On March 20, 2019 PDC*line Pharma reported that grants exclusive license in South Korea and exclusive option in other Asian countries to LG Chem Life Sciences Company, for the development and commercialization of PDC*lung cancer vaccine for lung cancer (Press release, PDC Line Pharma, MAR 20, 2019, View Source [SID1234554037]).

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The total deal value is 108M€ (123M$) plus significant tiered royalties on net sales in Asia.
Under the terms of the agreements, PDC*line Pharma will co-operate with LG Chem, who will have the full rights in South Korea and an exclusive option for other Asian countries, to develop and commercialize the company’s drug candidate, PDC*lung, in lung cancer. PDC*lung is constituted of a PDC*line loaded with HLA-A2 restricted peptides derived from six shared tumor antigens.
Under the terms of the agreement, PDC*line Pharma will continue developing its PDC*lung candidate in the EU, US and global markets outside of Asia, and LG Chem will be responsible for future development and commercialization in its territories.

On March 20, 2019 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) and Eli Lilly and Company (NYSE: LLY) reported six projects that aim to improve the delivery of gastric and gastroesophageal junction (GEJ) cancer care in the United States (Press release, Eli Lilly, MAR 20, 2019, View Source [SID1234554022]). The quality improvement studies will focus on methods of intervention that can be implemented across a variety of different oncology practice settings. These projects are eligible to receiving funding from Lilly Oncology after completing contract negotiations. Forty-nine letters of intent were submitted in response to the RFP and subsequently 19 full proposals were requested for review.

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"As part of our mission to facilitate care that helps patients live better lives, we’re honored to support research that enhances outcomes and experiences for people with gastric and gastroesophageal junction cancers," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "This project is intended to identify disparities in care between the community and academic setting, and define scalable, shareable solutions that will rapidly improve adherence to guidelines and quality of care."

The following studies were selected by the NCCN ORP:

Dan G. Blazer III, MD; Daniel P. Nussbaum, MD; Linda M. Sutton, MD; Duke University Health System and Duke Cancer Network Affiliates; The DCN Passport: A Novel, Patient-Centered Approach to Improve Care for Gastric/Gastroesophageal Junction Cancer Across an Academic-Community Oncology Network
Efrat Dotan, MD; Fox Chase Cancer Center; Improving the Approach to and Management of the Older Patient with Metastatic Gastric Cancer
Jae Kim, MD; City of Hope National Medical Center; Telehealth Intervention for Self-Management of Dietary Quality of Life After Gastric Cancer Surgery
Veena Shankaran MD, MS; University of Washington/Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center; Randomized Pragmatic Trial of a Proactive Financial Navigation Intervention in Patients with Newly Diagnosed Gastric and Gastroesophageal Junction Adenocarcinoma
Qiuling Shi, PhD; Loretta A. Williams, PhD; The University of Texas MD Anderson Cancer Center; Symptom Management Through an Automated Alert System to Improve Adherence During Systemic Therapy for Patients with Gastric/Gastroesophageal Junction (GEJ) Cancer
Kuang-Yi Wen, PhD; Sidney Kimmel Cancer Center (SKCC) at Jefferson; mChemoCoping – GC: A Text Messaging System Enabling Real-Time Monitoring and Management of Chemotherapy Side Effects Among Patients with Gastric Cancer (GC)
"NCCN ORP congratulates all of the collaborators, and looks forward to their contributions to the future of gastric and GEJ cancer care," said Dr. Koh.

"Lilly is proud to work with the NCCN ORP to research better ways for delivering high-quality cancer care to patients with this aggressive disease," said Maura Dickler, MD, Vice President of Late Phase Development, Lilly Oncology. "By utilizing novel approaches and advancing technology, these studies will help us to address some of the largest disparities in care that exist for patients undergoing treatment for gastric and GEJ cancers."

The NCCN ORP was responsible for the Request-for-Proposals (RFP) process, application review and evaluation. A committee led by NCCN and including a medical representative from Lilly determined which proposals would be eligible to receive funding. Project funding will be provided directly by Lilly upon mutual agreement of project terms and conditions.

