On June 28, 2021 The National Cancer Institute reported that it has awarded the Lung Cancer Metabolism Working Group at Moffitt Cancer Center with a Research Program Project Grant (P01CA250984) (Press release, Moffitt Cancer Ctr, JUN 28, 2021, View Source [SID1234584400]). The grant, which will provide more than $10.2 million over five years, will support team research across several Moffitt programs, including Cancer Biology and Evolution, Molecular Medicine and Immuno-Oncology. All projects will focus on investigating lung cancer metabolism.

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Moffitt’s program project consists of four projects and four shared cores. The goal is to unveil common metabolic mechanisms regulated by common genetic drivers across non-small cell lung cancer, specifically lung adenocarcinoma and squamous cell carcinoma, and small cell lung cancer. Researchers will then use that information to utilize standard of care therapeutics or develop new therapies that can target the common molecular signatures.

"Many of the driver genes mutated in lung cancer, like p53, Nrf2 and myc, are transcription factors, which are difficult to target therapeutically and have been deemed ‘undruggable.’ But by learning more about the cancer metabolism and how malignant cells are rewiring their metabolic network to survive, we can develop novel therapies to target those rewired cells while preserving the integrity of normal surrounding tissues," said Elsa Flores, Ph.D., principal investigator for this grant, chair of the Department of Molecular Oncology and leader of the Cancer Biology and Evolution Program.

Lung cancer is the leading cause of cancer deaths worldwide. There are two types of lung cancer: non-small cell lung cancer, which accounts for roughly 80% to 85% of cases, and small cell lung cancer, which has been classified by the NCI as a recalcitrant tumor – a type of cancer with a five-year relative survival rate of less than 50%.

Common therapy for both lung cancer types includes surgery, radiation, chemotherapy and immunotherapy. These treatments can be debilitating for patients, and for those treated with chemotherapy and/or radiation, healthy surrounding tissue can be harmed. Although immunotherapy has improved lung cancer outcomes, it only works for a small subset of patients.

"We see about 1,800 new lung cancer patients each year in our thoracic clinic. We are seeing what works and what doesn’t. We know improvements can be made to appropriately apply standard of care treatments and even develop new, more targeted therapies, but first we need to further our understanding of the basic biology of lung cancer disease progression. These four projects will help our team do just that," said Eric Haura, M.D., co-principal investigator of the grant, associate center director of Clinical Science and director of the Lung Cancer Center of Excellence.

Preliminary data for this project was supported by Moffitt’s Lung Cancer Center of Excellence and Miles for Moffitt.

On June 28, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS), reported that Professor Dr. Richard P. Baum and Dr. Harshad R. Kulkarni, in conjunction with 3B Pharmaceuticals (Clovis’ licensing partner and discoverer of FAP-2286), published a retrospective report of their independent experience with FAP-2286 in named-patient use in The Journal of Nuclear Medicine (Press release, Clovis Oncology, JUN 28, 2021, View Source [SID1234584399]). In the first named-patient experience of the investigational compound conducted at Zentralklinik, Bad Berka, Germany, patients were treated with the FAP-targeted radiotherapy FAP-2286 linked to the radionuclide lutetium-177 (177Lu) as a therapeutic agent after prior confirmation of tumor FAP-positivity in patients by PET/CT imaging.

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In this palliative use setting, FAP-2286 was administered on a named-patient basis to 11 patients with progressive and metastatic adenocarcinoma of the pancreas, breast, rectum, and ovary after prior confirmation of FAP expression. According to the authors, administration of 177Lu-FAP-2286 demonstrated high uptake and long retention in primary and metastatic tumor lesions and an acceptable toxicity profile. The report concludes that the data warrant further investigation of 177Lu-FAP-2286 in clinical studies to systematically evaluate its safety and efficacy, and to define the patient population who would benefit most from treatment.

The Clovis Oncology-sponsored Phase 1/2 LuMIERE study of 177Lu-FAP-2286 is evaluating the compound in patients with advanced solid tumors. FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients appropriate for treatment in LuMIERE.

"We believe the early clinical experience from named-patient use validates our plans to further investigate FAP-2286 as a therapeutic and imaging agent across a variety of solid tumor types," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are very pleased to move FAP-2286 into formal clinical development with the recent initiation of the Phase 1/2 LuMIERE study of FAP-2286, a novel peptide-targeted radionuclide therapy in patients with solid tumors."

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

About the LuMIERE Clinical Study

LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

On June 28, 2021 Polyphor AG (SIX: POLN), a research driven clinical stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance reported that its global Phase III study, FORTRESS, evaluating balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2 negative, locally recurrent or metastatic breast cancer, did not meet its co-primary endpoint (Press release, Polyphor, JUN 28, 2021, View Source [SID1234584398]).

