On June 15, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega") reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company’s lead product candidate, OTX-2002, for the treatment of hepatocellular carcinoma (HCC) (Press release, Omega Therapeutics, JUN 15, 2022, View Source [SID1234616023]). OTX-2002, an Omega Epigenomic Controller, is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

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"This is an important milestone for our Company, an IND achieved in approximately 26 months since we started working on the early constructs in discovery which culminated in OTX-2002. We are excited that this represents the first of many anticipated IND applications and the transition of the company to its next stage," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "This also marks a milestone regulatory submission for the first epigenomic controller, a new class of programmable mRNA therapeutics enabled by our OMEGA platform. We believe our approach to engineering epigenomic controllers has immense potential across a broad range of diseases, including HCC, which carries a 5-year survival rate of only 10%. We look forward to advancing OTX-2002 into the clinic and bringing it one step closer to patients in need."

The Company plans to initiate a Phase 1 clinical trial in the U.S. to evaluate OTX-2002, following FDA clearance.

About OTX-2002
OTX-2002 is a first-in-class Omega Epigenomic Controller in development for the treatment of HCC. OTX-2002 is a mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The MYC oncogene is associated with aggressive disease in up to ~70% of patients with HCC. An IND application has been submitted to the FDA.

On June 15, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology reported that it has received clearance from the US Food and Drug Administration to commence Phase I studies with PT886, its anti-claudin18.2/anti-CD47 bispecific antibody being developed for patients with gastric, gastroesophageal junction (GEJ) and pancreatic cancers (Press release, Phanes Therapeutics, JUN 15, 2022, View Source;an-anti-claudin18-2anti-cd47-bispecific-antibody-being-developed-for-patients-with-gastric-gastroesophageal-junction-and-pancreatic-cancers-301568015.html [SID1234616022]).

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"The clearance of our second IND this year is an important milestone for Phanes and the opportunity to bring this potential first-in-class bispecific antibody to cancer patients who have such a high unmet medical need is what drives us every day," said Dr. Ming Wang, Founder and CEO. "We have built a strong pipeline in immuno-oncology by leveraging our proprietary technology platforms and expect to file one additional IND with PT217, an anti-DLL3/anti-CD47 bispecific antibody for the potential treatment of small cell lung cancer and other neuroendocrine cancers. This continues to be a transformational year for Phanes as we now progress two programs into the clinic".

PT886 is a native IgG-like bispecific antibody assembled with Phanes’ proprietary PACbody and SPECpair platforms. Its advancement into clinical stage further validates Phanes’ bispecific antibody technology platforms.

Gastric, gastroesophageal junction (GEJ) and pancreatic cancers are considered as some of the most incurable cancers worldwide. In patients with advanced or metastatic gastric or GEJ adenocarcinoma, the median overall survival is no more than 10 months and that for pancreatic cancers is equally dismal with a median overall survival of 6-11 months. The multi-center, Phase I clinical trial of PT886 is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT886 in adult patients with metastatic gastric adenocarcinoma, GEJ adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC) that have progressed after available standard therapy or for which standard therapy has proven to be ineffective, intolerable or is considered inappropriate.

On June 15, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing as an alternative to surgical tumor removal, reported ProSense was featured in a categorical course titled "Cryoablation for the Treatment of Breast Cancer: Breast Interventions for the Interventionalist" on Tuesday, June 14, 2022 at the Society of Interventional Radiology (SIR) Annual Scientific Meeting in Boston ("SIR 2022 Conference") (Press release, IceCure Medical, JUN 15, 2022, View Source [SID1234616021]).

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ProSense was well received by physicians, potential U.S.-based customers including medical clinics and hospitals, and international distributors interested in partnerships. The categorical course, which provided information and training on image guided breast cancer cryoablation, came on the same day that IceCure announced its cryoablation system will be distributed in mainland China by Shanghai Medtronic Zhikang Medical Devices Co. Ltd. ("Shanghai Medtronic"), an affiliate of Medtronic plc (NYSE: MDT), and Beijing Turing Medical Technology Co. Ltd. ("Turing"), with the first systems expected to be delivered in 2022.

The categorical course was presented at SIR 2022 Conference by a panel of experts in radiology and breast cancer, including:

Dr. Kenneth Tomkovich, Diagnostic and Interventional Radiologist at Princeton Radiology, Director of Breast Imaging and Interventions at CentraState Medical Center, and Co-lead Investigator of IceCure’s landmark ICE3 study of ProSense in the treatment of small, low-risk, early-stage malignant breast tumors;
Professor Eisume Fukuma, Director of Breast Cancer at Kameda Medical Center, Japan, a pioneer in the study of breast cancer cryoablation, and ProSense user;
Dr. Alexander Sevrukov, Assistant Professor, Director, Women’s Diagnostic Center at Methodist Hospital, a participant in the ICE3 trial, and ProSense user;
Dr. Monica L. Huang, Associate Professor, Department of Breast Imaging, Division of Diagnostic Imaging at the University of Texas MD Anderson Cancer Center;
Dr. Jason Shames, MD, MBS, Assistant Professor of Radiology, Associate Director of Research, Division of Breast Imaging, Co-Director, Breast Imaging Fellowship at Thomas Jefferson University; and
Dr. Gao-Jun Teng, Professor of Radiology at the Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, and former President of the Chinese Society of Interventional Radiology
Dr. Tomkovich commented, "The inclusion of a categorical course on breast cancer cryoablation at the SIR 2022 Conference represents a major shift in the way the interventional and breast radiologist can approach the treatment of small, low-risk, breast cancers and highlights the interest of the professional community about how they can offer such treatments to their patients. The promising interim ICE3 clinical data continues to show that cryoablation for certain types of breast cancers is safe, effective, and is the future of breast cancer care."

IceCure CEO, Eyal Shamir, added, "On the heels of the announcement of our distribution agreement with Shanghai Medtronic and Turing, this is an ideal time for ProSense to be featured at the SIR 2022 Conference as we work toward regulatory approval in early-stage breast cancer following the filing of our pre-submission package to the U.S. Food and Drug Administration in November 2021. We extend our gratitude to the panel of experts who presented ProSense in the categorial course. Several of the doctors have been using ProSense and their perspective is invaluable for IceCure’s potential customers and partners."

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.