On February 13, 2018 GT Biopharma Inc. (OTCQB: GTBP) (Euronext Paris: GTBP.PA) reported that Dr. Jeffrey Miller, Deputy Director of the Masonic Cancer Center, University of Minnesota will be presenting at the Keystone Symposia: Emerging Cellular Therapies: T Cells and Beyond; ‘Novel Ways to Activate and Target NK Cells to Treat Cancer’ (Press release, GT Biopharma , FEB 13, 2018, View Source [SID1234539534]). This presentation will highlight GT Biopharma’s TriKE and TetraKE platforms.

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. Miller will be presenting to leaders in the field of cell therapies at the conference on Feb. 14th from 5:00 -7:00 pm MT. He will be discussing GT Biopharma’s unique single-chain, tri-specific NK cell engager (TriKE) and tetra-specific NK cell engager (TetraKE) platforms targeting hematologic malignancies, sarcomas and carcinomas (solid tumors). The presentation will address both the TriKE and TetraKE constructs, as well as our second-generation anti-CD16-IL-15-anti-CD33 TriKE (OXS-C3550); another first-of-its-kind, single-chain, tri-specific NK cell engager (TriKE).

NK cell cancer-killing activity is expected to be increased by bringing the NK cells in close proximity to the cancer cells. This may be achieved by ‘engagers’ that bind to CD16 on the surface of NK cells and bind specific proteins (such as CD33) on the surface of cancer cells, thus forming an immune synapse between the NK cell and the cancer cell. Our lead TriKE, anti-CD16-IL-15-anti-CD33 (OXS-3550) is expected to be in the clinic in the second half of 2018. The TriKE constructs utilize the inclusion of interleukin-15 (IL-15), a peptide that leads to proliferation and activation of the NK cells. This further increases NK cancer-cell killing capabilities and improves their function in the tumor microenvironment (Vallera et al,2016).

Unlike traditional CAR-T platforms, TriKEs are potentially a cost effective cell therapy and not relegated to treating liquid tumors only. GT Biopharma believes that TriKEs are an antibody platform that can be tailored to treat any form of cancer, liquid or solid tumors.

Dr. Jeffrey Miller said, "I am pleased to present additional information regarding these immune-oncology platforms. As a researcher, I continue to believe that both have the potential to generate candidates with the ability to have a significant impact on the treatment of cancer and other diseases."

GT Biopharma Chief Medical officer (CMO) Dr. Raymond Urbanski said, "The TriKE and TetraKE concepts and constructs potentially have significant advantages over current and other development-stage therapies. Dr. Miller is a luminary in NK cell biology and its applications, and we continue to be excited by the potential opportunity related to this technology."

Glioblastoma multiforme is the most common and deadliest of the glial tumors because it is hard to cure with a very high possibility of recurring. Diffuse intrinsic pontine glioma (DIPG) is a sub-kind of glioblastoma that mainly affects children. It has a 5-year survival rate less than 1%.

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!

According to the ABTA, there are nearly 700,000 people in the United States living with a primary brain and central nervous system tumor. Of these, 14.9 percent are glioblastomas. There is an estimated of 12,390 new cases predicted in 2017.
ACT001 is a drug designed and developed by Accendatech specifically used to target brain tumor for treatment of GBM and DIPG
​
ACT001
ACT001 is an investigational product currently finished testing in phase 1 clinical studies.

On February 13, 2018 Ziopharm Oncology, Inc. (Nasdaq:ZIOP), reported that management will host a conference call and webcast slide presentation on Thursday, March 1, at 4:30 p.m. ET to provide a corporate update and discuss financial results for the fourth quarter and year ended Dec. 31, 2017 (Press release, Ziopharm, FEB 13, 2018, View Source [SID1234523991]).

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 call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 3782628. To access the slides and live webcast or the subsequent archived recording, visit the "Investors & Media" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

On February 13, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of cancer immunotherapies has submitted a conditional Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the company’s lead Lm Technology product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent, recurrent or metastatic carcinoma of the cervix (PRmCC).

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 submission of the MAA represents a significant regulatory milestone for Advaxis and the ongoing development of our Lm Technology Platform," stated Anthony Lombardo, interim Chief Executive Officer of Advaxis. "The submission is based on the improvement in 12-month survival rates observed in the Phase 2 GOG-0265 study. We feel that these data support axalimogene filolisbac as a potential therapeutic option for patients living with PRmCC who are in desperate need of new treatment options beyond first-line therapy," added Lombardo.

