On November 25, 2019 Incyte (Nasdaq:INCY) reported that numerous abstracts, including data from its clinical development programs for ruxolitinib (Jakafi), itacitinib and ponatinib (Iclusig) will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2019 in Orlando, Florida from December 7-10, 2019 (Press release, Incyte, NOV 25, 2019, View Source [SID1234551640]).

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"We look forward to ASH (Free ASH Whitepaper) 2019 and the opportunity to present data for our approved and late stage compounds from our oncology portfolio," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These data strengthen the body of evidence supporting treatments that may deliver meaningful benefit for patients with rare cancers like polycythemia vera and myelofibrosis, leukemias and serious conditions such as graft-versus-host disease."

Select key abstract presentations include:

Oral Presentations

Risk of Hemorrhage in Patients with Polycythemia Vera Exposed to Aspirin in Combination with Anticoagulants: Results of a Prospective, Multicenter, Observational Cohort Study (REVEAL) (Abstract #168)

Saturday, December 7, 2019, 12:00-1:30p.m., Orange County Convention Center, Room W314, Level 3
Poster Sessions

Ruxolitinib (Jakafi): Myeloproliferative Neoplasms

U.S. OPTUM Database Study in Polycythemia Vera Patients: Thromboembolic Events (TEs) with Hydroxyurea (HU) vs Ruxolitinib Switch Therapy and Machine-Learning Model to Predict Incidence of TEs and HU Failure (Abstract #1659)1

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
A Retrospective Real-World Study of the Current Treatment Pathways for Myelofibrosis in the UK (The REALISM UK Study) (Abstract #1671)1

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Patient-Reported Outcomes (PRO) Data from Patients (Pts) with Essential Thrombocythemia (ET) Enrolled in the MOST Study (Abstract #1665)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Ruxolitinib (RUX) Induced Meaningful and Directional Changes in the Bone Marrow Microenvironment of Patients with Myelofibrosis Enrolled in the COMFORT-I Study (Abstract #2948)

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Baseline Mutational Status of Patients with Myelofibrosis and Anemia in the REALISE Trial and Impact on Outcome (Abstract #2952)1

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Ruxolitinib for Patients (Pts) with Polycythemia Vera: Responders vs Non-Responders as Defined in the RESPONSE Trial (Abstract #2947)1

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Disease and Clinical Characteristics of Patients with Myelofibrosis Enrolled in the MOST Study (Abstract #4190)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Real-World Dosing Patterns of Ruxolitinib in Patients with Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea (Abstract #4192)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Adherence to Treatment in Myelofibrosis Patients: Preliminary Results from Italian ROMEI Observational Study (Abstract #4179)1

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Impact of Disease Burden in Myelofibrosis Patients: A Sub Analysis from Italian ROMEI Observational Study (Abstract #4188)1

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Ruxolitinib (Jakafi): Graft-Versus-Host Disease

Disease Progression, Hospital Readmissions, and Clinical Outcomes of Patients with Steroid-Refractory Acute Graft-Versus-Host Disease: A Multicenter Chart Review (Abstract #1994)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Population Pharmacokinetics of Ruxolitinib in Patients with aGVHD Who Had an Inadequate Response to Corticosteroids (Abstract #4534)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Stratification of Responders and Non-Responders in the REACH-1 Trial Based on Serum Proteomic Analysis (Abstract #4531)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Itacitinib

Prophylactic Itacitinib (INCB039110) for the Prevention of Cytokine Release Syndrome Induced by Chimeric Antigen Receptor T-Cells (CAR-T-cells) Therapy (Abstract #1934)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
A Biomarker Signature to Predict Complete Response to Itacitinib and Corticosteroids in Acute Graft Versus Host Disease (Abstract #3279)

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Ponatinib (Iclusig)

