FDA Approves Keytruda after Surgery and Chemotherapy for Early Stage Lung Cancers

On January 27, 2023 Bonnie J Addario Lung Cancer Foundation, reported that the U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for adjuvant (additional) treatment following surgery and chemotherapy for stage IB, II, or IIIA non-small cell lung cancer (NSCLC) (Press release, Bonnie J Addario Lung Cancer Foundation, JAN 27, 2023, View Source [SID1234626612]). This approval was based on the KEYNOTE-091 clinical trial where people who took Keytruda after surgery and chemotherapy lived significantly longer without a recurrence of the cancer than those who did not. This new approval provides another treatment option after surgery for people with early stage NSCLC

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10-Q – Quarterly report [Sections 13 or 15(d)]

Myovant Sciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Cellinfinity Bio Announces Publication and Licensing of Key Technology for Directed Evolution of Cells That Allows for More Effective Adoptive Cell Therapy

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."

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Higher-Risk Myelodysplastic Syndrome

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.

Vedanta Biosciences to Present at Upcoming Investor Conferences

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