On June 26, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or "the Company") (Nasdaq:ZIOP) reported completion of enrollment of the third cohort of a phase 1 clinical trial evaluating Controlled IL-12 (Ad-RTS-hIL-12 plus veledimex, Ad+V), in combination with the PD-1 inhibitor OPDIVO (nivolumab) for the treatment of recurrent or progressive glioblastoma multiforme (rGBM) in adults (Press release, Ziopharm, JUN 26, 2019, View Source [SID1234537296]).

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!

Investigators from this multi-center trial, conducted at Northwestern University in Chicago, Brigham and Women’s Hospital in Boston, and The University of Texas MD Anderson Cancer Center in Houston, have indicated interest in expanding the study and the Company now expects to enroll additional patients at the highest dosing level, subject to final agreement by the Data and Safety Monitoring Board.

"We are pleased to complete enrollment of the dose escalation of Ad-RTS-hIL-12 + veledimex and nivolumab and explore the potential to expand this combination trial to further enrich our clinical experience," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "The enthusiasm for combining PD-1 inhibitors with IL-12 in the current study is evident, and we also look forward to initiating a phase 2 trial with Ad-RTS-hIL-12 plus veledimex and cemiplimab in the coming days."

Ziopharm’s Controlled IL-12 platform is an investigational gene therapy designed to induce and control the production of human interleukin 12 (hIL-12) a master-regulator of the immune system. In the setting of rGBM, the Company is leveraging the anti-tumor effects for Controlled IL-12 as monotherapy by combining with PD-1 inhibitors. Previously reported data from serial biopsies in patients with rGBM revealed that Controlled IL-12 results in sustained influx of T cells and upregulation of PD-1 expression, providing a compelling rationale for this combination. Initial phase 1 data from this trial were presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 2, 2019, showing Controlled IL-12 can be combined with PD-1 inhibitor OPDIVO and the initial data were consistent with immune mediated anti-tumor effects with a favorable safety profile.

Ziopharm anticipates reporting on further data from this combination trial (Clinicaltrials.gov NCT03636477) at medical meetings later this year and into 2020.

About Ad-RTS-hIL-12 plus veledimex

The Company has treated more than 100 patients, including more than 75 patients with rGBM, with Ad-RTS-hIL-12 plus veledimex and administered more than 1,300 doses of veledimex across three types of solid tumors, building a significant safety profile, mechanistic dataset and evidence of anti-tumor effects.

At the 2018 annual meeting of the Society for Neuro-Oncology, Ziopharm presented data from its phase 1 dose-escalation trial showing that Controlled IL-12 (Ad-RTS-hIL-12 plus veledimex) had a positive survival benefit, with 15 patients who received 20mg veledimex reaching 12.7 months median overall survival (mOS) at a mean follow up of 13.1 months. A subset of these patients (n=6) who received low-dose steroids (20mg or less of dexamethasone cumulatively over 15 days while receiving veledimex) had mOS of 17.8 months compared to 6.4 months mOS for patients (n=9) who received more than 20mg of dexamethasone during the same period. The survival data from patients who received the preferred dosing regimen of Controlled IL-12 with 20mg veledimex and low-dose steroids compare favorably to a benchmark mOS of 6 to 9 months for patients with rGBM that serves as historical control.

In February, the Company announced that it rapidly completed enrollment and treated 36 additional patients at 20mg veledimex dosing in less than six months in a substudy (Clinicaltrials.gov NCT03679754) to expand a phase 1 trial evaluating its Controlled IL-12 platform as a monotherapy for the treatment of rGBM. A majority (75%) of patients enrolled in the substudy were treated with low-dose steroids. At ASCO (Free ASCO Whitepaper) 2019, the Company presented data which confirmed that local, regulated IL-12 production using Ad+V in subjects with rGBM rapidly and safely activates the immune system, with adverse reactions consistent and predictable to those seen in prior studies, and promptly reversible upon discontinuation of veledimex. Mean follow-up was 3.7 months.

About Ad-RTS-hIL-12 plus veledimex in combination with PD-1 inhibitors

In this ongoing phase 1 trial to evaluate Controlled IL-12 in combination with the PD-1 inhibitor OPDIVO (nivolumab) (Clinicaltrials.gov NCT03636477), the Company reported initial data and observations at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting earlier this month. With a mean follow-up of 4.5 months, the Cytoindex (an emerging biomarker) improved compared with Ad+V as monotherapy lending support that the combination may lead to improved overall survival. Data from the first two cohorts evaluated increasing doses of PD-1 inhibitor revealed a similar safety profile as Ad+V monotherapy. Adverse reactions from the first two cohorts were manageable and reversible without synergistic toxicities, while adverse reactions during follow-on nivolumab dosing were consistent with reports for PD-1 inhibition. More than two-thirds of the patients in the study received low-dose steroids.

The Company expects to begin a phase 2 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Regeneron Pharmaceuticals’ PD-1 antibody Libtayo (cemiplimab-rwlc) in the coming days.

FDA Fast Track Designation

In April 2019, Ziopharm announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for the Company’s Controlled IL-12 program for the treatment of rGBM in adults. The Fast Track program is designed to facilitate the expedited development and review of drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

Learn more about Controlled IL-12 online at View Source

On June 26, 2019 Varian (NYSE: VAR) reported its third quarter fiscal year 2019 earnings release date (Press release, Varian Medical Systems, JUN 26, 2019, View Source [SID1234537294]).

