On December 18, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), reported a company developing novel cancer immunotherapies, reported the publication of new research in the journal Immunity that finds that IL-12 producing dendritic cells play an essential role in enabling tumor responses to anti-PD-1 immunotherapy (Press release, OncoSec Medical, DEC 18, 2018, View Source [SID1234532123]). The study was conducted by researchers from Massachusetts General Hospital, Harvard Medical School, Dana-Farber Cancer Institute, and OncoSec, among others. As noted in the study, OncoSec’s lead compound, TAVO (tavokinogene telseplasmid; plasmid plasmid IL-12), which delivers IL-12 directly into tumors, was found to play in important role in enhancing the expression of cytolytic genes within tumors that are associated with anti-tumor responses. The paper, titled "Successful Anti-PD-1 Cancer Immunotherapy Requires T Cell-Dendritic Cell Crosstalk Involving the Cytokines IFN-γ and IL-12" appears in the December 18, 2018 issue of Immunity.

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"The evidence continues to build that IL-12 plays an important role in eliciting anti-tumor responses with anti-PD-1 immunotherapies. We’ve seen this in our own pre-clinical data and in our clinical programs to date," said Christopher G. Twitty, Ph.D., Chief Scientific Officer of OncoSec. "This study elegantly demonstrated that a critical subset of IL-12-producing dendritic cells in concert with IFN-g+ T cells are necessary for an effective anti-PD-1 therapy. Additionally, it was reported that intratumoral delivery of IL-12 with our TAVO system dramatically enhanced the tumor’s immunogenicity as well as cytolytic signature, further supporting this important mechanism of action."

The study explored the transcriptional effects of TAVO monotherapy in melanoma patients and found that IL-12 activates a cytolytic gene signature in tumor-infiltrating lymphocyte (TIL). Furthermore, this TAVO-related anti-tumor immune signature was more pronounced in patients with better clinical responses compared to those patients with progressive disease. This publication continues to elucidate the power of IL-12 to activate CD8+ TIL in patient’s tumor.

On December 18, 2018 Celgene Corporation (NASDAQ:CELG) reported that it will present a business update and provide 2019 financial guidance at the 37th Annual J.P. Morgan Healthcare Conference on January 7, 2019 at 7:30 a.m. PT/ 10:30 a.m. ET (Press release, Celgene, DEC 18, 2018, View Source [SID1234532124]). The presentation and breakout session can be accessed live by webcast and will be made available in the Investor Relations section of the Company’s website at www.celgene.com.

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On December 18, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, reported it has earned an $8 million milestone payment from GlaxoSmithKline (GSK) (Press release, Epizyme, DEC 18, 2018, View Source [SID1234532125]). The milestone payment follows GSK’s initiation of patient dosing in a Phase 1 clinical trial of GSK3368715, a first-in-class protein arginine methyltransferase1 (PRMT1) inhibitor discovered by Epizyme and licensed to GSK. PRMT1 has been implicated in a number of human cancers.

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"We are very pleased to see the progress that GSK has made with its PRMT1 inhibitor program, which marks the second program under our collaboration agreement to enter the clinic," said Robert Bazemore, president and chief executive officer of Epizyme. "This milestone reinforces the promising role that epigenetic medicines may play in treating a variety of diseases, and our leadership in the discovery of novel epigenetic targets. It also validates our strategic business model of establishing collaborations that allow us to focus our internal resources on our lead programs, while facilitating the advancement of novel treatments for people with cancer. We look forward to GSK’s continued progress with this clinical program."

This Phase 1 study by GSK will assess the safety, pharmacokinetics, pharmacodynamics and preliminary clinical activity of GSK33368715 in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL) and selected solid tumors with frequent methyl-thioadenosine phosphorylase (MTAP)-deficiency.

About the Epizyme-GSK Collaboration
Under the terms of its collaboration and license agreement with GSK, Epizyme granted GSK exclusive worldwide license rights to methyltransferase inhibitors directed to three targets. Using its proprietary drug discovery platform, Epizyme discovered and optimized compounds targeting three methyltransferases. During the research term of the collaboration, which has been completed, Epizyme was primarily responsible for preclinical research on such compounds. GSK is responsible for subsequent research, development and commercialization of each program. Epizyme has earned an aggregate of $89 million in up-front, research and milestone payments to date, and may receive up to an additional $375 million from GSK if all remaining milestones are met. Epizyme is eligible to receive up to double-digit royalties on worldwide net sales of collaboration products

On December 18, 2018 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc"), a clinical stage biopharmaceutical company focused on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that Propanc has selected LaVoieHealthScience ("LHS") as its communications agency of record (Press release, Propanc, DEC 18, 2018, View Source [SID1234532126]). LHS is an integrated investor and public relations agency focused on advancing health and science innovations. Propanc is partnering with LHS to develop corporate awareness of Propanc as a health science innovator as it transitions its lead technology into human clinical trials.

