On September 8, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, reported the signing of a supply agreement for the therapeutic medical radioisotope actinium-225 (Ac-225) (Press release, NorthStar Medical Radiostopes, SEP 8, 2021, View Source [SID1234587432]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ac-225 is a high energy alpha-emitting radioisotope that is a mainstay for studies in targeted radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while its half-life limits unwanted radioactivity in patients. Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technology. NorthStar is positioned to be the first commercial-scale producer of Ac-225, applying its radioisotope production technology expertise to provide reliable supply for advancing clinical research and commercial radiopharmaceutical products.

Under the terms of the agreement, NorthStar will provide POINT with its electron accelerator-produced Ac-225 and POINT will use NorthStar’s Ac-225 in investigational studies of PNT2001, a next-generation Prostate-Specific Membrane Antigen (PSMA) for non-metastatic castrate-sensitive prostate cancer (nmCSPC); PNT2004, a Fibroblast Activation Protein-α candidate with potential pan-cancer applications; and to advance its novel Tumor Microenvironment (TME) tumor-targeting technology platform.

"NorthStar is at the forefront of U.S. radioisotope production as the only commercialized producer of the important medical radioisotope molybdenum-99 (Mo-99), and we are applying that same development expertise to rapidly advance large-scale availability of Ac-225," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Our Ac-225 process uses highly efficient electron accelerator production technology that provides increased capacity and scheduling flexibility. Like all NorthStar processes, it is environmentally friendly, non-uranium based and uses highly advanced technology. We are very pleased to enter this Ac-225 supply agreement with an industry leader such as POINT, with whom we share a vision to progress research and clinical availability of targeted radiotherapies for cancer patients as a potential treatment option."

"A resilient radioisotope supply chain is key to advancing our next-generation pipeline of targeted radiopharmaceuticals," said Dr. Joe McCann, Chief Executive Officer of POINT. "NorthStar’s deep experience and commercial competencies in radioisotope production make them an ideal partner, and we believe that their accelerator production technology will provide us with a differentiated and highly efficient supply route for the therapeutic radioisotope Ac-225."

On September 8, 2021 Huadong Medicine (SZ.000963) and Insilico Medicine ("Insilico"), an end-to-end artificial intelligence (AI)-driven drug discovery company, reported that the companies have entered into a co-development partnership to accelerate the discovery of breakthrough small-molecule therapeutics by leveraging an innovative approach to oncology (Press release, Huadong Medicine, SEP 8, 2021, View Source [SID1234587448]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to the collaboration agreement, Insilico and Huadong Medicine will launch a new drug discovery project involving the research and development (R&D) teams of both parties. The collaboration will leverage Huadong Medicine’s advanced innovative drug discovery and screening characterization platform, in combination with Insilico’s end-to-end AI-driven drug discovery platform, particularly the small molecule generation platform Chemistry42, in order to design and screen out potential first-in-class ("FIC") drug molecules with superior activity that may increase the druggability of targets. The project team will interfere with protein-protein interactions to hit undruggable targets that regulate tumor growth.

Insilico’s self-developed small molecule generation platform Chemistry42 combines AI technology with computational and medicinal chemistry methods to efficiently generate novel molecular structures with desired properties for specific targets. This platform helps to screen and obtain potential therapeutic molecules, which are verified in vitro and in vivo, and delivers rapid comprehensive solutions from hits to preclinical candidates ("PCC").

Huadong Medicine, a publicly-traded pharmaceutical company with fully integrated R&D, manufacturing, distribution, sales and marketing capabilities, has more than 10,000 employees and a sales force covering thousands of hospitals in China. In addition, Huadong Medicine’s R&D organization currently has more than 1000 FTEs involved in drug discovery, preclinical research, clinical research, CMC, and RA. Huadong Medicine focuses on innovation and transformation strategies and is committed to concentrating its advantages and R&D resources to build prospective products R&D pipeline in the fields of oncology, endocrine/metabolic, and autoimmune disease with the help of advanced technology and methods from its partners.

"Complementary advantages and cooperative innovation have increasingly become the trends of novel drug discovery and development. Insilico is honored to form a partnership with Huadong Medicine. By leveraging the strength of Insilico’s advanced small molecule generation platform Chemistry42 and Huadong Medicine’s powerful target verification and screening platform, we will hit previously undruggable targets by inhibiting protein-protein interactions, in order to meet unmet medicinal needs efficiently," said Feng Ren, Ph.D., Chief Scientific Officer and Head of Drug R&D at Insilico.

