On August 23, 2022 Whiterabbit.ai, an AI-technology company dedicated to making late-stage diseases a rarity, reported it signed a national distribution agreement with Arterys, a San Francisco-based AI-powered software company and developer of the world’s first internet platform for medical imaging, to expand the reach of Whiterabbit’s AI-driven software program ACT, nationwide (Press release, Whiterabbit, AUG 23, 2022, View Source [SID1234618581]). The program is designed to increase mammography screening compliance and volume.

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Arterys’ broad customer base of healthcare systems, some of which use its Breast AI software to detect breast cancer, measure breast density and deliver personalized risk assessments, will be able to purchase and integrate ACT into their compliance screening programs. Increasing the number of women who schedule their annual mammograms is essential to detecting cancer earlier. The partnership has the potential to significantly reduce the backlog of preventive screenings that were missed and remain overdue as a result of the COVID-19 pandemic.

"Our strategic partnership with Arterys further anchors Whiterabbit’s mission to make late-stage diseases a rarity through increased accessibility, supported by innovative AI-powered software," said Whiterabbit.ai CEO Alexander Sardiña, MD. "We believe AI has the power to transform healthcare through compliance, accurate disease detection and a patient-centric approach at cost reduction."

"Arterys is extremely pleased to add Whiterabbit’s AI ACT solution to our current suite of breast AI applications," said Dan Arnoff, senior VP of commercialization at Arterys. "ACT drives the compliance of screening mammograms, which in turn potentially reduces interval cancers. ACT combined with our current Breast AI solution for tomosynthesis provides the end user a very unique platform in the fight against breast cancer. Arterys is committed to developing the best of class AI solutions, deployed from a single cloud interface to maximize the power of AI to breast centers across the globe."

According to leading organizations dedicated to breast cancer research and education, it is estimated more than 287,800 women will be diagnosed with invasive breast cancer and more than 43,000 will die from breast cancer in 2022 in the U.S. Whiterabbit and Arterys are dedicated to transforming healthcare through the intersection of human intelligence and artificial intelligence to improve clinical outcomes for patients.

Trained on millions of data points, Whiterabbit’s ACT is designed to facilitate compliance among women with mammography recommendations using a personalized notification system that does not require intensive one-on-one follow ups. Additionally, ACT evenly distributes a clinic’s increase in patient volume throughout the year. Tested in more than 300 breast cancer screening centers across the U.S., ACT has a proven track record of more than 20 percent growth year over year in breast cancer screening volume.

On August 23, 2022 InnoCare Pharma (HKEX: 09969) and Keymed Biosciences (HKEX: 02162) reported that the Investigational New Drug (IND) of CM369, an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody, developed by a joint venture between the two companies called Tiannuojiancheng Pharma, has been approved by the China’s National Medical Products Administration (NMPA) (Press release, InnoCare Pharma, AUG 23, 2022, View Source [SID1234618579]).

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CM369 is a potential first-in-class drug co-developed by InnoCare and Keymed as a monotherapy or in combination with other therapies for the treatment of various cancers.

CCR8 is a highly promising immuno-oncology target. CM369 binds to CCR8 on Tregs and eradicates immunosuppressive Tregs through ADCC to augment the anti-tumor immunity in TME while preserving peripheral homeostasis. CM369 has the potential to deliver optimal tumor targeted Treg depletion and be more specific in anti-tumor activity than other immunotherapies.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: "CM369 is our third large molecule drug entering the clinical stage, and it is also the 12th innovative drug approved for clinical trial. CM369 selectively depletes Tregs in the tumor microenvironment, which is more specific than other immunotherapies. We will work with Keymed to accelerate clinical development, so that this potential first-in-class drug can benefit patients with advanced solid tumors earlier."

