On June 7, 2022 R-Biopharm AG, a leading German biotechnology company operating on a global scale, reported the acquisition of AusDiagnostics (Press release, R-Biopharm, JUN 7, 2022, View Source [SID1234615691]). R-Biopharm is expanding its product portfolio with the addition of the Australian specialist and manufacturer of molecular biology multiplex diagnostics, extraction reagents, and laboratory automation equipment. The company is thereby unlocking new market segments in clinical diagnostics and continuing on its path of steady internationalization. "The existing and future molecular biology multiplex analysis platforms for syndrome testing from system supplier AusDiagnostics broadens our molecular biology expertise and perfectly complements our present clinical diagnostics portfolio," states Christian Dreher, CEO of R-Biopharm. "The acquisition strengthens our position as a reliable partner for system solutions and offers our customers additional options for diagnostics."

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Upon its establishment in 2006, the Australian company introduced its patented Multiplex Tandem PCR (MT-PCR) on the market. The current technology allows the simultaneous detection of up to 24 pathogens or resistance genes from a single sample, thus shortening the lengthy test procedure in human and animal diagnostics as well as environmental, agricultural, and food analysis. The analysis platform is used in laboratories and hospitals throughout the world for detecting a broad range of diseases.

AusDiagnostics CEO Scott Gilroy said that the transaction marked an exciting new chapter for the company: "Both AusDiagnostics and R-Biopharm AG share the same commitment to innovation in the biotechnology space. This acquisition strengthens AusDiagnostics and will accelerate our global presence. We’ve experienced tremendous, industry-leading growth over the past two years, which has been underpinned by our broad suite of innovative products, talented team, and incredible, loyal customers. Joining the R-Biopharm group will allow us to further build on this and continue to deliver exceptional products and service for our Australian and international customers."

AusDiagnostics currently has 92 employees with offices in New Zealand, the USA, and Great Britain. Its production facilities in Australia and Great Britain supply a steadily growing network of more than 25 distributors and partners around the world – from which R-Biopharm expects further synergy effects for production as well as international service and support in its clinical diagnostics line.

On June 7, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the first patient has been dosed in the Phase I STAMINA-001 trial to evaluate ATG-037 as a monotherapy or in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors in Australia (Press release, Antengene, JUN 7, 2022, View Source [SID1234615725]).

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The primary objective of the study is to evaluate the safety, tolerability, recommended Phase II dose and preliminary antitumor efficacy of ATG-037 as a monotherapy and in combination with pembrolizumab. Secondary objectives include characterization of the pharmacology of ATG-037.

ATG-037 is an orally available, small molecule CD73 inhibitor. CD73 is an "immune checkpoint mediator"1 that interferes with anti-tumor immune responses by generating adenosine, which leads to immunosuppression in the tumor microenvironment. ATG-037 can reverse adenosine-mediated immunosuppression2. It has demonstrated promising preclinical efficacy as a monotherapy and in combination with ICIs and chemotherapy agents. In preclinical studies, this compound overcomes the "hook effect" that is common in anti-CD73 antibodies. In addition, GLP toxicology studies indicate the compound has a potentially wide therapeutic window.

"While ICIs are widely used in the treatment of various cancers, many patients have resistant or refractory disease, which has created a large unmet need," said Dr. Ganessan Kichenadasse, principal investigator, Southern Oncology Clinical Research Unit in Adelaide, Australia. "Mounting evidence suggests that adenosine plays a critical role in suppressing anti-tumor immunoactivity. CD73 can convert adenosine monophosphate (AMP) to adenosine. ATG-037, an orally available, small molecule CD73 inhibitor, can block the generation of adenosine. We are excited to be a part of the STAMINA-001 Trial. This Phase I study brings together a group of highly experienced Australian investigators to collaborate with Antengene. We are excited to assess the therapeutic potential of ATG-037 for patients with solid tumors as a single agent as well the exploring the opportunity for benefit with the addition of an ICIs."

"Developing agents that can act in the tumor microenvironment to reverse immunosuppression is one of the key focus areas for Antengene, " said Dr. Kevin Lynch, Antengene’s Chief Medical Officer. "Preclinical data presented at the 2022 American Association of Cancer Research Annual Meeting (AACR 2022) showed that ATG-037 had a stronger ability to restore T-cell function in higher-AMP environments compared with anti-CD73 monoclonal antibodies. These data highlighted the potential therapeutic advantages of small molecule inhibitors of CD73 over blocking antibodies, either as a monotherapy, or in combination with other immune-oncological treatments. We have been very pleased with the drug’s performance in preclinical studies and are hopeful that in this Phase I study ATG-037 can demonstrate the tolerability and signals of activity that will allow us to move forward into a broader development program. We are very excited about the start of this first in human clinical trial and look forward to next steps with ATG-037."

