On November 28, 2022 Siemens Healthineers and Atrium Health, a leading nonprofit health provider known for its top-ranked pediatric, cancer and heart care programs, reported a multi-year Value Partnership1 agreement (Press release, Atrium Health Levine Cancer Institute, NOV 28, 2022, View Source [SID1234624514]). This strategic agreement will focus on driving access to care in Atrium Health’s service region across the southeastern U.S., improving health equity and enhancing economic mobility. Atrium Health will purchase $140 million in Siemens Healthineers devices and equipment, including advanced imaging technology, radiation oncology and precision endovascular robotics.

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Utilizing Siemens Healthineers technology, Atrium Health will work to improve health care in rural and underserved areas. It will do so by strategically strengthening economic mobility, health equity and access and focusing on environmental sustainability in the region.

"This partnership between Atrium Health and Siemens Healthineers will create tremendous value for our communities and the health care field," said Eugene A. Woods, president and CEO of Atrium Health. "Together, we will reshape the future of health care, invent new technologies and grow the next generation of talented clinicians – all with a laser-like focus on equity and inclusive growth."

Through unique services and approaches within the Value Partnership, Siemens Healthineers will help Atrium Health meet its strategic goals, increase efficiency and work toward improving health in communities in North Carolina, South Carolina, Georgia and Alabama – and beyond. Through Siemens Healthineers, Atrium Health will continue to modernize its healthcare infrastructure to serve patients, use technologies like artificial intelligence to improve outcomes and quality, reduce costs in health care across the enterprise, as well as jointly develop education and workforce solutions to help encourage and enhance careers in health care.

"Siemens Healthineers is proud to continue its strong partnership with Atrium Health imaging service engineering teams to improve the quality of health care," said Dave Pacitti, president and head of the Americas, Siemens Healthineers. "Not only will this agreement nurture the development of the next-generation workforce in health care, but it will also serve as a foundation for future innovations."

"As an academic learning health system, Atrium Health is at the forefront of research and innovation that can improve the health of our population," said Dr. Rasu Shrestha, enterprise executive vice president and chief strategy and transformation officer for Atrium Health. "This agreement with Siemens Healthineers will help Atrium Health push the boundaries of innovations in clinical care, research and community impact, and also help us equip the new bed towers being built at our flagship hospitals in Charlotte and Winston-Salem, North Carolina with leading-edge technologies. This foundation will allow Atrium Health to lay the groundwork for our soon-to-be constructed projects such as Wake Forest University School of Medicine Charlotte and the adjacent ‘The Pearl‘ innovation district."

Through the Value Partnership model, hospitals can optimize business processes, expand capabilities and drive innovation. These innovative agreements rely on the entire Siemens Healthineers portfolio to create added value beyond equipment.

1 Value Partnership is an enterprise service offering from Siemens Healthineers.

On November 28, 2022 Strand Therapeutics, the programmable mRNA company developing curative therapies for cancer and other diseases, reported it has added an additional $45M to its Series A financing round, bringing the total amount raised in the Series A to $97 million (Press release, Strand Therapeutics, NOV 28, 2022, View Source [SID1234624513]). New investor FPV led the round, with participation from Eli Lilly and Company, Potentum Partners, and existing investors Playground Global, and a further unannounced syndicate.

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The funding will be used to advance Strand’s first drug candidate, a programmable mRNA therapy for solid tumor immuno-oncology into Phase 1 clinical trials next year. The funds will also be used to further develop its systemic delivery mechanism, which is designed to deliver tumor microenvironment-modifying mRNA to tumor sites and immune cells. To support these efforts, Strand will expand its multidisciplinary team across biology, bioengineering, bioinformatics, manufacturing, automation, and various G&A functions.

Strand’s mission is to improve the efficacy, safety, ease of delivery and cost-effectiveness of treatments for deadly and chronic illnesses, through the use of long-acting programmable mRNA-based therapeutics that can deliver multi-functional treatments. mRNA therapeutics sense biomarkers found in cancer cells and express proteins only inside cancer cells. Strand is developing a pipeline of programmable, long-acting mRNA therapeutics that will be delivered in nanoparticles. The result is the ability to precisely control the location, timing, and expression level of mRNA within the patient, which is expected to have a better safety profile.

"We raised this round at a step-up valuation from several of the most reputable global investors in the industry," said Jake Becraft, Ph.D., CEO & Co-Founder, Strand Therapeutics. "The idea behind Strand and programmable mRNA in cancer, is to stimulate an immune response against the tumor using messenger RNA. With support from a world-class investor consortium, we are set to accelerate clinical development for our lead candidate in oncology with first-in-human data expected shortly following trial initiation. Our technology will enable mRNA to reach its full potential and expand beyond the scope of vaccines into a rigorous therapeutic modality."

"Strand is bringing the promise and potential of messenger RNA-based therapeutics beyond vaccines to treat some of the hardest diseases to target such as cancer," said Pegah Ebrahimi, Co-Founder & Managing Partner of FPV. "mRNA is a future cornerstone of medicine, and Strand is on an ambitious path to push the industry beyond the challenges of traditional mRNA technologies with their precision. The convergence of biology and technology with next-generation programmable mRNA will fuel new opportunities for this ground-breaking technology to improve human lives, beginning with the millions of patients with cancer who desperately need new therapies with better efficacy and safety. We could not be more thrilled to back this remarkable team."

