On June 6, 2022 TwinStrand Biosciences, Inc., the pioneer in duplex sequencing technology, reported that the company will present several data sets as part of its sponsorship and participation in the annual Advances in Genome Biology and Technology conference in Orlando on June 6-9, 2022 (Press release, TwinStrand Biosciences, JUN 6, 2022, View Source [SID1234615650]). The studies will highlight advances in TwinStrand’s innovative technology and share recent research that demonstrates the power of duplex sequencing for some of the most demanding applications in clinical and foundational research.

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"At TwinStrand, we continue to make progress and see the impact of our technology in important areas like hematology-oncology, genetic toxicology, and cellular therapies," said Jesse Salk, M.D., Ph.D., TwinStrand’s Cofounder, and CEO. "We are pleased to share this progress with the AGBT community and look forward to forming new collaborations that leverage our highly sensitive and specific Duplex Sequencing technology which has consistently demonstrated its potential as a critical decision support tool in medicine, public health, and other fields of science where high-resolution insights are most impactful."

TwinStrand DuplexSeq AML-29 Minimal Residual Disease (MRD) Assays offer high-sensitivity detection of ultra-low frequency mutations in acute myeloid leukemia (AML) cases. The 29-gene panel covers loci that are mutated in up to 95% of adult AML patients and is several orders of magnitude more sensitive and specific than other next-generation sequencing-based (NGS) MRD assays. TwinStrand is a member of the Foundation for the National Institutes of Health Biomarkers Consortium, which recently launched a program to validate and standardize methods of detecting and quantifying MRD in AML patients.

TwinStrand DuplexSeq Mutagenesis Assays offer a novel NGS-based approach to mutational research that detects, quantifies, and characterizes genome mutagenesis. It is the first NGS technology able to directly measure ultra-rare mutations caused by chemical carcinogens, without requiring biological selection and is applicable in vitro and in vivo. The final output is comprehensive data on induced mutations including frequency, simple spectrum, and trinucleotide signatures. TwinStrand is collaborating with the Health and Environmental Sciences Institute (HESI), the UK branch of the European Environmental Mutagenesis Society (UKEMS), and the US National Institutes of Standards (NIST) to showcase the value of error-corrected NGS for various preclinical research and regulatory applications.

AGBT attendees can learn more about TwinStrand technology in the Escambia suite. The company will share details from its pioneering work and partnerships in the field of genetic toxicology, which has significant implications for future regulatory mutagenicity and carcinogenicity testing. Other data sets will showcase recent applications of TwinStrand DuplexSeq products in acute myeloid leukemia and allogeneic cell therapy, including:

Ultra-Sensitive Duplex Sequencing for Quantifying Multi-Individual Cell Therapy Sub-Population Fractions
Authors from TwinStrand Biosciences and Deverra Therapeutics
Duplex Sequencing for Ultra-Low Frequency Measurable Residual Disease Detection in Adult Acute Myeloid Leukemia
Authors from TwinStrand Biosciences, Fred Hutchinson Cancer Research Center, National Heart, Lung, and Blood Institute – National Institutes of Health, and Children’s Hospital Los Angeles
Duplex Sequencing Reveals Ubiquitous Clonal Hematopoiesis and Complex Donor-Recipient Clonal Dynamics Following Hematopoietic Stem Cell Transplant
Authors from TwinStrand Biosciences and Fred Hutchinson Cancer Research Center
Longitudinal Monitoring of Pediatric Acute Myeloid Leukemia Using Duplex Sequencing of Patient-Specific Panels Reveals Ultra-Low Frequency MRD that Marks Persistent Carcinogenesis and Complex Clonal Evolution
Authors from TwinStrand Biosciences, Fred Hutchinson Cancer Research Center, and University of California San Francisco

On June 6, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading 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 Antengene has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I Trial of ATG-018 in patients with advanced solid tumors and hematologic malignancies (ATRIUM Trial) (Press release, Antengene, JUN 6, 2022, View Source [SID1234615666]).

