On December 5, 2017 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, will present clinical data from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) at a Research and Development reception at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting (Press release, Verastem, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321050 [SID1234522395]). The event will take place on Sunday, December 10, 2017 in Atlanta.

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The event, which follows the oral presentation of the DUO data results at ASH (Free ASH Whitepaper), will feature a slide presentation and moderated panel discussion with recognized experts in the treatment of hematologic malignancies, including CLL/SLL, and a live Q&A session. Speakers will include Ian Flinn, MD, PhD, Sarah Cannon Research Institute, who will present results from the Phase 3 DUO study, and Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center, who will provide an update on duvelisib for the treatment of Peripheral T-Cell Lymphoma (PTCL). In addition, Lori Kunkel, MD, Verastem Clinical and Scientific Advisory Board, and Steven Bloom, Verastem Chief Strategy Officer, will participate in the discussion panel and Q&A session, which will be moderated by Robert Forrester, Verastem President and Chief Executive Officer.

The event will take place during the ASH (Free ASH Whitepaper) 2017 Annual Meeting and is open to analysts and institutional investors. Interested parties can access a live webcast of the event beginning Sunday, December 10, 2017 at 8:15 p.m. ET on the "Presentations" page of the company’s website View Source;p=irol-calendar. A replay of the webcast will be archived on the company’s website for 90 days following the event. For more information or to RSVP, please contact Maeve Conneighton at [email protected].
Duvelisib is Verastem’s first in class oral dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma which is currently being developed for the treatment of CLL/SLL, peripheral T cell lymphoma (PTCL), and other hematologic malignancies.

On December 4, 2017 OncoTracker, Inc., a private medical diagnostics company, reported a license agreement with Juno Therapeutics (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, to advance its program in multiple myeloma using gamma secretase inhibitors (GSIs) in combination with BCMA-directed CAR T cells (Press release, OncoTracker, DEC 4, 2017, View Source [SID1234553990]).

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Through its agreement with OncoTracker, Juno will gain exclusive rights to intellectual property within the field of combinations of GSIs and BCMA-directed engineered T cells.

James R. Berenson, M.D., President and CSO of OncoTracker stated, "In the past 12 months, we have made significant advances in personalizing treatment for multiple myeloma patients utilizing our proprietary sBCMA diagnostic test. Our test has broad ranging applications, including clinical trial monitoring, companion diagnostic testing, and most importantly, clinical practice testing and monitoring. We believe that our simple, proprietary blood test can accurately and rapidly assess benefit of ongoing treatments, can accurately predict both PFS and OS, and can identify patients that require immediate treatment vs. wait and watch categories."

"BCMA appears to be an important target for treating patients with multiple myeloma, and Juno is dedicated to investigating novel approaches to maximize efficacy for these patients. These licenses open up an important approach to improve the activity and outcomes for CAR T cells targeted at BCMA," said Sunil Agarwal, M.D., Juno’s President of Research and Development. "We plan to combine gamma secretase inhibitors with our BCMA CAR T product candidates, initially testing combinations in 2018."

1Pont M. "Gamma secretase inhibition increases recognition of multiple myeloma by BCMA-specific chimeric antigen receptor modified T cells." Presented at Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). November 8-12, 2017. National Harbor, MD.

On December 4, 2017 Kymab’s reported that data at the British Society for Immunology Congress demonstrates efficient identification and validation of human antibodies (Press release, Kymab, DEC 4, 2017, View Source [SID1234537007])

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Three poster presentations at the 2017 British Society for Immunology Congress describe how Kymab’s efficient human antibody platforms were able to identify an anti-PD-L1 antibody, KY1003, and show it was an effective anti-tumour antibody in in vitro and in vivo models.

In Rachael Kimber’s poster, Cell based screening cascade to select anti-human PD-L1 antibodies, the team describe a cell-based, in vitro screening cascade that enabled functional characterisation of anti-human PD-L 1 antibodies.

They identified a panel of potent fully human, antagonistic antibodies that bind human and cynomolgus PD-L1 and enhance T-cell activity, identifying a lead clone, KY1003, that has the characteristics of a clinically relevant PD-L1 antibody.

Lucy Hepburn presents Development and characterization of a human T cell:tumour cell co-culture assay for assessment of immunomodulatory antibodies, which suggests that prolonged co-culture of human T-cells with the A375 tumour cell line, designed to mimic chronic antigen stimulation, generates T-cells that appear ‘exhausted’.