Dr. Bo Chen, Co-founder, Chairman and CEO of Keymed Biosciences, said: "CCR8 is a specific target for Treg cells in tumors. CM369 has demonstrated durable efficacy and excellent safety in preclinical studies, and has a potential for combination with other therapies to kill tumor cells by synergistic effects. We look forward to working with InnoCare to accelerate the clinical development of CM369 at full speed, so that patients can benefit from our innovation as soon as possible."

On August 23, 2022 AdvanCell, an Australian radiopharmaceutical company with a platform technology for a revolutionary cancer treatment called Targeted Alpha Therapy, reported the closing of an A$18 million Series B financing round led by Morningside (Press release, Advancell, AUG 23, 2022, View Source [SID1234618578]).

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Andrew Adamovich, CEO and Founder of AdvanCell noted, "We are very pleased with our progress to date and delighted that we will continue our rapid growth with the support of our shareholders. We have had a long-term relationship with our lead investor, Morningside, and are excited to come closer still to our goal to ‘Change the Course of Cancer Treatment.’"

Targeted Alpha Therapies represent the most exciting opportunity to treat currently untreatable cancers. The technology harnesses the natural decay and radiochemical properties of certain elements, in combination with specific targeting molecules, to selectively deliver cell-killing radiation to the tumour cell. AdvanCell believes this precise and powerful treatment will rapidly become a leading pillar of cancer treatment, providing treatments for diseases for which there are currently no effective options. Targeted Alpha Therapies demonstrate incredible efficacy, however widespread adoption and large commercial product launches require a scalable and reliable global isotope supply. AdvanCell was established to solve this problem.

AdvanCell’s ability to produce isotope on-demand and at scale, and its in-house radiopharmaceutical manufacturing expertise positions AdvanCell to play a leading role in this rapidly growing market. With additional support from NSW Health Medical Devices Fund and the Federal government’s Research & Development Tax Incentive, AdvanCell has developed a world-first scalable manufacturing platform to produce alpha-emitting isotopes for research, pre-clinical and clinical use and to advance its own and its partners’ radiopharmaceutical products.

Anthony Aiudi from Morningside commented, "AdvanCell is leveraging its ability to make alpha isotopes at scale and in clinically useful amounts along with its radiochemistry expertise, to develop an exciting portfolio of Targeted Alpha Therapies. Targeted Alpha Therapies hold incredible promise however their development has been hamstrung by a lack of radioisotope supply. Together with the team at AdvanCell, we look forward to writing a new chapter in oncology, to target large patient populations with significant unmet needs."

Mr Aiudi has been appointed to the Board of AdvanCell, joining Mr Adamovich, Bill Ferris AC, co-founder of CPE Capital, Adrian "Adi" Patterson, former Australian Nuclear Science and Technology Organisation (ANSTO) CEO and Kevin Cameron, CEO of Ionetix.

Bill Ferris AC, Chair remarked, "Our executive team has articulated a credible pre-clinical and clinical pathway for the delivery of the Company’s novel Targeted Alpha Therapies. Having successfully developed the manufacturing platform essential for the reliable and scalable supply of isotopes, the Company is on schedule with its pre-clinical work and is now moving into first-in-human trials. AdvanCell is on track to become a leading radiopharmaceutical company with a platform technology enabling novel cancer treatments."

On August 23, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported its new publication in Cancer Research Communications that compares the immunogenomic response profiles to anti-PD-(L)1 or IL-2 therapy and the development of a novel response classifier to IL-2 treatment1 (Press release, GeneCentric Therapeutics, AUG 23, 2022, View Source [SID1234618577]). Cancer Research Communications is an open access peer-reviewed journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The study was conducted as a collaboration between Atrium Health Levine Cancer Institute, Sanofi, and GeneCentric and evaluated real-world data from patients diagnosed with renal cell carcinoma (RCC) who were treated with immune-oncology agents. Results suggest that common and distinct immune-related response markers for IL-2 and anti-PD-(L)1 therapy may help guide their use, either alone or in combination.

