On August 8, 2023 Race Oncology Limited ("Race") reported to shareholders with a strategic update, including an overview of revisions to corporate strategy, designed to optimise use of existing resources, while driving bisantrene’s commercial partnering and collaboration potential (Press release, Race Oncology, AUG 8, 2023, View Source [SID1234633884]).

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Key highlights:

New corporate strategy launched, detailing Race’s optimised clinical program and key areas of discovery, placing Race at the heart of cancer care
Lead clinical focus on investigating anti-cancer, plus cardio-protective and FTO properties in metastatic breast cancer, using the peripherally administered bisantrene formulation, RC220 with a view to improving therapeutic outcomes and heart health for patients with cancer
Secondary focus on pursuing increased anti-cancer / FTO benefits of bisantrene combined with current standard of care therapies in acute myeloid leukaemia (AML)
Targeted R&D program designed to maximise bisantrene’s partnering potential
Video update, presentation and shareholder information sessions available to provide additional background and offer Q+A opportunities
Investors are also invited to visit the Interactive Announcements page in Race’s Investor Hub to submit questions View Source
Read the strategic update summary and investor presentation here.

Non-Executive Chair, Mary Harney commented: "Through the course of conducting this review of strategy, Race drew upon a rich set of insights. We further reviewed our deep historic clinical dataset, as well as many preclinical studies across a range of indications. We investigated the many market opportunities for bisantrene and engaged with key opinion leaders to inform our view of unmet patient need. Finally, and of critical importance, we reviewed the paths to market which would position our lead asset most strongly with potential partners.

This strategic update delivers committed and planned programs, designed to optimally leverage bisantrene RC220’s potential in the areas of anti-cancer, cardio-protection and FTO inhibition. This has been a significant body of work – I thank the Race team for their dedication in driving toward the best outcome and am also grateful for the ongoing interest and support of our shareholders."

Race CEO and Managing Director, Damian Clarke-Bruce commented: "Race’s revised development program has been designed in such a way that our new bisantrene formulation can fit straight into a global pharmaceutical partner’s pipeline. Through our rigorous clinical development plan, Race will investigate bisantrene RC220 in both metastatic breast cancer and continue our clinical experience in AML, while investigating and expanding our knowledge of its mechanism of action. We have a clear regulatory pathway and a program that is supported by international key opinion leaders, for a drug candidate which has already been shown to improve patients’ lives.

We look forward to presenting the strategy to existing and potential new shareholders over the coming weeks as we seek to advance our position as a commercial partner with a life-changing therapeutic asset in bisantrene RC220."

On August 7, 2023 Aichi Cancer Center and NEC Corporation’s research group with Gifu University, Toyama University and Kitasato University Medical Center, reported to have developed a method for efficiently identifying the lung cancer antigens and the antigen-specific T cells that recognize the antigens through both a single-cell analysis of Tumor Infiltrating Lymphocytes (TILs) and NEC’s AI-based antigen prediction system that predicts immune response (Press release, NEC, AUG 8, 2023, View Source [SID1234633878]). Our paper describing the results of this study was published on August 6, 2023 in the "Journal for ImmunoTherapy of Cancer," which is the official journal of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in the United States.

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■ Research Background
Lung cancer is one of the most common cancers and one of the leading causes of cancer death worldwide. There are many types of cancer treatment, such as surgery, chemotherapy, radiation therapy, molecular targeted therapy, immunotherapy, and combinations of these. Recently developed immune checkpoint inhibitors (ICI) have attracted attention as a new therapy, and lung cancer is one of the most sensitive cancers to ICI, but it is effective in only a subset of individuals. Accordingly, new effective immunotherapies are required for lung cancer.

Cytotoxic T lymphocytes (CTLs) in TIL are crucial immune cells that can specifically recognize and eliminate tumor cells. Antigens targeted by CTL include patient-specific neoantigens and common antigens commonly expressed among patients such as cancer-testis antigens (CTA). In general, it is not easy to identify any antigens. If these antigens can be efficiently identified, a combination therapy with ICIs and antigen-specific immunotherapy may enhance the efficacy of treatment.

