On October 15, 2018 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that it will be highlighting its Phase 1b/2 clinical data for AU-011, the Company’s lead product candidate for the primary treatment of choroidal melanoma, in two oral presentations at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting being held October 27-30, 2018, at McCormick Place in Chicago (Press release, Aura Biosciences, OCT 15, 2018, View Source [SID1234529922]).

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!

"Following the positive interim results reported in July 2018 from this ongoing Phase 1b/2 study evaluating AU-011 in patients with choroidal melanoma, we are pleased to be sharing these updated, one-year results with the medical community at AAO this year," said Elisabet de los Pinos, Ph.D., Founder and Chief Executive Officer of Aura. "There are no FDA approved therapies for the treatment of choroidal melanoma, the most common type of primary eye cancer. Patients are currently treated with radiotherapy and surgery which typically results in severe vision loss, along with a plethora of other severe adverse effects and comorbidities. If approved, AU-011 will be the first targeted therapy for the treatment of choroidal melanoma, with the potential to preserve vision and transform the treatment paradigm for these patients."

In addition to the AAO clinical data presentations, Aura has been selected to present its innovative technology for the treatment of choroidal melanoma as part of the Innovation Showcase during the Ophthalmology Innovation Summit (OIS@AAO) taking place Thursday, October 25, 2018, at the Marriot Marquis Chicago. Dr. de los Pinos will give the presentation which will provide an update on Aura Biosciences.

Details for the oral presentations at AAO 2018:

Title: One-Year Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Primary Choroidal Melanoma

Presenter: Brian P. Marr, M.D., Columbia University Medical Center

Session: Ocular Oncology

Date and Time: Saturday, October 27, 2018, from 3:21 – 3:29 PM CT

Location: Room E350

Title: One-Year Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Primary Choroidal Melanoma

Presenter: Brian P. Marr, M.D., Columbia University Medical Center

Session: Ocular Pathology, Oncology

Date and Time: Monday, October 29, 2018, from 3:57 – 4:04 PM CT

Location: Room E350

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes to the liver in about 40-50 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

On October 15, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, reported the appointment of Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer ("CMO") (Press release, Mustang Bio, OCT 15, 2018, View Source [SID1234530345]). Dr. Sersch will oversee the clinical development of Mustang’s pipeline in CAR T technology and gene therapies. Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are delighted to welcome Martina to the Mustang leadership team. Her extensive global immuno-oncology drug
development expertise and vast array of experience in bringing innovative oncology products to market will help guide Mustang’s clinical development efforts and regulatory strategies in an exciting time of growth for the company."

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. Sersch is an experienced drug developer and physician with specialty training in oncology, infectious and tropical diseases. She has more than 17 years of experience in early- and late-stage clinical development in academia and industry. Prior to joining Mustang, Dr. Sersch served as executive director at Amgen, where she successfully led supplemental Biologics License Application filings in the area of hematology, as well as indication strategies for early- and late-stage compounds in hematology. Prior to Amgen, Dr. Sersch held positions of increasing responsibility on regional and global levels in oncology drug development, including novel immuno-oncology drugs at IRAD Oncology, Genentech, Roche and Pfizer. At Roche, Dr. Sersch was instrumental in the biologics strategy, where she led initiatives globally and regionally with a specific focus in Asia Pacific and China, including supporting the development of regional guidelines for drug development. Dr. Sersch obtained her medical and graduate degrees from Heidelberg University in Germany and subsequently trained in England, South Africa and the United States.

Dr. Sersch said, "I am thrilled to join Mustang to help advance the development of its CAR T and CRISPR/Cas9-enhanced CAR T therapies across multiple cancers, as well as its lentiviral gene therapy for XSCID. I look forward to working with the Mustang team as we strive to deliver promising new treatment options for patients and their families in areas of unmet medical need."

Shanghai, China – Virogin Biotech Ltd. ("Virogin") has been named 2018 Ernst & Young Fudan China’s Most Promising Enterprise, recognized within the ‘Health Reimagined’ category (Press release, Virogin Biotech, OCT 15, 2018, View Source [SID1234532328]).

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!

Hosted by global professional services firm Ernst & Young and Fudan University’s School of Management, these 8th annual awards identified prominent companies and future industry leaders that exhibit a commitment to innovation, sustained high growth, and potential to strengthen the economic development of China. At the industry awards ceremony, Virogin was recognized for their leadership in bio-innovative drug research and development.

