On September 23, 2021 AstraZeneca reported that has reached an agreement to collaborate with VaxEquity for the discovery, development and commercialisastion of the proprietary self-amplifying RNA (saRNA) therapeutics platform developed at Imperial College London (Press release, AstraZeneca, SEP 23, 2021, View Source [SID1234590197]).

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The strategic, long-term research collaboration aims to optimise and validate VaxEquity’s saRNA platform and apply it to advance novel therapeutic programmes. AstraZeneca will support VaxEquity with research and development funding and should AstraZeneca advance any of the research programmes into its pipeline, VaxEquity could receive development, approval and sales based milestones totalling up to $195 million and royalties in the mid-single digits per programme. AstraZeneca has the option to collaborate with VaxEquity on up to 26 drug targets and will also make an investment in VaxEquity to further the development of the saRNA platform.

VaxEquity was founded by Imperial College London and Morningside in 2020 based on the innovative saRNA technology developed by Professor Robin Shattock and his colleagues at Imperial College London, UK.

saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level. This has the potential to allow saRNAs to be delivered at lower concentrations than conventional mRNA therapeutics, leading to less frequent or lower dosing, lower costs and a much broader range of potential applications. The saRNA platform aims to underpin the next generation of RNA-delivered medicines enabling not only vaccines but also broad range of therapeutic applications.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said "This collaboration with VaxEquity adds a promising new platform to our drug discovery toolbox. We believe self-amplifying RNA, once optimised, will allow us to target novel pathways not amenable to traditional drug discovery across our therapy areas of interest."

Michael Watson, Executive Chairman of VaxEquity, said, "We are delighted to collaborate with AstraZeneca given its strong track record in innovation and welcome them as a new investor. We are also grateful for the ongoing support of our existing investor, Morningside Group. With our self-amplifying RNA platform, we aim to underpin the next generation of RNA-delivered medicines enabling not only vaccines but also broad range of therapeutics applications."

Professor Alice Gast, President of Imperial College London, said: "I am deeply proud of my colleagues’ work in pioneering self-amplifying RNA technology. This collaboration will help realise our ambition of building a lasting legacy from the great scientific advances Imperial made in this pandemic."

On September 23, 2021 Carevive Systems (Carevive), the leading oncology-focused health technology company centered on understanding and improving the experience of patients with cancer, reported Carevive SMART Data, a dataset containing information from patients about their experience with treatment, combined with demographic and clinical data (Press release, Carevive Systems, SEP 23, 2021, View Source [SID1234590229]).

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As the healthcare industry becomes more saturated with big data, the search continues for data that can inform decisions that positively impact the experience and outcomes of patients with cancer. Big data, defined by large datasets with substantial numbers of patients and a wide array of clinical and claims data, can support certain types of statistical analyses. However, these datasets are limited because their datapoints are discrete, providing only sequential snapshots of a patient’s health status, without a more continuous assessment of the patient’s experience on treatment, which can only originate from the patients themselves.

In response to the need for this type of dataset, Carevive uses its digital oncology platform to collect information from patients about their experience at weekly time points during treatment. These data are combined with demographic and clinical data to create Carevive SMART Data (Symptom Monitoring with Applied Remote Technology).

Carevive SMART Data are captured as part of Carevive OPT-IN. Carevive OPT-IN, the Oncology Pragmatic Trial Investigator Network, enables patient experience data to be collected from real-world patients who are receiving treatment for cancer. Carevive OPT-IN began in late 2020 to amplify the patient voice in their own care and improve their outcomes. Carevive SMART Data are collected as part of an ongoing, weekly conversation between the patient and their care team, facilitated by Carevive’s cloud-based, digital oncology platform that patients can access with a variety of devices, from any location. Providing patients with remote symptom monitoring enables longitudinal data to be collected describing the holistic patient experience, including symptoms, quality of life, physical function, and healthcare resource utilization.

Licenses to Carevive SMART Data are available for life science companies who would like to analyze patient-centric data combining longitudinal patient-reported outcomes (PRO) with EHR-derived clinical data. By listening to the patient’s voice in cancer care, Carevive can now address many important questions about the patient experience in cancer which have not been answered by big data.

Mordecai Kramer, Carevive’s Vice President of Data Generation & Outcomes, Life Sciences, summarizes the value of this novel dataset as follows: "We are excited about Carevive SMART Data and the holistic view of the patient experience that it provides. Since launching our registries, we are already seeing the value this longitudinal dataset creates for improving patient care and outcomes. We invite life science companies to join the Carevive SMART Data conversation and, together, answer pressing questions about real-world patients with cancer."

If you would like to learn more about Carevive SMART Data, please visit the website.

