On June 28, 2022 VeriSIM Life (VeriSIM) www.verisimlife.com, a leading artificial intelligence (AI)-enabled company providing services to de-risk R&D decision making for breakthrough drug development, reported that it has entered into a collaboration with Mayo Clinic to improve the preclinical translation of promising drug candidates (Press release, Mayo Clinic, JUN 28, 2022, View Source [SID1234616337]).

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Under the terms of the collaboration agreement, VeriSIM will leverage its proprietary BIOiSIM platform and Translational Index approach to reduce the number of outsourced preclinical experiments and help de-risk R&D decisions early-on to ensure expedited development of novel, safe and highly efficacious drugs.

VeriSIM will engage Mayo Clinic physician researchers in key disease areas including oncology, hematology, bone/joint-disorders, and neurological diseases.

"This collaboration will explore the full potential of our combined approach to developing best-in-class drug candidates to serve patients’ unmet needs," said Dr. Jo Varshney, founder and CEO of VeriSIM Life. "We are excited to expand our common mission and work with the world’s top research hospital and its drug discovery programs."

Dr. Jo Varshney, DVM and PhD, founded VeriSIM Life in 2017 alongside a cross-functional team of pharmaceutical scientists, software engineers and AI/ML and simulation experts. VeriSIM offers unprecedented value for the drug development industry by reducing the number of drug compounds likely to treat or cure specific illnesses and diseases.

Mayo Clinic participated in VeriSIM’s Series A financing and has financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

On June 28, 2022 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, and Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary technologies driving a new era of precision-based medicine, reported an agreement to co-develop, validate, and commercialize Acrivon’s OncoSignature test, a first-of-its-kind companion diagnostic (Press release, Akoya Biosciences, JUN 28, 2022, View Source [SID1234616318]). The test will be used to identify cancer patients most likely to respond to treatment with ACR-368, a targeted DNA damage response inhibitor therapy being developed by Acrivon. ACR-368 has been cleared by the FDA to be advanced in a Phase 2 master protocol trial to treat patients with ovarian, endometrial, and urothelial cancer based on predicted sensitivity to ACR-368.

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ACR-368 has been evaluated in over 1,000 patients and has demonstrated durable monotherapy activity, including complete responses, in a proportion of patients with platinum-resistant ovarian cancer. These patients currently have no effective treatment options, and the median survival time with this disease is less than one year. In addition to ovarian cancer, ACR-368 is being evaluated as a treatment for endometrial and urothelial cancers — two other high unmet need solid tumor types predicted by OncoSignature to be highly sensitive to the drug. The OncoSignature test, developed by Acrivon, will be run on Akoya’s PhenoImager solution during clinical development and, pending ACR-368 approval and commercialization, will enable physicians to identify and treat the patients most likely to respond to the therapy.

Akoya, in partnership with Acrivon, will develop, clinically validate, and seek regulatory co-approval for the OncoSignature test, and, pending ACR-368 approval, commercialize the test as the exclusive provider of the companion diagnostic required for prescribing ACR-368. The test will leverage the spatial phenotyping capabilities of the PhenoImager solution to localize and quantify the expression of a signature of clinically relevant protein biomarkers within the tumor.

"The ability to select patients for ACR-368 is a foundational part of our efficient clinical development strategy and is a critical part of our mission to bring our targeted therapies to the patients most likely to benefit from treatment," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and president of Acrivon. "We believe that Akoya is an ideal partner to develop and commercialize this next-generation companion diagnostic with their technically advanced, quantitative PhenoImager solution. We look forward to working with Akoya towards bringing this companion diagnostic to patients and clinicians around the world."

In the initial phase of this co-development agreement, studies were conducted in collaboration with Acrivon at Akoya’s CLIA-certified Advanced Biopharma Solutions (ABS) lab to complete the analytical validation of the clinical trial assay version of the OncoSignature test on the PhenoImager platform. ABS is a premium high-value partner for biopharmaceutical companies enabling the use of Akoya’s platform in clinical trials. In the next phase of the agreement, the companion diagnostic for ACR-368 will be developed and clinically validated.

