On March 24, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company,reported with leading patient advocacy groups to expand the Clear Your View initiative to raise awareness of the important role complete biomarker testing plays in guiding initial treatment decisions for newly diagnosed advanced colorectal cancer (CRC) patients (Press release, Guardant Health, MAR 24, 2021, View Source [SID1234577097]). Current medical guidelines call for testing all six biomarkers in advanced CRC before starting treatment,2 yet more than 60 percent of patients are not receiving complete testing which puts them at risk for inappropriate therapy.1

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Now in its second year, the Clear Your View campaign encourages oncologists to "stop, test, and wait" for complete biomarker testing results before starting first-line treatment. Last year, the campaign focused on improving biomarker testing rates in advanced non-small cell lung cancer (NSCLC), which remains suboptimal at 20 percent,3 and garnered support from patient advocacy groups GO2 Foundation for Lung Cancer, LUNGevity Foundation, ALK Positive, and Lung Cancer Action Network. Now the campaign expands its focus to colorectal cancer, the second leading cause of cancer death and third most commonly diagnosed cancer in the US,4 and garners support from Colorectal Cancer Alliance, Fight CRC, Global Colon Cancer Association, KRAS Kickers, and PALTOWN.

Targeted therapy matched to a patient’s genomic profile has been shown to significantly extend median overall survival rate for advanced CRC patients5 as well as NSCLC patients.7-13 Testing for all recommended biomarkers can help predict which patients are most likely to respond to a certain treatment and which will not respond, and is one of the best ways to ensure that the patient receives the best treatment from the start. For example, while over 60 percent of metastatic CRC patients have a biomarker that may predict poor response to anti-EGFR monoclonal antibody therapy, 72 percent of patients who received anti-EGFR therapy did not first complete guideline-aligned RAS and BRAF biomarker testing to determine eligibility – resulting in patients potentially receiving less efficacious, costly treatment.1 The growing number of targetable CRC biomarkers makes it imperative that all patients receive complete biomarker testing before starting first-line treatment.5

"For patients with advanced colorectal cancer, time is of the essence and receiving the best treatment from the start is critical in extending progression-free survival," said Andrew Spiegel, co-founder and executive director of the Global Colon Cancer Association. "We are proud to support the Clear Your View campaign and stand committed alongside Guardant Health, Colorectal Cancer Alliance, Fight CRC, KRAS Kickers, and PALTOWN to raising awareness and urgency around the importance of complete biomarker testing to improve survival for patients."

"Incredible progress has been made in personalized treatments for advanced colorectal cancer, including not only medicines in clinical trials, but available FDA-approved medicines, yet too many patients are missing out on these potentially life-changing treatments due to suboptimal biomarker testing rates," said Helmy Eltoukhy, Guardant Health CEO. "Additionally, many patients are being treated with potentially less efficacious treatments. Through the expansion of the Clear Your View initiative, we join the colorectal cancer community in urging wider adoption of complete biomarker testing to help ensure the best treatments for all patients suffering from advanced cancer."

On March 24, 2021 Bruker Corporation (Nasdaq: BRKR), a leading supplier of single-plane illumination microscopy (SPIM) technology for research on live cells and cleared biological samples, reported that two Luxendo MuVi and LCS SPIM light-sheet microscopes have been installed by Memorial Sloan Kettering Cancer Center (MSK) (Press release, Bruker, MAR 24, 2021, View Source [SID1234577096]). The funding for the two light-sheet fluorescence microscopes was supported by Cycle for Survival (View Source). The new SPIM microscopes will help researchers visualize the cellular and tissue hallmarks of cancer and translate those findings into better cancer treatment methods.

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"By understanding how cells mobilize to build organs, researchers can glean insights into why some cells become cancerous and lead to organ destruction," said Dr. Anna-Katerina Hadjantonakis, MSK Chair of the Developmental Biology Program. "Instruments such as these are useful for imaging across differing length scales — from subcellular to single cells to tissue-level processes — allowing researchers to study cellular dynamics and cellular motion, processes that enable cells to metastasize."

"Light-sheet fluorescence microscopy has emerged as a uniquely powerful method for high-resolution, cleared-sample and dynamic biological imaging," added Dr. Lars Hufnagel, Vice President and General Manager of Bruker’s Luxendo light-sheet microscopy business. "We couldn’t be more pleased that our technology will be assisting the great MSK researchers and programs in such important work."

