On July 7 , 2022 , Shenzhen Aixindawei Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Aixindawei" or "the Company") reported that the Phase I clinical study of its independently developed AKR1C3 enzyme – activated prodrug platform targeted anti-cancer new drug AST-001 injection successfully completed the first subject enrollment and the first dose at Jilin Provincial Cancer Hospital (Press release, Ascentawits Pharmaceuticals, JUL 7, 2022, View Source [SID1234650303]).

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This study is a Phase I/II clinical study of AST-001 injection in patients with advanced malignant solid tumors conducted in China (registration numbers: CTR20220934 , CTR20220935 ). The purpose is to evaluate the safety and tolerability of AST-001 monotherapy in patients with advanced malignant solid tumors and to evaluate the pharmacokinetic characteristics and preliminary efficacy of AST-001 and its metabolites in the subjects.

Dr. Jianxin Duan, founder and chairman of Aixindawei, said: " AST-001 injection is of great significance in the company’s R&D pipeline. Multiple preclinical in vitro and in vivo studies have demonstrated that AST-001 has good safety and broad-spectrum anti-tumor activity. In addition, AST-001 has shown significant efficacy in multiple in vivo animal tumor models with high expression of AKR1C3 and KRASG12D mutations. AST-001 obtained implicit clinical trial approval from NMPA in January 2022. With the joint efforts of the company, clinical principal investigators, research centers and other parties, we overcame the impact of the epidemic and successfully completed the enrollment of the first patient of AST-001 and the smooth administration of the drug, an important milestone. In the future, we will rapidly advance clinical research and strive to provide more treatment options for cancer patients as soon as possible to meet clinical urgent needs."

About AST-001

AST-001 is an innovative small molecule conjugate drug independently developed by the company through the AKR1C3 enzyme activation platform. It has the characteristics of First-In-Class and has global patents. After entering the tumor cells overexpressing the AKR1C3 enzyme, it is activated by the AKR1C3 enzyme to release effective drugs, achieving precise killing of tumor cells. Preclinical studies have shown that AST-001 has a broad spectrum of anti-tumor effects, significant effects and good safety.

About the AST-001-001 Clinical Study

The AST-001-001 study is a Phase I/II clinical study of AST-001 injection in patients with advanced malignant solid tumors conducted in China . The purpose of the study is to evaluate the safety and tolerability of solid tumor subjects receiving intravenous infusion of AST-001 , to evaluate the pharmacokinetic characteristics of AST-001 and its main metabolites in solid tumor subjects, and to preliminarily evaluate the efficacy and safety of AST-001 monotherapy in the treatment of malignant solid tumors. Professor Cheng Ying served as the principal investigator of the study, and the research was also conducted in multiple clinical research centers such as Jilin Cancer Hospital, Zhejiang Cancer Hospital, and the First Affiliated Hospital of Zhejiang University School of Medicine.

On July 7, 2022 Zhiyi Biotech reported that it has raised $15 million in its B++ funding round (Press release, Guangzhou Zhiyi Biotech, JUL 7, 2022, View Source [SID1234616554]). The funds will be used to boost the clinical development of the company’s live biotherapeutic products (LBPs) pipelines. It’s worth mentioning that Zhiyi has successfully completed a total of $45 Million in B, B+ and B++ funding , with investors including Qingkong SinoKing Capital, SDIC Venture Capital, KIP etc.

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Zhiyi is a clinical-stage biotech leading in LBPs in China. It has built up a complete technical and industrial platform, covering from the isolation and identification of new functional strains to the development of innovative LBPs. Notably, the lead drug candidate in Zhiyi’s pipelines, SK08, is the first LBP developed on a unique bacterial strain Bacteroides Fragilis, and whose clinical progress is ahead of other LBPs in China. Phase II clinical trial of SK08 carried out in China to treat IBS-D is expected to be completed this year, and phase Ib/II trial of SK08 combined with PD-1 inhibitor for advance solid tumor has been initiated already. Meanwhile, several products are undergoing IND filing to both FDA and NMPA. More programs are expected to enter clinical stage in the foreseeing year.

"We are grateful to have the support and trust from our investors," said Dr. Ye Wang, CEO of Zhiyi Biotech. " The progress in our pipeline is attributed to our team’s continuous effort and persistence in R&D. Zhiyi has been always focusing on the unmet medical needs and dedicating to develop accessible drugs to benefit more patients. We are looking forward to strengthening our international collaboration with peer companies, to promote development of the whole LBPs industry.