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ATG-018 is an orally-available, potent, selective small molecule ATR inhibitor. ATG-018 inhibits the ATR kinase, thus limiting cancer cells’ ability to repair damaged DNA, in a mechanism also known as synthetic lethality or the DDR.

The primary objective of the study is to evaluate the safety and tolerability of ATG-018 as a monotherapy, to determine the appropriate dose for Phase II studies and assess preliminary efficacy, if available; the secondary objective is to characterize the pharmacology of ATG-018. The study will be conducted in two parts (dose-escalation and dose-expansion). Icon Brisbane in Australia is the lead site for the study, which will be conducted at five sites across Australia.

"DNA is constantly exposed to damage by sources such as ultraviolet light, toxins, certain chemicals, and natural biochemical processes inside our cells. The DNA damage response (DDR) is able to identify DNA damage and to induce various biological processes that correct these changes." Said Dr Jim Coward, Chair of Icon’s Medical Oncology Research Committee and Associate Professor at University of Queensland School of Medicine. "The therapeutic landscape of antitumor agents targeting DDR pathways has rapidly expanded to include inhibitors of other key mediators of DNA repair and replication, such as ATR, ATM and DNA-PK[1]. Positive findings from the trials evaluating ATR inhibitors such as ATG-018 may help provide oncologists with a new tool for improving patient outcomes in challenging cases and give them new hope when other therapies have failed."

Dr. Bo Shan, Antengene’s Chief Scientific Officer commented, "ATG-018 has a solid preclinical data package including efficacy as a monotherapy in solid tumor models, oral bio-availability and potential predictive biomarkers for response. It is also one of Antengene’s first in-house programs to reach the clinic. The differentiated profile of ATG-018 may enable it to be used as monotherapy and open the door for novel collaborations and combination regimens that could benefit cancer patients around the world. We are very pleased to receive HREC approval for the Phase I ATRIUM trial for ATG-018 and we look forward to collaborating with Dr. Coward and the team at Icon Brisbane on this exciting trial."

About the ATRIUM Trial

The ATRIUM trial is a Phase I multi-center, open-label, dose finding study of ATG-018 monotherapy in patients with advanced solid tumors or hematologic malignancies. The primary objective of the study is to evaluate the safety and tolerability of ATG-018 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and/or biologically effective dose of ATG-018 monotherapy and preliminary efficacy, if available. The secondary objective is to characterize the pharmacology of ATG-018. As a Phase I study, there will be intensive safety monitoring throughout the trial.

About ATG-018

Discovered by the internal R&D Team at Antengene, ATG-018 is an oral, potent, selective small molecule inhibitor targeting ataxia telangiectasia and Rad3-associated (ATR) kinase. ATR kinase belongs to the phosphoinositide 3 kinase-related family. Inhibiting ATR kinase leads to increased accumulation of single-strand DNA breaks, particularly meaningful for tumor cells which rely on DNA damage repair (DDR). Preclinical studies have demonstrated that ATR inhibitor monotherapy or combination with other drugs (including DDR agents) could be promising therapeutic strategies for solid tumors (including gastric, esophageal, squamous cell carcinoma) and hematologic malignancies (chronic lymphocytic leukemia [CLL], diffuse large B-cell lymphoma [DLBCL] and multiple myeloma [MM]).

According to a preclinical poster presented at 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2022) Annual Meeting, ATG-018 has demonstrated potent in vitro and in vivo monotherapy efficacy in solid tumor/hematologic cancer models with certain homologous recombination deficiencies. These data were supported by a series of genetic alterations that correlated with ATG-018 sensitivity and could be potential predictive biomarkers. Taken together, these data suggest that ATG-018 could be a promising therapeutic agent for patients with such homologous recombination deficiencies/genetic alterations.

On June 6, 2022 Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the results of its Phase 2 clinical trial (Study RM-202) of rivoceranib, an orally administered tyrosine kinase inhibitor (TKI), in patients with progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC) (Press release, Elevar Therapeutics, JUN 6, 2022, View Source [SID1234615682]).

