On September 23, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that preliminary results from its ongoing Phase 2 basket trial, evaluating DPX-Survivac in combination with Merck’s Keytruda (pembrolizumab) and intermittent low dose cyclophosphamide (CPA) in patients with advanced and metastatic solid tumors, will be presented during the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, being held September 27 – October 1, 2019, in Barcelona, Spain (Press release, IMV, SEP 23, 2019, View Source [SID1234539701]).

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Presentation Details

Poster Title: "Safety and efficacy results of the combination of DPX-Survivac, pembrolizumab and intermittent low dose cyclophosphamide (CPA) in subjects with advanced and metastatic solid tumours (preliminary results)"

Presenter: Henry J Conter, M.D., Medical Oncology Director, William Osler Cancer Centre Date and Time: Sept. 30, 2019, 12:00-13:00 CEST – poster will be displayed all day

Abstract Number: 1208P
Session Title: Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Poster Display: Session 3, Poster Area – Hall 4

ESMO has published the official abstracts on its meeting website in advance of the ESMO (Free ESMO Whitepaper) Annual Meeting at 00:05 CEST on Sept. 23rd, 2019. The cut-off date for inclusion of data in the abstract was August 21st, 2019.

About the Phase 2 Basket Trial

IMV’s Phase 2 basket trial is an open label, multi-center study, evaluating DPX-Survivac across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer, non-small cell lung cancer (NSCLC) and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

Subjects will receive DPX-Survivac (SC: 2 x 0.25 mL every three weeks, followed by up to 11 x 0.1 mL every nine weeks), in combination with pembrolizumab (IV: 200 mg every 3 weeks cycle)

and CPA (oral: 50 mg BID on alternating weeks) across the five cohorts. The study is designed to assess primary endpoints of safety and objective response rate (ORR), with multiple secondary and exploratory measures.

The study included a safety lead-in, which included 20 patients from all five cohorts. The five cohorts are now expanded to recruit additional subjects following a Simon two stage design. Enrollment in the ovarian cancer cohort will be randomized 1:1 into two arms with and without CPA. All other cohorts will utilize a single-arm design and administer treatment with the triple combination. IMV expects to enroll 184 patients across clinical sites in the U.S. and Canada.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable T cell activation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

On September 23, 2019 Immune Therapeutics, Inc. (OTC: IMUN) (IMUN) ("Immune" "IMUN" or the "Company"), a clinical late-stage T-Cell Activation biopharmaceutical company focused on the development immunotherapies for the treatment of autoimmune and inflammatory conditions, cancer, HIV/AIDS and animal diseases on a global basis is reported the appointment of Michael K. Handley as the new Chief Executive Officer of Immune Therapeutics’ and Member of the Board of Directors (Press release, Immune Therapeutics, SEP 23, 2019, View Source [SID1234539700]). IMUN also announces the resignation of its former CEO, and Director, Noreen Griffin.

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Mr. Handley maintains an extensive background in the life science sector, dating back over two decades with cross-functional experience in product commercialization, regulatory and clinical affairs, operations, mergers and acquisitions, financing, market development and partnering/licensing. He has founded multiple health industry enterprises and held executive, management and advisory positions in a substantial number of leading public and private pharmaceutical and biotechnology companies. Mr. Handley retains an expansive history in drug development with multiple patents and peer-reviewed publications in the areas of oncology, anti-infectives, inflammation and neuroscience. He has assisted or led in the global commercialization of seventeen products that account for over six billion dollars in sales annually and has secured millions of dollars in private equity and venture capital for numerous high growth organizations.

"We are pleased to welcome Michael Handley, a highly regarded professional in our field, and believe he is a good fit with our development strategy and look forward to benefiting from his extensive experience and perspective. Mr. Handley is a distinguished Pharmaceutical Executive who adds a vast degree of knowledge and experience to Immune Therapeutics as we restructure and move forward with the development and commercialization of our pipeline of immunotherapies."" stated Dr. Roscoe Moore, Jr. DVM, MPH, PhD Former Assist US Surgeon Gen (retired)., Chairman of the Board, Immune Therapeutics. Dr. Moore Jr. added, "On behalf of the Immune Therapeutics Board of Directors, I would also like to thank Ms. Griffin for her contributions during the five years that she has led Immune Therapeutics, Inc."