Multicenter, Prospective and Retrospective Observational Cohort Study of Ponatinib in Patients with CML in Italy: Interim Analysis of the OITI Trial (Abstract #1652)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Real-World Treatment Patterns, Health-Care Costs and Predictors for TKI Changes in CML: Results from a Population Representative German Claims Data Analysis (Abstract #1645)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Interim Analysis of a Prospective Multicentre Study Using Next Generation Sequencing for Kinase Domain Mutational Analysis in CML Patients on First or Subsequent TKI Therapy (Abstract #2935)

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Sequence of Second Generation Tyrosine Kinase Inhibitors (TKIs) in the Treatment of Patients with Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukaemia – Real World Experience in the UK (Abstract #3434)

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Ultra-Accurate Assessment of Pretreatment ABL1 Kinase Domain (KD) Mutations in Patients (Pts) with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Using Duplex Sequencing (DS)2

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Real-Life Outcomes of Ponatinib Treatment in Patients with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL): Data from a Nationwide Belgian Registry (Abstract #4161)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Major Adverse Cardiac, Arterial Occlusive, and Venous Occlusive Events Among Chronic Myeloid Leukemia Patients Prescribed Ponatinib vs Bosutinib (Abstract #4751)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Full session details and data presentation listings for ASH (Free ASH Whitepaper) 2019 can be found at View Source

About Jakafi (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is also indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea as well as adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

About Iclusig (ponatinib)

Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc., since acquired by Takeda Pharmaceutical Company Limited, to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.

On November 25, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported it has secured a debt financing facility for up to $25 million from K2 HealthVentures, a healthcare-focused specialty finance company (Press release, Surface Oncology, NOV 25, 2019, View Source [SID1234551657]). Surface received a first tranche of $7.5 million upon closing. Two subsequent tranches totaling $17.5 million will become available to the Company upon the achievement of certain milestones.

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"Securing this debt facility bolsters our financial position and increases our financial flexibility as we advance our next wave of programs into clinical development," said Jeff Goater, chief executive officer of Surface Oncology.

Updated Financial Outlook:
Based upon its current operating plan, which includes the debt facility announced today and anticipated milestones under its Novartis collaboration, Surface now has a projected cash runway into 2022.

On November 25, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company, reported that it has presented updated clinical results from its Phase 2b trial of MDNA55 in patients with recurrent Glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer (Press release, Medicenna Therapeutics, NOV 25, 2019, View Source [SID1234551674]).

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The results were presented by Dr. John Sampson, MD, PhD, a Robert H. and Gloria Wilkins Distinguished Professor and Chair of Neurosurgery at Duke University School of Medicine at the 24th Society for Neuro-Oncology (SNO) annual meeting on November 24th, 2019 at the JW Marriott Desert Ridge Resort in Phoenix, Arizona. Dr. Sampson discussed updated efficacy results from the Phase 2b clinical trial of MDNA55 in rGBM patients using the interleukin 4 receptor (IL4R) as an immunotherapy target. IL4R is a biomarker for a more aggressive form of GBM which is overexpressed in 75% of glioblastoma patients, as well as in cells that make up the brain tumor microenvironment (TME).

"In this trial, particularly for patients with IL4R over-expression, a prognostic factor that is known to contribute to poor survival, it is gratifying to see that a single treatment with MDNA55 is able to produce impressive survival and tumor control." stated Dr. Sampson. "By combining precise drug delivery and a targeted therapy, MDNA55 could potentially provide new hope to a large majority of brain cancer patients expressing an important immunotherapeutic biomarker."

"We are delighted with the results of the Phase 2b trial thus far. We believe these results are evidence of the opportunity for MDNA55 to become a leading treatment option for a sizeable patient population with this devastating disease," said Dr. Fahar Merchant, President and CEO of Medicenna. "Results from 112 rGBM patients enrolled in this and earlier clinical trials show substantial improvements in tumor control and survival rates when compared to approved therapies for rGBM, and provide a comprehensive data package for our planned meetings with regulatory agencies early next year."