"The COVID-19 vaccines introduced the world to the astounding promise of mRNA therapeutics. While these vaccines literally saved the world, they represent "mRNA 1.0" which suffers from poor expression and nonspecific targeting of diseased tissues which have severely limited the scope of use," said Jory Bell, General Partner at Playground. "Over a decade ago, scientists at MIT began developing a synthetic biology solution to enable truly programmable drugs with the ability to target diseased tissues while avoiding healthy tissues. Those scientists eventually founded Strand Therapeutics to realize the full potential of "mRNA 2.0" and we are thrilled to continue to support Strand in its mission to bring precision mRNA therapies to patients."

Strand genetically programs logic circuits that control the location, timing, and intensity of expression of therapeutic proteins within the patient’s body, to enable the precise and controlled delivery of multiple disease treatments in an RNA-modality agnostic manner. Such genetic programming enables Strand’s mRNA to sense and implement cell-type specific expression by sensing and classifying the unique microRNA expression signatures of cells. The company signed a partnership deal with BeiGene to develop and commercialize multi-functional mRNA treatments for solid tumors.

On November 28, 2022 CytoSite Bio, a company developing precision imaging products that determine patient response to immuno-oncology therapy reported that shared new data at the Radiological Society of North American (RSNA) Annual Meeting in Chicago, IL (Press release, Cytosite Bio, NOV 28, 2022, View Source [SID1234624512]). In an oral presentation titled "Interim analysis of a first-in-human first-in-class phase I study of Granzyme B PET imaging for assessing single agent immune checkpoint inhibition response in melanoma and non-small cell lung cancer," data showed that CytoSite’s Granzyme B (GzmB) PET imaging using [68Ga-NOTA]-hGZP (CSB-111) was feasible and safe in human subjects. These data come from a Phase I trial assessing the safety and feasibility of GzmB PET imaging in subjects with melanoma and non-small cell lung cancer (NSCLC) receiving KEYTRUDA (pembrolizumab).

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"The interim analysis of data in the first eight subjects who underwent imaging from this study clearly demonstrates the promise of Granzyme B PET imaging as a tool to optimize cancer immunotherapy treatment decisions," said Ryan Sullivan, MD, Associate Professor of Hematology & Oncology at Massachusetts General Hospital and Principal Investigator of the study. "This non-invasive approach has the potential to inform physicians of the efficacy of the immunotherapy within weeks of the first immunotherapy dose rather than waiting for several months and often multiple scans to confirm response or progression, allowing for a rapid change in treatment which could save lives and transform the immune-oncology landscape. I am pleased that these early, promising data are showing how that option could become a reality."

CSB-111, a radiopharmaceutical which identifies Granzyme B released from the NK and T-Cells in the tumor, was shown to have favorable biodistribution and rapid clearance. Interim analysis of the first eight subjects showed that all tolerated the imaging well. As expected, subjects that showed robust uniform uptake above the blood pool in the lesions showed treatment response to ICI with continued disease remission during the 6-month follow-up, while subjects with low-level lesion uptake clearly below the blood pool level had progression on therapy.

"The data presented today validate CytoSite’s belief that our work to use PET imaging to detect Granzyme B has the potential to transform outcomes in immuno-oncology," said Jim Jenson, PhD, Co-founder and CEO of CytoSite. "If approved, our proprietary biomarker and approach to imaging could provide better tools for our oncologists to enable improved outcomes for patients with cancer and rapidly expanding options for new immunotherapies. These data represent a fantastic step toward our ultimate goal, and we look forward reporting results from our Phase 1/2 study upon study completion."

On November 28, 2022 Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company reported a late-breaking presentation of concurrent combination results of adagrasib and pembrolizumab in first line advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation (Press release, Mirati, NOV 28, 2022, View Source [SID1234624511]). Findings will be presented on December 7 at the 2022 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology (ESMO IO) Annual Congress as an oral presentation from 2:15 p.m.-2:25 p.m. CET / 8:15 a.m.-8:25 a.m. ET (Presentation #LBA4) during the "Proffered Paper session 1" session of the congress .

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Mirati Therapeutics will host a Virtual Investor Event following the session on Wednesday, December 7, 2022 at 5:00 p.m. CET / 11:00 a.m. ET / 8:00 a.m. PT.

Investors and the general public are invited to access the live webcast of the presentation at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 888-254-3590, confirmation code: 1294615. A replay of the presentation will be available approximately 2 hours after the event has ended at the same website.

On November 28, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer (CMBC) (Press release, Kintara Therapeutics, NOV 28, 2022, View Source [SID1234624510]).

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REM-001 was studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to-date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is focused on securing the funding necessary to restart a 15-patient study in CMBC patients in advance of a Phase 3 study.

"The receipt of Fast Track Designation represents an important regulatory milestone for our REM-001 Therapy program," said Robert E. Hoffman, President and CEO of Kintara. "We believe this designation is a key component of our future clinical and regulatory strategy as we continue to seek funding, in particular grants, to restart REM-001 clinical development as soon as possible."

Dennis Brown, Ph.D., Chief Scientific Officer of Kintara added, "This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address CMBC. We have extensive data in hand to support the advancement of this clinical program and look forward to the continued investigation of our drug candidate in the next study as planned."

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Some of the significant benefits of FTD include:

Enhanced access to the FDA including opportunities for more frequent meetings and written consultation throughout the remaining development of REM-001.

Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval.

FTD also allows for ‘rolling review’ where Kintara may submit completed sections of the REM-001 NDA as they become available rather than at the end of development.