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Mylan to Present at the Evercore ISI HealthCONx Conference

On November 25, 2019 Mylan N.V. (NASDAQ: MYL) reported that it will present at the Evercore ISI HealthCONx Conference in Boston on Tuesday, Dec. 3, 2019 at 11 a.m. ET (Press release, Mylan, NOV 25, 2019, https://www.prnewswire.com/news-releases/mylan-to-present-at-the-evercore-isi-healthconx-conference-300964141.html [SID1234551672]).

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Interested parties can access a live webcast of the presentation via the investor relations section of Mylan’s website at investor.mylan.com. An archived version also will be available following the live presentation and can be accessed at the same location for a limited time.

Medicenna Reports Promising Efficacy in Phase 2b MDNA55 Clinical Trial at the Society for Neuro-Oncology Annual Meeting

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]).

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."

Immunic, Inc. to Participate in Investor and Scientific Conferences in December

On November 25, 2019 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, reported management’s participation in the following investor and scientific conferences in December (Press release, Immunic, NOV 25, 2019, View Source [SID1234551676]):

December 3-5: Piper Jaffray 31st Annual Healthcare Conference: Sanjay Patel, CFA, Chief Financial Officer of Immunic, will present a company overview at the Piper Jaffray 31st Annual Healthcare Conference in New York on Thursday, December 5, at 12:10 pm EST.
December 4: Crohn’s and Colitis Foundation IBD Innovate Conference: Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present, for the first time, data on IMU-856 at the Crohn’s and Colitis Foundation IBD Innovate Conference in New York on Wednesday, December 4. The presentation, entitled, "IMU-856: A Small Molecule Modulator Restoring the Gut Barrier Function," will be given as part of the Small & Large Molecules session beginning at 11:40 am EST.

Marker Therapeutics to Present at Two Upcoming Investor Conferences

On November 25, 2019 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that its President and Chief Executive Officer, Peter L. Hoang, will present at two upcoming investor conferences (Press release, Marker Therapeutics, NOV 25, 2019, View Source [SID1234551675]).

Conference Details

Piper Jaffray 31st Annual Healthcare Conference
Date: Tuesday, December 3, 2019
Time: 1:00 p.m. EST
Location: New York, NY

Evercore ISI 2nd Annual HealthCONx Conference
Date: Wednesday, December 4, 2019
Time: 11:45 a.m. EST
Location: Boston, MA

Live webcasts of the presentations will be accessible from the investors section of the company’s website at www.markertherapeutics.com and will be available for replay following the event.

INHIBITOR Therapeutics Submits Investigational New Drug Application for Treatment of Patients with Late-Stage Prostate Cancer

On November 25, 2019 INHIBITOR Therapeutics, Inc. (OTCQB: INTI), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to inhibit progression of cancerous and non-cancerous proliferation disorders, reported that the company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) to seek clearance to initiate an IND-opening clinical study as a two-part, multi-center, randomized, double-blind, placebo-controlled, Phase 2b clinical trial that will evaluate the efficacy and safety of SUBA-Itraconazole capsules dosed in combination with docetaxel and prednisone in patients with metastatic castrate resistant prostate cancer (mCRPC) (Press release, Inhibitor Therapeutics, NOV 25, 2019, View Source [SID1234551673]). The proposed trial will be named PREDICT (Prostate Response Evaluating Docetaxel Itraconazole Combination Therapy).

Nicholas Virca, INHIBITOR’s President and CEO, said: "Following a pre-IND meeting with FDA in the first half of this year, FDA granted us a face-to-face End-of-Phase-2 (EoP2) meeting, which I am pleased to announce occurred last month. During that meeting, we gained FDA guidance and agreement on our protocol and statistical analysis plan for our proposed PREDICT trial. FDA indicated that we can follow the 505(b)(2) regulatory pathway given previous FDA approval of itraconazole. Assuming positive results demonstrating an improvement in radiographic progression-free survival (rPFS) as our primary endpoint, FDA indicated that the general design and planned analysis of our study would adequately address the objectives necessary to support a New Drug Application (NDA) submission. Further, FDA indicated that the final analysis of the key secondary endpoint of overall survival (OS) can occur following submission of the NDA for approval in the United States."

Mr. Virca continued: "I would like to acknowledge the stellar efforts of our regulatory and clinical team members over the last nine months to achieve this level of progress for our SUBA-Itraconazole Prostate program. Approximately 23,000 men in the U.S. are diagnosed each year with late-stage mCRPC that no longer responds well to androgen deprivation therapy (ADT) or previous treatment with chemotherapy or newer stand-alone anti-androgen therapies such as abiraterone, enzalutamide or apalutamide. We believe that SUBA-Itraconazole Prostate has the potential to address an unmet need in these patients, who exhibit disease progression or who have discontinued the other therapies due to toxicity or other reasons."

About Itraconazole in Prostate Cancer

In late-stage prostate cancer, up-regulation of the Hedgehog pathway in cells results in oncogene expression, which can interfere with the binding of ADT drugs to the androgen receptor (AR), causing biochemical resistance leading to mCRPC. Itraconazole acts on the essential Hedgehog signaling pathway component called smoothened (SMO) in human cells in a different manner than the FDA-approved drug vismodegib by preventing the ciliary accumulation of SMO normally caused by the Hedgehog pathway. Itraconazole also has a much shorter half-life than vismodegib, which may be the reason it appears to have fewer side effects than what has been reported for vismodegib in recent publications regarding its use in treating basal cell carcinoma. Thus, itraconazole may be more suitable than vismodegib for use in combination with chemotherapy due to its lower toxicity profile. Itraconazole has been tested as a treatment for mCRPC in a multi-institutional Phase 2 trial led by a prominent U.S. university and published in 2013.This trial showed that 90% of men with prostate specific antigen (PSA)-doubling times of less than 6 months, who achieved therapeutic levels of itraconazole, showed promising PSA reductions that correlated significantly with rPFS. The improved bioavailability of SUBA-Itraconazole may provide additional benefits to prostate cancer patients in two ways: 1) by achieving higher therapeutic levels of itraconazole at lower doses than those reported in the Phase 2 study, which used the generic formulation of the drug, and 2) by reducing the dose of chemotherapy based on enhanced uptake of docetaxel in the presence of itraconazole.