The studies will be conducted over a period of two years.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer by supporting investigator-initiated trials at NCCN Member Institutions and their affiliates. To date, it has supported more than 140 studies, with numerous publications in peer-reviewed journals. To learn more about the NCCN ORP and ongoing clinical trials, visit NCCN.org/ORP.

On March 20, 2019 Petra Pharma Corporation ("Petra"), a leader in phosphoinositide (PI) signaling pathway inhibition, reported it has secured a global license from Takeda Pharmaceutical Company Limited ("Takeda") to develop, manufacture and commercialize serabelisib and two additional PI3Kα-specific inhibitors (Press release, Petra Pharma, MAR 20, 2019, View Source [SID1234554009]). The agreement grants Petra a license for all human therapeutic uses, except for a subset of undisclosed rare-disease indications, which Takeda had previously out-licensed.

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Petra plans to initiate a Phase 1b/2 study with serabelisib in late 2019 to advance pioneering research and insights in PI signaling pathways with a focus on PIK3CA-mutated solid tumors. The PI3K signaling pathway is a frequently mutated pathway in human cancer.

"Today marks a transformational moment for Petra and a new era in the therapeutic use of PI3K inhibitors. We are pioneering new approaches that have the potential to increase tumor responses with PI3K inhibitors and minimize side effects, with profound clinical implications for patients diagnosed with a PIK3CA-mutated tumor," said President and CEO, Brian O’Callaghan.

Petra’s leading-edge research builds on the recent work of Scientific Co-Founder, Lewis Cantley, Ph.D. (Weill Cornell Medical Center) and his collaborators, whose paper in the August 2018 issue of Nature* identified strategies to disrupt the glucose/insulin feedback loop with the potential to dramatically improve the anti-tumor response.

"Current treatment modalities have been challenging due to an on-target effect of PI3Kα inhibitors causing hyperglycemia and consequent elevation of serum insulin, which can re-activate PI3K in tumors, allowing them to survive," said Dr. Cantley. "The approach Petra is taking disrupts the glucose/insulin feedback loop, which in preclinical models significantly increases anti-tumor efficacy."

This is the first licensing agreement between Petra and Takeda. Financial terms of the agreement were not disclosed.

* Hopkins BD, Pauli C, Du X, et al. Suppression of insulin feedback enhances the efficacy of PI3K inhibitors. Nature. 2018;560(7719):499-503.

On March 20, 2019 PDC*line Pharma, a biotech company developing a new class of potent and scalable antigen presenting cell, based on a proprietary cell line of Plasmacytoid Dendritic cells (PDC*line), reported that it has signed an exclusive licensing and option agreement with LG Chem Life Sciences Company, the life sciences division of LG Chem Ltd (Press release, PDC Line Pharma, MAR 20, 2019, View Source [SID1234553824]). This agreement, which includes a development and commercialization collaboration agreement, opens new markets to PDC*line Pharma and expands the global footprint of its PDC*line-based cancer vaccine.

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Under the terms of the agreements, PDC*line Pharma will co-operate with LG Chem, who will have the full rights in South Korea and an exclusive option for other Asian countries, to develop and commercialize the company’s drug candidate, PDC*lung, in lung cancer. PDC*lung is constituted of a PDC*line loaded with HLA-A2 restricted peptides derived from six shared tumor antigens.

PDC*line Pharma is eligible for upfront and near-term milestone payments, plus longerterm clinical development and regulatory milestones totaling up to €108M ($123M). The company will also receive royalties based on net sales of the licensed product in LG Chem’s Asian markets.

Under the terms of the agreement, PDC*line Pharma will continue developing its PDC*lung candidate in the EU, US and global markets outside of Asia, and LG Chem will be responsible for future development and commercialization in its territories.

Eric Halioua, president & CEO of PDC*line Pharma, said: "We are very pleased to cooperate with LG Chem and to start the development of our PDC*lung cancer vaccine in Asia. This licensing agreement is a great opportunity for PDC*line Pharma to expand the scope of its immuno-oncology clinical programs and bring our technology to numerous patients around the world. Furthermore, the agreement with LG-Chem Life Sciences Company, a leading pharmaceutical company in Korea, is a major endorsement for our unique PDC*line approach and its potential."