"We are honored to partner with Acrivon in the advancement of their promising therapy ACR-368, which has the potential to substantially impact the well-being of these patients," said Brian McKelligon, chief executive officer of Akoya. "We believe that the next generation of personalized medicines will go beyond the genetic markers currently being used today. Our spatial phenotyping technology and complete workflow solution with the PhenoImager platform can enable the sophisticated analyses necessary to achieve diagnostic capabilities required for patient selection, and we are excited to have Acrivon’s leading-edge OncoSignature test run on our solution."

About Acrivon’s Precision Predictive Proteomics (AP3) and OncoSignature Tests
Acrivon Predictive Precision Proteomics, AP3, is a proprietary, streamlined approach to develop patient selection tumor biopsy tests, called OncoSignature tests. The technology is engineered to be agnostic to underlying genetic alterations and designed to enable identification and treatment of the patients whose tumors are regulated by and sensitive to the drug based on direct protein measurement of the critical tumor-driving mechanisms. The AP3 approach leverages unbiased differential global phosphoproteomic drug profiling using mass spectrometry, biased tumor model analyses, and quantitative multispectral in situ imaging of patient derived xenograft (PDX) in vivo models and intended-use tumor samples and clinical trial biopsies, to identify and evaluate biomarkers. The output of AP3 is clinically actionable, drug-tailored, proprietary OncoSignature tests. These are automated, quantitative protein multiplex imaging tests applied to pretreatment tumor biopsies as a companion diagnostic (CDx) to select and treat the patients predicted to benefit from the drug candidate. The AP3 method is broadly applicable across drugs and drug candidates and is a transformative, efficient method to accurately match the right therapy to the right patient.

On June 28, 2022 Endevica Bio, a company developing first-in-class peptide drug candidates with better safety and efficacy properties, reported the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for its lead investigational product, TCMCB07, allowing the company to proceed with initiating clinical studies (Press release, Endevica Bio, JUN 28, 2022, View Source [SID1234616338]). TCMCB07 is an investigational melanocortin‐4 antagonist peptide designed to treat cachexia in people that have cancer and other chronic diseases. Endevica Bio plans to initiate Phase 2 clinical studies in pancreatic cancer in 2Q 2023.

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"The acceptance of the IND means that Endevica begins its next chapter on our quest to improve the lives of people who are suffering from the effects of cachexia. We have been so encouraged by the pre-clinical data on TCMCB07 that have been generated to date and are looking forward to the next phase of its development," said Russ Potterfield, CEO and Executive Chairman of Endevica.

"People with cachexia are suffering as their bodies can’t adequately process the nutrients they need to survive. The current standard of care, appetite stimulants and corticosteroids, are not adequate in effectively mitigating this condition," said Daniel Marks M.D., Ph.D., Chief Medical Officer of Endevica. "TCMCB07 has a lot of promise in its ability to modulate the body’s behavioral and metabolic response to chronic illness, and we are hopeful that it will be proven to be a safe and effective treatment option."

"We designed TCMCB07 to be a first-in-class peptide drug. We are confident that its ability to cross the blood-brain barrier and act on previously inaccessible target receptors will be profoundly beneficial for patient outcomes. This is just the first product in our pipeline of next-generation peptide therapeutics," said Kenneth Gruber Ph.D., Chief Scientific Officer and Founder of Endevica.

With the IND in place, Endevica will be finalizing its Phase 2a protocol for a multi-national trial, which is expected to generate robust data about this potentially life-saving compound.

On June 28, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported that the Company has entered into a collaboration agreement with GenFleet Therapeutics, an immuno-oncology focused biopharmaceutical company based in China, to advance Motixafortide through a randomized Phase 2b clinical trial in pancreatic ductal adenocarcinoma, or PDAC (Press release, BioLineRx, JUN 28, 2022, View Source [SID1234616319]).