On September 23, 2021 bioAffinity Technologies, a privately held biotech company, reported that the Australian Patent Office issued a Notice of Acceptance for bioAffinity subsidiary OncoSelect’s patent protecting compositions and methods to treat cancer using chemotherapeutic agents conjugated to porphyrins, resulting in targeted delivery of the drugs (Press release, BioAffinity Technologies, SEP 23, 2021, View Source [SID1234590228]).

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"bioAffinity is focused on being the leader in research, development and commercialization of porphyrin-based diagnostics and therapeutics to detect cancer early and treat cancer specifically"

The patent, titled "Porphyrin Compounds and Compositions Useful for Treating Cancer," will be the Company’s first awarded therapeutic patent. In addition to the Australian patent, bioAffinity and its subsidiary OncoSelect have 18 patent applications filed to protect therapeutic discoveries. bioAffinity also holds 17 awarded patents and eight patent applications related to its porphyrin-based diagnostic platform.

"bioAffinity is focused on being the leader in research, development and commercialization of porphyrin-based diagnostics and therapeutics to detect cancer early and treat cancer specifically," said bioAffinity President and CEO Maria Zannes. "We successfully developed our highly accurate CyPath Lung test for the early detection of lung cancer. Our test is based on the fluorescent porphyrin TCPP’s remarkable ability to bind to cancer and cancer-associated cells that can be detected by flow cytometry using automated analysis."

bioAffinity’s research to support the CyPath diagnostic platform has led to multiple discoveries related to cancer therapeutics, including use of novel compositions to attach chemotherapy drugs to porphyrins for targeted delivery into the tumor cell, with a much less deleterious effect on normal cells. Yet another discovery has led to the successful use of RNA interference to knock down expression of two genes that results in killing cancer cells with little or no effect on normal cells.

"We have built upon our diagnostic research to develop a diverse number of targeted therapeutics and provide novel life-saving strategies in the fight against cancer," Zannes said. "The Notice of Acceptance of this patent application not only protects our groundbreaking discoveries but also validates the strength of our science."

On September 23, 2021 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in aggressive cancers, reported that Chief Executive Officer, Zachary Hornby, will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Wednesday, September 29th, 2021, from 1:20-1:50 p.m. ET (Press release, Boundless Bio, SEP 23, 2021, View Source [SID1234590227]).

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On September 23, 2021 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an emerging RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, reported that preclinical research supporting its lead candidate, TTX-MC138, was published in Cancer Nanotechnology (Press release, TransCode Therapeutics, SEP 23, 2021, View Source [SID1234590226]). The article, entitled "Radiolabeling and PET-MRI microdosing of the experimental cancer therapeutic, MN-anti-miR10b, demonstrates delivery to metastic lesions in a murine model of metastatic breast cancer," resulted from research conducted at the Athinoula A. Martinos Center for Biomedical Imaging in the Department of Radiology at Massachusetts General Hospital and Harvard Medical School.

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This preclinical study developed a radio-labeled derivative of TTX-MC138 (referenced as MN-anti-miR10b) tagged with Cu-64, enabling highly sensitive and specific quantitative determination of its pharmacokinetics and biodistribution, as well as observation of delivery to metastases via noninvasive positron emission tomography-magnetic resonance imaging (PET-MRI). The key results of the study demonstrated that TTX-MC138, when injected intravenously, accumulated in metastatic lesions. These results suggest that TransCode’s TTX platform delivers its therapeutic candidate as intended and the company believes supports clinical evaluation of TTX-MC138. In addition, the investigation describes the development of a microdosing PET-MRI approach that could potentially be used for measurement of TTX-MC138 biodistribution in cancer patients and its delivery to clinical metastases. The capacity to carry out microdosing PET studies in patients under an exploratory investigational new drug application protocol would represent an important step on the path to clinical translation because it could facilitate and expedite approval from the U.S. Food and Drug Administration (FDA) for initial human studies.

"Our TTX technology builds upon prior experience with similar iron oxide nanoparticles that have long been used in humans for imaging, potentially enabling clinical studies that may de-risk future clinical trials by demonstrating successful drug delivery and assist in patient selection for future treatment," said Michael Dudley, CEO of TransCode Therapeutics. "For TransCode, we believe this study further confirms the pharmacokinetic profile of TTX-MC138, supporting the viability of our platform for delivery of RNA-based therapy to metastatic solid tumors. Our preclinical data further suggest the therapeutic potential of TTX-MC138, and we look forward to our Phase 0 study which has the potential to establish clinical proof-of-concept for this therapy."

TransCode expects to file an exploratory investigational new drug (eIND) application for TTX-MC138 in the first quarter of 2022 to support a Phase 0 study in patients with metastatic cancer. Under an eIND, FDA approval may be obtained more quickly and at lower cost than with a traditional IND for therapeutic agents.