About the MuVi and LCS SPIM Systems
Bruker’s SPIM systems avoid sample phototoxicity by sequentially illuminating a stack of small slices of the organism, allowing scientists to observe living organisms for extended periods of time without photodamage. In particular, MuVi SPIM allows fast 3D imaging of live cells and living objects, such as spheroids and whole specimens, without the need of sample rotation. Despite the fact that sample rotation is not necessarily needed for a non-isotropic acquisition, the MuVi SPIM system provides this degree of freedom such that isotropic resolution can be achieved.

The modular LCS SPIM for large, cleared samples has been designed to be compatible with a broad variety of clearing solutions and sample sizes. Its new sample mounting approach and innovative optical design enables unprecedented acquisition times and minimizes sample distortions while seamlessly integrating into existing clearing and sample preparation pipelines. To handle the vast amount of data produced by the light-sheet technique, Lux DATA comprehensive data processing and storage provides fast transfer and large-capacity storage and leverages multi-core- and multi-GPU-based processing.

On March 24, 2021 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and live audio webcast on Wednesday, March 31, 2021, at 8:00 a.m. EDT, to report fourth quarter and full year 2020 financial results (Press release, BiomX, MAR 24, 2021, View Source [SID1234577095]). To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

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On March 24, 2021 InteRNA Technologies, a clinical-stage biotech company developing microRNA (miRNA)-based therapeutics with a focus on cancer, reported that preclinical data investigating the Company’s lead candidate, INT-1B3, have been published in the peer-reviewed journals Molecular Therapy – Nucleic Acids and Oncotarget (Press release, InteRNA Technologies, MAR 24, 2021, View Source [SID1234577094]). INT-1B3 is a mimic of the tumor suppressor miRNA-193a-3p and has the potential to address multiple hallmarks of cancer at the same time. The published results include data from tumor cell lines and experimental tumor models and support the high therapeutic potential of INT-1B3 in solid tumor indications.

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"Publications of our preclinical data with INT-1B3 in two highly-ranked, peer-reviewed journals represent a major milestone for our research and development team, and recognition of the innovative scientific research conducted at InteRNA in the last few years," said Dr. Michel Janicot, Chief Development Officer of InteRNA Technologies. "Documenting the molecular mechanism of action of our miR-193a-3p mimic and consequent downstream biology in cancer cells strongly supports INT-1B3 as novel promising candidate for therapeutic intervention in oncology."

In the publication in Molecular Therapy – Nucleic Acids, results of extended RNA-sequencing and transcriptome-wide analysis after transfection of the miR-193a-3p mimic (1B3) in human tumor cell lines were presented, revealing insights into the underlying molecular pathways of 1B3’s tumor suppressor functions. Differentially expressed genes mapped by Ingenuity Pathway Analysis strongly indicated upregulation of the tumor suppressive PTEN pathway as well as downregulation of many oncogenic growth factor signaling pathways. Furthermore, the analysis pointed to an extensive link of 1B3 with cancer, based on predicted negative effects on tumor cell survival, proliferation and migration as well as induction of cell death in tumor cells. These data strongly suggest that 1B3 is a potent tumor suppressor agent which targets various key hallmark pathways across cancer types.

In the publication in Oncotarget, preclinical data from different tumor cell-based assays demonstrated multi-modal effects of 1B3 on cancer cells. 1B3 was shown to efficiently reduce target gene expression in tumor cells, leading to diminished cell proliferation and survival, induction of cell cycle arrest and apoptosis, increased cell senescence, DNA damage and inhibition of cell migration. In addition, the novel lipid nanoparticle (LNP)-based formulation of 1B3, INT-1B3, demonstrated pronounced anti-tumor activity as a single agent upon systemic administration in tumor-bearing mice at well-tolerated doses.

These preclinical results contributed to the decision by InteRNA to initiate a first-in-human clinical study with INT-1B3 in patients with advanced solid tumors. The first patient in the study was dosed in February 2021. The trial is conducted in clinical study centers in the Netherlands and Belgium and topline results from the dose escalation part of the study are expected by the end of 2021.

About INT-1B3

INT-1B3’s unique mechanism of action addresses multiple hallmarks of cancer simultaneously. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components across the PTEN tumor suppressor pathway and the oncogenic PI3K/Akt and Ras/MAPK pathways resulting in inhibition of proliferation and migration and induction of cell cycle arrest and apoptosis. The triggering of the immunogenic tumor cell death (ICD) process as well as downregulation of the adenosine-A2A receptor pathway through inhibition of CD39/CD73 leads to a decrease in immunosuppressive FoxP3/Lag3 regulatory T cells and monocytic myeloid-derived suppressor cells (mMDSCs), and maturation of dendritic cells. As a result, the immune system is activated, and long-term immunity is triggered by recruitment of CD8+ effector T cells leading to decreased metastasis development and improved animal survival compared to anti-PD1 treatment.

