On January 27, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that a poster presentation highlighting statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer (Press release, Oncolytics Biotech, JAN 27, 2020, View Source [SID1234553574]). The presentation was delivered at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper) in San Francisco.

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"We have identified another biomarker candidate for pelareorep," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These results correlate CEACAM6 levels with long term benefit in patients with pancreatic cancer. We are working with industry and academic colleagues to verify this important finding not only in pancreatic cancer but potentially in other GI indications where this biomarker is linked to clinical outcomes"

The poster, CEACAM6 is a candidate biomarker for Reolysin (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), highlights data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer. Data in the presentation associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer. PFS increased over 80%, from 5.72 months to 10.32 months (p=0.05).

"I am very encouraged to see additional data come from this important study by the Ohio State University Comprehensive Cancer Center," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "This statistically significant result highlights the potential for CEACAM6 to become an additional prognostic biomarker for pelareorep and could provide considerable clinical value as we investigate its potential in pancreatic and other GI cancers."

CEACAM6 is differentially expressed in pancreatic adenocarcinoma cells. High levels of CEACAM6 are known to block viral trafficking in virally infected cells, thereby decreasing viral replication. Study investigators speculated that altered CEACAM6 levels may be predictive for pelareorep sensitivity and may serve as a biomarker.

Key data and conclusions:

CEACAM6 was the most differentially expressed gene, with an eight-fold decrease in levels of mRNA, in long-term responders compared to early progressors in patients receiving pelareorep.

Low levels of CEACAM6 mRNA expression were associated with prolonged PFS in pelareorep-treated patients (p=0.05). This treatment effect was not seen in patients that were not treated with pelareorep (p=0.35).

In pelareorep treated patients, CEACAM6 mRNA expression level was very influential with a hazard ratio of 1.54 (p=0.01), suggesting that one unit increase in CEACAM6, corresponds to an increase in the risk of progression and/or death by 54% in this arm. There was no significant relationship seen in patients that were not treated with pelareorep

CEACAM6 may be included as a candidate biomarker of resistance to pelareorep and, in theory, could inhibit viral trafficking in tumor cells

The poster presentation was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona. It can be found on the Posters & Publications page of the company’s website: View Source

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On January 27, 2020 On Target Laboratories, Inc., a privately-held biotechnology company developing the use of fluorescent markers to target and illuminate cancer during surgery, reported the results of a multi-institutional Phase 2 clinical trial in which outcomes were improved for 26 percent of patients undergoing pulmonary resection for non-small cell lung cancer (NSCLC) (Press release, Applied BioMath, JAN 27, 2020, View Source [SID1234553595]).

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The results were presented today at the 56th Annual Meeting of the Society of Thoracic Surgeons (STS), held in New Orleans, LA., and were featured in a plenary session as a J. Maxwell Chamberlain Memorial Paper for General Thoracic Surgery, considered to be among the top-rated abstracts at STS.

"Our goal is to provide surgeons with new technology to help them provide a more complete resection to more patients. This gives patients the best chance of improved outcomes after surgery," said Christopher Barys, president and CEO of On Target Laboratories.

Lung cancer is the leading cause of cancer-related deaths in the United States. Pulmonary resection, either a wedge resection, segmentectomy, or lobectomy, is recommended for most patients who have operable stage I-II non-small cell lung cancer. Intraoperative molecular imaging (IMI)—also referred to as fluorescence-guided surgery—may increase the likelihood of a more complete surgical resection, which could translate into increased survival for patients and reduced re-operations or adjuvant treatment for hospitals.

Conducted over 18 months, the study included 92 patients eligible for analysis. There were no drug-related serious adverse events and 24 patients (26 percent) were impacted during pulmonary resection, with eight percent of patients having a change in their stage due to the use of IMI.

The study showed that IMI improved localization of small and peripheral lesions, which can be difficult for surgeons to identify visually or through manual palpitation, and enabled localization of otherwise unlocalizable lesions in 11 patients (12%). Further ten additional cancers were found in seven patients (8%). During the Specimen Check Phase, when the surgeon confirms the nodule is in the specimen and analyzes the margins, surgeons felt all margins were adequate, yet back-table inspection using IMI revealed inadequate margins in eight patients (9%).

"OTL38 is the first technique that is specific to imaging adenocarcinomas of the lung, which is one of the most common types of invasive lung cancer," said Inderpal (Netu) S. Sarkaria, MD, Department of Cardiothoracic Surgery at the University of Pittsburgh Medical Center in Pennsylvania. "Near-infrared imaging with OTL38 may be a powerful tool to help surgeons significantly improve the quality of lung cancer surgery by more clearly identifying tumors and allowing the surgeon to better see and completely remove them—one of the most vital components in the overall care of patients with this disease."

OTL38 is under development in two Phase 3 clinical trials for lung and ovarian cancer indications. Both trials are being conducted under a Special Protocol Agreement with the FDA. OTL38 has also received a Fast Track designation for both the lung and ovarian cancer indications and an orphan designation for ovarian cancer from the FDA.

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories’ fluorescent markers are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. These markers illuminate the cancerous lesions, lighting the way for the resection of malignant tissue and enabling surgeons to see and remove more diseased tissue.

