On September 21, 2021 Foundation Medicine, Inc. reported the appointment of Mia Levy, MD, PhD, as its Chief Medical Officer (Press release, Foundation Medicine, SEP 21, 2021, View Source [SID1234590076]). Dr. Levy is a practicing medical oncologist specializing in the treatment of breast cancer and a nationally recognized leader in biomedical informatics. She joins Foundation Medicine following an accomplished tenure as Director of the Cancer Center at Rush University Medical Center in Chicago.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Levy has devoted her career to developing systems to support data-driven decision-making in cancer care and research. She has contributed to more than 90 publications on cancer and led the development of My Cancer Genome, an international knowledge resource for precision medicine that provides accessible information to patients and physicians around cancer-driving mutations, clinical trials, and therapies. She previously served as Associate Professor of Cancer Research, Biomedical Informatics and Medicine at Vanderbilt University, and as the Director of Cancer Clinical Informatics for the Vanderbilt-Ingram Cancer Center. She is a forum member of the National Cancer Policy Forum for the National Academies, and a member of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee.

"Our goal is to empower physicians and patients with the genomic information needed to make informed treatment decisions," said Brian Alexander, MD, MPH, chief executive officer at Foundation Medicine. "Dr. Levy is uniquely positioned to lead our medical team as they work to make this information both available and indispensable at the point of care. She is an accomplished leader and a compassionate physician, and we are very excited to have her join Foundation Medicine."

Dr. Levy will lead efforts to deepen the company’s unparalleled insight into cancer genomics, generate new data to validate the use of comprehensive genomic profiling in oncology, enhance the utility of its high-quality genomic tests and bring innovative new diagnostic technology to patient care.

"We’re entering an exciting new chapter for decision-making in precision oncology as we learn more about the biology of cancer and make those learnings useful for physicians in the clinic," Levy said. "I’m proud to join Foundation Medicine’s team of world-class physicians and scientists, as we advance broader applications of its technology that can help shape treatment plans for more people living with cancer globally."

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Boehringer Ingelheim reported the acquisition of Abexxa Biologics Inc., a biopharmaceutical company taking a new approach in the fields of immuno-oncology and oncology research to develop the next generation of precision medicines designed to revolutionize cancer treatments (Press release, Boehringer Ingelheim, SEP 21, 2021, View Source [SID1234590068]). The acquisition will allow Boehringer Ingelheim to access Abexxa’s expertise in targeting cancer-specific proteins that are located inside the cell, rather than those expressed on the cell membrane. This enlarges the pool of potential cancer antigen targets. In particular, Abexxa’s technology could lead to the development of cancer immunotherapies that are effective in a broader range of patients and cancer types.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The acquisition of Abexxa bolsters our commitment to tumor-antigen discovery and new ways of targeting intracellular antigens. Their cutting-edge know-how and technologies for antigen discovery and novel antibody generation strongly complement the current approaches we have been applying successfully to enable immune-targeting of cancer cells," said Clive R. Wood, Ph.D., corporate senior vice president and global head of discovery research, Boehringer Ingelheim. "By expanding our portfolio of antibodies binding novel intracellular tumor antigens, we are striving to develop unique and broadly applicable new immunotherapeutic approaches for cancer patients," added Wood.

Abexxa’s innovative platform unlocks the ability to target intracellular antigens of cancer cells by recognizing their presentation on the cell surface by MHC class 1 molecules. While the Abexxa platform addresses the more common HLA-A2 peptide presentation, the company has developed specific expertise in the nonclassical MHC class 1 molecule HLA-E, which has the potential to impact a broader set of cancer patients’ antigens. More specifically, Abexxa has developed a first-in-class T-cell receptor (TCR)-like antibody that can be used to disrupt the NKG2A:HLA-E immune checkpoint axis in oncology. Abexxa molecules are also being formulated to recruit immune cells targeting HLA-E peptide complexes on tumors.

In 2016, Boehringer Ingelheim’s Venture Fund, the arm of the company that invests in ground-breaking therapeutic and digital health approaches, awarded Abexxa initial investment funding. Later that year, Abexxa won Boehringer Ingelheim’s Innovation Prize, which facilitates business growth and rewards new companies for their dedication to innovation. The prize allowed Abexxa to expand operations into a shared lab space in Cambridge, Massachusetts, to continue its research. Boehringer Ingelheim’s investment in Abexxa demonstrates how the company is seeking to foster innovation across leading biotech communities, including the Dallas-Fort Worth, Texas, area.

"The investment by Boehringer Ingelheim’s Venture Fund in 2016 was a defining moment for Abexxa," said Debra Wawro Weidanz, co-founder and CEO of Abexxa. "The acquisition by Boehringer Ingelheim allows our team to access the company’s expertise and capabilities in immuno-oncology and antibody development and to have the opportunity to translate Abexxa technology into a clinical asset," said Jon Weidanz, Ph.D., co-founder and CSO of Abexxa.

This transaction is the latest in a series of strategic acquisitions and collaborations that reinforce Boehringer Ingelheim’s overall oncology strategy, bringing together cancer immunology and cancer cell directed therapies to fight cancer. This strategy has further strengthened Boehringer Ingelheim’s position in oncology through the development of leading assets and robust capabilities in cancer vaccines, oncolytic viruses, T-cell engagers, antibody drug conjugates (ADCs) and myeloid and stromal cell modulators. By combining its world-class in-house research and development with that of highly innovative biotechnology companies like Abexxa, Boehringer Ingelheim is developing innovative cancer immunology therapies and accelerating the delivery of the next generation of cancer treatments.

Learn more about Boehringer Ingelheim’s innovation in oncology here.

The total transaction includes an upfront payment, milestones and other consideration payments. Abexxa will continue to operate in the Arlington, Texas, area as a Boehringer Ingelheim family company, collaborating extensively with the colleagues at Boehringer Ingelheim’s U.S. research site in Ridgefield, Connecticut.

On September 21, 2021 Magenta Therapeutics, Inc. (Nasdaq:MGTA), a clinical-stage biotechnology company developing novel medicines designed to bring the curative power of stem cell transplants to more patients, reported that the company will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28 at 4:40 p.m. ET (Press release, Magenta Therapeutics, SEP 21, 2021, View Source [SID1234590067]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat can be accessed on the Magenta Therapeutics website at View Source The webcast replay will be available for 90 days following the event.