On August 2, 2022 Jubilant Life Sciences reported its financial results for quarter ended June 30, 2022 (Presentation, Jubilant Life Sciences, AUG 2, 2022, View Source [SID1234618959]).

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On August 1, 2022 Medical and Biological Laboratories Co., Ltd. ("MBL"), a JSR Life Sciences Company, reported that MEBGEN BRAF Kit, an in vitro diagnostic reagent, was approved for detection of BRAF gene mutations (V600E or V600K) by the Ministry of Health, Labour and Welfare (MHLW) for production and marketing in Japan on July 7, 2022 (Press release, JSR, AUG 1, 2022, View Source [SID1234617164]).

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MEBGEN BRAF Kit was developed as a companion diagnostic for multiple anti-cancer agents in melanoma. The MEBGEN BRAF Kit is expected to be an important clinical diagnostic in guiding personalized medicine for patients with melanoma.

On August 1, 2022 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported that on Friday, July 29, 2022, the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the BEAM-201 Investigational New Drug (IND) application for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL) has been placed on clinical hold (Press release, Beam Therapeutics, AUG 1, 2022, View Source [SID1234617181]). BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate. The BEAM-201 IND was submitted at the end of June. The FDA indicated they will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending discussion with the FDA.

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On August 1, 2022 OriCell Therapeutics (Shanghai) Co., Ltd. ("OriCell" or "the Company") reported the completion of Series B financing totaling over US$120 million (Press release, OriCell Therapeutics, AUG 1, 2022, View Source [SID1234617197]). This round of financing was jointly led by Qiming Venture Partners and Quan Capital with participation by several leading international and Chinese investment funds, as well as existing shareholder C&D Emerging Capital. The new funding will go toward the development of OriCell’s cell therapy pipeline, and Company’s proprietary discovery platform, as well as the construction of a manufacturing plant for both clinical and commercial purposes.

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Helen Yang, Chairman and CEO of OriCell, stated, "We are grateful to our new and existing investors for their continued support in OriCell. We have achieved a number of significant milestones in terms of clinical development of our CAR-T and partnered bispecific antibody programs, as well as continued to strengthen our senior management team. We look forward to delivering more innovative discoveries and clinical milestones in the next three years. In today’s open, inclusive, and dynamic innovative pharmaceutical ecosystem in China, we endeavor to become a world leading cell therapy company with a broad vision that can integrate seamlessly into the global market."

OriCell’s Investigational New Drug (IND) submission for Ori-C101, Company’s first internally developed CAR-T product targeting GPC3 for the treatment of advanced liver cancer, was accepted by the National Medical Products Administration (NMPA) of China in June of this year. In data published at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, Ori-C101 demonstrated superior safety and efficacy in patients with GPC3-positive advanced liver cancer with an objective response rate (ORR) of 44% and disease control rate (DCR) of 78%. The longest follow-up thus far is more than 22 months, with additional follow-ups ongoing.

OriCAR-017, China’s first GPRC5D CAR-T product developed by OriCell for the treatment of relapsed and refractory multiple myeloma (RRMM) confirmed the product’s potential with clinical results from the investigator-initiated phase I trial (POLARIS) was presented in an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)2022 annual meetings, respectively. In all patients, the majority of adverse events (AE) were transient, manageable, and reversible. Only Grade 1/2 cytokine release syndrome (CRS) was observed with no dose limiting toxicity (DLT), neurotoxicity, or AE-related death. Responses were durable and deepened over time with 100% ORR and 100% MRD negative rate, including in 5 prior BCMA CAR-T relapsed patients. All patients were progression-free and followed up without additional therapy by the cutoff date of April 30, 2022. Presently, OriCell is accelerating its registration and clinical development in China and the United States.

An exclusive global license agreement for OriBs-001 (ATG101) was reached with Antengene in 2019. OriBs-001 (ATG101) is a PD-L/4-1BB bispecific antibody and has received the implied approval from the Center for Drug Evaluation (CDE) in China in March this year after receiving IND from the U.S. Food and Drug Administration (FDA) and Clinical Trials Notification (CTN) from the Australian Therapeutic Goods Administration (TGA).

In March this year, Dr. Weidong Cui joined the company as Chief Technology Officer. Dr. Cui has more than 20 years of experience in process development, GMP production and commercial operation of cell therapy drug products. As the former CTO at Fosun Kite, he has led the team to successfully complete the GMP production, IND registration, and NDA registration of the first CAR-T drug in China.

On August 1, 2022 As part of its continued commitment to expand the benefits of next-generation sequencing (NGS), Thermo Fisher Scientific reported that it is now accepting submissions for the fifth round of the Oncomine Clinical Research Grant program (Press release, Thermo Fisher Scientific, AUG 1, 2022, View Source [SID1234617213]). The program supports clinical and translational research that advances the use of genomic testing to unlock the promise of precision medicine for more cancer patients.

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The program awards independent clinical research teams with financial support worth up to $200,000 in reagents and general funding. Since its introduction in 2020, the Oncomine Clinical Research Grant program has provided support to more than 20 unique research projects across 11 countries in areas including hematology-oncology, immuno-oncology, liquid biopsy and gene fusion detection.

"NGS has the power to transform cancer treatment by matching patients with the right therapy quickly, but more research is needed to investigate new applications with the potential to address areas of unmet diagnostic need," said Jose Luis Costa, Ph.D., director of medical affairs for clinical next-generation sequencing and oncology at Thermo Fisher. "We launched the Oncomine Clinical Research Grant program to help fill this gap by supporting the next discoveries in genomic research that may advance precision oncology and improve patients’ lives in the future."

Spring 2022 Grant Recipients Named

Following the last call for proposals in the spring, the following researchers and projects have been selected as the latest grant recipients:

Matias Avila, B. Pharm., Ph.D., University of Navarra, Pamplona, Spain — "Mutational Analysis of Bile cfDNA for the Early Diagnosis of Biliopancreatic Tumors"
Wendy Erber, M.D., The University of Western Australia, Crawley, Australia — "Genomic Profiling and Disease Monitoring Using Plasma Cell-Free DNA in Acute Myeloid Leukemia"
Xiuning Le, M.D., Ph.D., MD Anderson Cancer Center, Houston, U.S. — "ctDNA Analysis to Understand Resistance and Response to Osimertinib Ramucirumab Combination Therapy in EGFR Mutant Non-Small Cell Lung Cancer"
Nir Peled, M.D., Ph.D., FCCP, Shaare Zedek Medical Center, Jerusalem, Israel — "Liquid Biopsy in Suspected Lung Cancer Solitary Pulmonary Nodules"
Two years into the program, studies supported by the grant are already delivering insights with the future potential to improve patient outcomes. Pathologist Brandon Sheffield, M.D., and his team at William Osler Health System leveraged the Oncomine Clinical Research Grant he received in 2020 to demonstrate cost-effectiveness and better care through rapid in-house genomic profiling in a community oncology practice. The Osler team’s findings were recently published in Current Oncology.

"Community hospitals, where the majority of cancer patients are treated, often rely on outsourced testing or single-gene testing – both of which significantly slow time to results," said Dr. Sheffield. "The Oncomine Clinical Research Grant accelerated our ability to demonstrate the benefits of bringing user-friendly, rapid NGS in-house to help clinical teams make fast and objective treatment decisions that benefit their patients."

Grant applications are open through Sept. 26, 2022. For more information on the Oncomine Clinical Research Grant Program and how to submit proposals, please visit www.oncomine.com/grants.