On September 21, 2021 Black Diamond Therapeutics, a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, and OpenEye Scientific, a leader in computational molecular design, reported that they are entering into a strategic partnership incorporating OpenEye’s Orion molecular design platform into Black Diamond’s proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine to advance Black Diamond’s efforts to develop MasterKey inhibitor cancer therapies (Press release, Black Diamond Therapeutics, SEP 21, 2021, View Source [SID1234590070]).

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OpenEye’s Orion Software-as-a-Service platform will enable Black Diamond to perform rapid simulations and analysis of protein motion through Orion’s powerful combination of a high-performance compute facility, scientific development environment, and browser-based analysis and collaboration tools. Black Diamond and OpenEye will collaborate to co-develop enhanced-sampling capabilities designed to deliver information on an accelerated time scale. With the increased capability to model large and complex systems, Black Diamond will enhance its ability to discover mutant selective MasterKey therapies that target families of oncogenic mutations.

"Our proprietary MAP drug discovery engine combines computational and experimental techniques to identify, validate, and aggregate oncogenic mutations, rendering them actionable by a single MasterKey inhibitor," said David M. Epstein, PhD, Co-Founder, President and CEO of Black Diamond Therapeutics. "Complementing our expertise in cancer genomics, protein function and medicinal chemistry, we believe our work with OpenEye will enable the expansion of Black Diamond’s therapeutic pipeline by enhancing a molecular understanding of intact, full-length oncoproteins activated by a diverse array of driver mutations."

OpenEye’s Orion molecular design platform integrated with Amazon Web Services’ Cloud environment allows Black Diamond to pursue scalable and parallel analyses of the conformational states of families of mutant oncogenes. The deployment of these large-scale perturbations provides Black Diamond with detailed structural and dynamic information on target proteins to guide drug discovery efforts. The arrangement between OpenEye and Black Diamond involves an upfront payment and potential downstream economics resulting from select Black Diamond products for OpenEye.

"We are beginning to see the marriage of computation and genomics not just through sequence analysis, but at the structural level," said Anthony Nicholls, CEO and Founder of OpenEye Scientific. "This shift is being hastened by the Cloud and its democratization of large-scale computation. We’re very proud to be able to work with Black Diamond to combine molecular simulation on our cloud platform, Orion, with their MAP drug discovery engine to accelerate their search for novel cancer therapeutics."

On September 21, 2021 HALO Diagnostics (HALO Dx) reported that now offers men with suspected metastatic and recurrent prostate cancer another groundbreaking advanced imaging option (Press release, HALO Diagnostics, SEP 21, 2021, View Source [SID1234590104]).

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HALO Diagnostics, known for pioneering MRI-guided Laser Focal Therapy for the treatment of prostate cancer, reported the adoption of imaging agent, PYLARIFY (piflufolastat F-18) Injection for use with targeted positron emission tomography (PET) imaging.

"PYLARIFY is a game-changer for early detection of metastasis and recurrence in men previously treated for the disease."

PYLARIFY, developed by Lantheus, targets a prostate-specific membrane antigen (PSMA) protein overexpressed on the surface of 95 percent of prostate cancer cells circulating in a man’s blood. It is the first commercially available, FDA approved PSMA PET imaging agent for prostate cancer.

"PYLARIFY is a molecular imaging game changer for early detection of metastasis in newly diagnosed prostate cancer patients, and for recurrence in men previously treated for the disease," said Dr. John Feller, HALO Diagnostics Chief Medical Officer. "Early and more precise detection gives patients multiple treatment options."

Prostate cancer is the second most common form of cancer affecting American men. An estimated one in eight will be diagnosed in their lifetime.

Of men with localized prostate cancer who undergo initial treatment, as many as 50 percent may experience recurrence within ten years. Recurrent disease is often detected by rising PSA levels; however, conventional imaging, especially at low PSA levels, is not able to identify the location and extent of the disease in most cases.

PYLARIFY enables visualization of microscopic amounts of cancer that have metastasized beyond the prostate by binding to PSMA and causing the cancer cells to "light up" on a PET scan, allowing the reader to better detect and locate the disease. Early detection saves lives.

The radiotracer is now included in the National Comprehensive Cancer Network (NCCN) guidelines for imaging prostate cancer.

To make an appointment with a HALO Diagnostics doctor, visit HALODx.com.

On September 22, 2021 SHINE Medical Technologies LLC reported that the company has changed its name to SHINE Technologies LLC (Press release, Shine Medical Technologies, SEP 22, 2021, View Source [SID1234590122]).

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SHINE’s new name highlights the company’s core technological competencies, skilled team and focus as a next-generation nuclear technology company. SHINE is pursuing a four-phase strategy for the development of nuclear fusion technology to achieve its ultimate goal: producing fusion energy. SHINE’s technology is currently being applied to advanced industrial inspection services and medical isotope production, phases I and II of the company’s four-phase approach, respectively.

"Our long-term goal is to create and deploy systems that produce clean fusion energy, and we are continuing to grow towards that goal by commercializing more near-term applications of fusion," said Greg Piefer, SHINE’s founder and CEO. "In addition, our merger with Phoenix earlier this year strengthened our position by enabling us to integrate a key technological capability that supports our near- and long-term plans."

