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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.”

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

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. 

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. 

Up to $2.5 million in funding from the National Center for Advancing Translational Sciences at the NIH will be used to develop an integrated computer vision system for label-free analysis and focus restoration 

PRESS RELEASE 

HOUSTON, Texas October 7, 2024. CellChorus®, the dynamic single-cell analysis companyTM, and the University of Houston today announced that the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) has awarded CellChorus and the University of Houston a Small Business Technology Transfer (STTR) Fast-Track grant to advance the development of the Time-lapse Imaging Microscopy In Nanowell GridsTM (TIMINGTMM) platform for dynamic single-cell analysis with label-free analysis. A two-year $2.1 million Phase II grant will begin after predetermined milestones are achieved under a $350,000 Phase I grant that is underway. 

TIMING assays are powerful and versatile high-throughput in vitro assays that quantitatively profile cell–cell interactions on a large scale, especially the interactions of immune cells with target cells. The platform has demonstrated value in applications including designing novel therapies, selecting lead candidates for clinical trials, predicting response, and evaluating potency and viability of manufactured cells in immuno-oncology. 

“By combining Al, microscale manufacturing, and advanced microscopy, the TIMING platform yields deep insight into cellular behaviors that directly impact human disease and new classes of therapeutics,” said Rebecca Berdeaux, Ph.D., Chief Scientific Officer at CellChorus. “The generous support of NCATS enables our development of computational tools that will ultimately integrate single-cell dynamic functional analysis of cell behavior with intracellular signaling events.” This STTR award will support the development of a scalable integrated software system capable of dynamic single-cell analysis on cells that are not fluorescently labeled. To increase the breadth of applications for translational medicine and other applications, there is a compelling need to make fluorescence channels available to integrate additional investigational probes concurrently. This label- free analysis will be based on new artificial intelligence (AI) and machine learning (ML) models trained on tens of millions of images of cells and be optimized for fast, high-throughput single cell analysis by any customer without computational science backgrounds. 

SAN DIEGO and SHANGHAI, Oct. 17, 2023 /PRNewswire/ — Bio4t2 received regulatory approvals to repeatedly administer patients with T cells engineered to express a chimeric antigen receptor (CAR) targeting BT-001, an antigen on solid tumors identified using the ™ PrismCore platform. The CAR-T, termed B4t2-001, are predicted to engraft without ™ preparative chemotherapy (lymphodepletion) based on the Bio-Engine technology enabling multiple infusions for each recipient to further improve the therapeutic effect. 

The PrismCore platform generates CAR-T that recognizes overexpressed self-antigens on solid tumors. Bio-Engine adapts the CAR-T to transiently recognize a subset of circulating blood cells to boost the numbers of infused genetically modified T cells without the need for preparative chemotherapy. Bio4t2 harnesses these technologies to unlock the commercial potential of CAR-T in patients with invasive cancers. 

Clinical trial repeatedly infuses CAR-T without lymphodepletion to treat solid tumors. 

A prior pilot investigator-initiated trial (clinicaltrials.gov NCT05621486) demonstrated that B4t2-001 can engraft to the range of 40 to 50% of circulating lymphocytes, even when lymphodepletion was omitted, and resulted in anti-tumor effects. 

“This new phase 1 trial builds off our pilot clinical study which concluded a few weeks ago,” said Dr. Laurence Cooper MD-PhD, Bio4t2, global clinical stage biopharmaceutical company combines PrismCore and Bio-Engine technologies to advance cutting-edge CAR-T therapy in phase 1 clinical trial. Executive Chairman of the board. “Treating solid tumors depends on identifying targets that are uniformly expressed across cancer cells and engrafting CAR-T without immunological exhaustion. We combine our PrismCore and Bio-Engine technologies to achieve both goals and advance our cutting-edge CAR-T for the many patients with solid tumors,” added Dr. Cooper. 