By using these T-cells, the team confirm that Kymab’s anti-PD-L1 antibody, KY1003, can enhance in vitro T-cell killing of A375 cells and inhibit immunosuppressive PD-1/PD-L1 signalling to increase tumour elimination by T cells in vivo.

Morgane Lecointre’s poster, Development of a "tumour-educated" T cell killing assay for predictive in vitro assessment of anti-PD-L1 antibodies, demonstrates how KY1003 can revert T-cell exhaustion in in vitro models using A375 tumour cells.

Importantly, KY1003 shows a strong anti-tumour efficacy in an in vivo human melanoma xenograft model. The approach is biologically relevant in validation of antibodies that target T-cell immune-modulatory molecules.

Notes to Editors
PDF versions of the posters
Cell based screening cascade to select anti-human PD-L1 antibodies (0.5 MB: Kimber et al., Poster P074)
Development and characterization of a human T cell:tumour cell co-culture assay for assessment of immunomodulatory antibodies (0.7 MB: Hepburn et al., Poster P077)
Development of a "tumour-educated" T cell killing assay for predictive in vitro assessment of anti-PD-L1 antibodies (4.3 MB: Lecointre et al., Poster P075)

On December 4, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) ("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 that the Company has made significant recent progress towards full scale Good Manufacturing Process (GMP) manufacture of its lead product, PRP, for First-In-Human studies, expected to commence in 2018 (Press release, Propanc, DEC 4, 2017, View Source [SID1234522367]). Research and development activities conducted with its European Contract Manufacturing Organization (CMO) experienced in the production of biopharmaceuticals, have been successful in developing a process capable of purifying and stabilizing the two active drug substances of the PRP formulation, trypsinogen and chymotrypsinogen, which is an important requirement during the manufacturing process. As a result, the Company is set to commence engineering runs of manufacturing the finished drug product, prior to full scale GMP manufacture of PRP for human trials. PRP is a solution for once-daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen.

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"We are delighted with the excellent progress made with our CMO in progressing PRP to its current stage of development and we are excited about our plans to move into First-In-Human studies next year," said Dr Julian Kenyon, Propanc Biopharma’s Chief Scientific Officer. "Purifying and stabilizing each active drug substance of PRP has been technically challenging. This is due to the nature of the proenzymes which are able to auto-activate themselves, which is not unexpected for biological molecules of this nature. The work conducted by our research and development team to meet this challenge has been first class and we look forward to progressing PRP through to clinical development."

The Company expects to file its first Clinical Trial Application (CTA) for a First-In-Human study in the UK next year, initially treating late stage cancer patients with solid tumors, before progressing into two larger Phase II Proof of Concept studies in both pancreatic and ovarian cancer patients. Preclinical animal studies demonstrating proof of concept, in vivo, as well as the completion of a GLP-compliant, 28-day repeat-dose toxicology study, which helps to confirm the starting dose in humans by identifying the No Observable Adverse Effect Level (NOAEL) in an animal species, has the management team confident it has undertaken the steps necessary to achieve the best possible results in its planned human studies. This is further supported by the FDA granting Orphan Drug Designation of PRP for the treatment of one of its lead indications, pancreatic cancer, with a second application filed for ovarian cancer under evaluation.

"I am pleased with the progress of PRP and look forward to preparing our lead product for First-In-Human studies next year," said Professor Klaus Kutz, Propanc Biopharma’s Chief Medical Officer. "The Company has undertaken significant work to prepare for this important milestone, and believe the product can benefit patients suffering from aggressive solid tumors, which are most often incurable. Extending life meaningfully, but without compromising the quality of life for patients, without the side effects normally associated with standard treatment regimens, remains a high priority. We remain hopeful that PRP can become a breakthrough product for many patients worldwide."

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 an estimated combined market segment of $14 billion in 2020, according to 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 November 29, 2017, Moleculin Biotech, Inc. (the "Company") was informed that the physician-sponsored Investigational New Drug application made by MD Anderson Cancer Center for a Phase I trial of the Company’s licensed drug compound WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma has been allowed by the U.S. Food and Drug Administration (Press release, Moleculin, DEC 4, 2017, View Source [SID1234522355]).

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