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At the primary analysis, balixafortide plus eribulin showed no improvement in the objective response rate (ORR) compared with eribulin alone (13.0% versus 13.7%; p=1.00) in the third line and later population (n=330 patients) followed for a minimum of 6 months. The clinical benefit rate, a key secondary endpoint indicating a stable disease or any confirmed response for a duration of at least 6 months as assessed by the IRC (independent radiological committee) was observed in 16.7% of patients in the balixafortide plus eribulin arm and 19.6% in the eribulin alone arm. The study confirmed the positive safety and tolerability profile of balixafortide in line with the previously reported Phase Ib study. Polyphor will continue to analyze the data, review with the experts and will decide about the future of the study in mid-July.

The board of directors is undergoing a strategic assessment and will consider a full range of options regarding the future of the company and will provide an update not later than end of July.

"Given the high unmet medical need for patients with HER2 negative breast cancer in a late stage of the disease, we are disappointed that the FORTRESS study did not meet its coprimary endpoint," says Gökhan Batur, CEO of Polyphor. "We thank all the patients, investigators and healthcare professionals as well as our employees for their active participation in this study."

About the FORTRESS study

The FORTRESS study (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which investigates the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer. The study had randomized 432 patients with HER2 negative MBC with at least 344 patients receiving third or subsequent line and 88 patients receiving second line chemotherapy.

About balixafortide

Balixafortide (POL6326) is a potent, specific, and highly selective antagonist of the chemokine receptor CXCR4, a G-protein coupled receptor (GPCR) that regulates the trafficking and homing of both cancer cells and cells of the patient’s immune system.

On June 28, 2021 Targovax ASA, reported that Victor Levitsky, Chief Scientific Officer of Targovax, is invited to present at the 4th Annual Next Gen Immuno-Oncology Virtual Congress-US Edition (Press release, Targovax, JUN 28, 2021, View Source [SID1234584397]).

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4th Annual Next Gen Immuno-Oncology Virtual Congress-US Edition, virtual
Date: 29 June 2021
Presenter: Victor Levitsky (CSO)
Time: 14:15 EDT / 20:15 CET
Title: Clinical efficacy and immuno-modulatory properties of oncolytic adenovirus ONCOS-102

On June 28, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to SNDX-5613 for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1) mutation. SNDX-5613 is the Company’s highly selective, oral menin inhibitor (Press release, Syndax, JUN 28, 2021, View Source [SID1234584396]).

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"Genetically-defined acute leukemias represent an underserved area marked by particularly poor prognosis and limited therapeutic options," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "As we move toward initiating our pivotal study, receipt of FTD from the FDA underscores SNDX-5613’s potential to meaningfully improve outcomes for patients with MLLr and NPM1 mutant acute leukemias."

About Fast Track Designation

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier. The FDA created this process to help deliver important new drugs to patients earlier and it covers a broad range of serious illnesses. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About SNDX-5613

SNDX-5613 is a potent, selective, small molecule inhibitor of the menin-MLL binding interaction that is being developed for the treatment of mixed lineage leukemia rearranged (MLLr) acute leukemias including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), and NPM1 mutant AML. In preclinical models of MLLr acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit. Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple preclinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML. SNDX-5613 is currently being evaluated in the Company’s AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias. SNDX-5613 was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with AML, and Fast Track designation for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged MLLr or NPM1 mutation.

About Mixed Lineage Leukemia Rearranged Acute Leukemias

Rearrangements of the MLL gene give rise to mixed lineage leukemia rearranged (MLLr) acute leukemias known to have a poor prognosis, with less than 25% of adult patients surviving past five years. MLL rearrangements produce fusion proteins that require interaction with the protein called menin to drive leukemic cancer growth. Disruption of the menin-MLLr interaction has been shown to halt the growth of MLLr leukemic cells. MLLr leukemias, which are routinely diagnosed through currently available cytogenetic or molecular diagnostic techniques, occur in approximately 80% of infant acute leukemias and up to 10% of all acute leukemias. There are currently no approved therapies indicated for MLLr leukemias.

About NPM1 Mutant Acute Myeloid Leukemia

NPM1 mutant acute myeloid leukemia (AML), which is distinguished by point mutations in the NPM1 gene that drive the leukemic phenotype, is the most common type of cytogenetically normal adult AML and represents approximately 30% of all adult AML cases. This subtype of AML has a five year overall survival rate of approximately 50%. Similar to mixed lineage leukemia rearranged (MLLr) leukemias, NPM1 mutant AML is highly dependent on the expression of specific developmental genes shown to be negatively impacted by inhibitors of the menin-MLL interaction. NPM1 mutant AML is routinely diagnosed through currently available screening techniques. There are currently no approved therapies indicated for NPM1 mutant AML.