On July 6, 2023 REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, reported Hua Nan Securities as the lead underwriter for its upcoming initial public offering (IPO) in Taiwan (Press release, REGimmune, JUL 6, 2023, View Source [SID1234642232]). The IPO is anticipated to take place in 2025, signifying an important milestone in REGiMMUNE’s expansion and entry into the Taiwanese financial market.

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REGiMMUNE Limited’s core technology stems from Riken, a renowned national research institute based in Japan. Our main area of concentration revolves around pioneering immunotherapies that regulate regulatory T cells, also known as Tregs. In 2006, we were founded in Japan, and subsequently REGiMMUNE group has reorganized its Taiwanese entity, REGiMMUNE Limited, to become the holding company for the entire group, and now owns 100% of REGiMMUNE Corporation, its Japanese subsidiary, and REGiMMUNE Inc, its U.S. subsidiary. Our company’s fundamental philosophy, "From Care to Cure for Immune Disorders," highlights our commitment to not only the care of immune diseases but also their cure.

REGiMMUNE Limited provides innovative therapeutic solutions to patients with autoimmune diseases and cancer through its reVax technology platform and antibody drugs. The lead program, RGI-2001, has the potential to be a first-in-class small molecule drug for preventing acute graft-versus-host disease (aGvHD), a fatal complication of allogeneic hematopoietic stem cell transplantation that results in rejection, by enhancing current therapeutic approaches with a novel mechanism. RGI-2001 was selected for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2022 and is planned to be submitted to the FDA for Phase III IND and begin discussions on Fast Track Designation and Breakthrough Therapy Designation, which will be awarded to breakthrough drugs. In the final quarter of 2023, with clinical trials scheduled to commence in the third quarter of 2024.

In March 2023, a licensing agreement regarding RGI-2001 was signed between REGiMMUNE and SanFu Biotech, which is a subsidiary of SanFu Chemical Group. This agreement grants SanFu Biotech the exclusive rights to develop and commercialize RGI-2001 in Asia. SanFu Biotech is considered a valuable strategic partner by REGiMMUNE in the Asian market due to their extensive resources in the biotechnology and biomedical sectors, as well as its exceptional innovative strategies. REGiMMUNE is excited to collaborate with SanFu Biotech to accelerate the progress of RGI-2001 in this significant market.

Taiwan’s biomedical sector boasts a robust clinical trial infrastructure, favorable access to capital markets, extensive research and development capabilities, and a vast human biological database. With steadfast government backing, Taiwan has established itself as a leader in Asia’s biotechnology and medical sector. REGiMMUNE is committed to harnessing Japan’s proficiency in fundamental research and Taiwan’s complete industrial ecosystem in applied research and development to maximize the commercial potential of fundamental research and foster mutually beneficial business opportunities. We are thrilled to partner with Taiwan’s biotech industry to explore the global market and aspire to become the first Japanese novel drug research firm to be listed in Taiwan and embody Taiwan-Japan collaboration in the biotech field, with the support of the officers and colleagues at all levels in Hua Nan Securities.

On July 6, 2023 Simcha Therapeutics ("Simcha"), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, reported that the first patient has been dosed in a Phase 1/2 clinical trial of ST-067, Simcha’s decoy resistant IL-18 agent, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced solid tumors (Press release, Simcha Therapeutics, JUL 6, 2023, View Source [SID1234633098]).

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The Phase 1/2 open-label, dose-escalation study is evaluating ST-067 in combination with pembrolizumab in a variety of solid tumors (NCT04787042). The objective of the study is to determine the maximum tolerated dose (MTD), the recommended Phase 2 dose (R2PD) and preliminary activity of ST-067 in combination with pembrolizumab. Secondary endpoints include assessment of safety, pharmacokinetics, pharmacodynamics and immunogenicity.

"We have observed encouraging anti-tumor activity in preclinical studies combining our decoy-resistant IL-18 with PD-1 inhibitors, and we look forward to now studying this combination in the clinic," said Sanuj Ravindran, M.D., CEO of Simcha Therapeutics. "KEYTRUDA has become the standard of care for many cancer patients, and we believe adding ST-067 could further improve clinical outcomes. This combination has the potential to become a powerful new therapeutic option for patients and physicians."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ST-067

ST-067 is the first "decoy-resistant" variant of IL-18, designed to be impervious to the decoy receptor IL-18BP, which blocks IL-18 from interacting with its receptor. ST-067 has been shown in preclinical studies to maintain strong immune stimulation in the tumor microenvironment and is currently in Phase 1/2 clinical development as both a monotherapy and in combination with KEYTRUDA (pembrolizumab).

On July 6, 2023 Tempus, a leader in artificial intelligence and precision medicine, reported a new collaboration to develop a companion diagnostic (CDx) test with TScan Therapeutics, a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of cancer patients (Press release, Tempus, JUL 6, 2023, View Source [SID1234633097]). The collaboration supports TScan’s screening protocol for its Phase 1 solid tumor clinical trial which is designed to enable customized mixtures of TCR-Ts to be administered to patients based on tumor antigen positivity and intact HLA expression.