“PrismCore identifies targets on invasive cancers and Bio-Engine harnesses normal blood cells to create a niche for CAR-T engraftment without the use of preparative chemotherapy,” said Farzad Haerizadeh, PhD, Chief Scientific Officer, and co-founder. “Based on the success of our pilot clinical study, Bio4t2’s CAR-T is predicted to attack the tumor again and again without the cost, complexity, and toxicities, associated with lymphodepletion,” said Haerizadeh. 

About the clinical trial 

The phase 1 investigator-initiated study (clinicals.gov NCT06072989) evaluates intra-patient repeat administration and inter-patient ascending doses of B4t2-001 targeting BT-001 without lymphodepletion in adult patients with solid tumors at Shanghai East and Shanghai Artemed hospitals in the People’s Republic of China. Furthermore, this trial assesses the safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy of autologous CAR-T.

About Bio4t2®

Bio4t2 is a global clinical stage privately held biopharmaceutical company generating CAR T that recognizes solid tumors using exclusive technologies. The proprietary PrismCore platform combines algorithmic learning with supervised and iterative designs of CARs to rapidly generate genetically modified T cells that recognize overexpressed self-antigens. The unique Bio-Engine technology enhances engraftment without preparative chemotherapy (lymphodepletion) facilitating repeat dosing of CAR-T. With operations in People’s Republic of China and USA, Bio4t2 swiftly translates 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

More than $274,000 in funding from NSF will be used to develop microscale arrays to improve development and delivery of novel therapies.

CellChorus®, the dynamic single-cell analysis companyTM, has been awarded a U.S. National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant to advance development of its Time- lapse Imaging Microscopy In Nanowell GridsTM (TIMINGTM) platform for dynamic single-cell analysis. The Phase I grant will be used to develop novel microscale arrays to support scaling dynamic single-cell analysis across the life sciences industry. 

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. 

“This funding will further development of novel arrays to build on the success of our early access laboratory based in Houston,” said Mohsen Fathi, PhD, Head of Technology at CellChorus. “This project will support scaling the only platform that can evaluate migration, contact dynamics, killing, survival, subcellular activity, and biomolecule secretion for the same individual cell over time and in high throughput to improve development and delivery of novel therapies.” 

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 higher rates of success to benefit patients in oncology, infectious diseases, and a wide range of other diseases and disorders. 

“This award builds on our recent funding from the National Institute of General Medical Sciences to advance development of a dedicated instrument platform for TIMING,” said Daniel Meyer, Chief Executive Officer of CellChorus. 

All proposals submitted to the NSF SBIR/STTR program, also known as America’s Seed Fund powered by NSF, undergo a rigorous merit-based review process. 

Once a small business is awarded a Phase I grant, it becomes eligible to apply for Phase II funding and additional supplements totaling up to $2 million. 

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. Experts in the field 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 Science Foundation under Award Number The content of this press release is solely the responsibility of the author and does not necessarily represent the official views of NSF.

About CellChorus 

CellChorus® 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 how cells move, activate, kill, and survive at single-cell resolution. The patent-protected platform can link TIMING data and insights with information from other analysis modalities such as single-cell RNA sequencing to provide a comprehensive understanding of cellular function, state and phenotype. Please visit cellchorus.com for more information. 

About the U.S. National Science Foundation’s Small Business Programs America’s Seed Fund powered by NSF awards more than $200 million annually to startups and small businesses, transforming scientific discovery into products and services with commercial and societal impact. Startups working across almost all areas of science and technology can receive up to $2 million to support research and development, helping de-risk technology for commercial success. America’s Seed Fund is congressionally mandated through the Small Business Innovation Research program. The NSF is an independent federal agency with a budget of about $9.5 billion that supports fundamental research and education across all fields of science and engineering. 

Source: CellChorus Inc. 

Company Contact: 
Daniel Meyer 

CellChorus Inc. 
TIMING@cellchorus.com

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.”

“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