On January 26, 2023 -Cellinfinity Bio, a privately held pioneer biotechnology company developing first/best-in-class cell therapy products against solid tumors and other diseases, reported the publication of CLASH (CRISPR-based Library-scale AAV perturbation with Simultaneous HDR knock-in), a platform that for the first time enables massively parallel genomic knock-in into human cells (Press release, Cellinfinity Bio, JAN 26, 2023, View Source [SID1234626605]). This technology is published in Nature Biotechnology on January 26. CLASH allows creation of a large library of precisely engineered cellular variants, enabling rapid and efficient selection of cells with desired properties for effective engineered cell therapies against variety of diseases. Cellinfinity Bio has an exclusive license of the published CLASH technology from Yale University.

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"The founding vision of Cellinfinity Bio is that we believe cells have infinite potential to cure human diseases," said Sidi Chen, Ph.D., Founder of Cellinfinity Bio and Associate Professor of Genetics, Yale University. "We develop highly versatile platforms such as CLASH and other technologies to engineer multiple types of primary human cells in order to bring advanced treatments to patients."

"Current CAR-T or CAR-NK therapies have major limitations and are generally not effective in patients with solid tumors. Our proprietary unbiased evolution technologies such as CLASH allow us to find universal modifications that can overcome many problems of current adoptive cell therapy, including poor tumor infiltration, immunosuppressive tumor microenvironment, and poor cell persistence," said Premal Patel, M.D., Ph.D., Chief Executive Officer, Cellinfinity Bio. "Furthermore, we can effectively evolve and engineer multiple other cell types, allowing development of next generation cell therapy against broad ailments." Cellinfinity Bio holds exclusive rights to the CLASH technology and the identified genetic modifications. The company has licensed other novel cell evolution technologies from Yale, such as a genome-wide gain-of-function screening platform for boosting T cell function developed in the Chen lab.

"An antigen-targeting receptor on T cells (e.g., TCR, CAR, etc.) is necessary but not sufficient for effective therapeutic activity against solid tumors in the setting of adoptive immunotherapy. Additional genetic modifications are required to endow immune cells with functional attributes to overcome the solid tumor microenvironment. Our unbiased genome-wide evolution technologies, including CLASH, have identified series of gene enhancements that substantially enhance the power of immune cells to kill cancers," said Margo Roberts, Ph.D., and Chief Scientific Advisor, Cellinfinity Bio. "We are rapidly advancing these next generation engineered cells towards the clinic."

On January 26, 2023 Syros Pharmaceuticals, Inc. (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to tamibarotene for the treatment of higher-risk myelodysplastic syndrome (HR-MDS) (Press release, Syros Pharmaceuticals, JAN 26, 2023, View Source [SID1234626607]). Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with azacitidine for the treatment of newly diagnosed HR-MDS patients with RARA gene overexpression.

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"Receipt of Fast Track designation for tamibarotene underscores both the potential of tamibarotene and the unmet need for HR-MDS patients, who have a poor prognosis due to the progressive nature of the disease"

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"Receipt of Fast Track designation for tamibarotene underscores both the potential of tamibarotene and the unmet need for HR-MDS patients, who have a poor prognosis due to the progressive nature of the disease," said David A. Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals. "No new therapies beyond hypomethylating agents have been approved since 2006, and approximately half of all patients diagnosed with HR-MDS patients ultimately progress to AML. We are grateful for the opportunity to potentially expedite the delivery of tamibarotene as a new standard of care for this population."

Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drug candidates intended to treat serious conditions and for which nonclinical or clinical data demonstrate the potential to address unmet medical need. The purpose is to help speed development of new drugs, making them available to the patient earlier. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate’s development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

Syros is evaluating tamibarotene in combination with azacitidine in newly diagnosed HR-MDS patients with RARA overexpression in the ongoing SELECT MDS-1 Phase 3 trial. This randomized, double-blind, placebo-controlled study is intended to enroll 190 patients. Syros currently has over 75 clinical sites open for recruitment in 12 countries. Syros expects to complete patient enrollment in SELECT-MDS-1 in the fourth quarter of 2023, with pivotal data expected in the third quarter of 2024.

Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed unfit AML patients with RARA overexpression, with initial data from the randomized portion of the SELECT-AML-1 Phase 2 trial expected in the fourth quarter of 2023 and additional data in 2024.

On January 26, 2023 -Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, reported that members of its executive team will participate at the following investor conferences (Press release, Vedanta Biosciences, JAN 26, 2023, View Source [SID1234626606]).

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William Blair Biotech Private Company Conference
Date: Monday, January 30, 2023
Virtual Fireside chat time: 2:00 PM ET

SVB Securities Global Biopharma Conference
Dates: January 31 – February 2, 2023
Virtual 1×1 meetings only

On January 26, 2023 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System that destroys tumors by freezing, reported its participation in the Society of Interventional Oncology’s Annual Scientific Meeting ("SIO2023") in Washington, D.C. on January 19 – 23, 2023 (Press release, IceCure Medical, JAN 26, 2023, View Source [SID1234626603]). ProSense was demonstrated throughout the duration of the conference at IceCure’s booth. Separately, in a breast session organized by SIO2023, ProSense was featured in a panel discussion on January 21st led by Dr. Kenneth Tomkovich and included Dr. Robert Ward, both ProSense users. The discussion included cryoablation as a treatment option as well as a mention of ICE3 interim trial results.

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Dr. Tomkovich, Diagnostic and Interventional Radiologist with Princeton Radiology and Director of Breast Imaging and Interventions at CentraState Medical Center, is Co-lead Investigator of IceCure’s landmark ICE3 study for the treatment of small, low-risk, early-stage malignant breast tumors. Dr. Ward, Assistant Professor of Diagnostic Imaging at the Warren Alpert Medical School of Brown University, Program Director for the Breast Imaging Fellowship, Associate Chief of Diagnostic Imaging at Women & Infants Hospital, specializes in women’s imaging and breast tumor cryoablation.

Commenting on the growing interest in ProSense, Dr. Tomkovich stated, "we are seeing increasing interest from interventional radiologists and interventional oncologists, many of whom are practitioners who previously were not treating breast cancer patients. Their interest appears to be driven by the encouraging ICE3 interim results, which can drive the development of new patient markets for practitioners while making the minimally invasive procedure more accessible to patients."

On January 26, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported Anatoly Dritschilo, M.D., CEO, will present and host one-on-one meetings with investors at the Lytham Partners Investor Select Conference, taking place virtually on January 31, 2023 (Press release, Shuttle Pharmaceuticals, JAN 26, 2023, https://www.prnewswire.com/news-releases/shuttle-pharmaceuticals-to-present-at-lytham-partners-investor-select-conference-on-january-31-301731807.html [SID1234626602]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Company Webcast

The Company’s webcast presentation will be available for viewing at 9:00am ET on Tuesday, January 31, 2023, on the Company’s website at View Source or View Source The webcast will also be archived and available for replay.

1×1 Meetings

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected] or register at View Source