On Target’s first novel compound, OTL38, targets folate receptors commonly found on many cancers, including lung and ovarian cancers. A small single dose of the compound is administered via IV infusion one to 24 hours before surgery, allowing the surgeon to identify malignant tissue during the procedure using the near-infrared camera.

On January 27, 2020, Generex and ALTuCell executed an Amendment Agreement to the SPA (the "Amendment"). Under the Amendment, closing will occur within 30 days of the full execution of the Amendment, subject to the conditions to closing under the SPA (Filing, 8-K, Generex, JAN 27, 2020, View Source [SID1234553616]). The parties agreed that Generex will pay the $2.5 million closing payment from certain specifically identified sources.

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If the closing is not completed within 30 days of execution of the Amendment, SPA will lapse unless the parties agree in writing to continue the transaction. Under the Amendment, Generex agreed to fund the ongoing operations of ALTuCELL during the extension period with a payment of $100,000, to be paid within 2 business days of signing the Amendment.

If ALTuCELL chooses to cancel the transaction as a result of delays due to forces beyond the control of Generex, including government regulatory delays or extended reviews by regulators that delay approvals of corporate actions, or by natural disasters or other unforeseen events beyond the control of Generex, ALTuCELL agrees to return all
payments made by Generex.

On January 27, 2020 Oncoceutics reported that the National Brain Tumor Society (NBTS) has committed to providing more than $200,000 in funding, with the potential for multiple years, to support a Phase II clinical trial of ONC201, the first imipridone dopamine receptor D2 antagonist (DRD2), in a molecular subset of high grade gliomas (Press release, Oncoceutics, JAN 27, 2020, View Source [SID1234558315]).

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The future clinical trial will evaluate the efficacy of single agent ONC201 in patients who have a recurrent form of high-grade glioma that exhibits low expression of epidermal growth factor receptor (EGFR), which is associated with elevated DRD2 expression and ONC201 sensitivity. The trial will be led by Clark C. Chen, MD, PhD, Lyle French Chair in Neurosurgery and Head of the Department of Neurosurgery, at the University of Minnesota Medical School who is co-PI of the trial along with Joshua Allen, PhD, Senior Vice President of Research and Development at Oncoceutics. Each year, approximately 5,000 patients are affected by this subtype of gliomas in the United States for which there are no effective therapies following first-line chemoradiation.

The project builds on previous results demonstrating the safety and efficacy of ONC201 in patients with high grade gliomas, in particular those with H3 K27M-mutant gliomas. Preclinical studies, led by Dr. Chen, using tumor tissue associated with The Cancer Genome Atlas (TCGA) and patient-derived xenograft (PDX) models of glioblastoma (GBM) have identified an additional subset of high-grade gliomas that exhibit low EGFR expression and, conversely, elevated DRD2 expression. These glioma cells are highly sensitive to ONC201 treatment both in vitro and in vivo. Preliminary data from clinical trial patients with recurrent GBM that harbor these characteristics suggest that treatment with ONC201 may translate into improved survival endpoints relative to patients who do not express these biomarkers.

"NBTS is committed to rapidly and directly improving treatments for brain tumor patients," said Kirk Tanner, PhD, Chief Scientific Officer, National Brain Tumor Society. "This clinical trial aims to extend the clinical utility of ONC201 to high-grade glioma patients beyond those that harbor the H3 K27M mutation where it has shown compelling single agent efficacy."

"It is gratifying to see the work done over the past seven years in my laboratory translate into a pivotal clinical trial. I am optimistic that the insights gained from this trial will contribute to improving the lives of patients afflicted with high grade gliomas," said Clark C. Chen, MD, PhD, Lyle French Chair in Neurosurgery and Head of the Department of Neurosurgery, at the University of Minnesota Medical School.

"The NBTS’s critical support for this project represents an important milestone to further inform patient selection for clinical trials with ONC201 based on biomarkers that expand its current development scope. I am delighted that Dr. Chen’s collaboration with our team has resulted in the convincing rationale to evaluate a new biomarker approach that will hopefully result in similarly positive outcomes that we are seeing in patients with H3 K27M-mutant high grade gliomas," said Wolfgang Oster, MD, PhD, CEO and Chairman of Oncoceutics.

On January 27, 2020 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the extension of the expiration date of the offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") any and all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc. ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (the "Allergan Notes") for new notes to be issued by AbbVie (the "AbbVie Notes") and the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes (Press release, AbbVie, JAN 27, 2020, View Source [SID1234553558]). AbbVie hereby extends such expiration date from 5:00 p.m., New York City time, on January 31, 2020 to 5:00 p.m., New York City time, on February 28, 2020 (as the same may be further extended, the "Expiration Date").

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On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture. Such supplemental indentures will become operative only upon settlement of the Exchange Offers.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the "Acquisition") and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended by the press releases dated November 18, 2019 and December 20, 2019 and as amended hereby (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and the Expiration Date of each of the Exchange Offers is expected to be extended to occur on or about the closing date of the Acquisition, which is expected to occur in early 2020. As a result, the Expiration Date may be further extended one or more times. AbbVie currently anticipates providing notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on January 24, 2020, the principal amounts of Allergan Notes set forth in the table below were validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Allergan Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" as defined in Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or not a "U.S. person" and outside the United States within the meaning of Regulation S under the Securities Act. Except as amended by the press releases dated November 18, 2019 and December 20, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the Offering Documents, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-3900 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source