■ Contents and results of this research
In this study by Aichi Cancer Center and NEC, we performed a single-cell analysis to determine the TILs characteristics of patients with surgically resected non-small cell lung cancer (NSCLC) (n=3) (Figure. 1). Then, we divided the TILs into 10 clusters based on gene expression profile, and identified the exhausted T cell cluster (Tex cluster) characterized by the expression of the genes called exhaustion markers (Figure. 2). We synthesized the TCRs contained in the identified exhausted T cell cluster and induced each of the TCRs into each corresponding T cell, and examined the immune responses to neoantigens predicted by NEC’s AI-based antigen prediction system and typical CTAs. It was confirmed that NEC’s AI-based antigen prediction system can accurately predict the antigens that cause the immune responses, and we identified four TCRs recognizing KK-LC-1 (one of the CTAs, *2), and five TCRs recognizing the neoantigens.

In addition, by re-clustering of TCR clones (n=140) that express nine TCRs, it was discovered that even antigen-specific TCR clones have different differentiation stage and functional status among individual TCR clones (Figure 4A), and that there is a bias in differentiation and function of TCRs for each antigen.

TIL single-cell analysis and AI to predict cancer antigens will facilitate the identification of lung cancer antigens and may lead to the development of personalized cancer vaccine therapies and engineered T cell therapies in NSCLC in the future.

■Researcher’s comment

Dr. Hirokazu Matsushita, Chief, Division of Translational Oncoimmunology, Aichi Cancer Center
In collaboration with NEC and leading research institutes, the Aichi Cancer Center has developed a procedure for efficiently identifying antigens and antigen-specific T cells using surgical samples from patients with cancer. Looking ahead, we will add a spatial analysis of the cancer microenvironment that contains antigens and antigen-specific T-cells to this system to further clarify the nature of the T-cells infiltrating the cancer. In addition to aiming to develop innovative cancer immunotherapies from these studies, we will apply the knowledge gained to other cancers as well.
Yoshiko Yamashita, Ph.D. Senior Professional, AI Drug Development Division, NEC Corporation
NEC is conducting clinical trials of personalized cancer vaccine therapies targeting neoantigens. We believe that we have taken a step forward in realizing even more sophisticated personalized cancer vaccine immunotherapies and engineered T cell therapies by using a method to identify antigen-specific T cells constructed in this study and an Attentive Variational Information Bottleneck (AVIB) method (*3) to predict interactions between TCRs and antigens using AI newly developed by NEC. We will continue to accelerate research and development to provide effective treatments to patients.

■Research support

Aichi Cancer Center Priority Project Research
NEC Corporation
Subsidy Program for Scientific Research by the Japan Society for the Promotion of Science
Japan Respiratory Foundation
Uehara Memorial Life Science Foundation

On August, 7, 2023 DotBio, the biopharmaceutical company pushing the boundaries of antibody therapeutic modalities to bring more effective therapies to patients, reported the closing of a USD 5.6 million Pre-Series A financing round (Press release, DotBio, AUG 7, 2023, View Source [SID1234646735]). The oversubscribed round was led by specialist life sciences investors Proxima Ventures, Gaorong Capital and AIM-HI Accelerator Fund.

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The funds will be used to commence pre-clinical studies, including animal efficacy and Chemical, Manufacturing and Controls studies, that will validate DotBio’s therapeutic candidates ahead of future clinical development. In addition, DotBio’s proprietary, modular DotBody platform will be scaled and automated to allow for the screening of thousands of multi-functional antibody prototypes against diverse extracellular and intracellular immune-oncology targets that are suited as next-generation clinical candidates.

Proxima Ventures, a specialist seed-to-growth healthcare Venture Capital firm based in Shanghai, led the financing. Haolin Sung, EMBA, a serial biotech entrepreneur and Partner of Proxima Ventures, joins DotBio as a member of the Board. Gaorong Capital is focused on early and growth-stage investments, with a specialty in new consumption, new technology and healthcare. Dr Beilin Le, PhD, an Executive Director of Gaorong Capital’s Healthcare Division, will join DotBio as a Board Observer. Dr Sujuan Ba, PhD, Co-Founder and CEO of AIM-HI Accelerator Fund, a US-based global not-for-profit organization dedicated to promoting breakthrough technologies and therapies in the cancer space, will join DotBio as a Strategic Advisor.