"The combination of AI and novel drug R&D can greatly improve the efficiency of drug R&D, and has the potential to significantly shorten timelines and reduce the cost of drug design, discovery, pre-clinical R&D, and clinical development. We look forward to collaborating with the leading international AI company Insilico, by leveraging respective advantages of both companies, in advancing the development of potential FIC drug molecules to meet increasing clinical medical needs, in addition to providing patients with more, better and ground-breaking treatment options," said Dongzhou Liu, Ph.D., Chief Scientific Officer and President of Global Research and Development at Huadong Medicine.

On September 8, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows (Press release, Regeneron, SEP 8, 2021, View Source [SID1234587396]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Morgan Stanley 19th Annual Global Healthcare Conference at 8:45 a.m. ET on Monday, September 13, 2021

Cantor Fitzgerald Virtual Global Healthcare Conference at 9:20 a.m. ET on Monday, September 27, 2021
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

On September 8, 2021 Endomag repored that A pioneering new technique known as ‘delayed’ sentinel lymph node biopsy could spare as many as four in five Americans diagnosed with high-risk ductal carcinoma in-situ (DCIS) from an unnecessary additional underarm surgical procedure (Press release, Endomag, SEP 8, 2021, View Source [SID1234587433]).1

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ductal carcinoma in-situ (DCIS) is the presence of abnormal cells inside a milk duct in the breast, and accounts for one in every five new breast cancer diagnoses.2 It is considered the earliest form of breast cancer and is non-invasive, meaning that the cancer has not spread beyond the milk duct and has a low risk of becoming invasive. If left untreated, DCIS can break down and become invasive, where the cancer spreads through the lymphatic system.

A common treatment for DCIS is a mastectomy, where the patient will undergo surgery to remove the entire breast. Until now, doctors would also remove the majority of lymph nodes in the underarm on the side of the affected breast tissue during the mastectomy, to assess whether the cancer has spread. This procedure is known as a sentinel lymph node biopsy. Every year over 50,000 American women with the earliest form of breast cancer receive this node surgery.3 Yet, 70-80% of women diagnosed with DCIS do not have invasive cancer,3,4 rendering this additional surgery unnecessary.

The new procedure, known as a ‘delayed’ sentinel lymph node biopsy, involves the use of the Magtrace lymphatic tracer, a magnetic lymphatic tracer used in axilla staging. It is the only tracer that will be retained long enough in the lymph nodes to enable this pioneering treatment. In the procedure:

The Magtrace lymphatic tracer is injected at the time of the mastectomy and DCIS surgery, naturally migrating to the nodes that the cancer is most likely to spread to, if the disease is invasive.
It remains in place for up to 30 days after it has been injected and will provide a magnetic signal to help the surgeon return to the nodes, if they need to.
This means that doctors can wait for pathologic analysis of the DCIS to confirm if it is invasive. This information can then determine whether a sentinel lymph node biopsy is necessary. In up to 80% of cases it will not be. 1
If pathology confirms that the DCIS is invasive, the long-lasting signal of Magtrace allows for the sentinel lymph node biopsy to still be performed to understand the extent of cancer migration to the lymph nodes.
"The delayed sentinel lymph node biopsy has really revolutionized our ability to maintain lymphatic integrity in women who have DCIS", explained Dr Kandace McGuire, Chief, Section of Breast Surgery Surgical Leader of the Multidisciplinary Breast Cancer Program at Massey Cancer Center, Virginia. "So, what we do is we inject the Magtrace lymphatic tracer at the time of the initial mastectomy. The great thing about this is that the tracer will stay in the lymph nodes for up to six weeks so that we have time to get pathology back. If there’s no invasive cancer, there’s no need to do a sentinel lymph node biopsy."

