On May 16, 2017 CANbridge Life Sciences and Amoy Diagnostics reported that they have entered into a strategic partnership to develop a companion diagnostic assay for CANbridge’s lead candidate, CAN008, a fully human Fc fusion protein (Press release, CANbridge Life Sciences, MAY 16, 2017, View Source [SID1234519169]). Previous clinical work, in a Phase II trial conducted in Europe, demonstrated a significant overall survival benefit for recurrent glioblastoma multiforme (GBM) patients with high expression of the CD95 ligand, or low methylation of CD95L promotor, CpG2. CAN008 is currently in a Phase I/II clinical study in GBM patients in Taiwan. CANbridge plans to initiate a CAN008 Phase II trial in GBM in China in 2018. The patients will be screened for the CAN008 biomarkers to determine trial enrollment eligibility.

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"We are pleased to partner with AmoyDx , a leader in providing highly-reliable and effective diagnostic solutions to clinical practices in China," said James Xue, CANbridge Chairman and CEO. "AmoyDX’s diagnostic CD95 IHC andCpG2 qPCR kits will provide CANbridge with personalized medicine tools in the Phase II trial to deliver optimized treatment to GBM patients as early as possible."

"We are excited that our diagnostic technology will play a key role in the CAN008 clinical development," said Dr. Li-Mou Zheng, Chairman and CEO of AmoyDx. "We believe that the joint effort by CANbridge and AmoyDx could help to realize the therapeutic potential of CAN008 in critically-ill GBM patients in China sooner. AmoyDx has multiple existing strategic partnerships with multi-national corporations providing diagnostic products and services in China and other countries. The CANbridge – AmoyDx collaboration is the first in which both parties are innovative Chinese companies with leadership positions in their respective fields."

About CAN008

CAN-008 is a fully human fusion protein which consists of the extracellular domain of CD95, fused to the Fc region of human IgG that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s previous developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan.

On May 16, 2017 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, reported that the ENCORE 601 non-small cell lung cancer (NSCLC) cohort enrolling patients with disease progression on or after PD-1 therapy (programmed death receptor-1 (PD-1) and/or programmed death ligand 1, (PD-L1)) has met the pre-specified objective response threshold to advance into the second stage of the Phase 2 trial, and will re-open enrollment immediately (Press release, Syndax, MAY 16, 2017, View Source [SID1234519168]).

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ENCORE 601, a Phase 1b/2 clinical trial evaluating the combination of entinostat plus Merck’s anti-PD-1 blocking therapy, KEYTRUDA (pembrolizumab), is enrolling two distinct cohorts of NSCLC patients: 1) patients who had previously progressed on PD-1 or PD-L1 therapy; and 2) patients naïve to PD-1 or PD-L1 therapy. To advance into the definitive stage of the Phase 2 study, at least 2 out of 20 NSCLC patients who had previously progressed on PD-1 or PD-L1 therapy or 3 out of 13 NSCLC patients previously naïve to PD-1 or PD-L1 therapy need to demonstrate an objective response, defined as either a partial response (PR) or complete response (CR), to entinostat – KEYTRUDA treatment.

The cohort of NSCLC patients who had previously progressed on PD-1 or PD-L1 will now re-open and enroll a total of 56 patients. Completion of enrollment is anticipated in the first half of 2018. Later this quarter, the Company anticipates being able to determine whether to expand the cohort of NSCLC patients naïve to PD-1 or PD-L1 therapy.

"PD-1 therapies have offered important clinical benefit to patients with NSCLC, but unfortunately only a subset of patients respond. There is tremendous need for new combinations to further improve responses to PD-1 therapies. The early data here with several objective responses to the entinostat – pembrolizumab combination in patients with NSCLC who previously progressed on PD-1 therapy is promising and certainly worth additional investigation," said Matthew D. Hellmann, M.D., medical oncologist and immunotherapy expert at Memorial Sloan Kettering Cancer Center.

"We are pleased to report that the entinostat – KEYTRUDA treatment combination has generated objective responses in patients whose disease has progressed on or after PD-1 antagonist therapies," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "This data, along with the responses we observed in the melanoma cohort earlier in the year, give us additional confidence in the ability of entinostat to enhance the patient’s response to immunotherapy. We look forward to providing additional details on these patient responses at an appropriate scientific forum."

On May 16, 2017 Propanc Biopharma Inc. (OTCQB: PPCHD) ("Propanc Biopharma" or "the Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported the Company awaits a response from the FDA to an Orphan Drug Designation (ODD) request for the use of its lead product, PRP, a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen (Press release, Propanc, MAY 16, 2017, View Source [SID1234519166]). Submitted in February 2017, the proposed orphan drug indication for PRP is the treatment of pancreatic cancer, one of the most lethal malignancies with a median survival of 6 months and a 5-year survival rate of less than 5%. The lethal nature of this disease stems from its propensity to rapidly disseminate to the lymphatic system and distant organs, and is a major unmet medical issue.

