On September 27, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the publication of a scientific article highlighting pharmacodynamic data from a Phase 1 dose escalation study of its lead asset mitazalimab, a best-in-class CD40 mAb agonist, in patients with advanced solid stage tumors (NCT02829099) (Press release, Alligator Bioscience, SEP 27, 2023, View Source [SID1234635442]).

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The publication in the journal Cells highlights how RNA sequencing was used to assess peripheral pharmacodynamic activity in patients from the Phase 1 study. The analysis revealed that at the current Phase 2 dose 900 μg/kg mitazalimab induced peripheral transcriptomic alterations consistent with immune activation expected from a strong CD40 agonist.

In particular, the transcriptomic alterations are in line with migration of effector cells (e.g. CD8+ T cells and natural killer cells) and B cells to tissues such as the tumor, while dendritic cells, monocytes, B cells and natural killer cells show transcription profiles consistent with increased immune activation. This activation of the immune system support the potential of mitazalimab to activate myeloid cells and overcome the immune suppressive mechanisms in the tumor microenvironment, which can induce anti-tumor responses and make the tumor more sensitive to other therapies, such as mFOLFIRINOX, in pancreatic cancer patients. The pharmacodynamic activity seen in this study is also in line with the immune phenotypic changes seen in the OPTIMIZE-1 study, with further details to be presented at AACR (Free AACR Whitepaper) Pancreatic on Thursday 28th September 2023.

The full article, entitled "Early pharmacodynamic changes measured by RNA sequencing in peripheral blood from patients in a phase 1 study with mitazalimab, a potent CD40 agonistic monoclonal antibody", is available online via this link.

"The publication of this article in the renowned, peer-reviewed journal Cells further underlines the importance of the CD40 research being carried out by our dedicated scientific team," said Søren Bregenholt, CEO of Alligator Bioscience. "The data presented here reinforce mitazalimab’s mode of action, validate the design of our ongoing OPTIMIZE-1 study and provide yet more clear evidence to support mitazalimab’s continued clinical development. We are now looking forward mitazalimab’s next major milestone, the topline readout from its evaluation in pancreatic cancer due early next year."

Mitazalimab is currently being evaluated in OPTIMIZE-1, a Phase 2 open-label, multi-center study to assess its safety and efficacy in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (NCT04888312). The study is on track for top-line readout in early Q1 2024.

On September 27, 2023 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported that the company will participate in the Emerging Growth Conference being held October 4 and 5, 2023 (Press release, Akari Therapeutics, SEP 27, 2023, View Source [SID1234635441]). President and CEO Rachelle Jacques will present an overview of the company and its lead asset nomacopan, a bispecific inhibitor of complement C5 and leukotriene B4 (LTB4), on October 4, 2023 from 11:25 am to 11:55 am ET.

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Questions may be submitted in advance at [email protected].

On September 27, 2023 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company dedicated to revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, reported the first patient dosed in the Phase 1a/b study of ADRX-0706 for the treatment of advanced solid tumors (Press release, Adcentrx Therapeutics, SEP 27, 2023, View Source [SID1234635440]).

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"We are pleased to announce this important milestone for Adcentrx that marks our transition from the discovery stage into a clinical stage company," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We are enthusiastic about the potential of ADRX-0706 to address the unmet needs of patients with Nectin-4 expressing cancers."

The first-in-human Phase 1a/b clinical trial of ADRX-0706 is an open-label, multicenter dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumors. The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects an initial data readout in the middle of 2024.

About ADRX-0706

ADRX-0706 is an ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. The ADC is produced using Adcentrx’s proprietary i-Conjugation technology and novel tubulin inhibitor payload, AP052, to generate an ADC with a drug-antibody ratio of eight (DAR 8). ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models, and has demonstrated significant efficacy across a variety of tumor indications.

On September 27, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported details of an abstract accepted for poster presentation at the upcoming Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting, which will be held in San Diego, November 3-5, 2023 (Press release, Actinium Pharmaceuticals, SEP 27, 2023, View Source [SID1234635439]).

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Details of the SITC (Free SITC Whitepaper) poster presentation:

Abstract Title: Preclinical evaluation of lintuzumab-Ac225, a CD33 antibody radioconjugate targeting myeloid-derived suppressor cells
Abstract Number: 1166
Session: November 4, 9:00 AM – 8:30 PM PT, Exhibit Halls A and B1

On September 26, 2023 Shanghai BioTroy Therapeutics reported that its self-developed novel anti-tumor drug BT02 has recently received Investigational New Drug Clinical Trial (IND) approval from the U.S. Food and Drug Administration (FDA) and has officially entered the clinical development stage (Press release, Biotroy Therapeutics, SEP 26, 2023, View Source [SID1234655091]).

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The advancement of cancer immunotherapy checkpoint inhibitors has revolutionized clinical practices with their profound therapeutic efficacy. Identifying novel, efficacious targets is pivotal in augmenting response rates and achieving clinical benefits. Historically, significant advancements at the target level have predominantly been achieved by international entities, including Medarex, Inc. (focusing on PD-1 and LAG-3 targets), Forty Seven, Inc. (specializing in CD47 target), and Jounce Therapeutics, Inc. (concentrating on ICOS target), all of which are leading biotechnology firms listed on NASDAQ. However, with the continuous enhancement of China’s foundational scientific research capabilities and the maturation of the innovative incubation investment landscape, a shift in this trend is anticipated. BioTroy Therapeutics has pioneered in advancing new target antibody drugs into clinical trials, concurrently contributing to the biological research of these targets. This initiative epitomizes the ‘from 0 to 1’ paradigm in original drug research and development, establishing a comprehensive global patent framework encompassing antibodies, epitopes, and targets for robust intellectual property protection. The investigational drug has demonstrated remarkable preclinical efficacy against a range of intractable late-stage solid tumors. The successful authorization of this clinical trial signifies a landmark progression in the development of its pipeline.

Dr. Jie Xu, founder of BioTroy Therapeutics and a distinguished figure in national scientific and technological innovation, remarked: ‘The discovery of therapeutic targets represents a crucial phase in drug development. Despite the scarcity of breakthroughs at the target level within the domestic realm, the clinical trial approval of BioTroy Therapeutics’ ‘from 0 to 1′ innovative drug harbors the potential to infuse newfound hope and vigor into the oncological therapeutic arena.’

BioTroy Therapeutics is a company engaged in the research and development of new tumor treatment targets and drugs. Established in Shanghai in 2020, it has completed financing of over 150 million RMB. BioTroy Therapeutics has established multiple research platforms including BioTroy Engine for tumor multi-omics analysis, receptor-ligand discovery, target signal transduction pathway research, antibody discovery and engineering, in vivo pharmacodynamics and translational medicine in large animals, biomarkers, and precision medicine. The company is committed to ‘from 0 to 1’ original target discovery and global intellectual property layout. It advances ‘first in class’ new drug development based on solid scientific research data and cutting-edge translational medicine concepts. The company’s main pipeline focuses on tumors that are unresponsive to PD-1/PD-L1 inhibitors, and has achieved encouraging results.