Ignacio Asial, Chief Executive Officer at DotBio, commented: "We are pleased to be supported by leading life science investors to close our pre-Series A financing round, allowing us to accelerate the development of our internal pipeline of multi-functional antibodies with the potential to treat a wide range of cancers and improve patient lives. We are making significant progress in developing intracellular antibody therapies, work that was highlighted in our Nature Communications publication in 2022. This round will allow us to accelerate these efforts, with the aim of revolutionizing how we target intracellular oncogenes. With partnered programs expected to enter the clinic in the near future, our humanized domain antibody continues to be de-risked, allowing us to develop more ambitious therapeutic modalities. I’m very pleased to welcome Mr. Haolin Sung to our Board of Directors, whose global experience in biotech venture creation, management, and funding will be of great value as we enter this next phase of growth."

Haolin Sung, Partner at Proxima Ventures, replied: "I’m pleased to work with the DotBio team at a time when new, multi-targeted therapeutic modalities are gaining global momentum and pushing the boundaries of what is possible in therapeutic discovery. DotBio’s approach to identifying and derisking multi-specific antibodies by comparing thousands of prototype molecules in a data-driven approach is at the cutting edge of science. I’m excited about the Company’s modular technology platform and believe it will open up unprecedented possibilities for patients around the world through the facilitation of rapid prototyping of potential new therapies that target both extracellular and intracellular disease drivers. I look forward to supporting the company on its mission to deliver more effective oncology therapies that can reach patients faster."

Beilin Le, Executive Director at Gaorong Capital, added: "The DotBio team has demonstrated that their humanized domain antibody technology platform is unique, differentiated, and has the potential to revolutionize the multi-functional antibody space. Their partnerships with CStone Pharmaceuticals, Junshi Biosciences, and Uni-Bio Science Group highlight the company’s value and expertise. Remarkably, DotBio’s out-licensing of a DotBody module to Junshi Biosciences in 2022 resulted in the rapid development of JS207, a bi-specific antibody for oncology indications, which has already progressed to Investigational New Drug (IND) filing in 2023. As JS207 moves through clinical trials, it will further validate the effectiveness of DotBody technology. I can’t wait to see the company scale and advance its internal pipeline".

On August 7, 2023, Huihe Biotechnology (CytoCares) reported that the company conducted CC312 at the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) for the treatment of relapsed/refractory patients The Phase I first-in-human trial in adult patients with CD19-positive B-cell malignant hematological tumors has completed the enrollment and administration of the first patient (Press release, CytoCares, AUG 7, 2023, View Source [SID1234635269]). Judging from the current clinical safety testing data of the first patient, the first patient tolerated it well and did not take the drug. Related adverse events occurred. The hospital and the sponsor will strictly follow the plan to conduct DLT observation and safety assessment. The main purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of CC312, and to determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CC312. As a globally innovative clinical project, its safety research is crucial to the drugability of the CC312 project.

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CC312 is the first drug for clinical use developed on the first T cell activation platform independently developed by Huihe Biotech. It is a triple drug that targets B cell surface antigen CD19, T cell antigen CD3 and T cell costimulatory molecule CD28. Specific T cell adapter (TriTE ). CC312 can form a bridge between tumor cells (B cells) and T cells, and coordinately regulates T cells by activating the CD3 signaling pathway of T cells and the costimulatory signal CD28 pathway, inducing long-lasting and sustained T cell activation, making T cells Kill tumor cells more effectively.

Preclinical studies have shown that CC312 exhibits significant anti-tumor activity in tumor cell lines expressing CD19 antigen, and is expected to provide better treatment options for patients with CD19+ refractory/relapsed B-cell malignancies. In addition, preclinical safety data indicate that CC312 is well tolerated in Hu-HSC mice and cynomolgus monkeys, and no administration-related toxicological abnormalities were observed in histopathological studies.

Mr. Huang Yingfeng, CEO of Huihe Biotech , said: "The current treatment of B-cell malignant hematological tumors cannot fully meet clinical needs, and there is an urgent need to research new treatment methods. We are very pleased to have completed the enrollment of the first patient with CC312, which is consistent with expectations. The patient’s medication process went smoothly and post-administration observation is ongoing. We will continue to rapidly advance the clinical research of CC312 and look forward to bringing safer and more effective treatment options to patients as soon as possible."

On August 7, 2023 Hubro Therapeutics reported that NOK 41,1 mill has been raised in a private placement (Press release, Hubro Therapeutics, AUG 7, 2023, View Source [SID1234635192]).

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The funds will be used to continue the company’s development of lead candidate vaccine FMPV-1, adjuvant GM-CSF and companion diagnostics, as well as preparing for initiation of the phase 2 study with FMPV-1/GM-CSF in MSI-colorectal cancer.