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TCR-Ts genetically reprogram a patient’s immune system to recognize and fight their cancers. TScan plans to enroll patients with solid tumors including non-small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and cervical cancer. Up to 40% of these tumors lose half of their HLA genes, which is a frequent and overlooked cause of resistance to immunotherapies such as TCR-Ts. TScan is collaborating with Tempus to use the xT assay, Tempus’ 648-gene panel, to prospectively identify patients with HLA loss in the tumor to select TCR-Ts that recognize HLA genes still intact in the patient’s tumor.

"Utilizing the assay developed in collaboration with Tempus will help determine if the clinical trial participants’ tumors have undergone partial HLA loss and so will enable us to choose the most appropriate TCR-Ts that are customized for the patient’s tumor antigens and preserved HLA genes," said Debora Barton, M.D., Chief Medical Officer at TScan. "The breadth and depth of selection criteria in this study, including the Tempus companion diagnostic, has the potential to help a significant number of patients across multiple solid tumor types through identification of patients most likely to respond to TCR-T treatment."

"This CDx work is unique because we’re looking for information that’s not currently in the list of readouts you typically receive from next-generation sequencing of a solid tumor," said Michael Yasiejko, Executive Vice President at Tempus. "Tempus is uniquely positioned to develop a custom pipeline to extract information from standard tests that need to guide TCR-T therapy development and ultimately help identify patients that may benefit from these therapies."

On July 6, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported the publication of a review of the company’s clinical development program evaluating CMN-001, a dendritic cell-based immunotherapy electroporated with autologous tumor RNA to treat metastatic renal cell carcinoma (mRCC) (Press release, CoImmune, JUL 6, 2023, View Source [SID1234633095]). The review is published in Human Vaccines & Immunotherapeutics, a peer-reviewed journal sponsored by the International Society for Vaccines.

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"Engineering dendritic cells to treat cancer is a long sought-after goal for cell-based immunotherapies," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "CMN-001 is specifically designed to elicit an adaptive T-cell response against the antigens present in the patient’s own tumor tissue. With more than two decades of clinical experience with CMN-001, we are implementing lessons learned for a new study that reflects the changing landscape of therapies available to treat mRCC. We have an exciting opportunity to combine and sequence therapies with three distinct mechanisms of action and look forward to advancing this development program."

The publication, titled, "A review of the clinical experience with CMN-001, a tumor RNA loaded dendritic cell immunotherapy for the treatment of metastatic renal cell carcinoma," reviews the early clinical development of CMN-001, including a previously completed multicenter Phase 3 clinical trial that demonstrated synergy between CMN-001 and an mTOR blocker, everolimus, in a retrospective data analysis.

CoImmune has designed an ongoing randomized Phase 2b clinical trial that builds on the mechanism of action of CMN-001 and underlying immune and clinical outcomes observed. In this trial, CMN-001 is being combined with first-line checkpoint inhibition therapy and second line lenvatinib/everolimus in poor-risk mRCC patients. The trial is actively recruiting with plans to enroll 90 patients.

"Clinical trials employing antigen-loaded dendritic cells have been shown to be safe and provide positive clinical benefit in small proportions of patients, and we are looking for ways to improve the overall efficacy to attain durable clinical responses," said Mark DeBenedette, Ph.D., Vice President of Research and Development of CoImmune. "Based on the surprising benefit of everolimus as a subsequent second-line therapy revealed in a retrospective analysis of more than 90 patients – a benefit that only manifested if subjects were administered CMN-001 – we have a rationale for evaluating this combination further in poor-risk mRCC patients who have limited treatment options today."

On July 6, 2023 Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, reported the completion of patient enrollment for its Phase III bridging clinical trial of Hexvix, a drug used for the diagnosis of bladder cancer (Press release, Asieris Pharmaceuticals, JUL 6, 2023, View Source [SID1234633094]).

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The study is a prospective, self-controlled, multicenter Phase Ⅲ trial aimed at investigating the additional detection rate and safety of Hexvix and blue light cystoscopy (BLC) versus white light cystoscopy in patients with non-muscle invasive bladder cancer (NMIBC) including tumors with stage carcinoma in situ (CIS), Ta, and T1.

This study is led by Peking Union Medical College Hospital and the Chinese Academy of Medical Sciences. Professor Li Hanzhong, head of the Department of Surgery at Peking Union Medical College Hospital, serves as the Principal Investigator to lead a team of top experts in the field of bladder cancer in China to carry out this study. The company will closely track the subsequent progress of this clinical trial.

In January 2021, Asieris entered into a license agreement with Photocure ASA (Photocure, OSE:PHO), a bladder cancer specialty company based in Oslo, Norway, to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan.

In December 2021, Hexvix was put into pilot use in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province and the first prescription in China was issued at Hainan General Hospital, with the first patient operated successfully. It received approval from the National Medical Products Administration (NMPA) for phase III clinical trials in the first quarter of 2022 and was included in the real-world clinical data pilot program.

"Completing patient enrollment for the Phase III bridging clinical trial of Hexvix marks a significant milestone for Asieris Pharmaceuticals." said Dr. Linda Wu, Chief Development Officer of Asieris," We are thrilled to have reached this stage in the development of a drug that has the potential to revolutionize the diagnosis of bladder cancer. Our goal is to provide healthcare professionals with a more effective and reliable way for patient with bladder cancer."