By preventing surgery, the new ‘delayed’ sentinel lymph node biopsy spares women’s lymph nodes and leaves the lymphatic system undamaged, reducing the risk of life-altering complications connected with lymph node surgery. One of these is lymphedema, a condition affecting over 10 million Americans,5 caused by a build-up of lymphatic fluid that escapes into the body when the system is disrupted. Lymphedema, while manageable, is largely incurable,6 and causes lifelong swelling, altered sensation, pain and limitations in range of motion.7

"It felt wonderful to know that I would only have a sentinel lymph node biopsy if I truly needed it," explained Theresa Poon, who benefitted from the delayed Sentinel Lymph Node Biopsy procedure. "I was very scared of lymphedema. The swelling can just happen at any time, and even though it’s very rare, it’s always in the back of your mind. To be offered the possibility of not having any lymph nodes removed if I didn’t have invasive cancer was great."

Research from Uppsala University Hospital in Sweden and University Hospitals Cleveland has shown that the delayed Sentinel Lymph Node Biopsy procedure has reduced surgical interventions in 78.3% and 87% of cases respectively, and reduced costs to the healthcare system by 24.5% for women without invasive breast cancer.1,7 In total, over 160,000 women across more than 700 hospitals in over 45 countries have already been able to access more precise and less invasive breast cancer treatment thanks to Magtrace and Endomag’s other breast cancer treatment technologies.

"Women with breast cancer face so many difficult choices, so it’s gratifying to know that for high-risk DCIS patients, we can take one away without compromising their care and offer a real chance of avoiding unnecessary surgery," said Mathew Stephens, Chief Marketing Officer at Endomag. "Our new campaign, #SaveOurNodes, seeks to ensure that all women with high-risk DCIS are aware of this new surgical option. With advice from expert breast surgical oncologists who offer the technique and other patients who have had the procedure, we hope this campaign helps to provide more clarity on the best treatment approach for them."

Find out more about the campaign and the ‘delayed’ sentinel lymph node biopsy technique by visiting www.saveournodes.com, which features more information and resources about the procedure. There is now an ever-growing number of hospitals across the US practicing ‘delayed’ sentinel lymph node biopsy and Endomag will continue to work to improve access for all breast cancer patients.

On September 8, 2021 Science 37 and Foundation Medicine reported a collaboration to enable decentralized clinical research in oncology that will optimize recruitment and enrollment, improve patient retention, and expand access to precision cancer care (Press release, Foundation Medicine, SEP 8, 2021, View Source [SID1234587449]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

It is estimated that less than 1 in 20 patients with cancer participate in clinical trials.1 Further, more than 80 percent of clinical studies globally fail to enroll patients within the sponsor’s desired timeline.2 Lack of participation in clinical research may hinder a patient’s ability to access the latest therapeutic options and slow the pace of treatment discovery.

As part of this novel offering, Foundation Medicine’s FoundationSmartTrials patient identification solution will be used to identify patients who may be eligible for a trial based on results from its tissue and blood-based comprehensive genomic profiling (CGP) tests. Science 37 will then enroll the appropriate patients and provide ongoing support via its operating system—underpinned by its technology platform and specialized networks of mobile nurses, telemedicine investigators, remote coordinators and connected devices.

"Many advanced cancer patients are unable to travel to or visit in-person clinical trials sites, so it’s critical that we work across the ecosystem towards new and innovative solutions to improve access to clinical trials regardless of a patient’s location," said Jonathan Cotliar, M.D., Chief Medical Officer at Science 37. "Combining our operating system with Foundation Medicine’s precision oncology expertise sets us on an exciting path with the goal of accelerating treatment discovery while bringing the research directly to patients."

This partnership builds on a collaboration between Foundation Medicine and Science 37 to provide decentralized trial services for Roche’s ALPHA-T trial. The ALPHA-T trial seeks to assess the efficacy and safety of alectinib for patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic solid tumors excluding lung cancer. This type of tumor-agnostic approach represents a ground-breaking advance in cancer treatment and demonstrates further progress towards achieving personalized healthcare for patients with these types of cancers.

"Beyond providing high quality genomic profiling to support informed decision making, we’re committed to empowering practitioners to act on those decisions by identifying personalized treatment options, including clinical trials. Through this partnership with Science 37, leveraging our combined assets and expertise, our goal is to improve access to clinical trials for patients who aren’t frequently able to participate," said Brian Alexander, M.D., M.P.H., Chief Executive Officer at Foundation Medicine. "As we explore this decentralized approach to research, we hope to continue innovating on this model for other clinical programs in the future. Ideally, we’ll create a learning system where physicians and patients have more options, and their experiences help inform treatment for patients in the future."