Mr. Handley is currently the Chief Executive Officer and Chairman at Aletheia Therapeutics Corp. a private biopharmaceutical company focused on the development and commercialization of therapies for the treatment of cancer. Additionally, he holds board positions at Medavate Corp. and Symbios Technologies, Inc. He has held leadership positions at Johnson & Johnson and Amgen, as well as Genentech, where he assisted in the launch of Avastin & Tarceva. Mr. Handley retained numerous roles in an Executive capacity that contribute to his seasoned global expertise in the drug development arena including former Chief Executive Officer and Director at Armis Biopharma, Inc., Vice President of Quality, Clinical and Regulatory Affairs at Vessix Vascular, Inc. (acquired by Boston Scientific), Chief Compliance Officer and Vice President of Global Regulatory Affairs at The Spectranetics Corporation (acquired by Phillips) and Executive Affiliate/Senior Principal for the management-consulting firm Pittiglio Rabin Todd & McGrath (acquired by PricewaterhouseCoopers). In addition to a multitude of other healthcare positions, Mr. Handley graduated from Colorado State University with degrees in Biology and Physiology and minors in chemistry and neuroanatomy. He also attended the executive MBA program at the Graziadio School of Business and Management at Pepperdine University.

"Michael Handley has had a distinguished career as a successful drug developer in the biopharmaceutical industry with expertise in leading clinical strategy, design and management of novel oncology and inflammatory programs, experience that aligns perfectly with our goal to bring our T-Cell Activation therapies to patients in need," said Noreen Griffin, former Chief Executive Officer and Director, Immune Therapeutics. "Mike brings to Immune Therapeutics significant business development and strategy experience, perfectly suited to help us maximize the opportunities we see with our platform. On behalf of the entire team, I want to welcome Michael K. Handley and we look forward to his leadership and contributions."

"I am excited to be joining Immune Therapeutics and leading the effort to develop and commercialize the next generation of immunotherapies" said Mr. Handley. "I believe there is an opportunity to fundamentally change the way we treat cancer and other disease states by using new agents that target the activity of the human immune system."

On September 23, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at the 2019 Cantor Global Healthcare Conference as follows (Press release, Eagle Pharmaceuticals, SEP 23, 2019, View Source [SID1234539699]):

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Date: Wednesday, October 2, 2019
Time: 7:45 a.m. Eastern Daylight Time
Location: Intercontinental New York Barclay Hotel, NYC
Webcast: View Source

The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company’s website at www.eagleus.com, under the Investors + News Section.

On September 23, 2019 Anchiano Therapeutics Ltd. (Nasdaq: ANCN) ("Anchiano" or the "Company"), a pivotal-stage biopharmaceutical company focused on the discovery and development of targeted therapies to treat cancer, reported that Anchiano Therapeutics, Inc., the Company’s U.S. subsidiary, has entered into an exclusive worldwide collaboration and option to license agreement with ADT Pharmaceuticals, LLC ("ADT") to develop novel small-molecule inhibitors of RAS and PDE10/β-catenin (Press release, Anchiano Therapeutics, SEP 23, 2019, View Source [SID1234539698]). This collaboration reflects Anchiano’s ongoing strategy to grow a pipeline beyond its pivotal-stage asset, inodiftagene vixteplasmid, with programs that have the potential to address significant clinical needs, while leveraging Anchiano’s expertise in small-molecule oncology development.

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"We are excited to bring both of these important programs aimed at difficult-to-treat genetically-defined cancers into our portfolio. They complement our pivotal program and Codex trial and underscore our commitment to develop therapies with targeted approaches," said Frank Haluska M.D., Ph.D., President and Chief Executive Officer of Anchiano. "Mutations in RAS are found in approximately one-third of all cancers. Recent exciting advances have been made in treating a subset of these cancers, but the successful development of a RAS-targeted therapy with broad inhibitory activity, irrespective of RAS isoform or mutation, has the potential for great clinical impact. Likewise, APC or β-catenin alterations are found almost uniformly in colorectal cancer and polyposis syndromes, and are observed in other tumor types as well, but effective targeted approaches to these lesions have been lacking. We are enthusiastic about the opportunity to develop PDE10 inhibition to target the Wnt/APC/β-catenin pathway where it is an oncogenic driver."

