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

On January 27, 2020 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported data from initial feasibility studies of its novel visceral lesion applicator (VLA) have been accepted to be presented at the Annual Meeting of the Society of Interventional Oncology in New Orleans from January 30 – February 3, 2020 (Press release, OncoSec Medical, JAN 27, 2020, View Source [SID1234553575]).

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The Company’s visceral lesion applicator (VLA) technology is designed to treat non-cutaneous, internal tumors through the direct delivery of OncoSec’s lead product candidate, TAVO (plasmid-based interleukin-12), or other immunologically relevant genes. Visceral lesions are typically difficult to treat, and include gastrointestinal tumors, pancreatic tumors, and hepatocellular carcinomas.

The study, titled, "Novel Controlled Delivery of Potent Anti-Cancer Immunotherapy Directly to Deep Visceral Lesions," will be featured in a poster displayed throughout the Society of Interventional Oncology’s annual meeting from January 30 – February 3, 2020 at the New Orleans Marriott.

About the Society of Interventional Oncology
The SIO Annual Scientific Meeting offers sessions on medical technology and how to implement new technology in oncologic practice. The conference provides a multi-disciplinary approach to cancer care. The annual meeting brings together international health care providers for international sharing of ideas. The conference leverages a combination of state-of-the-art lectures, panel discussions, invited papers, and selected abstracts of basic, translational, and clinical research to promote meaningful dialogue.

On January 27, 2020 ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported dosing of the first patient in a Phase 1b clinical trial being conducted under a collaboration with Astellas Pharma Inc., to evaluate the combination of ORIC-101, ORIC’s investigational glucocorticoid receptor (GR) antagonist, with XTANDI (enzalutamide) as a treatment for patients with metastatic prostate cancer that is progressing on enzalutamide (Press release, ORIC Pharmaceuticals, JAN 27, 2020, View Source [SID1234553596]).

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Research conducted by ORIC’s co-founder Charles Sawyers, MD, published in Cell, has elucidated that increased expression of GR in prostate cancer is associated with resistance to enzalutamide therapy. Furthermore, preclinical data generated by ORIC demonstrated that inhibition of GR signaling by ORIC‑101 can re-sensitize treatment-resistant prostate cancer models to enzalutamide.

"Enrollment of the first patient in this Phase 1b clinical trial of ORIC-101 marks the second clinical trial for this program and another major milestone for ORIC," said Jacob M. Chacko, MD, Chief Executive Officer. "Just as the glucocorticoid receptor has been linked to treatment resistance for multiple classes of chemotherapeutics across a variety of solid tumors, there are also strong scientific rationale and preclinical evidence supporting its linkage to prostate cancer resistance. We are delighted to collaborate with Astellas on this important study assessing the potential of ORIC-101 to benefit patients with metastatic prostate cancer that has progressed on enzalutamide, for which there are limited treatment options today."

The Phase 1b trial is a multi-center, open label, dose finding study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ORIC-101 combined with enzalutamide when administered to patients with metastatic prostate cancer that has progressed on enzalutamide. Once the recommended Phase 2 dose of ORIC-101 in combination with enzalutamide has been identified, the study will enroll patients into expansion cohorts based upon GR expression using ORIC’s proprietary immunohistochemistry assay.

"Despite the introduction of novel antiandrogen therapies for the treatment of prostate cancer, such as enzalutamide, the majority of responsive patients will ultimately become treatment resistant, resulting in poor prognoses for men diagnosed with this devastating condition," said Pratik S. Multani, MD, Chief Medical Officer. "We are excited to evaluate the therapeutic potential of ORIC-101 to overcome what we believe may be a key mechanism of resistance to antiandrogen therapy."

Under the terms of the clinical trial collaboration and supply agreement with Astellas, ORIC is sponsoring and conducting the Phase 1b study of ORIC-101 in combination with enzalutamide. Astellas, which commercializes XTANDI in the United States with Pfizer Inc, is providing enzalutamide for the study. ORIC maintains global development and commercial rights to ORIC-101 and rights to develop the program in combination with other agents.

Further details about the clinical study are available at ClinicalTrials.gov (NCT04033328).

About Metastatic Prostate Cancer

In the United States, prostate cancer is the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society estimates there are approximately 175,000 new cases of prostate cancer and over 30,000 deaths from the disease in the U.S. annually.

In men with prostate cancer, the disease is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body, such as the bones, lymph nodes, bladder and rectum. Men are considered hormone (or castration) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels. Men are considered castration-resistant if their disease progresses despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen. Over 50,000 men are estimated to develop metastatic prostate cancer in the U.S. annually.

On January 27, 2020 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported it intends to offer and sell, subject to market and other conditions, 5,095,000 shares of its common stock in an underwritten public offering (Press release, Alector, JAN 27, 2020, View Source [SID1234553559]). In addition, Alector expects to grant the underwriters a 30-day option to purchase up to 764,250 additional shares of Alector’s common stock. All of the shares in the proposed offering will be sold by Alector. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities and Cowen are acting as joint book-running managers for the proposed offering.

A registration statement relating to the securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The proposed offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to the proposed offering may be obtained from:

Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or by email at [email protected];
Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, or by email at [email protected];
BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email [email protected]; or
Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926.