January 2025

Scientist, physician, and entrepreneur Laurence Cooper joins the BioOra board

Scientist, physician, and entrepreneur Laurence Cooper joins the BioOra board

 03-09-2023

While doing practical training in paediatrics at the Fred Hutchinson Cancer Center (known as approved products using engineered T-cells, and no established manufacturing pathway to take the innovation into clinics.”

Dr Laurence Cooper

The director emeritus of the clinical research division at the Hutch, Don Thomas was awarded the Nobel Prize in Medicine for his development of bone marrow transplantation (BMT). 

Laurence says, “Don and his spouse and research partner Dottie taught us bone marrow transplants not only restore the generation of blood cells, but also the production of new immune cells, or T-cells. And these T-cells can exert a curative anti-tumour effect, particularly for blood cancers.” This was the foundation for directly infusing T cells as therapy.

An early adopter of CAR-T cell therapy

Laurence explains, “If someone has cancer, their immune system has lost the initial battle. To restore the ability of their T-cells to kill cancer, you have to provide those T-cells with new tools. That’s where genetic programming comes in.” 

Relocating to California to use bone marrow transplantation techniques to introduce genetically modified T-cells to cancer patients, Laurence learned chimeric antigen receptors (CARS) could be used to redirect T-cells. T-cells have native receptors that detect some targets, but CARS can redirect them to immediately recognise cancer as a threat. For example, one can stably express a CAR onto the cell surface of T-cells enabling them to recognise the target CD19 on B-cell malignancies. Indeed, Dr. Robert Weinkove and his team at Malaghan Institute in partnership with Callaghan Innovation are investigating how home-grown CD19-targeting CAR-

From biotech entrepreneur to biotech governance

On Laurence’s entrepreneurial journey he met Dr. Farzad Haerizadeh, Chief Scientific Officer of Bio4t2, a US based start-up developing CAR-T therapies to treat patients with solid tumours, that is part of Bridgewest Group’s investment portfolio. Bridgewest invited Laurence to join the Bio4t2 Board, which he now chairs. 

As Laurence became more immersed in commercialization of CAR-T therapy to treat cancers, he became interested in the production side. “Supply chain complexities make manufacturing these living drugs expensive. BioOra has a role to play in automating production to reduce costs.” 

“BioOra also has important CD19 CAR-T clinical data through their collaboration with the Malaghan Institute. The clinical data looks encouraging and the clinical need is there. At present, New Zealand patients with CD19 malignancies such as leukaemia and lymphomas often have to travel abroad to get their lifesaving CAR-T treatments.” 

“BioOra has an opportunity to partner with Malaghan Institute and the government to provide scalable, cost effective homegrown cancer therapies, giving Kiwis the opportunity to be cured locally.” 
Dr Laurence Cooper. 

Significance

Laurence believes New Zealand has a global role to play in advanced T-cell engineering. “The 

Bridgewest team is building a cluster of companies contributing to CAR-T therapies. Part of their group is embedded in New Zealand under the leadership of Saum Vahdat. Through Bridgewest’s international network they can bring the power of larger populations and resources to bear on solving problems for New Zealand, while enhancing and exporting New Zealand innovation to the world.” 

“When Covid-19 struck, New Zealand was initially left to find its way forward without the benefit of a significant resident immunology innovation engine to offer in-house translatable solutions. New Zealand is blessed with smart people, but not yet the infrastructure required to rapidly solve immunological emergencies. The government had no choice but to raise the drawbridge to save lives. But it came at a cost.” 

“I’m an outsider, and I’m parachuting into this conversation, but one learning from Covid-19 is New Zealanders can’t expect others to come to the rescue. This applies not only to infectious threats, but also advanced cancers. The country can help safeguard its future by funding biotech.” 
– Laurence Cooper 

My area of expertise, pediatric oncology. Worldwide, about 400,000 children are diagnosed with cancer each year. Chemotherapy, while it saves many lives, wreaks havoc on the child, on family finances, on emotions, and on people’s potential. Of the survivors, many kids who receive chemo will be part of the medical system for much of their lives because they are chronically injured by the treatment that saves them.” 

“Do we want to live in a world wedded to chemotherapy? Or do we want to build a future where you or your child receives cancer-killing T-cells in a single infusion and you are cured with minimal side effects?” 
– Laurence Cooper 

“As a paediatric cancer doctor I want to help fix that problem and that is the world I want for your and my grandchildren. The goal is to eliminate the need for chemotherapy. And New Zealand should benefit from realising this dream.” 

If you’ve got a novel idea, apply to the Bridgewest Ventures Deep Tech Incubator today! 

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Malaghan Institute and BioOra deliver automated manufacturing to scale up CAR T-cell cancer therapy in NZ

Malaghan Institute and BioOra deliver automated manufacturing to scale up CAR T-cell cancer therapy in NZ

MEDIA RELEASE | PĀNUI PĀPĀHO 16/08/2023

In a significant milestone for New Zealand’s first CAR T-cell clinical trial, partners at the Malaghan Institute and  BioOra have started the clinical production of CAR T-cells using a new automated process – a shift that is key  to scaling up this ground-breaking cancer therapy in New Zealand and “taking it to the people,” says  Malaghan Institute Director Professor Graham Le Gros. 