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As shared in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, the results of Study RM-202 demonstrate the clinical effectiveness of rivoceranib for the treatment of patients with progressive R/M ACC, as indicated by substantially reduced tumor progression during the 6 months after rivoceranib treatment compared to that during the 6 months prior to rivoceranib treatment [-7.0 (-43 to 35) mm vs. 20.5 (5 to 180) mm].

The open-label study (NCT04119453) was conducted at 11 sites in the U.S. and South Korea to investigate the efficacy and safety of rivoceranib in patients with progressive R/M ACC. With 80 patients, including 53 (66.3%) based in the U.S., Study RM-202 is the largest to date involving a TKI in ACC patients.

All 80 participants demonstrated tumor progression within 6 months prior to the trial (by requirement). The study found an overall response rate (ORR) of 15.1% (a 30% reduction based on RECIST), and though not a study endpoint, the remaining 85% of patients had a reduction of tumor size.

"With every participant exhibiting a recent growing lesion upon entering this Phase 2 trial of rivoceranib, these results demonstrate significant clinical effectiveness and rivoceranib’s promise as a potential new treatment for patients with R/M ACC," said Saeho Chong, chief executive officer of Elevar. "Our entire Elevar team is greatly encouraged by these results, and we are fully focused on advancing rivoceranib through the regulatory process."

Other Study RM-202 key findings:

52% of patients had a response according to CHOI (size or density); CHOI is believed to be more correlated with median overall survival (mOS) than RECIST v1.1 (size only)
CHOI for Response: >10% reduction in tumor size or >15% reduction in tumor density
Median duration of response (mDoR) of 14.9 months
Median progression-free survival (mPFS) of 9 months versus published data of a baseline of 2.8 months for R/M ACC, and disease control for ≥ 3 months in over 60% of patients, regardless of prior vascular endothelial growth factor (VEGFR) therapy
Rivoceranib adverse event profile similar to other TKIs
"There is no approved standard of care for R/M ACC, so as we investigate rivoceranib’s potential as a treatment option we remain steadfastly focused on the many patients who now have or someday will be diagnosed with this disease," said Dr. Hyunseok Kang, medical oncologist at the University of California San Francisco and the primary investigator for Study RM-202. "The positive results demonstrated in this Phase 2 trial of rivoceranib represent a vitally important step forward for them."

Rivoceranib, which has been given orphan drug designation in the U.S., is a small molecule anti-angiogenic, with more than 6,000 patients studied in multiple cancers. Elevar has worldwide commercialization rights for rivoceranib, excluding China.

About ACC

Adenoid Cystic Carcinoma (ACC) is a rare malignancy that occurs within the secretory glands, most commonly in the major and minor salivary glands of the head and neck, but also found in the breast, skin and elsewhere. It is diagnosed in about 4 of every 1 million people each year – representing a combined 3,100 annual cases in the U.S., EU and Japan – and it afflicts more than 200,000 patients throughout the world, accounting for 5 percent to 7 percent of all head and neck malignancies, according to the Adenoid Cystic Carcinoma Research Foundation. There is no approved standard of care for R/M ACC patients. A previous study showed a baseline progression-free survival (PFS) of 2.8 months for ACC (Kang EJ, et al. Clin Cancer Res. 2021;27:5272-5279).

About Rivoceranib

Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib, co-developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (JHP) in China and Elevar Therapeutics globally, with the exception of China. It has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy. Clinical studies are underway in multiple tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (combination with camrelizumab), adenoid cystic carcinoma and colorectal cancer (combination with Lonsurf). Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and hepatocellular carcinoma (U.S.). Elevar holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Apatinib is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, JHP, under the brand name Aitan.