As stated by the Ernst & Young Fudan China Most Potential Enterprise Selection Jury, "the award-winning companies represent a creative, entrepreneurial, diversified and inclusive corporate paradigm in today’s highly disruptive business world".

Virogin’s CEO and co-founder, Chris Huang says: "For Virogin, this award is testament to the work of our core team, all whom possess extensive experience and deep background in technology development, clinical advancement and business operations. At present, the company has three independent R&D projects and ongoing cooperative research and development projects. Our clinical product VG161 will enter clinical phase in the first half of 2019. We look forward to continuing our R&D work, and strengthening relations with our strategic partners to advance our SynerlyticTM platform."

On October 15, 2018 Advanced Proteome Therapeutics Corporation ("APC" or the "Company") (TSXV: APC) (FSE: 0E8), reported the successful completion of the first phase of the Collaboration of APC with Noria Pharmaceuticals Inc. in the rapidly growing and dynamic field of antibody radioisotope conjugates which is expected to have a major impact in the fight against cancer (Press release, Advanced Proteome Therapeutics, OCT 15, 2018, View Source [SID1234530347]).

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!

APC has succeeded in creating a construct using its proprietary, site-selective, linker technology with Noria’s proprietary MacroPa radioisotope chelation technology in combination with a well-established, commercially successful antibody. The excellent bio-affinity/targeting capability of the parent antibody has been preserved in the novel antibody-MacroPa conjugate in measurements performed by an independent laboratory. This accomplishment sets the stage for studies of targeted alpha-particle therapy, which is intended to carry a uniquely powerful radiation source to specific treatment points to destroy tumor cells.

In light of this development, APC and Noria have agreed to move forward with the second phase of their announced collaboration (July 17, 2018 (GLOBE NEWSWIRE) which will involve radiolabeling and testing utilizing cell lines and animal studies.

Dr. Allen Krantz, CSO and Founder of APC commented "We look forward to demonstrating the superiority of our site-selective approach to creating antibody-radioisotope-conjugates with Noria’s novel chelation technology that have commercial potential and advance cancer therapies." This program evokes synergies with our independent efforts involving targeted beta therapy for cancers and will allow us to leverage our technology in both initiatives.

Bill Dickie, APC’s President and CEO, stated that "it is exciting to witness the speed with which we have successfully applied APC technology to the development of vehicles for the targeted delivery of radiopharmaceuticals. These programs provide an important dimension to our overall mission involving anti-cancer therapeutics, which include recently announced (Oct. 09, 2018 (GLOBE NEWSWIRE)) positive results with antibody-amanitin conjugates which will be more fully reported shortly.".

Dr. Allan Green, President and CEO of Noria commented "We are indeed excited to continue our collaboration with APC and look forward to working with them to create superior antibody-based therapies.

On October 15, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported it has filed an IVD pre-submission with the US Food and Drug Administration (FDA) for use of its Cchek artificial intelligence based cancer detection technology, as a prostate cancer test (Press release, Anixa Biosciences, OCT 15, 2018, View Source [SID1234530496]). The FDA’s Pre-Submission Program (Pre-Sub) allows medical device and in vitro diagnostic (IVD) manufacturers to discuss specific aspects of the regulatory process and requirements with FDA. In the submission, Anixa requested a face-to-face meeting with the FDA to discuss the agency’s feedback on the proposed preclinical and clinical performance testing plan required to support a pre-market application, and to determine the appropriate regulatory path.

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. Amit Kumar, CEO of Anixa stated, "We are pleased to request a Pre-Sub meeting with the FDA. This meeting will be an important step in the commercialization path for Cchek as a prostate cancer test, which will be the first in a series of cancer detection and confirmation tests using our Cchek technology." Dr. Kumar continued, "This is a major milestone event for us as we begin the process of interfacing with the FDA on our diagnostic testing technology."

Dr. Kumar added, "This request for a meeting is in addition to a meeting already scheduled with the FDA regarding our CAR-T ovarian cancer therapy. I want to make clear that these are two separate and independent paths that address two different potential products. We are excited to have both of our programs ready for discussions with the FDA, and we plan on sharing the results of those meetings as appropriate."