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Propanc is developing new cancer treatments targeting high-risk patients, particularly cancer survivors, who need a follow-up, non-toxic, long-term therapy designed to prevent cancer from returning and spreading. Its lead product, PRP, is an enhanced proenzyme formulation designed to enhance the anti-cancer effects of multiple enzymes acting synergistically. The company’s initial target patient populations include pancreatic, ovarian and colorectal cancers. Propanc’s treatment for pancreatic cancer received Orphan Drug Designation by the U.S. Food and Drug Administration in 2017. For more information on PRP’s Mechanism of Action, view this video at: View Source

"As we move closer to the clinical trials stage, it’s critically important to build the right reputation amongst key stakeholders. LHS, with its proven track record in providing integrated communications to global health science innovators, will be a great long-term partner as we continue to drive PRP forward with our drug discovery efforts," said James Nathanielsz, CEO and Executive Chairman of Propanc. "LHS stood out with its deep understanding of our value proposition across targeted channels and audiences, its team of high-touch senior communicators, and proprietary approach to creating targeted messaging mapped to stakeholders as the underpinning of a strategic communications program. We are looking forward to a long and productive relationship."

Donna L. LaVoie, President & CEO of LHS commented, "We are delighted to be working with the Propanc Biopharma team to bring attention to their pioneering work targeting cancer stem cells. We look forward to supporting Propanc Biopharma as it brings novel therapies into the clinical trials stage to provide new hope for patients suffering from metastatic cancer."

On December 17, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patients have been enrolled in two global Phase 3 clinical trials of its investigational anti-PD-1 antibody, tislelizumab (Press release, BeiGene, DEC 17, 2018, View Source;p=irol-newsArticle&ID=2380809 [SID1234532091]). These trials are evaluating tislelizumab combined with chemotherapy as potential first-line treatments in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, and in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

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"Available data have shown promise for anti-PD-1 antibodies in patients with advanced gastric or gastroesophageal adenocarcinoma and in patients with advanced esophageal carcinoma. We are looking forward to investigating tislelizumab globally in these Phase 3 trials," said Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. "Gastric and esophageal cancers are among the most common malignancies in Asia and collectively are responsible for over 800,000 deaths annually in China1 alone. We are hopeful that these global studies of tislelizumab may ultimately lead to improved treatment options for patients diagnosed with these malignancies."

Global Phase 3 Trial in Advanced Gastric or Gastroesophageal Adenocarcinoma

The global, randomized, double-blind, placebo-controlled Phase 3 trial is designed to enroll 720 patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Patients will either receive 200 mg of tislelizumab or placebo combined with platinum- and fluoropyrimidine-based chemotherapy, the standard chemotherapy treatment, intravenously once every three weeks.

The co-primary endpoints will be progression-free survival (PFS) and overall survival (OS). Secondary endpoints include overall response rate (ORR), duration of response (DOR) and quality of life (QoL), as well as safety and tolerability.

Global Phase 3 Trial in Advanced ESCC

The global, randomized, double-blind, placebo-controlled Phase 3 trial is designed to enroll 480 patients with unresectable, locally advanced recurrent, or metastatic ESCC. Patients will either receive 200 mg of tislelizumab or placebo combined with platinum- and fluoropyrimidine-based chemotherapy, intravenously once every three weeks.

The co-primary endpoints will be PFS and OS. Secondary endpoints include ORR, DOR, and QoL, as well as safety and tolerability.

For more information about these trials, patients and physicians should email BeiGene at [email protected].

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Discovered by BeiGene scientists, tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. The new drug application (NDA) for tislelizumab in China for patients with R/R cHL has been accepted by the China National Medical Products Administration (NMPA, formerly known as CFDA) and granted priority review status. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumors in the United States, Europe, Japan, and the rest of world outside Asia.