On June 6, 2022 JSR Corporation (Head Office: Minato-ku, Tokyo, Representative Director and CEO: Eric Johnson, JSR Corporation) reported that it has entered into a facility usage agreement with AuB Co., Ltd. (AuB), a company engaged in the study of intestinal microbiota in athletes, for the Collaborative Lab, a collaborative research facility with startups, which is located in a new research laboratory "JSR Bioscience and Informatics R & D center (JSR BiRD)" in Kawasaki City, Kanagawa Prefecture, which opened last July (Press release, JSR, JUN 6, 2022, View Source [SID1234615601]).

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AuB, founded in Oct 2015, is a company that conducts food-tech business based on research into the intestinal bacteria of athletes. Representative director Keita Suzuki is a former top athlete who was a professional player for the Urawa Red Diamonds, a J.League soccer team, and also played for Japan’s national team. Since its foundation, the company has analyzed the intestinal environment of more than 750 athletes (1,700 samples), developed proprietary materials based on this knowledge, and developed a business to sell them externally. In the future, the company is also considering entering the pharmaceutical field.

JSR is developing its life science business as a core business, focusing on diagnostic reagent materials, bioprocess materials, and drug discovery support businesses. At the same time, JSR is engaged in research on the microbiome, etc. as next-generation technology research, and is pursuing the realization of innovation that leads to new products and services required for a healthy and long-lasting society. Through joint research with AuB in collaboration labs, we aim to further accelerate next generation research and commercialize it.

On June 6, 2022 Artiva Biotherapeutics, Inc., an oncology company whose mission is to deliver highly effective, off-the-shelf allogeneic natural killer (NK) cell therapies that are safe and accessible to cancer patients, reported the appointment of Thorsten Graef, M.D., Ph.D., as Chief Medical Officer (Press release, Artiva Biotherapeutics, JUN 6, 2022, View Source [SID1234615617]). As a highly respected drug development leader, Dr. Graef brings to Artiva more than a decade of experience building and managing clinical development organizations, global multidisciplinary groups and cross-functional teams.

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"I am delighted to welcome Thorsten to our team. He brings substantive expertise to Artiva, including having led the development of IMBRUVICA through its registration in a number of indications, coupled with his recent experiences in the NK cell therapy space," stated Fred Aslan, MD, CEO of Artiva. "He joins Artiva as we transition from being a company with a single clinical trial to one with potentially multiple trials in both hematopoietic and solid tumor indications where we hope to demonstrate the clinical impact of allogeneic, off-the-shelf, NK cell therapies."

"I was impressed by Artiva’s Manufacturing-First approach and pragmatic development program choices," stated Dr. Graef. "NK cell therapies are making good clinical progress, but to achieve registration and commercial success, therapies will also need to be truly off-the-shelf and cost-effective with a scalable process in place. This is where I believe Artiva’s investments in manufacturing can strengthen and accelerate our development plans."

Most recently, Dr. Graef served as Chief Medical Officer at Acepodia USA, with responsibility for all of the company’s research and clinical development activities. Prior to his role at Acepodia, he served as Vice President of Oncology Early Development at AbbVie Inc., overseeing clinical activities, including the development and regulatory preparations of 20+ clinical assets. In addition, he held a series of senior leadership roles, including Head of Global Clinical Development, at Pharmacyclics LLC before and after AbbVie Inc.’s acquisition of the company in May of 2015, where he led the development of IMBRUVICA (ibrutinib). Prior to Pharmacyclics, Dr. Graef served as medical director of Merck Research Lab, Oncology at Merck & Co., Inc.

Prior to his time in the life sciences industry, Dr. Graef was an attending physician in the hematology, oncology, and immunology department at the University Hospital of Düsseldorf in Germany. He received his M.D. in internal medicine and his Ph.D. in molecular medicines from Heinrich-Heine University Medical School in Düsseldorf and completed his postdoctoral research fellowship at the Stanford University School of Medicine. Dr. Graef has published more than 50 original peer-reviewed publications, including many in top journals, such as NEJM, Lancet, Blood, PNAS, and Journal of Experimental Medicine.