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Under the terms of the agreement, GenFleet will fully fund, design and execute a randomized Phase 2b clinical trial that will enroll approximately 200 first-line metastatic PDAC patients in China. This randomized controlled study will aim to evaluate the superiority of Motixafortide in combination with an anti-PD-1 and chemotherapy compared to chemotherapy alone, the current standard of care. As part of the collaboration, BioLineRx will supply Motixafortide, while GenFleet will supply the other study drugs for the trial. Trial oversight will be administered by a Joint Development Committee. GenFleet will be eligible to receive low-to-mid-single digit tiered percentage royalties on future Motixafortide sales, if approved.

"This collaboration is based on the highly encouraging results from our Phase 2a COMBAT/KEYNOTE-202 study of Motixafortide in combination with an anti-PD-1 and chemotherapy, which provide strong support for continued development in this very challenging disease," stated Philip Serlin, Chief Executive Officer of BioLineRx. "With its broad solid tumor oncology pipeline and highly experienced development team, we believe we have found an outstanding partner in GenFleet to execute a rigorously designed randomized Phase 2b trial."

"At the same time, we remain on track to submit our New Drug Application (NDA) for Motixafortide in stem cell mobilization in the U.S. in the next few months, and we are continuing our pre-launch activities in anticipation of potential FDA approval in 2023."

"Together, these programs demonstrate the potential versatility of Motixafortide and its promise of new combination therapies targeting both hematological and solid tumor cancers," Mr. Serlin concluded.

"The results of the COMBAT/KEYNOTE-202 Phase 2a study demonstrate the benefit of combining the CXCR4 inhibitor Motixafortide with an anti-PD-1 and chemotherapy in a second-line setting," said Qiang Lu, Chairman of GenFleet. "We believe that this combination could be beneficial to patients in a first-line setting as well, and we hope to confirm this in a randomized trial. We are thrilled to be partners with BioLineRx in the development of this late-stage clinical asset, and look forward to initiating this important trial as quickly as possible."

In parallel, BioLineRx is continuing its collaboration with Colombia University in an on-going Phase 2 investigator-initiated study (NCT04543071) to evaluate Motixafortide in combination with the anti-PD-1 LIBTAYO (cemiplimab) and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in first-line PDAC patients.

MSQ Ventures served as advisor to BioLineRx on this transaction.

About Pancreatic Cancer

Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. Its incidence rate in the US is estimated at 3.2% of new cancer cases. In 2022, approximately 495,000 individuals globally are expected to be diagnosed with this condition, 62,000 of them in the US; and the incidence of pancreatic cancer is expected to continue to increase. Symptoms are usually non-specific and as a result, pancreatic cancer is often not diagnosed until it reaches an advanced stage. Surgical resection does not offer adequate treatment since only 20% of patients have resectable tumors at the time of diagnosis. Even among patients who undergo resection for pancreatic cancer and have tumor-free margins, the five-year survival rate is only 10-25%. The overall five-year survival rate among pancreatic cancer patients is 8%, which constitutes the highest mortality rate among solid tumor malignancies. The overall median survival is less than one year from diagnosis, highlighting the need for the development of new therapeutic options.

Despite advances in chemotherapeutics and immunotherapy, increases in median and overall survival rates in pancreatic cancer have been modest. Pancreatic cancer remains an area of unmet medical need, with very limited new approved therapies for the majority of PDAC patients since the approval of nab-paclitaxel (Abraxane) in combination with gemcitabine for first-line treatment in 2013 and Onivyde in combination with fluorouracil and leucovorin for second-line treatment in 2015. The limited clinical benefits demonstrated by these existing standard treatment options reinforce the need for additional approaches.