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"We remain committed to providing a first-in-class treatment which can halt the growth and spread of aggressively spreading cancers like pancreatic cancer, but safer compared to standard treatment approaches," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "We will work with the FDA to provide a strong rationale why PRP qualifies for orphan drug designation, which provides exciting potential benefits to fast track the development process and provide attractive benefits for up to seven years when we achieve market approval."

Responsible for 331,000 deaths worldwide in 2012, the aggressive biology and resistance to conventional therapeutic agents leads to a typical clinical presentation of incurable disease at the time of diagnosis. Propanc Biopharma intends to introduce a new therapy which targets and eradicates cancer stem cells, the cells responsible for the aggressive dissemination, resulting in a meaningful life extension for patients.

"Propanc Biopharma is an innovative, entrepreneurial organization dedicated to the development of targeted and safer cancer therapeutics and we look forward to receiving a response from the FDA in the next two months regarding our orphan drug designation request, as we head towards First-In-Human studies for our lead product, PRP," said James Nathanielsz, Propanc’s Chief Executive Officer. "We are also pleased to acknowledge the recent appointment of Dr Scott Gottlieb as the new commissioner at the FDA, who supports and welcomes innovation from industry, whilst continuing to protect the interests of public health. We believe there is an opportunity to set a new agenda for healthcare reform at the FDA, which could help drive change worldwide for future generations."

Under the Orphan Drug Act (ODA), drugs, vaccines, and diagnostic agents qualify for orphan status if they are intended to treat a disease affecting less than 200,000 American citizens. Under the ODA, orphan drug sponsors qualify for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance and may get clinical trial tax incentives.

The rationale for developing PRP, a formulation combining pancreatic proenzymes trypsinogen and chymotrypsinogen for intravenous administration for the proposed indication pancreatic cancer, is based on a set of in-vitro studies on cancer stem cells generated from pancreatic cancer cell lines as well as xenograft and syngeneic mouse models of pancreatic cancer. In summary, these data indicate that the dramatic reduction of cellular markers associated with the process of epithelial-mesenchymal transition (EMT) as a consequence of PRP treatment, could not only reverse the EMT process with the implication to stop tumor progression and metastasis, but also seem to suppress the development of cancer stem cells (CSCs). Consequently, these results are strong indicators of the therapeutic potential of PRP that could be categorized as an anti-CSC therapeutic drug.

Recent development progress for PRP includes successful completion of a GLP-compliant, 28-day repeat-dose toxicity study with no toxicological findings after administration, indicating a broad safety margin and providing sufficient data to support a safe starting dose in First-In-Human studies. The Company has also commenced development of the GMP-compliant investigational medicinal product (IMP) manufacture of PRP to support preparation of a planned clinical trial application in the UK.

Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.

On May 16, 2017 Privately held Synlogic, Inc., reported it has entered into a definitive merger agreement with Mirna Therapeutics, Inc. (NASDAQ:MIRN) under which Synlogic will merge with a wholly owned subsidiary of Mirna in an all-stock transaction (Press release, Mirna Therapeutics, MAY 16, 2017, View Source [SID1234519165]). The merged company will continue under the Synlogic name and will focus on advancing Synlogic’s drug discovery and development platform for Synthetic Biotic medicines, which are designed using synthetic biology to genetically reprogram beneficial microbes to treat metabolic and inflammatory diseases and cancer. Synlogic also recently closed a $42 million Series C preferred stock financing from leading biotechnology investors, including Aju IB Investment, Ally Bridge Group, Arctic Aurora LifeScience, CLI Ventures, Perceptive Advisors, Rock Springs Capital, and other undisclosed new investors. Existing investors, Atlas Venture, Deerfield, New Enterprise Associates (NEA), and OrbiMed also participated in the financing.

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"We believe that our Synthetic Biotic medicines are efficient and targeted biologic engines with the potential to have a transformative impact on the treatment of human diseases. While many conventional medicines address one molecular dysfunction, these living medicines have the potential to uniquely and effectively compensate for entire processes or pathways to treat patients with significant unmet medical need," said Jose Carlos Gutierrez-Ramos, Ph.D., Chief Executive Officer of Synlogic. "This merger and our recently completed Series C financing are projected to provide the capital to progress our two lead metabolic disease programs through patient proof-of-concept studies as well as advance the development of our earlier product candidates."

By mid-2017, Synlogic plans to initiate a Phase 1 healthy volunteers study for its lead candidate, SYNB1020, which is for the potential treatment of Urea Cycle Disorders (UCD) and hepatic encephalopathy (HE), both diseases where patients experience elevated ammonia levels. Following success in the first study, the company plans to open two parallel studies in symptomatic patients with UCD and HE. The company’s second development candidate SYNB1618 will be studied in Phenylketonuria (PKU), which is caused by defective metabolism of the amino acid phenylalanine.