Michael Boyd M.D., Ph.D., President and Chief Executive Officer of ADT, added, "We are thrilled to partner with Anchiano, a company with a well-respected management team with a track record of success in development of targeted cancer therapies in their prior experience. We have confidence that this team has the knowledge, capability, and commitment to fully develop these two programs, and a shared vision of bringing new therapies to patients in need."

Under the terms of the collaboration and license agreement, Anchiano will be granted an exclusive option to license the RAS and PDE10/β-catenin inhibitors in exchange for a $3 million upfront payment to ADT and will fund certain research activities. At any time through obtaining an Investigational New Drug (IND) designation, Anchiano will have the option to exclusively license the compounds worldwide and will be responsible for all aspects of pre-clinical and clinical development and global commercialization. If Anchiano exercises its option, it will be responsible for development and commercialization and will incur additional payment obligations, including milestone and royalty payments to ADT.

LifeSci Advisors, LLC acted as exclusive transaction advisor to Anchiano.

Dr. Haluska added, "In addition to the news of our option to license agreement, we are also providing an enrollment update on our pivotal Phase 2 Codex trial of inodiftagene vixteplasmid in BCG-unresponsive non-muscle invasive bladder cancer patients. We currently have 31 patients enrolled or in active screening, of which 23 have been dosed. We had previously estimated that enrollment for the 35-patient interim analysis would be complete by the end of September, allowing for the 12-week readout to take place in the fourth quarter of this year. While at this time we are close to that projection, our conservative estimate is that data collection and interim analysis will be completed by the first quarter of 2020."

About the Pan-RAS Program123

Oncogenic mutations in the RAS family of genes (KRAS, HRAS, and NRAS) are present in approximately 30% of cancer. RAS plays a pivotal role in signal transduction pathways leading to tumor cell proliferation and survival. ADT’s program has identified novel small molecules that exhibit potent and selective inhibition of activated RAS signaling regardless of isoform or mutation, or pan-RAS inhibition.

Historically, direct inhibition of RAS has been challenging. However, investigational compounds that selectively target the KRAS G12C mutation recently have shown antitumor activity in the clinic, clinically validating RAS as a therapeutic target. These current investigational drugs are mutation specific—with G12C representing approximately 11% of KRAS mutations in cancer. A broadly active pan-RAS inhibitor with the potential to treat RAS-driven cancers regardless of RAS isoform or mutation would be clinically useful.

The RAS inhibitor program is comprised of a novel series of indene derivatives that potently, selectively and reversibly inhibit growth of tumor cells harboring mutant RAS, while having greater than 100-fold selectivity over cells with normal RAS activity. Inhibitory activity has been observed with low nanomolar potency in KRAS-, HRAS-, and NRAS-driven tumor cell models with a variety of mutations across a variety of tumor types. These compounds inhibit downstream signaling through RAF and PI3K pathways, initiate cell-cycle arrest and induce apoptosis, demonstrated blockade of GTP loading of RAS in the nucleotide-free state in cell-free biochemical assays, and have exhibited in vivo activity in RAS mutant tumor models. They have potential for RAS inhibition in a broad variety of clinical settings.

About the PDE10/β-catenin Program45678

Genetic alterations in components that make up the Wnt signaling pathway, which includes APC (adenomatous polyposis coli) and β-catenin, are prevalent in a number of cancer types, occurring in upwards of 80% of colorectal cancers. Additionally, germline mutations of APC lead to the hereditary cancer syndrome Familial Adenomatous Polyposis (FAP). Wnt signaling controls the level of intracellular activated β-catenin, a key effector of oncogenic signal transduction, and oncogenic alterations in Wnt, APC, or β-catenin all result in elevated and uncontrolled levels of β-catenin. Recent studies have shown that the cyclic nucleotide phosphodiesterase 10A (PDE10) is overexpressed during early stages of tumorigenesis and is essential for tumor cell growth. PDE10 inhibition activates protein kinase G and leads to the degradation of the oncogenic pool of β-catenin to suppress critical proteins essential for tumor cell proliferation and survival. Thus, targeting PDE10 provides a novel approach to selectively suppress β-catenin-mediated transcriptional activity.