On July 7, 2022 Kernal Biologics, Inc. (Kernal Bio) — a development-stage mRNA-technology company developing cancer therapeutics designed to improve patients’ survival rate and quality of life — reported the completion of a $25 million Series A financing led by Hummingbird Ventures. Amgen Ventures, HBM Genomics and Civilization Ventures along with other VCs, family offices and high net worth individuals also participated in the round (Press release, Kernal Biologics, JUL 7, 2022, View Source [SID1234616552]).

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The new capital will extend Kernal’s mRNA 2.0 platform and support the filing of an IND for Kernal’s immuno-oncology candidate KR-335. In connection with the financing, Firat Ileri, Managing Partner of Hummingbird Ventures joins the board.

"We have closely followed the work of the Kernal Bio team over the past few years and we are excited to see them bring their mRNA technology to fruition in an area of medicine with high unmet medical need," said Firat Ileri, Managing Partner of Hummingbird Ventures. "Kernal Bio is building on the success stories of Moderna and Pfizer/BioNTech with legacy mRNA technologies. We are delighted to partner with them to bring this innovative approach to cancer patients."

"There’s a major unmet need to improve outcomes for cancer patients and Kernal Bio has built a strong rational for the use of its novel mRNA technology in cancer therapeutics," said Kernal Bio Co-founder and Chief Executive Officer Yusuf Erkul, M.D. "This financing further validates that rational. Our breakthrough onco-selective mRNA approach can enable specific protein expression in malignant cells, widening the therapeutic window of mRNAs in oncology."

Additionally, Manfred Kraus Ph.D., who was previously the Scientific Senior Director at the Tumor Microenvironment Thematic Research Center at Bristol-Myers Squibb (BMS), joins the company as Vice President of Research and Development. Before BMS, Dr. Kraus was a Director at Pfizer’s Oncology Research Unit where he led the in vivo pharmacology teams supporting the oncology portfolio from new target identification to clinical proof of concept. Previously, he worked in the oncology departments at Astra-Zeneca, Merck & Co., and Serono.

Dr. Kraus earned his Ph.D. in immunology with Dr. Klaus Rajewsky at the University of Cologne in Germany, followed by post-doctoral training at Harvard Medical School investigating the role of B cell receptor signaling in mature B lymphocytes. His scientific accomplishments include the discovery of the tonic BCR-mediated survival signal in mature B cells. Dr. Kraus pushed our understanding of the role of ITAM and non-ITAM phosphorylation in the CD79a/b signaling subunit of the B cell receptor plus advanced and mentored technical innovation such as conditional gene-targeting, reversible RNAi in mice and multi-parametric flow cytometry. He is an author on 27 peer-reviewed articles and an inventor on four patents.

"We are thrilled to have Dr. Kraus join Kernal as he brings extensive drug development experience in oncology which will help us to expand our mRNA 2.0 platform and advance our lead program. Dr. Kraus will oversee the expansion of our R&D team as well as the advancement of our therapeutic programs into the clinic," said Burak Yilmaz, M.S., Co-founder and President of Kernal Bio.

On July 7, 2022 Emergent BioSolutions Inc. (NYSE: EBS) reported that it has entered into an agreement with Ridgeback Biotherapeutics ("Ridgeback Bio"), a biotechnology company focused on emerging infectious diseases, intended to create a collaboration to expand the availability of Ebanga (Ansuvimab-zykl) (Press release, Emergent BioSolutions, JUL 7, 2022, View Source [SID1234616551]). Under the terms of the contemplated collaboration, Emergent will be responsible for the manufacturing, sale, and distribution of Ebanga in the United States and Canada, and Ridgeback Bio will serve as the global access partner for Ebanga, ensuring it remains available to patients in endemic countries free of charge through Ridgeback Bio’s compassionate use program. Ebanga was approved by the U.S. Food and Drug Administration (FDA) in December 2020 for the treatment of Ebola.

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Ebanga is a monoclonal antibody with antiviral activity provided through a single injection and was developed for the treatment of Ebola by Ridgeback Bio under license from the National Institute of Allergy and Infectious Diseases. Ridgeback Bio provided funding and operational support for clinical testing, with additional funding received under contracts with the Biomedical Advanced Research and Development Authority for late-stage manufacturing and regulatory activities and ensured that the work necessary for FDA approval of Ebanga was completed.

