On May 16, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported ATG-101, a novel PD-L1/4-1BB bispecific antibody being developed by the company, has completed its quantitative and systems pharmacology (QSP) modeling that will provide data guiding the first-in-human study of ATG-101 (Press release, Antengene, MAY 16, 2021, View Source [SID1234580077]). Antengene plans to submit a clinical trial application for the first-in-human (FIH) study of ATG-101 in Australia starting in mid-2021, to be followed by submissions in US and China.

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QSP is a highly innovative methodology that has been used recently in drug discovery and development. QSP supports the pharmacological research of drugs through modeling and simulations, and quantitatively determines drug pharmacology and dynamical properties through integrated pharmacokinetics (PK), pharmacodynamics (PD), and statistical modeling, in providing evidential support to the design, decision-making, and dose selection in clinical trials1. In December 2020, Antengene entered into a strategic collaboration with Applied BioMath, LLC to initiate the pharmacology modeling of ATG-101 to determine the starting and efficacious doses for the first-in-human study of the drug candidate. Completing this QSP modeling will deepen our understanding of ATG-101’s antitumor mechanism and provide us with the quality data that will enhance the first-in-human study of ATG-101.

"We collaborated with Applied BioMath to best prepare our team for predicting accurate starting and efficacious doses for our first-in-human studies of ATG-101," said Dirk Hoenemann, M.D., VP, Head of Medical Affairs for Asia Pacific Region (APAC) and Early Clinical Development. "The Applied BioMath models provided us with a thorough understanding of ATG-101’s antitumor mechanism which enabled us to better design clinical trials moving forward, including our first-in-human trials."

"Systems pharmacology modeling is uniquely suited for the translation of antibody therapies from in vivo experiments to first-in-human studies," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Complicated mechanism of actions, as is common in modern antibody therapy designs, requires more sophisticated translational approaches than traditional methods and systems pharmacology has a proven track record of providing accurate translation for such therapies."

To date, Antengene has achieved multiple progress with the development of ATG-101, and is actively preparing to initiate clinical trials of ATG-101 in multiple countries and regions, including China, Australia, and the U.S. In China, Antengene has previously entered into a partnership with Wuxi Biologics for the chemistry, manufacturing, and control (CMC) manufacturing of ATG-101 to further optimize and accelerate the development of ATG-101.

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking PD-L1/PD-1 binding and 4-1BB stimulation. In the presence of PD-L1 over-expressed cancer cells, ATG-101 showed a significant and PD-L1 crosslinking-dependent 4-1BB agonist activity, thus enhancing therapeutic efficacy, and mitigating hepatoxicity simultaneously. ATG-101 demonstrated potent activity in preclinical animal models, including strong tumor-suppressing effect in models of PD-1/PD-L1 inhibitor-resistant or -relapsed tumors. Meanwhile, the GLP toxicology study has produced results highlighting a favorable safety profile.

At present, Antengene has already completed the preclinical study of ATG-101, and is actively preparing to initiate clinical trials of ATG-101 in multiple countries and regions, including China, Australia, and the U.S. Antengene plans to submit a clinical trial application for the first-in-human (FIH) study of ATG-101 in Australia starting in mid-2021, to be followed by submissions in U.S. and China.

On May 15, 2021 Arbella Therapeutics, a U.S. early stage biotechnology company focused on the discovery and development of innovative small molecule therapies, and Hangzhou Polymed Biopharmaceuticals ("Polymed"), a leading biopharmaceutical company in China, reported a collaboration to develop and commercialize ARB-085 – a preclinical development candidate targeting dual EGFR and HER2 Exon 20 mutations – in Greater China and South Korea (Press release, Polymed Biopharmaceuticals, MAY 15, 2021, View Source [SID1234630620]).

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Under the terms of the collaboration, Arbella is eligible to receive an upfront collaboration fee and additional payments contingent on certain development and regulatory milestones, plus royalties on net product sales. Polymed will lead the development and commercialization of ARB-085 in Greater China.

"We are glad to have begun this partnership with Polymed to progress ARB-085 in China, where there is a significant unmet medical need for the treatment of non-small cell lung cancer caused by genetic mutations. We look forward to working in close collaboration with Polymed to continue the development of ARB-085 as we progress toward the clinical stage," said Fred Martin, Ph.D., Founder and Manager of Arbella.

"We look forward to a successful collaboration with Arbella for developing ARB-085," said Dr. Jason Shaoyun Xiang, the founder and CEO of Polymed. "In addition to pushing forward highly innovative internal PROTAC projects, Polymed is leveraging its capabilities for collaboration with leading world-class institutions to bring urgently-needed therapeutics into clinical development", said Dr. Xiang.

Discovered through research conducted in collaboration with the Dana-Farber Cancer Institute ("DFCI") of Harvard University, ARB-085 is a potent and selective dual EGFR/HER2 Exon 20 insertion inhibitor for non-small cell lung cancers, currently in preclinical stage.

On May 14, 2021 Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, reported that it has agreed to issue bonds with an aggregate principal amount of USD 1.5 billion across two tranches (Press release, Fresenius, MAY 14, 2021, View Source [SID1234579978]):

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USD 850 million bonds with a maturity in December 2026 and an annual coupon of 1.875% and
USD 650 million bonds with a maturity in December 2031 and an annual coupon of 3.000%.
The proceeds will be used for general corporate purposes, including the refinancing of outstanding indebtedness.