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"It is exciting to share the initial findings from this important collaboration where we attempted to identify the immunogenomic differences between IL-2 and anti-PD-1 responders in renal cell carcinoma," said Dr. Asim Amin, medical oncologist, Atrium Health Levine Cancer Institute, and study co-principal investigator. "Using RNA expression analysis, we were able to identify key characteristics that are unique to each treatment modality, as well as those that are shared between the two. With this work we were able to develop a novel IL-2 response signature that may have prognostic potential."

A primary focus of the study was to obtain a deeper understanding of the tumor microenvironment similarities and/or differences that may lead to IL-2 or anti-PD-(L)1 therapy response. Retrospective tumor samples and corresponding clinical response data were collected from patients with a primary diagnosis of RCC who were treated with high-dose IL-2 (HD-IL-2; aldesleukin) and compared to existing data from a similar cohort of RCC patients treated with the anti-PD-1 nivolumab2. Tumor samples from HD-IL-2 treated patients underwent RNA sequencing (RNAseq) prior to immunogenomic analysis. As a result, a novel RNA-based IL-2 treatment response signature was discovered that could ultimately assist in further developing diagnostics for next-generation IL-2 agents, several of which are in clinical development.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney and renal pelvis cancer in adults. In the United States, it is estimated that there will be approximately 79,000 new cases of kidney and renal pelvis cancer in 2022 and almost 14,000 deaths. Kidney and renal pelvis cancer, which includes RCC, is considered the 8th most common type of cancer. Standard treatment options for RCC are surgery, radiation, chemotherapy, targeted therapy or immunotherapy.

On August 23, 2022 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, reported the signing of a long-term supply agreement for the therapeutic radioisotope actinium-225 (Ac-225) with Aktis Oncology, Inc (Press release, NorthStar Medical Radiostopes, AUG 23, 2022, View Source [SID1234618576]). Under terms of the agreement, NorthStar will be a major supplier of high purity non-carrier-added (n.c.a.) Ac-225 to Aktis. Aktis will use NorthStar’s Ac-225 to advance development of its proprietary tumor-targeting agents intended to deliver transformative efficacy for patients with solid tumors.

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Ac-225 is a high energy alpha-emitting radioisotope of increasing interest for clinical studies investigating the use of targeted radiopharmaceutical therapy, which combines select molecules with therapeutic radioisotopes 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 have been 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 for advancing clinical research and commercial radiopharmaceutical therapy products. The Company will use its electron accelerator technology to produce n.c.a. Ac-225 that is free of long-lived radioactive contaminants and byproducts associated with other production methods. Such contaminants pose regulatory and waste management challenges for pharmaceutical companies, hospitals, and health systems.

"We are very pleased to enter this Ac-225 supply agreement with Aktis Oncology, and we look forward to working with them in their efforts to provide targeted alpha radiopharmaceuticals to treat patients with cancer," Stephen Merrick, Chief Executive Officer of NorthStar Medical Radioisotopes. "NorthStar is poised to be the first commercial-scale producer of Ac-225, utilizing our n.c.a. Ac-225 production technology that is environmentally preferable and non-uranium based, utilizing state-of-the-art electron beam accelerator production that provides increased capacity and scheduling flexibility. Construction of our dedicated Actinium-225 Production facility is well underway, with initial production of radiochemical grade Ac-225 planned for late 2023. We expect to submit a Drug Master File to the FDA in 2024, which, upon acceptance, will allow NorthStar to provide cGMP grade Ac-225."

"Aktis Oncology is harnessing the power of targeted alpha radiotherapy to treat a broad range of cancers, including breast, lung, colorectal, bladder, and liver cancers," said Matthew Roden, PhD, Aktis Oncology President and Chief Executive Officer. "Aktis is pleased have NorthStar as an experienced and reliable partner in innovative, accelerator-based radioisotope production technology as our programs advance towards the clinic. We look forward to working with NorthStar to supply Ac-225 to deliver highly transformative treatments for patients with cancer."