Phoenix commercialized phase I, advanced industrial inspection services, over a decade ago by utilizing its fusion-based technology for nondestructive testing. These applications take neutron images or perform other assay measurements of modern materials in detail, ensuring that the quality and safety needs of clients in the aerospace, defense and energy industries are met.

SHINE’s phase II involves the application of fusion to the production of medical isotopes. The company expects to produce diagnostic isotopes for heart disease and other applications and is producing therapeutic isotopes for certain cancers. SHINE anticipates producing these isotopes at commercial scale at facilities on its campus in Janesville, Wis.

"The goal of each phase of our approach is to create social and economic value while building additional capacity and capability, and deepening our scientific understanding of fusion technology as we progress to clean energy production," Piefer said.

SHINE’s next step will be to explore the use of its technology to recycle nuclear waste in phase III. Carbon-free nuclear power currently faces a major political obstacle because it produces radioactive waste, some of which can last for millions of years. If successful, SHINE’s phase III is expected to help mitigate this problem by recycling a portion of this waste and using fusion to shorten the half-life on long-lived waste forms. Importantly, SHINE’s work in this phase could help fission power become a more sustainable form of carbon-free energy.

The goal of phase IV is to generate clean, abundant and affordable fusion energy. SHINE believes its achievement of this goal will be built on the strength of its skilled team, including their experience with challenging nuclear technology projects, the breadth of the company’s unique technological capabilities, and the experience expected to be gained from operating many powerful fusion systems in the field during phase III.

"We are excited that our new name more clearly reflects our core technological competencies, strong team and long-term ambitions," Piefer said. "SHINE was founded on differentiated technology, and a unique, lean and phased approach to developing nuclear technology. It’s great to be telling the world more about the company we’ve built, with an updated brand that reflects it."

On September 21, 2021 Provectus (OTCQB: PVCT) reported that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 (rose bengal disodium) for the treatment of neuroendocrine tumors (NET) metastatic to the liver (mNET) refractory to somatostatin analogs (SSAs) and peptide receptor radionuclide therapy (PRRT) (NCT02693067) was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, held online from September 16-21, 2021 (Press release, Provectus Biopharmaceuticals, SEP 21, 2021, View Source [SID1234590071]).

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Highlights from the ESMO (Free ESMO Whitepaper) 2021mNET Presentation:

Baseline disease characteristics
N = 12 patients: 50% male; median age of 66 years (range 47-79)
Primary tumor sites: 7 small bowel (58%), 2 pancreas (17%), 1 caecal (8%), and 2 unknown (17%)
NET grades: 5 Grade 1 (42%) and 7 Grade 2 (58%)
Refractory to SSA and PRRT; all symptomatic progressive disease
Chromogranin A (CgA): median 1,585 μg/L (35-10,370)
PV-10 treatment
Median number of injected lesions: 1 (1-4)
Median number of injection cycles: 1 (1-4); 8 patients (67%) received 1 PV-10 cycle; 4 patients received multiple cycles
Safety
Injection site pain in 9 of 12 patients (75%)
Grade 3 photosensitivity reaction in 1 patient; Grade 3 elevation of hepatic enzymes in 1 patient (resolved by Day 7); carcinoid flare in 2 patients
Injected-lesion efficacy (RECIST)
42% partial response (PR) and 42% objective response rate (ORR)
Patient-level efficacy (RECIST)
83%a disease control rate (DCR) (10 of 12 patients)
Median progression-free survival (PFS): 9.2 months (1.0-41.8)
Median overall survival (OS): 22.5 months (5.5-41.8); 6 patients (50%) undergoing response follow-up (data cut-off: April 30, 2021)
Immune response
Upregulation of NK cells and activated CD4+ T cells observed in peripheral blood collected 7-28 days post-PV-10 injection
Biomarkers and quality of life (QOL)
CgA stable in 10 patients (83%)
Health-related QOL assessments stable or improved at one month in 8 of 11 patients (73%); maintained at 3 months in 6 of 10 patients (60%)
a Typographical error on the poster

A copy of the poster is available on Provectus’ website at View Source

Simone Leyden, Chief Executive Officer and Co-Founder of NeuroEndocrine Cancer Australia, and International Neuroendocrine Cancer Alliance (INCA) Research Chair, said "The safety and efficacy data from this Phase 1 clinical trial of single-agent PV-10 present a promising therapy for refractory, symptomatic, neuroendocrine cancer patients with liver metastases, a patient population who are underrepresented when it comes to new medical research and treatment options. We look forward to seeing PV-10’s future use in this refractory setting, and also in Phase 2 combination therapy testing for earlier lines of neuroendocrine cancer treatment."

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, added, "These data may initially position single-agent PV-10 behind somatostatin analogs and peptide receptor radionuclide therapy in the Australian patient treatment setting. Our clinical trial database should lock in the fourth quarter of 2021, providing us the opportunity to finalize data collection and analysis prior to assessing PV-10’s regulatory prospects and options."

