On September 12, 2023 CYTEA|BIO reported its collaboration with EFS Besançon (PIBT) and Bionoveo (Press release, CYTEA BIO, SEP 12, 2023, View Source [SID1234635092]). This partnership is aimed at propelling the development and manufacturing of our state-of-the-art cell therapy products. These groundbreaking therapies signify a novel category of medical progress, harnessing the potential of allogeneic natural killer (NK) cells sourced from human umbilical cord blood (UCB) armed with a chosen monoclonal antibody (mAb), expertly designed with a high-affinity Fc region.

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Alan Cookson, the CEO of CYTEA|BIO, remarked, "Through this collaboration, our commitment lies in advancing the realm of cell therapy and addressing a pressing, unmet medical necessity for patients grappling with glioblastoma. At the forefront of our inaugural clinical trial stands our flagship product, CYT-102, holding the promise of enhanced treatment outcomes and renewed hope."

This collaboration marks a milestone where expertise converges, aspirations align, and medical innovation takes center stage. Together, we are venturing into uncharted territories, guided by our dedication to scientific excellence and patient well-being. The synergy between CYTEA|BIO, EFS Besançon, and Bionoveo resonates with the potential to redefine medical standards and reinvigorate the lives of countless individuals.

As we embark on this remarkable journey, the path ahead may present challenges, yet it is illuminated by the prospect of reshaping the landscape of healthcare. Through relentless determination and collaborative spirit, we strive to make a lasting impact. The core of our endeavor remains rooted in compassion, guided by purpose, and driven by a commitment to improving lives. The future is promising, and we are poised to drive positive change.

On September 12, 2023 Exai Bio reported non-small cell lung cancer (NSCLC) data further validating that its novel RNA- and generative AI-based liquid biopsy platform detected early-stage disease with high accuracy (Press release, Exai Bio, SEP 12, 2023, View Source [SID1234635082]). The study of nearly 900 subjects demonstrated stage I sensitivity was 95% at 90% specificity. The use of Exai’s proprietary generative AI technology, derived from large independent datasets of tumor and blood samples, enhanced both sensitivity and specificity beyond what is achievable using standard machine learning techniques. The high detection of stage I tumors could have major clinical implications to enable earlier disease detection at initial diagnosis as well as molecular residual disease (MRD) monitoring.

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Today’s study also revealed the platform’s novel capability to subtype cancer biology using a routine blood draw. In a pilot sub-study including 100 NSCLC patients, cell-free RNA patterns were used to distinguish adenocarcinoma from squamous cell carcinoma. The accuracy of Exai’s prediction was equivalent to tissue subtyping, highlighting the potential to use a blood-based test in lieu of or in conjunction with surgical pathology. Beyond this initial technology demonstration, Exai’s platform enables further novel insights into cancer transcriptional activity for clinical monitoring as well as in accelerating drug development programs for the biopharmaceutical industry. These results will be presented today at the 2023 World Conference on Lung Cancer (WCLC).

Earlier lung cancer detection could lead to better treatment options and improved outcomes, however, finding small tumors and early-stage disease is still a major clinical challenge," stated Sandip Patel, Professor, Medical Oncology, University of California, San Diego. "Blood-based tests for the accurate and sensitive detection of lung cancer could significantly improve patient care, especially as new therapies are utilized in the neoadjuvant and adjuvant setting for treating non-small cell lung cancer."

"Over the past year, Exai has generated compelling evidence demonstrating that our innovative liquid biopsy platform can detect cancer at the earliest stages and shed insights into cancer biology," stated Pat Arensdorf, CEO of Exai Bio. "Based on strong results across multiple studies, we are actively developing a range of blood tests that aim to detect, define and monitor cancer at the earliest actionable stage for patients."

Exai’s platform uses the latest next generation sequencing techniques to generate a comprehensive profile of cell-free RNA and identify a novel category of cancer-associated, small non-coding RNAs, termed orphan non-coding RNAs (oncRNAs). OncRNAs are transcribed and actively secreted from cancer cells and are stable and abundant in the blood of cancer patients. Exai has created a catalog of hundreds of thousands of oncRNAs and tens of thousands of patient oncRNA profiles, spanning all major cancer subtypes. When combined with Exai’s proprietary artificial intelligence, this unique platform has several scientific and practical advantages over tests that focus on circulating tumor DNA (ctDNA) including sensitivity, specificity, and informative properties for active cancer biology.

Exai’s universal platform can be used across multiple cancer care settings such as screening and early detection, monitoring, molecular residual disease and therapy selection.

World Conference on Lung Cancer Presentation Details

Presentation Title: AI-Based Early Detection and Subtyping of Non-Small Cell Lung Cancer from Blood Samples Using Orphan Non-Coding RNAs

Session Title: Emerging Technologies in Lung Cancer Screening

Date: Monday, 9/11/23, 9:00 pm PDT

Authors: M. Karimzadeh, T. Cavazos, J. Wang, M. Multhaup, Y. Fang, J. Ku, J. Wang, X. Zhao, K. Wang, R. Hanna, O.I. Afolabi, A. Huang, D. Corti, K. Garcia, T. Joshi, D. Nguyen, Y. Kong, P. Arensdorf, K. Chau, A. Hartwig, H. Li, S. Patel, H. Goodarzi, L. Fish, F. Hormozdiari, B. Alipanahi

On September 12, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported an update on development of its PD1-Vaxx clinical drug candidate (Press release, Imugene, SEP 12, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/b84086de-66ea-1143-ed9d-b6751a178dfa/Imugene_PD1_Vaxx_Update.pdf [SID1234635074]).

