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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 , 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported the timely completion of construction on its expanded current good manufacturing practice (cGMP) manufacturing facility in Houston (Press release, Kiromic, JUL 7, 2022, View Source [SID1234616535]). This significant milestone was accomplished within the timeline established by the Company, specifically June 30, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The expanded facility located at Kiromic’s headquarters is one of the conditions required for the Company to begin the activation of its cell therapy clinical trial for the Deltacel product candidate by the end of this year. The completion also addresses a key component in the clinical hold communication the Company received from the U.S. Food and Drug Administration (FDA) in June 2021.

"The on-time completion of our cGMP manufacturing facility is one of the conditions necessary to begin the activation of the Deltacel clinical trial by the end of this year," stated Pietro Bersani, Kiromic BioPharma’s Chief Executive Officer. "The facility supports an expanding product pipeline of cell therapies designed to target solid tumors, furthering our commitment to delivering lifesaving treatments to patients with cancer who have limited therapeutic options. We believe our allogeneic, off-the-shelf manufacturing process will result in shorter lead times and lower costs, thereby increasing the availability of these promising cellular therapies for oncology patients."

The expanded 34,000-square-foot facility includes flexible cellular therapy and viral vector suites, a dedicated cGMP microbiology lab, a dedicated cGMP quality control (QC) lab, a research and development laboratory, and an FDA Code of Federal Regulations (CFR-9) compliant vivarium.

On July 7, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the company has received Investigational New Drug (IND) approval of clinical trial from the NMPA (National Medical Products Administration) for its novel targeted protein degrader ICP-490 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL) (Press release, InnoCare Pharma, JUL 7, 2022, View Source [SID1234616517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ICP-490 is developed from InnoCare’s molecular glue platform. By specifically binding to CRL4-CRBN-E3 ligase complex, ICP-490 induces ubiquitination and degradation of transcription factors including Ikaros and Aiolos, thereby downregulating the expression of IRF4, an oncogenic transcription factor that drives multiple myeloma to exert direct anti-myeloma effects. It also has immunomodulatory effects by enhancing the function of effector T cells, resulting from Ikaros and Aiolos degradation and the degradation-mediated releasing of interleukin IL-2.

Multiple myeloma (MM) is a malignant tumor with clonal abnormal proliferation of plasma cells, which is characterized by abnormal proliferation of bone marrow plasma cells and most of them with overproduction of monoclonal immunoglobulin (M protein). MM is often accompanied by multiple osteolytic lesions, hypercalcemia, anemia, kidney injury, etc. MM accounts for about one percent of tumor diseases and 10 percent of blood tumors1.

Non-Hodgkin’s lymphoma (NHL) is the most common hematological malignancy in the world, accounting for nearly three percent of cancer diagnosis and death2. NHL ranks among the top 10 common malignant tumors in China. Its common types include diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, "InnoCare has built a strong pipeline in the field of blood tumor. With the approval of ICP-490 for clinical trials, InnoCare will further strengthen its blood tumor pipeline and aim to provide better treatment options for those patients in China and around the world."