On June 13, 2019 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management will provide a corporate overview at the JMP Securities Life Sciences Conference at 2:00 p.m. EDT in New York City (Press release, CTI BioPharma, JUN 13, 2019, View Source;p=RssLanding&cat=news&id=2401339 [SID1234537063]).

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Presentation details:

Event:

JMP Securities Life Sciences Conference

Date:

Thursday, Jun. 20

Time:

2:00 p.m. EDT

On June 13, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported that Christopher G. Twitty, Ph.D., Chief Scientific Officer, will present compelling immunological data from multiple clinical trials using the Company’s novel biomarker technology at World Pharma Week (WPW) 2019 taking place June 17-20 in Boston (Press release, OncoSec Medical, JUN 13, 2019, View Source [SID1234537064]).

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Dr. Twitty’s presentation, titled "Reversing Resistance to Definitive Anti-PD-1 Failures with Intratumoral IL-12 and Pembrolizumab Combination Therapy," will focus on approaches to overcome immune resistance mechanisms in cancer, namely reinvigorating T cell exhaustion with DNA-based cytokines, chemokines and T cell engaging antibodies.

Specifically, Dr. Twitty’s presentation will highlight:

Immunological data from OncoSec’s biomarker program taken from the OMS-102, KEYNOTE-695 (metastatic melanoma), and KEYNOTE-890 (metastatic triple negative breast cancer) clinical studies;
Developments associated with OncoSec’s visceral lesion applicator (VLA) and its next-generation plasmids;
Therapeutic rationale for intratumoral delivery of IL-12 for treatment across multiple solid tumor types.
The presentation will be made during the Combinations Strategies and Clinical Trials in Immuno-Oncology track, which is part of Cambridge Healthtech Institute’s Third Annual Clinical Innovation for Combination Immunotherapy meeting. A link to the meeting’s agenda and speaker panel can be found here.

With more than 1,500 senior delegates and 130 exhibitors slated for this year’s conference, WPW attracts renowned experts across the global medical sciences community and is dedicated to all stages of pharmaceutical R&D, from discovery though preclinical development and translational research to clinical biomarkers.

On June 12, 2019 CutisPharma, Inc. reported its acquisition of Silvergate Pharmaceuticals and the unveiling of its new corporate brand for the unified company: Azurity Pharmaceuticals (Press release, Azurity Pharmaceuticals, JUN 12, 2019, View Source [SID1234625386]).

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"I am thrilled to announce the combination of two strong companies with a rich legacy meeting the needs of underserved patients, such as children and the elderly," said Neal I. Muni, MD, MSPH, Azurity Pharmaceuticals’ Chief Executive Officer. "Azurity’s mission, to make safe, high-quality treatments for patients requiring customized formulations for their care, is significantly bolstered by our combined resources and capabilities."

NovaQuest Capital Management, LLC, the majority owner of Azurity Pharmaceuticals, supported CutisPharma and its management team in the transaction. Goldman Sachs Specialty Lending Group continues to support the company as a lender and arranged the debt financing for the transaction.

Azurity’s management team will be comprised of leaders from both the legacy CutisPharma and Silvergate teams. Azurity’s Corporate Headquarters and Manufacturing Facility will be located in the Greater Boston area (Woburn, MAand Wilmington, MA, respectively); its R&D Campus will be located outside Kansas City, MO and the Corporate Satellite Campus will be located outside Denver, CO.

Both companies have achieved several key milestones over the past year, including CutisPharma’s FDA approval and launch of FIRVANQ (vancomycin hydrochloride) for oral solution for the treatment of Clostridium difficile-associated diarrhea in early 2018, and Silvergate’s submission of a New Drug Application (NDA) for its lead pipeline drug, SG-05, to the FDA, currently under review. Together as one company, Azurity will offer its valued customers a comprehensive portfolio across 12 products that serve multiple therapeutic areas.

On June 12, 2019 Alkermes plc (Nasdaq: ALKS) reported the initiation of the monotherapy expansion stage of its ARTISTRY-1 clinical trial to evaluate the efficacy, safety and tolerability of ALKS 4230 in treating patients with renal cell carcinoma or melanoma (Press release, Alkermes, JUN 12, 2019, View Source;p=RssLanding&cat=news&id=2401218 [SID1234537031]). Initiation of this portion of the ongoing study follows the identification of 6 µg/kg/day administered intravenously as the recommended monotherapy dose of ALKS 4230 to evaluate in these select tumor types. The maximum tolerated dose of ALKS 4230 has not yet been reached, and the dose-escalation stage of the ARTISTRY-1 study is continuing. ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.

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"At the 6 µg/kg/day dose, data from the dose-escalation stage of ARTISTRY-1 demonstrated the tolerability profile we set out to achieve for ALKS 4230, along with desired lymphocyte cell expansion without corresponding Treg activation. This validates our design rationale for ALKS 4230, and we now look forward to progressing into the expansion stage to evaluate ALKS 4230 as monotherapy in select tumor types," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We plan to present the first efficacy data from across the ALKS 4230 development program at a medical meeting later this year, pending conference acceptance."