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 Company will report results for the third quarter of fiscal year 2019 after market close on Wednesday, July 24, 2019. The news release will be followed by a teleconference available to all interested at 1:30 p.m. Pacific Time. To access the teleconference call and replay:

Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415, and enter conference ID 13691935. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, July 26, 2019.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for Third Quarter Earnings Results.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

On June 26, 2019 3P Biopharmaceuticals (3P) and Norwegian biopharmaceutical company Nordic Nanovector have extended their collaboration agreement for the biopharmaceutical development of Betalutin late stage manufacturing for B-cell non-Hodgkin lymphoma (NHL) treatment (Press release, 3P Biopharmaceuticals, JUN 26, 2019, View Source [SID1234537291]).

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 non-Hodgkin lymphoma (NHL) is cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.

3P and Nordic Nanovector started their collaboration in 2013 and successfully advanced Betalutin project through these years.

The current agreement is consolidating the relationship describing how both companies will successfully progress the project up to the regulatory submission of the product including development, clinical supply and late-stage activities, such as process characterization and validation.

"Our partnership with Nordic Nanovector is a great example of how together we can achieve more than planned and succeed in the late stage of Betalutin development," said Dámaso Molero, General Manager at 3P Biopharmaceuticals.

He also added, "this project demonstrates how we can bring together various parties to successfully reach the project goals by using complex technologies in this challenging project."

HH1 (Lilotomab) is a murine IgG1 antibody that targets the human glycoprotein CD37, which is found on the surface of B cells and B cell tumors.

The antibody is a component of Betalutin, a radioimmunoconjugate molecule (RIC) which is being developed for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).

On June 26, 2019 CBM BioPharma Inc. ("CBM") reported that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance and Issue Fee Due in CBM’s patent application related to the treatment of pancreatic cancer (Press release, CBM BioPharma, JUN 26, 2019, View Source;trademark-office-allows-patent-claims-for-cbm-biopharma-incs-patent-application-for-pancreatic-cancer-treatment-300875038.html [SID1234537290]).

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!

CBM has received from the USPTO a Notice of Allowance for patent application 15/115,393. This application is licensed from the University of Texas by CBM. Once the patent issue fee is paid, the new patent will protect one of CBM’s lead drug candidates, Gem-DHA, a novel gemcitabine derivative intended for the treatment of pancreatic cancer. Preliminary data indicates that Gem-DHA is more effective than gemcitabine in mice pancreatic cancer models. This asset is to be sold to Spherix Inc. (NASDAQ: SPEX) as part of the previously announced Asset Purchase Agreement between CBM and Spherix. The transaction is subject to shareholder approval by Spherix shareholders and other customary closing conditions.

Anthony Hayes, Spherix CEO, stated, "I am very excited by the potential of this drug and especially by the data showing that Gem-DHA works better in reducing the growth of pancreatic tumors than the first-line chemotherapy drug gemcitabine. The data indicates that Gem-DHA preferentially concentrates itself in the pancreas relative to other organs, suggesting it may be a promising candidate for further trials in pancreatic cancer. We are constantly working to return value to our shareholders and this news is another data point that establishes the value of the CBM assets."

On June 26, 2019 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA;OTCQB: MDNAF), a clinical stage immuno-oncology company, is reported new data on MDNA55 was published in the March 2019 issue of the journal Immunotherapy (Press release, Medicenna Therapeutics, JUN 26, 2019, View Source [SID1234537289]). The authors of the publication entitled "Combination immunotherapy with IL-4- Pseudomonas exotoxin and IFN-α and IFN-γ mediate synergistic antitumor effects in vitro and in a mouse model of human ovarian cancer", are investigators in different branches of the National Institutes of Health (NIH) and FDA’s Center for Biologics Evaluation & Research.

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!

In the published pre-clinical data, MDNA55 (IL-4 fused to Pseudomonas exotoxin) was shown to effectively target and kill ovarian cancer cells overexpressing the IL-4 receptor (IL4R), consistent with previous data showing the antitumor effect of MDNA55. New results have now shown that MDNA55, when combined with approved drugs called interferons (IFN-α and IFN-γ), act in a highly synergistic fashion to kill tumor cells and increase survival in an aggressive mouse model of metastatic ovarian cancer without causing damage to vital organs. These data suggest that this novel combination could provide a unique and effective approach to treating ovarian cancer.

Ovarian cancer is the seventh most common cancer in women worldwide with over 250,000 new cases diagnosed annually. Ovarian cancer is a difficult and trying disease where more than half of the patients treated with conventional therapy simply do not respond. Because it is most often diagnosed in its advanced stage, the prognosis for women with ovarian cancer has been very poor. Historical progression-free survival in ovarian cancer is 10 to 12 months for first-line treatment and 6 to 8 months for second-line treatment. The IL4R is known to be expressed in 60% of patients with ovarian cancer.

IL-4-Pseudomonas exotoxin was developed by Dr. Raj Puri (a co-author of the publication) at the USFDA and previously licensed to Medicenna and named MDNA55, a first-in-class, fusion cytotoxin that specifically targets the IL4R which is over-expressed by 20 different cancers affecting more than a million cancer patients every year. To date MDNA55 has been used to treat over 130 patients in multiple clinical trials, including over 110 patients with recurrent Glioblastoma (rGBM), building a significant safety profile, evidence of anti-tumor effect and mechanistic dataset in patients with the most aggressive form of brain cancer. MDNA55 has been the subject of a recently completed Phase 2b open-label study in patients with rGBM at first or second relapse. Promising interim top-line results from the rGBM study were announced last week.