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DNAtrix’s Oncolytic Virus Expressing OX40 Ligand Treats First Patient in Recurrent Glioblastoma Clinical Trial

On November 26, 2018 DNAtrix, a leader in oncolytic virus immunotherapies for cancer, reported the treatment of the first patient with DNX-2440, an oncolytic virus expressing OX40 ligand (OX40L) (Press release, DNAtrix, NOV 26, 2018, View Source [SID1234534217]). The first-in-human Phase 1 study is evaluating the safety and efficacy of DNX-2440, administered by Alcyone’s Microtip Cannula at the time of biopsy, to patients with recurrent glioblastoma for whom surgery is not possible or planned. DNX-2440 is the second DNAtrix oncolytic adenovirus to advance into the clinic.

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DNX-2440 is engineered from DNAtrix’s highly potent oncolytic adenovirus, DNX-2401 (tasadenoturev), which has already demonstrated the ability to selectively kill tumor cells and trigger a powerful immune response directed against the tumor in several clinical studies. In addition to these mechanisms, DNX-2440 expresses OX40L, a critical costimulatory molecule known to enhance antitumor immune responses.

Extensive preclinical data have shown that DNX-2440 elicits tumor-specific immune memory and an abscopal effect (shrinking of an untreated tumor distant from the treated tumor), leading to prolonged survival in difficult-to-treat animal models of cancer, including gliomas, melanomas, and breast and lung cancers.

"Based on our observations from past studies with DNX-2401, we expect DNX-2440 to be safely administered and well tolerated, and to enhance clinical responses and prolong survival in patients with this devastating disease," said Ricardo Diez Valle, MD, Principal Investigator of the study at Clínica Universidad de Navarra, in Spain.

"DNX-2440 should trigger an immune response directed to tumors that are otherwise refractory to single agent immunotherapies," said Frank Tufaro, PhD, CEO of DNAtrix. "We now have two unique products in development and are planning to evaluate DNX-2440 for other malignancies, reinforcing our commitment to developing oncolytic immunotherapies for difficult to treat tumors."

ABEONA THERAPEUTICS ANNOUNCES CEO TRANSITION

On November 26, 2018 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported the immediate termination of its Chief Executive Officer, Dr. Carsten Thiel due to personal misconduct that violated the Company’s Code of Business Conduct and Ethics (Press release, Abeona Therapeutics, NOV 26, 2018, View Source [SID1234531740]). The Company has appointed its Head of Research & Development and Chief Medical Officer, Dr. João Siffert, as Interim Chief Executive Officer.

Dr. Thiel’s termination follows an investigation by independent members of the Company’s Board of Directors and external counsel into allegations of misconduct towards colleagues that the Board concluded violated the Company’s Code of Business Conduct and Ethics and was inconsistent with its expectations for Abeona’s CEO.

Dr. Thiel’s termination is not related to the condition of the Company’s finances, operations or clinical programs, nor due to any disagreement with the Company regarding its management of financial reporting, scientific data or other practices.

"We expect all employees, regardless of title or responsibility, to conduct themselves ethically and in accordance with company policies, and are committed to ensuring an environment of respect, integrity and ethical conduct at Abeona," said Steven H. Rouhandeh, Chairman of the Board and Executive Chairman. "The Board is confident that Abeona is in good hands while we search for a new CEO as João’s deep expertise in drug development and gene therapy will ensure that the company continues operating effectively without interruption."

Dr. Siffert has successfully led multiple drug development programs from pre-clinical to regulatory approvals in the U.S. and Europe, and has held several scientific leadership positions in biotech and pharma, including programs in gene therapy. In 2017, Dr. Siffert was appointed to the Board of Directors of gene therapy developer AveXis, which was subsequently acquired by Novartis. He served as Chief Medical Officer for Ceregene from 2007 to 2011, where he was responsible for clinical development of adeno-associated viral (AAV2)-based gene therapies for Parkinson’s and Alzheimer’s diseases. Dr. Siffert also led the R&D and medical organizations at Avanir Pharmaceuticals and Avera Pharmaceuticals before most recently guiding translational research, clinical development, regulatory, and medical affairs as Chief Scientific and Medical Officer for Nestle Health Science.

