On September 23, 2021 Akeso, Inc. (the Company, 9926.HK) reported that the National Medical Products Administration (the NMPA) of China has officially accepted the new drug application for the world’s first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104) for the treatment of relapsed or metastatic cervical cancer, which has received priority review. Cadonilimab, independently developed and manufactured by the Company, is the first PD-1 based bi- specific antibody drug in the world to submit new drug application (Press release, Akeso Biopharma, SEP 23, 2021, View Source [SID1234590230]).

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Cadonilimab is the second innovative antibody drug of the Company to submit the new drug application and the fifth new drug application submitted by the Company in China and in the United States.

The clinical trial data has shown that Cadonilimab has favorable efficacy and safety profile for the treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy. Among the target indication population, Cadonilimab has shown better efficacy compared to the published data of PD-1 monoclonal antibody on the market. Relevant clinical data will be published in relevant international conferences and medical journals.

Director of Oncology and Gynecology, Fudan University Cancer Hospital, Prof. Wu Xiaohua said, "Although PD-1 monoclonal antibody for the treatment of cervical cancer indication has been approved for global market launch, but the clinical study results show that it only achieves an objective response rate of not more than 15% in second-line or more PD-L1 positive patients. The efficacy and safety data of Cadonilimab as monotherapy shown in the phase II pivotal clinical trial are encouraging. Not only does it achieve a high response rate among PD-L1 positive population, it also shows good effect in PD-L1 negative population, with a significant improvement in the median progression-free survival, offering better treatment for patients with advanced cervical cancer in China. 2030 is the critical year for both initiatives ”Global Strategy to Accelerate the Elimination of Cervical Cancer” and ”Healthy China 2030”. The Company believes that as the first self-developed bi-specific antibody drug in China, Cadonilimab will facilitate the smooth implementation of the global cervical cancer initiative and the health strategy of China as mentioned above."

Chairman-designate of Chinese Medical Association Gynecological Oncology Branch, Prof. Kong Beihua from the Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, said, "Cervical cancer has the highest incidence among gynecological malignancies in China, and patients with advanced recurrent metastatic cervical cancer are refractory to routine treatment. This represents one of the biggest challenges faced by gynecologic oncologists with significant clinical needs. The clinical efficacy of immune checkpoint inhibitors as monotherapy is not satisfactory. Despite the potential improvement in efficacy in combination with other treatments, its clinical application is greatly restricted due to severe toxic side effects. The clinical trials of Cadonilimab have demonstrated high efficacy, low susceptibility to toxic side effects as well as safe and controllable results to patients with advanced recurrent metastatic cervical cancer who have failed routine treatment. Cadonilimab has already entered the fast track designation process, this is good news for both doctors and patients, which will lead China’s oncotherapy to enter immunotherapy new era ahead of the world, as well as improve the prevention and treatment of cervical cancer in China, benefiting the patients and making good cause for celebration."

Founder, president & CEO of Akeso, Inc., Dr. Xia Yu said, "Cadonilimab is developed by scientists at Akeso with years of dedication. It is a bi-specific antibody new drug with global patent that targets simultaneously PD-1/CTLA-4 and also the first PD-1 based bi- specific antibody drug in the world to submit new drug application. We much appreciate the excellent efforts from the Akeso team, clinical research center, medical experts and departments of drug administration at all levels for this. The Company will dedicate its leading advantages in the field of bi-specific antibodies, accelerate the clinical research of Cadonilimab in other indications. We are looking forward to the advantages of Cadonilimab in the immuno-oncology therapy to benefit more oncology patients.

Milestones of Cadonilimab for treatment of cervical cancer:

July 2021, the phase III clinical trial of Cadonilimab in combination with chemotherapy for treatment of advanced cervical cancer officially initiated.

Feb 2021, the Food and Drug Administration of the United States (the FDA) granted orphan drug designation to Cadonilimab for treatment of cervical cancer.

Oct 2020, Cadonilimab for treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy was included in the list of "Breakthrough Therapy Designation" by the Center for Drug Evaluation (the CDE) under the NMPA.

July 2020, the FDA granted fast track designation to Cadonilimab for treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy.

Currently major indications of Cadonilimab include gastric cancer, lung cancer, liver cancer, esophageal squamous cancer, nasopharyngeal cancer, etc. Among which the phase III clinical trial for first-line treatment of gastric cancer has officially initiated.

About Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.

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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