Highlights from the presentation include:

With a single treatment with MDNA55, a therapy designed to target the IL4R, the median overall survival (mOS) in IL4RHigh subjects (n=21) is 15 months. This shows a survival advantage of up to nine months when compared to approved therapies (mOS of 5.4 to 9.2 months with Temozolomide, Avastin and Lomustine).
Among the 38 evaluable subjects, irrespective of IL4R expression, 82% of the subjects experienced tumor shrinkage or stabilization from nadir. The mOS of patients showing tumor control (n=31) was significantly longer when compared to patients with progressive disease (mOS of 15 months vs 8.4 months, respectively; p-value of 0.0112)
Updated analysis include the first 40 subjects treated with MDNA55 continues to show an impressive overall survival rate at 12 months (OS-12) of 45%, irrespective of IL4R expression, and OS-12 of 58% in patients showing a treatment response (n=32). This is an improvement of up to 150% when compared to approved therapies for rGBM (OS-12 is 18-34%).
Safety data continue to show a better safety profile when compared to previous MDNA55 trials with no systemic toxicities or drug related deaths.
"The consistent and extremely encouraging results presented by Key Opinion Leaders at the SNO conference continues to add an impressive data set for the safety and efficacy of MDNA55," added Dr. Merchant. "We look forward to presenting additional analysis and results at various conferences over the coming months."

"We now have readout from 87% of our trial population which continue to show very promising outcomes with MDNA55," added Dr. Martin Bexon, MD, Head of Clinical Development at Medicenna. "A median survival of 15 months in IL4R patients and a tumor control rate of 82% from nadir is especially promising considering that patients in this study have a worse prognosis than most due to the absence of IDH mutations, de novo GBM at initial diagnosis and ineligibility for resection, with more than half of the patients harbouring tumors with an unmethylated MGMT promoter."

On November 24, 2019 DNAtrix, a leader in the development of oncolytic viruses for cancer therapy, reported that updated safety and efficacy data from the fully-enrolled Phase 2 CAPTIVE / KEYNOTE-192 study of DNX-2401 (tasadenoturev), DNAtrix’s oncolytic adenovirus, followed by pembrolizumab for patients with recurrent glioblastoma (Press release, DNAtrix, NOV 24, 2019, View Source [SID1234551636]). The data demonstrate that the therapy elicits durable clinical activity and has a favorable safety profile. These results are being presented at the Society for Neuro-Oncology (SNO) Annual Meeting held from November 22-24, 2019 in Phoenix, Arizona.

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A total of 48 patients with recurrent glioblastoma were treated at 15 participating clinical sites with the regimen of DNX-2401, followed by pembrolizumab. The majority of patients experienced clinical benefit following treatment, including durable complete and partial responses. Interim median overall survival for patients is currently 12.3 months. In addition, the interim safety analysis demonstrates that the therapy has a positive benefit-risk profile, there were no unanticipated adverse events and patients remained on pembrolizumab for a median of 5.5 months with a maximum of 34 cycles.

"The data hold great promise for patients afflicted with glioblastoma, the most common form of adult brain cancer. Glioblastoma is a disease associated with near uniform fatality. The results are striking in this context," said Clark Chen, MD, PhD, Professor, Lyle French Chair in Neurosurgery and Department Head at the University of Minnesota, presenting author for the CAPTIVE / KEYNOTE-192 study. "The results suggest that the combination of DNX-2401 and pembrolizumab has the potential to revolutionize the care of glioblastoma patients. I look forward to the rigorous studies aimed to validate the efficacy of DNX-2401."

"These interim data from our CAPTIVE trial are a significant milestone for us in the development of DNX-2401 as an innovative treatment for glioblastoma," said Frank Tufaro, PhD, CEO of DNAtrix. "Importantly, these data suggest that DNX-2401 has a superior clinical benefit and safety profile compared to currently approved chemotherapy for recurrent glioblastoma, and we are particularly pleased that, together with pembrolizumab, DNX-2401 elicited a number of robust and durable antitumor responses."

