On April 18, 2023 DELFI Diagnostics, Inc., a pioneering developer of a new class of high-performance, accessible liquid biopsy tests for early cancer detection and monitoring, reported proof-of-concept data demonstrating how DELFI’s platform can be used for monitoring the treatment of patients with advanced cancer without requiring any prior genomic information about the patient’s tumor (Press release, Delfi Diagnostics, APR 18, 2023, View Source [SID1234630279]). The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Annual Meeting and builds on earlier studies showing the potential of using DELFI’s technology for treatment monitoring.

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The DELFI-Tumor Fraction (DELFI-TF) score tracked mutant-allele fraction scores (MAFs) in side-by-side assessments, and also identified cancer signals in patients with clinical disease burden who had false negative MAF assays. Today, MAF assays are a common clinical measure of tumor burden. Researchers demonstrated that the DELFI-TF score and MAF results were equally predictive of clinical outcomes, and that changes in DELFI-TF scores over time anticipated later changes in radiologic assessments of disease response.

"Legacy liquid biopsy approaches to cancer treatment monitoring rely either on prior knowledge about the genomic makeup of a patient’s tumor or deep sequencing looking for expected alterations. Each approach is high cost, and subject to various types of errors and failures," said Peter Bach, MD, DELFI’s Chief Medical Officer. "These proof of concept findings show that the whole-genome fragmentation analysis that underlies the DELFI-TF assay could be used to measure tumor burden, patient prognosis, and treatment response without the need for tumor tissue."

Researchers from DELFI and the Netherlands Cancer Institute, and the University Medical Center Utrecht looked at 174 patients undergoing therapy for metastatic colorectal cancer and collected a total of 692 blood samples at various time points before and after treatment. They found that the DELFI-TF score predicted survival outcomes in the overall study population, regardless of the patient’s BRAF or RAS status, two genes that are commonly mutated in CRC. Patients whose change in DELFI-TF was below the median over time showed both longer progression-free survival (HR = 2.03, 95% CI: 1.247-3.318) and overall survival (HR = 3.05, 95% CI: 1.58 – 5.90).

The study builds on prior work demonstrating the potential of the DELFI platform to monitor patients with metastatic cancer undergoing treatment with immunotherapy. In that study, presented at ESMO (Free ESMO Whitepaper) in 2022, researchers showed that the DELFI-TF score was as effective as imaging at tracking progression and progression-free survival. The work was awarded "Best Poster" in the Translational Research, Tumor Agnostic session.

"This is another example of the power of DELFI’s unique platform to provide high quality results using low-cost methods and a common wet-lab process that is used in all our applications and products in development," said Nicholos Dracopoli, PhD, DELFI Co-Founder and Chief Scientific Officer.

Also at AACR (Free AACR Whitepaper), DELFI and other researchers using the DELFI platform presented data describing the platform’s strong performance in a training set that will be used to develop DELFI’s first lung cancer screening product. Researchers also shared promising initial data on the DELFI platform’s ability to detect early stage ovarian cancer.

On April 18. 2023 NeoPhore Limited, a small molecule neoantigen immuno-oncology company, reported that it has signed a strategic collaboration agreement with Professor Chris Lord’s lab at The Institute of Cancer Research, London (Press release, NeoPhore, APR 18, 2023, View Source [SID1234630278]). The collaboration will use NeoPhore’s proprietary small molecule inhibitors of DNA mismatch repair (‘MMR’) to investigate single agent activity against tumours with defined genetic backgrounds.

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Building on the seminal discoveries and ongoing research of its scientific founders and collaborators, NeoPhore is developing a pipeline targeting novel proteins in the DNA mismatch repair pathway to treat cancer. The Company’s first-in-class MMR modulators induce neoantigen expression and increase immunogenicity in solid tumours that become exquisitely sensitive to immunotherapy.

Professor Chris Lord is Professor of Cancer Genomics and Deputy Head of the Division of Breast Cancer Research at The Institute of Cancer Research (ICR), as well as the Deputy Leader of the Breast Cancer Now Toby Robins Research Centre and the Cancer Research UK Gene Function Team at the ICR.

Professor Chris Lord, Lead Researcher on the project from the ICR, said: "We are excited about this new collaboration with NeoPhore. Identifying new ways of treating cancer is central to much of what we do here at the ICR and this project will focus on exactly that. Our hope is that by working with NeoPhore, we can find new vulnerabilities in cancer cells that can be targeted by drugs that NeoPhore has discovered."

