On March 9, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of small protein therapeutics to address difficult-to-treat cancers, reported that two abstracts have been accepted for presentation during the late-breaking research sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 8-13, 2022 in New Orleans, LA (Press release, Sapience Therapeutics, MAR 9, 2022, View Source [SID1234609808]).

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Details of the poster presentations are as follows:

Abstract Number: 8125
Title: Characterizing the PK/PD relationship of C/EBPβ antagonist peptide ST101 in a mouse orthotopic breast cancer model
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Session Date and Time: 4/13/2022 9:00:00 AM
Location: New Orleans Convention Center, Poster Section 16

Abstract Number: 8148
Title: β-catenin antagonist peptide, ST316, attenuates Wnt-dependent oncogenic activity
Session Title: Late-Breaking Research: Molecular/Cellular Biology and Genetics 1
Session Date and Time: 4/11/2022 9:00:00 AM
Location: New Orleans Convention Center, Poster Section 16

Abstracts and full session details can be accessed through the AACR (Free AACR Whitepaper) meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2022 | April 8-13, 2022 | New Orleans

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). This is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: a Phase 1 dose escalation/regimen exploration phase and a Phase 2 expansion phase. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, Sapience has initiated dosing in patients with GBM and metastatic cutaneous melanoma, and will soon commence dosing in patients with refractory, locally advanced or metastatic hormone-receptor-positive breast cancer and castrate-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as Orphan designation from the U.S. Food and Drug Administration and the European Commission for the treatment of glioma.

About ST316
ST316, a first-in-class β-catenin antagonist, is currently being evaluated in IND-enabling studies. β-catenin is a critical member of the canonical Wnt signaling pathway, a well-known development stage pathway that has been considered an "undruggable" cancer target, as small molecules have proven ineffective or toxic. Wnt/β-catenin signaling drives cancer initiation and contributes to tumor growth, angiogenesis and metastasis. ST316 exerts its activity through disruption of the BCL9/β-Catenin interaction to suppress transcription of Wnt target genes regulating proliferation, migration, invasion, and the metastatic potential of tumor cells.

On March 9, 2022 Cellevolve Bio ("the Company" or "Cellevolve"), a development and commercialization company focused on cell therapies and Seattle Children’s Therapeutics, a venture at Seattle Children’s, bringing cutting edge, curative technologies and therapies to defeat pediatric cancer and other diseases that impact children, reported a collaboration aimed at developing and commercializing a suite of novel multiplex CARs for the treatment of pediatric CNS malignancies (Press release, Cellevolve, MAR 9, 2022, View Source [SID1234609823]). The collaboration utilizes Seattle Children’s renowned Cure Factory facility for early clinical GMP research on novel CARs, and its new VectorWorks facility to expand lentiviral vector manufacturing for tailored cell therapy products. Additionally, Dr. Michael Jensen, acclaimed pediatric cancer research scientist, co-founder of leading cell therapy companies, Juno and Umoja, and Chief Therapeutics Officer at Seattle Children’s Therapeutics, will be named Cellevolve’s Founding Advisor and Chair, Scientific Advisory Board.

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Cellevolve and Seattle Children’s Therapeutics will collaborate on advancing the BrainChild research program, which currently includes three pediatric Phase 1 clinical trials at Seattle Children’s – BrainChild-01, BrainChild-02 and BrainChild-03. Both organizations have agreed to an exclusive agreement in which Seattle Children’s Therapeutics will conduct early-stage discovery and pre-clinical, Phase 1 development while Cellevolve leads Phase 2 and subsequent clinical development with key Seattle Children’s Therapeutics involvement.

"Today is an exciting day for Cellevolve as we continue to grow our pipeline through this monumental collaboration with Seattle Children’s Therapeutics, a world class pediatric research organization with a demonstrated ability to translate promising research into novel therapies," said Derrell Porter, MD, MBA, Founder and Chief Executive Officer, Cellevolve. "Cellevolve is thrilled to be able to work more closely with one of the brightest minds in cell therapy in Dr. Michael Jensen, an internationally recognized, pediatric hematologist-oncologist who has an unparalleled devotion to developing and testing promising T-cell treatments."

Seattle Children’s Therapeutics will receive payments upon achievement of developmental milestones, and Cellevolve will provide financial support for early-stage discovery and preclinical development and Phase 1 clinical development. Seattle Children’s will also receive an equity stake in the company. Cellevolve will receive global license and worldwide rights to assets resulting from the collaboration. The funds will also help enable Seattle Children’s Therapeutics to launch a fourth BrainChild trial and invest in expediting its immunotherapy research to fulfill its vision of developing and testing next-generation cell and gene therapies like cancer and other life-threatening and debilitating diseases that afflict children.

"Our initial therapeutic focus on pediatric CNS malignancies aligns with my lifelong devotion for developing novel therapies for children with life-threatening diseases who deserve futures full of promise," said Michael Jensen, MD, Vice President and Chief Therapeutics Officer, Seattle Children’s Therapeutics. "I’m excited about the benefit this collaboration could bring towards fulfilling that aspiration."