"This relationship with Ridgeback Bio builds on our strategic focus and deep expertise in developing and supplying medical countermeasures against serious health threats," said Robert G. Kramer, CEO of Emergent. "Ebanga is crucial in the ongoing fight to contain Ebola and we are excited about the future of this collaboration to create a healthier, more secure world."

"We’re thrilled to collaborate with Emergent BioSolutions in making sure that the United States and Canada receive the supply they need of Ebanga, while also continuing our ongoing local support for the prompt treatment of outbreaks that includes free patient access and funding on-the-ground support through our Rapid Response Program," said Wendy Holman, CEO of Ridgeback Bio.

About Ebanga
Ebanga (ansuvimab-zykl, formerly referred to as mAb114) is a monoclonal antibody with antiviral activity provided through a single injection. Ebanga development has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Numbers 75A50119C00059 and 75A50120C00009.

On July 7, 2022 SunHo BioPharmaceutical Co., Ltd. ("SunHo"), a clinical-stage leading biopharma in immunocytokines with full-set of capabilities from discovery to commercialization, reported that IAP0971 (PD1-IL15 immunocytokine) and IAE0972 (EGFR-IL10 immunocytokine), two first-in-class immunocytokines developed in-house for the treatment of locally-advanced or metastatic malignant tumors have entered Phase 1/2 clinical trials (Press release, SunHo BioPharmaceutical , JUL 7, 2022, View Source [SID1234616550]). The first patient has been dosed respectively in June.

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"We are excited for achieving this important milestone, which also marked the first step to what we hope will ultimately allow us to bring an innovative cancer immunotherapy to patients who otherwise do not respond to or become relapsed/refractory of current therapies", said Dr. Liusong Yin, the Executive President and Chief Science Officer of SunHo, "We focus on innovative immunocytokines to build the next leading global biopharma of immunotherapy, and to bring perceivable benefits and affordable medicine to patients worldwide, by innovation and collaboration."

About IAP0971

IAP0971 is the world’s first PD1-IL15 immunocytokine receiving IND approval from both FDA and NMPA. It was developed by SunHo based on their own proprietary and patented AICTM (Armed ImmunoCytokine) platform.

SunHo designed IAP0971 based on the deep understanding of the tumor microenvironment and limitations of current immunotherapy. On the one hand, IL15/IL15Rα complex in IAP0971 specifically binds to the IL2/15Rβ and IL2/15Rγ expressed on T cells and NK cells and promotes the proliferation and activation of T cells and NK cells, without activation of Treg cells or inducing apoptosis of activated T cells which are common side effects of IL2-based therapies. On the other hand, the expression of PD1 on CD8+ T cells in tumor microenvironment is much higher than that in peripheral blood and peripheral lymphoid organs, so that anti-PD1 antibody in IAP0971 can specifically target IL15 into the tumor immune microenvironment, to recruit, activate and reinvigorate immune cells, and achieve a much-enhanced anti-tumor immunity. IAP0971 fuses the anti-PD1 antibody and IL15 cytokine, acts in the same location and on the same cells at the same time showing great cis-synergy, which will further improve the effectiveness and therapeutic window of IAP0971.

The indications of IAP0971 include lung cancer, cervical cancer, head and neck squamous cell carcinoma, liver cancer, lymphoma, and other locally-advanced or metastatic malignant tumors.

About IAE0972

IAE0972 is the world’s first EGFR-IL10 immunocytokine receiving IND approval from both FDA and NMPA. It was also developed by SunHo based on their own proprietary and patented AICTM (Armed ImmunoCytokine) platform.

IAE0972 was designed to solve the problems of immune cell exhaustion in current immunotherapy, and to lift the limitations of current EGFR-based monoclonal antibodies. IL10 in IAE0972 is a potent activator of antigen-specific CD8+ T cells in the tumor microenvironment and can restore the tumor-killing activity of tumor-infiltrating lymphocytes by restoring the oxidative phosphorylation metabolism of Terminally Exhausted T cells. Anti-EGFR antibody can specifically enrich IAE0972 in tumor microenvironment, so that IL10 can reinvigorate antigen specific CD8+ T cells and facilitate its proliferation, while preserving the tumor cell proliferation inhibition activities of EGFR antibody. Relying on the synergy of EGFR antibody and IL10 cytokine, IAE0972 can effectively and specifically activate the immune system to kill EGFR-positive tumor cells, solving the drug resistance, high skin toxicities, and other clinical problems of existing drugs.

The indications of IAE0972 include colorectal cancer, head and neck squamous cell carcinoma, squamous non-small cell lung cancer, and other locally advanced or metastatic malignant tumors.