The Board has formed a search committee to identify a permanent successor, with the assistance of a leading executive search firm

Molecular Templates to Present at the Evercore ISI and BMO Healthcare Conferences

On November 26, 2018 Molecular Templates, Inc. (Nasdaq: MTEM), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported that its management will provide a corporate update at the forthcoming Evercore ISI HealthCONx BioPharma, MedTools, and Devices Conference, and the BMO Capital Markets Prescriptions for Success Healthcare Conference (Press release, Molecular Templates, NOV 26, 2018, View Source [SID1234531657]).

Evercore ISI HealthCONx – BioPharma, MedTools, & Devices Conference
Date: Wednesday, November 28
Time: 7:35 am Eastern Time
Location: Boston Harbor Hotel
Webcast: View Source

BMO Capital Markets 2018 Prescriptions for Success Healthcare Conference
Date: Wednesday, December 12
Time: 9:00 am Eastern Time
Location: The Mandarin Oriental, New York

BIOGEN TO PRESENT AT THE EVERCORE ISI HEALTHCONX

On November 26, 2018 Biogen Inc. (Nasdaq:BIIB) reported that it will present at the Evercore ISI HealthConX. The webcast will be live on Wednesday, November 28, 2018 at 9:30 a.m. ET (Press release, Biogen, NOV 26, 2018, http://investors.biogen.com/news-releases/news-release-details/biogen-present-evercore-isi-healthconx [SID1234531641]). To access the live webcast, please visit Biogen’s Investors section at View Source An archived version of the webcast will be available following the presentation.

Aptose Biosciences Doses First Patient in Re-Initiation of Phase 1b Clinical Study of APTO-253 in Relapsed or Refractory Hematological Malignancies

On November 26, 2018 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that dosing has commenced in the first patient in its Phase 1b clinical study of APTO-253 in patients with relapsed or refractory hematologic malignancies (Press release, Aptose Biosciences, NOV 26, 2018, View Source [SID1234531640]). APTO-253 is the only known clinical-stage molecule that can directly inhibit expression of the MYC oncogene, shown to reprogram survival signaling pathways in cells and thereby transform cells and contribute to drug resistance in many malignancies, including acute myeloid leukemia (AML).

"We are pleased to announce the successful re-initiation of patient dosing in our clinical trial with APTO-253, our first-in-class inhibitor of the MYC oncogene that has the potential to benefit a large patient population across various therapeutic areas, and we look forward to providing updates moving forward," commented William G. Rice, Ph.D., Chairman, President and CEO. "As the clinical protocol requires only one patient at each of the two lowest dose levels, we have and will continue to carefully select patients for those first two dose levels. Relapsed/refractory AML patients tend to be acutely sick, and we seek to complete those two lower dose levels with a favorable tolerability profile. Indeed, we hope this thoughtful approach will allow expeditious escalation to higher dose levels and may provide greater benefit to the AML patients."

About the APTO-253 Clinical Trial

The Phase 1b, multicenter, open-label, dose-escalation clinical trial of APTO-253 is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamic responses and establish the recommended Phase 2 dose and efficacy of APTO-253 as a single agent. APTO-253 will be administered once weekly, over a 28-day cycle. The study is expected to enroll up to 20 patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) patients. The study is designed to then transition, as appropriate, to single-agent expansion cohorts in AML and MDS, followed by combination studies. More information can be found at www.clinicaltrials.gov.

About APTO-253

APTO-253 is a clinical-stage, small molecule, targeted therapeutic agent that inhibits expression of the MYC oncogene, leading to cell cycle arrest and programmed cell death (apoptosis) in human-derived solid tumor and hematologic cancer cells. The MYC oncogene is overexpressed in hematologic cancers, including acute myeloid leukemia (AML). Aptose researchers have reported the ability of APTO-253 to induce cell death, or apoptosis, in multiple blood cancer cell lines including AML, as well as in vitro synergy with various classes of conventional approved and investigational therapies for AML or myelodysplastic syndromes (MDS). New findings reveal that APTO-253 might also serve certain solid tumor patients with BRCA1/2 mutations, but without causing toxicity to the normal bone marrow functions.