This clinical trial, a single-center study at The Queen Elizabeth Hospital (TQEH) in Adelaide, Australia that completed enrollment in 2020, is led by Tim Price, MBBS, DHlthSc (Medicine), FRACP, Head of Clinical Oncology Research and Chair of the combined Hematology and Medical Oncology Unit at TQEH and Clinical Professor in the Faculty of Medicine at the University of Adelaide. The primary endpoint of the trial is safety. Secondary endpoints include ORR of injected target and measurable bystander lesions, target lesion somatostatin receptor expression, and biochemical response. Disease response assessments are conducted by independent review using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Six patients in the first cohort each received one percutaneously-administered injection of PV-10 to one target lesion per treatment cycle. Patients in the six-person second cohort can receive PV-10 injections of multiple lesions per cycle.

About PV-10

Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days. This IL PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory advanced cutaneous melanoma, IL PV-10 may restore disease-specific T cell function, which may also be prognostic of clinical response. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to tumors of the liver. Systemic administration of PV-10 is also undergoing preclinical study as prophylactic and therapeutic treatments for refractory and high-risk adult solid tumor cancers, and as a treatment for relapsed and refractory blood cancers.

About NeuroEndocrine Cancer Australia

NeuroEndocrine Cancer Australia is the only Australian not-for-profit medical charity focused on neuroendocrine tumors. It was co-founded in 2009 by Simone Leyden and her brother Dr. John Leyden through shared experiences with their sister Kate’s diagnosis of pancreatic neuroendocrine carcinoma and liver metastases. For more information, please visit NeuroEndocrine Cancer Australia’s website at www.neuroendocrine.org.au.

On September 21, 2021 Nektar Therapeutics (NASDAQ: NKTR) reported it has entered into a new oncology clinical collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the maintenance regimen of NKTR-255, Nektar’s interleukin-15 (IL-15) receptor agonist, in combination with avelumab, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma (UC) in the Phase II JAVELIN Bladder Medley study (Press release, Nektar Therapeutics, SEP 21, 2021, View Source [SID1234590105]).

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NKTR-255 is wholly owned by Nektar and is currently being evaluated in two separate clinical studies in both liquid and solid tumors. The novel IL-15 agonist is designed to activate the IL-15 pathway to expand both natural killer (NK) cells and memory CD8+ T cell populations.1 Avelumab, which is marketed in the U.S. as BAVENCIO, is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

"We are excited to partner with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the combination of NKTR-255 with avelumab in urothelial carcinoma," said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "Preclinical studies suggest that avelumab may induce lysis of tumor cells via antibody-dependent cell-mediated cytotoxicity, or ADCC, indicating an additional mechanism of action, and providing an opportunity for potential synergy when combined with an NK cell stimulator, such as NKTR-255."

Under the new collaboration, Merck KGaA, Darmstadt, Germany and Pfizer Inc. will include the combination of NKTR-255 plus avelumab in the new JAVELIN Bladder Medley study. The study is a recently designed global, multi-center Phase II umbrella trial evaluating different avelumab-based combinations, compared with avelumab monotherapy, as potential maintenance therapy regimens for patients with locally advanced or metastatic UC that has not progressed with a first-line platinum-containing chemotherapy regimen. Nektar will supply NKTR-255 for the trial. Nektar and the Merck KGaA, Darmstadt, Germany-Pfizer alliance will each maintain existing global commercial rights to their respective medicines. The study is expected to begin enrolling patients in the first quarter of 2022.

BAVENCIO (avelumab) is indicated in the U.S. and Europe for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

NKTR-255 is an investigational agent in clinical development and is not approved alone or in combination with avelumab (or any other agent) for use in any country.

About Urothelial Carcinoma
Bladder cancer is the 10th most commonly diagnosed cancer worldwide, with approximately 573,000 new cases and 213,000 deaths.2 It is more common in men than in women, representing the 6th most common cancer and the 9th leading cause of cancer death among males. Incidence rates for men and women are respectively 9.5 and 2.4 per 100,000. Mortality rates for men and women are respectively 3.3 and 0.9 per 100,000.2 Noninvasive cancers reflect a large proportion of all bladder cancers2, and only 25% to 55% of patients receive any second-line therapy after first-line chemotherapy.3-9 In the U.S. and EU5 markets, approximately 40% to 50% of patients receive an immune checkpoint inhibitor in second-line therapy.10

BAVENCIO Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO monotherapy include lymphopenia; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

For full US Prescribing Information and Medication Guide for BAVENCIO, please see View Source

About NKTR-255
NKTR-255 is a novel polyethylene glycol (PEG)-conjugate of recombinant human interleukin-15 (rhIL-15), which was designed to retain all known receptor binding interactions of the IL-15 molecule. The investigational candidate is uniquely designed to overcome known challenges of recombinant IL-15 and other IL-15 agonists, which are rapidly cleared from the body and have shown diminishing response to successive doses. Through an extended circulating half-life and optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances functional NK cell populations and formation of long-term CD8+ mediated immunological memory, which may lead to sustained anti-tumor immune response.