Ribon Therapeutics, a Clinical Stage Biotechnology Company Targeting Stress Support Pathways in Cancer and Inflammation, Announces CEO Transition for Its Next Phase of Growth

On February 17, 2022 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported that the Board of Directors has appointed Prakash Raman, Ph.D., as President, Chief Executive Officer and member of the Board of Directors (Press release, Ribon Therapeutics, FEB 17, 2022, View Source [SID1234608235]). Dr. Raman has succeeded Victoria Richon, Ph.D., in these roles. Dr. Richon will remain actively involved in the Company as an R&D advisor to the Board of Directors and Chair of the Scientific Advisory Board, where she will work closely with Dr. Raman and executive leadership to advance Ribon’s scientific activities.

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"Since joining Ribon in 2015 as founding President, Vicky has built an exceptional research and development organization that has created a novel pipeline of first-in-class drugs in clinical development," said Jodie Morrison, Chair of the Board of Directors of Ribon Therapeutics. "The Board is excited to welcome Prakash, whose scientific background and strong business acumen are an excellent complement to our executive management team. This leadership transition allows Ribon to enhance its focus on its pipeline capabilities, business development and strategic growth plans while enabling Vicky to continue to contribute to the advancement of our innovative science as R&D Advisor to the Board of Directors and Chair of our Scientific Advisory Board. On behalf of the Board of Directors, I sincerely thank Vicky for her many contributions to the Company."

"It was only several years ago that the role of NAD+-utilizing enzymes in stress support pathways in cancer and inflammatory disease was considered an emerging science and not well understood," said Dr. Raman. "Under Vicky’s leadership, Ribon has advanced this family of enzymes to the clinic, where initial data have demonstrated PARP7, an NAD+-utilizing monoPARP, inhibition and early signs of antitumor activity in patients, a remarkable achievement. I am honored to join such a strong scientific organization with great potential for transforming the lives of patients with high unmet needs through the application of truly innovative science. I look forward to a collaborative and productive relationship with Vicky and the organization at Ribon to shepherd the company through its next phase of growth."

"I am pleased to welcome Prakash to Ribon at this important time for the Company," said Dr. Richon. "Prakash has the experience and skill set to carry the business forward toward our goal of bringing novel medicine to patients with cancer and inflammation. I look forward to a strong collaboration with the team in my role as SAB Chair as we work together to achieve our Company’s mission."

Dr. Raman brings to Ribon decades of biopharmaceutical business development and executive leadership experience, blending his scientific background, program and portfolio management and strong business development experience. Prior to joining Ribon, he served as Senior Partner, Chief Business Development Officer at Flagship Pioneering, where he leveraged the platforms and assets in Flagship’s network to generate opportunities for significant value creation. Prior to Flagship, Dr. Raman spent nearly fourteen years at Novartis, most recently as Vice President, Global Head of Novartis Institutes for Biomedical Research (NIBR) Business Development and Licensing (BD&L). During his time at Novartis, Dr. Raman was instrumental in forging key collaborations in immuno-oncology, executing many out-licensing opportunities and guiding the acquisitions of Advanced Accelerator Applications, Endocyte, IFM Tre and Selexys. In addition, he has led cross-functional drug discovery and early development project teams that successfully progressed compounds to clinical testing in patients. Prior to Novartis, Dr. Raman spent six years as a Senior Scientist at Millennium Pharmaceuticals and two years as a post-doctoral fellow at The Scripps Research Institute. He completed his undergraduate work at the Indian Institute of Technology, Bombay, and received his Ph.D. in Organic and Medicinal Chemistry from the University of Wisconsin-Madison.

Ribon, named a "Fierce 15" Biotech Company by Fierce Biotech in 2021, is pioneering the discovery and development of first-in-class precision therapies targeting stress support pathways in cancer and inflammation for patients with limited options. By leveraging its proprietary BEACON+ platform, the Company is building a pipeline of selective, small molecule inhibitors to numerous NAD+-utilizing enzymes. Ribon’s lead program is RBN-2397, a PARP7 inhibitor in clinical development for the treatment of cancer. The expansion portion of the RBN-2397 Phase 1 trial is currently underway in a number of defined patient cohorts, including squamous cell carcinoma of the lung (SCCL). Ribon is also advancing a second clinical candidate, RBN-3143, a potent and selective PARP14 inhibitor for the treatment of patients with inflammatory diseases.

Gracell Biotechnologies Doses First Patients in First-in-Human Clinical Trial Evaluating GC012F, its Dual-Targeting FasTCAR-T Therapy, in B-Cell Non-Hodgkin’s Lymphoma

On February 17, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company",NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it has dosed multiple patients in a clinical trial evaluating GC012F, the Company’s autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 in B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, Gracell Biotechnologies, FEB 17, 2022, View Source [SID1234608251]). NHL is the fifth most common cancer in the U.S.[1]

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The Phase 1 investigator-initiated trial (IIT), being conducted in China, is a first-in-human study evaluating FasTCAR-enabled BCMA/CD19 dual-targeting GC012F for the treatment of relapsed or refractory (r/r) B-NHL. GC012F is the first BCMA/CD19 dual-targeting CAR-T in human trials for B-NHL. Most B-NHL cells express CD19, and data also suggest that 39% to 97% clinical samples of NHL cells also express BCMA. [2] [3] [4] By simultaneously targeting BCMA and CD19, GC012F is designed to improve efficacy outcome in r/r B-NHL patients.

GC012F, developed using Gracell’s proprietary FasTCAR platform which enables next-day manufacturing, GC012F is currently also being evaluated in IIT studies in China including relapsed/refractory multiple myeloma. In November 2021, GC012F was granted Orphan Drug Designation by the U.S. Food and Drug Administration.

