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.

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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

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]).

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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

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.

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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).

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"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.

On November 26, 2018, Idera Pharmaceuticals, Inc. (the "Company") reported that it has entered into an Equity Distribution Agreement (the "Agreement") with JMP Securities LLC ("JMP"), pursuant to which the Company may issue and sell shares of its common stock, $0.001 par value per share, having an aggregate offering price of up to $50,000,000 (the "Shares") through JMP as its agent (Press release, Idera Pharmaceuticals, NOV 26, 2018, View Source [SID1234531639]).

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Subject to the terms and conditions of the Agreement, JMP will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions, by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), or if specified by the Company, by any other method permitted by law, including but not limited to in negotiated transactions. The Company or JMP may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions.

The Company has agreed to pay JMP commissions for its services in acting as agent in the sale of the Shares in the amount of 3.0% of gross proceeds from the sale of the Shares pursuant to the Agreement. The Company also has agreed to provide JMP with customary indemnification and contribution rights.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, which is attached hereto as Exhibit 1.1 and incorporated by reference herein.

Morgan, Lewis & Bockius LLP, counsel to the Company, has issued a legal opinion relating to the legality of the issuance and the sale of the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares to be sold under the Agreement, if any, will be issued and sold pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-219851), previously filed with the Securities and Exchange Commission ("SEC") on August 10, 2017, amended September 1, 2017 and September 8, 2017, and declared effective by the SEC on September 8, 2017. A prospectus supplement related to the offering is being filed with the SEC on November 26, 2018. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares nor shall there be any sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.