Dr. Jeewoong Son, president of LG-Chem Life Sciences, said: " We are delighted to start this strategic collaboration with PDC*line Pharma, a great partnership to further expand LG Chem’s cell-based cancer immunotherapy portfolio. PDC*line Pharma’s technology is backed by cutting-edge science and we believe we can extend its reach by bringing this novel therapy to a greater number of cancer patients."

On March 20, 2019 Xynomic Pharmaceuticals, Inc. ("Xynomic"), a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corporation (Nasdaq: BCAC), jointly reported that Xynomic and its collaborators will present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2019 Annual Meeting to be held in Chicago from May 31, 2019 – June 4, 2019 (Press release, Xynomic Pharmaceuticals, MAR 20, 2019, View Source [SID1234534943]). The presentation will show Phase 1 data of XP-105 (also known as BI 860585), Xynomic’s Phase 2 ready, ATP-competitive, third generation mTORC1/2 Inhibitor, used alone or in combination with exemestane or paclitaxel in patients with advanced solid tumors. XP-105 is a potent dual inhibitor designed to overcome mTORC1 inhibition resistance. An oral presentation titled "A Dose Escalation Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of mTORC1/2 Inhibitor XP-105 (BI 860585) as Monotherapy and in Combination with Exemestane or Paclitaxel in Patients (pts) with Advanced Solid Tumors" will be presented by Dr. Filippo G. De Braud, a lead investigator at Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. This Phase 1 trial enrolled a total of 90 patients; 41 were in Arm A where XP-105 was used as a monotherapy (the "monotherapy arm"), 25 were in Arm B where XP-105 was used in combination with exemestane (the "exemestane combination arm"), and 24 were in Arm C where XP-105 was used in combination with paclitaxel (the "paclitaxel combination arm"). Combination regimens showed higher activity as compared to monotherapy. In the monotherapy arm, stable disease ("SD") was reported in 8 pts (20%), with a median duration of 11 months. In the exemestane combination arm, 4 (16%) partial responses ("PR") were reported. In the paclitaxel combination arm, 1 complete response ("CR") and 4 PRs were reported (OR rate 21%). Disease control rate (CR/PR/SD) was 20%, 28%, and 58% in the monotherapy, XP-105/exemestane, and XP-105/paclitaxel arms, respectively. In the XP-105/paclitaxel combination the most frequent drug-related adverse events ("AEs") were diarrhea and fatigue (58.3% each), hyperglycaemia (54.2%), and anaemia (50%). Grade ≥3 AEs were hyperglycaemia, fatigue, diarrhea, anaemia, and leukopenia.

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In addition, Xynomic will sponsor an investigator meeting on Friday, March 22, 2019 in Athens, Greece. The investigator meeting will bring together European Union ("EU") physicians, care providers and clinical research coordinators. The participants are from current and prospective clinical trial sites in the potentially pivotal Phase 3 clinical trial of testing Xynomic’s abexinostat, in combination with pazopanib, against renal cell carcinoma. The participants will be presented with trial design, protocol, and study management as a part of the preparation of the trial start and patient recruitment.

Furthermore, Xynomic’s board of directors has appointed Ms. Jinwei Coco Kou as the Interim Chief Accounting Officer. Ms. Kou is responsible for overseeing all accounting functions such as ledger accounts, financial statements, and cost control systems. Before joining Xynomic, Ms. Kou had extensive experience in internal controls, multinational operations and corporate finance of high-tech companies. From 2017-2018, Ms. Kou was the Chief Financial Officer at Salion Food Condiment Company Limited (a company approved for listing by the Hong Kong Stock Exchange). From 2008-2016, she was a Managing Director at Marcum Bernstein & Pinchuk LLP, one of the largest independent public accounting and advisory services firms in the United States, with multinational offices. From 2005-2008, Ms. Kou worked for Deloitte Touche Tohmatsu. Ms. Kou is a CPA in both the United States and China. Ms. Kou holds a Bachelor degree in Economics majoring in Finance, and a Master’s degree in Economics majoring in Risk Management and Insurance, both from Peking University. Ms. Kou holds an Executive MBA degree jointly granted by Columbia Business School, London Business School and Hong Kong University Business School.