ADT’s program has identified small molecules that selectively and potently inhibit PDE10 and suppress Wnt/β-catenin signaling in preclinical models. PDE10 inhibition has been shown to downregulate β-catenin expression, and inhibits polyp and tumor growth. It has potential for application in the treatment of cancer as well as spontaneous and familial polyposis syndromes.

Conference Call and Webcast Information

Company management will discuss the licensing agreement and corporate update on a call scheduled for Tuesday, September 24, 2019 at 8:00 am Eastern Time. To participate in the call, dial 1-877-451-6152 (domestic) or 1-201-389-0879 (international) fifteen minutes before the conference call begins and reference the conference passcode 13694843. The live conference call and replay can be accessed via audio webcast at View Source

On September 17, 2019, AbbVie Inc. ("AbbVie") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with Morgan Stanley & Co. International plc, HSBC Bank plc and Merrill Lynch International, acting for themselves and as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which AbbVie agreed to issue and sell to the Underwriters €1.4 billion aggregate principal amount of its senior notes, consisting of €750 million aggregate principal amount of 0.750% senior notes due 2027 and €650 million aggregate principal amount of 1.250% senior notes due 2031 (collectively, the "Notes") in a registered public offering (Press release, AbbVie, SEP 23, 2019, View Source [SID1234539697]). The offering of the Notes was made pursuant to a Prospectus Supplement, dated September 17, 2019 and filed with the Securities and Exchange Commission (the "SEC") on September 19, 2019 (the "Prospectus Supplement"), and the Prospectus dated September 13, 2018, filed as part of the shelf registration statement (File No. 333-227316) that became effective under the Securities Act of 1933, as amended, when filed with the SEC on September 13, 2018.

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The Underwriting Agreement contains customary representations, warranties and covenants of AbbVie, conditions to closing, indemnification obligations of AbbVie and the Underwriters, and termination and other customary provisions.

AbbVie expects the offering of the Notes to close on September 26, 2019, subject to customary closing conditions. AbbVie intends to use the net proceeds from the offering of the Notes, together with cash on hand, (i) to redeem, satisfy and discharge or repay at maturity all of its 0.375% senior notes due 2019 in an aggregate outstanding principal amount of €1.4 billion, and to pay any premium and accrued interest in respect thereof, and/or (ii) for general corporate purposes.

Please refer to the Prospectus Supplement for additional information regarding the offering of the Notes and the terms and conditions of the Notes. The foregoing summary of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement attached as Exhibit 1.1 hereto.

Certain of the Underwriters and/or their affiliates have in the past performed, and may in the future from time to time perform, investment banking, financial advisory, lending and/or commercial banking services, or other services for AbbVie and its subsidiaries, for which they have received, and may in the future receive, customary compensation and expense reimbursement.

The representations, warranties and covenants of each party set forth in the Underwriting Agreement have been made only for purposes of, and were and are solely for the benefit of the parties to, the Underwriting Agreement, may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures made for the purposes of allocating contractual risk between the parties to the Underwriting Agreement, instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. In addition, certain representations and warranties were made only as of the date of the Underwriting Agreement or such other date as is specified therein. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Underwriting Agreement, which subsequent information may or may not be fully reflected in the parties’ public disclosures. Accordingly, the Underwriting Agreement has been included with this filing only to provide investors with information regarding the terms of this agreement, and not to provide investors with any other factual information regarding the parties, their respective affiliates or their respective businesses. The Underwriting Agreement should not be read alone, but should instead be read in conjunction with the periodic and current reports and statements that AbbVie and/or its subsidiaries file with the SEC.