About CAPTIVE / KEYNOTE-192
CAPTIVE / KEYNOTE-192 is a Phase 2 multicenter study evaluating a single intratumoral injection of DNX-2401 (tasadenoturev) followed by standard dosing with pembrolizumab every three weeks to determine the safety and efficacy in patients with recurrent glioblastoma.

About DNX-2401 (Tasadenoturev)
DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and kill cancer cells to elicit an immune response. Prior clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 is currently being evaluated in several clinical trials, including a multicenter Phase 2 study evaluating DNX-2401 with pembrolizumab for adult patients with recurrent glioblastoma. DNX-2401 has been granted PRIME and Orphan designation by the EMA, and Fast Track and Orphan designation by the FDA.

On November 23, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq:ZIOP), reported the presentation of new interim analyses of clinical data from two ongoing substudies in its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex (Ad+V), both as monotherapy and in combination with a PD-1 inhibitor, for the treatment of recurrent or progressive glioblastoma multiforme (rGBM) in adults, at the 2019 Society for Neuro-Oncology (SNO) Annual Meeting in Phoenix (Press release, Ziopharm, NOV 23, 2019, View Source [SID1234551642]).

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"Recurrent GBM is a complex disease which grows by walling itself off from the immune system, making it so devastating. It appears that placing IL-12 within the tumor and then controlling the production of this cytokine, drives T cells into the tumor, enabling the immune system to adapt, which leads to anti-tumor activity," said Laurence Cooper, M.D., Ph.D., CEO of Ziopharm. "We are encouraged by the findings presented at SNO, as we advance the clinical development of Controlled IL-12 as a monotherapy and in combination with immune checkpoint inhibitors, including a phase 2 study which is currently enrolling."

The Company announced in February 2019 the completion of the enrollment in an "Expansion" substudy (Clinicaltrials.gov NCT03679754) that enlarged the phase 1 "Main" trial (Clinicaltrials.gov NCT02026271) by an additional 36 patients with rGBM receiving Ad-RTS-hIL-12 plus 20mg/day veledimex for up to 14 days. Results from this substudy were presented yesterday (7:30 pm MST) in a poster presentation titled "Survival of Subjects with Recurrent Glioblastoma Receiving Intra-tumoral Administration of IL-12 Managed with Low-dose Dexamethasone":

Interim Update Reported

Decrease in tumor from baseline (time of Ad+V administration) resulting in a patient’s lesion being too small to measure, assessed as a partial response (per iRANO), with follow up ongoing

Subjects were comparable to the Main study except a higher percentage in the Expansion substudy had multifocal disease vs. unifocal disease and fewer recurrences

Based on study design there was, as expected, a higher percentage of subjects in the Expansion substudy as compared with Main study (75% vs 40%) who received low-dose concurrent steroids

Local, regulated IL-12 production using Ad+V in subjects with rGBM rapidly and safely activates the immune system

Peak serum IL-12 at Day 3 with downstream production of endogenous IFN-g peaking at Day 7 in Expansion substudy (and Main study)

MRI findings of pseudoprogression, consistent with immune-mediated anti-tumor effects

20mg V subjects (Main + Expansion, n=20) with unifocal disease at entry, receiving low-dose steroids (defined as <20 mg cumulative dosing of dexamethasone) continued to show a trend towards longer median overall survival (mOS, 16.2 months)

Adverse reactions (ARs) were consistent with prior studies of Ad+V, predictable, dose-related, and promptly reversible upon discontinuation of veledimex

No drug-related deaths were reported

In the Main study, six subjects with unifocal disease at entry, receiving low-dose steroids (defined as <20 mg cumulative dosing of dexamethasone) were previously reported to have mOS of 17.8 months. The mOS for these patients in the Expansion substudy (n=14) has not been reached at a mean follow up of 9.7 months.