The expected settlement date is May 18, 2021.

On May 14, 2021 Southern Research, the groundbreaking scientific discovery and research institution headquartered in Birmingham, on Thursday reported that its board of directors has appointed Josh Carpenter, Ph.D., as its new president and CEO, and Allen Bolton as its new executive vice president for Strategy and Finance (Press release, Southern Research Institute, MAY 14, 2021, View Source [SID1234580024]).

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Both appointments are effective June 1.

Founded in the Magic City in 1941, Southern Research is an independent, non-profit scientific research organization where more than 400 scientists and engineers work across three divisions: Life Sciences, Engineering, and Energy & Environment. Southern Research has attracted national research partnerships with leading industries in the fields of pharmaceuticals, biotechnology, defense, aerospace, the environment and energy.i

"Josh and Allen are forward-thinking leaders who are ready to chart a bold new course for Southern Research," stated University of Alabama at Birmingham President Ray L. Watts, who is chairman of the Southern Research board of directors. "They have the full support of the Board as they begin to lead an amazing team of scientists, engineers and innovators who are working to solve problems and change the world for the better."

Southern Research generates over $150 million in annual economic impact and supports more than 1,000 Alabama jobs.

"The work of Southern Research results in life-changing advancements and innovative solutions," said Southern Research board member Mark Crosswhite, who also serves as the chairman, president and CEO of Alabama Power Company. "Josh and Allen’s vision and expertise will play an important role in leading this institution forward as a continued center of excellence."

Carpenter most recently served as director of Innovation and Economic Opportunity for the City of Birmingham, where he led the City’s efforts in workforce development, COVID recovery and business expansion. Previously, he served as the director of External Affairs at UAB. He earned his doctorate in political economy from the University of Oxford where he studied on a Rhodes Scholarship.

"I am truly honored to take the helm of Southern Research and lead this incredible team that is finding solutions to improve people’s lives around the world. Southern Research has had 80 successful years, but I know the best is yet to come," commented Carpenter.

Bolton most recently served as senior vice president for Finance and Administration at UAB, where he was also a member of the board for Southern Research. He was previously an executive in finance and strategy at the Medical College of Wisconsin, and was senior associate dean for Administration and Finance at the UAB School of Medicine as well as executive administrator at the Comprehensive Cancer Center, the largest research center in the University of Alabama System.

"Discoveries made at Southern Research have provided breakthroughs in cancer research, pushed the boundaries of science and saved lives. I am grateful for this opportunity to work alongside dedicated and talented people who have an unmatched passion for science and discovery," concluded Bolton.

On May 14, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of an investigational hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), reported that it will present new clinical data from a Phase I/IIa study of Temferon in patients affected by glioblastoma multiforme (GBM) in an oral presentation at the 2021 American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place virtually on May 11-14, 2021 (Press release, Genenta Science, MAY 14, 2021, View Source [SID1234579979]).

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The data presented at ASGCT (Free ASGCT Whitepaper) are from Genenta’s ongoing trial of Temferon in patients with GBM. The presentation focuses specifically on patients who have undergone a follow-up surgical procedure for their cancer. In addition to being a treatment option, follow-on surgery provides investigators with an opportunity to understand the impact of therapies at a cellular and molecular level.

The ASGCT (Free ASGCT Whitepaper) presentation shows that genetic markers of Genenta’s Temferon were detectable in tumor specimens from all four patients with progressive disease who underwent follow-on surgery. Furthermore, the expression of interferon- (IFN) responsive gene signatures in those tumors was increased compared with pre-treatment levels, which suggests that interferon-α (IFN-α) had been released locally in the tumor by cells derived from Genenta’s investigational treatment.

Carlo Russo, Chief Medical Officer at Genenta Science, said: "These preliminary results provide exciting indications that Temferon acts in the way we anticipated even in the relatively inaccessible setting of glioblastoma multiforme. The data are encouraging and in line with our pre-clinical results, with early evidence that Temferon delivers biological effects that may impact the progression of individual lesions."

One of the four patients had two lesions removed at the second surgery; one was a prior lesion that had not been removed during the first surgery and was stable; the other was a relapsing progressing lesion that had developed at the first surgery site. Compared with the progressing tumor, the stable lesion displayed a higher proportion of T cells and Tie2 Expressing Monocytes (TEMs) within the myeloid infiltrate and had a higher IFN-response signature.

The data presented at ASGCT (Free ASGCT Whitepaper) also supported the initial safety and tolerability profile of Temferon. Concentrations of IFN-α in the plasma and cerebrospinal fluid of patients remained low, while IFN-α responses were identified in myeloid cells that infiltrate tumors. Temferon-derived differentiated cells also persisted in peripheral blood and bone marrow for up to 18 months at lower levels, indicating the potential durability of the intervention. No dose limiting toxicities have been identified.

Presentation Details:

Title: Changes in the Tumor Microenvironment in Patients with Glioblastoma Multiforme Treated with IFN-a Immune Cell & Gene Therapy (TEM-GBM_001 Study)

Time: Friday May 14, 2021 at 1.30 PM Eastern Time (7.30 PM CET)

Presenting: Carlo Russo, CMO