About the STAMINA-001 Trial

The STAMINA-001 trial is a Phase I multi-center, open-label, dose finding study of ATG-037 monotherapy or combination therapy with pembrolizumab in patients with locally advanced and metastatic solid tumors. Subjects will begin with two monotherapy cycles and then be allowed to receive the addition of pembrolizumab. The primary objective of the study is to evaluate the safety and tolerability of ATG-037 and to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) and/or optimal biological dose of ATG-037 monotherapy and preliminary efficacy. Secondary objectives include characterization of the pharmacology of ATG-037. As a Phase I study, there will be intensive safety monitoring throughout the trial.

About ATG-037

ATG-037 is an orally-available, highly selective small molecule that completely blocks the activity of CD73. CD73, an ecto-5′-nucleotidase, catalyzes the conversion of adenosine monophosphate (AMP) to adenosine. Adenosine production leads to significant immunosuppression in the tumor microenvironment, now recognized as one of the most important immunomodulatory pathways in the tumor microenvironment.

Many human tumors overexpress CD73 and this expression is frequently associated with poor prognosis. Blocking CD73 has been shown to be effective in controlling tumor growth and metastases and CD73 inhibitors may increase the therapeutic activity of ICIs and chemotherapy agents. Clinical data so far indicate that CD73 inhibitors add little additional toxicity to standard of care treatments.

On June 7, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP), a clinical-stage biotherapeutics company using its proprietary DIAMOND artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a focus on immuno-oncology, reported it has entered into a sponsored research agreement (SRA) with Principal Investigator James W. Welsh, M.D. of The University of Texas MD Anderson Cancer Center (Press release, Kiromic, JUN 7, 2022, View Source [SID1234615692]).

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Under the two-year SRA, in vivo preclinical data will be generated from Kiromic’s Gamma Delta T cell (GDT) allogeneic therapies. This SRA is intended to evaluate efficacy and patient safety outcomes to support three new investigational drug (IND) applications to the U.S. Food and Drug Administration (FDA).

"We believe that the SRA will enable us to generate key in vivo data efficiently and swiftly that will demonstrate the synergistic advantages of our Gamma Delta T cell therapies in combination with existing anticancer treatment modalities. These submissions will expand the total number of our product candidate therapies to five. The first of these three new IND submissions – the Deltacel – is expected to be submitted during the second half of the year," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "Importantly, we expect to begin the activation of the Deltacel clinical trial by the end of this year. We believe utilizing non-genetically engineered Gamma Delta T cells as our first-in-human study is ideal to establish the tolerability and safety of our proprietary allogeneic cell therapy platform."

In addition to Deltacel/KB-GDT – Kiromic’s non-engineered Gamma Delta T cells that are expanded, enriched and activated through a proprietary method – the second IND is expected to focus on Procel/KB-PD1, a genetically engineered product candidate targeting PD-L1+ tumors. The third IND is expected to focus on Isocel/KB-ISO, a genetically engineered product candidate targeting mesothelin isoform 2+ tumors. This isoform of mesothelin is a tumor-specific target identified by Kiromic’s proprietary DIAMOND AI bioinformatics platform.

The SRA and the anticipated filing of the three IND applications described above will expand Kiromic’s therapeutic pipeline to five allogeneic GDT clinical trials as follows:

Deltacel in combination with a standard antitumor modality
Procel in combination with a standard antitumor modality
Isocel in combination with a standard antitumor modality
Procel as monotherapy
Isocel as monotherapy

On June 7, 2022 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that it has released the updated results from a Phase Ib/II study of the Bcl-2 inhibitor lisaftoclax (APG-2575) in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) in a Poster Presentation at the 58th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ascentage Pharma, JUN 7, 2022, View Source;ascentage-pharma-releases-updated-data-demonstrating-lisaftoclaxs-apg-2575-therapeutic-potential-in-patients-with-rr-cllsll-301563282.html [SID1234615726]).

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Entering the fifth consecutive year in which company’s abstracts were selected for presentations by the ASCO (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma showcased results from multiple clinical trials of its five drug candidates, including favorable data of lisaftoclax, a key drug candidate of the company’s apoptosis-targeted pipeline, in Chinese patients with R/R CLL/SLL showing an objective response rate (ORR) of 67.4%. Lisaftoclax was well tolerated, and all adverse events were manageable. No dose-limiting toxicity (DLT) were observed at up to 800 mg/day. The risk of clinical tumor lysis syndrome (TLS) in patients on daily dose ramp-up was minimal.

Prof. Jianyong Li, Director of the Hematology Department, Jiangsu People’s Hospital, and the principal investigator of this study, said, "Lisaftoclax is a Bcl-2 selective inhibitor that can induce apoptosis and suppress the growth of tumor cells. In this Phase Ib/II study, lisaftoclax as a single agent showed favorable preliminary efficacy and safety, and a daily ramp-up schedule that is patients’ friendly. We look forward to further evaluating the efficacy of lisaftoclax as a single agent and in combinations in patients with R/R CLL/SLL."

