On March 21, 2023 Carina Biotech (Carina), a cell therapy immuno-oncology company, reported four poster presentations from preclinical studies of its LGR5-targeting CAR-T platform in colorectal cancer at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting that will take place in Orlando, Florida on April 14-19 (Press release, Carina Biotech, MAR 21, 2023, View Source [SID1234629094]).

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"We are looking forward to sharing preclinical data related to our LRG-5 targeted CAR-T platform in colorectal cancer at the upcoming 2023 AACR (Free AACR Whitepaper) meeting. The data expand upon the preclinical evidence supporting our LGR5 CAR-T cell candidate CNA3013 and the planned Phase 1/2a clinical trial in patients with advanced colorectal cancer patients. This follows the greenlight for our CNA3103 Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) in January 2023," stated Deborah Rathjen, PhD, Carina’s Chief Executive Officer.

Poster Presentation Details
Title: Development of a flow cytometry-based assay for measuring specific CAR expression on LGR5-targeting CAR-T cells
Lead Author: Timona Tyllis, Chemokine Biology Laboratory, Department of Molecular and Biomedical Science, The University of Adelaide, Adelaide, South Australia
Session Category: Clinical Research Excluding Trials
Session Title: Adoptive Cell Therapy 2
Session Date and Time: Monday Apr 17, 2023 from 1:30 PM ET – 5:00 PM ET
Location: Poster Section 37
Poster Board Number: 19
Published Abstract Number: 3199

Title: Development and in vitro validation of an LGR-5 targeting CAR-T against colorectal cancer
Lead Author: Veronika Bandara, Centre for Cancer Biology, an Alliance between University of South Australia and SA Pathology, Adelaide, South Australia
Session Category: Immunology
Session Title: CAR T-cell Therapy 2
Session Date and Time: Tuesday Apr 18, 2023 from 9:00 AM ET – 12:30 PM ET
Location: Poster Section 23
Poster Board Number: 4
Published Abstract Number: 4085

Title: In vivo efficacy of LGR5-targeting CAR-T cell therapies developed for the treatment of colorectal cancer
Lead Author: Dylan McPeake, Chemokine Biology Laboratory, Department of Molecular and Biomedical Science, The University of Adelaide, Adelaide, South Australia
Session Category: Immunology
Session Title: CAR T-cell Therapy 2
Session Date and Time: Tuesday Apr 18, 2023 from 9:00 AM ET – 12:30 PM ET
Location: Poster Section 23
Poster Board Number: 2
Published Abstract Number: 4083

Title: Assessing LGR5 expression levels on colorectal cancer tissue samples for use in a LGR5-targeting CAR-T cell therapy clinical trial
Lead Author: Emma J. Thompson, Centre for Cancer Biology, an Alliance between University of South Australia and SA Pathology, Adelaide, South Australia
Session Category: Clinical Research Excluding Trials
Session Title: Diagnostic and Prognostic Biomarkers 4
Session Date and Time: Tuesday Apr 18, 2023 from 1:30 PM ET – 5:00 PM ET
Location: Poster Section 40
Poster Board Number: 2
Published Abstract Number: 5545

On March 20, 2023 NRG and TerThera reported the companies signed an agreement for irradiation services in the High Flux Reactor in Petten, the Netherlands to produce Terbium-161 (Press release, TerThera, MAR 20, 2023, View Source [SID1234644370]). The non-carrier-added (NCA) Terbium-161 is produced by neutron irradiation of highly enriched Gadolinium-160 targets in the Dutch research reactor.

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Terbium-161 is a promising novel radionuclide for cancer treatment, that can meet the growing demand in cancer healthcare, exhibiting comparable (radio)chemical characteristics to known radiolanthanides. Early research suggests however that as much as 16-fold increase in Auger and conversion electrons are emitted by Terbium-161 resulting in improved anti-tumor capabilities for primary and (micro)metastasized cancers. The first case report, published in February 2023, observing the increased therapeutic value of disseminated metastatic disease using Terbium-161 PSMA for Radioligand Therapy (RLT) after a single cycle provided early confirmation of Terbium-161’s potential.

The first batches have been successfully irradiated, delivered to TerThera’s production location for processing into the final product, and distributed globally to support preclinical and clinical initiatives. Thanks to the irradiation agreement, the two companies will work together to ensure a reliable and uninterrupted supply of Terbium-161 in support of cancer healthcare around the world.

Vinod Ramnandanlal, Commercial Director at NRG, commented: "NRG is pleased to announce a supply agreement with TerThera, a Dutch company. The Netherlands is extremely strong in the world market for medical isotopes. The irradiation agreement for the production of Terbium-161 is also positive news for doctors and patients worldwide."

Philippe van Overeem, CEO of TerThera, commented: "This irradiation agreement assures reliable access to Terbium-161 on a global level. In times of scarce availability of therapeutic radionuclides, TerThera will bring its product to GMP quality before the end of 2023 to broaden the access for clients all around the world."

