On June 15, 2022 OncoBeta GmbH reported Perth’s Hollywood Private Hospital in Australia is the latest medical facility to participate in the global phase IV EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT – for the treatment of non-melanoma skin cancer [NMSC]) treating its first patients with Rhenium-SCT as part of the international study (Press release, OncoBeta, JUN 15, 2022, View Source [SID1234616020]).

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The first Perth patients were treated at Hollywood Private Hospital on 3 June, and are part of 210 adults participating in the international study that will follow their progress over the next 24 months.

The EPIC-Skin study is being conducted through study centres located in Australia, Austria, Germany and the United Kingdom. The first patients to be treated globally with Rhenium-SCT as part of the EPIC-Skin study occurred on the Gold Coast in late February, with other centres in Australian cities scheduled to participate in the study over the coming months.

Treating physician at Hollywood Private Hospital, Associate Professor Joe Cardaci, has been treating patients with Rhenium-SCT since 2018.

"Rhenium-SCT allows for a targeted and non-invasive treatment of NMSCs without damaging adjacent healthy tissue. The EPIC- Skin study offers the opportunity to further demonstrate the efficacy of this new non-invasive epidermal radioisotope therapy. With NMSCs very prevalent in Australia, it’s important that as a medical community we continue to investigate new treatment options to ensure we are improving patient outcomes," said A/P Cardaci.

There are more than 7.7 million cases of NMSC each year, and incidence rates are increasing globally.1,2 Standard treatments for NMSCs are surgery-based approaches, which may have a risk of scarring or loss of function. Rhenium-SCT uses a non-invasive paste containing ß-emitting particles directly to the lesion, which target cancer cells without the need for surgery, in one single session.3-5

Dr Sam Vohra, Medical Director at OncoBeta Australia, says, "The aim of the EPIC-Skin Study is not to reverse the existing treatment options but rather to show Rhenium-SCT is a patient friendly treatment alternative for NMSCs."

The EPIC-Skin study will measure Patient Reported Outcomes such as quality of life, treatment comfort and cosmetic outcomes, as well as further evaluating the efficacy of Rhenium-SCT for the treatment of NMSC. To provide a simple and streamlined way to record their experiences, patients in the study will utilise the Clinical Study app.

Shannon D. Brown III, CEO and Managing Director at OncoBeta, says, "NMSC is a significant health concern in Australia and around the world. This study will offer new insights into the treatment of NMSC and the role of Rhenium-SCT in the suite of treatments available to patients. The EPIC-Skin Study will be critical in assisting us in improving patient outcomes for those suffering with NMSCs."

Clinicians who are interested in enrolling patients in the study can contact OncoBeta directly at www.oncobeta.com/contact.

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans.2 The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.6

The Rhenium-SCT is a painless*, single session†, non-invasive therapy that provides aesthetic results, even in cases otherwise considered difficult to treat.3-5 The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The Rhenium-SCT is a precise, personalised therapy that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient’s skin and the application is safe and simple for the applying physician. Most cases of NMSCs (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT in one single session.†5 Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.5

On June 15, 2022 WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO), and Wugen Inc., a clinical-stage biotechnology company based in St. Louis and San Diego, reported a partnership to produce Wugen’s WU-NK-101, a novel immunotherapy that harnesses the power of memory natural killer (NK) cells to treat cancers (Press release, WuXi ATU, JUN 15, 2022, View Source [SID1234616019]). WuXi ATU will provide manufacturing and testing services for WU-NK-101 to enable the delivery of this innovative cell therapy product to cancer patients.

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Wugen aims to develop a pipeline of off-the-shelf cell therapy products to treat a broad range of hematological and solid tumor malignancies. As Wugen’s first program from the company’s proprietary MonetaTM platform, WU-NK-101 leverages the hyper-functional, long-lasting anti-tumor functionality of memory NK cells to manufacture next-generation, off-the-shelf cancer cell therapies at commercial scale. WU-NK-101 is currently in development to treat acute myelogenous leukemia (AML) and solid tumors.

WuXi ATU’s integrated CTDMO platform enables the development of WU-NK-101 by leveraging the company’s Good Manufacturing Process (GMP) cell therapy manufacturing and testing capabilities to support regulatory filings and clinical trials.

"We are delighted to partner with WuXi ATU," said Dr. Dan Kemp, President and Chief Executive Officer of Wugen. "With WuXi ATU’s cell therapy manufacturing expertise, integrated GMP manufacturing and testing capabilities, we can keep advancing our allogeneic WU-NK-101 program into clinical trials and accelerate the timeline for delivering convenient, effective therapeutics to patients."

"The development of allogeneic NK cell therapies is a significant step towards accelerating the progress of these innovative cancer therapeutics into the clinical pipeline," said Dr. David Chang, Chief Executive Officer of WuXi ATU. "We’re delighted to partner with Wugen to help make these life-saving cancer treatments less challenging to produce and more accessible to patients in need."

