On March 1, 2021 Akoya Biosciences, Inc., The Spatial Biology Company, reported a collaboration with the Bloomberg-Kimmel Institute for Cancer Immunotherapy (BKI) and the Bloomberg Center for Physics and Astronomy at the Johns Hopkins University School of Medicine (Press release, Akoya Biosciences, MAR 2, 2021, View Source [SID1234575965]). The agreement brings together Akoya’s Phenoptics multiplex immunofluorescence (mIF) platform for spatial phenotyping and Johns Hopkins’ AstroPath platform, an interdisciplinary team of immunologists, pathologists, oncologists, and astrophysicists focused on immuno-oncology biomarker discovery and validation. As part of the collaboration, researchers will develop, validate, and clinically implement novel spatial phenotypic signatures for immunotherapy and facilitate more effective drug development using Phenoptics technology.

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Immunotherapies utilize the immune system to combat cancer and are revolutionizing the field of oncology. Despite this great progress, most patients do not respond to immunotherapy, creating a pressing need for clinically validated biomarkers that accurately predict which patients are likely to benefit from a particular treatment.

A recent multi-institutional study found that mIF, which preserves the spatial context of cellular expression and whole tissue architecture, more precisely predicts response to immunotherapy compared to gene expression profiling, tumor mutational burden (TMB), and current single-marker immunohistochemistry1. The Phenoptics mIF platform provides an end-to-end solution with the reproducibility, sensitivity, and throughput needed to overcome the biomarker challenge by turning spatial data into actionable intelligence.

The AstroPath program applies an innovative approach to analyze large mIF datasets by using celestial object–mapping algorithms to rapidly identify optimized predictive signatures. The program leverages the principles of immunology, pathology, computer science, and astronomy to lay the foundation for rapid, efficient biomarker discovery. The real power of the AstroPath platform comes from the unique combination of knowledge and skills of the principals involved – Dr. Janis Taube, Director of the Division of Dermatopathology, Dr. Drew Pardoll, Director of the Bloomberg~Kimmel Institute for Cancer Immunotherapy, and Dr. Alex Szalay, Bloomberg Distinguished Professor in the Department of Computer Science, an avid astrophysicist and big data expert.

This collaboration lays out an integrated process for biomarker development from discovery to eventual clinical use. Johns Hopkins will receive support to further develop its AstroPath biomarker platform and Akoya will work with AstroPath and its partners to convert AstroPath discoveries to standardized high-throughput assays for clinical and translational studies. Together, the teams will help immuno-oncology groups within pharmaceutical and biotech companies take full advantage of biological information made available by multiplexed immunofluorescence, to accelerate development of new immunotherapies and commercialize predictive tests that can identify upfront those patients likely to respond to specific immunotherapies.

Cliff Hoyt, Vice President of Translational and Scientific Affairs at Akoya, commented, "We have worked closely with the Johns Hopkins team as they have refined multiplexed immunofluorescence methods and integrated them into their AstroPath platform. This paves the way for us to rapidly explore the deep spatial biology of whole tissue sections. Now, we look forward to making this method available to researchers developing new immunotherapies and to enable better stratification of patients once new biomarkers become validated and standardized."

"Through the AstroPath collaboration, we have a unique opportunity to push the limits of our Phenoptics platform in the realm of spatial tissue exploration, and broadly disseminate the discoveries and inventions from a world-leading interdisciplinary team of experts at Johns Hopkins," said Brian McKelligon, Chief Executive Officer of Akoya. "The results of this collaboration could help reshape the future of immunotherapy biomarker development."

The latest findings from the AstroPath platform can be viewed in this virtual Science/AAAS presentation by Dr. Janis Taube and Dr. Alex Szalay.

On March 2, 2021 ARTMS Inc., the global leader in the development and commercialization of novel technologies and products enabling cyclotron production of the world’s most needed medical radioisotopes, reported that it received $300,000 funding from Innovate BC as part of its Ignite program (Press release, ARTMS Products, MAR 2, 2021, View Source [SID1234575964]). The funding will be combined with over $600,000 from additional sources to further develop and validate the production of zirconium-89 (Zr-89) ­for use in Positron Emission Tomography (PET) imaging scans of cancer patients eligible for immuno-oncology (IO) therapies.

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"While immuno-oncology therapy holds great promise for many cancer patients, the challenge is understanding which patients will benefit from a given therapeutic. The Ignite funding will help us advance the development of Zr-89, a leading medical isotope utilized in identifying potential IO responder patients."