On March 20, 2023 Nex-I reported that it signed a business agreement (MOU) with Arontier for joint research and development of AI-based antibody new drugs (Press release, NEX-I, MAR 20, 2023, View Source;mode=VIEW&num=39&category=&findType=&findWord=&sort1=&sort2=&page=2 [SID1234643436]). The signing ceremony was attended by key officials of Nexi, including Nexi CEO Kyung-wan Yoon, Nexi Chief Operating Officer Jin-beop Son, Arontier CEO Ko Jun-soo, and Arontier Chief Strategy Officer Son In-seok.

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The goal of this MOU is to improve NexI’s antibody new drug development method using AD3, an AI-based innovative new drug development platform developed by Arontier, to discover more efficient and precise new drug candidates.

Junsu Ko, CEO of Arontier, said, "Arontier can handle target protein structure and candidate material exploration at the same time, and through this collaboration, data and preclinical data such as Arontier’s AI-based interpretation technology and Nexi’s immune anticancer drug refractoriness inducers are available. "We will be able to use our research experience to obtain competitive results," he said.

Kyung-wan Yoon, CEO of Nexi, said, "Through this collaboration, both companies will be able to create results in the development of new antibody drugs by converging their respective technological capabilities," and added, "We expect that more accurate and rapid development will be possible using AI technology."

Meanwhile, Nexi is a biotech that develops new antibody drugs targeting immunotherapy refractory inducers, and is expected to lead solid cancers such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and malignant melanoma in 2024. We plan to enter phase 1 clinical trials for the pipeline ‘NXI-101’.

On March 20, 2023 CHARM Therapeutics ("CHARM"), a 3D deep learning biotechnology company discovering and developing transformational medicines, reported a strategic discovery collaboration with Bristol Myers Squibb (NYSE: BMY) for the identification and optimisation of compounds against Bristol Myers Squibb selected targets (Press release, CHARM Therapeutics, MAR 20, 2023, View Source [SID1234629184]). CHARM will leverage DragonFold, its proprietary deep learning platform that identifies novel molecules through protein-ligand co-folding, to discover novel compounds.

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"CHARM is excited to collaborate with Bristol Myers Squibb for the discovery of new potential medicines utilising our proprietary DragonFold platform. The CHARM team is looking forward to a productive collaboration," said Laksh Aithani, co-founder and CEO of CHARM.

"We’re continually sourcing cutting-edge technologies that will help us accelerate our efforts to treat diseases where patients are suffering and new options are needed," said Michael Ellis, Senior Vice President, Small Molecule Drug Discovery, Bristol Myers Squibb. "We look forward to leveraging CHARM’s insights in 3D deep learning to help shape how we discover and advance critical medicines, underscoring our mission of transforming patients’ lives through science."

Under the terms of the agreement, CHARM is responsible for the early discovery of compounds against targets of interest to Bristol Myers Squibb, who has the option to license and develop compounds from the collaboration. In addition to an upfront payment and investment in CHARM, which provides significant additional operational runway, CHARM is eligible to receive additional payments should Bristol Myers Squibb exercise its option to any of the program compounds.

On March 20, 2023 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical stage cell therapy company and an Australian leader in cell therapy, reported that it has successfully completed a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) and has received positive feedback on the development plan for CHM 2101 (Press release, Chimeric Therapeutics, MAR 20, 2023, View Source [SID1234629156]).

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This is a significant milestone towards an Investigational New Drug (IND) Application and Phase 1 clinical trial for CHM 2101. The objective of the meeting was to facilitate FDA regulatory communication and guidance through the IND submission process for CHM 2101. The pre-IND meeting package included details and specific questions regarding the clinical development plan and technical operations, including drug product manufacturing and quality release plan for CHM 2101.

The company received positive written responses from the FDA that provide a clear path to an IND submission for CHM 2101 and validates the team’s efforts and accomplishments in preparing CHM 2101 for clinic.

"The positive feedback we received from the FDA was encouraging and aligns clearly with our development plan for CHM 2101," said Jennifer Chow, Chimeric’s Chief Executive Officer and Managing Director. "We are highly appreciative of the FDA’s support and guidance as this brings us closer to potentially transforming the lives of patients with gastrointestinal and neuroendocrine tumours."

CHM 2101 is a first in class, 3rd generation autologous CAR T cell therapy invented at the worldrenowned cell therapy centre, the University of Pennsylvania. Preclinical evidence for CHM For personal use only 2101 was published in March 2022 in Nature Cancer, with the data demonstrating strong evidence of efficacy with complete eradication of eight different types of gastrointestinal cancers with no relapse or toxicity. Chimeric is focused on advancing CHM 2101 towards a phase 1A clinical trial in gastrointestinal and neuroendocrine tumours.