"Following a thorough review of strategic alternatives, we are delighted to announce this transaction with Synlogic, which we believe is in the best interest of Mirna’s stockholders," said Paul Lammers, M.D., M.Sc., President and Chief Executive Officer of Mirna. "Synlogic is advancing an exciting potential new class of medicines supported by a strong drug discovery and development platform, an experienced management team and a strong set of investors."

About the Transaction:

Following the merger, current Synlogic shareholders are expected to own approximately 83 percent of the combined company and the current Mirna stockholders will own approximately 17 percent of the combined company. The exchange ratio is based on Mirna’s expected cash at the time of the close, and the actual allocation will be subject to adjustment based on Mirna’s net cash balance at closing.

The transaction has been approved by the board of directors of both companies. The merger is currently expected to close in the third quarter of 2017, subject to the approval of the stockholders of each company and the satisfaction or waiver of other customary conditions.

Wedbush PacGrow acted as exclusive strategic advisor to Mirna for the reverse merger transaction and Latham & Watkins LLP served as legal counsel to Mirna. Leerink Partners LLC acted as exclusive financial advisor to Synlogic for the reverse merger and as exclusive placement agent for the Series C financing, and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to Synlogic.

Management and Organization:

Following the merger, Jose Carlos Gutierrez-Ramos, Ph.D., Synlogic’s Chief Executive Officer will become the chief executive officer of the merged company. The board of directors will be comprised of seven directors, including two directors currently serving on Mirna’s board. Upon closing of the transaction, the merged company will operate under the Synlogic name and the company’s common stock will trade on the NASDAQ global market under a ticker symbol to be announced at a later date. The corporate headquarters will be located in Cambridge, Massachusetts.

Conference Call and Webcast:

The companies will host a conference call to discuss the proposed transaction as well as Synlogic’s platform and pipeline assets on May 16, 2017 at 8:30 AM ET. The live webcast can be accessed on the Events & Presentations page of Mirna’s website or by dialing +1-844-815-2882 (U.S.) or + 1-213-660-0926 using the conference ID number 24465241. The conference call will be archived on both the Mirna and Synlogic websites for at least 30 days.

About Synthetic Biotic Medicines:

Synlogic’s innovative new class of Synthetic Biotic medicines leverages the tools and principles of synthetic biology to genetically reengineer beneficial, probiotic microbes to perform critical functions missing or damaged due to disease. The company’s two lead programs target a group of rare metabolic diseases – inborn errors of metabolism (IEM). Patients with these diseases are born with a faulty gene, inhibiting the body’s ability to breakdown commonly occurring by-products of digestion that then accumulate to toxic levels and cause serious health consequences. When delivered orally, these medicines can act from the gut to compensate for the dysfunctional metabolic pathway and have a systemic effect. Synthetic Biotic medicines are designed to clear toxic metabolites associated with specific metabolic diseases and promise to significantly improve the quality of life for affected patients.

On May 16, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has initiated the first site for its MAGE‑A4 SPEAR T-cell study in patients with multiple malignant solid tumors. This study is now open for enrollment (Press release, Adaptimmune, MAY 16, 2017, View Source [SID1234519148]).

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This is Adaptimmune’s third wholly-owned therapeutic candidate to enter clinical trials. The Company already has ongoing studies to evaluate its T-cell therapies targeting the MAGE-A10 cancer antigen in patients with non-small cell lung cancer, urothelial cancer, melanoma, or head and neck cancers; and AFP in patients with hepatocellular carcinoma.

"We are excited to initiate this study to evaluate our MAGE-A4 T-cell therapeutic candidate in patients with multiple malignant solid tumors," said Rafael Amado, Adaptimmune’s Chief Medical Officer. "Preclinical evaluations of our MAGE-A4 affinity matured T-cell receptor show optimized targeting of, and specificity for, MAGE-A4 expressing cancer cells. MAGE-A4 is among the most commonly expressed cancer embryonic antigens; therefore, we have the opportunity to evaluate the potential of this promising therapy in a wide range of cancers."

This is a Phase I, open label, dose escalation study designed to evaluate the safety and anti-tumor activity of Adaptimmune’s MAGE-A4 therapeutic candidate in patients who are HLA-A*02 positive and have inoperable locally advanced or metastatic melanoma, urothelial, head and neck, ovarian, non-small cell lung, esophageal, and gastric cancers expressing MAGE-A4. The study will enroll up to 32 patients. The primary objective of the study is to evaluate the safety and tolerability of MAGE-A4 SPEAR T-cell therapy. Additional objectives include anti‑tumor activity, persistence of genetically modified cells in the body, and evaluation of the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion.

Additional information about this study is available at www.clinicaltrials.gov by searching on NCT03132922.