On March 24, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that its collaborator, Memorial Sloan Kettering Cancer Center ("MSK"), has commenced patient enrollment in the Phase 1 study evaluating Iomab-ACT for targeted conditioning prior to treatment with MSK’s CD19 targeted CAR T-cell 19-28z (Press release, Actinium Pharmaceuticals, MAR 24, 2021, View Source [SID1234577093]). Iomab-ACT is a low dose version of Actinium’s Phase 3 drug candidate Iomab-B, a CD45 targeting antibody radiation conjugate ("ARC"). Actinium and MSK were jointly awarded National Institutes of Health Small Business Technology Transfer grant funding for this first ever trial to evaluate ARC-based targeted conditioning prior to CAR-T therapy. The scientific rationale for this trial builds on preclinical data published in 2020 and is further supported by clinical observations from the SIERRA trial to justify combining MSK’s 19-28z CAR T-cell therapy with Iomab-ACT. Manufacturing of patient CAR T-cells has commenced and patient conditioning with Iomab-ACT followed by 19-28z CAR T-cell infusion is expected early in the second quarter of 2021, with proof-of-concept data expected in the second half of 2021.

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Results of a Phase 2 trial in 53 patients with relapsed and refractory B-cell acute lymphoblastic leukemia with MSK’s 19-28z CAR-T published in the New England Journal of Medicine reported complete remissions in 83% (44/53) of patients, median event-free survival (EFS) of 6.1 months and median overall survival (OS) was 12.9 months at a median follow up period of 29 months (range 1 – 65 months). There was a 26% (14/53) rate of Grade 3 of greater cytokine release syndrome (CRS), with 1 patient death as a result, and 42% of patients experienced Grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS).

Dr. Dale Ludwig, Actinium’s Chief Scientific and Technology Officer, said "MSK’s 19-28z CAR T-cell therapy has produced high response rates in patients with relapsed or refractory B-ALL who have previously undergone several lines of standard therapy. However, toxicities such as cytokine release syndrome and neurologic toxicity, as well as durability of response, remain a significant challenge. The ARC technology Iomab-ACT employs enables the delivery of targeted radiation that selective and specifically targets immune cells including those implicated in the CAR-T-associated toxicities of neurotoxicity and cytokine release syndrome. We are eager to begin treating patients in this first of its kind pilot study to explore the potential of Iomab-ACT targeted lymphodepletion to modulate the immune system and improve the safety profile of CAR T-cell therapy. We are hopeful this technology may ultimately enhance our ability to deliver CAR T-cell therapies more safely. Positive results from pilot study could have a meaningful impact on the way we condition patients for CAR-T and other adoptive cell therapies, which have transformed the treatment of patients with blood cancers."

Sandesh Seth, Actinium’s Chairman and CEO, said "This is a major milestone for Actinium and one we are very excited by. Adoptive cell therapies like CAR-T and gene therapies have emerged as some of the most promising areas in medicine and hold tremendous promise for patients, many of whom have limited or no treatment options remaining. This promise has led to a large and growing field of therapies where we intend to establish Iomab-ACT as the universal solution for targeted, non-chemotherapy conditioning, that harnesses the power of radiation. With Iomab-B nearing complete enrollment in the Phase 3 SIERRA trial for bone marrow transplant conditioning, starting to treat patients in this Iomab-ACT trial for CAR-T conditioning could not come at a better time. We look forward to continuing to build out our strategic business unit in targeted conditioning to best serve patients seeking potentially curative bone marrow transplant, adoptive cell therapy and gene therapy to improve patient access and outcomes."

About Iomab-ACT

Iomab-ACT targets cells that express CD45, an antigen found on immune cells such as lymphocytes and macrophages as well as leukemia and lymphoma cancer cells and delivers the radioisotope warhead iodine-131 to achieve cell depletion. Iomab-ACT is intended to deplete CD45+ immune cells such as macrophages that are implicated in CAR-T related toxicities and may also have an anti-tumor effect on chemo-refractory cancers. Iomab-ACT is a low dose extension of Actinium’s lead program, Iomab-B, which is being studied in a pivotal Phase 3 trial for targeted conditioning prior to a bone marrow transplant. Preclinical data supporting Iomab-ACT’s application in targeted lymphodepletion prior to ACT such as CAR-T was recently published in the journal Oncotarget (https://www.oncotarget.com/archive/v11/i39/).

In addition, clinical data with trace doses of Iomab-B has shown transient, reversible lymphodepletion in patients and drug clearance pharmacokinetics that fit within the vein-to-vein time of CAR-T manufacturing and administration.