“This isn’t just a process change, this is a step change, it’s about democratising a cutting-edge cancer therapy  that New Zealanders deserve to have access to, and reducing inequities in cancer outcomes.”  

Malaghan Institute Clinical Director Dr Robert Weinkove says moving manufacture from a time-intensive manual process to an automated one will allow the team to manufacture CAR T-cells more consistently and at  scale. 

“This automation is critical to enable us to treat more patients – within our clinical trial programme at first and, we hope, as a future standard of care. This a huge milestone for our CAR T-cell programme, and  demonstrating that this can be done here will put New Zealand among leaders internationally in this field.” 

CAR (chimeric antigen receptor) T-cells are patients’ own immune cells that have been gene-engineered to  redirect them against their cancer. CAR T-cells have become a standard of care for certain blood cancers  overseas, but are not yet funded in New Zealand.  

Dr Weinkove says until recently, the  Malaghan Institute has manufactured patients’ CAR T-cells manually, a time intensive process requiring over 40 hours of skilled operator time inside a specialised clean room for each patient’s dose.  

“Working with BioOra, this process has now been largely automated with manufacture of patient CAR T-cells taking place in a closed system – Lonza’s Cocoon Cell Therapy Manufacturing Platform. Automating the manufacture provides significant advantages including increased throughput and lower costs, while maintaining quality.” 

The production of CAR T-cells is complex, involving multiple steps, so automation demanded careful  optimisation and validation, says Dr Weinkove. “Teams at the Malaghan Institute and BioOra worked closely  with New Zealand regulators to develop a world-leading process for manufacture of CAR T-cell products here  in Aotearoa.” 

In 2019, the Malaghan Institute began enrolling patients to ENABLE, a phase 1 safety trial of a novel ‘third  generation’ CAR T-cell construct for relapsed and refractory B-cell non-Hodgkin lymphoma, developed in  partnership with Wellington Zhaotai Therapies Ltd. More than 20 patients have been treated in the trial, with  the final patient in the ‘dose escalation cohort’ treated in January 2023. The phase 1 trial has been extended to add a ‘dose expansion cohort’, in which patients are receiving CAR T-cells manufactured using the new  automated process. The Malaghan Institute, BioOra and Wellington Zhaotai Therapies Ltd are planning a  larger phase 2 trial from 2024, to establish the effectiveness of these CAR T-cells. 

In 2021, the Malaghan Institute formed a new company with Bridgewest Ventures – BioOra – to automate the  manufacture of CAR T-cell therapy with a vision of delivering this new type of therapy locally, and at lower cost. The Malaghan Institute and BioOra will work together to complete the phase 1 trial using the automated  manufacturing process and during the planned phase 2 trial. 

BioOra CEO Andi Grant says affordability and accessibility of cell therapies is both a New Zealand and global  problem, largely caused by overseas companies adopting high cost, labour and capital intensive clinical and  manufacturing models.  

“BioOra and the Malaghan Institute are applying smart, digital, decentralised and automated clinical and  manufacturing approaches here in New Zealand, with the goal first and foremost to ensure affordable access  for New Zealanders,” she says.  

“Our strategic partners, Lonza, who have developed the Cocoon technology, tell us we are the first in the  Southern Hemisphere to treat patients using a GMP licensed manufacturing platform that has the Cocoon at  its base. That we are the first just affirms for us that, once again, that New Zealand is at the forefront of  innovation and BioOra will be successful in achieving our goal of applying these same approaches globally to  enable access to a breadth of CAR T products”. 

Digital assets 

A range of digital assets, including an infographic, photos and video footage of the Cocoon is available to  download via this Dropbox link. 

Media enquiries 

Gail Marshall | Head of Communications, Malaghan Institute of Medical Research 
gmarshall@malaghan.org.nz | +64 21 360 432 
malaghan.org.nz 
bioora.com

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Bio4t2 announces first patient infused with CAR-T targeting solid tumors

Bio4t2 announces first patient infused with CAR-T targeting solid tumors

SAN DIEGO, Jan. 10, 2023 /PRNewswire/

Bio4t2 dosed the first patient with T cells bearing a chimeric antigen receptor (CAR) that targets overexpression of BT-001 antigen present on various types of solid tumors. The CAR-T (B4t2-001) was developed from Bio4t2’s PrismCoreTM platform.

“This first-in-human study marks the initial therapeutic to be evaluated from Bio4t2’s technology,” said Dr. Laurence Cooper MD-PhD, Executive Chairman of the board. “PrismCore is capable of rapidly generating CAR-T to safely target self-antigens, opening a new frontier to delivering CAR-T to treat many types of solid tumors. This clinical trial is at the cutting edge of CAR-T biology and provides a path to treating the enormous numbers of patients who suffer from invasive cancers worldwide,” added Dr. Cooper. 