Dr. Matthew Baker, Chief Executive Officer of NeoPhore, stated: "We are excited to collaborate with Prof. Chris Lord who is a prominent and respected researcher in the field. Access to his team’s scientific expertise will allow us to investigate new mechanisms of action of the MMR pathway in a variety of solid tumours. We believe that this impactful collaboration has the potential to broaden the use of MMR inhibitors beyond neoantigen generation. Ultimately the results of the collaboration have the potential to provide significant patient benefit in a variety of solid tumour indications."

This is the 4th collaboration agreement NeoPhore has signed since 2017, having entered collaborations with University of Turin, St George’s University of London and Memorial Sloan Kettering Cancer Center (MSKCC).

On April 18, 2023 Pyramid Biosciences, Inc., a privately-held, clinical-stage biotechnology company focused on developing transformative medicines for patients with cancer, and its partner GeneQuantum Healthcare (Suzhou) Co. Ltd, a privately-held biotechnology company based in China, reported data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 highlighting the preclinical efficacy and safety profile of GQ1010, a potential best-in-class antibody drug conjugate (ADC) targeting trophoblast cell surface antigen 2 (TROP2), across several in vitro and in vivo models (Press release, Pyramid Biosciences, APR 18, 2023, View Source [SID1234630277]).

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The poster presentation highlights several preclinical studies which showcase the differentiating attributes of GQ1010. Specifically, in a mouse syngeneic MC38 colon cancer model, the combination of GQ1010 plus anti-PD-1 therapy showed compelling synergistic tumor growth inhibition, which was superior to DS-1062 plus anti-PD-1. In this study, the GQ1010 combination reported 5 of 6 animals achieved a complete response, compared to zero of 6 animals with the DS-1062 combination.

In addition, GQ1010 showed more potent in vitro cytotoxicity and a superior bystander effect versus DS-1062, and increased in vivo tumor growth inhibition with GQ1010 monotherapy compared head-to-head with either DS-1062 or TRODELVY across multiple cancer models.

Safety findings with GQ1010 in a non-human primate (NHP) study indicated a differentiated profile and highest non-severe toxic dose (HNSTD) of greater than 30 mg/kg, which may translate to a wider therapeutic window in human studies relative to more advanced TROP2 ADCs in development. Plasma stability studies showed 98% retention of drug-to-antibody ratio (DAR) for GQ1010, attributable to its unique, irreversible cleavable linker chemistry.

"These preclinical findings are driven by GQ1010’s unique ADC design, which utilizes site-specific enzymatic conjugation technology and a novel linker-payload which confer potent cytotoxicity and better stability in the plasma," said Qin Gang, Ph.D., CEO of GeneQuantum Healthcare. "The preclinical differentiation seen with GQ1010 provides further validation of the capabilities of the GeneQuantum platform to produce best-in-class bioconjugates, as was also observed in a Phase 1a study of the HER2-directed ADC, GQ1001."

"TROP2 is a highly validated target in oncology, and TROP2-directed therapies are an important potential treatment option for a large number of cancers," remarked Brian Lestini, MD PhD, CEO of Pyramid Biosciences. "However, despite the TROP2 agents currently approved or in development, there remains significant unmet need for therapies that improve efficacy while reducing the potential for serious toxicities and optimizing therapeutic index and combinability. Preclinical data demonstrates the potential for GQ1010’s unique ADC chemistry to provide a superior, best-in-class clinical profile and improve patient outcomes. Based on this preclinical data, we are excited to be moving GQ1010 into clinical development."

The AACR (Free AACR Whitepaper) annual meeting poster presentation details are as follows:
Title: Preclinical characterization of GQ1010, a next generation Trop2 ADC with the best-in-class potential against diverse Trop2 positive solid tumors
First Author: Yajun Sun
Session: PO.ET02.06 – Antibody Drug Conjugates
Abstract #: 1549

About TROP2
TROP2 is a cell surface glycoprotein that is highly expressed in a variety of tumors including breast, lung, pancreatic, ovarian, and prostate cancer, and plays a role in tumor cell proliferation. Currently TRODELVY (Gilead) is the only approved TROP2 ADC, with indications in triple-negative breast cancer, hormone-receptor positive breast cancer, and urothelial cancer. Clinical data have also been previously reported for TROP2 ADCs in development by Daiichi-Sankyo and Merck & Co.