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Mr. Raghwa Gopal, President/CEO of Innovate BC, commented about the work with ARTMS, "We’re excited to help accelerate game-changing innovation like ARTMS’ proprietary approach to producing critically important, high-quality radiopharmaceutical medical isotopes for cancer patients. Past winners have solved critical market problems that other companies have tried to solve for 50 years."

"We want to thank the Innovate BC team for their support and confidence in ARTMS," said Dr. Michael Cross, Chief Operating Officer and project lead at ARTMS. "While immuno-oncology therapy holds great promise for many cancer patients, the challenge is understanding which patients will benefit from a given therapeutic. The Ignite funding will help us advance the development of Zr-89, a leading medical isotope utilized in identifying potential IO responder patients."

The overarching goal of this project is to utilize ARTMS’ proprietary QUANTM Irradiation SystemTM (QISTM) hardware system and expertise in solid targetry to produce high-quality and high-activity Zr-89 for the radiolabeling of molecular targeting ligands, such as antibodies, which are used in the non-invasive monitoring of the immune system by Immuno-Positron Emission Tomography.

Dr. Paul Schaffer, Principal Investigator and Chief Technology Officer of ARTMS remarked, "The emergence of Immuno-PET using Zr-89-based radiopharmaceuticals as a companion diagnostic with immuno-therapy allows physicians to better understand their patient’s specific molecular signature and thereby enables a personalized medicine approach with their treatment."

With the goal of providing efficient and cost-effective radioisotope supply solutions, ARTMS continues to drive a paradigm shift in the practice of nuclear medicine by disrupting the current supply chain with its award-winning QIS hardware and consumable products.

On March 2, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that President and Chief Executive Officer Todd C. Brady, M.D., Ph.D. will participate in analyst-led fireside conversations at the H.C. Wainwright Global Life Sciences Conference and the Oppenheimer 31st Annual Healthcare Conference (Press release, Aldeyra Therapeutics, MAR 2, 2021, View Source [SID1234575963]).

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H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, March 9, 2021
Time: 7:00 a.m. ET
Oppenheimer 31st Annual Healthcare Conference
Date: Tuesday, March 16, 2021
Time: 9:20 a.m. ET
To view these events, please visit the Investor & Media page of the company’s website. After the presentations, the events will remain archived on the website for 90 days.

On March 2, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Company will host a conference call with Dr. Neal Shore, medical director of the Carolina Urologic Research Center who will provide a clinical perspective on Vicineum, Sesen Bio’s product candidate for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, Sesen Bio, MAR 2, 2021, View Source [SID1234575962]). In addition, members of the management team will provide a corporate update. The conference call is scheduled for Monday, March 15, 2021 at 8:00 a.m. ET.

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Neal Shore, M.D., FACS is the medical director of the Carolina Urologic Research Center and is an internationally recognized expert in Urologic Oncology. Dr. Shore is a practicing Urologist at the Atlantic Urology Clinic and he is the National Director of Urology Research for the 21st Century Oncology. He has conducted more than 350 clinical trials, including over 200 trials in bladder cancer, and serves on the Boards of the Duke Global Health Institute, the Society of Urologic Oncology and the Bladder Cancer Advocacy Network. Dr. Shore has authored over 200 peer-reviewed publications and founded both the CUSP Clinical Trials Consortium and DASHKO, large urology practices data registries. A graduate of Duke University and Duke University Medical School, Dr. Shore completed a 6-month clinical research fellowship in Pretoria, South Africa, and then completed his General Surgery/Urology training at New York Hospital Cornell Medical Center and at Memorial Sloan­ Kettering Cancer Center in New York City. He is a Fellow of the American College of Surgeons. Dr. Shore is a paid consultant to Sesen Bio and served as a clinical investigator for the Phase 2 and Phase 3 clinical trials of Vicineum for NMIBC.

To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2441628. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in high-risk, BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On March 2, 2021 AVEO Oncology (Nasdaq: AVEO) reported that Michael Bailey, president and chief executive officer of AVEO, will present at the H.C. Wainwright Global Life Sciences Conference, being held virtually on March 9-10, 2021 (Press release, AVEO, MAR 2, 2021, View Source [SID1234575961]).

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A replay of the pre-recorded presentation can be accessed on Tuesday, March 9, 2021 in the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.