Childhood cancers are the leading cause of childhood mortality1 and data from Seattle Children’s Therapeutics’ Phase 1 studies will inform the development of future trials, including those targeting multiple proteins present on the surface of cancer cells. While the initial focus is on pediatric cancers, the collaboration allows for expansion to the adult CNS population.

Reference

National Cancer Institute. (2022). Cancer in Children and Adolescents. Retrieved from View Source,the%20United%20States%20(1).

On March 9, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to CFT8634 for the treatment of soft tissue sarcoma (Press release, C4 Therapeutics, MAR 9, 2022, View Source [SID1234609962]).

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The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

"Patients living with synovial sarcoma currently have limited treatment options. After first-line treatment with chemotherapy, the benefit of which is typically of limited durability, patients with metastatic synovial sarcoma tend to do poorly. The FDA’s decision to grant orphan drug designation to CFT8634 is an important recognition of the potential of our targeted protein degrader to address this dire unmet medical need faced by patients and their families," said Adam Crystal, M.D., Ph.D., chief medical officer of C4 Therapeutics.

CFT8634 is a BiDAC degrader targeting BRD9 for the treatment of cancers that are dependent on BRD9, including synovial sarcoma and SMARCB1 deleted cancers. BRD9 has been considered an "undruggable" target because inhibitors of the bromodomain of BRD9 are not effective in treating these cancers. However, C4T’s TORPEDO platform was leveraged to discover CFT8634, an orally bioavailable, selective degrader of BRD9. Unlike BRD9 inhibition, BRD9 degradation is efficacious in preclinical models of synovial sarcoma. In December 2021, the FDA cleared C4T’s investigational new drug (IND) application for CFT8634 to proceed with the proposed Phase 1/2 trial in patients with synovial sarcoma and SMARCB1-null solid tumors. Site activation efforts have commenced and the trial remains on track to begin dosing patients in the first half of 2022.

On March 9, 2022 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported that two posters have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is being held April 8-13, 2022 at the Ernest N. Morial Convention Center in New Orleans, Louisiana (Press release, Shattuck Labs, MAR 9, 2022, View Source [SID1234609758]). The first poster will highlight preclinical data from the company’s GADLEN platform, while the second will highlight preclinical data from SL-9258 (TIGIT-Fc-LIGHT), derived from the company’s ARC platform, demonstrating its ability to broaden the activity of checkpoint inhibitors through targeted myeloid cell and effector lymphocyte activation.

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Presentation Details

Title: Bispecific gamma delta T cell engagers containing butyrophilin 2A1/3A1 heterodimeric fusion protein efficiently activate Vg9Vd2 T cells and promote tumor cell killing
Presenter: Dr. Anne Lai, Ph.D., Principal Scientist, Shattuck
Session: Immunology – Immunomodulatory Agents and Interventions 2
Date/Time: Tuesday, April 12, 2022, 1:30 p.m. to 5:00 p.m. ET
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37
Abstract Number: 3514

Title: LIGHT (TNFSF14) costimulation with TIGIT blockade broadens the activity of checkpoint inhibitors (CPIs) into CPI refractory and resistant tumors through targeted myeloid cell and effector lymphocyte activation
Presenters: Dr. George Fromm, Ph.D., Vice President of Research and Development, Shattuck, and Kyung Jin Yoo, Research Associate, Shattuck
Session: Immunology – Combination Immunotherapies 2
Date/Time: Wednesday, April 13, 2022, 9:00 a.m. to 12:30 p.m. ET
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37
Abstract Number: 4214

Additional meeting information can be found on the AACR (Free AACR Whitepaper) website, View Source The posters will be available under the Events & Presentations section of the Company’s website shortly after the event.

On March 9, 2022 QSAM Biosciences, Inc. (the "Company") (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153-DOTMP (CycloSam), for the treatment of cancer and related diseases, reported that a 1-for-40 reverse stock split of the Company’s common stock will become effective on Thursday, March 10, 2022 (Press release, QSAM Biosciences, MAR 9, 2022, View Source [SID1234609777]). The reverse stock split was approved by the Company’s Board of Directors in connection with the Company’s application to list its common shares on The NASDAQ Capital Market.

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Pursuant to the reverse stock split, each forty (40) shares of the Company’s outstanding common stock, $0.0001 par value per share, will be automatically combined and converted into one (1) outstanding share of common stock, $0.0001 par value per share. As a result of this reverse stock split, the Company’s outstanding common shares will be reduced to approximately 1,686,321 shares, exclusive of convertible preferred shares and convertible notes representing approximately an additional 450,000 issuable common shares.

Shares of the Company’s common stock will be assigned a new CUSIP number (74738N202) and are expected to begin trading on a split-adjusted bases, beginning on Thursday, March 10, 2022. As part of the reverse stock split, a "D" will be placed on the ticker symbol for 20 business days. After 20 business days or until listing on the Nasdaq Capital Market, the symbol will then change back to QSAM.

No fractional shares will be issued and any fractional shares resulting from the reverse stock split will be rounded up to the next whole share. Stockholders holding shares of QSAM common stock at registered brokerage firms, should consult with their broker for further information on their account. Stockholders who hold shares with our transfer agent will receive information in the mail about their accounts over the next few days.