“This clinical trial is at the cutting edge of CAR-T biology and provides a path to treating invasive cancers.”

– Dr. Laurence Cooper

“We are excited to have started the clinical trial for our first CAR-T therapy targeting BT-001, which is a novel antigen for such therapies,” said Farzad Haerizadeh, PhD, Chief Scientific Officer, and co-founder. “Our CAR-T is calibrated through PrismCore to discriminate between levels of BT-001 on tumors versus healthy cells. Indeed, B4t2-001 in preclinical studies in rodents and non-human primates, safely exhibited potent antitumor activity with long-term protective capacity. This trial helps validate the platform enabling the development of safe and effective CAR-T therapies against multiple types of solid tumors,” said Haerizadeh. 

About the clinical trial The phase 1 investigator-initiated study (clinicaltrials.gov NCT05621486) evaluates ascending doses of B4t2-001 targeting BT-001 in patients with solid tumors. This trial assesses the safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy of autologous CAR-T as a single agent after lymphodepletion in adult subjects at Shanghai East and Shanghai Artemed hospitals in China. 

About Bio4t2 

Bio4t2 is a global clinical stage privately held biopharmaceutical company generating CAR-T that recognize self-antigens over-expressed on solid tumors using an exclusive technology. The proprietary PrismCoreTM platform combines algorithmic learning with supervised and iterative designs of CARs to rapidly generate genetically modified T cells with desired effector functions. 

With operations in China and USA, Bio4t2 can swiftly translate CAR-T into clinical trials to understand their therapeutic potential. Bio4t2 is a Bridgewest Group portfolio company. 

Media Contact: 
Jenny Bourbiel 
jbourbiel@bridgewestgroup.com 

General Contact: 
Farzad Haerizadeh 
info@bio4t2.com

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CellChorus Awarded $2.3 million SBIR Fast-Track Grant by the National Institute of General Medical Sciences

CellChorus Awarded $2.3 million SBIR Fast-Track Grant by the National Institute of General Medical Sciences

Published: Jun 20, 2023

Up to $2.3 million in funding from NIH will be used to scale the company’s TIMING platform for use in any laboratory or facility to improve development and delivery of novel therapies HOUSTON, Texas – June 21, 2023. CellChorus®, the dynamic single-cell analysis companyTM, announced that the National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health (NIH) has awarded CellChorus a Small Business Innovation Research (SBIR) Fast-Track grant to advance the development of its Time- lapse Imaging Microscopy In Nanowell GridsTM (TIMINGTM) platform for dynamic single-cell analysis. The two-year $1.9 million Phase II grant will begin after predetermined milestones are achieved under a $324,000 Phase I grant that is underway. 

Immune cell-based therapies are revolutionizing patient care by engineering or recruiting cells to fight disease. Understanding the therapeutic potential of these therapies is complex due to the variation in how cells interact and perform, as well as the need to monitor immune cell function over time. To advance the next generation of cell-based products, the field requires the ability to profile individual cell-cell interactions and performance at scale. 

The TIMING platform comprehensively studies cells to gain a comprehensive understanding of how immune cells move, interact, kill, survive, and secrete biomolecules at single-cell resolution. Data and insights from the TIMING platform enable the field to develop, manufacture and deliver novel therapies faster, at less expense, and with https://www.biospace.com/article/cellchorus-awarded-2-3-million-sbir-fast-track-grant-by-the-national-institute-of-general-medical-sciences/ 

CellChorus Awarded $2.3 million SBIR Fast-Track Grant by the National Institute of General Medical Sciences | BioSpace higher rates of success to benefit patients in oncology, infectious diseases, and a wide range of other diseases and disorders. 

“This funding will support development of a product offering that builds on the success of our early access laboratory,” said Laurence Cooper, MD, PhD, co-founder of CellChorus. “As the next frontier of cellular analysis, dynamic single-cell analysis will increase the impact that immunotherapies have in improving the lives of patients.” 

The CellChorus TIMING platform is available through a commercial service offering in the CellChorus Innovation Lab. Data from TIMING assays have been featured in more than 20 peer-reviewed papers across a range of cell types and therapeutic areas. Industry leaders have leveraged TIMING data in many different applications, including research, preclinical development, clinical development, manufacturing, and the identification of biomarkers predictive of patient response. In addition to providing data on cellular movement, morphology, interactions, killing, survival and subcellular activity over time, the TIMING platform can provide data on individual cell phenotype and biomolecule secretions. Individual cells of interest can be retrieved for linked downstream analysis such as transcriptional profiling. 

This grant is supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number R44GM149106. The content of this press release is solely the responsibility of the author and does not necessarily represent the official views of the NIH. 

About CellChorus 

CellChorusR is the leader in applying artificial intelligence to quantify the function and performance of cells over time to improve the development and delivery of novel therapies that improve patient care. The company applies Time-lapse Imaging Microscopy In Nanowell GridsTM (TIMINGTM) with neural network-based detection to identify 

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