Selection of the recommended phase 2 dose of ALKS 4230 as monotherapy was made following the completion of five dose-escalation cohorts, spanning a dose range of 0.1 µg/kg/day to 6 µg/kg/day, in 36 patients who were refractory to prior administered therapies known to demonstrate clinical benefit. Data from the completed cohorts demonstrated dose-dependent pharmacodynamic effects on circulating natural killer (NK) cells and CD8+ T cells, and minimal and non-dose dependent effects on immunosuppressive regulatory T cells (Tregs). The newly initiated monotherapy expansion stage will assess objective efficacy measures of ALKS 4230 administered intravenously daily for five consecutive days in up to 105 patients refractory to prior administered therapies with renal cell carcinoma or melanoma, two tumor types for which high-dose IL-2 has demonstrated durable anti-tumor responses as a monotherapy treatment.1

Data from the initial four cohorts of the dose-escalation stage of ARTISTRY-1 were presented at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Treatment with ALKS 4230 at 3 µg/kg/day resulted in a dose-dependent increase in circulating NK cells and CD8+ T cells with a near 4-fold and 2-fold expansion, respectively, and minimal, non-dose-dependent change in Tregs. Further effector-cell expansion was observed in cohort 5 at the 6 µg/kg/day dose, with minimal increase in circulating Tregs. No dose-limiting toxicities were observed in cohort 5. Fever and chills were the most common treatment-related adverse events (AEs) for ALKS 4230 across all cohorts, and the safety profile observed with ALKS 4230 was consistent with the known profile of cytokine therapy.

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Program
ARTISTRY is an Alkermes-sponsored clinical program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, the newly initiated monotherapy expansion stage and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors.

ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.

On June 12, 2019 Prelude Therapeutics, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of small molecule drugs that target key drivers of cancer cell growth, survival and resistance, secured $60 million in Series B financing; taking its total investments to date to $95 million (Press release, Prelude Therapeutics, JUN 12, 2019, View Source [SID1234537048]). The financing was co-led by Prelude’s two existing institutional investors, including OrbiMed Advisors LLC.

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Since its launch in July 2016, Prelude has made rapid progress in its first discovery program targeting Protein Arginine Methyltransferase 5 (PRMT5), a member of the arginine methyltransferase family. PRMT5 plays an important role in several cellular processes that drive cancer cell proliferation, cell cycle progression and resistance to apoptosis in hematological malignancies and solid tumors.

Proceeds from the Series B financing will be used to advance Prelude’s proprietary PRMT5 inhibitor, PRT543, through proof of concept clinical studies. PRT543 is in a parallel dose escalation Phase 1 clinical trial for solid tumors, myeloid malignancies and lymphomas.

Series B funding will also be used to advance additional differentiated compounds from the PRMT5 program and strengthen Prelude’s discovery, preclinical and clinical development infrastructure to support a rapidly advancing pipeline beyond PRMT5. Prelude has established several drug discovery programs and compounds from these early-stage programs are also expected to enter preclinical development in the second half of 2019 with a potential IND-filing in 2020.

"We are very appreciative of the continued support of our current investors, who have been integral to the founding of Prelude and the creation of our growing pipeline," said Kris Vaddi, PhD, Founder and CEO of Prelude Therapeutics. "We believe PRMT5 inhibitors represent a promising new class of drugs to treat cancers, including ones that have developed resistance to existing targeted therapies. We are also pleased to have assembled such a talented, experienced and proven leadership team to address some of the most pressing gaps in cancer treatment."

Prelude Management Team

Dr. Vaddi founded Prelude in July 2016 and serves as CEO and a member of the Board of Directors. Prior to Prelude, Dr. Vaddi was a member of the founding team of Incyte Corporation in 2002 and most recently served as a group vice president. He initiated and championed JAK research programs at Incyte that led to the discovery, development and approval of Jakafi (ruxolotinib) for Myelofibrosis and Polycythemia Vera and Olumiant (Baricitinib) for rheumatoid arthritis. Dr. Vaddi received his Doctorate in Veterinary Medicine from APAU in India and his PhD from the University of Florida.

On May 1, 2019, David Mauro, MD, PhD, was named Chief Medical Officer. Dr. Mauro comes to Prelude with strong drug development experience in positions of increasing responsibility at Bristol-Myers Squibb, Merck and most recently Checkmate Pharmaceuticals as its Chief Medical Officer. Dr. Mauro earned his MD and PhD from Temple University School of Medicine.

Beginning July 1, 2019, Brian Piper, MBA will join Prelude as Chief Financial Officer. Mr. Piper most recently served as Chief Financial Officer at Aevi Genomic Medicine, where he was responsible for leadership and management of corporate financing and reporting, corporate fundraising efforts and investor relations. Prior to that, Mr. Piper held roles of increasing responsibility in finance, program and alliance management and investor relations at Shire Pharmaceuticals.