"Dual-targeting CD19 and BCMA represents an innovative approach for the treatment of B-NHL. This study of GC012F for r/r B-NHL marks an important step in the product candidate’s development to expand to additional indications and we look forward to confirming its potential to treat B-NHL, an indication for which patients are in need of additional treatment options," said Dr. Martina A. Sersch, Chief Medical Officer of Gracell. "We are confident that this study will further validate GC012F, our FasTCAR platform and our dual-CAR technology."

[1] View Source

[2] Blood Cancer Journal (2020) 10:73

[3] Blood. 2017;130:2755.

[4] Hum Gene Ther. 2018; 29(5): 585.

About GC012F

GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in China for the treatment of multiple myeloma and B-cell non-Hodgkin’s lymphoma. GC012F simultaneously targets CD19 and BCMA to drive fast, deep and durable responses, which can improve efficacy and reduce relapse in multiple myeloma and B-NHL patients.

About B-NHL

Non-Hodgkin’s lymphoma (NHL) is a group of blood cancers that developed from lymphocytes, most commonly derived from B cells (B-NHL). Globally, approximately 510,000 patients are diagnosed with NHL every year with over 77,000 patients diagnosed in the United States, and approximately 68,000 diagnosed in China in 2020. B-NHL accounts for approximately 85% of NHL diagnoses.

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

Arbutus to Report Fourth Quarter and Year End 2021 Financial Results and Provide Corporate Update

On February 17, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported that it has scheduled its fourth quarter and year end 2021 financial results and corporate update for Thursday, March 3, 2022 (Press release, Arbutus Biopharma, FEB 17, 2022, View Source [SID1234608219]). The schedule for the press release and conference call/webcast are as follows:

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A live webcast of the conference call can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 3977368.

XOMA to Present at Aegis Capital Corp Investor Conference

On February 17, 2022 XOMA Corporation (Nasdaq: XOMA), a biotechnology royalty aggregator playing a distinctive role in helping companies achieve their goal of improving human health, reported its Chief Executive Officer, Jim Neal, will present at the Aegis Capital Corp Virtual Conference on February 24, 2022 at 11:00 AM ET (Press release, Xoma, FEB 17, 2022, View Source [SID1234608236]). The conference will be held from February 23-25, 2022, from 8:30 AM until 5:30 PM ET daily, and can be viewed at https://bit.ly/3BoscUs.

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XOMA’s presentation will be available by request to Aegis during the conference. The presentation can also be accessed by visiting the investor relations section of the Company’s website at www.xoma.com. A replay of the presentation will be available and archived on the site for 90 days after the event.

REVEAL GENOMICS® Markets HER2DX®, The World’s First Genomic Test for Personalized HER2+ Breast Cancer Treatment

On February 17, 2022 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up that is seeking to revolutionize precision oncology through diagnostic innovation, reported that has launched its first genomic test (Press release, REVEAL GENOMICS, FEB 17, 2022, View Source [SID1234608252]). The HER2DX test predicts the risk of HER2+ breast cancer recurrence in newly diagnosed patients and the likelihood that they will respond to pharmacological treatment. This innovative tool, which combines a patient’s clinical data and the tumor’s genomic profile, is the world’s first specialized genomic test for HER2+ breast cancer.

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"This is our first product launch. It encapsulates our vision, which is to help patients and physicians improve outcomes and quality of life by using more accurate information," says Dr. Patricia Villagrasa-Gonzalez, CEO of REVEAL GENOMICS.

HER2DX is a 27-gene plus clinical feature-based classifier that provides accurate estimates of the risk of recurrence and the probability of achieving a response to anti-HER2 drugs in early-stage HER2+ breast cancer. HER2DX is currently provided as a Laboratory Developed Test (LDT) whose quality system is based on the UNE-EN-ISO 9001:2015 standard for collecting, receiving, and processing biological samples. It is also undergoing ISO 15189 accreditation. The reliability of the test has been described in a study1 published in The Lancet’s EBioMedicine.

HER2DX uses smart analytical software to stratify patients into low- and high-risk groups. The HER2DX algorithm was derived from a dataset of 434 patients and was validated in an external dataset of 268 patients. The algorithm was also validated using the data of more than 1,000 patients available from public datasets.

HER2DX is performed on RNA isolated from FFPE breast cancer tissues where only one sample is necessary. The results are obtained in 7-10 working days. The current assay measures the expression level of 27-genes by digital multiplex technology, and then REVEAL GENOMICS proprietary software, weighted together with clinical variables, outputs an individual patient-level risk score and a pCR likelihood score.

An excellent debut on the diagnostic test market
As a result of the launch of the HER2DX test in Spain in January of this year, the company has already signed deals with Spanish private hospitals, which now include the test in their treatment portfolio. "Based on our stepwise reimbursement approach, we are initially targeting hospitals in Spain and Italy and will subsequently be expanding to other E.U. countries and the U.S., where we are exploring marketing strategic partners," Dr. Villagrasa-Gonzalez explains.

Another goal of the company for upcoming years is to see HER2DX become the routine test option in public and private hospitals. Consequently, it is currently conducting the required clinical studies so that the test is recommended in national and international clinical guidelines and so that it can be covered by health reimbursement arrangements in the short term.

Dr. Villagrasa-Gonzalez adds that "over the past few months, we have put a lot of effort into bringing HER2DX to market. Considering that the company has only been in existence for 18 months, to have developed and brought our first product to market is definitive proof that we have a solid project."

REVEAL GENOMICS was incorporated in September 2020 with private funding. This year, the company plans to increase its capital with injections from additional private sources. Moreover, it is preparing a round of Series A funding for 2023 to provide the initial boost for its international expansion.