On October 2, 2024 ImmunoPrecise Antibodies Ltd. (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutic research and technology company, and Biotheus Inc. (Biotheus), a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, reported that the two parties have entered into a Material Transfer and Evaluation Agreement (MTEA) pertaining to a Talem therapeutic antibody asset for the development of a bispecific therapy against solid tumors (Press release, ImmunoPrecise Antibodies, OCT 2, 2024, View Source [SID1234646998]). Under this MTEA, Biotheus will obtain the rights to further evaluate the suitability of Talem’s Artificial Intelligence (AI)-enhanced TATX-20 lead candidate for the development of novel bispecific antibodies for the treatment of hypoxic solid tumors.

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Under this agreement, Biotheus will receive a specialized antibody asset from Talem Therapeutics, a subsidiary of ImmunoPrecise Antibodies. Biotheus plans to use this asset in conjunction with its own proprietary technology and binders to develop a new class of cancer-fighting drugs. These innovative therapeutics, known as bispecific antibodies, are designed to simultaneously target two different targets on tumors, specifically those found in oxygen-deprived environments. This approach could potentially lead to breakthrough therapies that address the complex challenges of treating cancer, particularly in difficult-to-target tumor environments. The ultimate goal is to identify the most promising molecule for advancement into clinical trials, potentially accelerating the development of novel cancer treatments.

"We are happy to enter into a collaboration with ImmunoPrecise Antibodies, a leading AI-driven biotech with powerful multi-omics modelling expertise." stated Xiaolin Liu, Co-founder, Chairman, and CEO of Biotheus. "Biotheus’ broad expertise in antibody discovery and development is powered by our fully integrated capabilities. By virtue of the AI-informed molecules spawned by ImmunoPrecise’s platform, we aim to develop novel bispecific antibodies with first-in-class potential and bring forth breakthrough therapies to cancer patients in the world."

Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies, stated: "We’re excited to transfer our AI-enhanced therapeutic antibody asset to Biotheus for bispecific molecule development. This strategic move leverages our cutting-edge technology in antibody discovery and Biotheus’ expertise in bispecific engineering. Our collaboration aims to accelerate the creation of innovative cancer treatments, potentially leading to groundbreaking clinical outcomes. This agreement not only demonstrates the value of our AI-enhanced assets but also sets the stage for a long-term, mutually beneficial partnership that could transform the landscape of cancer therapeutics. We anticipate this collaboration will drive significant value for both companies and, most importantly, for patients in need of advanced treatment options."

The transfer of this therapeutic asset to Biotheus aims to accelerate the development of targeted therapies that could potentially improve outcomes for patients with solid tumors. Following the transfer, Biotheus will evaluate the TATX-20 lead candidate. If the evaluation proves successful, Biotheus intends to further develop the bispecific molecules, with the objective of creating a clinically successful product that addresses the challenges associated with treating hypoxic solid tumors resistant to current therapies.

On October 2, 2024 Etcembly reported a groundbreaking new research study aiming to uncover new targets for cancer therapies by analysing the immune cells of cancer survivors (Press release, Etcembly, OCT 2, 2024, View Source [SID1234646997]).

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The ETCh study is recruiting people aged 18-65 who are living with or have survived cancer to join the study, as well as healthy volunteers. Participants will be asked to donate a small amount of blood up to five times over the course of one year, and provide information about their health.

Unlocking the secret to surviving cancer

The ETCh study is rooted in the well-established concept that long-term survivors have beaten cancer due to their immune system’s ability to recognise and eliminate cancerous cells. However, a systematic search for the specific targets recognised within tumours has yet to be undertaken.

In this study, blood samples will be collected from people who are living with or have survived cancer as well as healthy individuals. The research team will conduct an extensive analysis of the immune repertoire at an unprecedented scale by sequencing millions of antibodies and T cell receptors (TCRs) from each participant.

Etcembly’s advanced AI platform, EMLyTM, will then perform an in-depth analysis to identify which of these are likely to play a role in recognising and destroying cancer cells, and determine the aberrant molecules in tumours that they target.

These molecules could become new targets for next-generation immunotherapies that harness the power of a patient’s own immune system to combat cancer. The team expects to identify new targets within 12 to 18 months, which will then enter Etcembly’s pipeline for developing novel TCR-based therapies.

Harnessing the power of TCRs

This approach will allow Etcembly to delve deep into the immune response of cancer survivors and find vital clues to future cures.

Nick Pumphrey, Chief Scientific Officer at Etcembly says, "There is an urgent need to discover new cancer targets that traditional approaches have largely failed to deliver. By approaching the problem from the opposite direction, we can identify TCRs and targets from cancer survivors that have proven their ability to beat cancer, allowing us to develop therapies that are more likely to work for others."

On October 2, 2024 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported that the U.S. Food & Drug Administration (FDA) cleared an IND application for ALE.P02, an anti-CLDN1 ADC with a tubulin inhibitor payload (Press release, Alentis Therapeutics, OCT 2, 2024, View Source [SID1234646996]). A Phase 1/2 clinical trial in patients with CLDN1+ squamous tumors is expected to start during the first quarter of 2025.

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"ADCs have shown great potential in the treatment of cancer," Luigi Manenti, Chief Medical Officer of Alentis. "Squamous cancers originating in the head and neck, cervix, esophagus and lung are characterized by high CLDN1 expression, and ALE.P02 provides a first-in-class opportunity for these patients who need new therapies after first-line treatment fails."