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, "Lisaftoclax is the first China-developed Bcl-2 inhibitor entering clinical development in China, also the world’s second and China’s first Bcl-2 inhibitor being investigated in pivotal trials. Data released at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting suggest that lisaftoclax may offer an effective, safe, and more ‘user friendly’ treatment alternative to patients with R/R CLL/SLL. We are taking firm steps forward with this clinical development program to allow patients to benefit from this novel therapeutic as soon as possible. Meanwhile, we are also evaluating lisaftoclax monotherapy and combinations in patients with solid tumors."

Dr. Zhai continued, "Furthermore, we are proud to be able to present clinical development progress for a number of Ascentage Pharma’s drug candidates, which highlight our capabilities in global innovation. Honoring our mission of addressing unmet clinical needs in China and around the world, we are now accelerating our clinical programs to bring more safe and effective therapeutics to patients in need."

The highlights of this abstract on lisaftoclax are as follows:

A phase Ib/II study of lisaftoclax (APG-2575), a novel BCL-2 inhibitor (BCL-2i), in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL).

Abstract: #7543

The aim of this multicenter, open-label study was to evaluate the safety, antitumor activity, PK, and pharmacodynamics (PD) of lisaftoclax in Chinese patients with R/R CLL/SLL.

As of January 25, 2022, 45 patients had been enrolled. Lisaftoclax was administered orally once daily at 3 dose cohorts (400, 600, or 800 mg) in 28-day cycles, with 15 patients in each cohort.

Lisaftoclax monotherapy demonstrated favorable safety profiles in all three dose cohorts, and no DLT was observed during the Phase I study.

The risk of TLS in patients on daily dose ramp-up was extremely low, which was consistent with the observations of the Phase I study. The median duration of treatment was 7 cycles. and the ORR in the 43 efficacy evaluable patients with R/R CLL/SLL was 67.4%, including 1 complete response (CR) and 28 partial responses (PRs).

BCL-2i lisaftoclax was well tolerated up to 800 mg/day. There were no significant new or unmanageable safety findings. The recommended Phase II dose (RP2D) of lisaftoclax was determined as 600 mg. Lisaftoclax may offer a treatment alternative for patients with R/R CLL/SLL, with a daily ramp-up schedule that may be more convenient and "user friendly".
Appendix: A list of Ascentage Pharma’s abstracts selected by this year’s ASCO (Free ASCO Whitepaper) Annual Meeting

On June 7, 2022 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported the appointment of industry veteran Andrew S. Sandler, M.D., as its Chief Medical Officer (Press release, Alpine Immune Sciences, JUN 7, 2022, View Source [SID1234615693]). Dr. Sandler joins Alpine from Kiadis Pharma, a Sanofi Company, where he was Chief Medical Officer. Dr. Sandler’s anticipated start date is August 17, 2022.

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"We are very excited and fortunate to have Andy join the Alpine team. His appointment comes at a time where we are quickly advancing our three development programs across multiple oncology and autoimmune disease indications," said Stanford Peng, M.D., Ph.D., President and Head of Research and Development at Alpine. "Andy is a highly experienced Chief Medical Officer with extensive clinical development expertise, and has a passion for developing novel therapies for patients with life-threatening and debilitating diseases."

"I am thrilled to join the Alpine team and continue to advance the clinical strategy and development of the company’s extremely promising pipeline, including acazicolcept, davoceticept, and ALPN-303," said Dr. Sandler. "I look forward to integrating with the development teams to continue to advance these exciting therapies that were built from Alpine’s directed evolution platform and have the potential to improve the lives of many patients."

Dr. Sandler brings over 25 years of industry and clinical practice experience. Prior to his role at Kiadis Pharma/Sanofi, Dr. Sandler was Senior Vice President of Medical Affairs at Medivation (Pfizer). Before that, Dr. Sandler held various roles including Chief Medical Officer, Executive Vice President, Research and Development, Seattle Site Head, and Senior Vice President, Clinical and Medical Affairs at Dendreon Pharmaceuticals. Earlier in his career, Dr. Sandler was Chief Medical Officer at Spectrum Pharmaceuticals and Vice President and Head of Global Medical Affairs for Oncology at Bayer Healthcare Pharmaceuticals. Dr. Sandler also previously held various positions at Berlex Oncology/Schering AG and Seattle Genetics, Inc.

Dr. Sandler holds a B.S. degree in Neuroscience from the University of Rochester. He obtained his M.D. degree and completed his residency in Internal Medicine at Mount Sinai Medical Center, followed by a fellowship in Hematology/Oncology at the University of California, San Francisco. Dr. Sandler also holds a Certificate in Epidemiology and Biostatistics.