Cellevolve Announces Expansive Global Collaboration with Seattle Children’s Therapeutics to Advance Research for Childhood Brain Cancers

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).

Cyteir Therapeutics to Report Fourth Quarter and Full Year 2021 Financial Results on March 16, 2022

On March 9, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that it will host a conference call and live audio webcast on Wednesday, March 16, 2022 at 4:30 p.m. ET to discuss fourth quarter and full year 2021 financial and operational results (Press release, Cyteir Therapeutics, MAR 9, 2022, View Source [SID1234609822]).

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The live audio webcast can be accessed via the Investor Relations section of the Company’s website at www.cyteir.com. The archived webcast will remain available for replay on Cyteir’s website for 30 days.

Catamaran Bio to Present Preclinical Efficacy Data on Allogeneic Solid Tumor CAR-NK Program at AACR Annual Meeting 2022

On March 9, 2022 Catamaran Bio, Inc., a biotechnology company developing off-the-shelf chimeric antigen receptor (CAR)-NK cell therapies to treat cancer, reported that the company will present preclinical efficacy data for its CAT-179 program, an allogeneic solid tumor CAR-NK cell therapy, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, being held in New Orleans, Louisiana, April 8-13, 2022 (Press release, Catamaran Bio, MAR 9, 2022, View Source [SID1234609821]). CAT-179 is an allogeneic, cryopreserved HER2-targeted CAR-NK cell therapy engineered using Catamaran’s TAILWIND platform.

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Details of the poster presentation are as follows:

Presentation Title: Allogeneic natural killer cells engineered to express HER2 CAR, interleukin 15 and TGF beta dominant negative receptor effectively control HER2+ tumors
Session Title: Adoptive Cell Therapy 1
Session Date & Time: Sunday, April 10, 2022, from 1:30 p.m. – 5:00 p.m. CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 36
Abstract Number: 555

The abstract is now available on the AACR (Free AACR Whitepaper) conference website.

FogPharma Announces Selection of Clinical Development Candidate Directly Targeting β-Catenin

On March 9, 2022 FogPharma, a biopharmaceutical company pioneering a new class of precision medicines that could ultimately prove applicable to all therapeutic targets, including those previously considered "undruggable," reported the selection of its lead product development candidate, FOG-001, a first-and-only-in-class direct β-catenin inhibitor (Press release, FogPharma, MAR 9, 2022, View Source [SID1234609820]). FOG-001 represents the first of FogPharma’s proprietary, conformationally hyperstabilized α-helical polypeptides (Helicon polypeptides), a new class of therapeutics designed to combine the targeting strength and specificity of antibodies with the broad tissue distribution, intracellular target engagement and oral dosing optionality of small molecules.

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Dysregulation of the Wnt/β-catenin signaling pathway has been shown to occur in at least 20% of all human cancers. In biochemical and cellular studies, FOG-001 has been shown to potently, precisely and selectively disrupt the interaction of β-catenin with its obligate transcription factor, TCF. Preclinical studies have demonstrated the ability of FOG-001 to cause tumor growth inhibition and regression by disrupting β-catenin-dependent signaling. FOG-001, the inaugural member of FogPharma’s TCF-Catenix family of direct-acting β-catenin antagonists, combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell, where it directly binds the key oncogenic driver β-catenin; and FOG-001 blocks TCF-β-catenin engagement at the most downstream node in the canonical Wnt pathway, thus abrogating the signal transmission mechanism by which most, if not all, known Wnt pathway mutations are believed to drive oncogenesis.

"The selection of FOG-001 as our development candidate, within two and a half years of initiating the discovery of a TCF-Catenix drug for a target widely considered "undruggable," underscores the rapid progress being made at FogPharma as we seek to advance medicine by a quantum leap. We are rapidly achieving mastery in the rapid deployment of a new therapeutic modality designed to surmount the challenges of intractable disease-driving targets," said Gregory Verdine, Ph.D., founder and chief executive officer of FogPharma. "Genetic evidence has long implicated β-catenin as being a principal driver of human cancer, but this target had been frustratingly beyond therapeutic reach, until the discovery of FOG-001. We look forward to advancing our first Helicon drug candidate, FOG-001, into clinical development, with the overarching aim of providing a fundamentally new and potentially significant treatment option for the large number of cancer patients whose disease is driven by derangement of the Wnt pathway."

FogPharma plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for FOG-001 and initiate clinical development by mid-2023.

About FogPharma’s Universal Druggability Platform
FogPharma’s Helicon peptide drug discovery engine integrates directed evolution, proprietary α-helix conformational hyperstabilization chemistry, highly multiplexed drug optimization technology, artificial intelligence including deep learning and machine learning, structure-based drug discovery, and multiscale manufacturing to rapidly discover Helicon polypeptide therapeutics against important, previously intractable targets with broad applicability to virtually all disease areas.

Guardant Health to Present New Data from its Broad Portfolio of Blood Tests at the American Association for Cancer Research Annual Meeting

On March 9, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present new data from its broad portfolio of blood tests at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 8-13, 2022 (Press release, Guardant Health, MAR 9, 2022, View Source [SID1234609819]). Included in the presentation will be data from its multi-cancer screening assay, next-generation Guardant SHIELD.

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"We are excited to share the feasibility data for our innovative multi-cancer screening assay. This data will demonstrate that our assay provides sensitive detection of early-stage cancers with accurate tissue of origin identification," said AmirAli Talasaz, Guardant Health co-CEO. "The data to be presented at this year’s AACR (Free AACR Whitepaper) meeting demonstrates our deep commitment to providing physicians with the resources to help patients at all stages of cancer live longer and healthier lives."

Full List of Guardant Health Presentations

Development of a highly-sensitive targeted cell-free DNA epigenomic assay for early-stage multi-cancer screening (Abstract 2141). Session MS.CL11.02 – Biomarkers 2, oral presentation.
CDK4/6 inhibitors (CDK4/6i) is effective in the real-world setting for hormone receptor-positive metastatic breast cancer (HR+ MBC) with ESR1 mutations and fusions (Abstract 5248)
Multiomic, plasma-only circulating tumor DNA (ctDNA) assay identifies breast cancer patients with minimal residual disease (MRD) and predicts distant recurrence (Abstract 3403/9)
Genomic landscape of circulating tumor DNA alterations in patients with paraganglioma and pheochromocytoma (Abstract 5790)
Predictive ability of circulating tumor DNA by Guardant360 in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations (Abstract 3400/6)
Longitudinal evaluation of ctDNA molecular response for monitoring clinical benefit and investigating treatment related impacts in metastatic colorectal cancer patients treated with different drug regimens (Abstract 5748)
Occurrence of BRAF class II and III alterations is common across solid tumors and is associated with inferior clinical outcomes in NSCLC and melanoma (Abstract 4122/6)
Characterization of sub-clonal RAS/BRAF alterations in an anti-EGFR treated advanced CRC cohort using a liquid biopsy-based real world clinical genomics database (Abstract 5245)