"Anti-CLDN1 ADCs are exciting because they address the urgent need for novel targets in the ADC space," added Tony Mok, Professor of Clinical Oncology at the Chinese University of Hong Kong. "ALE.P02 is particularly promising for squamous cancers, including HNSCC and NSCLC, where CLDN1 is often overexpressed. The unmet medical need in these indications is significant, and I look forward to the results of the Phase 1/2 study."

Dr. Roberto Iacone, Chief Executive Officer of Alentis said, "ALE.P02, entering the clinic, marks a significant advancement in our oncology pipeline. We can maximize our development plan by leveraging insights from human clinical trials of lixudebart (ALE.F02), used as the backbone antibody for Alentis’ ADCs."

Dr. Iacone added, "For our second ADC program, ALE.P03, with its topoisomerase I inhibitor payload, we plan to initiate a first-in-human clinical trial in 2025."

About ALE.P02
ALE.P02 is a first-in-class ADC designed by linking a tubulin inhibitor, a potent cancer drug, to our antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This combination could be a powerful new tool to fight the many squamous cancers that overexpress CLDN1 with less toxicity than traditional cancer drugs.

On October 1, 2024 Excellos Inc., a cell therapy contract and development manufacturing organization (CDMO) member of Blood Centers of America (BCA), reported that it has been selected to manufacture Galapagos’ CAR-T cell therapy candidate, GLPG5101, for its recently FDA cleared ATALANTA-1 clinical study in patients with relapsed/refractory non-Hodgkin lymphoma in the U.S (Press release, Galapagos, OCT 1, 2024, View Source [SID1234646992]).

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Galapagos (Euronext & Nasdaq: GLPG) is a clinical stage biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life across the globe.

Excellos was selected upon completion of an extensive site audit and assessment process and will provide end-to-end manufacturing of Galapagos’ CAR-T cell therapy on Galapagos’ platform at Excellos’ new purpose-built manufacturing facility in downtown San Diego, CA.

Galapagos’ innovative, decentralized manufacturing platform could address many of the limitations that CAR-T cell therapy production is currently facing. It has the potential to offer greater speed and scalability, with the delivery of fresh, fit cells with a median vein-to-vein time of seven days and the possibility for greater physician control and improved patient experience.

"We are excited to manufacture Galapagos’ CAR-T cell therapy candidate using their decentralized manufacturing platform. This collaboration will enable the efficient production and delivery of fresh, fit CAR-T cell therapies within a median vein-to-vein time of seven days," said Thomas VanCott, CEO of Excellos. "Our team is proud to have demonstrated our agility in initiating technology transfer, our state-of-the-art facility, and our expertise in executing production and analytics, all of which are critical to advancing this groundbreaking therapy."

This project represents the first site initiation under the recently announced strategic collaboration between Galapagos’ U.S. entity GLPG US, Inc. and BCA. Under this agreement, BCA’s national network of blood centers will provide decentralized manufacturing services for Galapagos’ CAR-T cell therapy product candidates, close to cancer treatment centers across the U.S.

"Blood Centers of America is pleased to be actively engaged with Galapagos in site identification, assessment and initiation to build a nationwide decentralized cell therapy manufacturing network," stated Bill Block, President/CEO of BCA. "The Excellos project is enabled by the broader agreement between BCA and Galapagos which allowed Excellos to move efficiently from site assessment to the start of technology transfer. BCA will use the insights from this first initiation to accelerate the integration of multiple BCA sites into Galapagos’ decentralized manufacturing network, with the goal of providing patients convenient access to our local facilities and healthcare providers within their communities."

On October 1, 2024 CEL-SCI Corporation (NYSE American: CVM) reported its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine (Leukocyte Interleukin, Injection) in head and neck cancer (Press release, Cel-Sci, OCT 1, 2024, View Source [SID1234646991]).

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Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market.

This partnership marks a continuation of the successful cooperation between the two companies, building on their previous collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer.

In addition to the positive outcome from its recent meeting with the FDA regarding the path to approval for its first-line investigational cancer immunotherapy, CEL-SCI achieved other major milestones including receiving pediatric waivers from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

This confirmatory study represents a crucial step toward potential marketing approval of Multikine. The study, set to enrol 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on patients with no lymph node involvement and low PD-L1 tumour expression. Patients will be enrolled across multiple sites globally, underscoring the strength of Ergomed’s global clinical trial management capabilities.

Geert Kersten, CEO of CEL-CI commented, "Ergomed is a trusted partner. Our past experience taught us that they are highly competent and motivated. Their enrolment was fast and the study was clean. The plan is for the study to commence in Q1 2025 in multiple countries."

Dr. Sy Pretorius, CEO of Ergomed Group, added, "We are excited to once again partner with CEL-SCI on this significant trial for Multikine. Our prior collaboration has set a strong foundation for this new phase, and we are committed to leveraging our global expertise in oncology clinical research to support this critical confirmatory study. Together, we aim to advance innovative therapies that can make a real impact on patients’ lives."

Multikine has already demonstrated promising results in its prior studies, showing a significant improvement in survival rates. In the target population for the confirmatory study, patients treated with Multikine had a 5-year survival of 73% vs 45% survival in the control patients, with a hazard ratio of 0.35. The confirmatory study is designed to provide the final data required for regulatory approval, bringing Multikine one step closer to becoming a breakthrough treatment option for head and neck cancer patients worldwide.