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Imugene announces the grant of a new patent (number 2019-553504) by the Japanese Patent Office. The granted claims protect Imugene’s immunotherapeutic PD1-Vaxx, a first-in-class programmed death-1 (PD1) vaccine, currently in clinical development for non-small cell lung cancer (NSCLC).

The patent titled "HUMAN PD1 PEPTIDE VACCINES AND USES THEREOF" will expire on 28 March 2038 and protects the composition of matter and method of treatment in cancer of Imugene’s PD1-Vaxx for the generation of a therapeutic antibody response against the PD1 checkpoint target.

Imugene’s PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction and produce an anti-cancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.

Last week marked 1000 days cancer free for a patient with late-stage NSCLC who was recruited and dosed in December 2020. This week Professor Michael Boyer M.D., MBBS, FRACP, PhD, Chris O’Brien Lifehouse Hospital will present a trial-in-progress poster in person at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in Singapore. The poster presentation can be downloaded from Imugene’s website, View Source

Imugene MD & CEO Leslie Chong said: "Attaining the key Japanese patent, on top of gaining protection in the USA this year, is a very important milestone. Recruitment in the Phase 1 PD1-Vaxx trial, as monotherapy or in combination with atezolizumab in adults with NonSmall Cell Lung Cancer, has increased markedly recently with strong interest from new clinical sites to participate in this innovative study".

On September 11, 2023 Xspray Pharma announced a resolution to its patent litigation with Bristol Myers Squibb (BMS) concerning its product, Dasynoc (Press release, Xspray, SEP 11, 2023, View Source [SID1234650015]). The settlement clears all pending claims, paving the way for Xspray to introduce Dasynoc to the market on September 1, 2024, pending final FDA approval. The launch may occur earlier under certain circumstances. The contested patents and their associated regulatory exclusivities expire on September 28, 2026.

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The parties will proceed to file a dismissal with the United States District Court for the District of New Jersey, eliminating the need for any additional litigation on this matter.

"This settlement provides clarity on the launch date of our leading product, Dasynoc, benefiting the market. It also allows Xspray to shift its focus towards ensuring a successful product debut in 2024. Funds that were previously earmarked for litigation can now be redirected towards advancing Xspray’s future products" commented Per Andersson, CEO Xspray Pharma.

On Setember 11, 2023 Orano Med SAS, "Orano Med", a biotechnology company developing Lead-212 (212Pb) Targeted Alpha Therapy against cancer, and Orbit Discovery Ltd, "Orbit", a leader in the discovery of therapeutic peptide hits, reported that they have entered into a collaboration to discover specific Peptide Receptor Radionuclide Therapies against cancer cells and advance the development of novel radiopharmaceuticals (Press release, Orano Med, SEP 11, 2023, View Source [SID1234635088]). Under the terms of the agreement, Orbit will deploy its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumours.

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Radioligand therapies rely on a simple concept: combining the ability of biological molecules such as peptides to target cancer cells with the short-range cell-killing capabilities of radioisotopes. This approach results in an increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. It opens new perspectives for patients with difficult to treat cancers and the global market of targeted radiotherapies is expected to grow at a CAGR of 30% between 2023 and 2030.

The collaboration will harness the capabilities of Orbit’s peptide display engine to identify peptide candidates specific to tumour-associated targets. The proprietary technology enables the screening of large peptide collections through the combination of DNA encoded libraries and bead-based presentation. Orbit’s peptide display engine is uniquely equipped to address soluble targets and targets in situ, both on and in cells, allowing for significantly faster discovery times of relevant peptide leads based on affinity screens and/or functional screens. Orano Med will focus on subsequent development of the peptides for clinical use after conjugation with lead-212, one of the most promising alpha emitter isotopes for use in radioligand therapy.

Dr Neil Butt, Chief Executive Officer, Orbit Discovery, said: "We’re delighted to continue expanding our existing portfolio of partners by collaborating with Orano Med who have a strong track record of discovering novel radiopharmaceuticals." He continued: "We’re very proud of our proprietary screening platform at Orbit and acknowledge its role in empowering the next wave of peptide therapeutics."

Julien Dodet, Chief Executive Officer, Orano Med, commented: "Since the inception of Orano Med, we have recognised the value of collaboration." He added: "In our strategy to develop and deliver 212Pb Targeted Alpha Therapy for cancer patients, we’re delighted to work with Orbit Discovery and leverage its technology and expertise in peptide ligand discovery to build our pipeline of radiotherapies."

Orbit Discovery will be attending Boulder Peptide Foundation in California, 18th – 21st September.

For further information, please visit: www.orbitdiscovery.com and www.oranomed.com