chapters and seven patents.

Radioimmunotherapy (RIT) is an emerging approach for the diagnosis, therapy, and monitoring of solid tumors. Often using paired agents, each targeting the same tumor molecule, but labelled with an imaging or therapeutic isotope, radioimmunotherapy has achieved promising clinical results in relatively radio-resistant solid tumors such as prostate.

The clinical use and optimization of a radioimmunotherapy approach is, in part, influenced by the targeted tumor antigen, several of which have been proposed for different solid tumors.

Glypican-1 (GPC-1) is a heparan sulfate proteoglycan (HSPG) overexpressed in multiple cancers. Multiple studies indicate the prominence of this cancer biomarker with significant diagnostic and therapeutic potential.

Recent advances in monoclonal antibody (mAb)-based biopharmaceuticals targeting GPC-1 show promise toward managing GPC-1-positive solid tumors clinically. However, a key challenge in RIT is the manufacture of the antibody to obtain a high yield stable product that can be distributed to treatment centers. Using the patented anti-GPC-1 Miltuximab® as a case study for new cancer treatment, we have illustrated a pathway:

to achieve manufacture of the molecules suitable to treat large pools of patients
for preclinical to clinical translation

Topic 2：IND-enabling CMC Strategies for mAb and bsAb: Faster and Better

Speaker: Rubin Jiang, Director of Antibody Process Development & MSAT
Date: Dec. 06^th, 2022
Time:16:00-17:30 (AEDT)

Rubin Jiang, Director of Antibody Process Development & MSAT, received his Master's degree in Biotechnology from Northeastern University in 2014. In the same year, he worked at Sanofi-Genzyme as a process engineer for upstream process development of antibodies and recombinant proteins. From 2014 to 2020, he worked in the process development department of Merck Sharp & Dohme as a researcher and senior researcher, responsible for the upstream process development, process characterization and validation, as well as leading the upstream process development of Merck Sharp & Dohme's continuous production and process on-line analysis (PAT) upstream development. During this period, he participated in the publication of 7 academic articles. From mid-2020 to 2022, he worked in Hangzhou Yi'an Jishi as Deputy Director and Director, responsible for upstream process development department, in charge of CDMO upstream process development, and also promoted and enhanced fed-batch process and continuous perfusion process platform.

Therapeutic antibodies represent a rapidly expanding category of drugs offering new clinical applications. However, their development has been challenged by the difficulty to generate such intricate molecules. Here, ProBio will share a talk about IND-enabling CMC Strategies for mAb and bsAb.

Proprietary fast CMC platform guaranteeing the delivery of monoclonal antibody with high titer.
The fast CMC turnaround from DNA synthesis to tox batch has been shortened to 6 months.
Optimizing bispecific antibody CMC strategies, by combining cell line development, upstream cell culture process development, downstream purification process development and analytical method development, it is faster and better to produce bispecific antibodies in multiple formats.