About COMBAT/KEYNOTE-202

In December 2020, BioLineRx announced final positive results from its Phase 2a COMBAT/KEYNOTE-202 triple combination study of Motixafortide in second line PDAC. The highly encouraging results demonstrated improvement across all study endpoints, including overall survival, progression free survival and overall response rate, in the most challenging PDAC patients, as compared to historical data. All patients were diagnosed at Stage IV, and greater than 70% had liver metastases, a key determinant of poor prognoses in this patient population.

On June 28, 2022 Siemens Healthineers and The Ohio State University Wexner Medical Center reported a new alliance, aimed at advancing personalized medicine and improving access to high quality, cost-effective healthcare (Press release, Siemens Healthineers, JUN 28, 2022, View Source [SID1234616339]). Through the five-year strategic partnership, Siemens Healthineers and Varian, a Siemens Healthineers company, will provide comprehensive technology and services that will build on previous successful collaborative projects. The university and medical center will contribute research initiatives from scientists, physicians and patients. This work forms a living lab, a place where early scientific validation will speed breakthroughs in individualized medicine and health care delivery.

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The initiative includes an outpatient expansion of The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). Outpatient Care West Campus, scheduled to open in 2023, will feature cutting-edge imaging and treatment technology made by Siemens Healthineers, including Varian, which has worked with the OSUCCC – James for nearly a decade. The advanced precision cancer care in this new outpatient center includes proton therapy (ProBeam 360°) and radiosurgery (Edge radiosurgery system) as well as oncology focused interventional radiology (Artis Q Ceiling). West Campus will build on this technology, including the current treatment planning capabilities (Eclipse), to offer the most advanced diagnostic and treatment planning tools, including Digital PET (Biograph Vision 600) and Dual Source Dual Energy CT (Somatom Drive and Somatom Force). Siemens Healthineers will also bring new technology to Ohio State’s new inpatient hospital, scheduled to open in 2026, and three other outpatient facilities in New Albany, Dublin, and Powell.

This technology investment is another bold step forward in realizing Ohio State‘s vision of a cancer-free world. Working with Siemens Healthineers, including Varian, Ohio State leads the only university-based International Training Center of Radiation Oncology and Cancer Consortium with a training-dedicated linear accelerator and planning environment. The consortium uses big data approaches to advance education, research and patient care at 37 institutions around the world.

"With Varian, Siemens Healthineers is ideally positioned to pioneer the next-generation of cancer technology that addresses the growing need for personalized cancer care, and we view this partnership with OSUWMC as an important opportunity to advance this goal. The James Cancer Hospital is the third largest cancer hospital in the country and we’re proud to build on our longstanding relationship and assist them with innovative technology that will provide data and images to help customize treatment based on patient needs," said David Pacitti, President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers.

Researchers at OSUCCC – James and Siemens Healthineers intend to explore opportunities in intelligent radiation dosimetric contouring algorithms that are uniquely tailored to the individual patient. One potential objective is to create a platform that combines clinical, imaging, pathology and genomic data with artificial intelligence to drive pathways of care in nearly real time, allowing providers and patients to make even more well-informed, evidence-based decisions together.

"This work not only supports a key step in our mission to improve the lives of our patients, but together we will research ways technology can accelerate breakthrough health discoveries and the care delivery process for all patients in the future," said Peter Mohler, vice president for research at The Ohio State University and chief scientific officer at its Wexner Medical Center.

One of the initial collaborative projects targeting patient access is the co-development of advanced cardiac imaging methods for the Siemens Healthineers Magnetom Free.Max. The new 80cm bore system offers access to larger and/or claustrophobic patients that previously may not have been able to be scanned. Developing new advanced MRI sequences will expand the system’s capabilities to help even more patients.

The two organizations will also work to advance vascular robotics beginning this summer using the Corindus CorPath GRX system, with goals of enhancing precision, efficiency, and patient access to highly specialized endovascular procedures.

"We are energized by this partnership and its potential to bring our organizations together across multiple enterprise-wide projects that will drive meaningful, life-changing advancements in health care discovery, delivery, and access for all," said Jennifer Dauer, chief strategy and transformation officer at Wexner Medical Center.