On June 14, 2018 AIVITA Biomedical reported the randomization of its first patient in the Company’s Phase II clinical trial for newly diagnosed advanced ovarian cancer (Press release, AIVITA Biomedical, JUN 14, 2018, View Source [SID1234527445]). The double-blind study will enroll approximately 99 patients who will receive AIVITA’s patient-specific ovarian cancer vaccine, or a control agent. This milestone achievement is the first application of AIVITA’s new ROOT OF CANCER technology, a revolutionary immunotherapy that targets cancer-initiating cells.

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!

AIVITA has received seven patient tumor specimens from a single clinical site, and has successfully generated a treatment for each patient, yielding a 100% manufacturing success rate. Given the success of patient recruitment and manufacturing, AIVITA will now expand the clinical study to multiple centers.

"I’m very proud that our AIVITA team has so clearly demonstrated feasibility and reproducibility in manufacturing these patient-specific treatments," said Dr. Robert Dillman, AIVITA’s Chief Medical Officer. "Quick, reliable and cost-effective production is critical for the viability of both patient and company."

AIVITA’s ROOT OF CANCER technology may soon be applied to both melanoma and glioblastoma multiforme patients. The Company is seeking approval to commercialize the treatment of melanoma patients in Japan and was recently approved to conduct a Phase 2 clinical study in glioblastoma multiforme by the US FDA.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of female cancer deaths, with an estimated 22,240 new diagnoses in 2018 and 14,070 deaths. The median age at diagnosis is 63, with a 5-year survival rate of less than 50% for all, and about 35% for the two thirds who have advanced disease (stage III or IV) at the time of initial diagnosis. Current standard of care includes surgical debulking and several courses of chemotherapy.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

The ovarian Phase II double-blind study will enroll approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%).

For additional information about AIVITA’s AVOVA-1 trial patients can visit www.clinicaltrials.gov/ct2/show/NCT02033616

On June 14, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed the comprehensive characterization of its proprietary cell clone known as 22P1G (Press release, PharmaCyte Biotech, JUN 14, 2018, View Source [SID1234527315]).

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 22P1G cells constitute the cells in the Master Cell Bank (MCB) that were prepared and tested by PharmaCyte’s contractor, Eurofins Lancaster Laboratories. The cells from the MCB will serve as the active pharmaceutical ingredient (API) in the company’s Cell-in-a Box capsules that will be used (together with low doses of the cancer prodrug ifosfamide) for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) in its planned clinical trial.

The comprehensive characterization studies include long-term stability of the cells, and stability of the potency of the cells as a therapeutic. All studies performed are required by the U.S. Food and Drug Administration (FDA).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, elaborated on the significance of the studies saying, "PharmaCyte is complying with all of the FDA guidelines and recommendations for all cell tests and other recent studies with the 22P1G cells. Successful completion of these studies was a pre-requisite for the approval by the FDA for us to conduct a clinical trial in patients with LAPC. Our treatment is primarily dependent upon genetically engineered live-human cells that produce a particularly potent cytochrome P450 enzyme that can activate the chemotherapy prodrug ifosfamide (clone 22P1G cells).

"With each individual batch, these cells must be stable for the long term, and the properties of the 22P1G cells must remain consistent from batch to batch. The newly completed studies provide evidence that both requirements have been met. Our pancreatic cancer treatment utilizes 22P1G cells that have been encapsulated using the Cell-in-a-Box technology. For treatment of LAPC patients, the capsules containing the cells are implanted near the pancreatic tumor so that a high local concentration of the cancer-killing ifosfamide metabolite is produced near the tumor."

On June 14, 2018 Apexigen, Inc., and Yale Cancer Center reported a clinical trial collaboration to evaluate Apexigen’s APX005M in combination with cabiralizumab and Opdivo in patients with advanced solid tumors (Press release, Apexigen, JUN 14, 2018, View Source [SID1234591001]). The Phase 1/2 clinical trial will evaluate the safety, tolerability, and preliminary activity of APX005M in combination with cabiralizumab and Opdivo in metastatic NSCLC, metastatic melanoma and RCC patients whose disease has progressed on prior anti-PD-1/PD-L1 therapy (www.clinicaltrials.gov: NCT03502330). In addition to providing funding, Bristol-Myers Squibb will supply Opdivo and cabiralizumab, an investigational antibody being developed in partnership with Five Prime Therapeutics.

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!

APX005M is an investigational compound that is designed to activate CD40, a key immune co-stimulatory receptor essential to regulating the activation of both innate and adaptive immune responses against cancer. Cabiralizumab (FPA008) is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R) and depletes immunosuppressive tumor associated macrophages (TAMs). Preclinical data from Yale researchers and others have demonstrated that treatment with a combination of CD40 activation and inhibition of CSF-1R modifies tumor-associated macrophages and activates T cells in tumors. This results in converting a "cold" into an "inflamed" tumor microenvironment capable of eliciting protective T cell responses in tumors that are either unresponsive or insensitive to immune checkpoint blockade.

"There is an urgent need to find effective therapies for the growing number of patients who have not responded to checkpoint inhibitors," said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. "CD40 has a fundamental role in the activation of both innate and adaptive immunity, and we believe that CD40 activation by APX005M will become a key component of a number of promising new I-O therapeutic regimens for treating cancer patients."