The MAA submission is built around data from the GOG-0265 study which examined overall survival rates in 50 women and showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with PRmCC, representing a 55% improvement over an expected, model-predicted,12-month survival rate of 24.5%.2 More than 50% of treated women in this study had previously received multiple prior lines of therapy including treatment with bevacizumab and subsequently experienced progression of their disease.2

"Despite the availability of preventative measures, metastatic cervical cancer continues to be a major public health concern associated with high mortality rates within Europe," said Mansoor Mirza, M.D., Chief Oncologist at the Copenhagen University Hospital in Denmark and Medical Director of the Nordic Society of Gynaecological Oncology (NSGO). "The results from GOG-0265 are encouraging and could represent a meaningful step forward in the care of women suffering from PRmCC, which has seen very little innovation in almost 30 years."

In the GOG-0256 study, axalimogene filolisbac was generally well-tolerated with mostly Grade 1 and 2 flu-like adverse events associated with cytokine release which were managed with standard medical care. This safety profile is consistent with the ongoing clinical experience of axalimogene filolisbac across all clinical trials.

The EMA will evaluate the totality of the data, including results from GOG-0265 as well as supportive data from other clinical trials evaluating axalimogene filolisbac. In parallel with the MAA review process, the company will continue assessing partnership opportunities for the potential commercialization of axalimogene filolisbac in Europe.

The company has also decided to align and simplify its strategy by using axalimogene filolisbac exclusively in all ongoing and planned HPV-related cancer clinical trials, including the upcoming ADVANCE trial, previously planned with ADXS-DUAL. The strategic decision to harmonize all trials to axalimogene filolisbac is based on its clinical profile to date in over 250 patients, and its demonstration of similar activity in both HPV 16 and 18 subtypes in GOG-0265. The company believes that harmonizing to a single product candidate for all HPV-related programs will streamline developmental, regulatory and commercialization strategies.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based investigational immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack.

Axalimogene filolisbac has already achieved multiple regulatory milestones, including classification as an EMA advanced therapy-medicinal product for the treatment of cervical cancer, receipt of the U.S. Food and Drug Administration (FDA) Fast Track Designation as an adjuvant therapy for treating high-risk, locally advanced cervical cancer (HRLACC), receipt of a Special Protocol Assessment agreement with the FDA for the Phase 3 AIM2CERV trial, and orphan drug designations in three HPV-associated indications (PRmCC, head and neck, and anal cancer). In addition, axalimogene filolisbac will be studied in combination with nivolumab in the ADVANCE trial, a potential registrational trial for patients with PRmCC, which is planned to begin in 2018.

On February 13, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported recent product launches from Athenex Pharmaceutical Division ("APD") (Press release, Athenex, FEB 13, 2018, View Source;p=RssLanding&cat=news&id=2332087 [SID1234523939]). These launches highlight the continued portfolio growth with an emphasis on oncology or oncology supportive therapy, a business strategy of Athenex’s commercial business as an effective supplement to its progressing clinical pipeline focused on oncology.

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!

Athenex has brought the following products to market in its 503B (outsourced sterile preparations) and Specialty (finished-dose specialty injectable products) businesses:

503B Products

Epinephrine 2 mg and 4 mg in 250 mL in 0.9% Normal Saline (2 SKUs)
Norepinephrine 4 mg and 8 mg in 250 in 0.9% Normal Saline (2 SKUs)
Specialty Products

Caspofungin Acetate for Injection 50 mg per vial; 70 mg per vial (2 SKUs; vials)
Doxorubicin 5 mL, 25 mL, 100 mL; (3 SKUs; vials)
Etomidate Injection 20 mg per 10 mL; 40 mg per 20 mL; (2 SKUs; vials)
Gemcitabine for Injection 1 mg (1 SKU; vials)
Paclitaxel Injection 30 mg per 5 mL; 100 mg per 16.7 mL; 300 mg per 50 mL; (3 SKUs; vials)
Jeffrey Yordon, Athenex’s Chief Operating Officer and President of APD, commented, "These product launches underscore a continuation of our ongoing commitment to bring needed, quality oncology products to market on both the 503B and Specialty Injectables sides of our business. As part of a broader effort to build our commercial platform and capabilities, we will continue to look for opportunities to bring additional products focused mainly on oncology and oncology supportive care therapies to our customers throughout 2018 as well as generate additional revenue to help fund our clinical programs."

Athenex is committed to quality and product labeling innovation. cGMP processes are followed for each of Athenex’s products, and a Certificate of Analysis is provided for each batch of 503B products so customers are able to see measurable results from repeatable tests. Additionally, Athenex’s AccuraSEE, a proprietary and highly differentiated approach to package and labeling, has a unique design to give caregivers accurate information and reduce the risk of medication errors.