Literature shows that multifocal GBM is associated with worse prognosis compared to unifocal disease. 1,2 The data from the Main study and the Expansion substudy are consistent with this prognosis, with mOS of 10.1 months for patients (n=13) with multifocal disease at entry that received 20mg veledimex and low-dose steroids.

The Company previously reported on serial biopsies in patients with rGBM which demonstrated Controlled IL-12 resulted in sustained influx of T cells with upregulation of PD-1 expression. This supports combining Ad-RTS-hIL-12 plus veledimex for up to 14 days with the PD-1 inhibitor nivolumab (Clinicaltrials.gov NCT03636477). The Company announced completion of dose escalation in June 2019 and recently reported enrollment of an additional 12 patients at the highest dosing level. Data and observations presented today (5 pm MST) in a poster presentation titled "PD-1 Inhibition can be Combined with IL-12 in Subjects with Recurrent Glioblastoma":

Interim Update Reported

Decrease by 64% in a patient’s tumor from baseline (time of Ad+V administration) resulting in a partial response (per iRANO) with follow up ongoing

Enrollment is complete per 3+3 (Ad+V and nivolumab) dose-escalation, as well as an additional 12 patients enrolled to the third cohort (highest dose)

Cancer Manag Res. 2018;10:4229–4235

Int. J. Mol. Sci. 2017, 18, 2469

Mean follow up is 4.8 months (with a minimum of 0.9 months and a maximum of 16.9 months); active dosing is ongoing, and mOS has not been reached

Serum IL-12 was detected in all subjects following initiation of Ad+V, which is consistent with previously reported data on Ad+V as monotherapy

MRI findings of pseudoprogression, consistent with immune-mediated impact on tumor

No dose limiting toxicities, no serious adverse events that were considered related to the combination with nivolumab and no clinically significant overlapping toxicities were observed

Drug-related toxicities in the combination substudy were comparable to the Main study, being predictable, dose-related, and promptly reversible upon discontinuation of veledimex and with no drug related deaths

"The two phase 1 trials evaluating Controlled IL-12 yield encouraging clinical data. We now have the experience to dose Ad-RTS-hIL-12 + veledimex as monotherapy and in combination with immune checkpoint inhibitors in patients with recurrent glioblastoma. While it is early days, the approach appears to be working as we can regulate IL-12 using a switch, we see evidence of pseudoprogression followed by anti-tumor effects, and there is encouraging survival in some patients with rGBM which is typically rapidly fatal," said Dr. Antonio Chiocca, M.D., Ph.D., poster author and Professor of Neurosurgery at Harvard Medical School, Surgical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, and Chairman of Neurosurgery and Co-Director of the Institute for the Neurosciences at Brigham and Women’s Hospital.

"Recurrent glioblastoma is a devastating brain cancer with few treatment options demonstrating success and a significant need for new treatment options. The Controlled IL-12 platform, that appears to have activity as monotherapy, supports combining Controlled IL-12 with a PD-1 inhibitor. This combination builds on a solid scientific rationale and has yielded data of relevant immune activity that supports continued development," Rimas Lukas, M.D., poster author and Associate Professor of Neurology (Neuro-Oncology), Northwestern University Feinberg School of Medicine and Department of Neurology, University of Chicago.

These data support Ziopharm’s continued development of its Ad-RTS-hIL-12 plus veledimex as a drug to control the production of IL-12 as monotherapy and in combination with PD-1 inhibition. The Company commenced a phase 2 trial to evaluate Controlled IL-12 in combination with Regeneron Pharmaceuticals’ PD-1 antibody Libtayo (cemiplimab-rwlc) in June 2019.

Learn more about Controlled IL-12 online at View Source The posters presented at the SNO 2019 Annual Meeting will be available on the Company’s website in the "Scientific and Medical Publications" section.