On April 18, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported it has entered into a binding term sheet with Deverra Therapeutics, Inc. ("Deverra Therapeutics") pursuant to which it has obtained an exclusive right, until August 31, 2023, to negotiate towards the acquisition or license of assets from Deverra Therapeutics related to its proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages (Press release, Deverra Therapeutics, APR 18, 2023, View Source [SID1234630276]). Deverra Therapeutics is currently advancing clinical programs investigating these technologies in relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with respiratory viral infections.

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The transaction, if finalized, would provide Coeptis with, among other assets, exclusive rights to two FDA approved Investigational New Drug (IND) applications and two Phase 1 clinical trials (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections. In addition, Coeptis would gain access to a highly scalable allogeneic cellular immunotherapy platform that is being developed to generate and deliver off-the-shelf (no HLA matching), cost effective, on demand cell therapies to a broad patient population. Deverra expects phase I clinical trial data from its AML study to be complete during 2H 2023.

Additionally, subject to the successful negotiation and completion of any proposed transaction, Deverra Therapeutics’ current Scientific Founder, Chief Scientific Officer and EVP, Research & Development, Colleen Delaney, MD, would be expected to assume the position of Chief Scientific and Medical Officer at Coeptis Therapeutics. Dr. Delaney is a world-renowned expert in cell and gene therapy research with more than 20 years’ experience in the translation of scientific discovery to clinical practice, including all aspects of cell therapy product development.

"This transaction would greatly expand Coeptis’ technology portfolio by incorporation of a cutting-edge allogeneic cell therapy platform with extensive safety and clinical data and align itself with leading experts in the field of cell and gene therapy," said Dave Mehalick, President and CEO of Coeptis Therapeutics. Mr. Mehalick continued, "The addition of these clinical and pre-clinical immune effector cell programs would significantly diversify our R&D capabilities and bring a clinical pipeline with multiple novel approaches to combination cellular immunotherapy approaches, not yet achieved by others. Importantly, the substantial capabilities of the allogeneic cell therapy platform would open new pathways for Coeptis to consider expanding its cell-based therapies beyond autologous CAR T. We are excited about the possibility of exploring the application of both the SNAP-CAR and GEAR technologies to allogeneic, off-the-shelf immune effector cells. The NK and macrophage (MAC) immune effector cell generation from Deverra’s platform combined with Coeptis’ target specific CARs has the potential to result in development of allogeneic NK and MAC cell therapies."

Dr. Delaney stated: "Deverra’s allogeneic cell therapy platform has been in use clinically since 2006, and we have generated significant clinical and safety data since that time. This platform has been shown to provide extreme flexibility and optionality in the generation and modification of multiple distinct immune effector cell types from a single platform. We are excited about the prospect of bringing together our established allogeneic cell platform with the novel targets and technologies from Coeptis to generate first-in-class allogeneic cell therapies to treat a wide range of life-threatening disorders in a cost effective and clinically accessible way."

The proposed transaction is subject to confirmatory due diligence, negotiation and execution of definitive documentation based on agreed terms and other closing conditions, including third party approvals, as well as a right of first refusal in place that a third party possesses and will have a right to exercise. There can be no assurance that the parties will reach a definitive agreement related to the proposed acquisition or license of assets or that, even if any such agreement is reached, any such transaction will be successfully consummated.

On April 18, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported that the Company will host the first in the series of virtual ‘Meet the Expert’ events titled Blocking TGFβ with CRB-601—a New Play for an Old Target, on April 25th at 11:00 AM ET (Press release, Corbus Pharmaceuticals, APR 18, 2023, View Source [SID1234630275]).

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The event will feature Jeffrey Clarke, MD (Duke University School of Medicine) and Joan Seoane, PhD (Vall d’Hebron Institute of Oncology). These distinguished researchers will discuss the challenges and potential opportunities in targeting Transforming Growth Factor β (TGFβ) in oncology. Dr. Clarke is a leading expert in the area of immuno-oncology in the setting of NSCLC, and Dr. Seoane has published extensively on the role of TGFβ in tumor immunosuppression and development of translational tools to guide treatment.

This event will focus on CRB-601, an anti-integrin αvβ8 monoclonal antibody that blocks the activation of latent-TGFβ expressed within the tumor microenvironment. This blockade is designed to reduce local TGFβ levels that are known to promote tumor growth. In non-clinical studies, CRB-601 significantly inhibits tumor growth both as a single agent and in combination with checkpoint inhibition. CRB-601 is scheduled for IND submission in the second half of 2023.

A live Q&A session will follow the formal presentations. To register for the event, please click here.