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On June 15, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the pricing of an upsized underwritten follow-on offering of 7,000,000 shares of common stock at a price to the public of $16.00 per share (Press release, Arcellx, JUN 15, 2022, View Source [SID1234616018]). The offering was upsized to 7,000,000 shares of Arcellx’s common stock from the original offering size of 4,000,000 shares. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Arcellx, are expected to be $112 million. In addition, Arcellx has granted the underwriters a 30-day option to purchase up to an additional 1,050,000 shares of common stock on the same terms and conditions. The offering is expected to close on June 21, 2022, subject to the satisfaction of customary closing conditions. All of the shares in the proposed offering will be sold by Arcellx.

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BofA Securities, SVB Securities, William Blair and Canaccord Genuity are acting as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective today. The offering is made only by means of a prospectus, copies of which may be obtained, when available, from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]. William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at 1-800-621-0687, or by email at [email protected]; or Canaccord Genuity LLC, Attention: Syndicate Department, 99 High Street, 12th Floor, Boston, MA 02110, or by telephone at (617) 371-3900, or by email at [email protected]. Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On July 15, 2022 Paige, a global leader in clinical AI applications in pathology, reported a collaboration with Janssen Research & Development, LLC (Janssen) to evaluate the potential of a hematoxylin and eosin (H&E)-based, artificial intelligence (AI)-powered biomarker test to predict the presence of certain actionable alterations in the fibroblast growth factor receptor (FGFR) genes in patients with advanced urothelial cancer, also known as bladder cancer (Press release, Paige AI, JUN 15, 2022, View Source [SID1234616016]).

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This biomarker test, developed by Janssen, is a first-of-its-kind screening tool to predict the occurrence of actionable genomic alterations. The goal is to improve rates of confirmatory molecular testing and accelerate recruitment of patients into biomarker-driven clinical trials that are enrolling patients with certain tumor FGFR mutations.

Bladder cancer is the tenth most common cancer worldwide1, and approximately 15% of people with advanced disease have alterations in the FGFR gene.2,3 Currently, most patients with bladder cancer do not have their tumors sequenced to identify potential genomic alterations and potentially inform more targeted treatment decisions. For those who are tested, results from today’s confirmatory molecular FGFR tests can take weeks to be returned to the ordering physician, slowing time to trial enrollment and treatment. Leveraging existing H&E data to provide guidance for care can reduce barriers for clinical trial recruitment by providing results for a digitized image of a routine biopsy in less than one hour.

The technology is currently being evaluated in Janssen’s clinical trials to screen for FGFR gene alterations in adult patients with advanced urothelial cancer using the Paige Platform, a comprehensive digital pathology software platform that is inclusive of an FDA-cleared and CE-marked viewer and storage capabilities that is compatible with existing digital pathology solutions, including most scanners, monitors, and laboratory information systems (LIS). As more clinical trial sites adopt a digital pathology workflow, Paige will be able to support local testing.

"We are excited to mark a new chapter in deploying Janssen’s AI technology in a clinical setting to efficiently detect biomarkers, in this case some rare gene mutations and fusions," said Jill Stefanelli, Ph.D., President and Chief Business Officer at Paige. "With the global deployment of our Paige Platform underway, we will make our capability broadly available in support of the clinical development of targeted and other classes of therapeutic drugs and patient identification for future biomarker and drug development programs."

On June 15, 2022 Imagia Canexia Health, a genomics-based cancer treatment testing company that accelerates access to precision care by combining AI expertise with advanced molecular biopsy solutions, reported the CE-IVD marking for its Imagia Canexia Health Insights Platform (ICHIP) to operate across Europe (Press release, Canexia Health, JUN 15, 2022, View Source [SID1234616015]). ICHIP provides intricate molecular and computational genome analysis, from targeted next-generation sequencing (NGS) data, for individual cancer patients. The company offers a unique clinical solution for European oncologists to quickly generate reports—including therapeutic and clinical trial recommendations. This new approval furthers Imagia Canexia Health’s mission to combine advanced genomics, oncology, artificial intelligence, and informatics to enable health systems to provide cost-effective testing in-house—thus delivering precision cancer treatments to patients no matter where they live.

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Clinicians receive next-generation sequencing (NGS) data sourced from human tissue or blood samples. These insights are collected, as well as processed, on Illumina’s NextSeq and MiSeq devices. Then, ICHIP uses AI to detect and analyze genomic variants, match interpretations, identify potential clinical trials, as well as generate a cancer-treatment results report. This creates a new ability to integrate clinical and genomic patient data, augmenting treatment decisions by oncologists. With this crucial information, health professionals can rapidly access data about a cancer patient’s genetics, as well as describe the potential associations between detected variants and specific therapeutics, all while making the most informed care-management decisions.

"Achieving the CE-IVD mark, a highly regarded standard around the globe, represents an important milestone that reflects the technological quality and rigor upon which we built the Imagia Canexia Health Insights Platform (ICHIP)," said Imagia Canexia Health CEO Geralyn Ochab. "Our company takes pride in the platform’s ability to quickly provide specialists with vital information to fight cancer, now supporting European oncologists with life-saving information for their patients."