"This most exciting collaboration between Apexigen and Yale is a result of studies with tumor bearing mice that are poorly responsive to inhibitors of PD-1/PD-L1. Based on these studies, we believe that activation of the innate immune system by APX005M in combination with cabiralizumab will enhance the activity of nivolumab, leading to a novel therapeutic approach for the increasing population of cancer patients who progress on currently approved immune checkpoint inhibitors. This is the first time this combination of drugs has been given to patients and we are eager to initiate this new clinical trial," said Harriet Kluger, M.D., Professor of Medicine at Yale Cancer Center and Principal Investigator of the trial.

On June 13, 2018 Nordic Nanovector ASA (OSE: NANO) reported that it has received approval from the Regional Committees for Medical and Health Research Ethics (REK) in Norway with regard to the Clinical Trial Application (CTA) for the Archer-1 Phase 1b trial with Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab in second-line follicular lymphoma patients (2L FL) (Press release, Nordic Nanovector, JUN 13, 2018, View Source [SID1234553498]).

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!

Nordic Nanovector has now received all necessary approvals to begin Archer-1 in Norway and will commence start-up activities immediately. Archer-1 is a Phase 1b clinical trial designed to investigate the safety, tolerability, pharmacokinetic and preliminary efficacy of the Betalutin/rituximab combination in approx. 20 2L FL patients, and the study will initially be conducted in Norway. Further countries are expected to be added later. The first patient is expected to be dosed in the second half of 2018.

On June 13, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that Kevin Hrusovsky, President, Chairman and CEO of Quanterix, and Founder of Powering Precision Health (PPH), has been named by EY as a finalist for the Entrepreneur Of The Year 2018 Award in the New England program (Press release, Quanterix, JUN 13, 2018, View Source [SID1234527301]). The recognition acknowledges Hrusovsky’s achievements in healthcare technology innovation, Quanterix’ outstanding financial performance, and his personal commitment to improving precision medicine and human health.

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!

"We are honored to be recognized by EY for this award," said Hrusovsky. "For me, this recognition represents the many people and institutions that we’ve been working with who are driving a precision health vision to eradicate and prevent some of today’s most lethal diseases, namely cancer, Alzheimer’s and infectious disease forward. It’s a privilege for us to be recognized alongside other entrepreneurs and business leaders who are all pioneers in their respective fields."

Hrusovsky has a more than 25 year-long track record commercializing disruptive technologies in the life science industry. His impressive career has been propelled by a unique leadership style marked by transparency, passion, and purpose. Since joining Quanterix less than four years ago, Hrusovsky has transformed the company from one that lacked mission and direction into a successful public entity with industry-leading technology that has the power to transform the way we diagnose and treat disease. The key is his focus on putting science first. With Hrusovsky at the helm, Quanterix now has over 200 peer-reviewed publications backing the abilities of its Simoa technology, a significant industry accomplishment. He’s also expanded the applications for Simoa in the drug development industry, with 18 out of the top 20 pharmaceutical companies having used the technology to date in over 700 clinical trials.

Two years ago, Hrusovsky realized that more needed to be done to drive a true transformation in our healthcare system. As such, he launched PPH as a forum where all key stakeholders, from the world’s leading medical professionals and innovators to patients and patient advocates, could come together to share their latest research and truly revolutionize medicine. Now in its third year, PPH has sparked a true movement, one that puts science before profits and closely examines how we can prevent diseases, not just treat them. Today PPH has more than doubled in size and is considered the leading industry conference focused on advancing precision health.

Hrusovsky also serves on the Board of Directors of several companies shaping the future of precision health, including Quanterix, BioreclamationIVT, Cell Signaling Technology, 908 Devices, SynapDx and Solect Energy. He also serves on the Educational Board of the Massachusetts Biotech Council, the Advisory Committee for the Center for Biomedical Engineering at Brown University, the Association for Laboratory Automation, the JALA Editorial Board, and the Strategy Committee of Children’s Hospital Boston.

Hrusovsky was selected as a finalist by a panel of independent judges. Award winners will be announced at a special gala event on June 28, 2018 at the Westin Boston Waterfront. Now in its 32nd year, the program has expanded to recognize business leaders in more than 145 cities in more than 60 countries throughout the world.

Regional award winners are eligible for consideration for the Entrepreneur Of The Year National competition. Award winners in several national categories, as well as the Entrepreneur Of The Year National Overall Award winner, will be announced at the Entrepreneur Of The Year National Awards gala in Palm Springs, California, on November 10, 2018. The awards are the culminating event of the Strategic Growth Forum, the nation’s most prestigious gathering of high-growth, market-leading companies.

Sponsors

Founded and produced by EY, the Entrepreneur Of The Year Awards are nationally sponsored in the US by SAP America, the Kauffman Foundation and Merrill Corporation.

In the New England region, gold sponsors also include Boston Private Bank, fama PR, the Isenberg School of Management at the University of Massachusetts Amherst, Nixon Peabody, True Search, and Woodruff Sawyer. New England silver sponsors include Chatham Financial, Empire Valuation Consultants, Morgan Lewis, Sullivan & Worcester, and T3 Advisors.